Risk Prevention in Ophthalmology

Risk Prevention in Ophthalmology

Marvin F. Kraushar, MD Editor

Risk Prevention in Ophthalmology

Marvin F. Kraushar, MD Clinical Professor of Ophthalmology University of Medicine and Dentistry of New Jersey Newark, NJ and Clinical Associate Professor of Ophthalmology The Mount Sinai School of Medicine New York, NY USA

ISBN: 978-0-387-73340-1

e-ISBN: 978-0-387-73341-8

DOI: 10.1007/978-0-387-73341-8 Library of Congress Control Number: 2007932967 © 2008 Springer Science+Business Media, LLC All rights reserved. This work may not be translated or copied in whole or in part without the written permission of the publisher (Springer Science+Business Media, LLC, 233 Spring Street, New York, NY 10013, USA), except for brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed is forbidden. The use in this publication of trade names, trademarks, service marks, and similar terms, even if they are not identified as such, is not to be taken as an expression of opinion as to whether or not they are subject to proprietary rights. While the advice and information in this book are believed to be true and accurate at the date of going to press, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper. 9 8 7 6 5 4 3 2 1 springer.com

Preface

Just as patients do not come to a medical office with the intention of suing the physician, physicians have no intention of harming their patients. The extensive training physicians undertake and the nature of the services they provide make them dedicated to doing their best for the well being of their patients. Medical training itself inculcates physicians with the philosophy of not making mistakes. The criterion for establishing medical malpractice is negligence on the part of the physician that is the proximate cause of an injury suffered by the patient. The definition of negligence refers to “an unintentional act or failure to act.” If a physician acts in a negligent manner regardless of whether he or she causes harm to a patient, it is an unintentional error. Allegations of negligence are thus not simply a legal challenge for physicians but are also a professional and psychological affront. It is very unsettling for the physician who acts with the best of intentions to face the allegation that his or her care was negligent. For physicians, who are trained to search for the truth, the process of litigation is antithetical to their manner of reasoning. The adversarial system of the law is not necessarily a search for the truth but rather the selective presentation of only that evidence that is favorable to the plaintiff or to the defendant. Physicians are usually uncomfortable and unfamiliar with this process in much the same way as are patients in a medical office or in the operating room. The natural desire of the physician is to devote his or her time and effort to the practice of good medicine and to spend as little time as possible considering the possibility of litigation. As a result, most physicians know relatively little about medical malpractice litigation, and unfortunately many view this lack of knowledge as a badge of honor. For these physicians, contemplation of litigation is an unnecessary burden on the practice of medicine, and many regard with disdain those physicians who participate in malpractice litigation as defense or plaintiff experts. The average physician discounts the importance of modeling the practice of medicine in order to minimize the risk of litigation and also to maximize the opportunities for successfully defending lawsuits. Failure to implement these modalities can increase the tendency for a patient to sue and/or compromise the defense of a lawsuit.1 Paradoxically, many of these suggested practice patterns are identical to the advice of practice management consultants whose job it is to grow practices and to whom physicians listen attentively.

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The frequency and severity of claims against physicians have multiplied many times during the past few decades. This has been referred to as a “malpractice crisis,” a misnomer implying that malpractice is the problem. There is, however, no demonstrable actual increase in malpractice. There has been a significant change in the physician–patient relationship. Advances in medicine have proved to be a double-edged sword. Although they have greatly improved the quality of medicine, the advances have also increased patient expectations. Unfortunately, many patients not only want to be cured but they also expect to be cured, and anything less than a complete cure will be unsatisfactory.2 During the course of physician–patient encounters there is something the physician does or fails to do that leads the patient to consider a lawsuit. Thus, in many instances, the problem is not necessarily the litigious patient but rather the lawsuit-causing physician. As an in-house reviewer for medical malpractice insurance companies and as an expert witness, I have reviewed over 900 medical malpractice claims for the purposes of collecting data for publications. This experience has revealed specific recurrent patterns of physician behavior and patient management that encourage litigation and others that discourage it. Fear of the unknown can be unpleasant for both the patients contemplating their prognosis and the physicians involved in medical malpractice litigation. It is the purpose of this book to provide sufficient enlightenment about medical malpractice litigation to allay the anxieties of physicians regarding lawsuits, thus maximizing their performance and enjoyment of the practice of medicine. This book presents, in a clinical, nondidactic manner, the basic elements of the law regarding medical malpractice litigation as they apply to the practice of medicine in order that the physician can understand that which is required for more effective risk prevention. The presentation is unique in that material is presented almost exclusively by physicians and from the physician’s point of view rather than by attorneys as a treatise on the law in order that it can be more easily incorporated into the routine practice of medicine. The concept of informed consent is presented from the physician’s point of view in order to stress that it can be a powerful risk prevention measure instead of merely a legal encumbrance. Discussion of the sequence of events in a medical malpractice lawsuit is presented by a physician rather than by an attorney in order to be more physician friendly. It is designed to help the physician navigate the journey more easily by means of simplification of the facts and with suggestions that have stood the test of time The chapters by the defense’s and plaintiff’s attorneys and the judge are designed to avoid legal terminology wherever possible and will familiarize the physician with “secrets of the trade” and how best to manage the litigation process, discovery, trial testimony, and especially cross examination. The chapter on expert witnesses is important for those who may act as an expert and even more important for anyone who is a defendant in order to understand the preeminent role an expert plays on behalf of a plaintiff or a defendant. The chapters on the ophthalmic subspecialties and related fields are intended to cover those problems that most commonly lead to litigation and the means by which to maximize risk management. Being sued for malpractice is a significant psychological trauma for any physician no matter the circumstance or the outcome. It will definitely alter the

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physician’s self-image and the way he or she regards patients and enjoys the practice of medicine. Following any lawsuit, even if it is dropped without payment or successfully defended, it will be difficult thereafter not to view patients as potential adversaries. To this end a chapter has been included to assist physicians in coping with the psychological effects of litigation. Furthermore, because most physicians are not trained businessmen, a chapter is devoted to simplifying the evaluation and selection of medical malpractice insurance policies and companies, which can be a daunting process to the uninformed physician. Duplication of effort in discussing some subjects has been minimized wherever possible, but it is difficult to avoid completely because of the multiplicity of authors and the overlap of some subjects. Therefore, some topics (i.e., informed consent) are appropriately discussed in more than one chapter. The current system of malpractice litigation is at best inadequate, inefficient, unfair, and wasteful. “Canadian physicians are only one-fifth as likely to be sued as are American doctors.”3 Does this mean that American doctors are only 20% as caring or competent as their Canadian counterparts? Too many frivolous claims are initiated in the United States. “Eighty-three percent of the 2,827 claims closed in the United States in 2005 resulted in no payments.”4 These nonmeritorious claims cost the physicians’ insurance companies money to defend whether they were eventually dropped by the plaintiff or successfully defended in court by the physician, and it is the physician who must unfairly bear this financial burden, which would seem more appropriately placed on the plaintiff. On occasion, a nonmeritorious claim may need to be settled because the medical details are too complicated for a jury to comprehend. “The use of malpractice awards for social justice is frequently prominent in the thinking of juries. This is a most inefficient method of accomplishing … redistribution of wealth. Much of this wealth is redistributed to the legal profession.”5 Only a fraction of the money awarded in meritorious claims goes to patients. Although the number of medical liability lawsuits is stabilizing the severity of claims and the cost of defending them continues to rise (17% in 2005).4 The trial bar avers that the jury is the best and most impartial judge of evidence. If juries are in fact the most impartial “triers of fact,” why do attorneys “venue shop” for locations with jury pools that are notoriously more favorable to one side or the other? Does the fact that malpractice insurance premiums in those venues that are currently hotbeds of litigation, such as South Florida, West Virginia, parts of Texas, and three counties in Illinois,6 can be over 26 times more expensive than premiums in other less litigious parts of the country mean that those local physicians are less competent? General surgeons in Dade County, Florida, paid an average of $299,420 for malpractice insurance in 2006, while the average premium in Minnesota was $11,306.7 “Furthermore, in litigated cases, it is the severity of the patient’s disability, not the occurrence of an adverse event due to negligence, which best predicts the payment of claims to plaintiffs.”8 Government and private insurers are presently considering “pay for performance” incentive systems in which the quality of care by physicians is evaluated through physician clinical performance assessment (PCPA). “There is concern that PCPA may increase litigation risks if plaintiff attorneys are able to use the data as evidence to bolster malpractice claims.”9

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“According to a new nationwide survey, six in ten doctors have considered leaving medicine because they are discouraged by the health care system. The medical liability environment is one of the top six reasons.”10 The outcome options for a physician defendant in medical malpractice litigation are uniformly poor. In today’s hyperlitigious environment, insurance companies tend to add every lawsuit to the physician’s claim total and increase the premium for coverage accordingly. This is usually the case not only in the event of a jury verdict for the plaintiff but even if the claim is voluntarily dropped, dismissed by the court, or after a defense verdict, because in each instance the insurance company incurs expenses. The net result is, therefore, if the physician is sued he or she loses regardless of the outcome. It is truly a no-win situation. Attorneys often file “shotgun” lawsuits aimed at every physician who provided any services to a patient. This is to protect the attorney as well as the patient. If an attorney fails to name the appropriate physician prior to expiration of the statute of limitations, that physician can theoretically never be sued for the malpractice. This puts the attorney at risk for a malpractice lawsuit by the patient. If one or more physician defendants are later dropped from the suit, the claim will still be added to their lawsuit total by the insurance company, thus affecting their premium. Thus the physician has literally paid the price of protecting the attorney. Another bias of legislation that is prejudiced against physicians is the statute of limitations for filing a medical malpractice lawsuit on behalf of a minor. In many states the statute runs until the child’s twenty-first birthday and even a year or two beyond. For example, in the 1960s, the only ophthalmologist practicing in a suburban city volunteered to evaluate the retinas of premature newborns before discharge from the hospital. The service was essentially pro bono, because at that time it was not the rule for newborns to be covered by medical insurance. In 1981, the ophthalmologist was sued by the parents of a child he had seen 20 years earlier and who was blind from retrolental fibroplasia (as it was called at the time). The limits of the ophthalmologist’s malpractice insurance policy in 1961, the year he saw the patient, were the typical $10,000/20,000 that practically every physician had at that time. The 1981 lawsuit was for $3 million, and the ophthalmologist, aged 62 years and near retirement, was concerned about depleting his financial resources. Two years later the lawsuit was dismissed by the court. Unfortunately, the physician had already lost 30 pounds and practically all of his hair. Jury awards have escalated at an alarming rate in recent years. It is not difficult to imagine an award for retinopathy of prematurity 20 years from now to be in the range of $30 million, thus threatening the retirement funds of today’s ophthalmologists, who are typically covered by $2–$5 million. This threat explains why so many vitreoretinal specialists are presently unwilling to see premature infants. In 2007, the President of the American Medical Association wrote11: Medical liability is one area in which we seem to make little progress as long as we “soldier on” and live with the terror of the tort system. There is no question that as long as we continue to allow ourselves to be subjected to the inequities of this system, we will never see meaningful change. It is clearly time that we face this undeniable fact. The day will most certainly come when we must say ENOUGH.

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The questions are when do we say it, and in what manner do we express this sentiment? The unfortunate situation is presently that among any 100 physicians in a room there will be 200 opinions. Until and unless we are willing to act as one, we have no choice but to suffer and endure. In the current political setting any chance physicians have for favorable, meaningful reform of the tort system in the near or intermediate term is remote at best. Although political activism for tort reform presents hope for the future, under the present circumstances it is essential that physicians recognize the inequities and limitations of the system and learn how best to deal with them. The optimal solution is effective risk prevention, enabling the physician to stay out of court and avoid putting his or her fate in the hands of any jury. To this end I offer the following chapters. Marvin F. Kraushar, MD

References 1. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little, Brown; 1977:xiii. 2. Kraushar MF. Practical and philosophical considerations of the physician-patient relationship. Ann Ophthalmol 1987;19:83–84. 3. Professional issues: quickview. JAMA, September 11, 2006, p.13. 4. Reports assess liability situation. In brief. Am Med News, December 25, 2006. 5. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL: Aesculapius; 1984:7. 6. Rose JR. Is your state a haven for “litigation tourists”? Med Econ 2006;Feb:10. 7. Sorrel AL. Liability insurance rates mostly hold steady or drop this year. Am Med News, December 11, 2006:1–2. 8. Spicer J. Professional liability insurance II. The legal environment. NJ Med (Suppl) 2002; 99:23–28. 9. Kesselheim AS, Ferris TG, Studdert DM. Will physician-level measures of clinical performance be used in medical malpractice litigation? JAMA 2006;295:1831–1834. 10. Adams D. Doctor morale shaky as practice stressors surge. Am Med News, January 15, 2007:1–2. 11. Plested WG III. Starting the new year with our priorities set realistically. Am Med News, January 22, 2007:20–21.

Contents

Preface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Contributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Part 1

General Considerations

Chapter 1

Basic Medical Malpractice Terminology . . . . . . . . . . . . . . . . Marvin F. Kraushar

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Chapter 2

The Defense Attorney . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E. Burke Giblin

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Chapter 3 The Plaintiff’s Attorney . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lee S. Goldsmith

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Chapter 4 The Trial Judge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . David S. Cramp

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Chapter 5 The Medical Expert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Edward L. Raab

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Chapter 6 Sequence of Events in a Medical Malpractice Lawsuit. . . . . Marvin F. Kraushar

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Chapter 7 Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Marvin F. Kraushar

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Chapter 8 The Five Most Effective Risk Prevention Strategies . . . . . . . Marvin F. Kraushar

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Chapter 9 Revelation of Adverse Events and the Conundrum of an Apology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Peter H. Morse and Marvin F. Kraushar

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Contents

Part 2 Risk Management in the Ophthalmic Subspecialties and Related Fields Chapter 10 Anesthesia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Peter H. Morse and Marvin F. Kraushar

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Chapter 11 Cataract Surgery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Stephen A. Kamenetzky

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Chapter 12 Cornea: External Disease and Contact Lenses . . . . . . . . . . Peter R. Laibson

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Chapter 13 Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Simon K. Law

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Chapter 14 Emergencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Peter H. Morse

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Chapter 15 Glaucoma . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Robert F. Sanke and Paul P. Lee

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Chapter 16 Neuroophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Andrew G. Lee

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Chapter 17 Oncology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Devron H. Char

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Chapter 18 Ophthalmic Plastic Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . Tanuj Nakra and Norman Shorr

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Chapter 19 Pediatric Ophthalmology . . . . . . . . . . . . . . . . . . . . . . . . . . . . Edward L. Raab

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Chapter 20 Refractive Corneal Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . James J. Salz and Anne M. Menke

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Chapter 21 Retina and Vitreous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Marvin F. Kraushar and Peter H. Morse

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Chapter 22 Uveitis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C. Stephen Foster

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Part 3

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Personal and Business Considerations

Chapter 23 Physician and Defendant: Living and Coping with a Double Life . . . . . . . . . . . . . . . . . . . . . . . . . . . Sara Charles

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Chapter 24 Medical Malpractice Insurance: Selection of Companies and Policies . . . . . . . . . . . . . . . . . . . . . . . . . . . Eric S. Poe

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Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Contributors

Devron H. Char, MD Clinical Professor of Ophthalmology, Stanford University School of Medicine, Director, The Tumor Foundation, San Francisco, CA, USA Sara Charles, MD Professor of Psychiatry, Emerita, University of Illinois School of Medicine, Chicago, IL, USA David S. Cramp Judge of the Superior Court, Trenton, NJ, USA C. Stephen Foster, MD, FACS, FACR Clinical Professor of Ophthalmology, Harvard Medical School, Cambridge, MA, USA E. Burke Giblin, Esq. Certified Civil Trial Attorney, Supreme Court of New Jersey, Morristown, NJ, USA Lee S. Goldsmith, MD, JD Goldsmith, Richman & Harz, LLP, Englewood Cliffs, NJ, USA Stephen A. Kamenetzky, MD Clinical Professor of Ophthalmology and Visual Sciences, Washington University School of Medicine, St. Louis, MO, USA Marvin F. Kraushar, MD Clinical Professor of Ophthalmology, University of Medicine and Dentistry of New Jersey, Newark, NJ; Clinical Associate Professor of Ophthalmology, The Mount Sinai School of Medicine, New York, NY, USA

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Contributors

Peter R. Laibson, MD Professor of Ophthalmology, Thomas Jefferson University of Medicine, Philadelphia, PA; Attending Surgeon and Director Emeritus Cornea Service, Wills Eye Hospital, Philadelphia, PA, USA Simon K. Law, MD, PharmD Associate Professor of Ophthalmology, Jules Stein Eye Institute, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA Andrew G. Lee, MD Professor of Ophthalmology, Neurology and Neurosurgery, University of Iowa Hospitals and Clinics, Iowa City, IA, USA Paul P. Lee, MD, JD James P. Gill, III, M.D., and Joy Gillis Professor of Ophthalmology, Department of Ophthalmology, Duke University Eye Center, Duke University School of Medicine, Durham, NC, USA Anne M. Menke, RN, PhD Risk Manager, Ophthalmic Mutual Insurance Company, San Francisco, CA, USA Peter H. Morse, MD Clinical Professor of Surgery, Department of Ophthalmology, Sanford School of Medicine, University of South Dakota, Sioux Falls, SD, USA Tanuj Nakra, MD Visiting Assistant Professor of Ophthalmology, Division of Orbital and Ophthalmic Plastic Surgery, Jules Stein Eye Institute, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA Eric S. Poe, Esq., CPA, JD Vice President of Marketing & Business Development, New Jersey PURE, Princeton, NJ, USA Edward L. Raab, MD, JD Professor of Ophthalmology, Professor of Pediatrics, The Mount Sinai School of Medicine, New York, NY, USA James J. Salz, MD Clinical Professor of Ophthalmology, University of Southern California, Los Angeles, CA, USA

Contributors

Robert F. Sanke, MD, JD Clinical Associate Professor of Ophthalmology, University of North Dakota, Trinity Medical Center, Minot, ND, USA Norman Shorr, MD Clinical Professor of Ophthalmology, Director, Fellowship in Orbital and Ophthalmic Plastic Surgery, Jules Stein Eye Institute, David Geffen School of Medicine, UCLA, Los Angeles, CA, USA

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Part 1

General Considerations

Chapter 1

Basic Medical Malpractice Terminology Marvin F. Kraushar

Introduction There are several basic terms and phrases that bear on the process of medical malpractice litigation. Familiarization with them will facilitate the understanding of the development and conduct of a lawsuit.

Standard of Care Physicians are expected to provide care that falls within a certain level of quality. This level is referred to as the standard of care. The standard is defined as that level of care provided by the average physician in the same specialty, in the same community, during the same period of time. This definition can cause a false sense of security for the physician who may mistakenly feel comfortable in being compared to the “average” physician and not to the “best” physician. The phrase “average physician” is a nebulous concept and does not truly refer to the physician in the 50th percentile. In fact, it refers to practically every physician because practically all medical care is within the accepted standard. Generally, the law recognizes that medicine is not an exact science. A poor result may occur even though the physician followed the accepted standard of care. Therefore, whether the doctor was negligent is not determined solely by the outcome but by whether he or she followed the accepted standard of care. By this standard, missing a retinal break in a symptomatic patient may not constitute negligence if the jury concludes that the doctor’s evaluation met the standard of care. Nonetheless, it is essential that the appropriate method for detecting the break, namely, performing a dilated fundus examination, was used and that the physician has the appropriate level of expertise with the instruments in order for the care to be within the “standard.” The community is usually the entire country now that dissemination of knowledge is widespread and basic equipment is readily available. The standard of care is not always a firm, black and white concept. It is defined for the jury by the experts for the plaintiff and the defense, and this is often accomplished by the selective presentation of information that is favorable to the side of the presenter.

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Both experts will review the same facts and come to diametrically opposed conclusions. It is commonly this testimony on which the jurors, who typically have no knowledge of their own regarding the facts, will depend during deliberations. The bottom line is that an error by a physician may be excusable provided he or she made a competent attempt to do the right thing.

Tort A tort is a private or civil wrongful act as opposed to a public or criminal wrongful act. The law seeks to restore the injured party to the status he or she enjoyed prior to the injury. Because the injured or lost body part cannot be completely physically restored, the manner of restitution (making the plaintiff whole) is in the form of compensatory damages (monetary indemnification).

Negligence Negligence is the tort of an unintentional act or omission. The level of care that “breaches” or falls below the standard of care is judged negligent. Negligence occurs when the physician does or fails to do something that the average physician in the same specialty under the same circumstances would not have done or failed to do and has thus “deviated from,” “breached,” or “fallen below” the standard of care. Negligence in and of itself does not constitute malpractice unless it is the proximate cause of an injury suffered by the patient (see next section).

Proximate Cause To prevail in a medical malpractice lawsuit, the plaintiff has the burden of proving he or she suffered an injury that was caused by the physician’s negligence. This is the concept of proximate cause. When an ophthalmologist fails to use povidone iodine prior to cataract surgery and endophthalmitis occurs, it is reasonable to assume there was negligence that was a substantial factor in the causation of an injury to the patient. These facts meet the criteria for the determination of medical malpractice. Failure to use povidone iodine is a deviation from the standard of care that increased the risk of infection. Suppose an ophthalmologist fails to use povidone iodine prior to cataract surgery that is uneventful and uncomplicated. Suppose further that endophthalmitis does not develop, but 3 weeks following surgery a rhegmatogenous retinal detachment occurs. The surgeon was negligent in failing to use povidone iodine and there was an injury suffered by the patient, but the negligence was not the proximate cause of the retinal detachment. These facts would not meet the criteria for medical malpractice. A final

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example is that of an ophthalmologist who fails to use povidone iodine prior to cataract surgery that is uncomplicated and no postoperative complication occurs. The ophthalmologist deviated from the standard of care and was thus negligent, but there was no injury suffered by the patient and thus there was no medical malpractice.

Allegations When a patient initiates a lawsuit, he or she alleges deviations by the physician from the standard of care. The allegations are failure or delay in diagnosis, failure or delay in treatment, negligent treatment, and/or problems relating to informed consent. The plaintiff alleges that one or more of these deviations from the standard of care decreased the chance for a more favorable result. This “doctrine of loss of chance” is the basis of lawsuits in most jurisdictions.

Maloccurrence Maloccurrence is not a legal term. It is often used by physicians to describe “what went wrong” as bad luck and not the result of malpractice.

Medical Misadventure Medical misadventure is a nonmedical and nonlegal term used by insurance companies to describe “what went wrong” in the management of a patient.

Respected Minority The type of treatment rendered to a patient need not be the choice of most physicians in the same specialty in order to be within the standard of care. However, the care rendered must be respected as a reasonable alternative by at least a substantial minority of colleagues.

Vicarious Liability Physicians can be sued because of responsibility for the acts of someone else. The obvious example is the negligence of a nurse/technician, fellow, and so forth, employed in the physician’s office. Lawsuits have been brought against ophthalmologists who

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caused injuries to patients in the operating room by using improper medications without checking to see whether the nurse gave the physician the correct medication. Retinal toxicity caused by too high a concentration of an intravitreal antibiotic during pars plana vitrectomy for endophthalmitis would be the responsibility of the pharmacist and the hospital for whom he or she works. The surgeon would most likely be named in the lawsuit initially. The performance of a “covering physician” is of paramount importance. It is essential that whoever sees a physician’s patients in his or her absence is competent and responsible. This applies to those persons over whom we have some control (partners, fellows, etc.) and thus for whose negligence we may have legal responsibility and also to those persons over whom we have little or no control (house staff, colleagues, etc.) and for whose negligence we are not legally responsible. Conversely, we must treat the patients of other physicians as we would treat our own. Make sure to document the facts of phone calls from patients of those physicians for whom you are covering and pass along the appropriate information the next day. Create a separate dedicated file in which you keep this information as well as the documentation that you transmitted it. This will be powerful exculpatory evidence if you are eventually named in a lawsuit.

Chapter 2

The Defense Attorney E. Burke Giblin

Helping Your Defense As I reflected on cases our firm has successfully defended for physicians, it occurred to me that two of the most important elements that helped us to achieve a successful outcome were, first of all, extensive preparation, and, second, teamwork between the defendant physician and the defense attorney. I will outline some of the techniques that we provide to our clients to help them toward a successful outcome at trial and will discuss how physicians have helped us to successfully prepare their cases.

Preparation for Your Deposition Is Essential Any discussion about how a physician can assist defense counsel in achieving a favorable outcome must, of necessity, start with a discussion about preparation for the physician’s deposition. Once a physician has placed his position on the record at his deposition, it becomes extremely difficult to alter that position at the time of trial. In some jurisdictions, depositions may be videotaped and the videotaped deposition may be used at trial. Naturally, this makes deposition preparation even more important. Generally, prior to the deposition, the physician should review all relevant records, depositions, and expert reports that are available. The data should be reviewed self-critically, as if the physician were serving as the expert witness for the opposing side. If there are any weaknesses identified, the physician should discuss this with the defense attorney prior to the deposition in order that these “problem” areas may be handled as effectively as possible. The physician should be extremely well versed in the medical issues involved in the case. I typically suggest to my clients that they should go over the medicine as if they were going to be asked to present the case during a board certification examination. In some cases, if there is uncertainty regarding certain medical issues, an early expert review may be recommended to obtain early guidance regarding these issues.

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It is important that physicians meet with their attorney prior to their deposition, at which time the attorney will go over general techniques for testifying at a deposition and will also discuss the specific issues involved in the case. The defense attorney should also discuss with the defendant physician the specific issues germane to the particular case prior to the deposition. I have learned that it is often helpful that there be some role playing wherein the defense attorney questions the physician as if the defense attorney were the opposing attorney. Some physicians have found it helpful to have this role playing videotaped so that they can see how they appeared when answering difficult questions and thereby potentially improve their performance at the actual deposition. Whether or not videotape is used in the deposition preparation process, some role playing is usually very helpful because it is often easier to answer difficult questions for the second time at the actual deposition rather than for the first time at the deposition. In some jurisdictions, there are rules that make preparation for the deposition particularly crucial. These are rules that limit the ability of the defense attorney to direct a defendant physician not to answer a question at a deposition. Accordingly, the preparation session is extremely important because the defense attorney has limited capability to direct a physician not to answer even improper questions. For example, without proper preparation, a physician may not know, if asked, whether to criticize the care of a codefendant physician.

Working with Codefendants As a general proposition, it is usually preferable from the defense perspective to avoid “fingerpointing” among codefendants. Once fingerpointing begins, it typically accelerates, and the plaintiff almost invariably wins such cases. There may be rare instances, however, when fingerpointing among defendant physicians is unavoidable. In these circumstances, it is important for the defense attorneys to try to work together to attempt to minimize the fingerpointing to the extent the factual scenario allows. In certain jurisdictions, physicians cannot be forced to provide their “opinions” against their will. In this instance, a physician does not have to offer an opinion critical of another physician unless that opinion was one that was formed as a part of treatment of the patient. In other words, opinions formed in order to provide treatment may be considered factual, and therefore the physician may have to state his or her opinion if it is asked. However, if the physician is simply reflecting back, after the litigation has started, as to whether another physician’s conduct was appropriate, a physician may choose not to offer such an opinion. It is extremely important that any opinions critical of another physician be discussed with defense counsel prior to providing the opinion at a deposition or trial. This will ensure that the defense attorney is aware of the opinion and can deal with the issue in the best way possible given the circumstances.

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Questions Physicians Frequently Ask About Testifying Our clients have frequently asked whether they can be forced to answer questions with merely “yes” or “no” at the time of deposition or trial. Many judges will give the witness the following options. The witness can answer either “yes” or “no,” or he may tell the attorney asking the question, “I cannot answer the question ‘yes’ or ‘no.’ ” We typically advise our clients that if a simple “yes” or “no” does not fairly explain their position, they should explain and not limit their answer to just one word. If the opposing attorney insists on a “yes” or “no” answer and the judge allows this, the witness should state, when appropriate, that he is not able to fairly answer the question “yes” or “no.” In the event the physician is ultimately forced to answer with only a “yes” or “no,” he will have a chance to explain when the defense counsel gets the opportunity to ask questions following cross-examination. Clients also often ask whether they should be their own expert witness. Again, this is something that must be decided on a case-by-case basis. Theoretically, if the physician is serving as his own expert, the scope of cross-examination is broader. However, in my experience, most judges allow a very broad scope of crossexamination of a defendant physician regardless of whether the physician is serving as his own expert. Accordingly, I often have the defendant physician serve in the role of an expert on certain issues, because I have found that the scope of crossexamination usually is not much different. However, there may be times when it is extremely important to limit the scope of the defendant physician on a particular issue. Therefore, the physician should be sure to discuss this issue with his attorney because this is something that must be decided on a case-by-case and issue-by-issue basis.

General Differences Between Deposition and Trial It is helpful to have an understanding of the differences between deposition testimony and trial testimony. In general, a deposition gives the opposing counsel the opportunity to learn what a witness may say at the time of trial. Opposing counsel is seeking to obtain information that will assist him in cross-examining the witness at trial. Accordingly, it is usually the role of the physician at his or her deposition to attempt not to educate opposing counsel more than is absolutely required. Certainly, if a specific question is asked, the physician must answer it completely. However, as previously discussed, physicians should generally not volunteer additional information beyond what is specifically asked. As with any general rule, however, there may be exceptional circumstances in which the defense attorney may want the physician to bring out certain points during the deposition even if the opposing attorney does not inquire about these points. In contrast to the deposition, trial testimony is the physician’s opportunity to explain facts that are favorable and to expound upon his theory of the case. Accordingly, when your attorney questions you during direct testimony, you will be trying to educate the jury. Your answers will likely be much more detailed and easy

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to understand when you are testifying at trial than when you were testifying at a deposition. This is not to suggest that any fact or theory should be unfairly covered up at a deposition even though inquired about in an effort to surprise the opposing attorney at trial. It simply means that at a deposition answers should generally be limited to exactly what is inquired about and nothing more.

A Judge or a Jury? Many physicians jump to the conclusion that it would be better to have their case decided by a judge rather than by a jury. In reality, this is not always true. In any event, the defendant physician often has no option in this regard. In many jurisdictions, if the plaintiff requests a trial by a jury, which plaintiff’s attorneys almost invariably do, then the law provides that the trial will be decided by a jury rather than by a judge regardless of the defendant’s wishes. In defending doctors in malpractice cases for over 30 years, I have encountered only four or five situations in which defendants have had the option of a trial by a judge rather than by a jury. Interestingly, in each instance, the insurance carriers for the physicians decided that they would not agree to allow the case to proceed to a trial by a judge rather than by a jury. The rationale for this decision was that the carrier’s experience with judges deciding medical malpractice cases had not been good. The carriers believed that judges tend to want to make everyone happy and to come up with a compromise verdict, whereas jurors tend to be more decisive and more willing to turn away a sympathetic plaintiff if the treatment was proper. The greater decisiveness of the jury may be a function of the fact that six or more individuals are making the decision rather than just one individual, as in the case of a judge trial, and that none of the jurors knows any of the attorneys. In contrast, the judge often knows the attorney for the plaintiff and the attorney for the defendant and is frequently focused, as part of his daily routine, on settling cases for a compromise amount. As juries typically find in favor of the defendant in the great majority of cases when the treatment is proper, this probably accounts for the decision of the insurance companies to go with a jury in those rare cases when there has been an option. Obviously, insurance carriers may make a different decision based on the circumstances of any individual case. For example, if the particular venue is known for having poor jurors or if the injuries are particularly severe or the proposed judge is well respected. In the event that a case involves poor treatment and the plaintiff has significant damages, it would likely be to the advantage of the defendant physician to have a judge determine his case rather than a jury. However, the only cases, in my experience, when the option of a judge trial has been presented to the defense have been those that were medically defensible and the plaintiff’s attorney felt that he could get the case resolved more quickly and efficiently, and with the possibility of a compromise verdict, by agreeing to proceed to trial with a judge. In one such case, the plaintiff’s attorney appeared to have had a longstanding, and apparently very friendly, relationship with the proposed judge. Of course, the option of having the case decided by this particular judge was declined.

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The Roles of the Judge and the Jury As noted, medical malpractice cases are almost invariably tried before a jury. In a jury trial, the judge will explain to the jury that they will be the sole judges of the facts. Jurors alone have the responsibility of deciding the factual issues in the case. The determination of the jury as to the facts must be based solely on the evidence admitted during the course of the trial. The evidence will consist, generally, of the testimony of witnesses who appear in court and testify as well as any depositions or answers to interrogatories that are read to the jury. Also, exhibits, which in a medical negligence case typically involve medical records, may also be admitted into evidence and go with the jury into the jury room. When it comes to the facts, it is the recollection and evaluation of the evidence by the jury that controls. Indeed, the judge will instruct the jury that if the attorneys, or even the judge, say anything about the facts in the case that disagrees with the recollection of the evidence by the jury, it is the jurors’ recollection that controls. The jury is instructed that they must decide the case based on the instructions as to the law given to them by the judge and applied to the facts as found by the jury. In contrast, the judge rules on the admission or rejection of evidence and passes upon questions of law that may arise. At the end of the case, the judge charges the jury as to the law that applies. There is much debate in legal circles as to how much consideration the jury gives to the instructions of law given by the judge. Based on my observations, most jurors certainly try to listen carefully to the judge’s instructions regarding the law, but hearing the law read only one time may be confusing to even the most attentive juror. In some instances a judge will provide the jury with a written transcript of his charge on the law, or repeat the charge, to assist the jury in following the law. I will not attempt to discuss herein everything that is covered in the charge. In general, however, the judge will define the standard of care to which a physician is held based on the applicable law of the state in which the case is being tried. The judge will also typically discuss the legal concepts relating to proximate causation and damages. I generally provide my clients with either a written or an oral outline of the judge’s charge. I believe it helps the physician to be aware, in advance of his testimony, of the standard of care to which he or she is held as well as the concept of proximate causation.

Jury Selection I will now turn to the various aspects of a trial and discuss some of the ways that physicians can assist in their own defense at trial. I will start with jury selection. I recommend that our physician clients be present during jury selection. In most cases, the jurors, not the judge, will ultimately decide the case. Accordingly, it is important that the physician provides the attorney any input that he may have about any particular juror.

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Usually the questions that are asked by the judge or counsel eliminate most jurors who are obviously biased toward one party or the other. After the jurors are questioned, each attorney typically gets a number of opportunities to excuse jurors with or without cause. If there is any juror in the jury box with whom you are not comfortable, let your attorney know. Your attorney may or may not follow your recommendation, but at least your attorney will have your input before making the ultimate decision. As your attorney uses up his or her available challenges of jurors, your attorney will probably frequently be studying the jurors who remain available for selection. In a recent case, I had used up five of my six available challenges. My physician client indicated he was somewhat concerned about one of the potential jurors in the jury box and suggested I might wish to use my last challenge to excuse him. I looked at the panel of jurors who remained available to replace this juror, which consisted of three more potential jurors, and then suggested that my client do likewise. After looking at the three remaining potential jurors, my client and I agreed that the chance that any of those who remained would be better was probably slim, so we did not exercise the final challenge.

Opening Statements I have listened to opening statements that have lasted anywhere from ten minutes to three hours. Every case differs in terms of complexity, and, accordingly, there is often significant variation in the lengths of the opening statements. However, in my experience, I would estimate that opening statements in medical malpractice cases average between 20 and 40 minutes. The opening statement is a summary of the facts and theories each attorney intends to prove. Typically, each attorney will identify the witnesses whom he intends to call during the case. The defense attorney will usually provide a summary of the defense theory, typically including comments indicating that the treatment complied with accepted standards of care as well as any defense theories on proximate causation. Many legal commentators believe that the opening statement is more important than the summation. It is thought that the opening statement provides jurors with their first impression of the case, and, once an impression is formed, it is thought that it tends to become fixed and difficult to change. In addition, when summations are given, the jurors have already heard all of the evidence and hence are more likely to have already made up their minds once and for all. Therefore, the summations may not be as important in many cases as the opening statements. However, summations should never be taken lightly, and, particularly in close or very complicated cases, the summations may be extremely important to tie together key pieces of evidence and theories that may not be readily apparent to a lay jury.

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The Plaintiff’s Case In a medical malpractice case the attorney for the plaintiff usually presents his witnesses before the testimony of the defendant physician. However, in some cases, the defendant physician is called by the attorney for the plaintiff as the first witness. In my experience, this often helps the defendant, particularly if the physician has been well prepared. A well-prepared defendant can defuse many of the arguments of the plaintiff early in the case and cause the jury to have an early impression favorable to the defense. Therefore, unless the plaintiff scores significant points during his examination of the defendant physician, the strategy of calling the defendant first often may turn out to be better for the defense than for the plaintiff. In many cases, the plaintiff’s attorney will not call the defendant during the plaintiff’s case but instead will read portions of the defendant physician’s deposition during the plaintiff’s case. The plaintiff’s attorney will typically “cherry pick” those portions of the defendant physician’s deposition that are thought to be favorable to the plaintiff’s case or that provide testimony that the plaintiff’s expert intends to rely on for his opinion. The fact that the defendant physician’s deposition is frequently read to the jury once again reinforces the importance of preparation by the physician prior to his or her deposition. In typical medical negligence cases, the plaintiff’s attorney will be calling witnesses who may include the plaintiff, relevant family members, and the plaintiff’s medical and/or economic expert witnesses. It is important that the defendant physician read over the depositions of both the plaintiff and the plaintiff’s expert(s). The defendant should advise his attorney of any thoughts that might be useful for crossexamination of either the plaintiff or the plaintiff’s expert(s). Possible examples of helpful suggestions for cross-examination include factual inaccuracies, conflicts with the medical records, conflicts with the medical literature, or weaknesses in the expert’s curriculum vitae such as limited experience in performing the treatment in question or lack of board certification. The defense attorney will often depose the plaintiff’s expert(s) prior to trial to elicit information that may be useful for cross-examination. Areas of inquiry may include the expert’s training and experience, any literature that the expert relies on or that contradicts the expert, whether the expert’s factual assumptions are accurate, and any weaknesses of logic in the expert’s theory of the case. In addition to taking a deposition of the plaintiff’s expert, there are services available that can provide information regarding testimony given by the plaintiff’s expert(s) in other cases. Transcripts of previous testimony may be obtained and reviewed by your attorney to determine whether there are any conflicting statements in the prior testimony that may be helpful to your case. Defense attorneys often hire private detectives in appropriate cases to perform surveillance of the plaintiff. A decision whether to perform surveillance is often made based on the index of suspicion of the defense attorney that the plaintiff may be misrepresenting his injuries based on the plaintiff’s deposition testimony and on

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comments by treating physicians that may suggest that the disability claimed in the lawsuit may be disproportionate to the findings on examination. Over the years, my firm has obtained some remarkable surveillance videos. For example, a plaintiff who was allegedly unable to walk without assistance was filmed climbing up and down ladders to work on the roof of his house. If the defendant physician suspects that the plaintiff is exaggerating his injuries, the physician should recommend to his attorney that surveillance be considered.

The Defendant’s Case In a typical medical negligence case, after the plaintiff’s attorney has presented all his witnesses and exhibits, the plaintiff’s attorney rests his case. The defense attorney will then typically move to dismiss any aspect of the plaintiff’s case that was not sufficiently proven. The standard to have a case dismissed by the judge is extremely difficult to meet, and in most competently presented plaintiff’s cases, very little of the plaintiff’s case will be dismissed. After motions presented at the end of the plaintiff’s case have been decided, the defense will begin presenting evidence. The defendant physician’s case typically involves the testimony of the defendant physician himself together with the testimony of any defense experts. In some cases, there may be factual disputes between the plaintiff and the defendant rather than merely different medical opinions based on the same facts, and in these cases there may be fact witnesses called by the defense to rebut the plaintiff’s factual evidence. In most cases, the testimony of the defendant physician will be more important than that of any other witness, including experts, called by the defense. Jurors look upon the case as a dispute between the plaintiff and the defendant, and hence the jurors often consider the testimony of the parties to be the most important. Obviously, if the jurors like and believe one party more than the other, that party is highly likely to receive a favorable verdict. Because the defendant physician’s testimony is so crucial, it is extremely important for the defendant to be well prepared. The defendant physician should read as much available information about the case as possible, including the depositions of the parties and experts. Most important, the physician should carefully study his own deposition. If there are any errors in the transcript, the physician should advise his attorney, preferably well in advance of trial. Before the trial begins, the defendant physician should meet with his attorney and begin the trial preparation process. The physician should plan to attend as much of the trial as possible. The more the defendant physician sees of the plaintiff’s witnesses, the better prepared the defendant will be to rebut what these witnesses have told the jury. Defendant physicians should naturally dress appropriately for trial. Generally, I recommend that health care professionals dress conservatively, for example, wearing a blue or gray suit without any ostentatious jewelry. In addition, I advise clients

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against reacting to the testimony provided by plaintiff’s witnesses, for example, making gestures such as shaking the head or rolling the eyes. I suggest that the defendant physician always remain very professional while the plaintiff’s witnesses are testifying. I also remind the defendant that he or she will have ample opportunity to set forth his or her side of the story when the defendant’s turn to testify comes.

Defendant Physician’s Testimony at Trial I recommend that the defendant physician speak to the jury as if he or she were explaining the medicine, and his or her thinking about the treatment, to a patient or to a friend. I have often suggested that the physician speak to the jury as if he or she were talking to a few friends in their living room, explaining why the treatment that was rendered was appropriate. It is important that the defendant physician appear to be helpful. For example, he or she should explain any medical terms that might be difficult for a lay juror to understand. Naturally, this should never be done in a condescending manner but only with an attitude of being helpful. If there are any points that can be made clearer by using a diagram or an anatomic model, the defendant physician should attempt to do so. It is advisable to go over any proposed drawings or models with the defense attorney prior to presenting them to the jury. When I am questioning my client during the trial, I typically stand in a location in the court room so that the witness is facing both me and the jury. This permits the defendant physician to easily include the jury in the discussion. In other words, the defendant physician will be able to look at me when responding to questions but also speak to the jury and include them in the discussion. I do not recommend that the physician speak only to the jury but rather that the physician speak to me and then frequently turn to the jurors to include them in the discussion. It is essential that the defendant physician never be arrogant or condescending. Likewise, the physician should never lose his temper. A little righteous indignation may be appropriate if the opposing attorney is being difficult, but the physician should never lose his or her composure. Defendants who appear professional and reasonable usually win. Many years ago I advised a physician that he should attempt to explain medical terms to the jury during his testimony. Unfortunately, he prefaced each explanation with the condescending statement, “You probably will never be able to understand this, but this part of the surgery involves.…” Naturally, he eliminated this preface to his explanations after I had a chance to speak with him during the first break, and he went on to be a good witness. In some cases, it may be appropriate to express sympathy for the plaintiff. Physicians are often concerned whether an expression of sympathy will be misconstrued as an admission of negligence. If properly done, an expression of sympathy for the injuries of the plaintiff can actually be very helpful to the defense as long as it is made clear that this does not constitute an admission of negligence. For example, in

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a case involving the loss of a child, a defendant physician recently indicated that he felt badly for his patient’s loss. His testimony went roughly as follows: “I feel very badly for Marge, as it is always very difficult to lose a child. However, we did everything in our power to help her child.” A defendant physician should acknowledge the limits of his or her expertise. For example, if a defendant physician is a family doctor and is asked a highly technical surgical question, it may be appropriate to state as follows: “This is a surgical issue on which I would defer to my consulting surgeon.” The defendant physician should try to avoid exaggerating or “sugar coating” his case. Weaknesses should generally be brought out and dealt with while the defense attorney is doing the questioning and before cross-examination. Naturally, it is not favorable when the opposing attorney is the one who exposes all of the weaknesses in the defendant’s case. Deposition testimony may be used by the opposing counsel to impeach the defendant physician if there is any difference between what the doctor said in his deposition and what the doctor says on the witness stand. If possible, the defendant physician should try to clarify any inconsistencies between the deposition testimony and the trial testimony when confronted with the prior testimony at trial. However, there may be times when you definitely misspoke in your deposition, and, of necessity, you have to change your testimony at the trial. Any need to change your deposition testimony should be thoroughly discussed with your attorney long before trial to give him the best opportunity to deal with this issue. Physicians should be willing to disagree with so-called authorities or commonly used texts if convinced that the literature is wrong. Hopefully, you or your expert witness can emphasize that the particular literature used by the plaintiff does not apply to the treatment in question or emphasize that there is other literature that supports your treatment choices. Physicians should attempt to appear confident. Take each question one at a time and answer it as best as you can, trying not to concern yourself with how you are doing. In other words, by doing your best on each question it is likely that the overall impression that you will make will be as good as possible. Do not hesitate to ask the cross-examining attorney to clarify any question. If it will leave the wrong impression, try not to answer questions simply “yes” or “no.” Likewise, if a question assumes improper facts, try to point out the error in the question’s assumptions when you answer. In a recent case, the theory of the plaintiff was that there was a purported delay in diagnosis of a blood infection that led to the patient becoming septic and dying. The attorney for the plaintiff wanted to get the defendant on cross-examination to sound as if he agreed with the theory of the plaintiff, that is, that the patient died from sepsis, which actually was not true. The attorney for the plaintiff engaged in the following series of questions: “Certainly sepsis causes death, true doctor?” If the physician answered this question simply by saying “yes” it would have sounded as if he agreed that sepsis was the cause of the death in this particular case. Fortunately the physician provided a better answer than just “yes” by stating, “In some cases sepsis may cause death, but it definitely did not in this case.”

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The plaintiff also attempted to cross-examine the defendant physician for an alleged delay in diagnosis during the night before the patient died by asking the following question: “That evening, you left the hospital without giving the decedent any treatment whatsoever and then you went home, isn’t that true doctor?” In reality, no treatment had been given because it was not indicated at that time. If the physician answered only “yes” it would sound as if he improperly failed to give indicated treatment and went home. Fortunately, the physician gave a better answer by stating, “After evaluating the patient and determining that no treatment was indicated, based on his condition at the time, I went home, that is correct.” In the event that the opposing attorney does not allow the defendant physician to answer questions completely, or to clarify improper assumptions, it is important that the physician be patient and not appear fazed. The physician should remember that his attorney will have an opportunity to ask additional questions following the completion of cross-examination to clarify any misimpressions created by the cross-examination. Physicians should keep trying their best, no matter what. Over the years, I have had many physicians indicate to me, after they finished testifying, that they felt they had not done well on cross-examination, when, in fact, I was able to tell them that they had done an outstanding job. Physicians should remember that cases are not typically won by l00 points to 0 points. Most competent plaintiff’s attorneys are able to score at least some points on cross-examination, and it should be kept in mind that, even if the final score is 5l to 49 in favor of the physician, it is reported only as a physician win. Most surveys indicate that when assessing the performance of professionals, the criterion which the public feels is most important is whether the professional “tried his best.” Indeed, whether the professional “tried his best” was generally thought to be even more important than the outcome. Therefore, if a physician appears to the jury as having tried his best in the circumstances, it is extremely likely that the physician will have a favorable outcome at trial. In concluding my discussion of the defendant’s physicians presentation at trial, I can state that I have almost never seen a well-prepared physician do poorly in his testimony. Although not every physician will have the ability to articulate his position the way Clarence Darrow might, well-prepared physicians virtually always provide their testimony in at least a satisfactory manner. Real estate agents say that the three most important factors in residential home sales are location, location, location. For physicians going to trial, the three most important factors are preparation, preparation, preparation.

Cross-Examination Styles Over the years I have seen many different cross-examination styles used by plaintiff’s attorneys. One style I categorize as the “dramatic questioner.” This attorney will often use a booming voice with “pregnant pauses” when he believes he has

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scored a point. The goal of this style of cross-examination obviously is to intimidate the witness. This type of plaintiff’s attorney is trying to upset the physician, and accordingly the physician should just keep trying to do his best to answer each question as reasonably as possible without allowing the histrionics of the questioner to bother him or her. Frankly, jurors generally do not like an attorney who comes across as a bully, so if the physician keeps answering questions calmly and reasonably, in the face of this style of questioner, the physician will probably end up doing very well. Another style of cross-examination is what I categorize as the “ingratiating questioner.” This type of attorney will attempt to get the physician to say “yes” to many innocuous questions, thereby trying to give the impression to the jury that the physician’s repeated answer of “yes” suggests that this attorney is actually scoring points. This attorney often will move gradually from innocuous questions to more difficult questions with the hope that the physician will continue to give “yes” answers. If the physician does not, this questioner will quickly return to the innocuous questions, once again getting the physician to repeatedly state “yes.” This approach is often used when the plaintiff’s attorney has very little merit to his case and therefore is not able to challenge the defendant physician with questions that go to the true merits of the case. The most dangerous type of plaintiff’s attorney is the one I categorize as the “prepared questioner.” This type of attorney usually has taken an effective deposition and knows in advance, based on the deposition, medical records, medical literature, or other sources, the answer to each question that he asks at trial. The “prepared questioner” is the most dangerous type because he or she will always have something to back up whatever question is asked.

The Defense Expert’s Testimony In the typical professional negligence case, the defense expert will testify after the defendant physician. It is important that the defense attorney bring the defense expert up to speed regarding what occurred during the testimony of the defendant physician. It is likely that many of the questions that the plaintiff’s attorney asked the defendant will also be asked of the defense expert. Accordingly, if time allows between the testimony of the defendant physician and the defense expert, this is an excellent opportunity for the expert witness to be prepared for the type of questioning to expect from the opposing attorney. The decision regarding which expert to use is a very important one. An expert witness for the defendant physician should have a good curriculum vitae. However, it is equally, if not more, important that an expert have the ability to communicate effectively with lay jurors. Some physicians may be extremely well qualified but nevertheless have a hard time communicating to lay jurors in a trial setting. Defense experts should have the ability to make difficult medical concepts understandable to a lay jury. Experts who use complex, technical, medical language, which may

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fascinate a group of physicians, may be too technical for a lay jury and leave them confused and unconvinced.

Summations Once the testimony is complete and all nontestimonial evidence has been offered, each attorney has the opportunity to argue on summation why his or her client should prevail. The summations tend to be much more argumentative than the opening statements. Demonstrative evidence, such as enlarged views of important records or diagrams, can be particularly helpful to accentuate favorable points during summation. I have listened to summations ranging in length from 15 minutes to 6 hours. The length of the summation is often a function of the complexity of the case. However, in the typical medical negligence case I have found that summations usually range from 30 minutes to an hour and a half. In my opinion, it is very unlikely that the attention of the jury will be held after about 90 minutes. Many attorneys attempt not to speak much longer than this during their summations because they believe that the jurors’ attention span will be exceeded.

Settlement Negotiations A certain percentage of cases do involve professional negligence, and usually these cases are settled prior to trial. Typically, the defense attorney will obtain expert review(s) that provide the defense attorney with an opinion as to whether the treatment rendered was proper. If multiple experts report that the treatment rendered was not proper, the attorney will typically recommend that the case be settled. Expert opinions may still be obtained that focus on weaknesses in the plaintiff’s case and help your defense attorney attain a settlement which is as favorable as possible in the circumstances. Typically after the weaknesses in the plaintiff’s case have been highlighted to the plaintiff’s counsel, settlement negotiations will begin, using the weaknesses in the plaintiff’s case as leverage to try to get the case settled at as reasonable a level as is possible. Physicians should advise their attorney of any weaknesses in the plaintiff’s case that can be emphasized in an effort to reduce the settlement value of the case.

Statute of Limitations The statute of limitations is the time period within which a case must be filed or else it is barred from being pursued. Physicians should discuss with their attorney whether any claim brought against them might be time barred by this statute in the jurisdiction in which the case is filed.

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The purpose of the statute of limitations is to require that cases be brought within a time period when witnesses are still available, memories have not grown dim, and evidence has not been lost. The goals of the statute are to achieve security and stability in human affairs and to ensure that cases are not tried on the basis of stale evidence. Such statutes determine the time period during which a claim must be brought. However, many state courts have concluded that because the statute of limitations is intended to be equitable in nature, the time period set forth should not be applied mechanically. These courts consider whether the plaintiff was unable to “discover” the fact that there was medical malpractice and whether the plaintiff brought the suit in a reasonably timely fashion after the plaintiff was able to “discover” that there was malpractice. Also, the defendant may be required to demonstrate prejudice due to the delayed notice of the claim in order to have a case dismissed on the basis of the statute of limitations. The classic case for extending the time within which a claim may be brought based on the so-called discovery rule involves situations in which a foreign body is left within a patient at the time of surgery and the patient does not discover the presence of the foreign body until after the time period set forth in the statute. In these “foreign body” cases, the courts stress that the patient is ignorant of the foreign body during the customary period of limitations. Accordingly, if the patient acts in a reasonably expeditious fashion after discovery of the foreign body, the claim should not be barred. In some jurisdictions, the discovery rule has been extended beyond “foreign body” cases to other types of medical malpractice matters. In some jurisdictions, defense attorneys joke that the courts have so attenuated the statute of limitations by liberal application of the discovery rule that the original intent of the legislature to have a statute of repose has been vitiated and there really is no such statute. For example, in a case in New Jersey it was concluded that a cause of action did not accrue until a patient was aware not only that he had been injured by a doctor but also that he suffered the injury because of the doctor’s fault. Even though years went by after the period set by the statute of limitations had passed while plaintiff searched for an expert willing to support his preferred theory of liability, the case was held not to be barred by the statute. The statute of limitations is also frequently extended for infants as well as for patients who are deemed to be incompetent. For a physician involved in a medical malpractice case, the defense attorney should handle all issues related to the statute of limitations, and hence it is not crucial to know all the nuances of the law of your state. However, if an extended time period has passed before you receive notice of a claim against you, it would be wise to discuss with your attorney whether there is a basis to have the case dismissed based on the statute of limitations. Generally, we advise taking the deposition of the plaintiff before filing a motion to dismiss based on the statute of limitations. In this way, the defense attorney can question the plaintiff in a way that will establish whether there is a basis upon which the plaintiff can claim application of the “discovery rule”. Once the motion to dismiss based on the statute is brought, the plaintiff will have an opportunity to

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think about reasons why he allegedly was unable to “discover” that there was a basis to bring the claim. If questions relating to “discovery” of the claim are asked at the deposition before any motion has been filed and thus at a time when the plaintiff may not be prepared, the plaintiff may be locked into answers that prevent the plaintiff from subsequently arguing that the time set forth in the statute should be extended based on the “discovery rule.”

When to Hire Your Own Attorney In a typical medical malpractice case, the insurance carrier will assign a defense attorney to defend you. It is important that the physician confirm that the attorney who has been assigned is someone who devotes a significant percentage of his or her practice to defending medical malpractice cases. The defense of medical malpractice cases is a highly specialized area, and insurance companies usually select attorneys who specialize in this area. It is certainly reasonable for the physician to inquire about the background of the assigned attorney to determine the attorney’s level of experience. Many insurance companies will respect a request for a particular attorney, at least among attorneys a company has preapproved as malpractice specialists. There may be occasions when a physician has to consider whether to hire his own attorney, for example, when a theory for damages is raised by the plaintiff which is not covered by the insurance policy. One such situation may be, if the plaintiff is claiming that a physician did something intentionally wrong, as opposed to merely being negligent. In these circumstances, a letter from the insurance company is usually sent to notify the physician that he will not be covered for any awards for damages arising out of theories premised upon intentional acts. In this case, the physician should consider retaining his own counsel. Another situation that will typically trigger a letter from an insurance company suggesting that the physician consider retaining his own counsel occurs when the plaintiff makes a demand in excess of the insurance coverage. The initial demands made by the plaintiff are often unrealistically high, but a demand in excess of the policy still triggers a duty on the part of the insurance company to notify the defendant physician that the demand exceeds the coverage. The carrier will typically recommend that the insured physician consider retaining personal counsel to protect himself regarding any amounts claimed in excess of the policy limits. The physician should discuss any situation involving the potential for exposure not covered by insurance with the defense attorney assigned to his cases as well as with personal counsel. In many instances, the assigned defense attorney will be able to resolve the issues raised by an unrealistic demand or a claim that there was an intentional action on the physician’s part, by merely speaking with the plaintiff’s counsel and asking him to drop such a claim if it is without merit, thereby helping the physician to avoid expending a great amount of money dealing with personal counsel. Also, a discussion with the assigned defense counsel and personal counsel may lead the physician to conclude that the demand made by the plaintiff is extremely excessive and unrealistic in the

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circumstances and the likelihood of any verdict in excess of the insurance coverage is so remote that there is no need on a cost/ benefit analysis for personal counsel to become actively involved. In some instances, there may be very little that personal counsel can add to the preparation of the case beyond what is already being done by the attorney assigned by the insurance carrier. Accordingly, there is a cost/benefit analysis that the physician must undertake to determine whether it would be beneficial to engage personal counsel to become actively involved simply because a plaintiff makes an excessive and unrealistic demand. Likewise, a plaintiff’s claims of intentional actions by a physician may be frivolous and the physician may be reassured by the assigned defense counsel and personal counsel that these claims will almost certainly be dropped voluntarily by the plaintiff; if they are not, a motion will be made to strike such claims. In this instance, once again, a cost/benefit analysis must be undertaken to determine whether it is necessary to expend significant amount of money on personal counsel to become actively involved when it is extremely likely that the count will be dropped or stricken before the case goes to trial. To a great extent, the decision as to how active personal counsel should be is often a function of the level of confidence that the physician has in the defense attorney assigned by the insurance company and the likelihood that any counts that are not covered by insurance will be dismissed before trial. Personal counsel is frequently needed when there is a conflict between the physician’s desire to settle a case and the insurance company’s desire to try the case. For example, a physician may have $1 million in coverage in a case where the value of the case, if tried and lost, is in the range of $5 to $10 million. A physician may determine that he wishes to protect himself from personal exposure by having the case settled, while the insurance company may feel that the case is medically defensible and therefore one that should be tried. In these circumstances, personal counsel’s involvement is extremely important. Some states provide protection to the physician in the event that the insurance company insists upon trying the case against the wishes of the insured physician and a verdict in excess of the policy limits is obtained by the plaintiff. The courts will look at the “good faith” of the insurance company in proceeding to trial in a case where they knew that a verdict would likely be in excess of the insurance coverage if the case was lost and the physician demanded that the case be settled prior to trial. Personal counsel can provide guidance to the physician prior to trial if a situation arises where the desire of the physician regarding settlement is in conflict with the desire of the insurance company. Indeed, in any situation where there is a conflict between the physician’s desire and the desire of the insurance company regarding how the case is being handled, personal counsel should be consulted.

Physician–Patient Relationship: When Does it Start? When Should it End? Once a physician undertakes to treat a patient, the physician may not abandon the patient. Generally, abandonment consists of a failure by the physician to continue to treat when treatment is still needed in a situation in which the physician has assumed responsibility and from which he has not been properly relieved.

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In general, the courts are very liberal in establishing a physician–patient relationship. Accordingly, once a physician undertakes treatment of any nature, it is important to know that the physician may risk a claim of abandonment if the physician does not provide the patient with reasonable notice that he or she is withdrawing from the care of the patient so as to permit the patient to obtain care from another physician. Although a physician who has been employed to treat a patient is generally under no duty to continue treatment forever, many courts have concluded that it would be unfair to the patient for the physician to withdraw from treatment without giving the patient a reasonable opportunity to obtain care elsewhere. When physicians contact us regarding withdrawing as a treating doctor, we generally provide them with the following procedure. We recommend that physicians notify the patient in writing that they intend to withdraw from providing further care. In the written statement (which should be sent certified mail, return receipt requested), the physician should advise the patient that he can no longer continue to provide treatment and expects that the patient will therefore seek care elsewhere. The physician should indicate that while the patient is in the process of seeking care elsewhere, if there is any emergent circumstance, of course the physician will help the patient. However, the physician expects that the patient will actively seek other care and will obtain other care in the near future. We also recommend that the physician include the names of other qualified physicians in the same geographic area as the patient. The physician can further remind the patient that he or she can consult with the local medical society, the local hospital, or other reference sources in order to find someone of his or her own choosing. We generally recommend that the physician include a statement that it will be expected that the patient will be under the care of another physician within a set period of time, often a month (although this can vary with the circumstances), and it will be presumed that after this time the patient has obtained alternate care, barring some extraordinary circumstances that the patient should bring to the physician’s attention.

Good Samaritan Laws Good Samaritan laws have been enacted in an effort to encourage the rendering of medical care to those who need it, but otherwise might not receive it, by persons who come upon such victims by chance. If you have provided care to a patient voluntarily in a circumstance that you believe might put you in the position of a “good Samaritan,” you should discuss with your defense attorney whether there is a good Samaritan statute in your state that might immunize you from a lawsuit. Unfortunately, the scope of good Samaritan statues is often not as broad as physicians would like. For example, at least one court has determined that a good Samaritan act in that jurisdiction cannot be invoked to immunize a hospital physician who assists a patient at a hospital during a medical emergency. The theory of the court was that the physician

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rendered aid in a fully equipped and staffed hospital to a patient who had been admitted for the purpose of receiving medical care, and therefore the good Samaritan act did not apply to immunize the physician from the patient’s medical malpractice suit. The point, however, is that if the circumstances in which you treated a patient who has brought a suit against you were such that you think that there is even a possibility that a good Samaritan act might apply, this issue should be raised with your defense attorney.

Damages In the typical medical malpractice claim, the plaintiff will be seeking compensatory damages for alleged acts of negligence. Compensatory damages are damages that are designed to reimburse the plaintiff, to the extent money is able to do so, for injuries that are proximately caused by the defendant physician’s negligence. Compensatory damages can include pain and suffering, lost wages, medical expenses, emotional distress, and other theories for damages that vary from state to state. In some cases, there may be a claim made for punitive damages. Punitive damages are damages that are intended to punish the wrongdoer in an effort to prevent the wrongdoer from repeating the offending act. Punitive damages typically flow from actions that were intentional, wanton, willful, or grossly negligent, not merely negligent. When punitive damages are claimed, they typically will not be covered by the insurance policy. As discussed earlier, this will typically trigger a letter from the insurance carrier advising that it will not indemnify the physician for any award of punitive damages, and hence the physician should consult personal counsel. As an aside, there are many attorneys who hold themselves out as experts in “asset protection.” These attorneys will work with the physician to situate his or her assets in a manner that it will be more difficult for a plaintiff’s attorney to get to. Generally, this asset protection plan must already be in effect before the claim is brought in order to be effective. To our knowledge, these asset protection plans have not been completely tested so their effectiveness is not entirely clear. In practice, many plaintiffs’ attorneys usually accept the insurance coverage as payment in full for any claims and do not typically go after personal assets of a physician. However, particularly when a physician is in a very high-risk specialty or jurisdiction, it may be worthwhile to meet with an attorney who specializes in asset protection. Even if these programs are not l00% effective, the more difficult it is for any plaintiff to get to personal assets, the better.

Joint and Several Liability Joint and several liability simply means that when several defendants are found liable, each is liable for the entire amount recovered. The plaintiff can select from whom to try to collect. For example, if three physicians are found liable, the plaintiff could choose to collect the entire amount from one of the three physicians. The

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theory is that it should be made easy for the innocent victim to collect from the culpable parties, and hence the plaintiff can choose to collect the entire award from any one of the three physicians found to be liable. This principle of law has led to outcomes in which a party who was found to be only one percent responsible was forced to pay for all or most of the damages. Some states have modified these harsh rules by statute. It is recommended that physicians consult with their defense attorney to determine what rules are applied in their jurisdiction.

Comparative Versus Contributory Negligence In some cases, a plaintiff may bring suit against a physician claiming that the actions of the physician were not reasonable in the circumstances. In reality, however, the patient may have acted unreasonably and this is the reason for the patient’s injuries. Contributory negligence means that the plaintiff did not act reasonably in the circumstances for his own protection and safety. In some jurisdictions, contributory negligence by the plaintiff may bar all recovery. However, other jurisdictions use comparative negligence, which means that the fault of the physician and the fault of the plaintiff will be apportioned. In other words, the negligence of the patient will not be a complete bar to recovery, but the recovery will be reduced to the extent that the plaintiff’s own actions contributed to the harm. Your defense attorney should be fully familiar with the comparative negligence or contributory negligence law in the jurisdiction in which your case arises. In the event that there was any negligence on the part of the plaintiff, you should alert your attorney in order to allow him to take any legal actions that are indicated. One of the difficult decisions that defense attorneys often have to make is whether to claim that a severely injured plaintiff is responsible for his own injuries. For example, if a plaintiff is paralyzed from the neck down and his contribution to these injuries is minor, your defense attorney may decide that the jury would be alienated if it is actively argued that the patient contributed in a small way to the ultimate injuries. Hence, a decision as to whether to argue comparative negligence at trial is often a very difficult judgment. In some cases, a defense attorney may decide to bring the negligence of the plaintiff to the attention of the jury as part of the overall factual situation but not ask the court to charge the jury that the defense is claiming comparative negligence by the plaintiff.

Note “The material contained in this publication is for educational purposes only and is not intended to serve as a substitute for the professional services an attorney would normally provide to a client, including up to the minute legal research. Accordingly, this material should not be relied upon as legal advice for any individual legal action.

Chapter 3

The Plaintiff’s Attorney Lee S. Goldsmith

Introduction As is often the case, perception and reality, when associated with a given set of circumstances, have no common ground. This appears to be especially true when applied to medical negligence litigation. The physician’s perception of the problem differs from that of the attorney and most certainly differs from that of the patient. No patient enters into a physician–patient relationship with thoughts of future litigation. There is a condition that is a problem or a perceived problem that warrants medical care and attention. The patient is seeking care from a professional in whom he will place his trust, even if there has been no past relationship. The need for care is present, and the trust is given. However, not all patients enter into the relationship blindly, and some assert their right to question decisions, especially as problems and levels of anxiety rise. The responses that the patient receives from the physician often determine the ensuing events. The patient and often family enter into the relationship with a level of anxiety independent of the level of education, the nature of the problem, and prior information that has been obtained or given. Notwithstanding the amount of research the patient and family have done or the amount of information that they have received from prior practitioners, the patient and family want answers and have questions. This need for information will compete with the amount of time that the physician has available or wants to give to the situation, and the resolution should be patient dependent. A patient with a cataract to be removed might demand an hour of time to obtain an explanation and then come back with additional questions. Another patient with glaucoma might require 15 minutes for an explanation, although an hour has been set aside. Indeed, the situation might be reversed. However, if the patient demanding an hour is only given 15 minutes, the seeds of discontent may have been sown. Each patient has to be treated individually, but consideration must be given to individual differences and needs and they cannot be dismissed casually. Studies have indicated that the degree of patient recall is limited after an informed consent is given. Because of anxiety, the memory lapses are understandable and this may well occur with members of the family, but certain facts remain. How long will M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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the surgery take? The time may be 1 hour and this is the information given to the family. However, the family is sitting outside the operating suite. When the 1 hour passes and there is a second or a third with no information being given, anxiety rises and questions will be asked and need to be answered. A “disappearing act” never works. Sending an assistant, a nurse, or a resident is never satisfactory. The person with whom they had the discussion has to show up and answer questions. If that does not occur, another seed is planted and discontent rises. Any physician who starts the day thinking about prospective patients bringing suit should probably not be practicing medicine. This negativity and hostility will be passed to the patient and create an environment that will encourage litigation. A physician who overbooks, does not keep appointment times, and rushes patients in and out of the office is potentially creating problems. The patients will forget these problems if the outcome is successful but will remember every slight and every inconsiderate action if there is a problem. Physicians should answer questions and be responsive even with the difficult patient and especially if there has been a problem. Good medicine avoids litigation. Good communication averts litigation. As a result of the changes in medical practice over the past 15 years, less time is being spent with the individual patient. Getting authorizations to provide care may be difficult, and delays in treatment lead to patient frustrations. The patients or family members cannot take out their grief with the insurance company so the physician will become suspect. Care not being given because the physician will not be paid can be perceived as care not being given because the physician is only interested in money. In addition, as the patient reads about physicians in the press relating to Medicare or Medicaid fraud and physicians read about malpractice lawsuits, the physician–patient relationship may be affected. Physicians state that they would never respond at the time of an accident because they may be sued, but they either forgot or do not know that physicians are not sued when they are good Samaritans. We as lawyers know that we will not win. Every time a physician does act as a good Samaritan, the good press that is engendered helps every other physician in every situation. A typical situation in which an attorney is called is when a combination of events occurs, that is, an untoward event or a patient or family member becomes upset, and these events are combined with an unresponsive or hostile physician. The physician has the initial relationship with the patient and family and can usually control the actions of the patient and family, but when physicians do not fulfill their obligations it leaves a vacuum to be filled by the attorney to the attorney’s benefit. Fact patterns seem to indicate that one of the physicians involved in a case either directly or indirectly goads the patient or the family to seek legal advice. The attorney is no more than the receptacle for the ill will and anger that has escaped the physician’s control. When the patient is no longer in the hands of the physician and is in the hands of the attorney, the attorney becomes the decision maker. In the Veterans Administration hospital system and in some states there is now the requirement that the physician tell the patient or the patient’s family if there has been a medical error. It is always important to speak to the patient and/or family after an incident. If the truth is not possible, tell them what you can but do not lie.

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Patients and their families are not stupid, and with the Internet available they can check on the information they have been given. When a physician does not talk to the patient or family, it is disastrous. When the patient and family are lied to it is even worse and will ensure legal intervention. An example, although unrelated to ophthalmology is as follows: a patient slipped and fell at home and suffered a subdural hematoma. The treating physicians concerned about potential seizures after surgery prescribed intravenous Dilantin. Intravenous Dilantin comes in two forms: Dilantin dissolved in alcohol or in propylphenylhydantoin. The latter costs about six times the former but is absolutely safe intravenously. The former is dangerous. If the mixture extravasates, there is the potential to lose a limb. The patient lost her hand, and the family was told it was due to an allergic reaction. Both of the patient’s daughters have their PhDs. The hospital and doctor now have a major lawsuit exacerbated by their lying to the family coupled with the pharmacy problems. This was a family who might well have never consulted an attorney had they been told the truth in the first place. They truly do not believe in litigation.

Case Analysis The experienced attorney is probably the potential defendant’s best friend. The attorney is interested in two things and in the following order. First, the attorney is interested in the nature and extent of the injury. The extent of the potential damages will determine whether any consideration is given to potential liability. The handling of medical malpractice cases is extremely costly. Money has to be expended to obtain records, to have experts review those records, and to hire court reporters for depositions, life care planners, and other potential damage witnesses. The basic case cost will run between $20,000 and $100,000. Unless a potential case can ultimately achieve damages in excess of at least $300,000, the patient’s claim will often not be considered. Second, the attorney is interested in the issue of liability. How clear is the potential for liability? How difficult will it be to prove liability in the particular case? The degree of difficulty in proving liability will be factored against the potential damages when the firm decides whether or not to accept the case. The greater the damages, the cloudier the potential liability can be, and, the smaller the potential damages, the clearer the potential liability must appear to the reviewer and ultimately the jury. Experienced lawyers know how to evaluate the damages in the individual case. What is an eye worth? What are two eyes worth?

Client Intake—History and Damages The initial client interview is done in two phases. The first intake will generally be done by a paralegal. The purpose is to get the basic information in the shortest period of time.

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Who is involved? Who are the potential defendants, and are there any potential conflicts of interest? If a name is raised that can create a conflict of interest, the conversation with the potential client will probably end. A conflict of interest is present if the firm has represented the physician in the past or if the firm has worked with the physician as an expert in the past. An ancillary question is, who is the individual seeking counsel? Is the potential defendant a world-renowned physician whom every juror will know, or is he someone whom the potential jurors might not care to see as a patient? What does the individual state is the problem? For example, “My husband underwent cataract surgery in the doctor’s office and died on the table.” This response will lead to follow-up questions. What are the damages? The ultimate answer might vary with the state (jurisdiction), but the follow-up questions will be the same. “How old was your husband? Was he 40 or 80? Was he employed, or was he retired?” In most states, the 80-yearold retired male would not create sufficient damages to warrant litigation regardless of how clear the liability might ultimately be. The information from the initial intake is then passed on to an attorney for a decision. The attorney will be looking at the record from two perspectives. Was there an act of omission? Was there an act of commission? An act of omission is a failure to act when action should be taken. Failure to order an eye examination for a premature infant receiving oxygen in a neonatal intensive care unit or failing to order antibiotics in the presence of an obvious infection would be acts of omission. An act of commission would include ordering the wrong antibiotics for an infection or taking a patient to the operating room when the procedure might be contraindicated. If the information obtained in the initial intake warrants follow up, a formal interview will take place. This will be conducted by an attorney with the purpose of fleshing out the information gathered initially. This will also allow the attorney to evaluate the client to determine the client’s ultimate ability to testify and the impression he will make. It would be nice to say that ancillary factors do not influence case selection, but they must. What is the attitude toward malpractice cases in a given county? The attorney might consider the fact that the case would be tried in a rural and conservative county and the potential plaintiff is a drug using exconvict with tattoos over obvious portions of his body (e.g., “kill” on his knuckles and a skull on his forearm). Proving a case for this individual would be extremely difficult. The jurors would recoil from his presence only a few feet from them while they are in the jury box. It would be a very courageous attorney who would take on such a case in a conservative county. However, if the case involves a mother with minor children and she is permanently injured, the damages would be evident and she would be a very presentable witness.

Medical Records—Collection and Review Based on the interviews and determinations, authorizations will have been obtained from the client. With these authorizations, the relevant medical records will be

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obtained. These are the records that surround the incident of initial concern. The initial materials will be used to focus in on the main events, and ultimately all of the medical records will have to be obtained. For example, if eye surgery was performed in a surgicenter or in a hospital, the records of the institution as well as the records of the treating physician and all of the subsequent treating physicians are obtained. The records of the subsequent physicians are important for the purposes of evaluating the nature and extent of the damages suffered. Once the records are obtained, they will be analyzed. This can be a relatively complex process. A patient might be in the hospital for months, and the records may amount to hundreds of pages. The largest record obtained in my firm was 4000 pages thick. No matter how long the record, the issue of malpractice will amount to only a few pages involving acts of commission. If a problem arose during surgery, attention would be focused on the day of the surgery and all of the notes and forms prepared for that day.

Internal Analysis The internal analysis will start with the numbering of the pages. This may be done through the copier if the records are scanned. Numbering the records allows for a thorough review and retrieval of specific pages at a later time. Concurrently the medical literature will be reviewed and a decision made as to whether the attorney believes there was negligence. If the answer is in the affirmative, the records will be sent to a medical expert for further review.

External Analysis The attempt is usually made to find an expert who has specific knowledge in the area in question. Does the surgeon use a laser to treat patients? Is the potential defendant a neuroophthalmologist? The attempt is made to find an expert with knowledge of the specific area and who has had some experience in reviewing cases and testifying so that he or she would be expected to be able to handle and withstand cross-examination. Some practitioners, while very good in their profession, do not have the added skills needed to be an expert. The selection of the expert is the second most important decision after the decision to accept the case.

Decision to Proceed Once an expert has agreed to testify, the decision will be made to proceed with the litigation. The complaint will be drafted and served on the physician(s). Defendants have many complaints about the process. Why is it that so many individuals are

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named as defendants? The easiest case for the plaintiff’s attorney is bringing into the case only one defendant. However, in a given set of circumstances, more than one physician may have seen the patient, and from the records no one can determine who did what with the patient or what the potential communications were among the defendants. Not knowing what will be said, or who may point the finger at a colleague, it is often necessary to name all involved physicians. If physician A is named and not physician B and the statute of limitations runs so that physician B cannot be included in the litigation and thereafter physician A blames physician B for the problems, then the plaintiff’s attorney could theoretically be liable for legal malpractice. Early in my career, I was assisting an attorney in a case in which an individual had a laminectomy and the vena cava was perforated from behind. The team realized the problem, a general surgeon was called in, and the patient was turned and opened. Despite the efforts of the general surgeon, the patient died on the table. The original attorney, wanting to be just and basing his case on the opinion of his expert, sued only the spine surgeon. The defense at the trial, through their expert, indicated that there was an error but had the general surgeon, who was not a defendant, done appropriate work the patient would not have died. The lawyer had committed malpractice by not naming and including the general surgeon in the lawsuit. At the time of the trial the statute of limitations had run so the general surgeon could not have been named a defendant. If the general surgeon had been sued he would have obviously felt abused, but under the circumstances of the state laws there would be no alternative. Therefore, the tendency among lawyers is to sue everybody and let the defendants fight it out among themselves. The second major gripe that physician’s have is the manner in which they are served the summons and complaint. This often is the physician’s fault. The process server wants only to serve the summons and move on to serve the next one, day in and day out. Every summons served earns a fee. Therefore, the easier it is to serve a summons, the less time the server will spend on any individual summons. If the server enters a doctor’s office during office hours it is because a call has been made and the process server knows that the doctor will be there and will theoretically be able to accept the summons quietly and professionally. However, if the physician is unwilling to come out of his office or tries to avoid the process server, the process server will use whatever means necessary to accomplish the task. Our process servers are always instructed to speak to the receptionist and quietly ask to speak to the physician after explaining why he or she is there. However, if the physician does not come out after a reasonable period of time or tries to sneak out the back door, the server is allowed to use his or her own judgment.

Interrogatories In most states, prepared sets of interrogatories will be served on both the plaintiff and defendant. Interrogatories are a series of questions that are prepared to give the opposing side some insight as to facts of the case. The interrogatories will often

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request additional information, and copies of the physician’s curriculum vitae will be attached as well as an additional copy of the records. There is a tendency to review the materials requested prior to turning them over to the attorney for attachment. During this review there can be a tendency to make a curriculum vitae look better or to “amend” the records. Resist all temptations, and never ever “amend” the records. As a physician, you make notes in patient records, and this may be your total physical involvement with those records. You may be unaware that an insurance company has previously requested a copy of the records. In one case we obtained the copy of the records obtained by the insurance company and they were different from the original records. In another case, a subsequent treating physician requested the records, and we obtained a complete copy of that physician’s records as well as the records of the first physician. When compared with the originals, they were different. In a third case, the patient obtained a copy of the records; when this occurs, we always re-request the records and then compare. Sometimes physicians’ egos make them believe that they are brighter and know more than anyone else, and, no matter how often they are told not to change, alter, or amend records, they cannot control the impulse to exhibit superiority and proceed to amend the records with disastrous results for them and great results for us. Another approach to the medical records comes with obtaining all the medical records as well as the billing records. The medical records are looked at carefully, and the billing records will be compared with the visits, pharmacy records will be compared with prescriptions, and when necessary the original records and their inks will be analyzed. The next best thing to finding changed records is to find charges to Medicare that are unrelated to treatment rendered. Getting an assist from either the state or federal government with insurance fraud is always advantageous. Although it may not have anything to do with quality of care, it does have a great deal to do with honesty and telling the truth. Similar statements can be made regarding the curriculum vitae. The curriculum vitae might be brought up to date, but the document should not be embellished. As attorneys, while we might not have access to the National Practitioner Data Bank, there are alternate ways to get information. We can access the websites of the state boards of medical examiners and of the National Board of Medical Examiners. Two other easy sources of information are the physician’s own website and the website associated with the hospital where the physician has privileges. As a routine practice during the first visit by the client to our office, we access and copy information from the client’s the website to obtain a snapshot of the physician at a given point in time. A quick search will be made to determine whether the physician has written any articles that are not included in the curriculum vitae. Finally, we Google the physician’s name. Prior to the depositions, the attorney has two goals. The first is to learn as much about the client as possible from as many sources as possible. In one case the defendant had written and submitted an article on the events involved in the case. The case was of interest, and the problems were worthy of publication. However, the article treated the situation in a manner that was directly opposite to the defendant’s subsequent medical testimony. In another case, the defendant basically set the standards in an article written on the subject matter of the lawsuit. Second and probably more important for the attorney is learning the medicine of the case as well as the defendant

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physician. The intelligent attorney will always be working with an expert. The attorney will start by reading the literature and relevant text materials. Then the attorney will sit down with the expert and spend the time reviewing the areas of negligence and discussing approaches to the deposition. By the time the deposition is taken, the attorney should be able to foresee every step in the procedure and be fully conversant with all of the records necessary for the deposition as well as the relevant literature.

Depositions Many attorneys believe that the deposition is the most crucial part of the case and requires maximum preparation. Attorneys may join their experts in reviewing surgeries or videotapes of the type of surgery performed, reading the relevant literature, and discussing the case at length with the expert who has agreed to testify on behalf of the plaintiff. The deposition questions will often be outlined in advance. How the deposition will be taken and the areas to be covered will vary depending on the rules of the particular jurisdiction and on the purpose for which the deposition is being taken. Ultimately, the process will be up to the individual attorney taking the deposition and on that individual’s techniques. I like to start a deposition with a question that I do not think will be anticipated for the purpose of getting the overly prepared witness flustered and more open to follow-up questions. A rule that some attorneys follow is to ask every question they can think of and then additional questions. The problem with this technique is that questions that should be asked will often be omitted. Questions that should be asked include the following circumstances: ● ●

● ●

All conversations between the witness and all other relevant witnesses Pertinent portions or questions in the curriculum vitae (including questions about failing the boards, retaking the boards, or articles written) The interpretation of laboratory tests and their relationship to the particular problem Areas of medicine not only directly pertinent to the theories of liability but also potentially relevant to any defense that might be raised

In our office, we will generally videotape the deposition so that the deposition can be reviewed and analyzed in the office after it has been completed. In addition, being on camera is something most individuals have not experienced and will often cause nervousness and agitation. This tape will be used for trial.

Trial Preparation Trial preparation will vary depending on the jurisdiction and on the relative rules in that jurisdiction. There is only minimal cross-state uniformity. In the state of New York, the attorneys do not exchange expert reports or even the names of the experts

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being used. What is supplied is a general outline of the credentials of the expert, which is generally sufficient to identify the individual. In Pennsylvania, expert reports have to be exchanged and have to be detailed so that each side will have a clear picture of what their opponent will say and the context in which it will be said. In New Jersey, not only are expert reports exchanged but also each side will have the opportunity to take the deposition or oral testimony, under oath of the opposing expert; therefore, prior to encountering the witness on the stand, attorneys can test the opinions of the expert. Depending on the state, or jurisdiction, the nature and degree of pretrial discovery will affect trial preparation. As a plaintiff’s attorney, I always assume that every case that I take will have to be tried, and I prepare each case from that point of view. As the date of the trial is set and approaches and there is no settlement, final trial preparations will begin. The following steps are likely to be included in the trial preparation. Models will be obtained and reviewed. We have models of many anatomic parts in the office. These represent the normal and will always be accepted by the court as part of the evidence. These are to be reviewed with the expert who will use them as part of the testimony prepared for the direct examination. They also help the expert to explain the anatomy as a basis for discussion of the errors that occurred. Charts will be prepared. These anatomic charts do not depict the normal, and they are prepared by a medical illustrator. The purpose of these charts is to show the abnormality that was present and the errors that occurred. They are used by the medical expert on direct testimony. However, when preparing these charts we know that they can be used by the defendant’s attorney not only in cross-examining our expert but also with his expert on direct examination. Therefore the illustrations must be carefully prepared so that when used by the defense they do not become damaging. Some years ago we were involved in a nonmalpractice case involving a young child who received trauma to his eye. The position of the plaintiff was that the blindness in the eye was caused by the trauma. The position of the defense was that the blindness in the eye was a result of Coats’ disease. The plaintiff had kodachromes taken of the retina and showed these to the jury. The defense’s expert brought to the jury colored photos in a text to demonstrate that it was not trauma but Coats’ disease that caused the blindness. During summation the plaintiff’s attorney showed the kodachrome slides and held up the book next to the slides. The jury was asked to compare the two. The two pictures did not look alike. The boy had been traumatized, and the jury found for the plaintiff. Some documents will be enlarged. There are usually portions of the records, be they hospital records, office records, or insurance records, that become important. The intention is to use these enlargements during the entire trial. They could be used by the experts. In one case that did not come to trial, the enlargement, which was a note in a hospital record written by a resident, was used by the plaintiff at a settlement conference. The patient had undergone a cataract operation that had gone badly. A week later when seen in the clinic the resident wrote: “This patient one week post butcherotomy.…” Obviously, it was an inappropriate note but caused the case to be resolved. This page would have been blown up and placed before the jury at every opportunity.

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The expert designated by the defendant will be investigated. The name of the individual would be sent out on various professional Internet list serves and prior reports, depositions, and trial transcripts would be obtained. There will be a literature search to determine what the defense expert has written and whether any of the prior testimony, prior reports, or literature conflict with the testimony expected to be given at the trial. These materials would be prepared for cross-examination during the trial. Depending on the case, we often subject the case to a pretrial mock trial. This is done by hiring a consultant, preparing the case as it would be presented during the actual trial, and then presenting the case to a “jury.” We tend to obtain the potential “jurors” from the county in which the case is to be tried. Questionnaires are given to the jurors before they hear the testimony. The entire case presentation is videotaped for review, as are the jurors’ deliberations. At the end of the case presentation and prior to deliberation, the jurors are presented with an additional questionnaire. We are looking for juror biases, weaknesses in the case, how the jurors react to particular witnesses, and how the presentation of the case should be changed. The changes are made in order to maximize the potential likelihood of obtaining a plaintiff’s verdict and a potential verdict that will be sizeable. After the mock trial is completed, final preparations begin. The opening to the jury will be revised, and the witnesses will be prepared for their direct examination. Potential cross examinations of witnesses will also be prepared. If appropriate, special questions will be briefed for discussion with the judge prior to jury selection. For example, suppose it is known that the plaintiff had contracted a venereal disease and that fact is in one of the hospital records. A motion may be made to have that fact excluded from mention at the time of trial as being irrelevant to the facts and the issues in the case. The only reason it might be mentioned is to do damage to the plaintiff’s reputation. After the trial presentation, a jury consultant may be hired. The consultant, who specializes in jury selection, will work with trial counsel at the time the jury is selected to sift juror information, assist in the determination of the type of questions to be asked during jury selection, and advise counsel on which jurors should be selected or rejected from the jury.

Conclusion ●

●

For a plaintiff’s attorney to be successful in handling a medical malpractice case, the first step, the evaluation and decision to accept a potential case, is the most crucial. Every potential juror is going to be a patient at some time in the future. Jurors like physicians and need physicians for their own care. We rely on the arrogance of the defendant physicians not only in assisting us in obtaining clients but also in helping us prove the case once the case is initiated.

Chapter 4

The Trial Judge David S. Cramp

The U.S. Supreme Court has said in Daubert v. Merrill Dow Pharmaceuticals, 509 U.S. 579 (1993), that trial judges have a gatekeeper role to play in determining the qualification of expert witnesses and whether the opinions of the experts are sufficient to send to a jury. Thus, in virtually every case in which a proximate cause between the event and damage to the plaintiff is alleged, a hearing would be required before the trial judge to determine three things: 1. Whether expert testimony is required 2. The qualifications of the expert 3. Whether the opinion is scientifically reliable It is the third question that is most vexing to trial judges. There are three means by which the proponent of expert testimony of scientific results can prove the reliability of the testimony: 1. The testimony of knowledgeable experts 2. Authoritative scientific literature 3. Pervasive judicial decisions that acknowledge such general acceptance of expert testimony The third circumstance almost never occurs in our jurisprudence, nor is there any requirement that an expert witness’s theory has achieved general acceptance within the scientific community. Rather, the test is whether the opinion is based on scientific principles and methodologies of the type reasonably relied on by experts in the scientific field. In most jurisdictions, the rule in most cases is that if a substantial minority of the applicable scientific community accepts a particular theory, it is admissible in evidence. To illustrate how far this theory may lead, the New Jersey Supreme Court recently held that the differential diagnosis methodology was reliable, and testimony about the methodology would be received by a jury. In reviewing the gatekeeper role as set forth in Daubert, lawyers will have to be particularly sensitive to the varying interpretation by the state’s Supreme Courts. For example, in New Jersey, Rule 702 governs the admissibility of expert testimony, and New Jersey has not yet fully adopted the decision in Daubert. These technicalities aside, the test (or standard) of Frye v. United States, 293 F. 1013 M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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(D.C. Cir. 1923) is almost unanimously accepted as the three-part standard in demonstrating reliability. These three methods have survived since 1923. General acceptance in the scientific community is not an end in itself. It is reliability that must be ensured. Consequently, unanimous belief or universal acceptance is not required, because there can always be some detractors to any scientific theory. The function of a trial judge is complicated in a field such as ophthalmology because it is complex, permitting a number of treatment modalities (often implicating surgery) that are all generally supportable. It is the task of the trial judge to determine whether an opinion of an expert commands sufficient respect in the field of ophthalmology that it should go to a jury with all of the other relevant evidence. It is particularly vexing for trial judges because, generally, they do not understand enough about ophthalmology to recognize that an opinion by an expert does not attract sufficient respect among practitioners. How would it be expected that a trial judge would have familiarity with the technical details of a field as wide-ranging as ophthalmology? How would a judge know about anterior segment surgery, cataract surgery, corneas, glaucoma, neuroophthalmology, ocular oncology, oculoplastics, refractive surgery, retina and vitreous, immunology, or even the basics of these so-called subspecialties? In each, there are technical requirements that would overwhelm the most avid student of scientific requirements—an attribute that most trial judges do not possess. Consequently, a hearing on the issues is of crucial importance. It is essential that a trial judge be supplied with enough information to make an informed judgment. To argue that an opinion by an expert requires no less than inclusion in a peer-reviewed medical journal may not carry the day if the peerreviewed material is weak or not on point or if the literature (any literature) contains an opinion that is strong enough but has not yet appeared in a peer-reviewed journal. The trial judge’s view is always subject to the prospect that an appellate court may disagree that the trial judge’s findings of fact are sufficient. The gatekeeper role is not one to which trial judges are accustomed. Junk science is a difficult concept that presents enormous problems for the trial judge trying to make a determination that is fair for everyone. Most judges simply do not know enough about the subject matter to make a reasonable determination. In a further example, in State v. Cavallo, 88 N.J. 508 (1982), the New Jersey Supreme Court stated, “The Frye test recognizes that most judges are experts in few, if any, fields of scientific endeavor … [and that] judges are not well-suited to determine the inherent reliability of expert evidence …” (Id. at 521). However, the Court said that judges “can decide whether the proffered evidence has gained general acceptance” in the scientific community (Ibid). Yet, the stakes are high. Trial judges instinctively know that scientific evidence may be viewed as conclusive by jurors. In United States v. Addison, 498 F.2d 741 (D.C. Cir 1994), the Court (after applying the Frye test) said: “Since scientific proof may in some instances assume a posture of mystic infallibility in the eyes of a jury of laymen, the ability to produce rebuttal experts, equally conversant with the mechanics and methods of a particular technique, may prove to be essential” (Id. at 744). Because ophthalmologists perform operations on eyes and are generally classified as surgeons, it becomes more than essential at a hearing on the subject of

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expert qualifications and proximate cause that all relevant information be brought forward to assist the trial judge in performing the “gatekeeper” function. The function is there. Use the opportunity. What may seem odd for a judge to say, and may seem idiosyncratic, is that, in my experience, jurors simply do not like expert witnesses. Jurors recognize that expert witnesses are paid, and jurors look hard at other areas, such as appearances, evidence of prevarication, and other incidents to make determinations. To some extent, jurors decide cases on facts that cannot be anticipated and on factors that cannot be foretold. Often, a show of arrogance by the defendant will be enough. I was once involved in a case in which the defendant appeared to display some arrogance about his being a defendant in the case. My Court Clerk hated him; the jury, as it turned out, hated him. My staff hated him. I would not have agreed. Yet, the jury decided the case against him. In one case, jurors waited and waited for the defense expert to testify. He arrived very late, and the defense attorney asked why he was late. He said, “I have to make a living.” The jury did not listen to a word he said and decided the case against the defendant. I am convinced that the jury held the expert’s remark against the defendant. I have tried many medical malpractice cases and am convinced that if a physician does his best to treat a patient properly, using his best skill and training, that doctor will prevail. It does take an enormous effort in court to be polite, to not betray any impatience, and to act vitally interested throughout the trial, but it is well worth it. I liked it when a physician defendant (openly) helped his attorney. The best cases I was involved in from the point of view of the defendant were those in which the defendant was respectful, helpful, and then explained in detail the theories and methodologies that he or she utilized in treating the defendant. In most states, the charge to the jury is very favorable to the defendant and can easily carry the day. However, there cannot be any slip ups such as a lackadaisically prepared defense. The most effective defense is when a physician can take the stand, effectively educate a jury, and steer the jury to the physician’s point of view. This, in my opinion, is worth all the expert witnesses who can be called. Here is one last thought. In a hospital setting, there is a tendency to let the resident complete the discharge summary. Often, the resident’s knowledge is incomplete. Why any physician would ever allow a resident to complete the discharge summary is incomprehensible to me. I guess that the practice has grown popular because of time constraints. However, beware, because a jury may believe that a physician who does not have time to do his own discharge summary does not deserve much time of the jury. Remember, when you get six people together as a jury, they become the most difficult people. They are impatient, cranky, and believe that their time is to be protected at all costs. They are often wrong, but they are the system. Learning to play the system is crucial. An intelligent defendant, actively involved in his or her case, is of the utmost importance.

Chapter 5

The Medical Expert Edward L. Raab

Introduction “Doctor, I need an expert witness. Will you help?” Note that this is a request, not a command, unlike a subpoena for jury duty. If you react with instant aversion, then say “no.” However, a positive response probably will lead to an interesting professional experience. Most physicians are unfamiliar with legal procedure. We are accustomed to being “in charge” in our usual environment, but the legal arena is unknown territory. This chapter, based on my own participation, presents an overview of the role of the medical expert and how it is fulfilled, particularly in malpractice litigation.

Why Are Experts Needed? The medical malpractice plaintiff must prove that the defendant physician’s acts or failures to act did not follow the applicable standard of care and that these were the direct and substantial cause of whatever harm the plaintiff has suffered. The jury (occasionally the judge) is responsible for determining whether this has occurred. Some conclusions can come from one’s own education and life experience. However, nonphysician jurors cannot call upon their own backgrounds to resolve questions involving medical care standards. An expert is required to inform and educate the jury through special knowledge and experience about the unfamiliar subject matter of the dispute. The unique feature of expert testimony is that it consists of opinions on matters in the case and that the jury will employ these opinions prominently in its findings.

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Who May Be a Medical Expert? The judge is the gatekeeper who determines whether the proffered expert is legally competent to serve as such after hearing the physician’s responses to questions about his or her education, residency, and possible fellowship training. In actual practice, the requirements usually are easily met by the holding of the pertinent professional licenses and specialty board or equivalent certification. A distinction should be made between competence to provide expert opinions and the weight that the jury will give to such testimony. Relevant experience in the field and publications are persuasive indicators of expertise. The court may not require practice in the ophthalmic subspecialty involved in the dispute, but a request to serve as an expert in an unfamiliar field is an invitation to courtroom disaster for both the expert and the case. I have seen this occur when a general ophthalmologist testifying on behalf of a plaintiff claimed it was malpractice not to have made strabismus measurements in nine positions, ignoring every other detail of a thorough analysis that led to an intelligent decision on treatment. The defense expert made short work of this textbook argument, which constituted the plaintiff’s entire case. In this instance, “will you help?” would have been better interpreted as “should I help?”

Basis for Expert Opinion The special qualifications (education, training, and experience) of the medical expert allow the expression of opinion, but the court will allow the jury to consider only opinions that are appropriately reached. Reliability of expert testimony depends on whether it is based on the kind of information a member of that discipline would ordinarily use to form a professional judgment and whether the foundation for that information is generally accepted within that professional discipline. Perhaps unduly, courts regard peer-reviewed publication as a prominent hallmark of validity. In any event, “junk science” derived from unproven, unaccepted methodology is disfavored, and you can be certain that the opposing attorney will explore this question of your sources.

The Process In deciding to serve, the physician undertakes certain obligations to the engaging attorney, who is fulfilling his or her own legal and ethical professional responsibilities of vigorous advocacy for the client. Doctors typically disparage attorneys for not comporting themselves “above the fray,” but this is an unfortunate misunderstanding of the lawyer’s role. If a potential expert will not actively assist the attorney in advocating for the client irrespective of whether plaintiff or defendant, including testifying if necessary, the assignment should be declined.

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The expert will be asked to review the case file, typically consisting of the pleadings (why and for what relief the plaintiff is suing and the answer to these allegations by the defendant), medical and hospital records, various documents from which each party learns the merits of the other’s case (“discovery”), depositions (examinations before trial of the parties and often of other individuals with personal knowledge of the circumstances), reports of the opponent’s experts and perhaps their depositions, and reports of economic experts on the extent of the plaintiff’s financial harm. Often some photocopies are illegible, and replacements should be requested. To protect the credibility of his testimony, the expert should require inspection of all available medical documents in the case. I have personally observed the extreme embarrassment of a witness whose opinion was given with no knowledge of convincing contrary information in a portion of the medical record with which he was never supplied. I find it helpful to do an initial general reading in order to learn what each side says about the case. This should be followed by a more detailed line-by-line analysis, particularly of the medical and associated records, which can consume much time. The first goal should be to address the most important issues. The expert’s analysis may cast matters in a different order of priority than that of the attorney, whose strategy will depend on knowledge of the medical facts and on how to have them presented in the most favorable light possible. The objectives are to point out the strengths as well as the weaknesses of the case and to identify any good argument for the other side. The attorney benefits most from being able to see, through the expert’s assistance, the case from both opposing perspectives. As part of a thorough attempt to assist, the expert should offer to read the day-by-day transcript of the trial, if one later takes place, to point out additional opportunities or problems. When the medical review indicates an unwinnable case, should the expert recommend settlement? My practice is to avoid direct suggestions on legal strategy. The advice can be conveyed indirectly by offering an estimate of the likelihood of prevailing based on the medical assessment. One way or another, the expert should deliver the message despite the probability of the loss of a witness fee. The element of surprise is not a part of litigation, which explains the discovery process and the requirement for exchange of information between the opposing parties. However, for valid strategic reasons, such as a decision that expert testimony on one or more issues will not be introduced or that a different expertise is required, a formal written report should not be prepared unless requested. If made, it should include a listing of every document reviewed, and it is proper to include a statement reserving the right to amend the opinion on the basis of later-received information.

Testifying Juries are inevitably influenced in one direction or another by a comparison, the so-called battle of the experts. For this reason, an attorney chooses an expert not only on the basis of the required qualifications but also for whether the expert will project

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an impression of knowledge and confidence. These latter qualities are assessed by the opposing lawyer as well in evaluating the expert’s effect on his client’s case. Trial procedure calls for the expert’s willingness to be flexible about dates and times for appearing. Delays because of revision of the trial schedule, juror problems, the intervention of other court business preempting the judge’s time, unexpectedly prolonged testimony of other witnesses, and other factors should be expected and accommodated, as these are generally outside of the attorney’s control. The compensation agreement should reflect a reasonable figure for time spent that includes such delays. The expert should appear punctually for the deposition or trial and treat the adversaries courteously at all times. Dress should be conservative. Depositions are most often conducted in a setting other than a courtroom, typically in the office of the attorney for one of the parties. This does not diminish the formal nature of the exercise. At depositions while temporarily off the record, confine conversation to “small talk.” During the trial, be extremely careful to avoid even informal interaction with the jurors or the attorneys for other parties, even extending to the courthouse elevators. Courtrooms generally are arranged so that the witness stand is just to one side of the judge’s bench, facing the “well,” which is where the parties’ attorneys have their tables. The jury box typically is along the side wall nearest the witness stand. Although attorneys ask the questions, testimony should be directed at the jury, in keeping with the expert’s role of educator and informer. Directly facing the jurors irrespective of the location of the questioning lawyer accomplishes this objective. Be prepared also for questions from the judge, who has the discretion to assist in clarifying the jury’s understanding of the issues. If your testimony involves a demonstration requiring you to step off the stand, ask the judge’s permission to do so. Answer only the questions asked; additional information can be inadvertently damaging. When you do not know an answer, this should be stated, but when applicable, point out that you do not know because nobody does. Pause before replying to the opponent’s question; this gives an opportunity for objection by the attorney engaging you if the question is improper. There should be no discussion of the case with uninvolved persons, colleagues who also may actually become witnesses themselves, and above all with the party for whom the expert is testifying. This last is because of the importance of avoiding even the appearance of collusion. The expert must be able to state under oath that no such collaboration has occurred. This does not preclude casual greeting or temporary intermingling provided that no substantive discussion of the case occurs.

“Minefields” for the Expert The appropriate goal of the opposing attorney during cross-examination is to discredit the testimony of the expert. Do not be intimidated by the questioner’s possibly brusque manner. Remember that it is not personal; on occasion my services

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have been solicited by a lawyer by whom I have been vigorously cross-examined in a prior lawsuit. One attempt at discrediting is to have the expert admit to no personal publications on the subject of the case. I counter this by indicating the extent of my handson clinical care experience and any unpublished lectures and pointing out that other subject areas in my field have taken priority for my literary efforts and have resulted in numerous publications. An additional point of attack is to ask how often the expert has testified in medical malpractice cases and whether it is always for the same side. The opposing attorney hopes to convince the jury that you are a “hired gun” and a biased one at that. Your answer must be truthful; to the extent that it presents a credibility problem, this was or should have been evaluated by the attorney who requested your participation. It is common to inquire about on what literature sources the expert relied. The opposing attorney hopes to raise the inference that the expert has been less than diligent and not up to date on the necessary information. An effective reply, if truthful, is that the expert did read not in order to form an opinion but to test the reasonableness of that opinion against those of knowledgeable colleagues concerning similar facts. Another minefield is whether a certain published work (usually professing an opinion other than the expert’s own) is considered an authority. This depends entirely on the definition of “authority.” If the witness believes that any opinion from that source ought to be followed without question or hesitation, the point must be conceded, but it is far more likely that an expert chosen for his or her qualifications can reply that while the opinions detailed in the suggested authority are worth considering, they do not necessarily apply to this particular case and in any event must be filtered through and reconciled with the expert’s own knowledge and experience. You might be asked whether your testimony is based on personal examination of the patient. This actually is irrelevant, because, as noted earlier, experts may rely in forming their opinion on the kinds of information customarily relied on by similarly situated practitioners of the discipline. The medical and associated records clearly fall under that criterion. Your best reply is a simple “no”; if necessary, the attorney who engaged you is probably able to elicit the same response from the opposing expert. An issue whose importance is usually overemphasized is whether and how much the expert is to be compensated for testifying. The correct characterization is that compensation is for time lost from income-producing activities, not for the testimony itself. This explanation will be entirely truthful if the hourly rate charged is reasonably related to that of the expert’s usual charges for medically related efforts.

More Advice Do not underestimate the abilities of the attorneys on both sides of the case, many of whom have specialized in this area of the law for a long period. Their lawyering skills and preparation for trial are likely to be considerable, and they are functioning

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in their own arena, to which the physician is essentially a stranger. Most important, the physician expert should understand that while the attorneys may seek to intimidate as part of trial strategy (risky in many instances), they are merely adversaries, not enemies. Learn the outcome of the case, and take the opportunity to hear the jury’s evaluation of your testimony, as may have been revealed in the customary postverdict interview. This and the attorney’s own evaluation of your efforts are very instructive for the further development of your interest and effectiveness.

Chapter 6

Sequence of Events in a Medical Malpractice Lawsuit Marvin F. Kraushar

Why Patients Sue We tend to overlook the fact that patients do not come to a medical office with the prior intent to sue. They come hoping to be cured. Something occurs during the course of the physician–patient relationship to cause the patient to seek an attorney to “find out why.” This is very often due to the unavailability of the physician to answer questions about a problem. It can also be the occurrence of an unexpected event (anything other than a perfect result). The problem is frequently the “lawsuitcausing physician” and not necessarily the “litigious patient.” The best means of risk prevention in these situations is for the physician and all members of the staff to demonstrate caring and compassion at all times. Patients tend to forgive a suboptimal result if they feel they were treated with understanding. While patients may not have the knowledge to judge their level of medical care, everyone knows when they are treated with respect. Patients who experience repeated rudeness in their encounters with the physician and/or staff will want retribution: Whenever one person treats another person shabbily, the human tendency is for the injured party to want redress for that shabby treatment. Patients are often moved by vengeance to sue their physician and they do not do such a thing hastily. It is not one mistake that angers patients but rather repeated insults that grate upon the patient until a mistake occurs that breaks the camel’s back. The frustrated patient needs only for damage to occur to complete the foundation for a lawsuit. It is not necessarily the money that patients who have been mistreated want. Suing is the only means to vengeance that is available to the patient.1

Most plaintiff attorneys agree that their angriest clients are patients suing for medical malpractice.

Prelawsuit Activities The physician is not part of a lawsuit until he or she is served with a summons. Prior to that moment many other actions will have been taken, and knowledge of these activities may alert the physician to the possibility of pending litigation. The patient

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has, for whatever reason, become dissatisfied with the level of care and/or compassion he or she has received and is no longer keeping appointments at the physician’s office. Thus the physician–patient relationship has been terminated, and the patient has spoken with someone, such as a family member, friend, or another physician, following which a decision was made to consult an attorney. The attorney has assessed the facts provided by the patient and decided there may be a worthwhile financial opportunity in a lawsuit (without which practically no case will be accepted). Larger law firms are typically more stringent in their financial assessment of potential suits and often turn over weaker and/or less lucrative claims to smaller firms or solo practitioners. Next, the attorney who accepts the case, with the written permission of the patient, has requested from your office a copy of the patient’s medical record. You may also have been advised by the medical records department of the institution at which you performed surgery that a copy of the records has been requested. By now the plaintiff’s case has evolved over a considerable period of time. At such time as the physician becomes aware of any of these developments it is imperative that the medical malpractice insurance company is contacted and brought up to date in order that it may begin its process so the plaintiff will not get even further ahead. The insurance company will not add this incident to the total of claims against the physician if no claim is filed. The medical records are the property of the physician. You must comply with the request for a copy of the patient’s record provided the request was accompanied by a release signed by the patient. Be certain not to send the original of the chart or any other information until you have contacted the insurance company. Avoid any temptation to alter the record, because the consequences of such an action can be devastating to the defense as is discussed in detail in another chapter. By no means should you hide or throw away the file in anticipation of claiming it was lost. A lost file is not only a sign of sloppy office management, it suggests intent to conceal unfavorable facts. Most requests for records are for matters other than a malpractice lawsuit (relocation to another part of the country, a second opinion, accident, insurance, claims for disability, etc.) Do not contact the patient or the patient’s attorney to inquire as to the reason for the request for records. Beware of a request for medical records by means of a “subpoena duces tecum.” This can be used by an agency investigating a physician (State Board of Medical Examiners, hospital credentials committee, etc.) or by an attorney for a patient who has a problem with someone other than the physician from whom the records are requested. The subpoena has an official appearance, which can be intimidating to physicians. The format of the document creates the assumption it is an order of the court, no release from the patient thus being necessary. In reality, nothing could be further from the truth. The natural tendency of the physician is to forward the requested material. Complying with the subpoena if no release is provided is a violation of federal Health Insurance Portability and Accountability Act (HIPAA) regulations, with the possibility of penalties and litigation for release of unauthorized information for which physicians have been successfully sued. Although it seems grossly unfair that physicians are held liable for compliance with these arcane documents in the absence of a properly executed release from the patient,

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the courts have ruled in these cases that ignorance of the law is not an excuse. Consult your insurance company for assistance before considering any response. The plaintiff’s attorney will also have obtained (and probably paid a retainer to) an expert medical witness for a review and opinion. Many states have a law requiring a “certificate of merit” to be executed and signed by a physician attesting to the likelihood of malpractice before a lawsuit can actually be brought. These certificates are hailed by the trial attorneys’ bar associations as a means of preventing frivolous suits. While a small number of suits may be avoided by this means, the criteria for the allegations in these certificates are intentionally vague and so broadly worded that any physician can sign one without fear of contradiction or retribution. A sample from one state reads, “I have read the materials presented to me regarding the treatment of this patient and it is my belief that there exists a reasonable probability that the care, skill or knowledge exercised or exhibited in the treatment of —— by the defendant fell outside acceptable professional standards or treatment practices.” The next step in many states is for the plaintiff attorney to venue shop for a jurisdiction with a reputation for jurors sympathetic toward plaintiffs. The choices are often limited to those counties where the patient resides, where the physician resides or practices, or where the alleged negligent treatment was given. Some states are more liberal than others in granting discretion for choice of venue. Larger urban centers are renowned for juries sympathetic to plaintiffs.

The Summons Once the claim is filed, the next step is service of the summons on the physician defendant. The summons contains the location of the court, the names of the plaintiff, the plaintiff’s attorney, the defendant, and the reason for instituting the suit. The physician should contact the insurance company as soon as possible. Although the summons is required to be served personally, it is often left with the physician’s receptionist or even mailed without a return receipt. The natural tendency for the physician if served in such a manner may be to indulge in wishful thinking and to disregard the summons because of apparent “improper service.” This is a mistake in practically every instance, because the law allows a great deal of latitude to plaintiffs in many phases of a lawsuit lest they be deprived of “their day in court.” Furthermore, by this stage, the plaintiff’s attorney has already spent a significant amount of time and money and is certain not to allow the statute of limitations expire for fear of being sued for malpractice by the patient. Further delay by the physician allows the plaintiff an even greater head start in the process, thus putting the defense further behind. The best course of action is never to make any decision regarding the lawsuit on your own. The insurance company should be called immediately, because there is generally a finite period of time within which the defendant’s attorney must answer the summons. The summons having been served, the physician is now, short of tendering a premature offer to settle, inextricably a defendant in a high stakes situation and must do whatever is possible to be in the most advantageous a position at all times.

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Selection of an Attorney The insurance company will assign an attorney to you. Although the insurance company also has a stake in the attorney’s management of the suit and doubtless feels the attorney is competent, you should try to find out something about him or her before agreeing to the assignment. Your personal attorney can do the appropriate research as to whether the assigned attorney is a relatively senior member of the law firm and can also get an idea of his or her track record because these facts are public and easily obtainable to those who are familiar with the procedures. It is rarely necessary for the physician to hire an attorney in addition to the one assigned by the insurance company. An attorney in whom you cannot feel confident or with whom you have difficulty relating should be replaced by the insurance company, which also has a stake in the best defense possible. You should also ask for a different attorney if there is more than one defendant and the attorney or his office represents a codefendant. If you are convinced there is a significant chance that your case is weak and the verdict may exceed your coverage (unusual in almost all cases), retaining a personal attorney is a good idea.

The Physician–Attorney–Insurance Company Relationship Complete cooperation with the attorney and the insurance company is essential to a successful defense. It is critically important that the physician educate his or her attorney regarding the medical facts of the lawsuit not only so that the attorney can provide a better defense but also for the attorney to be able to ask more relevant and probing questions of the plaintiff’s witnesses. To this end, it is imperative that the physician defendant critically review all the plaintiff’s and plaintiff’s expert witness’ allegations as well as any exculpatory evidence for the defense. This should be accomplished by a line-by-line review of all documents as well as a search of the pertinent literature. This exhaustive search usually results in penetrating questions with which the defense attorney can confront the opposition. By no means should this daunting task be left solely to the defense expert, who may be capable and well intentioned but who does not have nearly as much riding on the outcome of the lawsuit as the defendant. Of the utmost importance is a truly dispassionate personal review of the claim by the physician defendant. Any possible weakness no matter how personal or embarrassing should be divulged to the attorney in order to avoid damaging surprises at a later date such as during the deposition or in the courtroom. This information may also aid your attorney in counseling whether to consider settling the claim. No mention of the claim should be made to anyone outside the circle of the physician’s immediate family and the defense team.

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The Complaint The complaint document is served with the summons in some states or may be sent to the defendant’s attorney at a date after service of the summons and the response by your attorney. The nature of the allegations is usually a combination of several accusations. These include failure or delay in diagnosis, failure or delay to treat, negligent treatment, and/or informed consent problems. Lawsuits can also involve vicarious liability for the acts of others, such as operating room nurses or technicians covering physicians. The complaint is difficult and emotional reading for a defendant for two main reasons. First, it is a shotgun list of practically every possible manner in which the physician may have improperly managed the patient’s care. If the plaintiff’s attorney were to list only those alleged deviations readily apparent in the records and the expert’s report and the statute of limitations were thereafter to expire, the plaintiff might be precluded from alleging anything further should new information become available at a later date. This would not only harm the patient’s claim but it would also put the patient’s attorney at risk for a malpractice suit by the patient. This is also why practically any physician who interacted with the patient during the period of allegedly negligent treatment is also named as a codefendant. The unfortunate problem associated with this practice is that many medical malpractice insurance companies will count this as a lawsuit, and it can affect the codefendant’s future premiums even though the claim against him or her is eventually dropped because the insurance company will have incurred expenses involved with defending this claim no matter how short its lifespan. The second upsetting part of reading this document, if you practice in one of those states that allow it, is the “ad damnum” clause. Herein the plaintiff names the amount of money he or she is seeking as damages. This amount is usually extremely high for a couple of reasons. First, just as when you are negotiating the sale of a house, you can always come down in price but it is difficult to go up. Second, a large monetary demand can be intimidating to the physician defendant especially if it exceeds the limits of the malpractice insurance coverage, thus tending to encourage a settlement. In this document it is not unusual for the plaintiff’s spouse to ask for additional monetary indemnification because of “loss of consortium.” The allegation is that the injury suffered by his or her spouse because of the defendant’s negligence has prevented the plaintiff from fulfilling his or her spousal role. More recently some states have expanded the law to also permit children to make a similar claim. A nightmarish possibility is future expansion of the law allowing this same privilege to children and/or grandchildren not conceived at the time of the alleged negligent act.

The Narrative Summary At this point, many medical malpractice companies will send a representative to the physician’s office to obtain a summary in the physician’s words as to exactly what is on every line of the chart and related documents from the first to the last visit.

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The purpose of this is to create a document for a physician in the same specialty to do an in-house review for the insurance company. The reviewer will assess the strengths and weaknesses of the claim in order that the insurance company will have a clear-cut opinion of whether the claim is defensible and to determine how much money to put in reserve for the defense and any likely patient indemnification. The physician is often asked to meet with the reviewer and the claim manager from the insurance company to provide details for this purpose.

Selecting the Expert Witness The quality of expert testimony is one of the most important considerations regarding malpractice litigation. The plaintiff’s expert will state the defendant’s management was below the standard of care, and the defendant’s expert will state it was within the standard of care. The jury will deliberate as to whose opinion they believe. It can be a great help for the physician to recommend one or more possible experts to the attorney who may not be familiar with ophthalmologist expert witnesses. Although impressive expert credentials may make the jury accord more credence to the testimony, the choice should not be made purely on the basis of academic rank, high volume practice, number of publications, and so forth. The expert must be someone who can make a convincing, authoritative presentation and think on his or her feet (especially under cross-examination). More will be said about this in another chapter. Frequently an experienced attorney will suggest an ophthalmologist with a proven track record. To avoid the appearance of a conflict of interest, it should not be a personal friend or someone with whom you have worked closely in any medical or personal manner.

Discovery: The Process Once the battle is engaged, both sides have proscribed opportunities for fact finding. A great deal of patience is required on the part of the physician because the process is agonizingly slow. Discovery is accomplished mainly by review of records, reports by experts, interrogatories, and examination before trial.

Review of Records The plaintiff will request a complete copy of the patient’s record, with any additions since the original request was made. There may also be a request for a typewritten copy of the office record if the original record is not sufficiently legible. Everything in the record is usually requested, including billing, laboratory results, and reports to other physicians. The office medical records are the property of the physician.

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A request for a copy of the records, if accompanied by a release signed by the patient, must be forwarded to the requesting party but only after consultation with the physician’s malpractice insurance company.

The Expert’s Report It is the job of the defendant’s expert witness to establish the standard of care. He or she must then, based on review of the facts of the case, be able to state that the defendant provided treatment within the standard of care. The expert must also successfully undergo what is certain to be a rigorous cross-examination by the plaintiff’s attorney at the deposition and at the trial. This is why selection of the expert is such an important process. The same applies to the responsibility of the plaintiff’s expert who must be able to state the defendant’s performance was “below the standard of care.” The crux of the lawsuit is the manner in which, after reviewing the same materials, both the plaintiff’s expert and that of the defendant can, by the selective presentation of those facts that are corroborative to their respective side, state that the performance of the defendant physician was within or below the accepted standard of care. “In effect, then, your treatment is being measured not against what you know to be the accepted standards in the community, but against the testimony of the plaintiff’s hired expert as to these standards.”2 Both sides may retain the same or separate experts to determine whether “within a reasonable degree of medical probability” the alleged negligence was a cause of harm to the patient.

Interrogatories Interrogatories are a series of written questions sent by each side to the other to be responded to in writing. Some of the questions may seem absurd (“Name every course you have taken and every article you have read on the subject of . . . ”). The physician’s attorney will ease the pain of responding to questions of this type with appropriate legal jargon. The preparation of the responses is a joint effort between the physician and the attorney.

Examination Before Trial (Depositions) The importance of the deposition stage of a lawsuit cannot be overemphasized. This is the taking of sworn testimony from the person being deposed (the deponent). Each side has the opportunity to obtain testimony from persons on the other side. The depositions of the plaintiff and parties on his or her side usually precede those

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of the defendant. Some states allow deposition of the expert(s), and others do not. Those present at the proceedings include the deponent (plaintiff or defendant), attorney(s) from each side, and a court reporter who records the proceedings and produces a transcript. The defendant may attend the deposition of the plaintiff and/ or plaintiff’s witnesses and vice versa. Hearing what the plaintiff and his or her expert have to say prior to being deposed yourself can increase your understanding of their case and help in preparing for your deposition. You may also be helpful to your attorney during the deposition by suggesting questions during a break. Your presence may have some intimidating effect on the plaintiff who may thus be a little less likely to exaggerate. At the very least you should familiarize yourself completely with the transcripts of these proceedings regardless of whether you were present. The choice of location for the deposition is agreed to by both sides. It may be an attorney’s office, the physician’s office, or a neutral site. Although it may be convenient for the physician to be deposed in his or her office, it is not a good idea for the physician to give the plaintiff’s attorney the opportunity to learn any more information than is absolutely necessary. A predeposition conference between the physician and his or her attorney is always advisable to review the strengths and weaknesses and to frame responses to expected questions. The warm, jocular, casual, friendly demeanor of the opposing attorney is a smokescreen designed to make the deponent dangerously relaxed and off guard. Never forget that this is a high stakes situation, and both sides are looking for whatever edge can be exploited. Before the deposition begins, the court reporter will swear in the deponent. The end result of the deposition will be a transcript of the testimony sworn to, corrected by, and approved by the deponent upon which the opposing attorney will rely as a bible in the courtroom from which to cross-examine the witness. The opposing attorney is looking for information of two different types. First, there is a search for factual information regarding the medical nature of the claim. This may include references to nurses’ notes, the anesthesia record, drug interactions, and so forth. This can be a daunting experience for the physician deponent who must also be maximally prepared regarding the basis for the differential diagnosis and management, as well as the rationale for rejecting alternatives. Knowledge of pertinent literature will usually be helpful. The second thing for which the opposing attorney will be looking is how good a witness the physician will be in court. Personal appearance and demeanor are of paramount importance. Haughtiness and/or a short temper can and will be exploited in front of the jury to the detriment of the witness. At the deposition the opposing attorney may purposely attempt to frustrate or anger the physician by repeating questions, asking a series of questions that are obviously not germane, making derisive remarks, or being combative. Physicians sometimes make the colossal mistake of supposing they can be so knowledgeable and persuasive at the deposition that they will convince the opposing attorney there was no malpractice and the case will be dropped. This is usually a calamitous error because experience shows it is far easier to lose a case at the deposition than it is to win it. By the time the deposition occurs the plaintiff’s attorney

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has carefully vetted the lawsuit for the probability of success. He or she has spent a great deal of time and has spent money for an expert’s opinion. The plaintiff’s attorney is usually not taking the deposition to see whether the case is winnable. At this point he or she feels there is a good chance for success and is at the deposition to find out how good a witness the defendant will be and how best to exploit defense weaknesses. The physician defendant would be wise to deal with the reality of the situation and realize that, having come this far in the sequence of events, he or she will most likely be going to court. Because the transcript of the deposition will be used by the opposing attorney as part of your cross-examination to try to impeach your testimony, it is essential to give as little information as possible during the deposition. If you do not wish to hear opposing counsel say in court, “Doctor, on page two hundred fifteen, on line twenty of your deposition you said …” do your best not create two hundred fifteen pages of testimony. “The more you commit yourself, the more likely you are to contradict yourself in the deposition and in the trial.”3 An effective technique to employ is one that is advised when taking the oral examination for the American Board of Ophthalmology. After the question is asked, pause before answering. This serves three purposes. First, it allows your attorney to object if he or she feels the question is improper. Second, it gives you time to form a better response. Third, it takes more time. There is only so much time the opposing attorney usually allots for the deposition. An extra hour or so is one thing but with few exceptions attorneys are not anxious to come back another day. If you do not understand the question ask for it to be repeated by the court reporter. If you still do not understand, say so again and ask the attorney to rephrase it. If you can answer sufficiently by saying only “yes” or “no,” by all means do so and take advantage of the opportunity to add nothing further. If you are asked to answer with only a “yes” or “no” and you feel that this would not accurately represent your opinion, say, “I will be happy to answer the question but I cannot accurately respond with a yes or no.” If possible, in a reasonable manner, it is good to show some spine and stand up to unreasonable questioning by the attorney. Do not allow opposing counsel to put words in your mouth. “Isn’t it true, Doctor, that you do not necessarily always use povidone iodine in the preoperative prep prior to cataract surgery?” Do not fall for the trick of agreeing with opposing counsel that a particularly noteworthy physician, medical text, or publication is “authoritative.” Consult with your attorney if you are not certain as to the proper response to this type of question, which is asked frequently. Be certain not to ramble or to give information for which no question is asked. Rambling is not a characteristic of a good witness and may provide the opposition with information about which they were not previously aware and would not have requested. If information you feel is crucial is not asked for by opposing counsel, your attorney may choose to question you on the record about this information or may reserve such information until trial. “If you leave the deposition with the feeling that you did not get a chance to tell your story, you were a great success. The other side failed.”4 A transcript of the deposition will be sent to you for your signature. Prior to signing it you must read it completely and thoroughly to correct transcription

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errors. Although it is still possible to amend a material misstatement at this stage, you may be compelled to explain “this change” in your testimony in a second deposition or at trial. As any change in your testimony may damage your credibility, it is important to answer correctly the first time.

Settlement Some policies restrict the decision of whether to settle entirely to the insurance company. Physician-owned insurance companies typically leave the decision to the physician with the caveat that if the company advises settlement and the physician refuses there may be financial liability on the part of the physician in the event of a plaintiff verdict. Consideration of settlement should be preceded by a totally honest analysis of any weaknesses in the defense as well as strengths in the plaintiff’s case. Stubbornness and ego must be set aside. “A likely penalty for being dishonest in your self-assessment, is to be stunned by the size of the financial penalty assessed against you by the jury in a trial.”5 A lawsuit can be settled at any time from the earliest days of the discovery process, during the trial, and even during jury deliberations. A plaintiff’s attorney who feels his case may have been received less than optimally by the jury may approach the defense attorney during jury deliberations and say, “You can never know how a jury will vote. Suppose we settle before they reach a verdict.” Plaintiffs consider settlement to ensure a monetary reward. Defendants settle for several reasons. Some physicians wish to avoid the courtroom at almost any cost. A study of ophthalmic malpractice lawsuits showed the most frequent factors influencing the decision to seek a settlement included altered records, poor documentation, informed consent problems, failure to see a patient promptly, and failure to obtain or follow the advice of a consultant.6 Lawsuits may be settled for fear that the jury award might exceed the upper limit of the malpractice policy. “When discussing settlement, you have to take into consideration that the plaintiff does not yet know a certain fact damaging to the defense, and that the emergence of that fact will drive the price of the settlement sky-high.”6 In fact, when a “runaway jury” awards an amount in excess of the upper limit of the physician’s coverage, the judge may adjust the award to within the limits of coverage in some instances except those rare cases in which there are particularly egregious circumstances. Occasionally even in a strongly defensible lawsuit, settlement may be the optimal course of action if the exculpatory medical facts are beyond the comprehension of a jury. Another consideration for settling a lawsuit might be the sympathetic appearance of the plaintiff, such as a small child with poor vision or an adult whose eye has a poor cosmetic appearance following postoperative endophthalmitis. One case involved a patient with an unsuccessful repair of a retinal detachment whose wife had multiple sclerosis and claimed her husband could no longer button her blouse because he had only monocular vision and poor depth perception. The documents drawn in a settlement state there is no admission of liability on the part of either side. The decision is a draw. Settlements also include an agree-

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ment that the amount of the settlement and the facts of the lawsuit must remain confidential. This protection from publicity, which is not available after a jury verdict for or against the physician, is often an important consideration in the physician’s decision to settle. Unfortunately this freedom from publicity is not guaranteed. Recently a newspaper in New Jersey was able to take advantage of the state’s sunshine law to force the courts to reveal medical malpractice settlement information regarding the state’s physicians (the paper never asked for permission to reveal similar information for attorneys, businessmen, accountants, etc.). The rationale for revealing the data was the interpretation that the provisions of the settlement agreements prevent only the parties in the suit (plaintiff and defendant) from disclosing the facts, and, because the court is not a party to the lawsuit, the court documents such as the transcript of the proceedings may be revealed. To further compound the problem, revelation of the settlements was allowed not only for prospective settlements that had not yet materialized but also retroactively for those lawsuits that had been previously settled and in which the physicians had a reasonable expectation of confidentiality. This development has naturally had a chilling effect on physician decisions regarding settlement. Before considering a settlement it is advisable that the physician investigate the sunshine laws in his or her state. Settlement of a lawsuit can in some circumstances affect the physician’s future insurance premiums and insurability. The insurance company usually takes into consideration the specific circumstances of the case before making a decision to raise the premium. The physician should be familiar with the practices of the insurance company prior to making a decision. This is discussed in greater detail in another chapter.

The Trial Attendance Optimal preparation is essential for all parties. This is the ultimate high stakes situation, and any edge that can be obtained must be sought. Consider the world class competitive swimmer to whom hundredths of a second can be the difference between winning and losing, who shaves his or her arms, legs, and torso to reduce drag in the water in order to get every possible advantage. The physician must be thoroughly familiar with all pretrial testimony in the form of depositions, expert reports, documents, hospital records, test results, and so forth. In all probability the plaintiff and his or her spouse will be present at all times. The physician should optimally be present throughout the entire trial to demonstrate similar interest. “If you come to court only to testify you give the impression that you do not care very much about the result. The jury may conclude that you do not care because you have a large insurance policy, and may use such reasoning to justify awarding the plaintiff a large verdict.”7 The presence of the physician’s

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spouse is likewise desirable. Rather than sit in the audience chairs, it is advantageous for the physician to sit at or near the table with the defense attorney in order to offer information when appropriate.

Courthouse Conduct You never know when you will be in the presence of one of your potential jurors. Your appearance, demeanor, and presentation should be such that any juror with whom you come in contact will feel, “I would like to have him as my doctor.” It is an accepted reality that patients are less likely to sue physicians they like (see Chapter 8). This also applies to jurors when deliberating, and it should not be overlooked. “The attorney is under no such constraining image regarding demeanor, etc. His television personality is often portrayed as one who is tricky, argumentative.… The jury expects and accepts these characteristics in an attorney, but not in a physician.”8 If you have a choice, do not drive to court in an ostentatious car. Be well dressed in a suit or jacket and tie, but nothing flashy, and with shoes polished. Do not talk loudly in the parking lot, elevator, hallways, and elsewhere. Hold the door for those persons behind you. Courtesy is the order of the day. Do not in any way interact with any witnesses or jurors.

Selection of the Jury Because medical malpractice litigation is a civil suit, only six jurors plus alternates are selected. Jury candidates are called and questioned (voir dire) by both attorneys. Each side has a limited number of peremptory challenges that permit them to excuse jurors without an explanation. Otherwise jurors may be excused only if the judge is shown good cause to believe the juror cannot be fair and impartial. Occasionally a juror might lie because he or she wants to be on the jury. “Jury selection is mostly guesswork based on the attorney’s feelings about the individual juror.”9 A potential juror in my trial mentioned her father had undergone retinal detachment surgery. My attorney suggested perhaps we should accept her. I suggested he ask whether the surgery was successful. When she answered in the negative my attorney requested that she be excused. The original concept of a jury was that it be composed of “peers.” This is often an awkward criterion in today’s multifaceted society in which many members of the jury pool are scientifically and intellectually unqualified to comprehend the facts of the case. Yet it is these citizens upon whom our system of jurisprudence depends. “The forte of a jury is its ability to sense when someone is lying. . . . This ability, based on the collective experiences of the many different kinds of people who comprise a jury, allows the jury the inside track on reaching the correct conclusion.”9

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Opening Statements The judge will begin with instructions to the jury. This is a civil trial and not a criminal proceeding, and thus there is no requirement that the jury reach a verdict unanimously and “beyond reasonable doubt.” Only a majority is required, and the criterion is “the preponderance of evidence.” This means, is it more likely than not? In other words, a verdict for the plaintiff depends on whether there is at least a 51% probability of the evidence in his or her favor. Each attorney then presents what is essentially an outline of what he or she intends to establish with evidence and testimony. Because the plaintiff has the burden of proof, his or her side of the case is presented first. This gives an advantage to the plaintiff because first impressions tend to be more lasting. This may be balanced by the fact that the defendant goes last and his or her comments are more recent and fresher in the jury’s memory.

Testimony of Others Be prepared for gut-wrenching delays throughout the day. Often the judge will not enter the courtroom to start the morning for over an hour while he or she listens to motions in chambers from attorneys who may be involved in other cases. On occasion the judge may decide not to have a court session on a given day. Either attorney can ask to stop testimony to approach the judge with lengthy off-the-record arguments. When testimony begins, the plaintiff presents his or her side of the case first. The testimonies of the plaintiff and the plaintiff’s expert witness often consist of nonstop criticism of the defendant, which is not easy listening for the defendant. Understandably and with the exception of cross-examination, only that selected evidence that is favorable to the plaintiff will be presented, usually with exaggeration and sometimes with little consideration for the truth and occasionally by outright lies and unbelievable fabrication. Consider this example: A patient was seen in the morning by an ophthalmologist and was diagnosed with a condition that required surgery that day. She was told to go home and remain abstinent from food or liquids and that she would be called later in the day when the operating room was available. The surgical result was unfavorable, and the patient sued. At trial she attempted to make the surgeon look as bad as possible and stated that when she was called at home to go to the hospital she told the ophthalmologist she had lunch and claimed the physician instructed her to go to the hospital and say she had not eaten. To make the situation seem as bad as possible, she claimed she told the physician she had eaten onion soup, garlic bread, pork chops with sauerkraut, and three cups of coffee. Jurors will look at the physician during the testimony of others, and it is best not to show excess emotion. If the plaintiff or his or her expert exaggerates while testifying and you quietly turn your head slightly left-to-right-to-left, it may convey your disagreement to an observant juror.

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Expert witnesses, especially those testifying for the plaintiff, have been known to stretch the truth and occasionally to knowingly go beyond the boundaries of the truth. If the expert testifying against you is presenting obviously false testimony, there is little that can be done during the trial other than effective cross-examination and/or rebuttal by the defense expert. False testimony can be dealt with after the trial by reporting the expert to the specialty society for sanctions and/or for use by the attorneys of future defendants for cross-examination. The manner in which I dealt with a plaintiff expert who fabricated facts in his testimony against me (the jury verdict was in my favor) was to purchase a copy of his trial testimony and send it to the state board of medical examiners, which suspended his license.

Testimony of the Physician Defendant The courtroom can be as intimidating and unfamiliar to the physician defendant as the operating room is to the patient. If you have never testified, it is a good idea to find some time during the day during a period of inactivity when the jury is not present to sit in the witness chair and accustom yourself to the setting. On the day of your testimony, in order to get whatever edge possible, it can be helpful to pay attention to the smallest details of personal attire. Psychological studies have shown that the most persuasive combination of clothing is black shoes, a white shirt, navy blue suit, and a red tie. If you do not believe that this combination provides an edge, look at what the President or any member of congress wears when giving an important speech or interview. There is even a classic “power tie,” which is red with diagonal narrow stripes of white within black. The same studies show the least persuasive tie color is green. This is not to imply that if you dress this way a jury will believe everything you say, but you can bet successful politicians get an edge with it and so should you. In the final analysis, “The most effective witness is a doctor who has humility, compassion and conveys the impression that he did the best he could.”8 “No matter how correct one’s testimony is, it only counts if the jury believes it.”10 When you testify as a defendant you are only a fact witness. You are asked what you did and why you did it. Establishment of the standard of care or the breaching of it is the responsibility of the expert witnesses. Occasionally the plaintiff’s attorney will feel it appropriate to call you as the opening witness and begin with his “crossexamination” of you. For this reason it is helpful to meet with your attorney prior to trial to discuss both your direct examination and your cross-examination. Whenever your testimony occurs it is advisable to take with you to the witness stand any documents or records to which you may want to refer. Do not be macho and feel you appear more in command if you speak without looking at records. No one can remember everything, and jurors do not subtract points for consulting records. There is no substitute for accuracy. Consulting records will impress upon the jury your desire for hard evidence as opposed to saying, “I don’t know but I suppose it was. . . .” Remember that it is the jury who will decide the case and not the judge, attorneys, and so forth. Therefore, your testimony should be directed to the jury. Before you

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sit down, make a point of angling the witness chair toward the jury so you are facing them as much as possible (hopefully the jury will notice this action). It is a good rule of thumb to maintain eye contact with the jury, especially on direct examination when you are explaining your side of the case. When your attorney asks you a question be sure you turn to the jury before responding. Ask your attorney whether to face the jury or the opposing attorney during cross-examination. This advice can be easy to forget during contentious cross-examination. Generally, looking jurors in the eye as you speak makes them feel like your patient and enhances your credibility. As your testimony goes on and you tire it is easy to lose total concentration especially during the cross-examination and thus be caught off guard. If you feel yourself tiring it is perfectly permissible to turn to the judge and ask politely for a brief recess. In order to remain “politically correct,” wait for a lull in the questioning before making this request, and do not do it in the middle of or directly after a challenging set of questions. On cross-examination the opposing attorney is trying to invalidate the testimony of the witness on the direct examination. The court allows the attorney more freedom from restraint during cross-examination, and the witness must pay extra attention to questions before answering. “The basic principle is that a truthful witness will be able to weather cross-examination.”9 Remember, it is the jury whom you must convince, not the attorneys or the judge. Despite the fact that the jury pool is drawn from the entire local population, the makeup of the jury is controlled by the attorneys during the selection process. Naturally attorneys prefer someone who will be sympathetic to their side. With few exceptions they try to get jurors who are neither too dumb nor too smart. The ideal juror is one who can comprehend the material and still be persuaded by the attorney. For this reason, physicians, attorneys, corporate officers, and so forth are usually not selected. Typical jurors are merchants, laborers, retired persons, civil service employees, high school graduates, and lower level executives. Intellectuals and their ilk generally need not apply. Consideration to the above should be applied to framing responses to questions. Your demeanor should be calm and confident and your responses unhurried. Verbal jousting with opposing council on cross-examination is inappropriate. Although there may be great personal satisfaction with a clever riposte to an accusatory question, it will most likely not be understood by the average juror, and it may have the additional undesired effect of making the physician appear arrogant and, most important, unsympathetic. A calm, reasonable response will be better received and may even create sympathy for the “victim.”

Summations Once both sides state that they have presented all of their testimony, the defendant’s attorney makes a summation followed by that of the plaintiff’s attorney. Each attorney has the opportunity to explain to the jury how the evidence supports his or her side. The defense attorney goes first and the plaintiff’s attorney has the last word, which is another advantage for the plaintiff because it is he or she who has the burden of proof.

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The Charge to the Jury The judge has the obligation to explain to the jurors the specifics of the law as they apply to the case and by what means the jury should attempt to apply them. There is usually some advice on how to evaluate the facts and testimony and how to decide whether there is liability on the part of the defendant (negligence that is the proximate cause of an injury suffered by the patient). The judge explains to the jurors that if they find liability they are next to consider damages and the basic principles by which to ascertain monetary indemnification for expenses, loss of income, and pain and suffering. The jury is then excused to begin deliberations.

Jury Deliberations and the Verdict Jury deliberations are yet another opportunity for an agonizing wait. Because juries are typically unpredictable, you should disregard the fable that “a quick verdict favors the defendant,” and do not get depressed if the deliberations are lengthy. There are stories of bailiffs overhearing jurors who are eating and joking when they are supposed to be deliberating. A defense verdict brings a feeling of exhilaration to the physician. Unfortunately the process creates scars no matter the result, and it cannot change the way he or she will experience the future practice of medicine. Despite “winning,” the physician cannot avoid a sense of some loss of ego and self-confidence. The situation, on a personal level, is analogous to that of Mr. Raymond Donovan, a former presidential cabinet secretary who was acquitted in a corruption lawsuit and following the verdict asked a questioning reporter, “Now where do I go to get back my reputation?” A verdict for the plaintiff is a stunning shock to the physician’s psyche even if it was somewhat expected. There is also the additional problem of a newspaper article. Plaintiff’s attorneys will frequently call the local newspaper to report the verdict in order to get free publicity, which is powerful advertising. Many attorneys proudly frame and display the articles on their office wall. Peer and patient knowledge of the result is a natural embarrassment for the physician and can be difficult to manage. The psychological effects of litigation are discussed in greater detail in another chapter.

Appeal The attorney for the losing side can make a motion for a new trial or file an appeal if he or she feels errors in procedure have occurred that may have influenced the jury’s verdict. This is usually a difficult goal to achieve because appellate courts tend not to interfere with the decisions of lower courts and accord great weight to the opinions of the lower court judge who tried the lawsuit and who obviously saw no reason to prevent the case from concluding as it did.

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Countersuits The countersuit lawsuit, against the patient, the patient’s attorney, or both, is almost always “the impossible dream.” The burden of proof for the physician is to show that the plaintiff or his attorney acted with malicious intent in a malicious prosecution case. In a frivolous litigation case one must show the plaintiff and/or his attorney knew or reasonably should have known there was no basis to file the case. The law in this respect is stacked heavily in favor of the plaintiff and attorneys. Attorneys freely admit that the threat of a countersuit might discourage plaintiffs from litigation and would thus deprive them of their day in court (does “them” refer to the patient’s day or the attorney’s day?). The laws are constructed to make it difficult for anyone to prevail in a countersuit for any type of litigation because of society’s preference for resolving disputes through the court system. When a plaintiff and/or the plaintiff’s attorney have obtained a certificate of merit from a qualified expert, this will usually be sufficient to protect them from any defense countersuit. The first criterion for being able to countersue is discontinuing the suit by the plaintiff, dismissal of the suit by the court, or successfully defending the lawsuit in court. The next hurdle is to prove malice, which, in the absence of an admission, is very difficult. The physician must next prove that the publicity of the suit was the proximate cause of a decrease in income from the practice of medicine—a difficult task at best. This loss of income is the only indemnification the physician can recover. There is no recovery for pain and suffering despite the number of sleepless nights, episodes of heartburn, and anxiety attacks the physician has suffered. The physician cannot recover any of the cost for time away from the practice that was devoted to trial preparation, meetings with the attorney, the deposition, or the trial. Spending this time is considered one’s civic responsibility and is not reimbursable. The physician cannot even recover the cost of bringing the countersuit. Except in unusual situations, the best course of action for the physician is to sublimate any feelings of hostility and rejoice in the admittedly insufficient vindication of the verdict.

Retribution for an Unethical Plaintiff’s Expert Witness Unfortunately, as in any field of endeavor, there are unethical physicians who will bend the truth or even present outright junk science to make a frivolous claim appear meritorious in order to generate an expert’s fee. Although attorneys typically familiarize themselves with medical information from textbooks, they are nonetheless to a significant degree dependent on the opinion of their expert. Similarly, while judges who preside over medical malpractice cases may also read appropriate medical texts, they too are dependent on the facts presented by experts on both sides. This dependence can alter the decisions of a judge during the trial regarding what testimony and what evidence is presented to the jury.

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Unless the defense’s expert is able to effectively counter the false statements of an unethical plaintiff’s expert with his or her own trial testimony there is little else that a physician can do. In the event of a verdict unfavorable to the physician the option is an appeal. Appeals are generally based on problems with the conduct of the trial and are not specifically concerned with the accuracy of the evidence presented. If the verdict is favorable to the physician the option is a countersuit. As stated earlier, countersuing is a daunting task. Regardless of whether the jury verdict is favorable to the physician defendant he or she still has the opportunity to stain the reputation of the unethical plaintiff expert witness, thus reducing the possibility of future unethical testimony. The first option is reporting the facts to the specialty board that can censure or withdraw certification. This information will be available to attorneys looking for experts, thus making it more difficult for the physician to secure future expert witness opportunities. A stronger course of action is available to any physician defendant who is willing to spend a few hundred dollars plus significant additional time and effort. This involves obtaining copies of the deposition and trial testimony of the plaintiff expert and sending them to the state’s board of medical examiners along with a detailed letter noting where the unethical expert deviated from the medical facts. These documents will usually be submitted by the board to one or more physicians in your specialty for review. The process may take as long as a year or two. I have personally done this twice following favorable jury verdicts and the board suspended the licenses of the experts one of whom retired shortly thereafter.

References 1. Davis GG. Pathology and the Law: A Practical Guide for the Pathologist. New York: Springer; 2005:82. 2. Alton WG Jr. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown; 1977:4. 3. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL: Aesculapius; 1984:48. 4. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL: Aesculapius; 1984:49. 5. Davis GG. Pathology and the Law: A Practical Guide for the Pathologist. New York: Springer; 2005:111. 6. Kraushar MF. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol 1996;114:333–337. 7. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown; 1977:177. 8. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL: Aesculapius; 1984:60. 9. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown; 1977:180. 10. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL: Aesculapius; 1984:57.

Chapter 7

Informed Consent Marvin F. Kraushar

History A brief review of the evolution of informed consent law will provide an understanding of the current status of the physician’s duties with respect to disclosure. The writings of Hippocrates, one of the earliest to discuss professional conduct,1 include phrases such as “concealing most things from the patient” and “revealing nothing of the patient’s future or present condition.”2 In that authoritarian age patients were expected to be obeisant, and the purpose of physician–patient communication was solely to persuade the patient to accept therapy. de Mondeville, a medieval physician, believed hope to be of sufficient therapeutic benefit to justify avoiding the truth. He advised, “Promise a cure to the patient but tell parents or friends of any danger.”3 In the nineteenth century, Benjamin Rush wrote, “Educate the patient about his condition.”4 His purpose for patient education was to motivate compliance with the advice of the physician. Although Rush thus proposed an informed patient decision, he was not an advocate of consent. “Courts very much tend to rule on the basis of precedent or previous decisions. This is called ‘stare decisis.’ Generally it takes either a most unusual case or a growing amount of social dissatisfaction with existing law for courts to consider overruling the present law.”5 Actual legal doctrine evolving from court cases pertaining to present day informed consent requirements occurred mainly in the twentieth century. A patient consented to an examination under anesthesia and requested no surgery be performed. The physician found a fibroid tumor of the uterus and removed it. In 1914 the patient sued (Schloendorff v. Society of New York Hospitals) and Justice Benjamin Cardozo wrote in his opinion, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault, for which he is liable in damages.”6 As of this date the law required consent but not informed consent. There was an additional problem for physicians in this ruling insofar as assault is a criminal offense as opposed to a civil offense. A patient undergoing translumbar aortography was left with a permanent paralysis. He sued his physicians (Salgo v. Leland Stanford Jr. University Board of Trustees7) and claimed they failed to warn him of the risk of paralysis, and had he known of

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this risk he would not have consented to the procedure. In 1957, the court ruled that “physicians have the duty to disclose any facts which are necessary to form the basis of an intelligent consent by the patient to proposed treatment” and thus created the doctrine of informed consent. A patient sued her physician (Natanson v. Kline8) because of severe burns from radiation therapy and claimed she had not been informed of this risk. In 1960 the court ruled in her behalf and, fortunately for physicians, also established that informed consent liability was negligence, a civil offense rather than battery, a criminal offense. A patient sued his physician (Canterbury v. Spence9) after suffering paralysis following a laminectomy and claimed he had not been warned of the possibility of this risk and would not have consented to the procedure had he been so warned. In 1972, the court ruled it is the physician’s duty to warn patients of “risks and alternatives” to treatment. This phrase, “risks and alternatives,” should be part of the vocabulary of any physician with knowledge of risk prevention. The children of a woman who died from cervical cancer sued her physician (Truman v. Thomas10). She had refused a Pap smear more than once and claimed she would have consented to the test if she had been warned of the risks of not having it. In 1980, the court found in her behalf and ruled the patient must be warned of “the risks of a decision not to undergo the treatment.” This is the doctrine of informed refusal. According to Faden and Beauchamp,11 It was case law that introduced the concept of informed consent to medicine in the twentieth century using the language of “self-determination.” Shortly thereafter informed consent was transformed into a social context beyond the law from a malpractice issue to a moral duty incumbent on physicians.

Definition Performing an invasive diagnostic or surgical procedure with improper consent or no consent in most instances is actually battery. Battery is intentional (not accidental or careless) physical contact for which the patient has not given permission. It is a criminal offense that can be punishable by incarceration, although incarceration is extremely rare. However, an intentional tort such as battery may allow plaintiffs to recover punitive damages that are not covered by malpractice insurance. Negligence is an unintentional act or omission and is a tort, a civil offense for which there may be monetary consideration. Patients rarely sue for only informed consent problems, but allegations regarding improper informed consent are included in almost every medical malpractice claim. “Courts are allowing consent cases to go forward in cases where they are suspicious that there really was negligence but it can’t be proven.”12 Members of the medical and legal professions are faced with many problems when considering the critical question of whether the appropriate legal standard has been satisfied in any given

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instance. The inherent difficulty of securing a definition of “informed consent” that satisfies both legal and medical requirements is but one of these. It is no longer enough to equate consent with the mere completion of a form; rather, it is the process of communication between health care provider and patient upon which subsequent judgments as to the extent and validity of consent must be made.13 Informed consent is a continuum and not a single event and should be viewed by the patient and the physician as collaborative and not paternalistic. The process begins at the first encounter and continues through treatment and follow up. Physicians tend to regard the process as a legal requirement to protect themselves rather than as an ethical process to involve the patient. Consideration must be given to the fact that patients and physicians often have different models of illness. While physicians may think of diabetes as a disease of blood vessels, many patients regard it as simply a lot of injections. Likewise, patients and physicians may have different treatment goals. It is common for patients to expect a cure with as little of their own input as possible, and it thus falls to the physician to encourage the patient to be an active participant. The criteria for truly “informed” consent include the fact that there must be understanding by the patient of relevant information. This is often idealistic in those instances of patients with a language problem regardless of whether an interpreter is present or in the case of many elderly patients with early dementia as well as in other circumstances. The consent must be autonomous with no coercion, manipulation, or persuasion. The patient must understand the process as giving of permission. The consent is not truly “informed” unless the patient understands it as an act of authorization regardless of how well he or she understands the medical information, risks, benefits, alternatives, and so forth.

Purposes There are four purposes to obtaining informed consent. 1. The informed consent process enables the physician to comply with the legal requirement to “disclose sufficient facts and information which are necessary to form the basis of an intelligent consent by the patient” (Salgo v. Leland Stanford Jr. University Board of Trustees7). Unfortunately this is too often the only reason physicians become involved with informed consent. 2. Many studies have shown that patient involvement in decision making improves patient compliance, thus increasing the chance for a better result. 3. Patient education regarding risks is perhaps the most powerful risk prevention tool available to physicians. The typical patient comes to the physician expecting a cure. Patient expectations in our society are so high that to most people anything less than a perfect cure will be an unexpected event. “Surprise produces anger and anger produces lawsuits.”14 Negligence attorneys agree that their angriest clients are medical malpractice plaintiffs. Studies in several specialties have shown that explaining the possibility

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of complications reduces patient expectations and results in greater satisfaction with whatever result is achieved. There are also studies in several specialties that show that patient retention of facts is less than optimal. Priluk et al.15 had a 15-minute prepared preoperative informed consent discussion with detached retina patients on admission to the hospital and tested their recall prior to their discharge from their inpatient hospital stay (range 2–11 days). Forty-three percent of the patients, none of whom had yet been discharged, were unable to recall all the material in the preoperative informed consent discussion. Furthermore, 54% of the patients with incomplete recall actually denied they were ever given the information. The authors’ conclusion was that patients understandably tend to remember favorable facts and suppress threatening facts. A more recent study16 of cataract patients questioned as early as the first postoperative day had similar results. Studies in cardiovascular surgery17 and plastic surgery18 were equally discouraging. Despite the results of these studies, it still makes good sense that physicians do their best to educate patients regarding the possibility of complications and less than perfect results for the purpose of risk prevention and to document these efforts. There are both videotape and computer website services available to help physicians document that they have obtained an informed consent. 4. Going through the process of informed consent gives the physician the opportunity to document having done so. Although patients have certainly been known to lie or exaggerate on the witness stand, on occasion some may honestly lose recall of the conversation. To refute the allegations of the plaintiff it becomes the responsibility of the physician to establish that the process did in fact occur. The options for documentation are discussed later in this chapter.

Indications The indications for informed consent include any diagnostic, therapeutic, or surgical procedure with an element of risk. As a rule the more elective the nature of the procedure (e.g., LASIK) the greater is the indication for informed consent.

Exceptions In specific circumstances it may be permissible to intentionally disregard the requirement for informed consent.19 1. Public health emergency actions such as quarantine or vaccination are often required by law. 2. Medical emergencies in which delay might be harmful are also an exception provided there is no evidence to indicate the patient would refuse the procedure (e.g., blood transfusion for a Jehovah’s Witness).

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3. An incompetent person, such as a minor when no parent or legal guardian is available or a person with diminished capacity, can in the appropriate circumstances receive treatment without informed consent. 4. The concept of therapeutic privilege enables a physician to withhold all or part of the informed consent discussion if it is judged that there would be harmful effects from the disclosure. This is a nebulous concept that presents a slippery slope and should be avoided whenever possible. 5. Waiver of informed consent by the patient can release the physician from the requirement of informed consent. Such a patient may say, “I trust you and I don’t need to have you explain it to me.” This situation is a “catch 22” because this waiver is in and of itself an actual consent and must also be informed. The physician should not allow the patient to waive the process for two reasons. First, defending this admittedly unclear concept in court is a tenuous situation at best. Second, failure to use the informed consent process deprives the physician of the opportunity for patient education regarding risks, one of the strongest risk prevention tools available.

The Standard for a Lawsuit To recover damages for lack of informed consent the patient must prove the treatment carried a known risk of which he or she was not advised, the risk occurred as the result of the treatment, and a reasonable person in the patient’s place would not have undergone the treatment if advised of the risk.

The Process Presentation of Consent Material The environment for the discussion should be leisurely and unhurried, and privacy should be respected. The concerns of the patient should be elicited, and he or she should be encouraged to ask questions. The discussion should occur within “reasonable proximity to the procedure” (an admittedly nebulous phrase). Problems include balancing information overload versus underdisclosure. When in doubt it is advisable to give more rather than less information. The material should be well organized, unfamiliar terms should be avoided, and lay terms should be used when possible. It is easy to lose sight of the reality that information that is too complex and not easily understandable will not have the desired impact on the patient’s decision making. It may also cause the patient to feel that his or her participation is not truly desired by the physician. This may lead the patient to feel that the purpose of the consent form is solely to protect the physician. Early in my medical practice I

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completed what I felt was a superb informed consent discussion only to have the patient’s husband say, “Okay Doctor, that takes care of you, now how about us?” Printed materials and/or audiovisual materials can not only save time but also increase patient comprehension. Distractions such as anxiety, fear, or pain should be recognized and dealt with as the situation requires.

Setting The patient should be invited to ask any interested party accompanying him or her to be present in the room during the discussion. This has the added benefit of not having to repeat all of part of the process to an interested party who may have gone outdoors for a smoke. The names and relationships of all those accompanying the patient in the room where the discussion is held should be recorded. In addition, the same information for anyone who accompanied the patient to the office but is not in the room should also be recorded (e.g., brother George in waiting room). Recording this information precludes any credible testimony on behalf of the plaintiff as to what material was covered by person(s) who were not actually present at the discussion.

Discussant and Discussion The discussant should optimally be the physician who will perform the procedure and not a fellow, resident, nurse, technician, or other staff. It is preferable not to delegate this task. The physician is the most qualified person and will be the one charged with the responsibility of defending any lawsuit in the courtroom. If the presentation is made by a video of the physician, by other audiovisual aids, and/or by someone else, the physician should be present at the end of the presentation to answer any questions the patient may wish to ask of a medical nature. Lay vocabulary should be used to increase patient comprehension. The nature of the problem and why it is of concern should be covered. The technique of the procedure should be described as simply as possible. The patient must be informed who will be performing the procedure and what parts, if any, will be done by someone else.

Risks, Benefits, and Alternatives The discussion of risks is of paramount importance because of the opportunity for patient education. Patients rarely refuse a procedure even after learning of serious risks. Fear that a patient will refuse a necessary procedure after hearing of a serious risk is not usually a sufficient defense for withholding full disclosure. Do not make

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the mistake of assuming just because you tell the patient he or she might die or lose an eye it is not necessary to make full disclosure of lesser risks. This will not usually impress a jury favorably. Furthermore, incomplete disclosure deprives the physician of the opportunity for better risk prevention by means of patient education regarding risks. Until recently the criterion for which risks should be disclosed was any risk that a “reasonable physician” judged significant. With the passing of the authoritarian age of medicine into the present day environment of self-determination, the standard has shifted in most states to any risk that would affect the decision of the “prudent patient.” Despite the evolution of the informed consent doctrine over the years there is presently no definitive legal guideline as to what risks or what type of risk must be disclosed. A continuing conundrum is the lack of a workable definition of a “material” risk. The courts have stated that a material risk is one that the average patient would feel is significant when deciding whether to agree to a diagnostic, therapeutic, or surgical procedure. Exactly how the courts expect physicians to know what specific risk will affect the decision of a given patient in a given situation is unclear. Basically, the more remote a risk is, the less likely a patient will consider it material. Likewise, the more severe the risk, the more likely a patient will consider it material even if it is remote. It is neither necessary nor possible to include every risk in the discussion. The physician must convince the jury that he or she made a bona fide attempt to include those risks that would influence the decision of a “prudent patient.” When it is applicable, do not forget to include the risks of failure to improve vision as well as decreased or total loss of vision. Frankness and complete honesty are essential to the discussion of benefits. Be certain not to say anything that might be considered a guarantee. Angry patients frequently claim a better result was guaranteed. I recall a plaintiff who swore he was guaranteed to improve from 20/400 to 20/20 vision following panretinal photocoagulation for neovascular glaucoma secondary to a severely ischemic central retinal vein obstruction. The discussion of reasonable alternatives should include those choices that might affect the decision of the “prudent patient” with an explanation of your opinion of the appropriateness of each and why you have chosen the procedure you are recommending. The alternative of no treatment must be included with mention of the likely consequences.

Questions for and by the Patient Presentation of all the above material by the physician is optimal. At this point of the process, regardless of whether the physician has personally made the presentation, it is essential that he or she be present to ask whether the patient has understood the presentation and to answer any questions of a medical nature. Even if there are no questions for the physician, his or her presence adds the personal touch and demonstrates caring. It is the physician’s responsibility to answer if asked how

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many times he or she has performed the procedure. When physicians misrepresent their experience or success rates with new or established procedures, many states view this as a “deceptive and unconscionable act” and allow patients to sue under their consumer protection laws. There is no obligation for the physician to volunteer information regarding his or her malpractice litigation history. If asked, the physician may decline to answer. However, if there is a complication and the physician had lawsuits arising from a similar complication, the patient may claim the physician deprived them of informed consent because disclosure of this information would have caused them to choose another physician. If the physician chooses to answer he or she may not misrepresent their claims history. Questions of a nonmedical nature such as time of surgery, place, and so forth, can be answered by a nurse, technician, or other staff.

The Consent Form At such time as the patient and anyone else in attendance with him or her have no further questions it is time to present the consent form. There are three types of written consent documentation.20 The first is the long, detailed consent form, which is the traditional means. The short form states that the patient has been informed but does not list specific risks, benefits, and so forth. The third method is a detailed note in the patient’s record. There is still controversy as to the relative values of each type. The long form and the detailed note in the record are basically the most appropriate. Many physicians make their own forms with or without consulting an attorney or medical society. Some states, such as Texas, have mandatory forms that if executed properly are a very strong defense for physicians. The American Academy of Ophthalmology has consent forms that are excellent, and several are procedure specific. By no means should a physician rely on only the consent form given to patients on arrival at the hospital or ambulatory surgery center registration desk. Any jury can rightfully be expected to feel sympathy toward a patient who claims, “The clerk didn’t explain much to me and I was so nervous about the procedure I signed the form in order not to make trouble.” After the patient has had sufficient time to read the consent form and after all his or her additional questions have been answered, it is time for the signature. The signature can be witnessed by a patient’s family member. I prefer to also have someone from my staff act as a witness. I do not have any of my staff in the room during the informed consent conversation. My staff witness is called in at the time the form is to be signed by the patient. It will not be the responsibility of my witness to testify as to what was or was not discussed. If litigation ensues I want someone loyal to me to be able to testify only that it was the patient who signed the form and it was signed on the date written on the form and not 3 months after the complication had already occurred, as I have seen patients allege. After the consent form is signed and witnessed, I impress upon the patient that “what you have just signed is permission for me to do the procedure. It

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is not an irrevocable contract and you can change your mind at any time.” This is intended to reinforce the concept of patient authorization.

Documentation At this point the consent has been documented. “Any number of experts can testify as to the competency of whatever medical of surgical treatment may be in question. However no-one who was not actually present in the room throughout the discussion can testify accurately in behalf of either the physician or the patient as to exactly what was or was not discussed.”21 For this reason I have tape recorded all my informed consent conversations in my offices since 1980. I keep the recorder on the desk in the room where the discussion occurs. Before starting the discussion I say to the patient, “The conversation we are about to have is rather lengthy and instead of having someone take notes I am going to make a recording so I have a copy.” I have not had a single patient ever refuse the recording. I use a double-sided 2-hour tape on which I can typically record a dozen or more conversations per side (the average time is approximately 7–10 minutes). The name and date are written in a small spiral notebook kept on the recorder. I store the tapes and notebook pages with my yearly income tax returns. The act of recording takes practically no extra time. Begin the recording by stating, “This is (date) and this is Dr. (name) explaining informed consent to (the patient and the name and relationship to the patient of anyone else present in the room).” While the process of recording may appear cumbersome and/or over the top (some physicians use videotaping) it can be a powerful and effective defense tool. If the plaintiff has in fact suffered a bad result, regardless of whether there has been malpractice, a jury will often be more prone to accord greater credibility to his testimony. I strongly urge that you seriously consider the following rationale of an experienced negligence attorney22: The key to understanding what must be done to defeat a claim for lack of informed consent is this: The injured plaintiff need only testify that you did not tell him about the risk of the terrible complication that happened to him and that, if you had done so, he never would have agreed to the treatment; in order to defeat the claim, you cannot merely take the stand and assert the contrary. It will merely be your word against his—and he has the injuries, not you. You must produce corroboration of your testimony that you disclosed the risk. Your evidence must be as strong as possible, since the plaintiff is saying that the injuries from which he is suffering would never have occurred if you had disclosed everything to him, because he would never have agreed to the treatment. When you produce a tape recording of your explanation of the risk to the patient and the patient’s statement that he understands all the risks you have explained and agrees to the treatment, you destroy the plaintiff’s claim of lack of informed consent and go a long way toward destroying any other claims of malpractice he may be making.

A recording would have been powerful support for the physician alleged to have promised return of 20/20 vision following panretinal laser to the patient with 20/400 vision from neovascular glaucoma secondary to severely ischemic central retinal vein obstruction.

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Informed Refusal In 1980, Truman v. Thomas10 established the doctrine of informed refusal. Unfortunately relatively few physicians are familiar with this concept, and the need for appropriate action is usually overlooked. The court holds the position that the physician is the expert and the patient is ignorant with respect to most medical situations. When a patient refuses any recommended diagnostic, therapeutic, or surgical procedure, the physician may not assume the refusal was an informed decision. The patient must be warned of the risks of refusal. Most physicians are unaware of the many situations to which this concept can be applicable. In the average medical practice informed refusal situations arise far more frequently than do situations involving informed consent. Failure to keep a postoperative appointment, missing a followup appointment for continuing treatment, or a glaucoma patient missing an appointment for a visual field examination requires documented notification of the patient with mention of the risk of delayed examination or treatment. A patient you have never seen calls complaining of the recent onset of flashes and floaters. The receptionist gives the patient an appointment for the same day but the patient fails to appear and 3 weeks later is diagnosed with a retinal detachment by another ophthalmologist. Technically your office has not established a relationship with the patient but under some circumstances a clever attorney can bring a lawsuit claiming your office failed to warn the patient of the risk of not being seen promptly. Other examples include refusal of routine tonometry, bilateral pupillary dilation, and poor compliance in taking glaucoma medication. To provide adequate protection for the physician, the conversation regarding risks of refusal should be documented and signed by the patient with a witness as it would be for informed consent. This situation can involve anxiety for the patient and occasionally resentment or anger as well and may thus make the atmosphere inappropriate for suggesting a formal discussion with tape recording. This is nonetheless a potentially litigious situation and should not be taken lightly. The physician must sublimate any personal feelings of anger or resentment toward the patient who has questioned and/or disregarded his or her judgment and advice. Physician demeanor should be calm and understanding in order to maintain a good physician–patient relationship in the hope that the patient will eventually acquiesce. If the problem arises without a physician–patient encounter (e.g., missed appointment), a return receipt letter is called for as is chart documentation of any phone calls.

Conclusion Although it the physician’s duty to inform, it is the patient’s right to consent. The process can be neither complete nor utilitarian unless both parties recognize and comprehend their respective obligations. “Professionals would do well to end their traditional preoccupation with disclosure and instead ask questions, elicit the

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concerns and interests of the patient, and establish a climate that encourages the patient to ask questions.”23

References 1. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986:61. 2. Jones WHS: Hippocrates. Cambridge: Harvard University Press; 1923:297–299. 3. de Mondeville H. On the morals and etiquette of surgeons. In: Rieser SJ, Dyck AJ, Curran WJ, eds. Ethics in Medicine: Historical Perspectives and Contemporary Concerns. Cambridge: MIT Press, 1977. 4. Rush B. On the vices and virtues of physicians. A lecture delivered November 2, 1801. In: Sixteen Introductory Lectures. Philadelphia: Bradford and Innskeep; 1811:123–125. 5. Rosenberg AR, Goldsmith LS. Malpractice Made Easy. New York: Magazines for Industry; 1976:12. 6. Schloendorff v. Society of New York Hospitals, 211 N.Y. 128, 105 N.E. 93. 7. Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170, 181 (1957). 8. Natanson v. Kline, 186 Kan. 393, 350 P.2d at 1104. 9. Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972). 10. Truman v. Thomas, 165 Cal. Rptr. 308, 611 P.2d at 10. 11. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986:101. 12. Curren W. Consent law leaves physicians in limbo. AMA Medical News May 10, 1985:10. 13. Rozofsky FA. Consent to Treatment: A Practical Guide. Boston: Little, Brown; 1984:xxxv. 14. Bettman JW. Ophthalmology: The Art, the Law, and a Little Bit of Science. Birmingham, AL: Aesculapius; 1984. 15. Priluk IA, Robertson DM, Buettner H. What patients recall of the preoperative discussion after retinal detachment surgery. Am J Ophthalmol 1797;87:620–623. 16. Robinson G, Merav A. Informed consent: recall by patients tested preoperatively. Ann Thorac Surg 1976;22:209–212. 17. Leeb D, Bowers DG Jr, Lynch JB. Observations on the myth of “informed consent.” J Plast Reconstr Surg 1976;58:280–282. 18. Rozofsky JD. Consent to Treatment: A Practical Guide. Boston: Little, Brown; 1984:634. 19. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986:35–39 20. Rozofsky JD. Consent to Treatment: A Practical Guide. Boston: Little, Brown; 1984:634–642. 21. Kraushar MF, Steinberg JA. Informed Consent: Surrender or Salvation? Arch Ophthalmol 1986;104:352–355. 22. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little Brown; 1977:180. 23. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford University Press; 1986:307.

Chapter 8

The Five Most Effective Risk Prevention Strategies Marvin F. Kraushar

Introduction Although the choice of the strategies discussed in this chapter may seem obvious, physicians commonly have misconceptions about each, which causes them not to accord these tools their rightful value in risk prevention. The unfortunate result is improper or underutilization and greater exposure to medical malpractice litigation. By taking a novel approach to the value, understanding, and implementation of each of these strategies, physicians will be encouraged to avail themselves of their maximum benefits. What is needed is a contrarian view toward these processes and a 180 degree shift in physicians’ perspective of them as purely legal responsibilities. These strategies must be considered not as legal encumbrances but rather as opportunities for risk prevention. In this way they can work for the physician instead of against the physician. This is a classic example of, “when life gives you lemons, make lemonade.”

Good Result Experience shows that patients usually sue for a bad result and not for a good result. The problem is that patients and physicians often have differing opinions of what constitutes a good result. An example is a patient with 20/20 vision after uncomplicated cataract surgery who develops postoperative endophthalmitis following cataract surgery in the second eye. The diagnosis is made in a timely manner, and, following treatment with pars plana vitrectomy and intravitreal antibiotics, the patient regains 20/50 visual acuity. While the surgeons feel this is a superb visual result under the circumstances, the patient, who sees 20/20 in the first eye, may be less than completely happy. Fortunately, physicians have the opportunity to influence the patient’s opinion of the result prior to treatment by means of the discussion of risks during the process of informed consent. Advances in medical technology have resulted in higher patient

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expectations. For many patients anything less than a perfect result will be an unexpected event. Education of the patient regarding the fact that complications can and do happen will decrease expectations and achieve greater patient satisfaction with the eventual result. Realization of the possibility of a complication makes its occurrence less of a surprise. The patient will be less angry, and the risk of litigation will be reduced.

The Physician–Patient Relationship Breakdown of the physician–patient relationship is a sine qua non for almost every case of medical malpractice litigation. Patients do not visit the medical office with the intention of suing. Rather, they come with the hope of being cured. There is something that the physician does or fails to do during the course of treatment that makes the patient consider a lawsuit. The establishment and continued nurturing of the physician–patient relationship can overcome almost any problem that arises. The optimal means by which to accomplish this is to establish a feeling of collaboration with the patient through shared decision making.1 Understanding, caring, and compassion for the patient must be evident in the demeanor of everyone in the physician’s office. “A patient who cannot find a physician who will listen can probably find an attorney who will. As the physician–patient relationship falters, the attorney–client grows.”2 It is not rare for a patient consulting an attorney in regard to a possible lawsuit to be so fond of the treating physician whose care may have been negligent that he or she asks that the suit be directed only against anyone else who participated in the care. A classic example of good “bedside manners” is an internist I encountered during my internship who was widely regarded as greatly deficient in medical knowledge and skills. His practice was very large, and his patients revered him. During my emergency room rotation I assisted a resident for 2 hours just after midnight in stabilizing one of this physician’s patients who was on the verge of exsanguination from a ruptured esophageal varix. At 3:00 AM the physician, who had avoided appearing, called the emergency room and was brought up to date by the resident. Fifteen minutes later he entered through the back door, removed his jacket, loosened his tie, and rolled up his shirtsleeves. He went into the writing room and told the family, “We saved her.” I am certain the family never forgot this experience. Patients tend to be quick to forgive if they feel the physician cares. A superbly qualified ophthalmologist colleague of mine has built a successful practice and has the firm belief that, “Ya gotta make ‘em love ya.” The optimal aim of every patient encounter is to make the patients so pleased with their management that they will refer another patient to you. The means by which to accomplish a good relationship is part of the presentation of every successful practice management consultant. It basically relies on good communication. An excellent example is a study3 in which physicians were divided into two groups and asked to solicit the chief complaint of a new patient. One group was instructed not to interrupt the patient until he or she finished responding. Seventy percent of these patients took less than a minute to complete their statement. Seventy-seven percent of the patients in the other group were

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interrupted by the physician after an average of only 18 seconds, and 98% of them never got to complete their statement. Those patients who were interrupted had a lower opinion of the quality of their care than those who were allowed to speak without interruption. This is one of many studies proving that patients generally have a lower opinion of the quality of care received if they feel the physician communicated poorly. This can be a double-edged sword for the physician. These patients are less likely to refer other patients to the practice, and they are more likely to sue. Another study demonstrated that providing empathy and support to a concerned patient4 by means of “active listening” added only 1 minute to the length of patient visit, thus disproving the theory that empathy and relationship building are too time consuming to be worthwhile. Active listening involves using phrases such as, “I can see why you’re concerned. I’m sorry to hear that. It must be very difficult for you.” Listening in this manner encourages patients to be more actively involved in the treatment process, and their compliance leads to better results. Patients who are encouraged to express their concerns early in the treatment process are less likely to express concerns later. A physician examining a patient who is dissatisfied with the diagnostic or therapeutic result of another physician must be extremely cautious about comments.1 A history obtained from a dissatisfied patient can understandably be inaccurate. Without knowing the circumstances under which a suboptimal result occurred, it is difficult to assign blame. Medical malpractice suits have been intentionally or unwittingly instigated by deprecation of another physician to an already dissatisfied patient.5,6

Informed Consent Most physicians regard the process of informed consent as mainly a legal encumbrance. In reality, the discussion of risks is arguably the most effective means of risk prevention available. As has been noted in a separate chapter, educating patients to the fact that complications can and do occur and being as certain as possible of their acceptance of this fact is a very strong defense. Those physicians who fail to make optimal use of informed consent are losing a valuable opportunity to get a big edge in risk prevention. The importance of informed refusal, discussed in the chapter on informed consent, cannot be overemphasized. Too many physicians are unfamiliar with this concept, which occurs far more frequently than is realized. Physician vulnerability to this problem is equally as serious as that from informed consent.

Documentation and Medical Records Medical record keeping is viewed by physicians as mainly a legal encumbrance. What physician has not heard the warning, “Every time you write in a chart, medical record, operative report, etc., you create a legal document that can be used

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against you in court?” There are countless stories of physicians whose court testimony was impeached by a contradiction in the medical record. Conversely, an accurate and complete medical record is not only a strong defense strategy, it is also a very powerful risk prevention tool for the physician. The keys to good documentation are legibility, consistency, completeness, accuracy, and timeliness. Medical records tell a lot about the person who produced them. A thorough, organized, neat record indicates that the physician and his or her treatment are also thorough and organized.7 During the prelawsuit activities (see Chapter 6), before an attorney decides whether to accept a case, he or she will go over the written materials and will pay attention to the smallest details. So also will the physician who is selected as the expert witness for the plaintiff. If the attorney or the expert can find anything in the records that appears to be an error, he or she will be encouraged to go pursue the claim. If there is any deviation from an uncomplicated, perfect course and the exculpatory facts have been clearly noted, it will tend to discourage the initiation of a lawsuit. If a diagnosis has been missed and the appropriate facts are clearly present to excuse the mistake, litigation is far less likely to occur. The bottom line is to consider the questions, “Whom am I trying to convince?” and “How will this look to a jury or a plaintiff’s expert?” A typical example is the allegation of a missed retinal break. Because the standard of care requires only that the physician perform as well as the average physician in his or her circumstance, mistakes are permissible provided that the appropriate means were used to avoid them. Therefore, a retina drawing showing that the ocular fundus was examined is essential to include for support. Evidence that the anterior vitreous was examined for the presence of retinal pigment is also helpful. It is also appropriate to indicate the patient was advised to return if the symptoms worsened. All of the above steps are exculpatory in the event of a missed retinal break, but merely telling a jury you did the examination is usually insufficient. Juries tend to believe, “If it isn’t written in the chart, it wasn’t done.” This also applies to including pertinent negative findings. An example is failing to include denial of symptoms of cranial arteritis by an elderly patient with a central retinal artery obstruction. If the patient actually has the disease and suffers additional problems because of delay or failure to treat, a jury will not be favorably impressed by the physician’s explanation that he or she does not record pertinent negatives. One of the first documents the expert will read if there is a surgical problem is the operative report, which is the bottom line as far as evidence is concerned in a lawsuit involving surgery. The operative report should be dictated within 24 hours, because, if it is dictated a significant time after the operation, it may give the appearance of being contrived. When dictating the report the physician must anticipate it will be read by an expert in the same specialty. Therefore, it is essential that if a complication occurs the operative report must include information to show that the appropriate steps were taken to avoid the complication, the complication was diagnosed in a timely manner, and the complication was managed appropriately. This information can be essential in preventing or defending a lawsuit. Documentation that is also contemporaneous is a very strong defense. An ophthalmologist does an intravenous fluorescein angiogram on a patient at 2 PM. That

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evening the patient’s wife calls while the doctor is at the arena watching a basketball game and reports that her husband has chest pain, shortness of breath, and pain radiating to the left arm and asks whether it is related to the angiogram. The ophthalmologist says it sounds like a heart attack and tells the wife to call the emergency squad as soon as possible. The doctor forgets about the call and makes no note of the conversation in the office record the next day. The patient actually refused to call the emergency squad, remained at home, and died 12 hours later. A lawsuit for wrongful death followed in which the patient’s wife claimed the ophthalmologist had never suggested the possibility of a heart condition and said it was probably a transient reaction to the angiogram. The ophthalmologist eventually settled the claim. A note in the medical record entered the morning after the phone call would have been difficult to refute. Similar precautions should be taken when the ophthalmologist is on call for other physicians. I have encountered the following scenario on several occasions. An ophthalmologist performs uneventful cataract surgery and sees the patient on the first postoperative day. The corrected vision is 20/30, and everything looks fine. Two nights later, the patient calls after office hours with vague symptoms of mild discomfort and an itching feeling around the eye. The cataract surgeon (or a covering on-call ophthalmologist) decides it is not endophthalmitis and tells the patient to go to the office the first thing in the morning. On examination the next morning there is clearly endophthalmitis, and after appropriate treatment the best corrected vision is hand motions. Several weeks later the ophthalmologist (surgeon or covering ophthalmologist) writes a long note describing the questions he asked the patient during the evening phone call along with the patient’s responses, which he now adds to the chart as exculpatory evidence. This document, written long after the event, will certainly make a different impression on a jury than if it had been written in the record during or immediately after the examination the morning following the phone conversation. In my experience, the above scenario occurs more frequently in lawsuits involving the covering on-call physician than the operating surgeon. This may be because of unfamiliarity with the patient or the fact that we may on occasion be less concerned with the patients of others than with our own. When covering the practice of other physicians, it goes without saying that we should be as diligent as we would be with our own patients. To this end it is a good idea to keep a dedicated file of on-call encounters with patients of other physicians wherein information such as disposition of phone call messages and their contents are stored. It is good medical practice to entrust the care of your patients during your absence to only those physicians whom you know to be caring and competent. Alteration of records can be the most damaging evidence possible to the defense of litigation. Some malpractice insurance policies include a stipulation that alteration of the record may be grounds for the company to revoke responsibility for coverage of the insured. Analysis of ink, paper, watermarks, and so forth can enable an expert in document analysis to detect that part or all of a record was rewritten. If review of the record indicates there is an inaccuracy or omission, the best way to manage it is to draw a line through the problematic part of the chart in such a manner as to maintain

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the legibility of the original material and add the changes with the date of the change and the writer’s initials. Corrections of hospital chart entries by house staff, nurses, and other staff should be made as a separate dated note. Adding a change in the margin even though it is signed and dated can appear suspicious. Even the most minimal alteration of a medical record can cause a problem. A cataract surgeon operated on the eye of a patient with bilateral cornea guttata and brunescent cataracts. The patient was properly informed of the risk of postoperative corneal decompensation. The surgeon dictated the operative note as if everything went perfectly with no problems, when in fact the phacoemulsification time was greatly prolonged. The recovery room record showed the patient did not arrive until 1 hour and 15 minutes after the surgery started. In the anesthesia record one digit of the time when the operation was completed was altered in an obvious manner to indicate the surgery took 15 minutes instead of over an hour. The patient eventually developed bullous keratopathy, and the surgeon wrote in the office record that it was “probably due to the prolonged phaco time.” An eventual corneal transplant was unsuccessful. Approximately 1 year later the patient contacted an attorney to investigate the possibility of negligent surgery. The combination of the “perfect surgical procedure” in the operative note plus the office record note of “prolonged phaco time” in addition to the altered time of the duration of the surgery appeared suspicious to the ophthalmologist who was retained as a plaintiff expert. The statute of limitations was about to expire, so the attorney, after getting a “certificate of merit” from the expert, instituted a lawsuit to protect the patient’s right to sue. After reviewing all the documents and deposition testimony the plaintiff’s expert found no negligence and the claim was dropped. The process cost the physician’s insurance company money for in-office expenses (secretarial, attorney, medical expert, etc.). The claim was added to the physician’s record, and the cost of his subsequent premiums was raised significantly.

Identifying and Managing the Litigious Patient There is no accurate demographic profile of those patients who are likely to sue. One study8 indicated that attorneys are 10 times more likely to sue than the general population. Unfortunately, there is a mythical profile suggesting that patients who are chronic complainers, poorly compliant, and/or cynical or angry are more likely to sue.9 Although these patients can be more of a challenge to manage, studies have shown that they are no more likely to sue. However, according to Bradford,10 [If] a new patient looks like trouble, the best strategy is to tell him that you and he are not a good match and he’d best be served by another physician. Once you embark on a treatment plan it will become much more difficult to terminate him later on even if you do it by the book.

Even the most loyal-appearing patients sue. An example is a young physician’s widow with no insurance who was treated gratis for years and who bought the ophthalmologist a tie every Christmas. After developing a postoperative pseudophakic retinal detachment, she initiated a nonmeritorious lawsuit.

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The only reliable constant element regarding a patient’s likelihood of suing is that patients usually sue only for a bad result (or for a result that they feel is bad). It is important to alert office staff to report to the physician any patient behavior that is demonstrative of dissatisfaction with anything about their experiences in the office. Insufficiently trained office staff typically hesitate to report such information for fear the physician will affix blame to them. Practice management consultants advise that informing the physician of patient dissatisfaction is essential to improving the atmosphere in a way that pleases patients and makes their opinion of care received more favorable. This also alerts the physician to the fact that what he or she feels is a good result may not be viewed as favorably by the patient. Patients who achieve a bad result require a different pattern of management. These patients often harbor feelings of resentment and even hostility toward the treating physician. It is a good idea to flag the chart so all the staff is aware of the situation. Every possible effort should be made to maintain the physician–patient relationship through continuing patient visits. The patient should be seen twice as often as other patients would be in the same situation. If an appointment is missed the patient should be contacted by the staff member who can provide the most tender, loving care. If necessary, the office should offer to send and pay for a cab. The staff and the physician should be patient and solicitous and elicit the patient’s concerns while spending as much time as is required to assuage them. At the first sign of deterioration of the physician– patient relationship, the physician should consider referring the patient for a second opinion to a trusted, qualified colleague who has been advised of the situation. Mrs. Jones, I sense you are not happy with your result and that makes me unhappy also. Perhaps another ophthalmologist can come up with a fresh idea to help you. I would like to have my office to make an appointment for you to be seen by Dr.…

The aim of this referral is to prevent the patient from doctor/lawyer shopping on his or her own and to reduce patient–physician hostility. The second opinion physician can calm such patients’ anxieties by assuring them that everything was done properly and may even be able to assume the continuing care. In this manner the treating physician can maintain control of the physician–patient relationship. At the beginning of the series of events in a lawsuit (see Chapter 6) many insurance companies send a representative to the physician’s office to obtain a narrative summary of the records from the first day to the last visit. The typical narrative ends with the doctor saying, “And that’s the last time I saw the patient.” That is actually when the physician lost control of the physician–patient relationship and that is specifically what this patient management pattern is designed to avoid.

Risk Prevention Opportunities for Perceptive Ophthalmologists All ophthalmologists have occasion to see in the office patients who are dissatisfied with the treatment of another physician. Sometimes these patients harbor anxiety and resentment toward the treating physician. Because only the patient’s side of the

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situation is available, it is usually difficult to make a fair judgment of the treatment rendered. The criterion to which an expert witness is held is whether he or she can make a decision “within reasonable medical probability.” In this situation a dispassionate review of the available facts is essential. If it appears likely that the treatment was appropriate, the second ophthalmologist has a unique opportunity for risk prevention. He or she can reinforce the “treating physician–patient relationship” by saying something such as, “I would have done it the same way.” It may be appropriate to repeat all or part of the informed consent discussion as it applies to the treatment rendered. In this manner the patient’s anxiety and resentment toward the treating physician can be resolved and possible litigation avoided.

References 1. Saba GW, Wong ST, Schillinger D, et al. Shared decision making and the experience of partnership in primary care. Ann Fam Med 2006;4:56–62. 2. Kraushar MF. Practical and philosophical considerations of the physician–patient relationship. Ann Ophthalmol 1987;19:83–84. 3. Beckman HB, Frankel RM. The effect of physician behavior in the collection of data. Ann Intern Med 1984;101:692–696. 4. Frankel RM, Morse DS, Suchman A, Bechmen HD. Can I really improve my listening skills with only 15 minutes to see my patients? HMO Pract 1991;5:114–120. 5. Jacobsen HL, Tucker RD. How to defend yourself in an ophthalmic malpractice suit. Arch Ophthalmol 1985;103:1793–1794. 6. Bradford EW. Big mouths cause malpractice suits. Med Econ 1986;3:310–313. 7. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians. Boston: Little, Brown & Co.; 1977:60. 8. Kraushar MF. Medical malpractice experiences of vitreoretinal specialists. Retina 2003;23:523–529. 9. Kraushar MF. Recognizing and managing the litigious patient. Surv Ophthalmol 1992;37:54–56. 10. Bradford EW. Can you spot potential plaintiffs? Med Economics December 16, 2005:62–68.

Chapter 9

Revelation of Adverse Events and the Conundrum of an Apology Peter H. Morse and Marvin F. Kraushar

Introduction Disclosure of error and apology in the practice of medicine is an evolving concept and procedure. Currently, a few institutions have policies for disclosure of error that often include an apology.1 Approximately 30 states have passed legislation making physician’s apologies, including admission of fault, subsequently inadmissible in malpractice litigation. Not all these statutes are equally protective of physicians. Other states have laws allowing expression of regret, caring, and consolation without admitting fault.1 Recently, prompt disclosure of medical error to the patient in a timely manner has been endorsed as ethically proper by the American Medical Association (AMA). Furthermore, honest dialogue is regarded as a means of strengthening the relationship between a physician and a patient, thereby enhancing the prevention of litigation.2,3 No action should be taken by a physician or a member of his or her office staff before a thorough investigation of the case, circumstances, results, and possible attendant damages have been discussed with the insurance company and the appropriate lawyers. However, some states require that the patient or the patient’s family be advised of the adverse event during the episode of care or, if discovered afterward, in a timely fashion. Therefore, prompt investigation and evaluation on the physician’s part is recommended.

Modification of Behavior The spectrum of conventional social intercourse includes interaction among physicians, patients, and attorneys. Within the structure of civil behavior, apology is an integral category of demeanor. Because of the phantom of malpractice litigation with the accompanying anxiety and fear, a collapse of normal acceptable human behavior often occurs. The result is frequently manifest in ways ranging from inexcusable discourtesy to barbaric incivility between and among individuals.

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Ordinary Courtesies To avoid or mollify offense, an apology may be appropriate in many patient encounters. Common examples are apologies for a prolonged waiting time at an appointment, addressing a patient by his or her Christian name rather than surname, failing to allow a patient to complete a statement, and forgetting to fully and clearly explain a diagnosis and treatment plan. Circumstances become more complicated and threatening when there is patient dissatisfaction or mistrust and the feeling that a mistake in medical or surgical judgment may have been committed. Many physicians have a self-image of invincibility and devotion to perfectionism that renders a suspicion or admission of fallibility difficult or unachievable.1 Furthermore, physicians have an understandable tendency to resist both disclosure and apology because of the fear of potential litigation or of being reported by the patient to the hospital or to the state board of medical examiners.1

Gravity of the Offense An error in evaluation and treatment must be distinguished from an unfortunate result. Failure of treatment in complicated situations or diseases with a low expectation of improvement or cure is ordinarily not considered an offense requiring an apology.1 An unfavorable outcome often creates a feeling of guilt in the physician; however, consolation rather than an apology is a more appropriate response.

Prevention of Risk If disclosure to the patient is to be made, it should be done as soon as possible after the occurrence for which it is required. The physician having the greatest rapport with the patient and family should be the spokesperson. Complete information should be provided along with plans for further analysis and treatment. Additional assurances that plans have been made to prevent recurrence of adverse events are also advisable. Many failures occur because of a defect in systems or processes. The responsible people must attempt to correct errors and if necessary initiate changes in procedures to preclude similar mistakes in the future. The patient and family should be advised as the situation evolves. Complete honesty is important because the patient’s medical records are available to him or her and to involved attorneys. Statements made to a patient may be discoverable in a lawsuit, and care must be taken that the statements made are objective and factual.

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Explanations must be given without blame. If an attempt is made to conceal an error or injury to a patient, one might be guilty of “fraudulent concealment.”3 Disclosure and apology may be coincident but are not identical. Apology is appropriate when facts and evidence reveal a preventable error.3 An apology is not an admission of fault. However, protection against an admission of fault is not invariable, and one must be knowledgeable with respect to the situation in a particular jurisdiction. No statement by a physician or any health care personnel should be made without this information and counsel.

Structure and Effect of Apology An apology may be defined as an acknowledgment of responsibility for an offense or error that is coupled with an expression of remorse.1 The four components in the structure of an apology are acknowledgment of the offense; explanation or reason for the commission of the offense; expression of remorse, shame, forbearance, humility; and reparation.1 The following are several salutary mechanisms in apology. If the patient feels humiliated, an apology may restore dignity and self-respect. Concern for the wellbeing of the patient and the patient’s family may be communicated through apology. Patients often feel powerless after an offense, but the knowledge that changes are being made to correct the error and prevent future errors may restore a sense of power to the patient. Some patients and their families are vindictive and wish to witness suffering by those whom they view as the offenders. A physician’s appearance and manner during an apology may help to mitigate this desire on the part of the patient. Some patients require validation that the offense occurred and that it has become part of his or her history and identity. Especially when infants or children are injured, parents feel variable intensities of guilt and are comforted by the assurance that they are not at fault. Confirmation of shared values is important for continuing trust in a patient’s relationship with a physician. The patient must know that what he or she feels to be an error is also the opinion shared by those involved in his or her health care. An injured party also desires to feel some hope or promise for the future with knowledge that individuals or institutions responsible for the alleged offense are taking or have taken corrective and preventive measures. Emotions commonly felt by patients in adverse situations are anger, frustration, helplessness, abandonment, and fear. Physicians must be aware of this and be available and willing to have appropriate and empathic dialogue about the concerns of the patient and the patient’s family. Reparations may also be a therapeutic part of an apology and do not always require legal intervention. Reparations may take many forms, including facilitating subsequent appointments with physicians, canceling bills, and making a financial settlement.1

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Inadequate Apology The fact that an apology has been made is insufficient. In fact, an inadequate or cursory apology may worsen a situation. A peremptory “I am sorry” is not enough. Often apologies fail to acknowledge responsibility or attempt to make an excuse or partial excuse in the apologetic statement. Many vague, tangential, or oblique impersonal phrases are invoked in an apology. Examples include such phrases as “I am sorry for what happened” or “mistakes were made.” Conditional statements, such as “if there was an error” or “a mistake was made but” or “these things happen to the best of people,” should not be used. Unacceptable explanations, arrogance, or inadequate reparation may also degrade or negate the effect of an apology.1

Conclusion An apology when indicated may be regarded as a therapeutic intervention. All too often psychological aspects, which are part of complete patient care, are disregarded. A cleansing or catharsis for both physician and patient may be effected by a proper apology. Previous satisfactory relationships may be enhanced, and damaged relationships may be repaired. Rendering an apology by the physician may provide atonement by diminishing the feeling of guilt and shame and apprehension of retaliation. For the offended patient, receiving an apology may expunge a grudge and abate ineluctable corrosive anger, thereby facilitating forgiveness and reconciliation.1 Despite some evidence that apologies seem to decrease the prevalence of malpractice litigation, there is an understandable hesitancy and lack of certitude on the part of physicans.1,4 This aspect of medical practice should be further explored in that it may ameliorate heretofore insoluble aspects of patient care and medical–legal conflicts. It is a conceivable manner for negotiation between a physician and an injured patient. Furthermore, initiation or enhancement of cooperation between physicians and attorneys may be possible. Even if no formal method or procedure evolves, a greater comprehension of the psychology involved in the perception of injury by the patient may help to modify a physician’s interpersonal behavior and relationships.

References 1. Lazare A. Apology in medical practice: an emerging clinical skill. JAMA 2006;296:1401–1404. 2. Joint Commission on Accreditation of Healthcare Organizations. Standard R1.1.2.2, July 1, 2001. Available at: http://www.jointcommission.org/. 3. Perspectives on Prevention. Minneapolis: Midwest Medical Insurance Company, August 2006, pp. 1–4. 4. Zimmerman R. Doctors’ new tool to fight lawsuits: saying “I’m sorry.” Wall Street Journal May 18, 2004, A1.

Part 2

Risk Management in the Ophthalmic Subspecialties and Related Fields

The 13 chapters in Part 2 are not intended to be comprehensive recapitulations of “how to do it” with respect to the clinical management of patients with ophthalmic disease. The authors discuss only those problems that arise in the management of diseases in their field that, in their experience as consultants and experts, most commonly lead to litigation, and they offer opinions on how best to maximize risk management. For example, because presbyopia surgery is in its developmental infancy and the optimal procedure for specific candidates has not yet been determined, there is presently no significant track record regarding the malpractice litigation experience. The suggestions offered are not in any way intended to be regarded as establishing a standard of care. Because some diseases can appropriately be categorized in more than one field there is some overlap of discussion within chapters. While there is variation within these chapters with respect to the spectrum of diseases, there are also similarities in risk management modalities, such as establishing a good physician–patient relationship, having an effective discussion of informed consent, and maintaining adequate documentation. Additionally, many of these chapters have their own unique indications for these same modalities. For example, while informed consent is essential for all fields, it is of even greater importance for elective procedures such as clear lens exchange, cosmetic surgery, or LASIK. Although establishing a good physician–patient relationship can be relatively easily accomplished during the management of long-term problems such as glaucoma and strabismus, it is a more challenging task in the management of acute problems such as trauma and retinal detachment. The concept of documentation is of particular importance in the preoperative evaluation of cosmetic surgical patients. Based on the advice of noted ophthalmic pathologists, no specific chapter is devoted to the subspecialty of pathology because lawsuits of this nature are uncommon and are typically brought against the ophthalmologist managing the care of the patient, that is, the generalist, retinavitreous surgeon, pediatric ophthalmologist, ophthalmic plastic surgeon, ophthalmic oncologist, and so forth. The discussion of these problems is included in the appropriate subspecialty chapters.

Chapter 10

Anesthesia Peter H. Morse and Marvin F. Kraushar

Sixty percent of the total indemnity paid to a group of patients who brought lawsuits against ophthalmologists for complications related to the management of cataract was for claims involving anesthesia.1 In this study, complications of anesthesia had the highest ratio of indemnification per claim of any category. An analysis of claims of eye injury associated with anesthesia showed 30% were characterized by patient movement during ophthalmic surgery. Blindness occurred in all these cases, most during general anesthesia, but in one of four cases, under monitored anesthesia.2 Complications from the administration of anesthesia for ophthalmic surgery are relatively uncommon; however, the losses from these claims are more expensive because the most severe injuries involve significant loss of vision, serious physical disability, or death. Ophthalmologists traditionally administer topical and local (regional) anesthesia. An anesthesiologist or Certified Registered Nurse Anesthetist (CRNA) typically monitors regional anesthesia and administers general anesthesia. In many jurisdictions, regional blocks are given by anesthesiologists and CRNAs. This may create anxiety on the part of a patient unfamiliar with the person giving the anesthesia. In addition, a lawsuit arising from the actions of nonophthalmologic practitioners providing anesthesia to one’s patient may cause one to be sued for vicarious liability even though the practitioner is not in one’s employ. It is therefore imperative that the ophthalmic surgeon be familiar with the training, experience, and other pertinent credentials of personnel administering local anesthesia to his or her patients. Anyone giving anesthesia should pay meticulous attention to detail and be thoroughly familiar with ocular and orbital anatomy, physiology, and the pharmacology of the agents used. While anesthesia problems involving litigation usually involve permanent injury to a patient, they are not necessarily the result of a deviation from the acceptable standard of care expected of an ordinary, well-qualified practitioner. Because patients do not anticipate difficulties from anesthesia, practically any problem may elicit investigation for possible litigation.

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Topical Anesthesia Some topical anesthetics, especially cocaine, may cause clouding of the corneal epithelium. Idiosyncratic reactions are rare. Cocaine blocks the re-uptake of norepinephrine at nerve terminals causing a sympathomimetic effect. Ocular instillation, even with very low plasma levels, may create severe bradycardia.2,3 Bupivacaine, lidocaine, proparacaine and tetracaine have all been used topically and intracamerally for cataract extraction. Some claim this route of anesthesia is insufficient. Although it lacks akinesia and requires a cooperative patient, it is the method of choice for a large number of cataract surgeons. It is imperative that patients are carefully selected and appropriately counseled for this type of anesthesia, including a thorough discussion of informed consent. Additional sedation is generally required.4

Local Anesthesia General Considerations There is greater patient awareness in anticipation of and during procedures performed under local anesthesia than with general anesthesia. Therefore, critical and prolonged preparation is required. No haste should be evident and thorough informed consent should be obtained. If an anesthesiologist is involved, either in the administration or monitoring of anesthesia, he or she should spend time with the patient. Oversedation should be carefully avoided to facilitate patient cooperation. Often, hearing aids and dentures should be left in place for patient comfort. Attention is given to patient transport and positioning. Equipment for and personnel experienced with emergency resuscitation must be readily available. Risk factors for regional anesthesia include inadequate sedation, a communication barrier, lack of patient cooperation or desire, and patients with spontaneous chronic coughing, shortness of breath while recumbent, a recently operated or inflamed eye, prolonged operations, Parkinsonian head tremor, Alzheimer’s disease, and/or claustrophobia.4 General anesthesia should be considered for such patients. Complications following injection of local anesthetics are rare and estimated at 1 in 500. Awareness of possible interactions of a patient’s medications and anesthetic agents is paramount. Most reactions occur within 15 minutes of injection and are usually the result of apprehension, pain, oversedation, local anesthetic toxicity, method of needle placement, or injection of local anesthetic. Hypotension, bradycardia, diaphoresis, nausea, and cardiac arrest are usually elicited by fear, pain, or manipulation of the globe. True allergic reactions occur in less than 1% of local injections and are characterized by wheezing, urticaria, and respiratory distress.5-8 With the Nadbath block of the stylomastoid foramen for facial akinesia, the

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anesthetic may spread to the vagus, glossopharyngeal, or spinal accessory nerves, causing respiratory distress and dysphagia. Systemic complications may follow an overdose or intravascular injection of adrenline, which is often combined with the anesthetic to extend the duration of the local block. Hyaluronidase, used to hasten the onset and quality of the block, rarely causes an allergic reaction.9 Respiratory arrest may occur after intravenous sedation.7 Systemic toxicity from local peribulbar 4% xylocaine injection leads to toxic central nervous system dysfunction and cardiac depression. For a 70 kg patient, a total volume of 7.5 mL of 4% xylocaine is safe. For a smaller patient, no more than 5 mL should be given.4

Retrobulbar Hemorrhage Retrobulbar hemorrhage is estimated to occur in 1 of 700 retrobulbar blocks. Other citations of prevalence range from 0.1% to 1.7% of patients. Predisposing factors are elderly patients and those receiving corticosteroids, aspirin, nonsteroidal antiinflammatory medications, and anticoagulants.4 The mechanical tamponade of the hemorrhage causes increased intraocular pressure (IOP), which may cause central retinal artery compression or occlusion (CRAO). Osmotic diuresis, anterior chamber paracentesis, lateral canthotomy, and decompressive surgery may be required. The IOP should be measured and the optic nerve should be observed for arterial pulsation and pallor. Similar complications may occur following the injection of an excessive volume of anesthesia in the orbit. If the lack of clarity of the ocular media precludes adequate visualization of the optic nerve, an empirical lateral canthotomy may be advisable.10

Penetration or Perforation of the Globe Whenever any medication is injected near the outside of the eyeball and the tip of the needle cannot be visualized, maximal care must be taken to be as certain as possible that the needle tip is in the desired location prior to injection. Unintended insertion of a needle into the globe (penetration) or through the globe with an entry wound and an exit wound (perforation) is a rare complication. Myopic eyes, often longer than 26 mm, are at greater risk because of the posterior, staphylomatous bulge and the relative thinness of equatorial myopic sclera. Other estimates place high risk eyes at 23.5 mm or greater length. Perforation may occur with either retrobulbar or peribulbar (periconal) blocks. Direct damage by the needle to the fovea or optic nerve may occur. A retinal tear or detachment is also possible. Referral to a retinavitreous specialist is advisable if there is any difficulty completing a thorough examination of the ocular fundus.

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Although pain at the time of the block is typical when a needle enters the globe, many patients experience no pain, thus making a timely diagnosis more difficult. Penetration of the globe as opposed to a through and through perforation carries the additional risk of accidental injection of anesthetic into the eye. This will raise the IOP and the person administering the block will sense back pressure on the plunger of the syringe. Even a minimal amount of fluid injection into the eye can increase IOP sufficiently to cause partial or complete CRAO in which case the patient may complain of loss of vision. Another clue may be loss of the red reflex due to a vitreous hemorrhage from a choroidal or a retinal vessel. On withdrawal of the needle, there may be leakage of vitreous from the entry site with attendant hypotony. Every patient who receives medication of any kind by periocular injection in whom a postinjection vitreous hemorrhage is diagnosed should have a prompt, thorough examination of the ocular fundus to rule out the possibility of accidental intrusion of the needle. If the hemorrhage precludes adequate visualization and fails to clear rapidly, serious consideration must be given to the need for pars plana vitrectomy. The risk of this complication may be minimized by having the patient look in the primary (neutral) position of gaze rather than upward and nasally during retrobulbar injection. When giving peribulbar or retrobulbar injections, it is often forgotten that the globe curves outward in the orbit. Especially with peribulbar anesthesisa, the risk of perforation is enhanced because the injections are often given with the needle inserted straight backward rather than angled away from the globe toward the orbital wall. To avoid unintended intraocular injection of anesthetic, it has been recommended11 that once the practitioner thinks the needle tip is in the proper location and prior to injecting anywhere in the immediate vicinity of the outside of the eyeball, the syringe should be moved in and out as well as circumferentially. An experienced practitioner will be able to discern the difference between motion of the globe caused by traction on Tenon’s capsule as opposed to motion due to traction from an intrascleral needle. The risk of causing a retrobulbar hemorrhage with this maneuver is negligible and the usual consequences are far less dangerous than those of accidental intraocular injection of anesthetic. An example of this is a twenty-eight year-old male who presented with a temporal pterygium and vision of 20/20 in his right eye (OD). The visual acuity in his left eye (OS) was 20/200 because of amblyopia. The patient underwent removal of the pterygium following a subconjunctival injection of xylocaine 2%. The administration of local anesthesia and surgery were believed to be uneventful. When the patch was removed the following morning, the patient had hand motions vision OD. There was no evidence of retrobulbar hemorrhage, there was no proptosis of the eye, and there was a full range of motion. Examination of the ocular fundus revealed a cherry-red fovea with a pale retina secondary to CRAO from undetected accidental intraocular injection of the anesthetic. Despite immediate referral to a retinavitreous specialist and extensive therapeutic efforts, the visual acuity never improved. At trial there was a multimillion dollar award by the jury. Because an eye is anesthetized, it does not diminish the risk of inadvertent penetration and a number of cases involving intraocular injection of antibiotic or corticosteroid have occurred. Intraocular Gentamycin may cause irreparable loss of vision.

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One situation involved gross misdirection of the needle with tearing of the retina and subretinal injection of corticosteroid beneath the macula. Vision was lost and the claim was settled.

Amaurosis Temporary loss of vision may occur from anesthetic blocking the optic nerve or being accidentally injected into the eye. Patients having regional blocks, especially retrobulbar, should be warned of loss of vision up to perception of light and, if some vision is retained, it does not mean that the block is ineffective. Patients may also be aware of the microscope light and some movement during surgery.

Atrophy of the Optic Nerve In the 1950s and 1960s, there were numerous reports in the literature12 of optic atrophy of unknown origin developing six to twelve weeks after cataract surgery. At the time it was commonplace for the ophthalmic surgeon to stand at the contralateral shoulder of the supine patient and direct the patient to look superonasally at him during retrobulbar insertion of the anesthetic needle at the inferotemporal aspect of the orbit. In this manner the upward-inward gaze of the patient brought the posterior part of the globe and the optic nerve inferotemporally to facilitate the location of the needle tip as close to the optic nerve as possible for maximal anesthetic effect. In retrospect, this maneuver increased the risk of needle trauma to the optic nerve and the central retinal artery. This is an additional indication for the patient’s eye to be in the primary (neutral) position of gaze during the insertion of the needle. Another practice of anesthetic delivery, which has been discontinued, is intraconal injection. It was the aim of this technique to pierce the muscle cone with the needle in order to inject the anesthetic closer to the optic nerve and the ciliary ganglion. This technique had the added putative advantage of requiring a smaller volume of anesthetic and achieving the anesthetic effect faster without having to wait for diffusion of the anesthetic through the muscle cone. However, this technique carried the undesirable risk of placing the needle tip dangerously close to the optic nerve. Optic atrophy or central retinal artery occlusion may be caused by direct needle tip damage to the optic nerve or the central retinal artery or by injection into or hemorrhage within the optic nerve sheath. The fundus may resemble Purtscher’s retinopathy. If this is suspected, an urgent MRI might identify the problem and optic nerve sheath decompression can be performed. Celerity is essential for effective treatment. The standard needle provided in most operating rooms is 1.50 inches in length. It has been suggested13 that to avoid the risk of damaging the optic nerve the needle for retrobulbar injection should be no longer than 31 mm or 1.25 inches in length.

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Since the difference between a 1.25 inch needle and a 1.50 inch needle may not be readily apparent, it is a good idea for anyone who requests a 1.25 inch needle to check the label on the wrapper prior to injecting. In peribulbar injection, a 5/8 inch needle is sufficient. Needles should never be inserted beyond 25 mm of the orbital rim. While length of the needle is often emphasized, it is knowledge of the anatomy of the orbit and careful attention to technique of injection that is critical. Damage to the optic nerve may also occur following retrobulbar hemorrhage with or without acute retinal vascular occlusion. The increased orbital pressure may occlude the small nutrient vessels to the optic nerve without signs of retinal vascular occlusion. This complication may lead to late optic atrophy and result in partial to complete visual loss.

Penetration of the Optic Nerve Sheath The optic nerve has a complete dural cuff extending to the sclera. An injection of an anesthetic agent into this cuff leads to direct spread to the central nervous system via the subarachnoid space. This can lead to protean symptoms and signs, including increased or decreased cardiovascular vital signs, pulmonary edema, drowsiness, vomiting, and contralateral blindness because of reflux of the drug to the optic chiasm or an air bubble in the sheath. Contralateral oculomotor paralysis, facial palsy, deafness, vertigo, aphasia, loss of neck muscle power, vagolysis, shivering, convulsions, respiratory depression or arrest (apnea), neurological deficits, hyperreflexia, hemiplegia, paraplegia, quadriplegia, and cardiac arrest may be seen. If the diagnosis is made in a timely manner and if appropriate life support is instituted promptly and continued until the anesthetic is metabolized, permanent deleterious complications can be avoided.4,5,14

Brainstem Anesthesia Manifestations of brainstem anesthesia have interconnections with those of injection into the optic nerve sheath. The symptoms usually appear within 8 minutes but vary from immediate to 40 minutes. This complication occurs with either retrobulbar or peribulbar anesthesia. Symptoms and signs of this potentially fatal complication may be amaurosis, gaze palsy (ductional defects), dysphagia, shivering, tachycardia, hypertension, loss of consciousness, dilation of the contralateral pupil, apnea, and cardiac arrest4,5,14 Resuscitation equipment and personnel trained in its use must be available. Alertness and cognizance of this possible complication with institution of early therapy usually leads to full recovery. An an example, A CRNA administered a retrobulbar block to the right eye of a cataract patient. Within ten minutes, the patient noted bilateral amaurosis and shortly thereafter became apneic and lost consciousness. Following prompt recognition of the problem by the ophthalmologist, the patient was intubated and maintained on life support. When the patient regained consciousness and was extubated, she described

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the return of vision in only the left eye. The vision in the right eye was hand motions and never improved. A few weeks later the right optic nerve was noted to be atrophic. A lawsuit ensued alleging improper technique in administering the retrobulbar block causing irreversible damage to the right optic nerve and other temporary injuries due to injection of anesthetic into the subarachnoid space. The ophthalmologist was included in the suit with the CRNA. The defense claimed that the injury occurred because the patient suddenly lifted her head as the retrobulbar needle was inserted thus driving the needle tip farther posterior than was intended. The jury found for the defense.

Accidental Intravenous Injection Symptoms of accidental intravenous injection include cutaneous numbness, confusion, dizziness, drowsiness, twitching, unconsciousness, convulsions, coma, apnea, hypoxia, hypotension, bradycardia, ventricular fibrillation, cardiac arrest, and death. Routine withdrawal of the plunger of the syringe prior to injecting can help avoid this problem.14

Accidental Intra-arterial Injection As a result of accidental intra-arterial injection, acute grand mal convulsion may occur. This can be avoided by routine withdrawal of the plunger of the syringe prior to injection.14

Oculocardiac Reflex This trigeminal-vagal reflex is caused by traction on the extraocular muscles, pain, and pressure on or manipulation of the globe. A local anesthetic block usually ablates this reflex. The person administering the anesthetic should be aware that the injection may occasionally provoke an oculocardiac reflex at the time of injection because of rapid distention of the tissues by the fluid injected or hemorrhage. Symptoms and signs are bradycardia, nausea, arrhythmias, hypertension, loss of consciousness, or cardiac arrest.4,14

Myotoxicity Extraocular muscle palsies, most frequently involving the inferior rectus, have been described. The superior oblique, medial rectus, superior rectus, and levator

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palpebrae superioris have also been affected. Spontaneous recovery is usual but not guaranteed. The highest concentrations of local anesthetics should not be employed as they have been shown to be myotoxic. Caution must be used to avoid extraocular muscles during injection. Ophthalmologists have been successfully sued for this complication.14

General Anesthesia Complications arising during the administration of general anesthesia are not necessarily directly attributable to substandard technique. Some may be coincidental, and others may not be as likely without general anesthesia. It is common for surgeons to be named for vicarious liability in lawsuits regarding general anesthesia problems involving their patients. For example, a patient undergoing cataract extraction, bucked on the endotracheal tube during surgery and developed a choroidal hemorrhage and retinal detachment. The surgeon was included in the suit but the claim against her was dropped after a year of discovery. The anesthesiologist settled the claim because of an insufficient level of anesthesia. The claim against the ophthalmologist was added to the total of claims against her by the insurance company and her premium was increased the following year. The most common injury is corneal abrasion and, although it seldom has serious complications, insurance payments have been made for this problem. Patients in the cataract age group generally have a higher incidence of significant systemic disease, which can lead to problems in the use of general anesthesia.1 Most medical complications of general anesthesia in ophthalmology patients are from coexisting disease, mostly cardiac. For this reason, the ophthalmologist must be familiar with the patient’s medical history. It is strongly advisable to obtain preoperative medical clearance for patients with significant medical problems. Documentation of these reports should be kept in the patient’s medical record. Communication between the surgeon and the internist-consultant should include a discussion of the expected duration of the surgery and the medications to be used before, during and after the operation.1 As an example, an eighty-two year old woman with no significant medical history was admitted to the hospital for outpatient scleral buckle surgery under general anesthesia for a pseudophakic macula-on retinal detachment. An internist examined her at the hospital for preoperative medical clearance and noted a bruit over the left carotid artery. He advised the vitreoretinal surgeon report this finding to the patient’s family physician in order that Doppler studies could be scheduled a few days after the surgery. In the recovery room, the patient was noted to have suffered a stroke. It was postulated that an embolus had broken off the carotid atheroma as a result of extension of the neck during anesthetic intubation (Beauty Parlor Stroke Syndrome15). A lawsuit was brought against the anesthesiologist, the ophthalmologist, and the internist. After fifteen

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months of discovery, the suit was dropped on the recommendation of the plaintiff’s second expert. The anesthesiologist should also be thoroughly familiar with the patient’s general health, laboratory values, EKG, and chest X-ray, as well as current medications. Although the ophthalmologist is not primarily responsible, he or she should discuss concerns with the anesthesiologist prior to beginning the surgery. During surgery the ophthalmologist may be first to notice darkening of the patient’s blood indicating hypoxia. When exerting traction on a rectus muscle and an oculocardiac reflex occurs, the ophthalmologist must not only release the traction but may also give a retrobulbar anesthetic injection to block the reflex from recurring.

Intraocular Pressure If a patient has an intraocular gas bubble of sulphur hexafluoride (SF6) or perfluoropropane (C3F8) preoperatively or if the surgeon is considering using one of these gases, the use of nitrous oxide by the anesthesiologist is contraindicated because of the risk of absorption into the gas bubble and attendant critical increase in intraocular pressure (IOP). An example of a typical claim involving this problem is described in Chapter 21. Prolonged significant elevation of IOP with ischemic optic neuropathy or CRAO can occur in patients undergoing surgery in the prone position. In many patients, the mechanism is unknown. Increased intraorbital pressure is alleged as a possible etiology. Other patients have suffered CRAO because of improper head position with direct compression of the eye. Practically every occurrence of this problem is diagnosed when the patient awakens in the recovery room and complains of amaurosis in one or both eyes. Ophthalmologists are typically called for consultation in the recovery room. If the cause was not direct compression of the eye, urgent orbital decompression may be beneficial.

Malignant Hyperthermia Malignant hyperthermia (MH) is characterized by intracellular hypercalcemia. This problem is of clinical significance to ophthalmologists because there is a possible greater prevalence in patients with strabismus.4,5,16

Summary Little serious permanent disability is encountered from any form of anesthesia for ocular surgery. Most complications, even penetration of the globe during retrobulbar anesthesia, have no deleterious sequelae if managed appropriately.

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Because serious complications from anesthesia may cause blindness or death, it is not surprising that analyses previously cited reveal a significant risk of high indemnification for infelicitous results. Not all complications are manifestations of negligence. There will be differences of opinion regarding the use of local or general anesthesia, the agents used and the gauge, and the sharpness and length of needles used for local injection. These will depend upon the choice of the surgeon and the patient, as well as mitigating or jeopardizing circumstances. While the ophthalmic surgeon may be named in the lawsuit if his or her patient suffers a complication from general or local anesthesia administered by another person, the primary responsibility for the defense will rest with the anesthesiologist or CRNA. In this circumstance, the ophthalmologist’s defense will be stronger if he or she can document preoperative medical clearance if there was a preexisting medical problem that may have played a part in the complication. Familiarity of the credentials and experience of the nonophthalmic person administering a local anesthetic will enable the ophthalmologist to make a more informed decision regarding the capability of this practitioner. Awareness of possible hazards and meticulous attention to detail with obviate most local anesthesia problems. In the event of a complication from local anesthesia administered by the ophthalmic surgeon it is of paramount importance that he or she to dictate a contemporaneous operative note. The content should state that the appropriate means were used to minimize the risk of the complication, the fact that the problem was diagnosed in a timely manner and that it was managed properly. These facts will tend to dissuade a plaintiff’s attorney from advising litigation and will strengthen the defense of any subsequent litigation. Advanced preparation for rare emergencies, such as apnea and cardiac arrest, may well avert disaster. In recent years the specialty of ophthalmology has experienced myriad improvements in diagnostic capability, medical technology and surgical expertise all of which have decreased operating time, patient morbidity and dramatically improved outcomes. Ophthalmologists must guard against taking the possibility of complications too lightly and remember that most of their surgical patients are of advanced age and are likely to have significant medical conditions. There is always a risk that even a ten minute cataract operation with topical or local anesthesia on a patient in this age group still carries the threat of serious injury.1

References 1. Kraushar, M.F., Turner, M.F. Medical malpractice litigation in cataract surgery. Arch Ophthalmol 1987;105:1339–1343. 2. Gild, W.M., Posner, K.L., Caplan, R.A., Cheney, F.W. Eye injuries associated with anesthesia. Anesthesiology 1992;76:204–208. 3. Wilson, F.M. II. Adverse external ocular effects of topical ophthalmic medications. Survey of Ophthalmology 1979;24:57–58. 4. Smith, G.B., Hamilton, R.C., Carr, C.A. Ophthalmic Anesthesia, A practical handbook, 2nd edition, London, Sydney, Auckland. Arnold, 1996, pp 139–140.

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5. Donlon, J.V., Jr., Doyle, D.J., and Feldman, M.A. Anesthesia for Eye, Ear, Nose and Throat Surgery, in R.D. Miller (ed), Miller’s Anesthesia, 6th ed., volume 2, Philadelphia, Elsevier, Churchill, Livingstone, 2005, Chapter 65, 2527–2537. 6. Hamilton, R.C. Complications of ophthalmic regional anesthesia, In Kumar, C.M., Dodds, C., Fanning, G.L. (eds). Ophthalmic Anesthesia, Lisse, Netherlands, Swets & Zeitlinger, 2002, pp. 181–196. 7. Rubin, A.P. Complications of local anaesthesia for ophthalmic surgery. British Journal of Anaesthesia 1995;75:93–96. 8. Kay, M.C., Kay, J. Complications of Anesthesia for Ocular Surgery, in Charlton, J.F., Weinstein, G.W. (eds). Ophthalmic Surgery, Complications, Prevention and Management, Philadelphia, J.B. Lippincott Company, 1995, pp. 87–93. 9. Watson, D. Hyaluronidase, British Journal of Anaesthesia 1993;71:422–425. 10. Kraushar, M.F., Seelenfreund, M.H., Freilich, D.B. Central retinal artery closure during orbital hemorrhage from retrobulbar anesthesia. Trans Amer Acad Ophthalmol and Otolaryngol 1974; 78:65–70. 11. Kraushar, M.F., Cangemi, F.E., Morse, P.H. Prevention of accidental intraocular injection following inadvertent needle perforation of the eyeball. Ophthal Surg 1996;27:405–406. 12. Reese, A.B., Carroll, F.D. Optic neuritis following cataract extraction. Arch Ophthalmol 1958;45: 659–662. 13. Katsev, D.A., Drews, R.C., Rose, B.T. An anatomic study of retrobulbar needle path length. Ophthalmology 1989;96:1221–1224. 14. Smith, G.B., Hamilton, R.C., Carr, C.A., op. cit. pp. 148–180. 15. Weintraub, M.I. Stroke after visit to the hairdresser. Lancet 1997;350:1777-1778. 16. Smith, G.B., Hamilton, R.C., Carr, C.A., op. cit. p. 226.

Chapter 11

Cataract Surgery Stephen A. Kamenetzky

Introduction There are well over 2 million cataract operations performed yearly in the United States, making it the most commonly performed major surgical procedure in the Medicare population. Ophthalmologists have developed techniques and technologies over the years that make it one of the safest surgical procedures for patients, with an overall complication rate of less than 10%. Serious complications, such as loss of vision or infection, are even less frequent. The surgical advances have changed the procedure from one for which several days of hospitalization with sandbags to restrict head movement were required to an outpatient procedure with an initial recovery period measured in hours. Visual outcomes have improved, and patient satisfaction remains high. Despite this great progress and an enviable safety record (or perhaps because of them), lawsuits related to cataract surgery remain the number one cause of malpractice litigation against ophthalmologists. Ophthalmic Mutual Insurance Company (OMIC), the American Academy of Ophthalmology (AAO)–sponsored professional liability insurance company, which insures more ophthalmologists (about 3,700) than any other single carrier, has opened an average of 65 cataract-related cases yearly for the past 5 years. This incidence is twice that of any other ophthalmic subspecialty. There are many reasons for this frequency. The most important is the sheer volume of cataract operations performed. Also important, however, is the high expectation level present in patients undergoing the procedure. Largely through the fault of ophthalmologists themselves, the surgical skills required to achieve these exceptional results have been trivialized, creating a public perception of the procedure as being foolproof—a simple “no shots, no stitch, no pain” experience that will reliably restore the vision to the way it used to be. Naturally each patient absorbs this message and is always disappointed and often angry if this is not the outcome in his or her case. Patients have the impression that if the result is not perfect, someone must have made a “mistake” and legal action often is threatened. The risk of complications is inherent in all medical procedures, and their occurrence is not necessarily an indication of medical malpractice. Ophthalmologists have developed excellent techniques to deal with the inevitable issues that occur from time

M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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to time—how to handle a posterior capsular break, a small pupil, vitreous loss, or a dropped nucleus—and these refinements have allowed good visual results even when these situations or others like them arise. Even in cases with a poor visual outcome, a good physician–patient relationship can often prevent a future malpractice action. Complications that develop during surgery are characterized by their episodic and somewhat unpredictable nature and can be defended in most cases (if dealt with properly) as being inherent to the practice of medicine. There are other types of problems that are much more difficult to defend, and these are errors of process that allow seemingly preventable events to occur. Some of these errors are quite obvious: wrong patient, wrong eye, wrong lens inserted. Others, such as poor measurement techniques, number transpositions, unreasonable expectations, and poor documentation of events, are not always so clear until it is too late. Managing this type of issue (preventing errors rather than dealing with their consequences) falls into the area of risk management. It deals with the analysis of large numbers of events and determination of if and when mistakes were made and how best to prevent them from occurring again. Although risk management techniques were originally developed to save insurers money, the primary beneficiaries of this process when applied to the medical field are ophthalmologists and their patients in terms of better outcomes and reduced stress and anxiety. The tools required are simple in concept and inexpensive to implement. They involve both common sense and learning from the experiences, both good and bad, of others.

“An Ounce of Prevention Is Worth a Pound of Cure” A recent case with which I was involved will show just how important risk management issues can be. Some details in this case, as in the others discussed later in the chapter, have been altered slightly to protect the identity of the physicians involved, but the basic facts remain unchanged. A very skilled young ophthalmologist had scheduled several cases at a facility he did not often use. He brought with him one member of his own team who was familiar with his surgical routine, but she ended up serving as first assistant on all the cases and was therefore unavailable to work with the operating room personnel provided by the facility. The three cases went like clockwork with no surgical complications, and it was only at the first postoperative visits that it was discovered that all three patients had received the wrong power implants, including one patient who received a 29D lens instead of a 20D implant. In addition to potential malpractice litigation, the mistake resulted in state licensure action against the physician. Defending these actions caused a major disruption in the physician’s life and practice. This is an example of “perfect surgery” complicated not by technical inadequacy but rather by a cascade of preventable mistakes. How in the world could this have happened? In retrospect, it was easy to see. No one individual took charge to be certain that things were being done correctly, because everyone else assumed that someone else was doing so. It was in fact nonmedical process issues that went awry leading to medical liability consequences. The physician

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was “too busy” with surgical concerns to be sure that the powers were correct and did not consider this to be part of his responsibility. The first assistant assumed someone else had checked the powers as was done at the facility where the physician usually worked, so she did not inquire. The circulating staff, unfamiliar with the surgeon’s routine, did not know that the physician recorded the specific lens power in a set place in the medical record and expected the staff to look there before handing him the appropriate lens. They assumed that the lenses, which were all in the operating room on a table and not marked with patient identifiers, were stacked in the right order based on the operating room schedule, and they simply worked their way down the pile. At every point along the way, any of the individuals involved could have stopped this disaster from happening. Either the surgeon or the first assistant, knowing that they were operating with a crew unfamiliar with their routine, could have asked the circulating staff if they had checked the lens power against the chart record. The circulating staff, unfamiliar with that same routine, could have asked the surgeon how they were supposed to know which lens was intended for which patient. Each lens could have been clearly labeled with the correct patient’s name, or only one lens at a time could have been placed in view with the rest laid aside until the proper patient was in the room. There was no system in place that everyone understood, no process that required the “could have” possibilities discussed above to become the “must be” actions required to ensure an error-free environment. This was a risk management failure of major proportions. Much of the information in this chapter is related to similar risk management issues as they apply to cataract surgery and is based on the knowledge and experience gained from reviewing hundreds of cataract-related malpractice cases like the one above coupled with over 25 years as a practicing anterior segment surgeon. The suggestions that follow are general in nature rather than indicating, for example, which specific antibiotic (if any) should be used for preoperative prophylaxis. Many of the recommendations are personal opinions, and no attempt is being made, and no inference should be taken, that the standard of care for cataract surgery is being defined in this discussion. The standard of care is actually determined by the community of ophthalmologists, not a single individual, and will evolve as progress is made in the field. It is important that ophthalmologists follow the literature closely and stay abreast of the current best practices as they pertain to cataract surgery. That is the arena in which the standards of care are defined.

General Risk Management Issues OMIC has available on its website (www.omic.com) a large volume of risk management materials that all ophthalmologists, not just OMIC insureds, are free to access and download. These include articles on risk management and specific informed consent documents for many of the issues that are covered in this chapter. There are several areas that are important but not specific for cataract surgery. One is a legible medical record that accurately documents the events that have

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taken place in the care of the patient. The medical record should be contemporaneously generated and contain sufficient detail so that it can be used in a court of law if necessary to reconstruct the events that occurred. Entries should contain identifiers so that the individual responsible for the information (physician, nurse, technician) can be determined, and all entries should be initialed to attest to their accuracy. Electronic medical records are wonderful for many things, but they often contain errors that are repeated from examination to examination or boilerplate language that continues to be inserted long after it is relevant (such as a description of a cataract long after it has been removed), so they need to be reviewed closely. Never alter the medical record under any circumstance for any reason. This is particularly important following a complication at surgery. There is often the temptation to do this to document what “really happened,” but a very defensible case can be rendered indefensible by this action even if the intent was to clarify the situation rather than to obscure the facts. Attorneys spend a lot of time comparing various copies of records obtained at different times, and, once the honesty of the physician can be questioned, it is virtually impossible to win a case in front of a jury. Corrections or addenda when required should be clearly marked with the date, time, and identity of the person making the entry and should leave the original record intact. Careful and accurate communication with patients when complications develop is also critical. A truthful description of what occurred and how it was dealt with is not an admission of fault. All communications should be documented in great detail in the medical record, and any questions the patient asked and the answers provided should be included. Second opinions regarding treatment of complications should be obtained sooner rather than later and in all instances when the patient requests one. Informed consent for surgery needs to be well documented in the record and should be obtained, when possible, well before the date of surgery. Informed consent is a process (not merely a form that the patient signs) in which the operating surgeon needs to be intimately involved. Educational videos, other educational tools, and office personnel can be used to expedite the process, but the responsibility for being certain that adequate informed consent has been obtain remains with the operating surgeon. It is best if the document signed by the patient is procedure specific, with the actual risks and potential benefits clearly spelled out rather than a general “consent for surgery form” used by multiple specialties at a facility. The operative report must be an accurate record of what actually took place during each specific case. Increasingly, however, “predictated” operative reports that add the specific patient name, date, and eye treated to a previously created template that describes a typical case are being used. This type of documentation is not ideal under any circumstance (two surgeries are rarely totally identical) but may suffice in an uncomplicated case. However, if the surgery is complicated, they should not be used (even if amended by hand), because they rarely contain enough detail to be useful if litigation ensues. It is extremely important in complicated cases to have an exquisitely detailed operative report that describes what happened as well as both the actions and thought processes that went into treating the com-

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plication. If several choices of how to deal with the problem were considered, they should all be outlined and the reasons for choosing the one used clearly explained. Plaintiff’s expert witnesses are often critical of the defendant physician’s treatment of a complication, and a scanty operative note allows them to fill in the missing data in a way that is most beneficial to their client. If there are no holes in the operative report, they may quibble with the method chosen, but are on much weaker ground if it was a reasonable option because the physician who was there and faced with having to make a real-time decision will often receive deference from a jury that can understand that hindsight makes everything clearer. Postoperative instructions to patients should always be written and should be in a form that patients can clearly understand. This includes using languages other than English when appropriate. In particular, the patient must understand how to reach the physician at any time in the event serious problems develop before or between scheduled visits. If sample drugs are used, they should be clearly labeled with dosage and frequency directions. If the patient is to be comanaged, the plan for the transfer of care must be clearly understood by all parties. In particular, it is critical that the comanager have sufficient training, experience, and licensure to carry out the delegated duties.

Considerations Specific to Cataract Surgery Endophthalmitis The complication of endophthalmitis following cataract surgery is fortunately quite rare but unfortunately quite devastating in terms of return of useful visual function. The low incidence is somewhat surprising considering recent studies that demonstrate the frequency of bacterial contamination of the anterior chamber during cataract surgery. The incidence ranges from 1/1,000 to 1/3,000 and seems to be the same in most series worldwide. Because the frequency of endophthalmitis is so low, there are few well-controlled prospective studies of the risk factors involved in its development. The questions of whether to use preoperative prophylactic antibiotics and which one to use have no clear answer that can be supported by well-designed studies. There are new studies every year, some of which seem to show that the actual choice of a specific antibiotic is not critical. It is known that preoperative administration of antibiotics does lower the level of the bacterial flora of the conjunctiva, but it is not clear how this relates to the incidence of postoperative infection, because many of the bacteria that cause infections are not typically found in the normal conjunctival flora. Povidone iodine 5% applied topically during the preparation is thought to offer some protection. Despite lack of strong evidence of efficacy, most ophthalmologists in the United States do pretreat with topical antibiotics because of concerns regarding potential increased liability in the event an infection develops in an untreated patient.

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There are other issues that should be considered preoperatively as well. Lids and lashes should be well prepped and draped, and diseases such as blepharitis, meibomianitis, and lacrimal outflow obstruction should be adequately treated before elective cataract surgery is performed. Intraoperative and postoperative treatment with antibiotics is also common and accepted as the standard of care by most ophthalmologists. Drops, injections, collagen shields, and intracameral and subconjunctival routes of administration have all been used, but personal preference, rather than scientific evidence, seems to be the main driver in determining the route. The duration of postoperative treatment varies considerably, and there are no good studies available to answer the question of exactly how long antibiotic drops should be continued. Topical treatment is often continued until the frequency of topical steroids is reduced. There is also a feeling that the incidence of postoperative infection may be higher in patients who have suffered complications such as capsular rupture or vitreous loss, so these patients should be followed up especially carefully postoperatively. Self-sealing clear corneal incisions are popular now because of better surgical exposure, less astigmatism, compatibility with topical anesthesia, and brighter red reflex. There is some evidence in the literature (but also some to the contrary) to indicate that the frequency of postoperative endophthalmitis is higher when a clear corneal approach is used. This may be due to inadequate wound closure, which allows bacteria to enter the eye with rubbing or blinking. To avoid this issue, a meticulous watertight seal of the corneal wound is critical, and sutures or cyanoacrylate adhesive should be used if there is any concern at all about the integrity of the wound. Successful treatment of infection when it occurs depends on prompt diagnosis and early aggressive intervention. It is surprising how frequently the defense of cases with postoperative infection hinges on how and when the treating physician was first notified by the patient that there was a problem. Frequently these calls occur outside of normal office hours and are not documented contemporaneously (or even at all). Patients may not remember exactly what they told the physician and visa versa, and a poor visual result may further impair their recall when a legal case is brought. If there is a timely entry in the chart, in almost every instance the physician’s testimony will be believed if there is a conflict between the physician and the patient as to what actually transpired. All ophthalmologists need a system of making sure every conversation, in or out of the office, is promptly documented in the patient’s chart. The information should include the important details of the discussion, the time the actual conversation took place, and the time it was entered into the patient record. There are many systems available that allow this to be done relatively easily using either paper or electronic health records. The operating surgeon should also make sure that all physicians providing coverage or comanaging the patient follow these same guidelines. In addition to documenting all contacts with postoperative patients, it is also critical that those patients who complain of loss of vision, pain, or other atypical findings be seen promptly. How promptly is always the issue. Although there is no clear answer, it is better to err by seeing them sooner rather than later. If there is any doubt

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whatsoever in the ophthalmologist’s mind, the patient should be seen the same day as the call rather than waiting until the next day. Office staff should have a protocol in place that ensures that all postoperative patients get immediate appointments if they call the office with unusual postoperative complaints. Covering ophthalmologists and any comanagement partners should treat the patients under the same protocol. A recent case emphasizes the importance of this process and how lack of documentation and coordination with covering physicians can make a very defensible case, one that must be settled. An elderly man, after adequate work up and a good informed consent that included a warning about the danger of loss of vision, underwent cataract surgery that was complicated by capsular rupture and vitreous loss, which were appropriately documented and treated. The patient was examined the next day and was doing well, but later the same day the covering physician (the surgeon’s partner) was called and remembered being told only that the patient had a scratchy eye. She directed the patient to continue to take his drops and added acetaminophen and told him to come to the office for follow up the following day. When he did so, a severe bacterial endophthalmitis was diagnosed. Despite vigorous treatment, the patient lost the eye and filed suit. You might be wondering what the issue here is: endophthalmitis is a known complication that can lead to loss of the eye despite proper treatment. However, the situation was complicated by the fact that the covering physician never documented her conversation with the patient and his wife in the chart until almost 3 months after the event. She remembered the caller denying vision changes, redness, or pain and simply relating a foreign body sensation, and this is what was eventually entered in the chart. With no significant complaints and taking into account that the patient had been seen earlier that day, the covering ophthalmologist felt comfortable waiting to see the patient until the following day. The patient and his wife were adamant that the physician was told of pain and other more significant problems, and the covering physician was just as adamant that she had not been told any of this. Neither party had a written record of the conversation, but only the ophthalmologist has the obligation to have such a record. Interestingly, both the plaintiff and defense experts agreed that the treatment was below the standard of care if the patient’s version of what occurred was correct. They also agreed that it was not substandard care if the ophthalmologist’s recollection of the conversation was accurate. The result was a standoff, forcing the company to settle a case that certainly could have been defended. The physician now has an entry in the National Practitioner Data Bank and a large settlement on her record because of a situation that could easily have been avoided if standard risk management protocol had been followed. Patients whose postoperative clinical course falls outside the normal pattern should be considered to possibly have endophthalmitis until that diagnosis has been ruled out. Appropriate referral and consultation are indicated sooner rather than later, and a vitreoretinal surgeon comfortable with diagnosis and treatment of this condition is a valuable partner. This avoids the “if only you had come in sooner, we might have been able to save your eye” discussion, which can poison the well when this complication arises.

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Elective Refractive Surgical Procedures Involving Lens Extraction With improvements in surgical techniques and lens implant technology, clear lens extraction with lens implantation (refractive lens exchange) as a technique for improving uncorrected visual acuity has increased in popularity. This is now being performed not only for patients with high myopia and hyperopia but also for those with more moderate refractive errors and even for simple presbyopia. Patients undergoing this type of surgery with implantation of monofocal, multifocal, astigmatic, and accommodating lenses present unique problems for the ophthalmologist. As you might expect, patients who are paying significant sums out of pocket to be able to see without their glasses or contacts are quite demanding and have very high expectations. For this reason, patient selection is of critical importance. Those with preexisting pathology, such as corneal disease or retinal issues that would likely preclude a good visual result, make very poor surgical candidates. Patients who cannot comprehend the risks and have unreasonable (as opposed to high) expectations should be approached with caution. Very carefully documented informed consent is a must, with potential complications receiving the same attention as the proposed benefits of the procedure. Care should be taken not to guarantee results or exaggerate the likely visual outcome. Physicians should also not misrepresent their own experience with these procedures or the track record of the lens that will be used. In particular, it is important to be certain that the lens chosen will actually perform as advertised. In some states, in addition to malpractice cases being pursued by disgruntled patients, consumer fraud actions for false and misleading advertising have been filed in which patients have charged that the information given them as part of the advertising and marketing of the practice and the informed consent were misleading. From a purely risk management point of view, an ophthalmologist who cannot reliably perform a reproducible, complication-free cataract extraction should probably not perform elective refractive surgery involving lens extraction. If the posterior capsule breaks and vitreous is lost, it is less likely that the postoperative visual result will match preoperative expectations. Those performing this type of refractive surgery should have ready access to and sufficient training and experience with other corneal refractive surgery techniques that are often required to “touch up” the final product. In addition to the surgical skills required for these procedures, other issues must be addressed long before the trip to the operating room. The most important is accurate data collection. Without proper care in this area, technically successful surgery will not deliver the desired visual result. In a process that requires multiple measurements, the opportunity for measurement-induced error is high. These errors may be additive in their effect on the final vision obtained. For this reason, the preoperative refraction, anterior chamber depth, keratometry, and axial length must be determined with great precision using good technology and the findings accurately recorded. Errors in transcription occur much more frequently than you might imagine. Appropriate formulas for calculating the lens power should be used with particular attention to eyes that are either very long or very short. Data should be

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reviewed well before the trip to the operating room, and findings that do not make sense clinically should not be used until the issues have been resolved. Five minutes spent in checking and double-checking data preoperatively can save hours of pain, expense, and aggravation postoperatively. Preoperative consultation with experienced colleagues may also be quite helpful in dealing with more difficult or unusual cases.

Off-Label Use of Pharmacologic Agents General Considerations The Food and Drug Administration (FDA) is the agency that is responsible for approving new drugs for the treatment of disease. After assessing the safety and efficacy of a particular pharmaceutical agent, it requires the manufacturer to create a “label” that describes the dosage, frequency, route of administration, and other parameters to be used when the drug is administered to treat that particular condition. Once a drug has been approved for one condition, the FDA does not regulate its use for other diseases or purposes, considering that the “practice of medicine” is best left to the physician’s discretion. A major exception to this rule is that scheduled narcotics can be used for only those indications that have been approved. Ophthalmologists are using more and more pharmacologic agents “off label” during cataract surgery, and certain rules should be followed to limit liability. The FDA protocol indicates that “if physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.” More details are available on the FDA’s website (www.fda.gov). If a drug is used off label, it is important to be certain that its use will improve the safety or outcome of the procedure, that it has been carefully studied for the specific clinical situation, and that the risk/benefit ratio is clearly favorable. Use of drugs with only marginal utility and “fad of the month” choices should be scrupulously avoided because their use will be very difficult to defend if there is a problem. Similarly, if there are two drugs of equal efficacy and one is approved and the other is off label, use of the approved drug is always the safest choice. Most cataract surgeons do not get a specific informed consent document signed by the patient when they plan to use medications off label during a case. Although obtaining such a form is not absolutely necessary and certainly not the standard of care, it may be wise to do so, especially if the use of the particular medication is not widespread. OMIC has a sample consent form on its website that can be used as a template with modifications as needed. Regardless of whether a specific form is signed, the informed consent process should be followed, and the patient should be told the reasons why the agent is being used.

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Specific Drugs Used Off-Label During Cataract Surgery Intracameral lidocaine (1% nonpreserved) has been used for many years if sensation begins to return during the surgical procedure. It is generally believed to be safe and effective, although there is some evidence that its routine use does not increase overall patient comfort. If a capsular dye to stain the anterior lens capsule is necessary, it is recommended that the on-label trypan blue ophthalmic solution 0.06% be used instead of the off-label older agent indocyanine green, which is more difficult to formulate for intracameral use. Intracameral steroids and antibiotics are not generally used during routine cataract surgery by most ophthalmologists. There is no evidence that they have significant intraocular toxicity when properly formulated and administered. There is also no good evidence that they actually reduce the evidence of endophthalmitis or intraocular inflammation.

Anticoagulation and Cataract Surgery Before the advent of small incision cataract surgery, it was generally thought that aspirin, nonsteroidal antiinflammatory agents, and Coumadin® should be discontinued prior to cataract surgery to minimize the risk of bleeding. Although objective peer-reviewed data are lacking, the trend now is not to discontinue these agents prior to small incision surgery, particularly when topical anesthesia is used. It is thought that, for many patients, the systemic risk from stopping the drugs (stroke or thrombus formation) may be greater than the risk of bleeding during the procedure. Although there is not an absolute contraindication to the use of retrobulbar or peribulbar anesthesia techniques in patients maintained on anticoagulants, caution should be used and the increased risk of bleeding explained to the patient. Subtenon anesthesia is generally safe, but the frequency of subconjunctival hemorrhage is probably higher. All patients taking Coumadin® should have an international normalized ratio (INR) performed close to the surgery date to be certain that the value is not well above the desired therapeutic range. If the surgeon believes that the surgery should not be done with the patient taking Coumadin®, it is important that the decision be made in conjunction with the patient’s primary care physician or internist. Those physicians may agree to discontinue the drug if the risk is thought to be acceptable. However, ophthalmologists should never discontinue the drug on their own, as a complication that develops following that unilateral decision will likely result in a nondefensible situation. If discontinuing anticoagulation is not possible, the patient can be converted to intravenous heparin anticoagulation over several days and weaned from the Coumadin®. The heparin can then be briefly discontinued to allow the surgery to take place and then restarted along with the Coumadin® and continued until a stable INR is reached.

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Second Eye, Monocular Patients and Same-Day Bilateral Cataract Surgery The indications for removing a cataract from the second eye are no different from those for the initial surgery: the presence of a cataract that impairs visual function and the anticipated benefits of surgery exceed the risk. The time interval between surgeries is variable but should be sufficient to be certain that there are no complications in the first eye. In particular, it is important to verify that there is not a “power surprise” error that could translate as well to the second eye. For this reason, it is reasonable to quickly refract and not just pinhole patients during the follow-up office visits to make sure that all is well. Because the incidence of endophthalmitis peaks between 4 and 6 days after surgery, most ophthalmologists wait at least 1 to 2 weeks before operating on the second eye. Rushing the surgery can leave the ophthalmologist in a difficult position if complications occur. Functionally monocular patients should have the same indications for surgery as any other patient, but in reality this is usually not the case. A serious complication in a monocular patient can lead to a lot of second guessing, soul searching, and hindsight analysis on the part of both the patient and the operating surgeon. Additional attention to candid informed consent is critical to be certain that the patient fully understands the potential downside risks (including total loss of vision) of the surgery as well as the benefits. Memories fade when complications occur, and complete documentation of the process is critical. It is prudent to take a cautious approach when offering advice in this situation. Most surgeons do not perform bilateral cataract surgery on the same day because of the concern of bilateral simultaneous complications. There are reports of bilateral endophthalmitis in this situation. There may be instances when same-day surgery is in the best interest of the patient. For some individuals with advanced bilateral cataracts who require general anesthesia for surgery or those with significant health issues a single session may be most prudent. The reasons for taking this approach should be documented in the informed consent. Under these very unusual circumstances, the second eye should be prepped and draped after the first case is completed, a second set of instruments should be used, and special precautions should be taken to be certain that the correct implant is placed in each eye.

Cataract Surgery in the Presence of Ocular and Systemic Diseases Improvements in surgical techniques and advances in pharmacologic agents now make cataract surgery appropriate for many patients who would have been inoperable in the past. Special attention to preoperative and postoperative management is often required. Patients with significant systemic health issues should receive proper

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clearance from their physicians before surgery is performed. Issues such as hypertension, cardiac status, and diabetes should be stable before elective surgical procedures are performed. If a laboratory test or x-ray is ordered as part of the preoperative routine, it must be reviewed and the proper action taken if the result is abnormal. “Failure to diagnose” cases in which obviously serious pathology such as lung cancer is ignored because no one looked at the preoperative x-ray results are becoming more frequent and often result in sizeable judgments against the ophthalmologist even in the absence of any ophthalmology-related complication. Diseases such as glaucoma should be under good medical control before elective surgery is scheduled, and postoperative pressure management needs to be particularly aggressive to avoid further damage. Realistic expectations in the face of comorbid ocular conditions are essential, and the limits these conditions may place on postoperative acuity must be carefully explained and documented or the diminished vision postcataract surgery will be blamed on the surgery, not the underlying pathology. Patients with chronic uveitis should probably be treated preoperatively with steroids and/or immunosuppressive agents topically and/or systemically before elective cataract surgery is performed. Aggressive postoperative treatment is also usually required, and a flare up of the inflammatory process should be anticipated and the patient monitored accordingly. These patients often have capsular and zonular changes related to chronic steroid administration, and the planning for surgery should take these potential issues into account. Ophthalmologists should rarely if ever administer immunosuppressive agents without the assistance of an internist familiar with their use and complications. Patients with prostate disease need to be quizzed particularly carefully preoperatively to learn whether they have taken Flomax or similar agents that may make cataract surgery extremely difficult because of their effect on the iris tissue (“floppy iris syndrome”). Surgeons unprepared to deal with this issue will find themselves struggling to catch up in the middle of the case. At the present time, the literature suggests that stopping the medication does not mitigate the problem, and various treatment options have been described. Most importantly from a liability point of view, this issue has been so well documented that an ophthalmologist who fails to inform the patient of a potential problem or fails to prepare in advance for the additional risks of surgery may have difficulty prevailing if litigation ensues.

General Considerations for the Adoption of New Technology Ophthalmologists must keep current on the development of new technologies, surgical techniques, and pharmacologic advancements. Review of relevant scientific journals and attendance at continuing education seminars, meetings, and grand rounds at academic centers are ways this can be done. “Innovations” often appear with such rapidity that careful evaluation of their efficacy is difficult because true evidence-based research is lacking. This is particularly troublesome in the new technology area where the marketing division is often way ahead of any reasonable

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concrete evidence of superiority over currently available products. Many “breakthroughs” have been consigned to the waste can within a very short period of time. A healthy skepticism regarding some of the claims made for these products is important, because the ophthalmologist, not the company, is stuck with the result if the device does not perform as promised. This is of particular concern in the area of new lens implants, which are often promoted as a simple cure for almost every problem. It is often useful to check the European literature to see if lenses, which are often released earlier there, are still being used when they finally are approved for use in the United States. If the answer is no, beware, because “FDA approved” is not necessarily a synonym for “better.”

Anesthetic Issues in Cataract Surgery Improvements in anesthetic techniques have increased the options available for cataract surgeons, offering increased flexibility and safety. This increase means that they must become more adept and comfortable with a variety of choices, turning what was once a more or less routine decision into one that should be closely tailored to both the specific needs of the patient and the preference of the surgeon. Although topical anesthesia has increased in popularity recently, there is no correct answer in most instances to the question of which of the available techniques is “best.” Different ophthalmologists will choose different methods for similar patients and yet obtain very satisfactory results. Each technique has advantages and disadvantages, and a detailed discussion of this topic is beyond the scope of this chapter (see Chapter 10). It is important, however, during the preoperative examination to assess which technique might be best for that particular patient. Considerations include the type of surgical incision being considered, the level of anxiety of the patient and his or her ability to cooperate, the anticipated length and complexity of the procedure, and the level of experience and anxiety of the operating surgeon. Those who are relatively inexperienced or might take longer to complete the procedure might want to consider techniques that produce both prolonged anesthesia as well as akinesia. A totally uncooperative patient might do best with general anesthesia if the patient’s health permits this choice. Whatever technique is chosen, it is important that the surgeon be comfortable with it and that it be discussed in advance with the patients so they will know what to expect and what is expected of them. Surgeons who administer the agents themselves should obtain the informed consent. If the task is being delegated to an anesthesia professional, it is usually the responsibility of that individual to obtain the informed consent. When the injection has been delegated to another provider, such as an anesthesiologist, nurse anesthetist, or resident physician, the issue of the level of competence to perform the delegated task often arises. It is important that the operating surgeon be certain that those providers administering the injection are adequately trained. If there are any unusual anatomic issues, such as a shallow orbit, staphyloma, or extremely long axial length, the surgeon must communicate that information to the individual giving the

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injection, particularly if that person is not an ophthalmologist and would not be expected to be aware of this unusual condition. Including this information in the preoperative admission note is an easy way to accomplish this. The situation discussed above led to a very large settlement in a case I reviewed several years ago. A young monocular patient with 20/40 acuity was scheduled for cataract surgery under local anesthesia. Because the patient had a condition that would make communication during surgery difficult, it was thought that topical anesthesia would be contraindicated. A nurse anesthetist (CRNA) administered the local using a peribulbar technique and perforated the eye, and the vision was lost. Ordinarily this would be more of an issue for the CRNA (who was experienced in administering local injections for eye surgery) than for the ophthalmologist. However in this instance, the patient had a shallow orbit and an axial length of close to 30 mm. Neither of these issues was conveyed to the CRNA, and it was thought by experts that both issues should have been because they were unusual and not likely to be detectable by a CRNA based on his training and experience. The case resulted in a large settlement for the plaintiff. If an anesthetic soaked pledget is used as part of the preoperative routine, it is important that there be a protocol in place to ensure that it is removed before the surgery commences. This would seem to be a trivial issue, but legal action accusing ophthalmologists of negligence based on a retained pledget discovered weeks to months postoperatively is not nearly as unusual as one might think. Usually these end with no significant damages against the operating surgeon or facility, but the time and dollars spent to defend the incident can reach surprising levels.

Conclusion If you are like me, you probably assumed that most cases of medical malpractice related to cataract surgery are the result of technical incompetence: an unskilled ophthalmologist “botching” a cataract operation and paying the price. Actually, I have learned, and OMIC data confirm, that cases based on allegations of inadequate technical skill are the exception rather than the rule. The majority of claims and suits I have seen involve instances of either poor judgment or process errors (or both) rather than inferior technical ability. Why is this so? To some degree, it can be attributed to the high skill level of the typical practicing ophthalmologist. More important, however, is the fact that it is much less difficult to explain complications of a complex surgical procedure (which most patients and juries understand are often unavoidable) than it is to justify placement of a wrong power lens or transcription errors or other issues that most patients feel are easily avoided and should “never” occur. These process errors are not medical in nature and are more easily understood by patients (and juries), and no amount of rationalization can explain them away. Averting these problems clearly trumps having to deal with them. Prevention centers on preparation, and preparation in large part hinges on having proper policies and

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procedures in place to anticipate and avoid those problems that by their nature can be avoided. Whether the issue is as complex as careful preplanning for difficult surgical cases or as simple as checking the preoperative test results to avoid missing out-ofcontrol diabetes, time and effort spent in this fashion always pays a large dividend. Ophthalmologists who have ever been forced to deal with a claim or suit or even the threat of one will confirm this without hesitation. There is an old adage that “Judgment comes from experience and experience comes from bad judgment.” Risk management is simply a way of getting the experience needed for good judgment by learning from the bad judgment and misfortunes of others rather than having to make all the mistakes for yourself. No pain, all gain—now that is the way to go.

Chapter 12

Cornea: External Disease and Contact Lenses Peter R. Laibson

Introduction Malpractice as it relates to the cornea involves many of the same issues as other specialties in ophthalmology. Problems relating to informed consent, failure to diagnose, failure to treat appropriately, surgical complications, and poor outcome could potentially be faced by all ophthalmic surgeons. Graft rejection, on the other hand, is a problem unique to corneal specialists. Aside from refractive surgery, which is covered in Chapter 20, the main surgical operation that corneal specialists perform is the corneal transplant. Pterygium surgery is the second most common surgical procedure. There are very few lawsuits relating to corneal transplant or pterygium surgery, and most of these suits are the result of surgical complications and poor outcomes. In the over four decades that I have been at the Wills Eye Institute, there have been approximately 14,000 corneal transplants performed. Only eight lawsuits relating to corneal transplants are known, with none resulting in a verdict for the plaintiff. The Ophthalmic Mutual Insurance Company (OMIC) has several suits involving corneal transplants on file, and these also relate mostly to surgical complications or poor outcomes.

Case 1 Postoperative Endophthalmitis A 75-year-old woman underwent a corneal transplant for aphakic bullous keratopathy. Her preoperative vision was 20/60 in the right eye and 20/400 in the left eye, with normal intraocular pressure. The procedure was done under general anesthesia. A mechanical anterior vitrectomy was performed, and the wound was closed with four interrupted 10-0 nylon sutures and a running 10-0 nylon suture. The original four sutures were removed, leaving her with a 20 bite running nylon suture. The wound was tested for leakage postoperatively and was found to be secure. M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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Subconjunctival injections of gentamycin and cefazolin were given, as well as corticosteroids. The patient was seen on postoperative day 1 and was comfortable. The graft was clear and the wound intact, with normal intraocular pressure and vision of 20/200. An appointment was made for the following week, and she was instructed to call the office if there were any signs of increased pain, visual loss, redness, or any other untoward situation. The next morning the patient called and reported that her eye was more uncomfortable and she felt her vision was not as good. She was seen that morning, approximately 48 hours after the corneal transplant, at which time the wound was secure, the cornea slightly hazy, with many cells in the anterior chamber and a 3+ flare. These findings at this postoperative period are indicative of possible endophthalmitis, and she was referred to the retina service for evaluation and care. Subsequently, the retina specialist saw the patient that day and diagnosed bacterial endophthalmitis. She was admitted to the hospital and treated for this surgical complication. Unfortunately, the organism recovered was a streptococcal bacterium and the patient did poorly. The final visual acuity in the operated eye was hand motions, despite intensive appropriate care by the retina specialist for bacterial endophthalmitis. The patient sued the corneal surgeon for the surgical complication and poor outcome. As the patient could not obtain an expert witness to testify that there had been malpractice on the part of the corneal surgeon, the suit was dropped.

Comments There were several reasons that the suit could not be carried forward, which exemplify the appropriate postoperative care for a patient with a corneal transplantation: 1. The patient had been told to call the office at the first sign of any untoward situation, such as increased pain, loss of vision, ocular discharge, or increased redness. 2. The patient was appropriately seen the same morning that she called. It is important for surgeons to instruct the office personnel answering the telephone that patients who have had a corneal transplant be seen immediately, soon after surgery. These patients may be subject to elevated pressure, endophthalmitis, intraocular hemorrhage, or other complications within the first few days of surgery and therefore must be considered emergency patients. The office personnel answering the telephone must know to ask the specific question about whether the patient has had recent surgery. 3. The corneal transplant patient with endophthalmitis was seen promptly when she called and then appropriately referred to an ophthalmologist who specialized in the treatment of endophthalmitis. In some centers, the anterior segment surgeon treats endophthalmitis, but in others this is left to the vitreoretinal specialists. In areas where vitreoretinal specialists are not readily available, the ophthalmologist

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who is suspicious of endophthalmitis should initiate treatment if the patient cannot be seen that day by a vitreoretinal specialist. There are three important lessons to be learned from this patient with endophthalmitis. First, appropriate postoperative instructions must be given to the patient to call at the first sign of something unusual occurring. Second, instructions must also be given to the office personnel to make sure that, upon answering the telephone, the patient is seen as an emergency and not delayed for a day or several days for the convenience of the ophthalmologist. Finally, appropriate referral to the proper physician who is able to see the patient and treat the endophthalmitis as an emergency must be available for the patient. Documentation by the ophthalmologist is imperative throughout these steps. In the case of this patient, the poor visual outcome was unavoidable, as the infection was due to a streptococcal organism. The standard of care was observed, although the outcome was very unsatisfying. There are other emergent situations that can occur with a patient who has had a corneal transplant. One is a call from a patient, even weeks, months, or years after the surgery, concerning decreased vision. These patients may be subject to graft rejection and also must be considered as emergency patients. They must be seen within the next 24 hours to initiate therapy if this is graft rejection or to reassure the patient that it is not graft rejection. Another emergent situation is the patient who has had a herpes simplex virus infection. The answering service or the personnel who answer the phone during the day must ask the patient who calls with a complaint if he or she is a herpes simplex virus patient as well. Patients who call with a nonspecific red eye may have their examination delayed if it is merely a conjunctivitis, but if there is a history of herpes the patient must be seen immediately to rule out a new outbreak of dendritic keratitis or stromal keratitis.

Case 2 Suture Removal A patient who had a corneal transplant 1 year prior was seen by another ophthalmologist (not the corneal surgeon) for a foreign body sensation in the grafted left eye. Sutures were still in place, and the vision was 20/40− in the right eye and 20/30− in the operated left eye. The cornea was clear, but there was some pooling of fluorescein indicating a flat area inferiorly. Computed tomography (CT) was not performed. The sutures were buried and intact. Three sutures inferiorly were removed to alleviate the foreign body sensation from what was thought to be a dellen effect. The knot of the 5:00 o’clock suture was resistant, and, after cutting the suture and removing it with a jeweler’s forceps, a small 2:00 o’clock wound dehiscence of the graft host interface occurred. There was no aqueous leakage with the Seidel test. Five days later the vision

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had dropped to counting fingers at 3 feet, and there was 10D astigmatism present, which had not been present prior to suture removal. The ophthalmologist had informed the patient of the need for suture removal to hopefully alleviate the foreign body sensation. The physician did not get written consent for this procedure, nor was there a note on the chart indicating a risk/benefit discussion for suture removal. There was no documented discussion of alternate treatment. Although the vision could be improved with a contact lens, the patient was very unhappy with the visual result and a lawsuit ensued.

Comments This patient, who presented with foreign body sensation after corneal transplantation, had had excellent vision, with a clear cornea. Although the sutures were intact, the treating ophthalmologist felt that a dellen effect inferiorly might be the cause of the foreign body sensation. Generally speaking, corneal surgeons do not obtain written consent for suture removal after corneal transplantation, but because the ophthalmologist treating the patient was not the corneal surgeon, it would have been wise to obtain a written consent for this procedure. Lacking a written consent, documented discussion of the risk/benefit relationship of removing the sutures would be appropriate. Generally speaking, where vision is excellent after corneal transplantation, it is not wise to remove three adjacent sutures, as this may cause significant astigmatism. In this case, with the small wound dehiscence, although Seidel negative, the wound dehiscence and suture removal were responsible for the development of a significant amount of astigmatism. The standard of care would require a physician to discuss with the patient the possibility that suture removal could cause increased astigmatism, although the main reason to remove sutures is to eliminate astigmatism. The lesson here is that if one is not the corneal surgeon, it is preferable to use alternative means to treat a foreign body sensation short of suture removal unless the suture is loose or exposed. Three adjacent sutures should not be removed with excellent vision. Discussion of the risk/benefit relationship for removing these sutures should have been documented.

Case 3 Choroidal Hemorrhage After Surgery A 75-year-old patient with a history of Fuchs’ dystrophy and previous cataract extraction with an anterior chamber lens implant was scheduled for corneal transplantation and intraocular lens exchange in the left eye because of corneal edema. The patient’s vision had been decreasing in the eye to be grafted and also was

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significantly reduced in the right eye. An anterior vitrectomy was performed in preparation for a sutured posterior chamber lens. During surgery the patient suffered an expulsive choroidal hemorrhage, and an evisceration had to be done. The patient claimed that the surgeon had not informed him before the procedure that bleeding and hemorrhaging were additional risks of the procedure, even though he had told the physician he had an artificial heart valve and was taking Coumadin for a heart condition. The informed consent form, however, did include the possibility of infection, hemorrhage, and loss of vision as potential complications with this operation. The question arose as to whether this patient on Coumadin had an increased risk of choroidal hemorrhage or whether the age of the patient and the complicated nature of the surgery (corneal transplantation, intraocular lens exchange, and anterior vitrectomy) were the causes of the hemorrhage. One concern was the fact that a discussion between the surgeon and the patient relating to the increased risk of continued bleeding with patients on Coumadin was not explicitly documented on the chart, nor was there any documentation that a conversation had taken place between the surgeon and the patient’s cardiologist, although such an encounter had occurred. The surgeon felt that the surgery could be performed safely with the patient on Coumadin and, additionally, that taking the patient off Coumadin represented an increased and unwarranted cardiac risk. One potential expert witness for the defense felt that replacing the anterior intraocular lens with a posterior sutured intraocular lens prolonged the surgery and therefore increased the risk of a suprachoroidal hemorrhage, although he concurred that this was the appropriate surgery for this case. Coumadin did not increase the risk but would make controlling a hemorrhage more problematic. A documented discussion would have been helpful for the surgeon, but, despite this, the case was dismissed for cause. In two other corneal transplant surgeries, intraoperative and postoperative bleeding relating to suprachoroidal hemorrhages were the reasons the patients initiated litigation. Although these hemorrhages are rare, they do occur, particularly in long procedures such as penetrating keratoplasty, where the eye is open for an extended period of time. In one case, nausea and vomiting occurred after the corneal transplant, and the patient alleged she was not handled appropriately. There was no postoperative visit on day 1, but the patient was seen on the second day after surgery. The standard of care is generally a 24-hour visit after a penetrating keratoplasty. Even if that visit had occurred, in the case of a postoperative suprachoroidal hemorrhage, most surgeons would not have intervened surgically for at least several more days unless the intraocular pressure was significantly elevated. When the patient was seen on the second postoperative day and the choroidal hemorrhage recognized, observation only was indicated, which was the appropriate treatment, considering that the pressure was not elevated. In another case related to a suprachoroidal hemorrhage, while under general anesthesia during a corneal transplant procedure, the patient’s entire body spasmed as if awakening. This occurred after only 2 of 16 sutures had been placed in the donor button, causing expulsion of the intraocular contents coincidental with a choroidal hemorrhage. Unfortunately, the anesthesia chart did not mention the patient awakening or lightening.

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The surgeon’s operative report, however, references the complication, a suprachoroidal hemorrhage, but does not indicate that this resulted from the patient awakening during the general anesthesia administered for the corneal transplant. This intraoperative incident should have been mentioned in the anesthesia record and would have made it easier for the corneal surgeon to be dismissed from the case or be subject to minor liability. It is very important for surgeons who, in many cases, work under general anesthesia to make sure that the anesthetist intubates the patient and keeps the patient under deep enough anesthesia to complete the corneal transplant. The anesthetist in this case was responsible for the surgical complication.

Eye Banks and Litigation There has been at least one major lawsuit involving an eye bank donation of corneal tissue. The eye bank had removed the tissue without obtaining the family’s consent. To make matters worse, the family had consented to an autopsy but had particularly mentioned not to remove the eyes. A corneal surgeon in another state had received one of the corneas and had performed a corneal transplant. He was sued, along with the eye bank, but was eventually dropped from the suit when it was realized that it was the eye bank’s responsibility to obtain permission for use of the corneas and not the responsibility of the corneal transplant surgeon. Several other suits along these lines have been initiated, but the ophthalmic surgeon generally has been released. With over 1 million corneal transplants having been performed in the United States over the past 40 years, these suits are extremely rare, and the corneal surgeon should not be concerned about being involved. The Eye Bank Association of America, which has very strict guidelines for corneal donations and consents, monitors eye banks very strictly and requires appropriate education and training for member eye banks in their efforts to obtain appropriate legal consent.

The Emergency Room and Litigation The emergency room is a prime area for the genesis of lawsuits. Generally, ophthalmologists do not like to be called out of their busy offices or homes to see patients in the emergency room. Therefore, they often prescribe over the telephone. In addition, patients with ocular inflammation, decrease in vision, and pain frequently present themselves to the emergency room or accident ward first rather than being seen in the ophthalmologist’s office. Telephone consults by ophthalmologists and treatment in emergency rooms by nonophthalmologists both have the potential to lead to faulty diagnosis and inaccurate treatment, producing unnecessary discomfort, pain, and possibly loss of vision. There are several specific areas of concern from emergency room care that are illustrated by lawsuits that have occurred in these situations.

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Case 1 A patient called the insured ophthalmologist, complaining of irritation in the right eye. The ophthalmologist instructed the patient to go to the local emergency room, where she was seen with symptoms of conjunctival irritation, a small amount of purulent discharge, but a clear cornea. The pupil was slightly constricted. The emergency room physician called the ophthalmologist for consultation, and it was decided, over the phone, that since the cornea appeared to be clear, the patient had a corneal abrasion as opposed to a corneal ulcer. The patient was sent home with antibiotics, a prescription for pain medication, and a patched eye. Later in the day, the patient’s mother phoned the ophthalmologist and reported that the pain medication prescribed in the emergency room had worn off and the patient could no longer tolerate the patch. The ophthalmologist prescribed Demerol, and the patient was told to make an appointment in the office the following day. At that examination, a corneal ulcer was diagnosed, and she was immediately referred to a corneal specialist and admitted to the hospital. Aggressive antibiotics were administered, but the Pseudomonas infection, which was diagnosed, led to severe central corneal scarring and ultimately resulted in a corneal transplant. Eventually, the patient did recover good vision after the corneal transplant, but a lawsuit ensued, resulting in a judgment against the ophthalmologist.

Comments There are several facts that mitigate against the ophthalmologist. First, the emergency room physician, who was not an ophthalmologist, did not use a slit lamp in the examination. The ophthalmologist who sends a patient to be seen in an emergency room should make sure that the emergency room physician has access to a slit lamp and is familiar with slit-lamp examination. Just instilling fluorescein in the eye and using a Woods’ light, as is often done in smaller emergency rooms where a slit lamp is not available, is not appropriate for diagnosing ocular inflammation. The ophthalmologist who referred this patient to the emergency room should have known that and should have seen the patient himself or made sure the physician in the emergency room had access to the proper diagnostic materials. When pain occurred later in the day, the ophthalmologist prescribed Demerol by phone. It is essential that any emergency room physician, intern, resident, or consulting ophthalmologist treating an emergency room patient be thorough and complete in her or his evaluation before ordering medication. In addition, the ophthalmologist should have seen the patient if pain had persisted. The eye patch that the emergency room physician had applied was contraindicated in this case of a bacterial ulcer.1 It is now clear that contact lens abrasions should never be patched as part of the treatment, even if antibiotics are used. Contact lens corneal abrasions are notorious for initiating Pseudomonas infection in the cornea. In this situation, when the patient was

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seen on day 1, there was just a corneal abrasion from the contact lens and no sign of infection. Patching overnight, despite the use of erythromycin ointment, allowed the Pseudomonas organisms to multiply in a warm culture-like setting beneath the patch. It is not the ophthalmologist who is usually to blame for patching these contact lens abrasions or any abrasion but rather the emergency room physician, who is not cognizant of the fact that abrasions should not be patched and should be treated with frequent antibiotics. These patients with contact lens abrasions should be seen the next day to make sure their abrasions have healed. The patients should be told that if the eye is worse, they should call back immediately. Another aspect of infections related to contact lenses made headlines around the world in 2006. Up until that year, fungal corneal infections were generally very uncommon in contact lens users. Initially there was an outbreak of fungal corneal infections in Singapore, which then appeared in the United States.2,3 To have so many corneal infections (over 100) in a 1-year period was highly unusual. This outbreak of fungal keratitis has been traced to a contact lens solution manufactured by Bausch & Lomb—Renu with Moisture Lock. Not all of these infections were in patients who used the Bausch & Lomb solution, but a great majority of the infections were traced to patients who did use it. It is not clear why this particular commercial solution has been so prominent in fungal infections with contact lens use, but it is obvious that there is some process going on that allows fungal infection to occur despite the use of this supposedly antiinfective contact lens solution. No organisms have been found in it, but the ability of the solution to prevent fungal infections is obviously decreased. Numerous lawsuits are now underway, and these have been moved into class action suits because of the large numbers involved. The manufacturer rather than the ophthalmologist is the target of these suits. A similar situation developed 25 years ago with the organism Acanthamoeba, when patients who cleaned their contact lenses with salt solution made with distilled water and salt tablets succumbed to an outbreak of an Acanthamoeba infection. There had never been corneal infections caused by Acanthamoeba before 1980. The use of distilled water to make salt solutions was found to be the culprit in these contact lens infections, as Acanthamoeba is ubiquitous in most water solutions, even distilled water. Certainly not all Acanthamoeba infections can be traced to distilled water and salt tablets, but a great majority of them were so traced, and when this practice was stopped the number of infections due to Acanthamoeba with contact lens use significantly diminished.

Case 2 A 22-year-old man was seen in the emergency room following an accident at work, during which a foreign body struck his right eye. A full-thickness corneoscleral laceration and small hyphema were seen during the slit-lamp evaluation. No foreign body was found in the anterior chamber, which was deep, and there was no sign of aqueous leakage. The patient was given topical antibiotics, a patch was applied, and

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he was told to return the next day. His vision at this initial examination was 20/20 in the unaffected eye and 20/50 in the injured eye. The patient returned the next day with vision of 20/40, and no aqueous leakage from the anterior chamber was seen. The patch was stopped, the antibiotics were continued, and he was told to return in 4 days. The next day, the second day after the accident, the patient referred himself to an ophthalmologist when his vision decreased. Vision was noted to be hand motions now, and no leakage was seen from the wound. There was no view of the anterior chamber, and the patient was referred to a retina specialist who did a B scan. A reflective image in the vitreous was noted, but no retinal detachment was detected. It was felt that the reflection in the vitreous could represent a foreign body, and a CT scan confirmed an intraocular foreign body. The patient underwent a lensectomy, vitrectomy, and an unsuccessful attempt at removal of the foreign body. He was given intraocular antibiotics and 2 days later was taken back for further surgery to remove the foreign body. A pars plana vitrectomy with membrane peeling, partial retinectomy, and foreign body removal was done. Eventually the patient had an enucleation for uncontrolled endophthalmitis.

Comments In this case the emergency room physician who saw the patient could not be defended, as he did not do a CT scan, x-ray, or B scan at the initial visit. Although there was no aqueous leak, with a full-thickness laceration and a hyphema, it was essential to do the appropriate examination of the posterior pole to rule out an intraocular foreign body. Despite the attempts at foreign body removal, which were unsuccessful at first, the endophthalmitis that had ensued made it more difficult to remove the foreign body. Most of the liability in this case was placed in the hands of the initial physician who did not order the appropriate tests on the initial visit. Obtaining an x-ray, CT scan, or B scan when a full-thickness laceration is evident in the cornea or corneoscleral area should be routine to rule out the possibility of a retained intraocular foreign body.

Case 3 A 10-year old boy presented to the emergency room with tearing, conjunctival injection, and slight blurred vision in one eye. This condition had been present for 2 days prior to the emergency room visit. The physician in the emergency room, who was not an ophthalmologist, used a penlight and diagnosed conjunctival injection and follicular hypertrophy, but as the cornea appeared clear during the penlight

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examination, the patient was told that the cornea was not involved. The patient was treated as a possible bacterial conjunctivitis or an allergic conjunctivitis. The patient was given Blephamide drops to use four times a day. Blephamide is a combination of sulfacetamide 10% and prednisolone 0.25%. The patient was told to return in 2 days to the emergency room. When the patient returned, the eye was still infected, the vision was slightly reduced, and the patient still had discomfort. At this point, the emergency room physician referred the patient to an ophthalmologist for treatment. On examination that afternoon, the ophthalmologist found acute dendritic keratitis, with a dendritic ulcer in the cornea. Two days use of Blephamide probably made the dendritic lesion worse, as steroids are contraindicated with herpetic dendritic keratitis. Unfortunately, this patient went on to form stromal and disciform keratitis, with loss of vision and the necessity for chronic treatment of his herpetic stromal keratitis. Whether this would have occurred without the use of Blephamide is not clear, but the emergency room physician was sued.

Comments There is really no defense for any physician who starts topical steroids, even if combined with antibiotics, for anyone who has an acute red eye if there has been no slit-lamp examination to definitely rule out herpes simplex virus infection. If the emergency room physician had prescribed just an antibiotic and sent the patient to the ophthalmologist a day or two later, there would have been far less issue about treating this patient inappropriately, even if he did not improve. The important lesson here is that every emergency room physician, whether ophthalmologist or nonophthalmologist, must use a slit lamp to rule out herpes simplex virus infection if topical steroids are going to be used on the eye. Ophthalmologists seeing patients for external disease problems, either in their offices or in an emergency room, must not take short cuts in their diagnoses. Patients seen in the emergency room with corneal abrasions must have a full slitlamp examination with fluorescein dye, or a similar diagnostic dye, and they should not be patched but rather treated with antibiotics and seen appropriately in a day or two to determine how the disease course is going. Nonophthalmologists who do not use a slit lamp in the emergency room must never treat a patient with topical steroids, even though steroid, antibiotic combinations such as Blephamide, TobraDex, or Vasocidin are tempting to use to treat both the infectious part of the problem and the inflammatory component as well. These medications should be reserved for only those patients who have had a slit-lamp examination with appropriate diagnostic dye to rule out possible viral keratitis. Emergency room physicians/ophthalmologists must always order the appropriate tests, with x-ray, CT scan, or B scan, to rule out posterior segment involvement. With the slit-lamp appearance of a full-thickness scar, a posterior examination always should be done. A dilated fundus examination is not enough, as the foreign

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body may be in the far periphery or may have slipped behind the iris so that it is not visible on indirect ophthalmoscopy after dilated pupil examination. The last point to be made is the fact that physicians should err on the side of seeing the patients sooner rather than later. Follow up of a patient is particularly important for any ocular inflammation but particularly for possible infections, whether they be bacterial, fungal, Acanthamoeba, or viral. It must be impressed upon the ophthalmologist that if patients do not keep their follow-up appointments, they should be called, and this should be documented on the chart. Chart documentation of calls to the patient is critically important in the defense of lawsuits. With these precautions, the ophthalmologist can feel comfortable in diagnosing and treating appropriately and not fearing a lawsuit for a bad outcome. If the physician follows the standard of care, and if there is a bad outcome, it is a much easier case to defend. Acknowledgment I would like to thank OMIC (Ophthalmic Mutual Insurance Company) for providing background information. Further information can be found at www.omic.com.

References 1. Clemons CS, Cohen EJ, Arentsen JJ, Donnenfeld ED, Laibson PR. Pseudomonas ulcers following patching of corneal abrasions associated with contact lens wear. CLAO 1987;12(3):161–164. 2. Khor WB, Aung T, Saw SM, et al. An outbreak of Fusarium keratitis associated with contact lens wear in Singapore. JAMA 2006;295:2867–2873. 3. Chang DC, Grant GB, O’Donnell K, et al. Multistate outbreak of Fusarium keratitis associated with use of a contact lens solution. JAMA 2006;296:953–963.

Chapter 13

Drugs Simon K. Law

Magnitude of the Problem A review of data collected on 117,000 claims and lawsuits by the Physician Insurers Association of American (PIAA) reveals that medication errors are the second most frequent reason for claims against physicians and result, cumulatively, in the second highest indemnity paid, following faulty diagnosis and evaluation.1 According to a National Center for Health Statistics report in 1992, medications are ordered or provided at more than 19 million patient visits a year to an ophthalmologist’s office. With such a large volume of prescribing activity, it is not surprising that claims related to drug prescribing constitute a significant proportion of all claims for malpractice damages in ophthalmology.2 This chapter aims to help practicing ophthalmologists avoid malpractice litigation related to prescribing and using drugs in ophthalmic care. A series of topics pertinent to prescribing and using drugs in a routine ophthalmic practice are presented in a question and answer format.

What Is the Most Important Method to Avoid Medication Errors or Claims in Prescribing Drugs? Mistakes can occur in any step in drug prescribing and result in a malpractice claim. However, the first and likely the most important step in prescribing would be to administer a therapy appropriately for a specific diagnosis. In order to provide the best possible care for our patients, we have to keep ourselves up to date with the current medical information. In the digital era, the volume of medical information available can be intimidating. On the other hand, there also exist very sophisticated data retrieval systems on every conceivable aspect of medicine capable of collating publications on a given disease entity with related drug therapy. Ophthalmologists should establish and maintain at least a minimal screening process of the more significant publications in their specialty. Application of the published literature in patient care should follow four steps: (1) formulate a clear clinical question about a patient’s problem; (2) search the literature M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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for relevant clinical articles; (3) critically appraise the evidence for its validity and usefulness; and (4) implement useful findings in clinical practice. Such a conscientious and explicit practice of using the best external evidence when making medical decisions is called evidence-based practice. In an evidence-based review of available clinical studies, the highest rating is given to randomized trials and metaanalyses. However, clinicians must understand the limitation of the published literature in terms of its generalizability and applicability to their patients and integrate clinical expertise and patient’s choice into the clinical decision.3,4 Evidence-based reviews of current topics in medication use in ophthalmology are conducted and published in major journals to provide up-to-date information for ophthalmologists. Both for-profit and nonprofit organizations are providing evidence-based reviews in a wide variety of topics in medicine, many of which are accessible through the Internet or available to clinicians by subscription. One such nonprofit organization is the Cochrane Collaboration, founded in 1993 and named for the British epidemiologist Archie Cochrane. It is an international independent organization, dedicated to produce and disseminate up-to-date evidence-based reviews of health care interventions worldwide. The major product of the Collaboration is the Cochrane Database of Systematic Reviews, which is published quarterly as part of “The Cochrane Library” on the website www.cochrane.org. Another source of relevant information for prescribing in ophthalmology is the rigorous medical practice guidelines developed by the American Academy of Ophthalmology. Practicing ophthalmologists should be familiar with them. The practice guideline and the evidence-based approach may provide a basis for correct prescribing of medication and turning down patient demands for high-cost or questionably beneficial intervention and offer a refuge from malpractice litigation.5

What Is the Role of the Physicians’ Desk Reference in Prescribing? The Physicians’ Desk Reference (PDR) contains warnings issued by drug manufacturers of all relevant adverse information about all products they market. If a drug company has given such warnings and the physician has not heeded them, then the physician is clearly not on solid ground. However, clinicians should not rely on the PDR as the last word on product information, especially related to the safety of therapy. Some rare but severe side effects may be recognized only after market approval.4

What Medications Are Implicated the Most in Lawsuits Against Ophthalmologists? Corticosteroids and antibiotics are the two classes of medications most often implicated in claims against ophthalmologists. The reasons that these two classes of medications are linked to lawsuits are probably related to the severity of the diseases that require their use and their systemic effects and side affects.1,2,6

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What Kind of Medical or Drug Information Should Ophthalmologists Be Aware of When Prescribing? Allergy Prescribing a medication to a patient with a documented allergy to that medication is one of the most common causes of medication error claims. For this reason, all allergies to common medications used in the practice of ophthalmology should be recorded in a prominent place on the front of the chart or in another location that will not be concealed by other reports or notes. It is always a good practice before writing out a prescription to ask again if the patient has any known drug allergies. Because many prescriptions are handled over the phone, assistants should be trained always to check for drug allergies in the patient’s chart or verbally with the patient prior to finally issuing a prescription over the phone. The telephone conversation and prescription should be documented in the medical records.

Update of Medication Administration Before procedures that carry a significant risk, the proper techniques of drug administration, such as subtenon injection of steroid depot and topical application of silver nitrate, should be carefully reviewed. One may choose to consult a colleague who is experienced in the procedure to assist or supervise the first several times.

Drug Interaction We must be aware of interactions of drugs we prescribe with those that the patient is already using. Some of the interactions may have severe outcomes. For example, the potentiating effect of acetazolamide on warfarin sodium may result in a major hemorrhage.

How Much Documentation Is Necessary? In analyzing malpractice claims against ophthalmologists that were closed with patient indemnification of at least $250,000, altered records, poor documentation, and informed consent problems are among the most frequent factors influencing the decision to seek a settlement.7 Appropriate documentation is never too much. Adequate notations should be made in office records of what was prescribed and why. Diagnosis correlated to prescribed therapy is a must. A notation about

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follow up should also be included. Documentation in cases that require prolonged treatment should include that a discussion has taken place regarding the reasons for the prolonged treatment, the side effects and complications of treatment, and the consequences of not using the drug. Any pamphlets and fact sheets describing the risks of long-term drug therapy given to the patient should be documented, as well as telephone or email communication between the office and the patient. One may consider using a duplicated prescribing pad that automatically produces an extra copy of the prescription for filing either chronologically or as a part of the patient’s chart.

How Can Charts and Medical Records Help Avoid Prescription Errors? Keeping information regarding the current condition of the patient up to date can help ophthalmologists avoid possible adverse drug–drug or drug–medical condition interactions. A built-in system in the initial examination or follow-up forms or electronic medical record template to require obtaining the patient’s current list of medications or changes in medical condition, recent hospitalization, new medications, or newly developed allergies can serve such purpose. Some medications and medical conditions may affect the way we prescribe medications. Important examples are system anticoagulation therapy and decrease of pulmonary or cardiac function. A newly known allergic drug reaction may require a change in the ocular therapy. One way to alert the ophthalmologist is to place information regarding the allergic reaction and important systemic medical condition or medication on an area of the chart that is obvious or flashed on the initial page of the electronic medical record. For instance, a patient with chronic obstructive pulmonary disease or asthma, a sulfa allergy, or on systemic anticoagulation therapy would have this information listed on the chart in an obvious location.

How to Avoid Errors in Writing Prescriptions Although there are limited data on the rate of prescribing errors on an outpatient ophthalmic basis, such errors in an eye hospital setting may serve as a reference. In a single specialty eye hospital in the United Kingdom, 8% of prescription sheets were found to have errors. Errors consisted of incorrect patient details such as patient name, hospital number, or date of birth, illegibility, incorrect format, prescriptions for which the prescribing doctor could not be identified, and incorrect drug dosage, timing, or route of administration.8 Prescribing ophthalmologists should review and be familiar with the correct format of prescription writing as required by the pharmacy law and always write legibly.

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Prescribing errors regarding drug dose, schedule, or route of administration may be minimized with computerized medical record keeping. In a study of the impact of computerized prescribing on the outpatient prescribing errors in adult primary care practice, physician reviewers judged that advanced computerized prescribing with decision support (such as drug-dose checking and drug-frequency checking) could have prevented 97% of prescribing errors and 95% of potential adverse drug events.9 Other than error in prescription writing, failure of communication between physician and patient and among physicians caring for the same patient is another major source of malpractice claims in medication error. An analysis of medication error claims by the PIAA in which indemnity payments were made, problems in communication accounted for approximately 18% of all claims. They include communication failure between physician and patient (6.7%), inadequate medical history (4.7%), failure to note previously listed allergy (3.7%), and communication failure between physician and other provider (3.0%).10

How Should Ophthalmologists Handle Medication Refills? Refills are authorized by the physician or, more often, by the office personnel. Ophthalmologists should develop and train office workers to adhere to the policy of authorization of refill with appropriate documentation. In some instances, pharmacists have refilled the prescription and claimed they had been given a verbal order by the physician, and patients have lied to pharmacists by saying approval had been given by the physician when in fact it had not been given. It is not unusual to have patients miss follow-up appointments for a long period of time (months to years) but continue receiving refills of medications from different physicians and pharmacies. Patients who have missed follow-up appointments should be advised to return to be evaluated before further authorization of refill is given to the pharmacist.

How to Handle Drug Samples A sample is defined as a unit of drug intended not to be sold but rather to promote the sale of the drug. Samples from manufacturers and distributors may be distributed only to practitioners licensed to prescribe. When a sample is given to a patient, no charge should be incurred. Although samples are not required to be labeled as medication dispensed by a pharmacist, clear instruction of use should be given. Some physicians dispense medication directly to the patients as a way to supplement their incomes. Pharmacists asked the U.S. Food and Drug Administration (FDA) to stop such practice and apply the Durham-Humphrey Amendment’s standard to physicians as well. However, the FDA took the position that the labeling requirements

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of the law apply only to pharmacists, not physicians. On the other hand, many states enacted legislation in the 1980s mandating that dispensing physicians meet the same or similar dispensing requirements as pharmacists.11

Should Generic Eye Medication Be Used? Supposedly, a generic drug is a drug that has the same composition quantitatively as well as qualitatively of the active compound as the original drug. It also has the same pharmaceutical mode of action and the same bioavailability, as determined in bioavailability studies. However, this may not be the case with ophthalmic drops.12 The Drug Price Competition and Patent Term Restoration Act of 1984 laid the foundation for current generic drug policy. This act requires that the bioequivalence of the generic drug to the parent compound be demonstrated. Bioequivalent drug products are products that contain the same active ingredients; are identical in strength or concentration, dosage form, and route of administration; and have comparable bioavailability when studied under similar conditions. For bioequivalence to exist, bioavailability (the rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body) of the various products must be similar when administered at the same dosage and under similar conditions. However, bioavailability studies do not usually measure drug availability at the site of action, but only their concentration in blood or body fluids. It is obviously difficult to assess drug penetration and bioavailability by the eye. Animal testing also is unable to address the compliance issues that may result from generic substitution.12 According to Title 1 of the Drug Price Competition and Patent Term Restoration Act, exception excipients (or inactive ingredients) may differ from the referencelist drug. For a topical ophthalmic solution, exception excipients include preservatives, pH adjusters, antioxidants, thickening agents, buffers, and substances to adjust tonicity. In other words, essentially all excipients in a topical ophthalmic solution are considered exception excipients and can differ from the reference-list drug. Generally, if the exception ingredient in the generic product does not have a concentration that is greater than that in another approved product administered in a similar fashion, then it will be presumed safe. A quantitative difference is defined as a concentration greater then ±5% compared with the reference-list drug.12 In the case of ophthalmic products, considerations with respect to “generic equivalence” may also include the delivery device, namely, the bottle and droplet tip.13 Recent problems with generic ophthalmic products do suggest inequivalence to the brand products. For example, (1) some generic formulations of prednisolone acetate 1% were noted to have poorly suspended constitutions, and caking of the drug precipitated product clogging the dropper tip; and (2) generic diclofenac has been associated with many cases of corneal toxicity, ranging from superficial punctate keratopathy to full corneal melting.13 Problems with bioequivalence can be more severe in developing countries. Twenty percent of generic ciprofloxacin eye drops sold in India were underpotent.

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In a number of preparations the antibiotic content was sufficiently low as to have a potential impact on clinical outcome and possibly to the selection of resistant isolates in individual patients.14 Another example of differences between brand products and generic equivalents is Timoptic-XE (Merck) and timolol gel-forming solution (Falcon Laboratories). The generic product received an AB rating from the FDA in the absence of headto-head study data even though these products are suspended in different extendedrelease gel vehicles.13 Often, generic substitution is advocated for saving cost to the patients and the health care system. However, the calculated daily costs of some generic substitutions were found to be similar to those of the corresponding brand products.15 Although generic substitution of ophthalmic medications is widespread and increasing, little is known regarding the effectiveness of these generic products compared with the parent ophthalmic drugs. When questions about a generic substitution are raised, all that we can honestly answer as prescribing physicians is that a new generic drug has not been tested against the parent drug, and, therefore, it is unknown if the generic substitution will work in the same way. When generic substitution is required or allowed, it is the responsibility of the physician to be vigilant in monitoring the effectiveness of the generic substitution, the tolerability, and the compliance of the use of the generic substitution.

What Is the Responsibility of Ophthalmologists in Prescribing Drugs When Comanaging Patients with Other Specialists? There is a number of systemic illnesses that have ocular manifestations, and it is not uncommon that ophthalmologists have to manage such patients with other specialists. When comanaging patients with internists, such as rheumatoid patients on Plaquenil, patients with severe ocular inflammatory disease on a systemic corticosteroid or immunosuppressant, orbital cellulitis patients, or patients in treatment for tuberculosis, make sure that the individual areas of responsibility are clearly documented in the patient’s record (e.g., who is managing the dosage and monitoring the response or complications). Report all test results to the comanaging physician either in written form or with a documented phone call. Make sure the patient understands your role and any important symptoms that should be reported to you.16

Can Ophthalmologists Prescribe Off-Label Uses of Medication? Off-label use has always been widespread in ophthalmology, because few drugs are specifically FDA-approved for the eyes. The list of off-label treatments is long. For instance, ophthalmologists use intravitreal triamcinolone acetonide, labeled for

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intramuscular use, to treat age-related macular degeneration, diabetic macular edema, and retinal vein occlusion; glaucoma surgeons use 5-fluorouracil (5-FU) and mitomycin-C (MMC) for glaucoma surgery; and comprehensive ophthalmologists use MMC to prevent the recurrence of pterygia following excision, cornea surgeons use glue on the cornea. Once a drug is approved for use, individual physicians for any indication may prescribe it without violating federal law. The FDA considers such prescribing the “practice of medicine” and has chosen not to regulate such practices.17 Off-label use of a drug is sometimes the standard of care. What is important is that we have to make sure we are doing what the standard of care dictates. Physicians should consider if there are published peer-reviewed articles supporting the use of the new treatment and whether the treatment is being used by a reasonable number of other practitioners with the same level of training. Ophthalmologists should discuss all options with patients and be clear if the recommendation is an off-label use; and they should document the decision-making process and the informed consent discussion that led to using a drug off label. Ophthalmologists should also heed the drug’s history of adverse events and advise and monitor patients accordingly. Doctors who want to proceed should have the patient sign a consent form. A number of off-label consent forms are posted on the website of the Ophthalmic Mutual Insurance Company (www.omic.com), including forms for Avastin, MMC when used in glaucoma and refractive surgery, and off-label photorefractive keratectomy. 18

What Are the Requirements When Using Investigational Drugs? Two types of investigational new drugs (INDs) were formally recognized, those with commercial applicability or marketing potential (commercial INDs) and those designed to meet the needs of individual investigators (noncommercial INDs). The first method of obtaining an IND is to enroll the patient in an ongoing clinical trial by the drug’s sponsor, usually as part of a commercial IND. The other method to obtain a nonapproved drug is to enroll a patient under a “treatment” or “compassionate use” protocol (the vast majority of noncommercial INDs). The FDA clearly prefers incorporation of patients into an ongoing sponsored program.17 Patients enrolled in a commercial investigation of a new drug adhere to the protocol of the study that is approved by a local institutional review board. Patients are carefully monitored for effects and side effects of the drug during and often beyond the duration of the study. Informed consent from the patient is an integral part of the IND process. Failure to meet FDA requirements with experimental or investigational drugs may constitute strong evidence in support of a negligence action in the event of any proximate injury to the patient.

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Is it Legal to Prescribe Marijuana? Marijuana is listed as a schedule I controlled substances. Schedule I drugs are substances that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and lack accepted information on the safety of their use, even under medical supervision. However, marijuana has many supporters who firmly believe in its medicinal value. One of the medicinal values in ophthalmology is intraocular pressure reduction in glaucoma. Some states, such as California, have enacted laws allowing patients with legitimate medical need as certified by a physician the right to possess or grow marijuana. These state laws, however, do not change the fact that marijuana is a schedule I drug under federal law. The laws also do not allow marijuana to be dispensed by pharmacists. States that authorize medical marijuana place patients who wish to possess and use the drug in a conflict of law position. Although the laws allow a qualified patient to legally possess or grow marijuana, they do not define how much medical marijuana a patient may legally possess, resulting in some patients being arrested by the state for growing too many plants. Obtaining the drug or the plants creates additional problems because many patients cannot grow their own. In response, cannabis buyer cooperatives were created for the purpose of manufacturing and distributing marijuana to the patients. The U.S. Justice Department challenged the legality of one of these cooperatives, ultimately leading to a U.S. Supreme Court decision that the cooperative violated the Controlled Substances Act by manufacturing and distributing marijuana.19

How to Prescribe for Special Patient Groups Women with Childbearing Potential and Pregnant Women During pregnancy, any drug that is absorbed systemically can affect both the pregnant woman and the fetus. Therefore, the clinician must consider the adverse effects of the drug itself as well as its potential for teratogenicity. Medications are categorized by the FDA according to the potential risk to the fetus into five categories: Category A: Controlled studies with pregnant women have failed to demonstrate a risk to the fetus in the first trimester, and there was no evidence of risk in later trimesters. The possibility of fetal harm appears remote. Category B: Animal reproduction studies either have not demonstrated a fetal risk but there are no controlled studies with pregnant women or have shown an adverse effect that was not confirmed in controlled studies with women in the first trimester and there was no evidence of a risk in later trimesters. Category C: Animal studies have revealed adverse effects on the fetus (teratogenic, embryocidal, or other) and there are no controlled studies in women, or

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studies with women and animals are not available. Drugs should be given only if the potential benefits justify the potential risk to the fetus. Category D: There is positive evidence of human fetal risk, but the benefits from use by pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). Category X: Studies with animals or humans have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience, or both, and the risk of the use of the drug by pregnant women clearly outweighs any possible benefit. The drug is contraindicated for women who are or may become pregnant. Because it is almost impossible to ethically conduct controlled studies with pregnant women to evaluate the risk of a drug to the fetus, hardly any drugs that are used clinically are in category A. Most of the ophthalmic drugs are in either category B or C. A drug in category B is not necessarily safer than one in category C with regard to teratogenicity, because animal studies are often not applicable to human beings. Certainly, drugs in categories D and X should be avoided as much as possible. It is well known that systemic absorption of certain topical ophthalmic drugs by mucosa membrane can achieve therapeutic levels. Ophthalmologists should fully discuss the unknown risk of toxicity to the fetus with pregnant women or women with childbearing potential. This is particularly important for those ophthalmic illnesses that require chronic therapy, such as glaucoma. In addition to the possible teratogenic potential, the pharmacologic effects from systemic absorption of ophthalmic drugs on the fetus prior to delivery and the neonate after delivery should be considered. For instance, topical β-blocker usage before delivery may decrease the fetus’ heart rate, and topical pilocarpine usage before delivery may cause hyperthermia, hyperemia, diaphoresis, restlessness, or and seizures in the newborn. This symptom complex may be mistaken for neonatal meningitis and cause needless therapy.20 Particular caution is necessary and the risk/benefit ratio must be considered whenever drug treatment is contemplated for a pregnant woman. All routine nonessential ophthalmic medications should be avoided during pregnancy. Ophthalmologists are encouraged to refer to the National Registry of Drug-Induced Ocular Side Effects for updated information regarding the side effects of ophthalmic medications for pregnant or lactating women.

Nursing Women The potential toxicity of drugs and chemicals that are excreted in breast milk may be difficult to detect. Virtually all investigations of milk secretion and synthesis have been carried out in animals, and there are considerable differences in the compositions of milk of different species. Drug excretion into milk may be accomplished by binding to the proteins or to the surfaces of the milk fat globules. With few exceptions, all drugs that are present in the maternal circulation are transferred

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into milk. Unless studies on the nursing infant’s blood or urine are performed, there is no way of determining the actual amount of drug being absorbed by the infant from the milk.21 In one study, the timolol level (5.6 ng/mL) in the breast milk of a nursing mother on topical timolol therapy was six times higher than in the plasma (0.93 ng/ml).22 Nursing women who require chronic ophthalmic drugs should be counseled on the potential risks of excretion of drugs in milk and on the potential toxicity to infants. Alternatives including avoiding breast milk should be discussed.

Pediatric Populations Infants and children have increased potential for ocular and systemic drug-induced adverse reactions for several reasons. (1) They may receive an excessive dose owing to the difficulty in instilling drops, particularly if they are uncooperative; (2) administration of a drug may be continued by a parent or nurse who does not recognize early signs of drug toxicity; (3) differences exist between children and adults in their physiologic responses to the same drug; (4) drug absorption through the conjunctival epithelium and skin may be more rapid in infants; (5) metabolic enzyme systems are immature, especially in neonates, and may prolong the halflives of drugs; and (6) the dosage relative to blood volume, body weight, and surface area is greater for infants and children (blood in adults dilutes an absorbed drug 20 times more than in neonates).20 Ophthalmologists should be aware and cautious of some commonly used topical ophthalmic drugs that may have potent and dangerous systemic adverse reactions in pediatric populations. The list includes but is not limited to the following: 1. The systemic hypertension and cardiotoxic effects of the higher concentrations (10%, 2.5%) of phenylephrine (Neo-Synephrine) are especially dangerous in the infant with intracranial bleeding or with a left-to-right shunt. 2. Infants, blond children, children with spastic paralysis or brain damage, and children with Down’s syndrome have an increased susceptibility to anticholinergic (parasympatholytic) drugs, such as atropine, homatropine, scopolamine, and cyclopentolate. 3. Serious ocular and systemic adverse effects of corticosteroids instilled in the eye in high doses or on a long-term basis can occur in the pediatric age group. These effects include secondary open-angle glaucoma, posterior subcapsular cataracts, Cushing’s syndrome with adrenal suppression, and decreased resistance to bacterial, viral, and fungal infections. The potential danger of ocular side effects is magnified in children because it is often difficult to measure intraocular pressure accurately and to monitor lenticular changes. 4. Serious allergic reactions of some topical antibiotics, some leading to death, have been reported. Such reactions include irreversible bone marrow suppression with chloramphenicol, Stevens-Johnson syndrome, and aplastic anemia with sulfonamide.

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5. More pronounced systemic effects from topical antiglaucoma medications occur in pediatric patients, such as the systemic bronchopulmonary toxic effects of topical β-blockers in neonates and infants and the central nervous system depressive effects of selective α2-agonists. Phenylephrine 1% in combination with cyclopentolate 0.2% (Cyclomydril) can be safely given to all infants for mydriasis or cycloplegia. For cycloplegia in pediatric patients past early infancy and in darkly pigmented children, the 0.5% or 1% concentration can be used. Tropicamide (Mydriacyl) 0.5% or 1% eye drops combined with phenylephrine 2.5% eye drops also produce wide pupillary dilation for indirect ophthalmoscopy in infants and children.20

How to Reduce the Risk of Delivering Drugs Via a Needle to the Eye Drug delivery by needle in ophthalmic care includes peribulbar and retrobulbar injections of anesthesia, absolute alcohol, and major tranquilizers such as chlorpromazine; subtenon or subconjunctival injections of steroids, antibiotics, and antimetabolites; and intraocular or intravitreous injections of steroids, antibiotics, and newer medications such as anti–vascular endothelial growth factor. Because few drugs that are given subconjunctival or intraocularly are specifically FDA approved, and injection of medications into or around the eye with a needle carries significant risks, it is important for ophthalmologists to be especially vigilant to maintain clear communication with the patients, adhere to the off-label use requirement, be familiar with the current standard of care, and document appropriately. When reasonably confident that patients would benefit from a drug, ophthalmologists should discuss all options, the nature of off-label use, the current standard of practice of the proposed therapy, and the possible complications of the therapy. The common risks of direct drug delivery with a needle into the eye are bleeding, retinal detachment, and infection. An additional risk of injecting a steroid intraocularly is increased intraocular pressure. For an injection around the eye, such as retrobulbar or peribulbar injection and subconjunctival or subtenon injection, perforation or penetration of the globe may be the most alarming complication with serious outcomes that often lead to litigation.23 Ophthalmologists should take the time to review the proper technique for administration of mediation by needle around the eye or ask a colleague who is experienced in the procedure for supervision initially. In addition, one should also be aware of the clinical signs and symptoms to recognize a complication quickly and manage the patient’s injury promptly and properly. Signs and symptoms of complications include severe pain, sudden loss of vision, floaters, sudden increase in intraocular pressure, shallowing of the anterior chamber, vitreous hemorrhage, poor red reflex, hypotony, and a poking-through sensation. When a complication occurs, the ophthalmologist should maintain good rapport with the patient, keeping him or

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her fully informed of all aspects of the clinical situation, and obtain necessary and appropriate consultations. Appropriate risk management officers should be notified and early contact made with the insurance carrier.23

Do Not Forget that Some Patients Have Poor Eye Sight The following medical error reported anonymously on the Mortality and Morbidity Rounds on the Web (Web M&M) of the Agency for Healthcare Research and Quality (AHRQ), an online journal and forum on patient safety and health care quality, highlighted the importance of the physician’s awareness of the patient’s visual limitation in the compliance of medical therapy24: An elderly man developed a deep vein thrombosis during his hospital stay. At discharge, he was to receive enoxaparin (Lovenox) for self-administration at home in addition to other medications. Before leaving the hospital, he was given written information sheets regarding his medications and received counseling from a nurse and a pharmacist. Several days after discharge, the patient called the primary care triage nurse and stated that he had been discharged with a bag of medications and some injections, but that he could not administer them because he could not read the instructions. After retrieving his chart, the triage nurse noted that the patient was blind and, upon questioning, also learned that he lived alone.

Although the patient of this story was not receiving an ophthalmic therapy, any ophthalmic practice certainly has a number of patients who have very limited vision or are legally blind and experience similar difficulties in using their medications. Ophthalmologists need to identify any factors that might impede the patient’s compliance with therapy. It might involve a proactive and respectful discussion of their ability to perform self-care tasks, perform manual tasks independently, and read, understand, and follow written instructions. Ophthalmologists should also involve the caregiver of the patient in providing therapy. Alternative therapies need to be considered for patients who cannot adhere to a medical therapy.

How Does Compliance of Drug Use Legally Affect One’s Practice? Noncompliance could lead to an undeserved liability claim against the ophthalmologist. Sometimes when medical malpractice claims arise, the role of noncompliance in causing the injury or poor result may not be fully appreciated by those evaluating the claim. Thus, identifying noncompliant patients becomes extremely important for purposes of risk management. Poor compliance may reflect a suboptimum patient–physician relationship. In analyzing malpractice claims against ophthalmologists who suffered indemnifications of at least $250,000, Kraushar and Robb7 reported that 43% of claims of alleged

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malpractice occurred within 1 month of the initial physician–patient encounter and 17% occurred at the initial encounter. The lack of time for development of patient–physician rapport is a major risk factor of litigation.7

How Can the Ophthalmologist Improve a Patient’s Compliance with Drug Therapy? It has been reported that having a good understanding of disease improved patients’ regimen compliance by up to 10 times.25 Much research effort has been initiated by major ophthalmic organizations, including the American Glaucoma Society, to identify barriers to drug compliance and solutions to improve it. Some suggestions to improve compliance include the following: 1. Ask open-ended questions about the treatment regimen to reveal whether the patient is using the medication properly. For example, ask “How often do you use the timolol eye drop?” instead of “Are you using the timolol eye drop?” 2. Identify the reasons of noncompliance. Some of the reasons include difficulty in administration of the medication, intolerance of the medication, lack of understanding of the purpose for using the medication, inability to afford it, or belief that the inconvenience or side effects of a medication outweigh its benefits. 3. Provide patients with medication instructions or fact sheets. Patient Medication Fact Sheets for many common drugs, including β-blocker eye drops, oral corticosteroids, topical corticosteroids, long-acting miotic eye drops, miotic eye drops and gel, steroid eye drops, and ointment, can be ordered from the United States Pharmacopeial Convention (USPC) by writing to 12601 Twinbrook Parkway, Rockville, MD 20852, or by calling 800-227-8772. 4. Keep medical regimens, especially in chronic therapy, simple. For instance, maximize the monotherapy in glaucoma medical management or switch to another medication instead of adding more medication, use medications that require less frequent dosing, and avoid medications that had an immediate intolerable side effect upon instillation. Ophthalmologists should document such a communication with a patient to secure compliance with treatment, as well as any refusal or delay in treatment that is caused by a patient.

How Can Ophthalmologists Provide Patient Counseling Regarding Medications? In a study of glucocorticoid therapy, the PIAA Medication Error Study found that after “incorrect dose” “communication failure between physician and patient” was the most common error.2 With the increased availability of in the public media and especially on the Internet, many patients are well informed about the potential for drugs applied to the eye to affect a wide variety of body functions. Moreover, pharmacists are

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required to provide extensive information and counseling to patients about possible effects of their eye drops. However, an ophthalmologist who prescribes the eye drops should not delegate the responsibility to other professionals or to the media. It is inexcusable for an ophthalmologist who is knowledgeable about and experienced with the medications prescribed and familiar with the clinical condition of the individual patient to not review with a patient specific effects or side effects of a drug and provide instruction in the proper use of the eye drop. It is also important that the patient be aware of the potential for a generalized effect from the eye drop. A simple review and a periodic update of symptoms will foster awareness of systemic illnesses that could be affected by ocular therapy. In addition, it is equally important to communicate with primary care physicians about the ocular therapy and its potential effects. The physician should document that a discussion took place regarding the potential side effects of a prescribed drug and the consequences of not using the drug. Any pamphlets and fact sheets describing the risks of long-term drug therapy given to the patient should also be noted.

How to Avoid Claims Related to Problems Arising from Pupil Dilation Pupil dilation is part of the routine eye examination, but it may result in a short-term visual disturbance in some patients. There have not been many liability actions related to the use of dilating drops, according to the OMIC. However, it is wise to avoid surprising patients with even mildly distorted vision that they may blame as the cause of a problem after an eye examination.26 It is prudent to discuss the potential effects of glare, lack of accommodation, and possible blurred vision particularly with patients who drive to the office for their eye examination. Receptionists may alert each patient at the time the appointment is made that dilation may cause side effects, which might make driving difficult. This will allow the patient to arrange to have a friend or family member do the driving to and from the appointment. The OMIC Publication Archives also advises physicians who administer dilating drops to instruct patients to wear sunglasses and to avoid driving or operating dangerous machinery afterwards. Before cycloplegic or mydriatic drops are instilled, it is important to ask each patient about potential allergic reactions. If the anterior chamber is shallow, precautions should be taken to avoid acute glaucoma. Routine dilation by technicians or nurses prior to examination by the ophthalmologist is not encouraged.

Conclusion Ophthalmology is a unique specialty that provides both medical and surgical therapies in nearly equal proportions to the patients. The large volume of prescription activity places ophthalmologists in a vulnerable legal environment. However,

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by consistently acting in a timely and appropriate manner in the best interest of the patients, ophthalmologists will continue to enjoy the rewarding patient–physician relationship and to do no harm.

References 1. Medication Error Study. Washington, DC: Physician Insurers Association of America; June 1993. 2. Brick DC. Medication errors result in costly claims for ophthalmologists. Surv Ophthalmol 1995;40:232–236. 3. Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn’t. BMJ 1996;312:71–72. 4. Miller JW. Using a drug before the risks and benefits are known from a phase 3 clinical trial. Arch Ophthalmol 2004;124:1029–1031. 5. Trobe JD, Fendrick AM. The effectiveness initiative. Arch Ophthalmol 1995;113:715–717. 6. Bettman JW. Seven hundred medicolegal cases in ophthalmology. Ophthalmology 1990;97: 1379–1384. 7. Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol 1996;114:333–337. 8. Mandal K, Fraser SG. The incidence of prescribing errors in an eye hospital. BMC Ophthalmol 2005;5:4. 9. Gandhi TK, Weingart SN, Seger AC, Borus J, Burdick E, Poon EG, Leape LL, Bates DW. Outpatient prescribing errors and the impact of computerized prescribing. J Gen Intern Med 2005;20:837–841. 10. Bettman JW, Monica ML. Nonmedical issues in claims against ophthalmologist. OMIC publication archives. Digest, Winter 1994. Available at: http://www.omic.com/resources/risk_ man/deskref/medicaloffice/general/8.cfm. 11. Abood RR. Pharmacy Practice and the Law, 4th ed. Boston: Jones and Bartlett Publishers; 2005:101–144. 12. Cantor LB. Ophthalmic generic drug approval process: implications for efficacy and safety. J Glaucoma 1997;6:344–349. 13. Fiscella RG, Gaynes BI. Equivalence of generic and brand-name ophthalmic products. Am J Health Syst Pharm 2001;58:616–617. 14. Weir RE, Zaidi FH, Charteris DG, Bunce C, Soltani, Lovering AM. Variability in the content of Indian generic ciprofloxacin eye drops. Br J Ophthalmol 2005;89:1094–1096. 15. Fiscella RG, Green A, Patuszynski DH, Wilensky J. Medical therapy cost considerations for glaucoma. Am J Ophthalmol 2003;136:18–25. 16. Demorest BD. Minimize the risks of patient co-management. OMIC publication archives. Digest, Spring 1995. Available at: http://www.omic.com/resources/risk_man/desref/comanagement/1.cfm. 17. Lee PP, Yang JC. The nonapproved use of medications. Ophthalmology 1991;98:1071–1074. 18. Craven ER, Moran EC. Medical implications of using off-label drugs and devices. OMIC publication archives. Digest, Winter, 1996. Available at: http://www.omic.com/resources/ risk_man/deskred/clinical/28.cfm. 19. Abood RR. Pharmacy Practice and the Law, 4th ed. Boston: Jones and Bartlett Publishers; 2005:145–183. 20. Apt L, Gaffney WL. Toxic effects of topical eye medications in infants and children. In: Tasman W, Jaeger EA, eds. Duane’s Clinical Ophthalmology. Philadelphia: Lippincott Williams & Wilkins; 2002;43:133342–133752. 21. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol 1988;106:616–623.

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22. Lustgarten JS, Podos SM. Topical timolol and the nursing mother. Arch Ophthalmol 1983;101:1381–1382. 23. Boniuk V, Nockowitz R. Perforation of the globe during retrobulbar injection: medicolegal aspects of four cases. Surv Ophthalmol 1994;39:141–145. 24. Iezzoni LI. Discharge blindly. Agency for Healthcare Research and Quality (AHRQ) Web Morbidity and Mortality (Web M&M) Rounds on the Web. Case and Commentary. December 2005. Available at: http://www.webmm.ahrq.gov/case.aspx?caseID=111. 25. Zimmerman T. Facilitating patient compliance in glaucoma therapy. Surv Ophthalmol 1983;289(Suppl):S252–S257. 26. Deutsche RA. Discuss potential side effects of eye drops. OMIC publication archives. Argus, January 1992. Available at: http://www.omic.com/resources/risk_man/deskred/clinical/9.cfm.

Chapter 14

Emergencies Peter H. Morse

Introduction Regardless of how punctilious one is in the practice of medicine, there is no infallible protection against malpractice litigation. Attention to certain details, however, minimizes the risk. When reviewing potential medical malpractice cases, the omission of seemingly obvious examinations or precautions for whatever reason is often incomprehensible and an inchoation of disaster. The spectrum of diseases eliciting urgent consultation by a patient, from trivial to severe, may encompass nearly every ophthalmologic condition as well as many systemic diseases having ophthalmologic symptoms or manifestations. Not all ocular diseases threaten significant morbidity or blindness, and most ophthalmologic diseases are not emergencies. This chapter concerns problems that commonly prompt patients to seek immediate attention and that, if neglected, may cause preventable impairment or serious or irreversible loss of vision. The subjects outlined are areas of vulnerability repeatedly explored by attorneys.

Physician–Patient Relationship Over the past few years, great improvements have been made for emergent care. Emergency room physicians are generally knowledgeable about ophthalmologic disease, and most emergency rooms have adequate instruments for evaluation of a patient with ocular complaints. Nonetheless, visits by a patient to the emergency room or as an unscheduled appearance at an ophthalmologist’s office are frequent sources of litigation. The management of emergency ophthalmologic conditions, whether in the office or the emergency room, involves risks that are unique to these situations. By definition, in an emergency there is insufficient time to develop as meaningful a physician– patient relationship as would be possible in managing a more chronic condition such as cataract or diabetic retinopathy. Furthermore, the outcomes of acute problems such as a ruptured globe, a traumatically avulsed eyelid, or an intraocular foreign M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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body carry a significant risk of permanent severe vision loss or cosmetic deformity despite appropriate, competent, and successful management. For this reason, it is of paramount importance to provide to the patient pertinent information regarding risks, benefits, and alternatives by means of a discussion of informed consent that is properly documented in the record.

Responsibility There are many causes of unfortunate outcomes. Assigning responsibility to only the treating physician for any adverse event is unwarranted. Consultants may also commit errors. Paramedical personnel may give false reassurance or inaccurate information to patients. Certain diseases are unfortunately beyond the scope of treatment. Patients may delay seeking consultation for conditions that if treated at an earlier time would more likely than not have had a favorable outcome. An infant or child is dependent on the attentiveness and diligence of the parent or guardian. After urgent treatment has been rendered, patients may also neglect instructions for subsequent care. Common misdiagnoses or omissions by responsible medical personnel occur as a result of hasty evaluation and disposition or the assumption that the patient’s complaint is trivial. If misdiagnosis, faulty treatment, or false reassurance occurs, it is often assumed that the patient will return or seek another opinion. Unfortunately, this is not always the case. An abatement of symptoms may cause a delay in a patient’s return. Strangely, there is often a feeling by the physician of indemnity against malpractice comparable to a motor car accident in that the misfortune always happens to another person. Every step of patient care should be planned with the benefit of the patient as the objective and not for the purpose of avoiding malpractice litigation.

Emotional Issues In any medical consultation, there is patient anxiety. Emotion in urgent matters, which are of greater concern to the patient, is invariably involved to varying degrees in litigation. Strong emotional reactions are often seen on the part of patients, concerned relatives, physicians, and attorneys. A patient’s concerns, concepts, understanding of disease, expectations, or demands are often bizarre but need to be addressed. Attempts should be made by all responsible medical personnel to explore the facets in every situation. One must not assume anything without questioning and definition. No encounter between a physician and a patient is satisfactory without allaying the patient’s fears and formulating a comprehensible plan for treatment of the disease or injury. Often when asked if he or she has any questions, a patient feels lack

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of sufficient knowledge to respond. Use of unexplained medical terminology may also be confusing. It is best to ask, “What worries you about your eyes?” In addition to an oral explanation, written material given to the patient may be helpful.

Communication Lack of continuous communication between physician and patient and among physicians caring for a patient is a serious concern. A common patient allegation is “I was not told anything.” If the physician appears overwhelmed or rushed or is abusive to the office staff, an unfavorable impression is created. If there is an untoward occurrence, some medical practitioners attempt to escape by withdrawing and remaining incommunicative. Others manifest hostility toward the patient. Both of these defense mechanisms are very harmful. Paramedical personnel may be culpable. One lawsuit involved a patient postoperatively suffering excruciating pain caused by very high intraocular pressure following vitrectomy with fluid–gas exchange. Paramedical personnel caring for the patient failed to notify the surgeon and the patient was blinded. The verdict was against the hospital and its personnel.

History A history given by the patient may be inaccurate but must be recorded with care. If a history is written by a medical assistant, it must always be evaluated by the treating physician. If an injury occurs while a patient is at work, the date, time, location, and names of companies and individuals involved must be documented in the medical record.

Examination The patient’s visual acuity must always be noted. An examination must not be abbreviated or terminated because the patient is difficult or uncooperative. Sedation or general anesthesia may be necessary for some patients, especially children. Struggling with a patient needs to be avoided and can cause serious damage if there is a lacerated globe. A common mistake is reflex recording of PERLA (pupils equal in size, react to light and accommodation) despite the fact that the examination has not been performed. In general, consultation with an appropriate specialist is advisable when there is any uncertainty of findings or disposition. Consultations may involve ophthalmologists, otorhinolaryngologists, radiologists, neurologists, neurosurgeons, plastic surgeons, pediatricians, internists, and anesthesiologists.

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Documentation Detailed documentation is of the utmost importance. Meticulous record keeping includes history, findings on examination, results of tests, diagnosis, treatment, and prognosis. If an invasive procedure is contemplated, a signed informed consent from the patient must be obtained. Informed consent, including the probable outcome without treatment, the risks and benefits of treatment, and the likely results, is for the benefit of the patient, enabling him or her to make an intelligent choice. However, informed consent does not protect the physician from a malpractice suit. The following example illustrates oversight in treatment and documentation. A patient with intraocular pressure elevated to a dangerous level was given medication to reduce the intraocular pressure and sent home without further evaluation. This assumption of intraocular pressure control was erroneous and led to blindness. In such a case, one must not discharge the patient until the intraocular pressure is reduced to an acceptable level. This involves noting specific treatment and measurements of intraocular pressure, including the time interval. Malpractice litigation has occurred because this information was not obtained and documented and excessively elevated intraocular pressure resulted in injury to the patient. If a patient is referred to another physician, an appointment should be made and the patient provided with the name, address, and telephone number of the physician to whom the referral has been made. An explanation for the reason of referral is also important. Contents of telephone conversations, persons communicating, and dates and times should be recorded in the patient’s history. Documentation of a patient’s refusal of testing, treatment, or referral or leaving against medical advice must be made.

Special Case Situations Children, if frightened or in pain, may present particular problems in evaluation. Child abuse must always be considered. For children, sedation, a papoose board, or even general anesthesia are options. A child’s vision may sometimes be evaluated by using the “E” game or Allen pictures. Although a child may not always be examined with a slit lamp, the use of a magnifying lens with a penlight held by an assistant is very helpful. Often injuries to children occur while playing with another child when adults are not observing. Perforation of the eye with a sharp object is common. An asymmetry of the pupil may be seen in such injuries but is easily missed if the child is not calm and the examiner does not have adequate magnification and illumination. On occasion, intoxicated adults or adults in extreme pain present problems in examination.

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Ancillary Tests Commonly used tests to evaluate an urgent situation, especially one involving trauma, are computed tomography (CT) scan, magnetic resonance imaging, ultrasound, and conventional x-rays. In acute trauma, CT is good for bone imaging. There is no contraindication for use in cases of suspected or confirmed ironcontaining foreign body, pacemakers, or external life support. Computed tomography may be useful for patients with suspected intraocular foreign body, hemorrhagic chemosis, orbital fracture, intracranial or orbital hemorrhage, or ruptured globe. Magnetic resonance imaging is advantageous for evaluation of vascular lesions, intracranial diseases, intraocular tumors, cavernous sinus thrombosis, and optic nerve lesions. In general, soft tissue resolution is better with magnetic resonance imaging than with CT. Magnetic resonance imaging is, however, contraindicated for metallic foreign bodies, especially those containing iron, cochlear implants, cardiac pacemakers, intracranial magnetic vascular clips, and claustrophobic patients.1 Conventional x-rays are useful for visualization of foreign bodies, especially metallic. When CT is unavailable, an x-ray is often satisfactory and in some cases is preferable even when more sophisticated technologies are available.

Emergencies Most ocular disease or trauma is not emergent. Some argue that there is no ophthalmologic emergency. Others, however, regard chemical burns and retinal artery occlusions as emergencies.

Chemical Burns Irrigation of the eye with water immediately after contact with a potentially damaging chemical solution is the best and often only treatment available. This must be performed at the workplace, as delay caused by transportation of the patient to an emergency room or physician’s office may result in additional damage. The eye must be thoroughly irrigated and the lids retracted. Particulate matter must be removed from the fornices. Retained granules of lye may cause damage to the overlying retina if the chemical passes through the sclera. When there is extensive destruction of tissue, adequate subsequent treatment should be planned to prevent symblepharon.2 Thermal burns may also create deformity or malfunction.

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Central or Branch Retinal Artery Occlusions Treatment of central and branch retinal artery occlusions is controversial. Many ophthalmologists regard these occlusions as untreatable, and some regard them as indications of acutely threatening systemic disease. Central retinal artery occlusions may rarely be a manifestation of giant cell (cranial) arteritis. Evaluation by an internist is advisable and must extend beyond carotid artery auscultation and Doppler studies.3 Other physicians regard treatment with pentoxifylline, hyperbaric oxygen, intravenous recombinant tissue plasminogen activator, or selective ophthalmic artery catheterization with infusion of recombinant tissue plasminogen activator or urokinase to be helpful.4 Such treatments are not of incontrovertible efficacy and are not available in every medical facility.

Urgent Conditions Some conditions in and of themselves may not be urgent but may have an accompanying complication or occurrences that may require urgent treatment.

Giant Cell Arteritis Giant cell (cranial) arteritis must be considered especially in individuals over 70 years of age complaining of jaw claudication, pain in the head, face, and neck, fever, night sweats, lost of appetite, and general malaise with joint and body aching. Ocular symptoms and findings of giant cell arteritis include anterior or posterior ischemic optic neuropathy, central retinal artery occlusion, cilioretinal artery occlusion, cotton wool spots, poorly reactive pupils, conjunctival injection, corneal edema, low intraocular pressure, homonymous hemianopia, cortical blindness, abnormal extraocular movements from palsy of cranial nerves III, IV, or VI, diplopia, eye pain, and transient obscuration of vision. Similar pains including the eye may occur in internal carotid artery dissection. If the patient has arteritic ischemic optic neuropathy, immediate treatment does not restore lost vision but usually prevents involvement of the fellow eye or more serious fatal complications.5,6 Optic neuritis as a manifestation of giant cell arteritis must be distinguished from nonarteritic ischemic optic neuropathy and optic neuritis.7,8 Some encounters, as in the following case, illustrate complications arising from failure of protracted vigilance. An elderly lady complaining of sudden loss of vision in her right eye was seen in an ophthalmology clinic shortly before 5:00 PM. Markedly reduced vision with a pale swollen optic nerve was noted, and the patient was sent to the laboratory for erythrocyte sedimentation rate and

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C-reactive protein evaluations. A note requesting a report of the erythrocyte sedimentation rate and the ophthalmologist’s telephone number was sent along with the patient. She was given an appointment to see an internist early the next morning for evaluation of giant cell arteritis and corticosteroid maintenance or treatment. The laboratory failed to report the erythrocyte sedimentation rate value to the ophthalmologist, and the internist who saw the patient the next morning did not consider it sufficiently elevated to create suspicion of giant cell arteritis. The patient was treated with one aspirin tablet daily. One week later the patient experienced severe visual loss in her fellow eye and was taken to an emergency room. The diagnosis of giant cell arteritis was entertained, and highdose intravenous corticosteroids were instituted. Temporal artery biopsy confirmed the diagnosis of giant cell arteritis. A lawsuit was filed against the clinic, including both the ophthalmologist and the internist. The settlement was in favor of the patient. One must never assume that because the test result is requested that the report will be made. The ophthalmologist’s assumption was that if the result were abnormal a call would be made. Furthermore the patient was to see an internist the next morning was expected to receive appropriate treatment. The ophthalmologist was considered guilty for not diligently seeking the test result by calling the laboratory and the internist for not making the correct diagnosis. Another interesting complexity in this case was that the defense lawyer was hired by the insurance company to represent the clinic and not the individual physicians, who were thus considered equally culpable.

Edema of the Optic Nerve Heads Edema of the optic nerve head does not always cause decreased vision. Any swelling of the optic nerve head, whether unilateral (disc edema) or bilateral and usually associated with increased intracranial pressure (papilledema), requires prompt investigation. This topic is discussed in greater detail in Chapter 16.

Lid Lacerations Lacerations of the lids must be carefully repaired. Inattention to canalicular repair or notching of the lower lid margin may cause chronic epiphora. If the levator palpebrae superioris aponeurosis is severed and not repaired, blepharoptosis will occur. While none of the aforementioned injuries threatens blindness, some possible accompanying injury may well do so.9 In any lid trauma, the eye must be inspected as deeper lacerations may involve the eye itself and be associated with a retained intraocular foreign body. In one legal case, a dart had not only perforated the lid but had also entered the eye, creating a hole in the retina that was neglected.

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Corneoscleral Lacerations Corneoscleral lacerations are commonly not diagnosed especially in children with darker colored irides. Such lacerations often occur when the child is playing alone or with other children in which case an accurate history is impossible. With darker colored irides, there is less contrast between the iris and the pupil. Children are often frightened and in pain. Squeezing of the lids is reflex when any form of retraction is attempted. Sedation, magnification, and brighter illumination is required to adequately examine such infants. Delay or failure to repair such lacerations often results in visual impairment or blindness. Conjunctival lacerations must also be carefully examined to be certain that there is no underlying scleral perforation or laceration.10 One legal case involved a young child who was examined and diagnosed with conjunctivitis by an emergency room physician. Antibiotics were prescribed. Another opinion was sought a few weeks later, and a 6-mm corneoscleral laceration with iris incarceration and a teardrop-shaped pupil was seen. Review of the emergency room physician’s notes revealed the notation “PERLA,” which would have been impossible. An asymmetric or misshapen pupil is often a clue to severe trauma and frequently not observed. The child experienced a fibrovascular ingrowth with an irreparable tractional retinal detachment. The legal settlement was favorable to the plaintiff.

Rupture of the Globe Severe blunt trauma may cause a rupture of the globe. The eye may be deformed with visible loss or incarceration of intraocular content. However, especially with accompanying orbital hemorrhage, the rupture of the globe may be occult. The intraocular pressure may be normal. Surgical exploration may be required and must extend quite far posteriorly, often requiring temporary detachment of one or more rectus muscles to obtain adequate exposure.

Intraocular Foreign Bodies Occasionally intraocular foreign bodies cannot be distinguished from orbital foreign bodies, which carry much less risk. In any perforation or laceration of the eye, one must suspect and perform appropriate examinations to exclude a retained magnetic or nonmagnetic intraocular foreign body. This is particularly true when there is a history of hammering on metal. Such studies include CT scan, ultrasound, and x-rays.11 Lacerations and perforations of the globe frequently involve extensive surgical repair many times in several stages. Repair of the laceration, removal of a

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secondary cataract, removal of the foreign body, repair of retinal defect or detachment, and corneal transplant are common. The risk of infection, although possible, is surprisingly small but must not be disregarded. Retention of some foreign material may cause long-term toxicity and loss of vision. One legal case involved a man who was striking metal with metal and felt something fly into his left eye. He was seen by an emergency room physician who diagnosed a corneal tear with a misshapen pupil. An ophthalmologist came to see the patient in the emergency room and subsequently saw the patient in his office. Because the corneal laceration was self-sealing, it was not sutured until 10 days later. At this time, the traumatic cataract was removed and a posterior chamber intraocular lens inserted. No attempt was made to discover an intraocular foreign body. The patient’s vision in his left eye returned to 20/20. Eight months later, the vision in the patient’s left eye decreased to 20/40 and heterochromia iridis was noted. Still no examinations were performed to ascertain the presence of an intraocular foreign body. Approximately 13 months after the injury, the patient was legally blind with respect to both central vision and visual field. There was a marked decrease in the electroretinogram in the affected eye. A consultant confirmed the presence of an intraocular foreign body and the diagnosis of siderosis bulbi.

Endophthalmitis Exogenous endophthalmitis is most common as a complication of cataract surgery. However, it may be seen following any perforating trauma or intraocular surgery, including vitrectomy. The rate and degree of damage depends on the pathogenicity and virulence of the organism. If any suspicion of endophthalmitis exists, diagnosis and treatment are urgent. Not every case has a classic appearance, and pain is not always present. Anterior chamber and vitreous taps with Gram stain and intraocular fluid sent for culture and sensitivity should be requested. Unless the patient’s vision is reduced to the perception of light, intravitreal antibiotics are the treatment of choice.12

Orbital Disease The orbit may be affected by numerous conditions, some of which require prompt diagnosis and attention. The possibility of more serious disease will vary according to history and findings on examination. Orbital Cellulitis The symptoms and signs of painful proptosis, lid and conjunctival edema with ophthalmoplegia along with fever and general malaise should raise

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suspicion of orbital cellulitis. 13 Because immunodeficiency is increasingly common, one must entertain the possibility of mucormycosis. 14 Other syndromes or diseases that must be considered with various combinations of pain, proptosis, signs of congestion, vision loss, and defect in function of cranial nerves III, IV, V, and VI include the superior orbital fissure s yndrome, Tolosa-Hunt syndrome, cavernous sinus thrombosis, orbital apex syndrome, and carotid-cavernous sinus fistula. 15 If not expeditiously diagnosed and treated, some cases of cavernous sinus thrombosis and carotidcavernous sinus fistula can be fatal.

Orbital Hemorrhage Any cause of severe orbital hemorrhage may secondarily create an elevated intraocular pressure or pressure on the optic nerve, creating ischemia.

Orbital Fractures In cases of severe and often blunt trauma, an orbital fracture with compression of the optic nerve is possible. Orbital floor fracture with entrapment of a rectus muscle may not only cause an immediate impairment of extraocular movement (EOM) but also cause a persistent impairment of extraocular movements if there is permanent damage to the muscle.16 Patients manifesting orbital disease, especially those with systemic symptoms and signs, frequently require consultation with an appropriate subspecialist. Some of the differentiating aspects among these diseases are quite subtle, and, unless an ophthalmologist is thoroughly familiar with these diseases, serious errors may occur. Most ophthalmologists are not going to undertake treatment of complicated systemic diseases.

Cranial Nerve Palsies Cranial nerve palsies may appear as isolated phenomena. They are seldom emergent, but aneurysmal cranial III nerve palsy, usually with a dilated pupil, requires a prompt consultation with a neurosurgeon. This is especially the case in younger patients 20 to 50 years old without a high risk factor for vascular disease such as diabetes mellitus or hypertension.17,18 Although rupture of an aneurysm is uncommon, the possibility should not be disregarded. An on-call resident saw a patient with a cranial III nerve palsy. He was unfamiliar with the possible etiologies, performed a visual field examination, and sent the patient home. During the night, the aneurysm ruptured and the patient died.

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Flashes of Light and Floaters Ophthalmologically, the symptoms of flashes of light and floaters are most frequently associated with posterior vitreous detachment. At the time of posterior vitreous detachment, a retinal tear may occur. Prophylactic treatment of retinal breaks remains controversial. If a patient experiences such symptoms and is told by an ophthalmologist there is no evidence of ocular disease and later develops a retinal detachment, the possibility of a lawsuit is frequently explored.19

Rhegmatogenous Retinal Detachment Rhegmatogenous retinal detachment is not an ophthalmological emergency. However, most cases are surgically operated with 24 to 48 hours of diagnosis. More expeditious surgery is scheduled if the macula has not detached. Following successful surgery and especially if the macula was detached, the restoration of vision is often disappointing to the patient. Lawsuits are often explored because of allegations of delay in diagnosis and treatment.20

Angle Closure and Other Glaucomas If angle closure glaucoma is not diagnosed and the intraocular pressure is sufficiently high, permanent visual impairment as severe as blindness may occur.21 Other types of secondary glaucoma with acute or dangerously elevated intraocular pressure may cause similar damage. Hyphema, especially in patients with sickle cell disease, may elevate the intraocular pressure to threatening levels.22

Corneal Ulcer, Descemetocele, or Perforation A corneal ulcer with a descemetocele or perforation requires urgent surgical therapy.23

Iridocyclitis Iridocyclitis (iritis) or anterior uveitis is commonly misdiagnosed, especially when a patient is not examined with a slit lamp. Adverse sequelae of incorrect diagnosis rarely cause serious damage. The formation of posterior synechiae for 360° creating iris bombe with elevated intraocular pressure is an exception.

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Additional complications associated with iridocyclitis are peripheral anterior synechiae, hypotony, cystoid macular edema, and disc edema. Other manifestations usually from chronic disease are cataract, cyclitic membrane, and band keratopathy.24

Problems with Immunocompromised Patients Although not limited to immunocompromised patients, causes of acute loss of vision requiring prompt evaluation include endogenous endophthalmitis, necrotizing retinitis caused by cytomegalovirus, toxoplasmosis, or herpes viruses, and syphilitic chorioretinitis.25

Conclusion The optimum clinical evaluation and treatment of many diseases is often controversial, and no method guarantees success. Controversy is legitimate if there is more than one acceptable approach to a problem. Damages must be created by a deviation from an acceptable standard of medical care expected from a reasonably well-qualified physician encountering a situation with identical or similar circumstances. Occasionally unjustified malpractice litigation will occur. The best protection is to consider the benefit of the patient as primary. One of the pillars of the practice of medicine is to allay a patient’s fears, which often requires some self-sacrifice and inconvenience on the part of the physician. Meticulous and complete documentation is mandatory. If any uncertainty in diagnosis and treatment remains, consultation with another physician is very advisable. Proper communication with the patient and involved medical personnel is most important. When a patient is seen with an emergent or urgent situation, no abbreviation of important aspects of the examination should occur. The brief examples of litigation cited are not singular or unique but are recurrent themes in cases submitted by attorneys for review to potential expert medical witnesses.

References 1. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:55–77. 2. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:163–171. 3. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:335–338. 4. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist 2005;11(4):204–205.

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5. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:83, 356–358. 6. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist 2005;11(4):200–202. 7. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:358–360. 8. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist 2005;11(4):198–200. 9. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: Lippincott-Raven; 1998:84-85, 97–106. 10. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:81-82, 207–226. 11. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:83-84, 309–318. 12. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:82, 275–283. 13. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:85, 131–132. 14. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist 2005;11(4):214–215. 15. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:387–391. 16. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:85, 107–116. 17. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:369–372. 18. Purvin V, Kawasaki A. Neuro-Ophthalmic Emergencies for the Neurologist. Neurologist 2005;11(4):217–222. 19. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:347–348. 20. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:87, 285–307. 21. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:235–255. 22. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:231–234. 23. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:83, 194–198. 24. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:138. 25. MacCumber MW, ed. Management of Ocular Injuries and Emergencies. Philadelphia: LippincottRaven; 1998:144–150.

Chapter 15

Glaucoma Robert F. Sanke and Paul P. Lee

Introduction Treatment for glaucoma is similar to the treatment given in other areas of medicine, requiring thoughtful evaluation of the patient followed by an appropriate care plan. Research in glaucoma, however, has expanded the basic understanding of the nature of the disorder, creating situations and additional legal risks to confront the physician. Several major studies performed over the past 20 years have better identified the risk factors associated with both the presence and the progression of glaucoma.1–4 They also have increased those concerns that a physician must address to protect the patient’s vision and avoid legal liability. Situations now exist that were not imagined in the past. Established duties such as informed consent and standard of care continue to be applicable to glaucoma, but recently updated standards and expectations have been established for glaucoma as they have been for medicine in general. The more important ones are addressed here.

Glaucoma Management Glaucoma has been identified as a neuropathy of the optic nerve and divides easily into open angle and closed angle types. Established practice patterns already exist for the treatment of glaucoma and include medication, surgery, and laser therapy. Because a specific type of treatment may be personally difficult for the patient or of only temporary duration in halting damage to the optic nerve, there are situations in which the physician, exercising his or her best judgment in selecting a treatment plan, may sometimes choose to either follow an established practice pattern or select one that differs from commonly accepted treatment practices. The individual characteristics of the patient will influence the success of any treatment, and these must also be considered by the physician when formulating a treatment plan. The topical medicines used today, including β-blockers, prostaglandin agonists, and carbonic acid inhibitors, are now much easier for the patient to use because they are applied less often during the day and also have fewer side effects and less

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discomfort when applied. Laser trabeculoplasty has also been useful as the next step in treatment, often making it possible to avoid aqueous drainage surgery such as trabeculectomy, which was formerly the next step in cases of inadequate pressure control. Of all the alternatives, the use of topical agents is currently considered the first line of glaucoma treatment and is indicated for most patients. Despite the advantages, however, a number of patients will still find it difficult to take their medicines on schedule and in the manner prescribed. This lack of compliance will eventually result in the typical glaucomatous optic nerve changes accompanied by visual field loss. Compliance itself is the patient’s willingness and ability to adhere to the treatment plan established by the ophthalmologist and is based on factors specific to the individual patient. A lack of compliance is usually occasioned by a change in the patient’s mental or physical status or a lifestyle change. This type of noncompliance is not willful and not the result of failure of the interpersonal exchange between physician and patient. Noncompliance becomes a problem when it leads to damage to the optic nerve and vision loss. To prevent this damage and loss of vision, the ophthalmologist is justified in advancing treatment to the next level whether it be laser or surgical intervention even though medical treatment would still be effective. In such cases the physician is permitted to substitute his or her best judgment and to depart from the usual and customary practice of using topical agents that are still effective. Anyone treating glaucoma must have a continued awareness of the effectiveness of the treatment modalities prescribed. If glaucomatous change progresses and visual damage occurs, the physician must be prepared to alter treatment in order to best accommodate the situation of the patient.5

Risk Factors for Glaucoma The multicenter studies mentioned at the beginning of this chapter have identified several previously unsuspected risk factors that precede the development of glaucoma and that must be considered when evaluating the patient. Not including this new information into the patient examination can result in liability for any adverse consequences resulting from the oversight. Among both established and recently recognized risk factors are a reduced central corneal thickness, a family history of glaucoma, the amount of increase in intraocular pressure at diagnosis, the presence of high myopia, vascular disorders such as migraine, the patient’s age at diagnosis, African-American heritage, and the amount of increase in cup to optic disc ratio at the time of diagnosis. Furthermore, assuming that intraocular pressures in the “normal” range (10 to 21 mm Hg) preclude the possibility of glaucoma developing in a particular patient is unjustified, and even these low pressures may lead to the progression of glaucomatous optic nerve damage and a significant loss of vision. Individuals with two or more risk factors should be examined at more frequent intervals to identify early the onset of glaucoma, because damage to the optic nerve is cumulative throughout the patient’s life and early diagnosis will reduce later

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damage. This concern has become especially important as the nature of normaltension glaucoma has become better understood. This type of glaucoma is the situation in which the intraocular pressures remain within the “normal” range despite obvious and progressive optic nerve damage. Legal doctrine requires the physician to take reasonable precautions in treating the patient and addressing these risk factors for glaucoma has become a legal requirement. Failure to reexamine the suspect patient at appropriate intervals to ensure the early diagnosis of normal-tension glaucoma also violates the physician’s common law duty to the patient.6,7 Consider the following situation. A woman with high myopia was examined periodically by her physician to measure and treat the myopia. Other than occasional attacks of migraine, vertigo due to low blood pressure, and a family history of glaucoma, she was in excellent health with no subjective symptoms. Intraocular pressures were measured at each examination and were always within the “normal” range for these values. As part of his “routine examination” the physician had always examined her undilated fundus using a direct ophthalmoscope. On one occasion the patient was examined by another physician who dilated her pupils, examining her fundus using an indirect ophthalmoscope. Because of the unusual appearance of her optic nerves, he also performed a slit-lamp examination using a 90-diopter lens to better evaluate the discs. The patient was found to have a bilateral optic cup to disc ratio of 0.6 with shallowing of the cup temporally plus glaucoma-specific changes in her peripheral visual fields. The diagnosis of normal-tension glaucoma was made. The patient sued the original physician for her partial loss of peripheral vision because of his failure to do a dilated examination of the optic nerves, especially given her risk factors. Her original physician claimed as a defense that her intraocular pressures were always “normal,” and he had no reason to suspect glaucoma. The court held that her history of migraine and high myopia were risk factors for ocular problems including glaucoma and that a more thorough examination was indicated.

Pediatric Glaucoma Pediatric glaucoma is not adult glaucoma just as pediatrics is not adult medicine. Failure to remember this can lead to diagnostic and management problems with legal consequences. In the presence of the classic triad for primary congenital glaucoma consisting of epiphora, photophobia, and blepharospasm, the diagnosis will usually be obvious for the ophthalmologist. Enlargement of one or both corneas from the increased intraocular pressure makes the diagnosis easier. When only epiphora or photophobia is the presenting symptom in an infant, a more thorough examination is necessary to establish the diagnosis. This includes a dilated fundus examination, because disc changes can occur more rapidly even at lower pressures in infants. A cup to disc ratio of greater than 0.3 is rare in the normal infant while not at all unusual in congenital glaucoma. Having an index of suspicion followed by an appropriate examination will usually reveal the correct diagnosis, avoiding a failure to diagnose on the part of the ophthalmologist.

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Although primary congenital glaucoma is the most common type of infantile glaucoma, the physician must also have an awareness of other physical conditions that may lead to glaucoma. Secondary glaucoma can occur in the child with Marfan’s syndrome, aniridia, Sturge-Weber syndrome, and less commonly in neurofibromatosis. In these conditions and in cases of corneal dysgenesis, the measurement of intraocular pressure plus a dilated fundus examination focused on the disc are necessary to fulfill the physician’s duty to the patient.7

Options in Glaucoma Management Because of individual differences arising from the patient’s current health status and past medical history, an element of uncertainty exists in any patient’s response to a particular treatment. In the management of glaucoma it sometimes becomes necessary to alter the initial treatment plan if it fails to be effective in protecting the patient’s vision. The changes may include additional or different topical medications, laser trabeculoplasty, or surgical drainage procedures such as trabeculectomy or a tube drainage device.8,9 Consider the following situation. A patient had primary open angle glaucoma with intraocular pressures that were becoming increasingly difficult to control using topical medication alone. Laser trabeculoplasty had not provided sufficient pressure reduction. The surgeon originally planned a trabeculectomy and discussed this in detail with the patient, obtaining proper consent for the procedure. Trabeculectomy is creation of an opening into the globe under a flap of sclera with the flap covered by the bulbar conjunctiva and Tenon’s capsule, thereby providing a relatively controlled exit for the aqueous in the anterior of the eye. During the surgery the surgeon realized the condition of the conjunctiva would not allow for a successful trabeculectomy and decided instead to place a tube drainage device. He informed the patient, under local anesthesia, of his decision during the surgery itself, although the patient later stated he had no recollection of the conversation because of the medicine he had been given. Because the patient afterward complained of discomfort allegedly due to the presence of the drainage device attached to his eye, he sued on the grounds of lack of consent for the change of procedure. In the preoperative discussion the surgeon had raised the possibility of placement of a tube drainage device. Both the patient and the surgeon were aware of the need to control intraocular pressure to preserve vision. Despite this patient’s claim of pain and discomfort from the device, in this instance the surgeon’s experience in identifying conditions that could lead to an unsuccessful outcome was an important component of the surgery itself and was his successful legal defense. Preoperative consultation must include a brief description of possible contingencies to avoid later liability and must include the surgeon’s freedom to select what appears to be the best course during the surgery.

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Nontraditional Treatment for Glaucoma Glaucoma is a disorder whose etiology is still only partially understood, making treatment challenging and not always successful with consequences that are potentially debilitating to the patient. As a result, patients are often attracted to nontraditional treatment because of frustration with the limited results or with the difficulty in using their current treatment, because of their dissatisfaction with the physician, or a combination of these. The patient in such a situation may turn to nontraditional therapy such as special diets, exotic treatments, or the use of herbs or other botanicals, including cannabis, all of which have been touted for the treatment of glaucoma. This decision may be suggested or reinforced by information obtained from nonprofessional sources. The patient is likely to incur vision loss when using alternative treatments despite their glowing claims to preserve or enhance vision, and the physician should be especially on guard, without being offensive or appearing dogmatic, to avoid any perception of encouragement in unproven or untested treatments.10,11 Consider the following situation. A patient complained to her physician of her lack of faith in his prescribed remedies. He responded by pointing out that her pressures had remained under good control, and the progressive damage to her optic nerves had been stopped. The patient wanted not control but a cure and questioned the direction and adequacy of the treatment. She announced that she wanted to try a botanical treatment that was advertised in the media. The physician in his frustration said she was free to do what she felt was best but to let him know the result if she tried the botanical. The patient had not been seen for several years before being examined once again by the original physician. By then she had sustained increased damage to the optic nerves with a corresponding loss in visual field. The patient sued the physician because he gave no warning of the risk of damage if she pursued her plans for alternative treatment. The court held for the patient, saying that under the circumstances the physician erred by not warning the patient more emphatically and in a manner by which the patient would likely understand the potential risks of the alternate treatment, and for vaguely implying that the unorthodox treatment might be useful. The question arises whether the patient is actually aware of the risk that is being assumed. In the situation in which the patient knowingly fails to comply with the physician’s instructions or selects a course of treatment different from the one recommended by the physician, the law considers the patient to have accepted the consequences of his own actions. Legally this is termed the assumption of risk. The physician’s duty is to inform the patient of the potential risks for glaucomatous damage arising from the failure to follow customary practices. The physician must also point out any risk, if known, arising from the patient’s choice of alternative treatment. To be legally protected the physician should always place in the patient’s record information about the patient’s actions and decisions that may affect treatment.12

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Management of the Noncompliant Patient The physician–patient relationship may occasionally experience a strain or tension that interferes with good glaucoma care. This is particularly true because primary open angle glaucoma is a life-long condition that, although controllable, requires good communication and interaction to form a workable partnership between physician and patient. Like any long-term relationship, the effectiveness of the relationship may weaken because of interpersonal factors. If it becomes obvious to the physician that, despite the best efforts at reaching a workable accommodation, the treatment goals are not being reached because the patient is not cooperating, it is often advisable to terminate the professional relationship. The patient will usually find another ophthalmologist who can provide a workable situation. To continue in a negative relationship is to risk visual loss for the patient and potential liability to the ophthalmologist. There is a specific manner by which this can be accomplished, and the physician is advised to follow this protocol.13

Glaucoma Research and the Physician’s Professional Interests The physician who is treating glaucoma may sometimes be engaged in basic glaucoma research or clinical evaluation of an experimental medication, device, or procedure. Although the U.S. Food and Drug Administration (FDA) is authorized by law to investigate and approve for use additions to the treatment armamentarium, the individual physician may still be involved in the development of new treatments and as a result may make them available for a particular patient. Providing experimental treatment to the patient can also create a personal benefit for the physician that may be monetary or may advance his reputation or career in a nonmonetary way. In these situations the physician has the duty to inform the patient that he may also receive a potential benefit in addition to any benefit that may accrue to the patient. This is an extension of the doctrine of informed consent and in these circumstances it must be communicated to the patient.14

Technology in Glaucoma Treatment The field of glaucoma over the past few decades has expanded widely its diagnostic and therapeutic capabilities. Whereas 30 years ago topical medicines were the mainstay of glaucoma treatment, newer technology has since then slowly been added to the treatment options available. Lasers were the first addition. Argon laser trabeculoplasty alters the microstructure of the trabecular meshwork, increasing outflow of aqueous from the eye, and has been in use now for a number of years. More recently selective laser trabeculoplasty using a pulsed neodymium-YAG

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laser has been introduced and works in a similar manner. Mechanical drainage devices, such as the Krupin, the Ahmed, and the Baerveldt tube drains, have also become a regular part of glaucoma therapy. Because newer treatments, despite extensive evaluation, can still have as yet undiscovered negative consequences, a question arises concerning the nature and extent of the physician’s responsibility and liability for these consequences. The physician’s duty to inform the patient must include anything that may affect the patient’s decision to accept or reject treatment. This includes the use of a new medicine, a new technique, or a new instrument. In the case of something that is experimental, this status must also be communicated to the patient, emphasizing the possibility that unknown negative consequences may occur. When the physician has fully communicated all the information that may influence the patient’s decision, the patient’s free acceptance of any risk will have been established. When introducing new technology, it is important to stay within the parameters established by the manufacturer and by the FDA, which approves it use, and within any established and customary practices that would apply to the situation. As mentioned earlier, when departing from customary practice, the physician has the duty to fully inform the patient of this departure and to discuss possible risks that may occur. Everything necessary for the patient’s free decision must be provided in order to establish valid informed consent.15 Consider this situation. A glaucoma patient was advised of the availability of a new laser treatment that decreases the secretion of aqueous humor, and, following discussion of the treatment, the patient agreed to its use. The laser had been approved for this specific use by the FDA, and the physician used it according to the instructions provided by the manufacturer and within the purpose and guidelines established by the FDA. Following treatment with the new laser, the patient developed hypotony and a reduction in vision. She sued the manufacturer of the laser for failure of the instrument to control the intraocular pressure in the manner predicted, and she also brought suit against the physician for her loss of vision. The court in this case recognized that the physician had used the instrument according to the manufacturer’s established instructions as well as within the FDA guidelines and therefore held the manufacturer solely liable for the equipment failure and the resulting visual loss. As the practice of medicine in general and glaucoma management in particular changes with the increase in knowledge of diagnosis and treatment, issues will arise that may have legal consequences. Evidence-based medicine relating to newer drugs and instrumentation will alter the balance of duty and responsibility between the manufacturer and the physician who uses them.16 Recent advances in technology have already influenced medicine, and practice support systems such as telemedicine and electronic records will cause even further change and raise additional questions. Situations in glaucoma management will surely occur that cannot be imagined in today’s practice of medicine but that will nonetheless affect the legal environment. Especially in the area of glaucoma, keeping abreast of the latest knowledge and developments, always putting the patient’s best interests first, and giving consideration

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and respect to the patient’s point of view are the best approach to reduce the physician’s legal risk. Established legal doctrines and duties can be expected to continue unchanged, but, as the options for diagnosis and treatment increase, these established duties will expand and become more narrowly defined, resulting in new duties and responsibilities for the physician. Because glaucoma is a life-long disorder, frequent and appropriate evaluation of the patient at risk and initiation of treatment at the earliest signs of glaucomatous change will continue to be the best protection for the patient’s vision throughout his life. Attention to the patient’s individual situation and personal risk factors will enable the physician to establish the best and most effective treatment program while minimizing legal risk and liability. Putting the patient’s interest first has long been a pillar of established medicine, and this is just as true today as it ever was.

References 1. Collaborative Normal-Tension Glaucoma Study Group. Comparison of glaucomatous progression between untreated patients with normal-tension glaucoma and patients with therapeutically reduced intraocular pressures. Am J Ophthalmol 1998;126:487–497. 2. Heijl A, Leske MC, Bengtssen B, Hyman L, Hussein M. Reduction of intraocular pressure and glaucoma progression: results from the Early Manifest Glaucoma Trial. Arch Ophthalmol 2002;120:1268–1279. 3. Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol 2002;120:701–713, 829–830. 4. Lichter PR, Musch DC, Gillespie BW, et al. Interim clinical outcomes in the Collaborative Initial Glaucoma Treatment Study comparing initial treatment randomized to medications or surgery. Ophthalmology 2001;108:1943–1953. 5. Henderson v. Heyer-Schulte Corp. of Santa Barbara, 600 S.W.2d 844 (Tex. Cir. App.-Hous [1 Dist.] 1980), 28. 6. Restatement (Second) of Torts 282 (1965). 7. Helling v. Carey, 83 Wash.2d 514,519, 2d 981. 8. Preston v. Hubbell, 87 Cal App.2d 53, 196 P.2d 113 (Cal. App. 2 Dist. 1948), 98. 9. Kennedy v. Parrott, 243 N.C. 355, 90 S.E.2d 754 (N.C. 1956), 99. 10. Weil v. Seltzer, 873 F.2d 1453, 277. U.S. App. D.C. 196 (D.C. Cir. 1989), 161, 166. 11. Shorter v. Drury, 103 Wash.2d 645 P.2d 116 (Wash. 1985), 167. 12. Payton v. Weaver, 131 Cal.App.3d 38, 182 Cal Rptr. 225 (Cal. App. 1 Dist. 1982), 21, 24. 13. Lee PP. Medico-legal issues in glaucoma. In: Epstein DL, ed. Chandler and Grants Glaucoma. Baltimore: Williams & Wilkins; 1997:648–654. 14. Moore v. Regents of the University of California, 271 Cal. Rptr. 146, 793 P.2d 479 (Cal. 1990), 115, 284. 15. Kernke v. Menninger Clinic, Inc., 172 F.Supp.2d 1347 (D. Kan. 2001), 282. 16. Bujak JS, Lister E. Is the science of medicine trumping the art of medicine? Physician Executive 2006;32:18–21.

Chapter 16

Neuroophthalmology Andrew G. Lee

Introduction Why is neuroophthalmology a special risk for general ophthalmic medical malpractice claims? Neuroophthalmology is a relatively small part of most general ophthalmic practices. Unfortunately, several features of neuroophthalmic practice create special risk for the comprehensive ophthalmologist. It has been my experience that, although claims against neuroophthalmologists are rare, neuroophthalmic-based claims against comprehensive ophthalmologists are not. First, clinical decisions about neuroophthalmic conditions may have vision-threatening or life-threatening consequences. Second, because these are often “high stakes” decisions, earlier diagnosis and treatment make a big difference in final outcome. Third, as opposed to other more common ophthalmic subspecialties, neuroophthalmic consultation may not be easily accessible, timely, or available to the comprehensive ophthalmologist. Fourth, the cost of a neuroophthalmic paid claim is often higher than the typical ophthalmology claim. About 15% of the paid claims (n = 17) of the Ophthalmology Mutual Insurance Company (OMIC) closed with a “large loss” (≥$ 250,000). These 17 paid claims represented a disproportionate 59% of OMIC’s total paid indemnity (average $ 433,285). Interestingly, in the OMIC series, the number one payout was $ 790,000 for a “failure to diagnose brain tumor” that led to death. In addition, a second case of “failure to diagnose giant cell arteritis” ($ 250,000) was among the “large loss” cases.1 This chapter presents composite but real closed cases as well as a few modified cases drawn from the author’s medicolegal consultation practice to highlight specific areas of concern, risk management and the potential for systems based failures in neuroophthalmic cases. I want to emphasize that the recommendations in this chapter are meant to be guidelines for care and not necessarily the “standard of care.”

What Types of Claims Occur from Neuroophthalmology Cases? Although statistically, complications related to cataract surgery and undiagnosed retinal detachment are the most common causes of ophthalmic medical malpractice litigation, “missed diagnoses” in neuroophthalmology when they M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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occur tend to result in higher payouts. Kraushar et al. reported 121 ophthalmic malpractice claims, and “failure or delay in diagnosis” represented 35% of claims and 63% of indemnification. The “failure to diagnose” retinal detachment was the most common cause.2–4 In Bettman’s review of 412 claims, 9 (2%) were “motility,” 9 (2%) were neuroophthalmologic procedures,” and 8 (1.9%) were “tumors.”5–8 In my consultative medicolegal practice, “failure to diagnose or delay in diagnosis” (“sin of omission”) for giant cell arteritis, compressive optic neuropathy (e.g., meningioma), sellar/chiasmal/pituitary tumor, and toxic medication effect (e.g., ethambutol and chloroquine/hydroxychloroquine toxicity) have been the most common. “Failure to treat” is a less common claim than “failure to diagnose” in my experience, but “failure to timely diagnose and treat visual loss from papilledema” (usually pseudotumor cerebri) is the leading culprit.9,10

Case 1: Optic Atrophy A 55-year-old male with hypertension and diabetes presented with “acute awareness” of visual loss in his right eye (oculus dexter [OD]) while shaving the morning of presentation. An ophthalmologist examined the patient and found 20/50 OD and 20/20 OS (oculus sinister [left eye]). The pupil examination by the technician shows PERRLA (i.e., pupils equal, round, and reactive to light and accommodation). Slit-lamp examination discloses a “moderate nuclear cataract OD <more than> OS.” Ophthalmoscopy shows “possible mild optic atrophy OD and a normal optic nerve OS with a cup to disc ratio of 0.4.” The ophthalmologist writes the following: “Impression: ‘?’ mild optic atrophy and cataract OD. Plan: Return in 3 months.” The patient returns in 2 months with worsening vision OD to 20/100. The technician reports: “PERRLA.” Confrontation visual field testing shows an inferior altitudinal-type of visual field defect OD and is normal OS. The ophthalmologist records the following impression: “possible mild optic atrophy OD—likely old ischemic optic neuropathy due to inferior altitudinal defect” and “Return—3 months.” The patient calls the office and reports “worsening vision OD” and the ophthalmologist orders a “scan.” The patient returns 1 month later with a noncontrast head computed tomography (CT) scan that has been read as “normal.” The ophthalmologist tells the patient by phone that “there is nothing to worry about” and to keep the 3-month follow-up appointment. The patient seeks a second opinion 2 months later from a second ophthalmologist. The vision is now hand motions only OD and 20/20 OS. A right afferent pupillary defect is detected. The formal (Goldmann) visual field test shows inferior and central loss OD and a superotemporal visual field defect respecting the vertical midline OS. The optic nerve is diffusely pale OD. The second ophthalmologist tells the patient that he needs to have an “MR scan right away” and a postcontrast cranial magnetic resonance imaging (MRI) of the

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sella shows a pituitary adenoma compressing the right optic nerve and the junction of the optic nerve and chiasm. The second ophthalmologist tells the patient and his family that he needed to see a “neuroophthalmologist” and “that if only they had come in sooner the vision might have been preserved.” What went wrong? 1. I would recommend that the extremely common but insufficient clinical abbreviation for the pupil exam, “PERRLA,” should be avoided by the ophthalmologist. “PERRLA” makes no assessment of the relative afferent pupillary defect (RAPD), the single most important objective evidence for an optic neuropathy in a patient with unilateral visual loss. 2. “Optic atrophy” is not a diagnosis. It is an ophthalmoscopic description of a clinical examination finding and does not define the etiology. Describing the “optic atrophy” with adjectives such as “?,” “maybe,” or “possible” does not protect the ophthalmologist and does not obviate the need for differential diagnosis and evaluation. Patients with “optic atrophy” should have documentation of the presence or absence of clinical evidence for an optic neuropathy, including assessment for an RAPD, a formal visual field test, and possibly photographic or nerve fiber analysis (e.g., optical coherence tomography). Bettman in a review of 276 medicolegal cases disclosed the medical reasons for filing these claims were usually based on “sins of omission or commission in “basic ophthalmology” rather than the omission of sophisticated testing or procedures. The recommendations of Dr. Bettman included that physicians should plan for the care of emergencies, order imaging as needed, use consultants, stay well within one’s level of competence, and of course “document everything.” 3. Inferior altitudinal defect is common but not diagnostic in nonarteritic anterior ischemic optic neuropathy (NAION). The clinical diagnosis of NAION requires (i) a clinical history of acute unilateral visual loss, (ii) documentation of the initial optic disc edema phase (i.e., the “anterior” in NAION), and (iii) stability over time with resolution of the disc edema. The presence of optic atrophy at the first visit is not compatible with the diagnosis of acute NAION. The small cup to disc ratio is the structural risk factor (i.e., “disc at risk”) for NAION, and the fellow eye should be examined for this finding. I would recommend that any patient with unexplained visual loss have consideration for formal perimetry. Patients with a visual field defect on confrontation testing should undergo formal visual field testing to exclude a subtle lesion in the contralateral eye (e.g., junctional scotoma as in this case) and to detect a vertical step if present (e.g., homonymous or bitemporal hemianopsia). 4. The second ophthalmologist inadvertently adds “fuel to the fire” by suggesting that “earlier diagnosis and treatment” would have made a difference in the case and criticizing the care of the first ophthalmologist. Many cases of medical malpractice are triggered by the comments or criticism from another provide.

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Table 16.1 Common errors in evaluating optic atrophy • Failure to document presence or absence of clinical evidence for optic neuropathy in suspected optic atrophy (e.g., relative afferent pupillary defect [RAPD], formal visual field, optic nerve assessment) • Failure to document etiology for unexplained optic neuropathy (i.e., “optic atrophy” is not a diagnosis) • Failure to check or document presence or absence of RAPD or delegating this task to the technician (e.g., pupils equal, round, and reactive to light and accommodation) • Failure to perform, review, or interpret a visual field test (e.g., formal visual field), failure to confirm an abnormal confrontation visual field examination with formal perimetry, or failure to confirm with serial evaluation the stability of visual loss in a patient with suspected optic neuropathy • Failure to recognize that any optic neuropathy can produce any visual field defect • Failure to recognize a vertical step (e.g., hidden within diffuse depression or drift across the vertical meridian due to artifact, other superimposed causes of visual field loss, or poor test reliability) • Failure to perform a timely and appropriate neuroimaging study in unexplained optic neuropathy, junctional visual field loss, bitemporal hemianopsia, or homonymous hemianopsia* • Failure to order the correct neuroimaging study (e.g., for possible compressive optic neuropathy, in general postcontrast fat suppressed orbital and head MRI is superior to noncontrast CT scan for optic neuropathy) • Failure to review the neuroimaging study (even with a “normal” report) with the neuroradiologist • Failure to consider referral to a specialist (e.g., neuroophthalmologist) for unexplained, complex, and/or progressive optic neuropathy * I would recommend orbit and head with fat suppression and gadolinium magnetic resonance imaging (MRI) for optic neuropathy. Sella sequence cranial MRI with and without contrast should be performed for junctional or bitemporal loss. Cranial MRI with and without contrast is recommended for homonymous hemianopsia. Magnetic resonance imaging is superior to computed tomography (CT) in the majority of neuroophthalmic conditions (except for need for a faster study; for examination of bone, acute blood, fracture, trauma, and some orbital conditions; and for patients who cannot undergo an MRI). Contrast for both MRI and CT should always be considered unless there is a contraindication.

Table 16.1 lists some common errors that can complicate the evaluation of optic atrophy.

Case 2 A 12-year-old white female presented with headache and blurred vision in both eyes (OU). An optometrist notes 20/60 vision OU and bilateral optic disc edema with a macular star figure of exudate in both eyes. No vitreous cells were noted. The patient had an esotropia of 30 prism diopters in primary position that was incomitant in lateral gaze with a moderate abduction deficit OU. The optometrist calls the ophthalmologist’s office and describes the findings. The ophthalmologist diagnoses “infectious neuroretinitis OU and sensory esotropia” on the telephone

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and recommends laboratory testing with the pediatrician for cat scratch disease, Lyme disease, and tuberculosis and an appointment in 2 weeks in the office. The patient’s mother calls the ophthalmologist’s office and “demands” that the appointment be “moved up.” The receptionist tells her that she will work on the scheduling but the mother is “frantic.” The office phone encounter form states “Anxious mother called about scheduling.” The patient’s mother calls 1 week later and reports that the vision is worsening and that the headache is increasing. The laboratory evaluation from the pediatrician returns as “negative.” The pediatrician records the negative results but does not call the patient or the ophthalmologist. The patient’s mother calls a second time 2 days later and the ophthalmic technician discusses the case with the ophthalmologist and reassures the patient’s mother to keep the scheduled appointment. The patient develops worsening headache, does not keep the outpatient appointment, and instead is seen in the emergency room. A second ophthalmologist records the vision as hand motion OU with papilledema and bilateral sixth nerve palsies. A cranial CT scan shows a posterior fossa tumor. The blood pressure is normal. Urgent neurosurgical consultation and posterior fossa craniectomy with resection of tumor is performed at the second hospital, but the patient is left with no light perception vision and optic atrophy OU. The first ophthalmologist wonders why the patient did not show up for her appointment. A malpractice claim is filed 6 months later. At the time of deposition, the patient’s mother testifies she felt “neglected and that no one would help her,” that the technician told her “not to worry and stop being a worry-wart” and that “two more days would not make a difference.” The physician testified that the ophthalmic technician had informed him of the patient’s mother’s phone call and included details of the patient’s vision, symptoms, and signs. The physician testified that the patient’s mother was told to bring the child in to the office if she was worsening. No documentation of this content for the phone encounter was available in the chart. What went wrong? 1. Patients with bilateral optic disc edema should be presumed to have papilledema until proven otherwise. Optic disc edema from any cause (e.g., ischemic optic neuropathy, papilledema, malignant hypertension) may produce exudate in the macula and is not pathognomonic for infectious neuroretinitis. 2. Patients with a neuroophthalmic finding should be evaluated for other findings (i.e., “Is the finding isolated?”). Other symptoms (e.g., diplopia, headache) and signs (e.g., sixth nerve palsy) of increased intracranial pressure should trigger more aggressive and prompt evaluation, including neuroimaging. 3. Telephone triage may be appropriate in many circumstances. In general, however, objective neuroophthalmic findings should prompt further evaluation by an ophthalmologist or neuroophthalmologist rather than “diagnosis by phone.” 4. Communication among providers is important. If laboratory evaluation is performed and is positive or negative, then all of the physicians involved in the medical care of the patient should be informed. 5. Telephone calls should be documented, including persons involved, time and date of call, specific contents of the phone encounter, triage decision based on

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the facts of the case, and the disposition of the call and any recommendations for further urgent or emergency evaluation. In general, patients with potentially serious conditions should discuss the findings with the physician rather than the technician. Hepler emphasized that risk factors for litigation associated with ophthalmic staff include improper triage of emergency patients, perceived abandonment, lack of confidentiality, improper maintenance of medical records, and perceived lack of compassion and skill on the part of staff members, pejorative comments and editorial comments.11,12 Bettman cited the following important ophthalmic office personnel factors: “friendly, courteous attitude, no matter how ‘trying’ the circumstance, and proper training of the personnel in handling of emergencies.”2

Case 3 A 35-year-old African-American female presented with neck pain and blurred vision to the emergency room. A cranial CT was normal. A lumbar puncture showed normal cerebrospinal fluid content with no evidence of subarachnoid hemorrhage or meningitis. No opening pressure was performed. No visual acuity was measured, and no documentation of the fundus examination was recorded. The emergency room physician diagnoses “migraine.” The patient was referred to a neurologist in 1 week. The neurologist treated the patient with migraine medicine, documented the emergency room encounter findings, and recommended an ophthalmology consultation in 1 or 2weeks for the blurred vision. The neurologist saw “possible blurred disc margins” and started the patient on acetazolamide 250 mg per day. The patient then lost vision to hand motions OU over the next few days. The ophthalmologist documented papilledema OU and performed an optic nerve sheath fenestration OU, but the vision did not recover. An MRI scan is normal, and a repeated lumbar puncture showed an opening pressure of 500 mm of water. A lumboperitoneal shunt was performed, but the vision remained hand motion and optic atrophy OU developed. Table 16.2 lists some common errors that can complicate the evaluation and treatment of papilledema.

Table 16.2 Common errors in evaluation and treatment of papilledema • Failure to consider diagnosis of papilledema in bilateral optic disc edema • Failure to perform timely and appropriate evaluation, including neuroimaging and lumbar puncture • Failure to check blood pressure in bilateral optic disc edema for malignant hypertension • Failure to consider urgent surgical treatment (e.g., optic nerve sheath fenestration) for patients with visual loss at presentation • Failure to obtain an opening pressure at the time of lumbar puncture • Failure to measure visual acuity or formal perimetry or to perform ophthalmoscopy in a patient with possible pseudotumor cerebri

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Case 4 A 65-year-old white female developed new-onset headache. She saw her family care doctor, who diagnosed “sinusitis” and treated the patient with antibiotics. Two weeks later the headache worsened, and she had blurred vision OD. The family practitioner referred the patient to an ophthalmologist. On examination, the visual acuity was 20/40 OD and 20/30 OS. The technician recorded “PERRLA.” The fundus examination was normal OU. The patient was referred back to the family practice physician. The next day, Friday, July 4th, the patient called the office at 4:50 PM with complaints of increasingly severe headache. The receptionist who took the call informed the patient that the doctor had already “left for the holiday.” The patient went to the emergency room that night and had a CT scan of the head and a lumbar puncture that were normal. The patient reported to the emergency room doctor that she has had several episodes of transient monocular visual loss OD and jaw claudication for the past 3 weeks but had already been seen by her ophthalmologist and family doctor for these problems. The emergency room physician called the ophthalmologist, who was watching the fireworks with his family downtown. The ophthalmologist told the emergency room doctor to schedule the patient to be seen on Monday. The patient was discharged from the emergency room with the diagnosis of “migraine.” The next day, Saturday, the patient lost vision OU to no light perception. A second ophthalmologist saw the patient and diagnosed bilateral pallid disc edema consistent with arteritic anterior ischemic optic neuropathy. An erythrocyte sedimentation rate was normal at 15 mm/hr, but the serum C-reactive protein was elevated at 16 mg/dL. A temporal artery biopsy showed temporal arteritis, and the patient was treated with steroids without improvement in her vision. The family doctor, when notified of the impending lawsuit, altered the medical record to include a “negative review of systems” including “no jaw claudication.” The first ophthalmologist testified at deposition that he had asked the emergency room doctor on the phone about the presence of jaw claudication and recommended an erythrocyte sedimentation rate evaluation. There is no documentation in the emergency room record regarding this discussion. The family doctor, emergency room physician, and first ophthalmologist reach a substantial settlement with the patient. What went wrong? 1. New-onset headache with or without visual loss in the elderly should be considered to be temporal arteritis until proven otherwise. 2. The standard of care does not change based on time of day, day of week, or holiday. 3. Patients with possible temporal arteritis should be evaluated urgently, as the natural history of untreated giant cell arteritis can lead to blindness. In the Kraushar and Robb series, the most frequent risk factors were altered records, poor documentation, informed consent problems, failure to see the patient promptly, and failure to obtain or follow the advice of a consultant.

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Table 16.3 Common errors in evaluation of giant cell arteritis • Failure to evaluate new-onset headache in the elderly • Failure to triage or refer new diagnosis of temporal arteritis • Failure to consider or to document appropriately pertinent positive or negative review of systems (e.g., headache, scalp tenderness, jaw claudication, polymyalgia rheumatica) • Failure to consider occult giant cell arteritis in elderly patients with visual loss • Failure to order erythrocyte sedimentation rate (ESR) or C-reactive protein in suspected giant cell arteritis • Failure to consider that the ESR may be normal in temporal arteritis • Failure to start or maintain adequate corticosteroid therapy in giant cell arteritis • Failure to recognize the significance of “red flags” for giant cell arteritis (e.g., transient monocular visual loss preceding ischemic optic neuropathy, posterior ischemic optic neuropathy, bilateral visual loss, pallid disc edema, nonembolic central retinal artery occlusion, cilioretinal artery occlusion, ocular ischemic syndrome) • Failure to perform temporal artery biopsy* * I believe that establishing pathologic diagnosis is helpful in preventing inappropriate or too rapid tapering of the steroid treatment and for justifying continued treatment in the face of steroid related side effects.

Table 16.3 lists some common errors that can complicate evaluation of giant cell arteritis.

Case 5 A 65-year-old white female presented to her ophthalmologist with painless progressive visual loss OU. The past medical history was significant for Mycobacterium avium intracellulare infection of the lung treated by a pulmonary specialist with ethambutol 1,200 mg per day for 3 months. The patient saw an ophthalmologist and reported the visual blurring. The visual acuity was 20/40 OU, and a mild cataract was detected. The technician reported no relative afferent pupillary defect. The fundus was normal. The ophthalmologist diagnosed “mild cataract” OU. The patient returned 3 weeks later with worsening vision OU at 20/100 OU. The ophthalmologist wrote, “No disc edema or optic atrophy—doubt toxicity. Schedule visual field next visit.” Two weeks later, the patient underwent a computerized Humphrey 30-2 visual field (HVF) test that was unreliable OU. The ophthalmologist noted “? Mild temporal pallor” and wrote “HVF—unreliable” and recommended referral to a neuroophthalmologist. The ophthalmologist wrote a note to the pulmonary doctor about the possibility of ethambutol toxicity but told the patient that he has to “check with the pulmonary doctor” before stopping the medicine. The pulmonary doctor is “on vacation,” and the phone message from the ophthalmologist and the letter regarding the possibility of toxicity remained on the desk of the pulmonologist. Three weeks later the patient saw the neuroophthalmologist, who performed Goldmann perimetry that showed a dense cecocentral scotoma OU and counting fingers vision OU. The optic nerves showed bilateral temporal pallor. The ethambutol

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Table 16.4 Common errors in evaluating toxic optic neuropathy • Failure to consider medications as a potential cause for visual loss (e.g., ethambutol, hydroxychloroquine, chloroquine, amiodarone) • Failure to consider toxic retrobulbar optic neuropathy in differential diagnosis of unexplained visual loss (normal optic nerve initially) • Failure to consider that bilateral and symmetric optic neuropathy may not have a RAPD • Failure to perform formal visual field testing in patients with unexplained visual loss • Failure to repeat or further evaluate patients with an “unreliable” automated perimetry • Failure to communicate in a timely manner the need to discontinue potentially toxic medication to patient and prescribing physician • Failure to consider referring a patient with unexplained optic neuropathy • Failure to consider dose (mg/kg), duration of treatment, and risk factors for toxicity (e.g., body weight, renal or liver dysfunction)

was discontinued, but the patient did not recover her vision. The neuroophthalmologist scolds the patient for not discontinuing the medication sooner. Table 16.4 lists common errors that can complicate the evaluation of toxic optic neuropathy

References 1. Ophthalmic Mutual Insurance Company. http://www.omic.com/resources/risk_man/deskref/ litigation/16.cfm. 2. Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol 1996;114:333–337. 3. Kraushar MF, Turner MF. Medical malpractice litigation in ophthalmology: the New Jersey experience. Ophthalmic Surg 1986;17:671–674. 4. Kraushar MF. Recognizing and managing the litigious patient. Surv Ophthalmol 1992;37: 54–56. 5. Bettman JW. A review of 412 claims in ophthalmology. Int Ophthalmol Clin 1980;20:131–142. 6. Bettman JW. Office personnel and medicolegal claims. Surv Ophthalmol 1982;27:64–66. 7. Bettman JW. Seven hundred medicolegal cases in ophthalmology. Ophthalmology 1990;97: 1379–1384. 8. Bettman JW. Special problems in ophthalmic subspecialties. Ophthalmology 1979;86: 1246–1252. 9. Donin JF. Special risk areas in ophthalmology. Neuro-ophthalmology. Int Ophthalmol Clin 1980;20:93–107. 10. Donin JF. The neuro-ophthalmology trap: failure to diagnose. Ophthalmology 1979;86: 1240–1245. 11. Hepler RS. Ophthalmology personnel in risk management. What office personnel need to know to keep you out of trouble. Ophthalmology 1990;97:1385–1389. 12. Lanckton AV. How to avoid malpractice claims. Arch Ophthalmol 1996;114:339–340.

Chapter 17

Oncology Devron H. Char

It is relatively straightforward to avoid malpractice litigation involving patients with ophthalmic oncologic problems. Almost all cases in which a general ophthalmologist is named have to do with the failure to diagnose and institute treatment in a timely manner. Very few cases (almost all either eyelid or conjunctival neoplasms) are ones involving either treatment errors or poor treatment results that impacted either vision or life.1 Almost all malpractice suits involving general ophthalmologists and patients with eyelid or conjunctival lesions are those in which the physician has failed to diagnose and treat the tumor in a timely manner. Four major principles should avoid this problem in its entirety. First, any older patient with a unilateral “blepharitis or conjunctivitis” should have a biopsy either with a platinum spatula scraping (in the case of a conjunctival lesion) or with a forceps and scissors for a conjunctival or lid lesion. In neither setting will an incisional biopsy adversely affect systemic prognosis. Furthermore, the French, in the early 1700s, showed that many lid tumors could be “repaired” using the laissez-faire approach. Thus, the cosmetic effects of a biopsy similarly are negligible. Patients at risk for an eyelid tumor include those with various DNA repair syndromes, which can present in childhood (xeroderma pigmentosum, Bloom’s syndrome, etc.), patients who have a great deal of sun exposure, and those with a prior cutaneous malignancy. Worrisome is the eyelid mass or ulcer that is either pigmented or nonpigmented, often with new vessels in the area, loss of lashes, inflammatory changes, or other signs of chronic irritation. In this setting, a biopsy should be done. In the conjunctiva, the most common malignancies are epithelial tumors, either squamous cell carcinoma (or its localized precursor, intraepithelial carcinoma [also called conjunctival intraepithelial neoplasia]) or conjunctival melanomas. In either setting, one can quickly discern if it is possibly one of these lesions because both involve the epithelium. If topical tetracaine is placed in the eye and the lesion does not move when a Q-tip moves the conjunctiva, this is not one of those neoplasms. It is also important to test human immunodeficiency virus (HIV) status in a patient with possible squamous cell carcinoma who is under 50 years old, because there is a high prevalence of this malignancy in patients with acquired immunodeficiency syndrome (AIDS). In younger patients with squamous cell M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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neoplasia of the conjunctiva, HIV disease must be ruled out. Again, there is no negative effect of biopsy in conjunctival lesions. Orbital tumefactions and lesions that simulate them rarely lead to malpractice suits, although these can occur. Ironically, more commonly I have seen patients with undiagnosed thyroid orbitopathy than those with neoplastic processes sue an ophthalmologist for failure to diagnose and treat in a timely manner. The one area that can be problematic is childhood proptosis. Although most adults with orbital disease can be evaluated in a standard manner, children with proptosis require emergent evaluation to avoid preventable visual loss from either infections or tumors. Several investigations have shown that, in adults, the most common cause of unilateral or bilateral proptosis is thyroid orbitopathy. Any patient with proptosis or signs of optic nerve dysfunction (loss of color vision, afferent pupil defect, or changes in the nerve fiber layer or optic atrophy) should have good quality, thin section, orbital imaging. Ultrasonography in centers that manage many patients with ophthalmic oncologic problems is quite accurate, but, for the general ophthalmologist, high quality magnetic resonance imaging (MRI), preferably with thin sections and fat saturation gadolinium studies using a 3T magnet, is the best choice for imaging approach. The rational for this statement is that the quality of both computed tomography (CT) and MRI scans is really dependent on the equipment and on the patient’s cooperation. With excellent equipment and well-developed protocols, one can obtain as good a scan as those performed in a major ophthalmic oncologic center. In contrast, I have seen a number of suits where the ultrasound was diagnostic, but not correctly interpreted, even in large university centers without sufficient experience with ophthalmic oncologic processes. Most patients with thyroid orbitopathy present within 18 months of the diagnosis of hyperthyroidism, but a minority of patients will present with just eye signs and no systemic symptoms. As described earlier, vision loss of unexplained origin mandates an imaging study. Many years ago Jonathan Trobe noted that up to 80% of patients with compressive thyroid optic neuropathy were not diagnosed by the primary ophthalmologist. The scans will obviously allow the correct diagnosis in such settings. In addition, over 95% of patients with thyroid orbitopathy can be diagnosed by simple thyroid blood tests. A serum thyroid stimulating hormone (TSH) level is the first-line test for hyperthyroidism because a 2-fold change in the serum thyroxin level produces a more than 50-fold change in the serum TSH. Hyperthyroid patients have immeasurably low TSH levels. Those whose thyroid gland has either spontaneously involuted or been destroyed by the autoimmune processes often have thyroid stimulating immunoglobins. Both types of studies should be performed when this diagnosis is suspected. Intraocular tumors and lesions that simulate them generate the largest number of lawsuits I have seen. Most of the lawsuits regarding children are retinoblastoma cases and not initially diagnosed by the pediatrician. Frankly, I have not seen a retinoblastoma lawsuit directed against an ophthalmologist. As a profession we have been excellent when a child is referred with the possibility of an abnormal eye finding to have an appropriate evaluation in ophthalmic oncologic centers.

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The two most common problems that have led to litigation involving adults have been failure to diagnose and treat uveal melanoma in a timely manner and a failure to diagnose and treat an intraocular lymphoma. Diagnosis and management of an atypical uveal melanoma can be difficult. Historically, 20% of the eyes removed with a clinical diagnosis of a uveal malignant melanoma contained a simulating lesion on histologic examination. Similarly, 10% of eyes with opaque media that were submitted to the Armed Forces Institute of Pathology, had unsuspected uveal melanoma. In 2006, the diagnostic accuracy with patients who have a melanoma large enough to require treatment approaches 100% in major ophthalmologic oncologic centers. How do we avoid missing a patient with a uveal malignant melanoma? One, it is imperative to be overly cautious in the evaluation of patients with a unilateral media opacity. About three to four times a year, I manage patients with a unilateral cataract who have had axial length measurements and placement of an intraocular lens. With several of these patients, the surgeons actually had difficulty inserting the lens because there was a <more than>10 mm thick ciliochoroidal melanoma that made lens implantation difficult. Any patient with unilateral media opacity requires diagnostic ultrasonography in addition to axial length measurements. Another group of patients involved in litigation are those who have been seen with minimal retinal symptoms (flashes, floaters, visual field defect) or a sentinel vessel, were evaluated without dilation by an ophthalmologist, and then had the diagnosis of uveal melanoma made a year or two later in another office. Obviously, the lawyers query whether this could have been diagnosed earlier. The standard of care in most states requires a dilated fundus examination when the patient is seen for routine ophthalmic care, and it is imperative that this be documented on the chart. It is possible to defend the fact that a peripheral uveal melanoma was missed in the course of an ophthalmologic evaluation if there is documentation that the eye was dilated and the periphery was examined. What is much more difficult is the scenario when the patient has a tumor and there is no documentation that a dilated examination was performed. This becomes especially vexing with the patient who has symptoms of flashes, floaters, or a sentinel vessel peripherally and but for whom there is no evidence that a dilated examination had been performed. In a recent paper we published, approximately 35% of reasonable sized melanomas were not discovered on primary ophthalmologic examination. Those data can be interpreted two ways. One interpretation is that if this number of cases is missed, can you assume that it is not malpractice to be unable to diagnose a melanoma? The other interpretation is that a number of these cases should have been diagnosed (because the mean size of these tumors is over 5 mm in thickness), and perhaps we should be a little more judicious in our fundus examinations. A more difficult diagnostic problem is in the patient who unfortunately is not diagnosed as having a tumor prior to the surgical management of another condition (usually a unilateral media opacity or vitreous hemorrhage and retinal detachment following an anterior segment procedure), meaning the diagnosis is established late in the disease course. I will give you two disturbing examples. One was a patient we saw several years ago who had cataract extraction with a nonclearing vitreous

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hemorrhage. Vitrectomies were done on two separate occasions, and we were asked to see the patient when there were black masses growing out of the vitrectomy incisions. The second case was a patient who had intractable intraocular pressure elevation after cataract surgery and vitrectomy, and we were brought in after the patient had a Molteno valve with amelanotic growths around that area. As clinicians, I think the most difficult problem we face diagnostically is when a patient has a very atypical response to therapy. I have always approached such patients with the assumption that we possibly have made an error and therefore have to start the evaluation again from “ground zero” because of the possibility of a missed diagnosis. Certainly for a patient who has had a cataract and now for some reason develops a hemorrhage, or especially has a nonclearing hemorrhage, the possibility of a tumor should be considered, and diagnostic ultrasound makes good sense. Several rarer forms of malignancy can be difficult to diagnose, but because of their rarity they are less likely to initiate a lawsuit. We have seen a few patients present with a ring melanoma. Unfortunately, while these can be diagnosed with fine-needle biopsy, often they will present either as a unilateral glaucoma with just pigment present asymmetrically in the angle of one eye or, less commonly, as what appears to be a focal iris small tumor but with increased pressure in that eye. In either of these settings, the possibility of a melanoma that is a ring type should be considered and the patient referred for further evaluation. Intraocular lymphomas have generated several lawsuits. Any older adult with diffuse uveitis (involvement of the vitreous as well as the anterior chamber), especially with yellowish-white choroidal-retinal infiltrates, should be presumed to have an intraocular lymphoma until you prove it otherwise. The management of these patients is obviously outside the purview of a general ophthalmologist, but the possibility of an intraocular lymphoma should be raised for patients over 50 years old with “diffuse uveitis.” Obviously, most patients in this age group with this presentation would not have intraocular lymphoma, but the failure to consider this diagnosis can place the clinician in legal jeopardy. Several points are important to emphasize in commonality with other causes of ophthalmic malpractice litigation. I am impressed, having reviewed a number of cases, that the physician’s ability to be compassionate and caring are probably as important (and some would say more so) than the quality of their care in preventing or resulting in a malpractice case. There was a California physician who I thought was probably in the top 10% of practicing ophthalmologists but who I saw four different legal actions against mainly because, in each case, he managed to alienate patients who achieved less than perfect results (which certainly does happen to all of us). At the other extreme, there was another physician in Northern California who probably should have lost his license many times but was so charming that most patients did not initiate lawsuits against him even when they should have. If you are asked to perform a definitive procedure for an ophthalmic oncology problem, it is imperative to provide appropriate informed consent. In eyelid or conjunctival tumors, even though we have <more than>98% local control rate, I always counsel patients about a possible false-positive or negative pathology result (for both diagnosis and tumor margins). In eyelid surgery we also counsel

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patients that it may be necessary to do more than one procedure to reconstruct the eyelid (even though this is necessary 0.1% of the time). In cases with an intraocular tumor, the possibilities of false-positive or false-negative diagnosis, loss of vision, retinal detachment, cataract, and vitreous hemorrhage, as well as possible development of metastatic disease, should be discussed. A final three points that are pertinent to all ophthalmic malpractice litigation are the following. One, if one is sued, it is imperative that the chart remain untouched and no attempt made to revise it. Revision of a chart basically will destroy any chance of successfully defending a lawsuit. Two, it is important when you are sued to inform your malpractice carrier immediately about it and ask the carrier to quickly suggest a possible consultant (to review the case). Three, in the setting of a malpractice suit, further discussion with either the patient or his or her representatives should be avoided.

Reference 1. Char DC. Tumors of the Eye and Ocular Adnexa. Hamilton, Ontario: BC Decker; 2001.

Chapter 18

Ophthalmic Plastic Surgery Tanuj Nakra and Norman Shorr

Introduction: Special Considerations for a Unique Subspecialty In the family of ophthalmology subspecialties, ophthalmic plastic surgery is the adopted child. There are probably more differences than there are similarities with the other subspecialties. The diseases that oculoplastic surgeons treat are unique, and the surgeries they perform are quite different from those of ophthalmology colleagues. These unique attributes of ophthalmic plastic surgery warrant special consideration in the study of ophthalmology and the law. From a legal perspective, the practice of oculoplastic surgery has risks similar to those of other ophthalmology subspecialties, but perhaps most unique is the high visibility nature of the operations. The eye–periocular complex is arguably the most significant aesthetic feature of the entire body, and thus problems in oculoplastic surgery are highly visible to the patient. Problems in this area also fall under the scrutiny of all the patients’ family members and friends. Thus, there is a complex set of interactions between the patients’ emotions regarding their appearance and their functional oculoplastic problems. This emotion and high visibility are present not only with elective cosmetic procedures but also with reconstructive and functional surgeries, as well as medical treatments. The specialty of ophthalmic plastic surgery overlaps with other nonophthalmologic specialties. There is significant complementary interest with dermatology, head and neck surgery, neurosurgery, and general plastic surgery, and there are lessons to be learned from the legal experiences of these specialties. Each specialty has its own inherent risks that are transitive to the specialty of ophthalmic plastic surgery. For example, operating on skin brings up the subject of dermal fibrosis, which may cause functional limitations and cosmetically obvious permanent changes. Surgery in the orbit or on the face has the potential to cause muscular or neurologic impairment. Lacrimal surgery interfaces with intranasal and sinus surgery. Cosmetic surgery comprises a significant portion of the ophthalmic plastic surgeon’s practice, and certainly there are those who specialize only in cosmetic surgery. Anytime surgery is directed at a nonmedically necessary problem, patients have higher expectations and less tolerance for anything except a maximal result.

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Accordingly, building rapport with the patient is absolutely essential, and it is imperative to carry out extensive presurgical counseling, as well as pre- and postoperative photography. As subspecialists, ophthalmic plastic surgeons frequently function as consultants to comprehensive ophthalmologists, specialty ophthalmologists, as well as general practitioners. The role of a consultant has special legal implications. The words and attitudes of the consultant can lead the patient to seek legal counsel against the referring or previous physician if problems were missed or mismanaged. A consultant must maintain a nonjudgmental attitude and avoid inflammatory words. The consultant should carefully define the scope of the evaluation and redirect the patient to the referring physician for ongoing management and care of nonspecialty issues.1 A consultant may be named in a lawsuit primarily involving a patient and the referring physician. In general, this textbook is designed to familiarize ophthalmologists and subspecialists with the legal implications of practicing ophthalmology. A goal of this endeavor is to prevent legal action against the reader. Accordingly, this chapter is written with this end in mind. This chapter should serve as a guide for physicians and is not designed to delineate the standard of care in ophthalmic plastic surgery. We practice in a unique academic and university environment. Our approach is not necessarily representative of the community at large and should not be construed as the standard in the community

The Informed Consent: An Opportunity for Dialogue The process of informed consent is essential in the practice of quality medicine regardless of medical specialty. Informed consent is composed of information provided to and acknowledged by the patient. This process should not be considered solely a legal requirement or a malpractice prophylaxis maneuver but an opportunity to engage the patient in an educational session about the patient’s condition and options for management. One of the most effective tools at building rapport is to walk the patient through the process of informed consent. Although this book features a chapter dedicated to the details of informed consent in ophthalmology (see Chapter 7), there are several aspects of the process that deserve special attention with regard to ophthalmic plastic surgery. It is imperative that any physician performing ophthalmic plastic surgery procedures understands the following axiom: the more elective the procedure, the more extensive the requirements for a detailed informed consent. This statement is true not only from a legal viewpoint but also from an ethical and humanistic perspective. The process is an opportunity to fully educate the patient before a procedure that has the potential to significantly improve function and appearance but also carries the risk of producing a deterioration of function and perhaps cosmetic disfigurement. It is important to recognize and manage unrealistic expectations, as is

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demonstrated by the comment, “Doctor, I know you are a specialist, and so these things won’t happen.” These patients require extra time to be educated and to understand and to grasp the limitations and risks. When a patient has minimal or no preoperative medical symptoms and undergoes an elective procedure, the disappointment caused by an unsuccessful surgery or complications is all the more bitter. Consider the middle-aged female patient who undergoes elective upper blepharoplasty and experiences severe postoperative new-onset symptoms of dry eyes. Neglecting to discuss this potential postoperative effect prior to performing the surgery would be unfortunate from both a legal and an ethical perspective. Anything told to the patient prior to surgery is accepted as an explanation, whereas anything told to the patient after the surgery can be perceived as an excuse. Often the process of informed consent allows the physician to measure the patient’s expectations and then to help tailor the expectations appropriately. Explanations can be designed to encourage patients to focus on improvement, not perfection. “Ms. Jones, perfection is not possible, but we can certainly do our very best to achieve an improvement here.” If there are particular maneuvers that are usually performed to avoid complications during surgery, these may suggest potential areas for specific discussion during the informed consent process. For example, during inferior orbit surgery, we specifically identify the inferior oblique muscle to avoid injury, and so we discuss with patients the risks of double vision after surgery. Another example is our application of ointment to the cornea during eyelid surgery to prevent a corneal abrasion, and so we discuss with patients the risks of corneal abrasion or ulceration after surgery. With any given procedure, there is a distinction between what needs to be discussed during the informed consent process and what is not required by the standard of care. For example, while discussing the potential complications of ptosis surgery, it is prudent and necessary to review the potential need for revision surgery for asymmetry or contour abnormalities. Certainly, the vast majority of ptosis surgeons would discuss these possibilities, and this is what constitutes the standard of care. However, it may not be necessary in the discussion to bring up the possibility that a fire could erupt in the operating room as a result of electrocautery and cause first-degree burns to the facial skin. Although this scenario is a rare possibility, it falls under the category of rare and unusual circumstances that a physician is not required to review in the informed consent. If brought under courtroom scrutiny, the jury would be asked to make a determination of whether there was sufficient disclosure to allow the patient to make an informed consent.2 In fact, it may not be possible or practical to name every conceivable potential complication. The informed consent process in ophthalmic plastic surgery should always include three general items. First, when discussing surgery involving a skin incision or soft tissue manipulation, the potential for cosmetic disfigurement from unexpected healing should be revealed. Dermal and soft tissue healing varies from individual to individual, and therefore fibrosis outside of the standard deviation can lead to unpredictable results. Second, the rare but possible risk of vision loss, including blindness, should be discussed. In New York state, a plaintiff successfully prosecuted a case of corneal laceration during ptosis surgery; the informed

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consent process omitted the discussions of vision-related complications.3 Finally, patients must be informed that, with any surgery, there is the potential need for reoperation. The reasons to return to the operating room may be functional or reconstructive in nature. Perhaps the most important idea to convey during the informed consent process is the concept of risk. It is preferable to use real-world examples rather than quoting esoteric numbers. In our practice, we have a routine method of simplifying the discussion of surgical risk in order to facilitate understanding. Often the explanation is similar to the following scenario: Ms. Jones, I want you to know that there are risks of unwanted results and consequences as a result of your entropion surgery. Anything can happen—any question you ask, the answer could be yes. Is it possible that you could lose vision? Yes. Is it possible that you will not be happy with the results of surgery? Yes. Is it possible that you could die on the operating room table? Yes. But let’s talk about the chances that the event will happen. What are the chances that we could have an earthquake during surgery? What are the chances that you could be involved in a car accident the morning of surgery on your way here? What are the chances that you could have an infection after surgery?

As a final point, the process of informed consent is often perceived by the patient as a sobering discussion of potentially negative consequences. From a psychological perspective, a patient who has a positive outlook before surgery is more likely to be satisfied with the results of surgery. The physician should always end the discussion of informed consent on an upbeat but realistic note. “Ms. Jones, I believe that you are a good candidate for this surgery, and we can both look forward to the potential benefits of this surgery with a positive attitude,” or “You are an acceptable candidate for a potential improvement, recognizing that you have asymmetry.” Use of the word potential conveys optimism yet acknowledges that the result is not certain.

The Slippery Slope Concept: Planning for Disappointment Prevents Disappointment Maintaining the doctor–patient relationship is paramount to minimizing risk, as this relationship is based on mutual trust and understanding. Failing to anticipate events that will derail the doctor–patient relationship can be a physician’s legal Achilles’ heel. In particular, combining functional and cosmetic surgery sets up a delicate and complex set of expectations from the patient. For example, a patient may ask, “Doctor, while you are performing my ptosis surgery, can you remove some of my extra skin?” Alternatively, the physician may suggest, “As we are doing the ptosis surgery anyway, we should address the eyebrows . . . deal with the nevus on the eyelid . . . address the lower eyelids.” Payment for these procedures may involve a combination of insurance and self-pay. Any perceived imperfect result could be a set-up for disappointment. Patients focus on subtle asymmetry after ptosis surgery and blepharoplasty and wonder, “Will there be a need for more surgery? Shouldn’t

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reoperation be at no cost to me?” These events can begin a downward spiral of distrust and negativity stemming from disappointment that was not discussed, hence the slippery slope. The definition of cosmetic surgery should be made quite clear to the patient: cosmetic surgery is surgery that the insurance company deems not medically necessary. For example, dermatochalesis excision “on the side” during ptosis surgery is considered cosmetic surgery. In addition, the patient should be made to understand that all surgery, both medically necessary and cosmetic, is performed on a fee-forservice basis. This concept is self-evident for functional surgery. When explaining the risks of reoperation to a patient who undergoes insurance-covered scleral buckle surgery for retinal detachment, it goes without saying that the insurance company will also be billed if further vitrectomy surgery is required to complete the retinal detachment repair. On the other hand, patients often perceive cosmetic surgery to be in a different category of billing. After all, when a patient goes to a salon for a haircut, if he or she is unhappy with a certain aspect of the style, cannot he or she demand that the hairstylist “fix” the unacceptable area without charge? In the “slippery slope” model, the doctor–patient relationship breaks down from both sides. The patient is unhappy with the result and does not expect to pay for a “touch up.” The physician is unhappy because she did everything possible, spent an extra hour on the surgery, did her very best, and now the patient wants the physician to pay for the operating room cost and to absorb the cost of revision surgery. When both the patient and the physician become resentful, the “slippery slope” becomes more slippery, and the doctor–patient relationship quickly deteriorates. If there has been no preoperative discussion of how to manage disappointment, the patient proceeds with reoperation surgery full of resentment. If the revision surgery is not successful, the patient will have very little patience and may seek legal counsel. To anticipate the “slippery slope,” there should be a preoperative agreement, a fee-for-service arrangement, to manage perceived disappointment from cosmetic surgery or the cosmetic portion of a mixed cosmetic–functional surgery. A detailed discussion should take place prior to embarking on surgery regarding the fee-forservice nature of surgery and reoperations. This agreement should be discussed and documented. The essence of the agreement might be, “I will do my very best, and I will not take advantage of you. If we have to revise the surgery, there will be a fee.” If the physician prefers not to enter into detailed conversations with patients regarding financial arrangements, a responsible employee that usually handles financial discussions may perform the agreement. The practitioner unaccustomed to this concept of a fee-for-service relationship may be shy to discuss such detailed financial agreements regarding further surgery. However, a fee-for-service agreement does not undermine the doctor–patient relationship. In contrast, it strengthens the relationship by rooting the patient in the reality of the risk of complications and undesired results that are possible in all surgical endeavors, including cosmetic surgery. A patient who undergoes cosmetic surgery with a realistic and balanced outlook is much more likely to be satisfied with the results than a patient who is expecting an “extreme makeover” without compromise.

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Functional Eyelid Surgery: Risks and Pitfalls for the Busy Practitioner A major portion of the practice of an ophthalmic plastic surgeon focuses on functional eyelid problems. Frequently, these conditions require surgery. Despite the high frequency and usual straightforward nature of these procedures, several potential legal pitfalls exist in preoperative planning and surgical care for the various categories of procedures. Several risks are common for any eyelid surgery, and the material risks of harm must be discussed before surgery. During eyelid surgery, all imaginable harm may occur during the injection of anesthetics, as well as the incision and manipulation of eyelid tissue. The protective mechanism of the eyelids for the ocular surface may be negatively affected by surgery. Lagophthalmos, retraction, other types of eyelid malposition, and poor orbicularis function may lead to a compromised ocular surface. Sutures can rub against the eye or conjunctiva and cause irritation. The potential end result may range from dry eye and exposure keratopathy to chemosis and corneal ulceration. While it may not be feasible to name every conceivable complication, acknowledging that vision-threatening problems are rare but possible is highly recommended from a legal as well as an ethical perspective. One of the most common procedures performed is ptosis surgery. Yet, ptosis surgery perhaps is one of the most complex and unpredictable surgeries in the category of eyelid surgery. From a patient’s perspective, the surgery does not seem complex. After all, how difficult is it to just “lift the droopy eyelids a bit?” Only after lengthy explanations reviewing the contribution of eyebrow compensation, Herring’s law, and the difficulty of interpreting the intraoperative effects of local and intravenous sedation on levator function might a patient begin to understand the complexity of the surgery. Thus patients should be counseled on the potential need for reoperation after ptosis surgery for various reasons. Insufficient eyelid elevation, overelevation, contour abnormalities, and asymmetry are all possible results following ptosis surgery, even in the hands of a very experienced surgeon. We routinely quote a 20% reoperation rate after ptosis surgery for our patients. Prior to surgery, we try to prepare patients mentally for imperfection by openly discussing the possibility of minor asymmetries. When a less-than-perfect result occurs, patients are not surprised, and further management discussions can proceed. On the other hand, an excellent result causes a patient to celebrate. A delicate subcategory of functional eyelid surgery consists of eyelid neoplasms. Contrary to common belief, patients sue much more frequently from delay in diagnosis in oncology rather than morbidity related to the cancer itself or its treatment.3 A classic illustration of this scenario is the elderly patient with a “chronic chalazion” that does not respond to medical treatment; the underlying sebaceous cell carcinoma can rapidly become systemically malignant if not identified and managed appropriately. Multiple lawsuits have occurred over the misdiagnosis and/or delay in diagnosing eyelid neoplasms. In one analysis, the most common allegation group in malpractice is “failure to diagnose,” and the most common specific allegation is “failure to diagnose cancer.”4

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Cancer is a complex legal topic with emotional overtones, and it deserves special attention as any morbidity may cause a patient to seek to blame. When in doubt, perform a biopsy, and inform the patient of the risk of carcinoma upon presentation of the suspicious lesion. One of the most frequent office-based procedures in ophthalmic plastic surgery is the excisional biopsy of an eyelid lesion. Many surgeons routinely perform several of these procedures a day. The majority of cases carry benign clinical diagnoses: papilloma, inclusion cysts, hydrocystomas, nevi, and so forth. However, occasionally a lesion that may have appeared benign unexpectedly turns out to be a skin cancer. Therefore, a biopsy log should make its way into every ophthalmologist’s practice. Specimens sent for pathologic examination may take several days to be processed and read. Occasionally a patient will miss a follow-up appointment, especially if a small lesion was excised completely from a clinical perspective. Patients have little motivation to return to the biopsy surgeon if they were referred primarily for lesion excision. Occasionally, the pathology laboratory may not notify the physician of biopsy results, even if the final diagnosis is ominous. When both events happen, the results can be disastrous. A biopsy log lists all tissue sent for histopathology, and its regular review is a safety net for preventing diagnosed but unmanaged situations.

Orbit and Lacrimal Surgery: Avoid Management Pitfalls When faced with orbital and lacrimal disease, the ophthalmic plastic surgeon must navigate a wide differential of possibilities. General categories include neoplasm, inflammation, and infection. The differential may include diagnoses with severe potential morbidity or even mortality. Careful work-up is indicated, including imaging studies, if indicated. As in eyelid tumors, cases of orbital and lacrimal neoplasms can become legally ominous if not diagnosed promptly and managed appropriately. Orbital neoplasms have the potential to disfigure a patient, cause sensory and motor neuropathy, and produce further morbidity and/or mortality from local and systemic spread. Moreover, the treatments may also be disfiguring and/or cause visual and functional morbidity. Careful adherence to the specific standard of care for managing the individual cancer can prevent suits alleging inappropriate procedure or management. During the informed consent for orbit neoplasm surgery, the specific risk of pupil dysfunction after surgery should be discussed. For example, after a successful dissection and removal of an intraconal hemangioma, damage to the parasympathetic plexus entering the posterior globe can cause an irregular shape or dilation of the pupil. Despite the success in removing the neoplasm, a patient with light irides may have symptoms of glare or photophobia with a dilated pupil. A patient may even scrutinize the cosmetic consequence of asymmetric pupils. Graves’ disease often causes a significant impact on patients’ long-term quality of life. It is a frustrating and debilitating disease that often requires multiple

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stages of medical and surgical management. Patients who are confused, suffering a chronic disease, and experiencing permanent disfigurement and loss of function can become angry and depressed. If a careful doctor–patient relationship has not been nurtured through extensive education and empathy, lawsuits may result. The cornerstone of Graves’ disease management is careful patient education. Detailed discussions of the staged surgical approach to the disease is helpful in preparing the patient for the long road to improvement and the potential need for reoperation at any point.5 In addition, the patient can then accept the idea that orbital surgery may change or cause diplopia, and orbital or muscle surgery might improve or perhaps even worsen eyelid position. The reality that recession of an extraocular muscle may cause relative proptosis should be pointed out. Of course, any disease with the potential for optic neuropathy also requiring multiple surgeries bears the possibility for vision loss at any stage as a complication of management or as a direct effect of the disease process. Careful documentation of patient discussions and clinical evaluations can validate a carefully staged and appropriately explained management plan, even if the final result is not satisfactory to the patient. Pre- and postoperative photography visually documents the disease and results of surgery. Orbital and lacrimal infections have the potential to spread rapidly across the face and posteriorly into the cavernous sinus and cranial fossa. These infections can cause significant morbidity and, in rare instances, mortality. The vague nature of the initial clinical presentation and the unpredictability of the disease course require appropriate early evaluation and workup. A delay in management can lead to morbidity that might give a patient reason to seek legal counsel. Significant infections should prompt specialty consultation. Infectious disease specialists can provide valuable assistance in choosing appropriate antibiotics. Otorhinolaryngologists can assist in the management of sinusitis. The comanagement of facial fungal infections with an otorhinolaryngologist is highly recommended, as endoscopic sinus surgery is often indicated early in the evaluation and management of mucormycosis and aspergillosis. The ophthalmologist should maintain a high suspicion for these infections, as they are rapidly progressive and have significant potential for serious harm. Chronic dacryocystitis is usually caused by simple nasolacrimal duct obstruction, but in the back of the clinician’s mind should always remain the suspicion for nasal and lacrimal neoplasms that can masquerade as seemingly more straightforward diagnoses. Nasolacrimal duct obstruction can be a frustrating problem for patients. Surgery for nasolacrimal duct obstruction involves dissection into the nasal cavity, and bony removal maneuvers have the potential to inadvertently enter sinuses and to cause intranasal scarring and even cerebrospinal fluid leaks. These risks should be discussed with a patient prior to surgery. As in any surgery, complications should be carefully disclosed and monitored, not concealed. Vigilance and responsive care are of the utmost importance to maximize the care of the patient with orbital or lacrimal disease. The patient who requires surgery should have extensive counseling and education, as orbital and lacrimal diseases are frequently difficult for patients to understand.

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Ocular and Facial Trauma: Difficult for Both Patients and Surgeons In the treatment of a trauma patient, the physician is potentially facing an uphill battle from a legal perspective. Trauma patients are among the most frequent group to initiate legal action against their physicians, and several factors are stacked against the physician. Often a patient requires immediate or semiurgent surgery, and there is little time for the physician to develop rapport with the patient. Furthermore, the trauma often damages delicate periocular structures, and the patient has difficulty in differentiating loss of function from the trauma and saved function from the surgical repair. The patient may require several staged surgeries, perhaps with different subspecialists, which may lead to a protracted recovery. Despite heroic attempts at reconstruction, patients may still be severely disfigured from their perspectives. Several strategies may be helpful in minimizing the chances of a trauma-related legal action. A rapid and careful workup is required in cases of trauma. There should be a high suspicion for foreign bodies, especially intraocular organic and metallic foreign bodies. A patient with no apparent facial or ocular surface penetration may have an occult self-sealing corneal, limbal, or scleral wound. Intraocular foreign bodies, if missed, have very significant legal ramifications against the physician.6 The visual prognosis of an apparently uninjured eye can rapidly deteriorate in cases of endophthalmitis and/or metal toxicity. Immediate x-ray imaging should be performed in cases of suspected intraocular foreign body, and, if a foreign body is identified, urgent vitreoretinal consultation is needed. Similarly, there should be careful consideration of removing orbital foreign bodies. Imaging studies and the clinical history can help differentiate the two general categories of foreign body composition (organic and inorganic) and two general categories of penetration (stable or unstable). Unstable foreign bodies can affect orbital and globe function and may even penetrate into the cranial vault. Thus consultation with the neurosurgery service should be considered, if necessary. Generally, organic foreign bodies carry a risk of infection and should be removed, whereas inorganic and inert materials need not be removed unless their location is unstable. Facial fracture repair requires broad surgical exposure. As a result, there is inherent risk of collateral damage to orbital and facial function. Detailed preoperative discussions should include the risk of inducing strabismus and the rare risks of sensory and motor nerve damage. As is true in all circumstances, but especially in trauma situations, careful documentation is mandatory. Documentation of the accident and the preoperative workup, including radiologic results, should be performed. In the long run, patients have poor recollection of conversations at the time of emergency/urgent care, and so documenting the discussion of risks and alternatives should be performed. An ancillary staff member should witness surgical consents. Photodocumentation of the patient’s clinical examination is highly recommended, as patients immediately posttrauma may not be in a state of mind to digest the realities of the injury, and

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photography can capture the extent of the damage. Reviewing the preoperative photos with the patient during the recovery period is helpful in allowing the patient to understand better their preoperative state and to appreciate better their postoperative condition. A patient with a poor outcome may occasionally seek redress for grievances. Occasionally, the trauma/reconstructive surgeon may be called as a witness when the patient takes another party to trial. The surgeon may be asked to comment on the extent of the injury and on the long-term prognosis. Again, photographs taken by the surgeon at the time of initial evaluation may be quite helpful. Written documentation is crucial. As a pattern, the style of recording information into the chart should be nonbiased and matter of fact. Whatever is written in the chart may be asked to be read out loud to the jury, word for word. Opinions expressed by the patient should be in quotations or, alternatively, should be documented as, “The patient states that.…”

Cosmetic Facial Surgery: Minimize Risk by Managing Expectations Once a taboo topic, cosmetic surgery is now fashionable. “Honey, this surgery is you! Just let me remove these bags and lift right here—we’re going to make you young again.” Scripted television clip or real life? Reality-based television shows have brought cosmetic surgery to the center stage of modern entertainment and into the homes and minds of society in an unprecedented manner. Patients believe that the “extreme makeover” is not only possible but routine. Attending to the patients’ expectations of cosmetic surgery is perhaps the most important factor in successfully treating cosmetic patients and minimizing the legal risks involved. It is essential to balance a discussion of the proposed treatments with the potential risks and limitations. The discussion should not be hurried, and an attempt should be made to educate the patient as much as is reasonable with regard to the patient’s specific anatomy and the surgical techniques suggested to achieve a desired outcome. An educated patient is more likely to have realistic expectations. Effort should be made to understand the patient’s psychologic and psychiatric status. Simple direct questioning can uncover patients’ motivations for surgery. When patients expect that cosmetic surgery will transform their lives, save their marriages, or relieve their clinical depression, then the surgery is a setup for disappointment. Patients with body dysmorphic disorder often seek the services of a plastic surgeon, and subjective dysmorphia can extend to the face. Relatively minor facial features can become overly exaggerated in the patient’s mind and lead to obsessive scrutiny of these features. It is the duty of the surgeon to unearth these psychologic states with screening questions. Failure to identify those patients who harbor unrealistic expectations can result in an unsatisfied patient who will be more likely to sink into depression and surface with a lawsuit. Referring the patient for a second opinion by a trusted colleague who can deal with the patient in a friendly

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and knowledgeable manner can strengthen the patient’s confidence in the original physician’s impression and plan. There are several key points of discussion during a cosmetic consultation. Patients should understand that plastic surgery is about improvement, not perfection or transformation. Using a mirror, underlying subtle or obvious asymmetries and challenging anatomy should be demonstrated to the patient. Patients are often unaware that every human, including themselves, has subtle asymmetry. It should be explained that while improvement is possible, patients should still expect some asymmetry after surgery. After careful assessment of their skin type, patients should be given a realistic prediction of how their skin will heal and what type of scar to expect. Common risks, such as dry eye symptoms after blepharoplasty, should be thoroughly reviewed. Rare risks should be mentioned, and the patient’s reaction can often serve as a psychological test of their expectations: an informed patient with a balanced outlook should not be overly rattled by discussions of severe complications. As in other areas of ophthalmic plastic surgery, there is great importance for photodocumentation of the preoperative status of the patient. Not only do photographs serve a valuable purpose in demonstrating before and after results to both the patient and physician, they also can serve as a reminder to patients of asymmetries and irregularities that were present before surgery. It is common for a patient who has never noticed their relative right-sided mild blepharoptosis to focus on it extensively during postblepharoplasty self-examination. For this patient, demonstrating the preexisting ptosis in a preoperative photograph can prevent the patient from believing that the surgery caused the ptosis. An expanding area of the cosmetic ophthalmic practice includes the usage of paralytic agents (e.g., botulinum toxin A) and fillers (e.g., collagen, hyaluronic acid). Risks to discuss in detail with patients undergoing injection of paralytic agents should include the possibility of temporary ptosis and lagophthalmos. Patients receiving paralytic subcutaneous injections should be monitored for these complications and treated accordingly. Botulinum toxin A may spread inadvertently to an adjacent area and cause unwanted paralysis that can appear as if the patient has had a stroke. These unwelcome effects will occur in rare instances but can be devastating for the few patients to whom it does occur. The effects can last up to 3 months with no satisfactory treatment. For these reasons, a thorough informed consent is valuable. The multitude of facial fillers flooding the market has expanded options for facial sculpting; however, fillers can result in granuloma formation in select patients, as well as dissatisfaction with the result. If the filler is a nonabsorbable material, these problems may become significant chronic issues. The patient undergoing facial fillers should be informed of these risks. With the increasingly complex palette of laser skin resurfacing technologies, some ophthalmic plastic surgeons perform laser facial skin rejuvenation. Some risks are to the type of laser technology, ablative or nonablative, that should be discussed with patients. Ablative lasers may induce irregular pigmentation in patients with even mild to moderate skin pigmentation; dark-skinned patients should have pretreatment

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testing of a concealed skin patch to assess specific postlaser pigmentation results. Ablative lasers denude the epithelium and thus carry a risk of infection; consideration for viral and/or bacterial prophylaxis should be made for patients at risk. Carbon dioxide lasers have the specific risk of causing a fire in the procedure room. In our practice, we stop oxygen delivery, and remove all oxygen tubing from the patient. In addition, we outline the face with wet towels and keep a basin of water available in the event of a fire. These prophylactic maneuvers are recorded in the operative report. Nonablative lasers do not directly bare the dermis but can deliver significant energy to the specific dermal structures. Risks of posttreatment pigmentation abnormalities should be discussed, and full-thickness burns are possible. Occasionally, nonablative procedures can be quite painful, and patients should be informed of this reality. In this time of ubiquitous cosmetic facial surgery, there is an everexpanding subset of patients who have had a poor result. Either the patient is unhappy with the cosmetic outcome of the surgery, or the patient is experiencing dysfunction as a result of surgery. Ophthalmic plastic surgeons frequently encounter patients who present with the “overdone blepharoplasty,” who demonstrate signs of lagophthalmos and exposure. Other presentations include increased asymmetry after surgery, eyelid contour abnormalities, and periocular hollowness. It is challenging to treat this subset of patients, as they have preexisting resentment before even encountering the specialist. In these cases, it is appropriate to spend extra time assessing psychological status, educating patients, and dispelling false beliefs. A patient in this category may manifest strongly unrealistic expectations; the patient may say, “My previous doctor was terrible, but I know you can fix all my problems.” Unhappy patients seeking specialty consultation after previous surgery can manifest anger toward their previous physician or even openly express their litigious intentions. “My previous surgeon was a butcher.” It is inappropriate and detrimental to deride previous surgery or to encourage patients to seek legal counsel. No good can come of it, and surely it does nothing for managing the patient’s current functional and cosmetic complaints. A supportive attitude and a positive proactive affect may steer a patient away from continuing a spiral of negativity that may incite legal action.

Anesthesia Administration and Medications: Prevent Problems with Vigilance and Diligence Pain is alleviated during ophthalmic plastic surgery by the administration of anesthetic agents from a qualified, dedicated, anesthesia provider. The aspects of every surgical case that must be analyzed in great detail include the patient’s history and physical evaluation prior to the development of an anesthesia care plan. Close inspection of the patient’s underlying health should precede any surgical procedure or decision for pharmaceutical treatment. Complete preoperative evaluation by a generalist physician should precede elective surgery. Not only does this fulfill a legal recommendation that the examination be performed but also the examination may uncover important diagnoses pertinent to surgery, such as liver

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failure (which may increase bleeding time), hypertension (which might exacerbate intraoperative bleeding), or cardiac risk factors. In addition, the generalist may perform an assessment of the risk of preoperative cessation of aspirin and clodoprigel. The surgeon is best to avoid counseling the patient to stop these medications without the approval of the generalist or cardiologist. In perioperative care, there are numerous occasions in which the surgeon prescribes or administers drugs. Drug-related incidents of morbidity are the root cause of multitudes of malpractice cases. There have been many lawsuits for complications relating to the administration of local anesthesia. Perforation of the globe during the injection of local anesthetic agents is a most feared complication and has been successfully brought to trial. Injection of local anesthetic directly into an extraocular muscle belly can cause restrictive strabismus.7 Ophthalmologists should also be cognizant of drug interactions, such as the potentiation of warfarin by acetazolamide. Oral glucocorticoids are prescribed frequently for facial surgery and the treatment of orbital disease. Significant side effects are possible, including exacerbation of glycemic control for diabetics, inhibition of gastric protection, femoral head necrosis, and even psychiatric side effects. Often, eyelid and orbital disease is treated with triamcinolone suspension injection. These injections are performed so frequently that often informed consent is omitted, and even verbal explanation of complications is omitted. Complications such as glaucoma, systemic absorption, skin depigmentation, subcutaneous fat atrophy, and vascular occlusion do occur. The legal culpability of these complications of drug administration fall to the prescribing physician, and so physicians must maintain due diligence in prescribing medication and explain these risks to patients prior to administration. Ophthalmic plastic surgery is distinct from surgery of the other ophthalmic specialties by the relatively larger nature of the surgeries with greater potential for bleeding.8 Larger volumes of local anesthetic are often required, increasing the potential for systemic effects of injected agents. There have been several well-publicized cases of mortality from overdosage of injectable anesthetics in cosmetic surgery. Surgeons should maintain a working knowledge of the maximum dosages of lidocaine, Marcaine, and epinephrine to stay out of trouble. In addition, the recognition and treatment of local anesthetic toxicity is vital. A crash cart is generally a requirement for surgery centers and should be considered for any clinic situation where minor surgery is performed without intravenous anesthesia. Surgeons should maintain their certification in Advanced Cardiac Life Support for the safety of their patients, as well as for their own legal protection in the event that cardiopulmonary resuscitation care is required.

Conclusion: Conscientiousness and the “Art” of Medicine While practicing ophthalmic plastic surgery, it is easy to become bogged down with legal details, implications, and defensive practice maneuvers. However, this chapter and even this entire textbook can be distilled down to the following statement: avoid malpractice by running a conscientious practice and perfecting the “art” of medicine and surgery.9–14

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A physician who is diligent, thorough, and thoughtful will stay out of trouble in diagnosis and management. This is achieved by combining the cumulative knowledge of a physician’s training and ability with an attentive work ethic. Staying out of “trouble” is the key to avoiding lawsuits. After all, “trouble” is a maloccurrence that leads a patient to blame and leads a case to a court of law. Without “trouble,” there can be no lawsuit. Perfecting the art” of medicine is a complicated, esoteric subject. Yet it is essential to the practice of every physician and a crucial cornerstone in prophylaxis against malpractice. The art of medicine requires sensitivity and the ability to listen, which allow the establishment of rapport. The art of medicine is also engaging the patient in a detailed discussion of the clinical findings and treatment plan, empowering the patients to understand their clinical status and potential management options, which leads to realistic expectations. In the end, connecting with a patient as a fellow human being builds a relationship that does not break down, even in the face of adversity.

References 1. Brooten KE. Malpractice: A Guide to Avoidance and Treatment. 1987. Orlando: Grune & Stratton; 1987. 2. Alton WG. Malpractice: A Trial Lawyer’s Advice for Physicians (How to Avoid, How to Win). Boston: Little, Brown; 1977. 3. Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol 1996;114(3):333–337. 4. Lobe TE. Medical Malpractice, A Physician’s Guide. New York: McGraw-Hill; 1995. 5. Shorr N, Seiff SR. The four stages of surgical rehabilitation of the patient with dysthyroid ophthalmopathy. Ophthalmology 1986;93(4):476–483. 6. Bettman, JW. Ophthalmology: The Art, The Law, and a Bit of Science. Birmingham, AL: Aesculapius; 1977. 7. Ando K, Oohira A, Takao M. Restrictive strabismus after retrobulbar anesthesia. Jpn J Ophthalmol 1997;41(1):23–26. 8. Sarwer DB, Pruzinsky T, Cash TF, Goldwyn RM, Persing JA, Whitaker LA. Psychological Aspects of Reconstructive and Cosmetic Plastic Surgery. Philadelphia: Lippincott Williams & Wilkins; 2006. 9. Campion FX. Grand Rounds on Medical Malpractice. Chicago: American Medical Association; 1990. 10. Kraushar MF. Medical malpractice experiences of vitreoretinal specialists: risk prevention strategies. Retina 2003;23(4):523–529. 11. Kraushar MF. Recognizing and managing the litigious patient. Surv Ophthalmol 1992;37(1):54–56. 12. Kraushar MF, Turner MF. Medical malpractice litigation in cataract surgery. Arch Ophthalmol 1987;105(10):1339–1343. 13. Leaman TL, Saxton JW. Preventing Malpractice: The Co-Active Solution. New York: Plenum Medical Book Co.; 1993. 14. MacKauf SE. Advanced Medical Malpractice: Anesthesiology, General Surgery, and Neurology. New York: Practicing Law Institute; 1977.

Chapter 19

Pediatric Ophthalmology Edward L. Raab

Introduction Efforts that lower the physician’s risk also usually result in better patient care. Limiting risk exposure is to a considerable extent a common sense endeavor, the main thrust being to apply, as physicians typically do on a daily basis, the principles of best practice. Pediatric ophthalmology is characterized by the necessity to make crucial decisions and take actions intended to serve the young patient for a lifetime. Liability for inappropriate practice can in some instances be imposed 20 or more years beyond the event, and the damages could be monumental. This chapter details several situations in pediatric ophthalmology that if approached improperly could expose the physician to liability. Some aspects of the discussion extend to ophthalmologic practice beyond the care of children. While not to be taken as legal advice, appropriate avoidance measures will be suggested. Note: even though in any of these settings your status as an employee may shift the obligation of payment of a judgment elsewhere, you will nevertheless be cited in the National Practitioner Data Bank.

The Unaccompanied Minor What should take place when confronted with an unaccompanied minor presenting for examination? This would be unpermitted “contact,” as minors are considered to be without capacity to consent. Of all the items to be discussed, this probably is the easiest to address. It is more a matter of patient convenience than quality of care. In general, parents or a guardian (a reliable adult who may not always be formally appointed) are responsible for health care decisions for an underage child. There are legally defined exceptions for minors who are married, pregnant, parents, self-supporting, or a member of the military (so-called emancipated minors). Routine eye care is rarely permissible for a minor who does not qualify as one of these exceptions. M.F. Kraushar (ed.), Risk Prevention in Ophthalmology. doi: 10.1007/978-0-387-73341-8; © Springer 2008

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It is most unlikely that a child would on his or her own initiative report for an examination, especially one likely to include the dreaded “blurring drops,” against the express wishes of a parent. However, it would be hazardous to rely on this “real life” inference of parental consent. The safest course is to require written authorization or consent by telephone. The latter requires a reasonable good faith belief that the consenting person at the remote location is the appropriate individual. For problems that are more urgent but not true emergencies, relatives or an adult sibling may stand in for an absent guardian. Here, too, the circumstances should be such that there is reason to accept what is represented as to the accompanying adult’s identity.

Duty to Third Parties We have a duty of care to our child patients, exercised through their parents or guardian. The responsible adult legally is a stand in for the child. Can there somehow be an additional duty to third parties, one that usually does not exist toward those who may accompany or even assist a competent adult in a medical care setting? The following illustrations are derived from actual cases A young child received a poliomyelitis vaccination. Her principal care giver was a parent whose own resistance to infection was reduced by recent surgery. The child’s pediatrician did not inform the parent of the precautions to be taken in handling the child’s waste and secretions. The parent contracted the disease and successfully sued the physician for negligence in failing to provide the pertinent information.1 A psychiatrist was informed by a disturbed patient of intent to kill another person, whom the patient named. The psychiatrist concluded that warning the intended victim would violate physician–patient confidentiality. The patient accomplished the killing. The victim’s family successfully sued the doctor for the victim’s wrongful death resulting from the negligent failure to warn.2 The law distinguishes different degrees of closeness between third parties and patients, either child or adult. Those who are either responsible for the minor or for an incapacitated patient’s general welfare and have decisional power and regular interaction with such a patient, or those emotionally close to the patient but who may not be formally responsible, have been included within the duty to warn assumed by the physician, which arises when the third party is known to be at risk from a specific threat and when the harm is readily foreseeable. Accordingly, as just one example, the discovery by the pediatric ophthalmologist of a retinoblastoma as the explanation for a white appearance to the pupil, especially when bilateral, calls for investigation of parents, siblings, and perhaps close relatives in order to establish, by the detection of spontaneously regressed lesions and by modern genetic analysis, the likelihood of very young children of the family and its extension and of as yet unborn children being similarly afflicted. Omission of such widely practiced counseling and analysis could be regarded as negligent care, because there is a specific, foreseeable threat of harm to ascertained individuals. Once again, protection for the physician enhances overall quality of care.

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Promises “This operation will cure the glaucoma.” “These glasses will straighten your child’s crossed eyes.” Such absolute declarations should be avoided. We know from experience that such statements are not always true. They are promises of results and if relied on by the patient in accepting treatment can be viewed as making a contract. This is not the same as malpractice and has the strategic advantages of not requiring expert testimony, and a longer statute of limitations. The physician should studiously avoid any discussion that could be construed as an express promise. Expressing confidence that falls short of a promise in an outcome based on reliable evidence or your own experience (“therapeutic assurance”) is consistent with good medical practice and a much safer course.

Abandonment A physician–patient relationship can be terminated by the physician for any reason or for no reason provided it is done with adequate notice and an offer to furnish the patient’s record to a successor physician. However, bad consequences from abandonment of a patient during a course of treatment would be difficult to defend. Suppose you have under your care a child with an established diagnosis of juvenile rheumatoid arthritis. On one or more prior occasions, your examination has shown no uveitis. The patient does not appear for the next scheduled visit. Now suppose alternatively that in a similar situation, you have detected uveitis and prescribed treatment. As proposed above, this child too is a “no show.” In both instances, you have appropriately counseled the responsible adult of the necessity for periodic follow up. Is your risk different in the two situations? Abandonment applies when the patient is under an active course of care, which does not include merely a series of checkup visits for a certain diagnosis. Regardless, although the first scenario is essentially a periodic screening, best medical practice calls for at least a reasonable attempt to reschedule the appointment. Especially if such an effort is documented in the patient’s record, the risk of liability for a subsequent poor outcome is rather low. For the second child, a more vigorous attempt (again with documentation) to reestablish care is called for, as the child is in the midst of treatment for a potentially destructive disease. In another context familiar to the pediatric ophthalmologist, a child on an occlusion program for amblyopia, whose vision is periodically checked and the regimen adjusted, probably is under active treatment that may include the danger of occlusion amblyopia of the previously preferred eye, whereas the same child, undergoing interval vision checks once occlusion is discontinued, probably is not. There is no rigorous definition of what constitutes a “reasonable” or sufficiently “vigorous” attempt. These determinations are fact specific and will be decided by a jury, if matters go that far. Properly documented efforts are not only medically correct but the best defense against the necessity for a jury to consider the question at all.

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The Consultant Most pediatric ophthalmology patients are referred for care, not merely for guidance. The ophthalmologist may report to the referring physician, but this is largely informational. A referral for diagnosis and treatment by a physician who is not a member of our specialty clearly implies that the patient (through his or her guardian) and the ophthalmologist understand that they are in a mutual undertaking. Consider the following: you attend grand rounds or you are with a colleague in the staff dining room or at the scrub sink. You comment on a case. Your advice is followed; harm to the patient results, and you are sued. What is your risk of liability in this setting? As shown in several courts,3 reasonable jurors probably would not find any implication of a physician–patient relationship in this type of encounter, the existence of which most likely is even unknown to the patient. In another context involving an unaware patient, the outcome could be different. Suppose now that you are the ophthalmologist on call for your hospital’s pediatric emergency room, and you are informed of a patient with an eye problem. Must you see the patient, or is telephone advice sufficient? Several cases have indicated that it would be a departure from the standard of care to not personally attend a patient in these circumstances when indicated by the communicated findings.4 In the end, it is a matter of judgment; the response involves a weighing of the likely consequence of the injury if not immediately attended by a knowledgeable specialist against the inconvenience of your personal participation. Although the patient has not consulted you or even necessarily knows your identity, he or she has presented for care by the hospital, of which you are the understood designee to carry out the hospital’s obligation. When in doubt, go. There also are occasions when you as the treating ophthalmologist seek consultation for your patient. What if in this instance you do not accept the consulted ophthalmologist’s recommendations? Given that you found it necessary to go beyond your own capabilities in the first place, are you at risk for a malpractice verdict if you ignore the advice and the case has a poor result? Ultimately, you are not bound to follow a consultant’s recommendation, but your reasons for rejecting it should be documented. What is important is that these reasons be sound and preferably based at least in part on your own experience and that it is clear that you considered the consultant’s suggestions.

Right Eye or Left Eye? Imagine the disaster (it has happened) when a mistake as to side occurs in an enucleation, even though in most cases the eye indicated for that operation is readily apparent. The possibility of error for interventions of a less critical nature also cannot be ignored; should correction of strabismus involve the only good eye of an amblyopic patient or one with a structural defect in one eye, other than in limited special circumstances (e.g., null-point motor nystagmus)?

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Surgical facilities have increasingly become aware of the necessity to guard against such errors. Marking the operative site on the patient and “time outs” for verbal review of the proposed procedure among all participants are now institutional policy at many facilities, reinforced in some instances by state law or regulation. Errors of this type usually occasion much finger pointing, but the last clear chance for prevention lies with the surgeon. No source, including the patient’s impression, the hospital’s operation schedule, and the insurance company’s authorization, other than your own record establishes the ultimate facts. It is my practice to have my entire record available at the procedure and affix the sheet stating my plan to the wall or an instrument stand for ready reference rather than to bring only a short summary prepared as a brief admission note, because other questions about examination details may arise during the operation, especially in repeat strabismus procedures. The risk avoidance value of observing this ritual exceeds by far any slight inconvenience.

Novel Treatment There are occasions when the physician finds justification for treatment that is neither established nor experimental, such as disinsertion and reattachment of all four horizontal rectus muscles for motor nystagmus.5 In such situations, the actual surgical handling may be entirely conventional; it becomes “novel treatment” by application in a novel setting.6 What risk-limiting precautions are appropriate here? Professional common sense should prevail. Most important, there should be no increase in the expected occurrence rate of dangerous complications. Second, the remedy should relate logically to what is known about the abnormal condition. Published experience with the treatment by other ophthalmologists is valuable for this purpose. If there is no such prior evidence and the treatment is essentially untried, this calls for adherence to a full investigational protocol. Again, whatever lessens risk has a positive effect on quality of care.

Off-Label Prescribing The term off label refers to the use of drugs and devices not authorized by the U.S. Food and Drug Administration (FDA), usually because they have not been evaluated for safety and efficacy in certain populations or in certain dosages. The package inserts for such drugs typically contain the warning “not approved for children” or a similar message. This situation is changing somewhat. Since 1998, the FDA has had a “pediatric rule” that requires studies on children as part of a new drug application unless children do not contract the disease the drug treats or the outcome is already known.

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Among the most serious conditions leading the pediatric ophthalmologist to prescribe off label are certain forms of childhood glaucoma, retinoblastoma, and severe uveitis from various causes. In such cases there are few effective alternatives, so it is even possible that failure to prescribe off label could be deemed malpractice. What liability exposure attaches to off-label prescribing? The FDA provides a Practice of Medicine Exemption under which it is lawful to vary the conditions of use of a drug from those detailed in the package insert without FDA approval, provided that the unapproved use is based on reasonable medical evidence, without fraudulent intent and that it requires the same judgment and prudence as exercised in medical practice in general. The items of prudence considered critical are a good faith effort to evaluate all that is known about the drug and informed consent from the child’s caregiver, many of whom will notice the “not approved for children” warning. I have found it best to anticipate their hesitation by pointing out the difference between disapproved and nonapproved and that what is known about the drug’s effects, as well as prior experience, reasonably indicates that its use is appropriate.

Retinopathy of Prematurity Experience has shown retinopathy of prematurity (ROP) to be a leading risk setting for the pediatric ophthalmologist. Modern concepts of appropriate care for premature infants are based on the premise, firmly supported by recent technical advances and a body of sound clinical studies, that the disastrous consequences of ROP can be avoided in most cases. The key is timely detection.7 Legal action mostly involves a break in the screening sequence once the infant is discharged from the nursery. Consider the following actual occurrence: A pediatric ophthalmologist provides ROP screening services to the neonatal intensive care unit (NICU) of a regional hospital. The NICU has sole responsibility for identifying the infants at risk requiring screening. Examination of one such infant results in a properly charted note stating a diagnosis of “immature retina” in zone 2 and recommending a repeated screening in 2 weeks. The attending neonatologist misinterprets the note as conclusively ruling out ROP and transmits this information in his discharge note to the infant’s succeeding pediatrician, who considers the follow up to be only routine and elective. The parents arrange the next appointment by a delayed effort and cannot secure an appointment until several weeks later. At this examination, advanced ROP is evident, with a poor visual outcome. The pediatric ophthalmologist is named as one of the defendants in the subsequent lawsuit. This is a rather typical scenario for ROP incidents that result in malpractice lawsuits. Omitting discussion here of how liability might be apportioned between the hospital neonatologist and the successor pediatrician, what was the ophthalmologist’s exposure, and how might it be minimized?

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The case points out the importance of a thoroughly understood practice pattern among these participants. While “immature retina” arguably should have been understood by the neonatologist as not eliminating the possibility of ROP, especially because a short interval repeated screening was recommended, there should be an established understanding among the involved physicians regarding what meaning such an ophthalmologic description conveys. There should be further understanding of whether responsibility for follow up is shared by the ophthalmologist or remains with the nursery or the subsequent pediatrician during the stage of screening, however many sessions are required before terminating scrutiny. Because the latter two coordinate all care during and following discharge, logic suggests that the responsibility best remains with them, but this is entirely a local determination. However, at the point where any degree of ROP has been detected, the capacity to address the matter has gone beyond the primary care givers, and it would be difficult for the pediatric ophthalmologist to deny some share of responsibility while being in the better position to carry out the necessary treatment or to secure this service from a colleague. In the case described above, no ROP was evident at the first screening, but through a misunderstanding of the result, follow up was not arranged appropriately through no fault of the ophthalmologist. What then constituted his risk? It was that there was no system in place within his office for spotting compliance failures and assisting in efforts at rectification. Other opportunities for a break in the system can occur. It is important that when medical considerations prevent the ophthalmologist from accomplishing the screening, this should be documented in the chart and some type of reminder should exist for restoring the infant to the schedule. When the screening ophthalmologist is not the person responsible for treatment, this too increases the possibility of a communication failure and gives a further responsibility to ensure compliance when the referral for treatment arises. It is best to memorialize this or any other variation of understanding in a document freely available and universally adopted, but consistent custom and practice will govern in the alternative. Be aware that these understandings fix the working relationships at a particular institution, but no agreement to assign responsibility for any aspect of care elsewhere from where the facts of the specific case indicate it should lie will immunize against liability for negligence. The patient is not bound by arrangements between the involved physicians.

Final Thoughts Try to accomplish an entire examination in one visit; it limits what might otherwise “fall through the cracks” if the patient does not return. You might avoid missing a retinal lesion, causing what may otherwise appear to be a routine strabismus problem or one that explains why an infant with supposed amblyopia is not improving with adequate occlusion.

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Although it may seem clear that a tearing infant has lacrimal obstruction, always harbor a suspicion of congenital glaucoma. No ophthalmologist, especially not a pediatric ophthalmologist, should overlook this possibility. Surgical over- and undercorrection of strabismus occurs frequently enough. Avoid characterizing these as complications, because they are within the spectrum of foreseeable outcomes, even though disappointing. Your informed consent procedure should establish this view. Your informed consent discussions should include risks, benefits, and alternatives respecting the proposed treatment, but full disclosure still leaves room for you to rank the alternatives. Remember also to present not only the alternatives but also their risks and benefits as well as those of your preference. As to risks, the discussion is not complete without giving some idea of the likelihood of any risk materializing. I have seen several instances of adults with strabismus unduly discouraged from improving their self-image and business/social acceptance through surgery by an exaggerated estimate of the risk of intractable postoperative diplopia. Surely this unusual complication should be revealed, but in proper perspective relative to the likelihood of achieving the anticipated benefits.

References 1. Tenuto v. Lederle Laboratories, et al. 90 N.Y.2d 606; 687 N.E.2d 1300; 665 N.Y.S.2d 17 (N.Y. Ct. App. 1997). 2. Tarasoff v. Regents of University of California, et al. 13 Cal.3d 177; 529 P.2d 118; 118 Cal. Rptr. 129 (Sup. Ct. Cal. 1974). 3. Sawh v. Schoen. 215 A.D.2d 291; 627 N.Y.S.2d 7 (N.Y. A.D. 1st Dept. 1995). 4. Thomas v. Corso. 265 Md. 84; 288 A.2d 379 (Md. Ct. App. 1972). 5. Hertle RW, Dell’ Osso LF, FitzGibbon EJ, Yang D, Mello SD. Horizontal rectus muscle tenotomy in children with infantile nystagmus syndrome: a pilot study. JAAPOS 2004;8(6):539–548. 6. Cowan DH. Innovative Therapy v. Experimentation. 21 Tort&Ins. L.J. 1986;21:619–623. 7. American Academy of Pediatrics, Section on Ophthalmology, American Academy of Ophthalmology, American Association for Pediatric Ophthalmology and Strabismus. Screening examination of premature infants for retinopathy of prematurity. Pediatrics 2006;117(2):572– 576. Erratum in Pediatrics 2006;118(3):1324.

Chapter 20

Refractive Corneal Surgery James J. Salz and Anne M. Menke

Introduction Few ophthalmic subspecialties generate as much public enthusiasm and criticism as refractive eye surgery: Tiger Woods’ professional success after his refractive surgery may lend a certain glamour to LASIK (laser-assisted in situ keratomileusis), but websites devoted to “LASIK disasters” abound. In this chapter, a refractive surgeon with extensive research and clinical experience and a health care risk manager assess how refractive surgery has fared in the courtroom. To provide the reader with an overview of the topic of medical malpractice and refractive surgery, we present overall ophthalmic claims experience and compare the incidence of refractive surgery claims to that of other types of eye cases (e.g., cataract surgery). Then each of the three most common refractive surgery procedures—radial keratotomy (RK), photorefractive keratectomy (PRK), and LASIK—are analyzed from a risk management and professional liability perspective, followed by a discussion of recent cases with multimillion dollar awards that have garnered national attention. The chapter concludes with a review of pertinent literature and a discussion of how to minimize the risks of a claim.

Ophthalmic Mutual Insurance Company’s Overall and Subspecialty Claims Statistics Formed by members of the American Academy of Ophthalmology (AAO) in 1987, Ophthalmic Mutual Insurance Company (OMIC) now insures about 35% of ophthalmologists who can choose their own liability carrier. Through 2005, OMIC had 2008 closed cases, of which 424 (21%) resulted in an indemnity payment. Payments ranged from a low of $500 to a high of $1,800,000, with a median payment of $75,000. Overall, OMIC has paid $55,950,884 in indemnity payments on behalf of its insured ophthalmologists. Ophthalmic Mutual Insurance Company tracks claims by ophthalmic procedure and subspecialty and is thus in a position to respond to those ophthalmologists who

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believe that refractive surgeons have more claims and larger indemnity payments than ophthalmologists who do not perform refractive surgery. This impression is reinforced by articles about the large awards in some of the recent LASIK cases, leading nonrefractive surgeons to surmise that they are not as great a risk to an insurance company and should, therefore, be charged lower premiums. A look at the data challenges some of these assumptions. Figure 20.1 graphs refractive and cataract claims between 1998 and 2004 and shows that cataract consistently and significantly exceeds LASIK in number of claims. Figure 20.2 compares the incidence or frequency of claims filed from 2002 Refractive Claims by Date Reported (through 12/31/2004)

100 90

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0 95

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Figure 20.1 Refractive versus cataract frequency, 1998–2004

Claims by Ophthalmic Subspecialty Opened per year July 1, 2005 90 80 70

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30 20 10 0

al

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Figure 20.2 Claims by ophthalmic subspecialty

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through 2005 for the various subspecialties in ophthalmology. Here again, cataract claims rank highest in all 4 years, arguably reflecting its status as the most frequently performed surgery in the United States. Although LASIK was second after cataract in 2002 (79 cataract, 55 refractive, 40 retina), general or comprehensive ophthalmology began outranking it as of the following year (cataract 88, general 37, refractive 31). By 2004, it was a distant third (cataract 57, general 29, refractive 16), and its frequency continues to decline. The incidence of claims is important in setting premiums, but the average and total payments for these claims are perhaps even more important. Figure 20.3 shows the average settlement in 11 categories. Pediatric ophthalmology and neuroophthalmology both averaged over $300,000, while general ophthalmology was sixth at $155,377, LASIK eighth at $95,562, and cataract ninth at $86,366. Although some may be tempted to imagine that retinopathy of prematurity (ROP) cases are driving the pediatric figures, claims involving ROP did not even make it into the top 10 payments for that age group. Figure 20.4 summarizes the total amount of money paid out for the various subspecialties between 2001 and 2004. Here, general ophthalmology ($6,215,092) was by far the highest, with cataract second ($3,713,747), pediatric ophthalmology third ($3,184,014), and LASIK fourth ($2,484,613). One reason that general ophthalmology, excluding cataract and LASIK surgery, is the highest relates to a million-dollar award involving a patient who had a lung lesion listed in his x-ray report from his routine physical examination performed as part of his preoperative work-up. The report was not reviewed by the ophthalmologist, anesthesiologist, or the nursing staff, and the patient died a couple of years later from lung cancer.

$350,000 $300,000 $250,000 $200,000 $150,000 $100,000 $50,000 $0

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Figure 20.3 Average settlement by ophthalmic subspecialty

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J.J. Salz and A.M. Menke $7,000,000 $6,000,000 $5,000,000 $4,000,000 $3,000,000 $2,000,000 $1,000,000 $0

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2) r( te en ic rg 0) 0) (1 Su (4 e al os er gn en ia G D re ilu ) Fa (5 a 0) ne (1 or C ric ) at (2 di h t P e ph O ) ro (9 eu a N 3) om (1 uc s la ic st la G

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Figure 20.4 Total settlement by ophthalmic subspecialty

Refractive Surgery Claims by Procedure Radial Keratotomy The OMIC experience with RK claims has been surprisingly favorable. Figure 20.5 shows the incidence of refractive claims by procedure from 1989 through 2002. There were only a handful of RK claims up to about 1996 when PRK was approved by the U.S. Food and Drug Administration (FDA). Very few surgeons continued performing RK after 1996, and it is generally accepted that it was a transitional procedure with many associated problems. The size of the optical zone, number of incisions, direction of the incisions, metal versus diamond blades, amount of myopia, patient age, incision depth, crossing incisions, peripheral re-deepening, and postoperative cortisone drops were all subjects of great debate—without much hard science to settle the questions. The RK procedure itself weakened the peripheral cornea and unusual results— so called “over- and underresponders”—were common. It was performed by hand, usually in a private office, with relatively inexpensive equipment after attending RK courses, which were readily available from both corporate and private sponsors, and with little regulation controlling the equipment or the surgeons. The procedure caused anywhere from 3 to 4 to 32 to 64 permanent scars in the cornea. Glare and star bursting around lights at night were considered to be not complications but instead expected postoperative events. Optical zones were generally only as small as 3.0 mm, but some surgeons made them as small as 1.0 mm in an attempt to push the limits of the operation to include more potential patients. With all of these known problems, why was the OMIC experience generally favorable? The answer is that OMIC implemented underwriting requirements and provided risk management support specific to RK. In order to be covered for

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60 Projected

50

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40 30 20

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'89 '90 '91 '92 '93 '94 '95 '96 '97 '98 '99 '00 '01 '02 year

Figure 20.5 Refractive surgery, 1989–2002

the RK procedure, the insured ophthalmologist had to complete an application questionnaire that asked about the training, patient selection (amount of myopia and astigmatism), number of incisions, and size of the optical zone. Proctoring was required for surgeons new to the procedure. Unless the policyholder agreed in writing to abide by the requirements, coverage for RK malpractice claims was not available. Initially only unilateral surgery was permitted, and insureds used an informed consent form provided by the company. To assist surgeons who performed RK, the ophthalmologists on OMIC’s Risk Management Committee and OMIC staff offered written support via underwriting requirements for the proper performance and risk management seminars that covered informed consent, complications, and discussions of malpractice issues. OMIC also staged a mock trial involving a fictional RK malpractice case, with ophthalmologists on OMIC’s Board of Directors starring as the judge, plaintiff, defendant, and their attorneys at the American Academy of Ophthalmology’s annual meeting. Although a few policyholders left the company because they felt these requirements were too restrictive, the net result of these underwriting and risk management efforts was a very favorable claims experience. The OMIC surgeons did not use small optical zones or 32 incisions with crossing transverse incisions, nor did they perform RK on patients who were −10D. They informed their patients of the risks and benefits and asked them to sign a detailed informed consent about the procedure. Thus, even though the RK procedure was far from ideal, very few OMIC surgeons were sued, and none of the suits resulted in significant judgments. This was not necessarily the case for ophthalmology in general. There were many lawsuits and several large awards, some over a million dollars. They generally involved inappropriate surgery with too many incisions, optical zones that were too small, and poorly informed patients.

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Photorefractive Keratectomy The OMIC claims experience for PRK parallels the RK claims history. Figure 20.6 graphs the claims experience for RK, PRK and LASIK between 1995 and 2006. There have been very few PRK claims—none for the past 5 years—nor has OMIC paid any large PRK awards. There are several reasons why the PRK claims are significantly lower than the LASIK claims. First, there are fewer PRK cases performed than LASIK. The annual International Society of Refractive Surgeons of the American Academy of Ophthalmology (ISRS/AAO) survey of members tabulates approximately nine LASIK procedures for every one PRK.1 Fewer cases performed translates to fewer possible law suits. It is also generally accepted that PRK is an inherently safer procedure despite the small risk of infection and corneal haze. When infections do occur, they are easier to treat as they are on the surface rather than under a LASIK flap, more responsive to antibiotics, and thus only occasionally lead to severe visual loss. Corneal haze usually clears with time and rarely causes permanent visual loss; use of mitomycin C has further reduced this risk. Two complications associated with LASIK, corneal ectasia and dry eye syndrome, are uncommon after PRK. Post-LASIK ectasia and preexisting form fruste keratoconus have resulted in two recent multimillion dollar plaintiff awards; this issue is addressed in more detail later in the discussion of LASIK. Finally, high volume surgery and comanagement are more commonly associated with LASIK than with PRK. Most corporate-type laser centers focus on LASIK, and these centers perform a high percentage of the laser vision procedures in the United States. Both high volume surgery and comanagement were associated with increased claims frequency in a study of the OMIC refractive surgery claims

Refractive Claims by Date Reported (through July 1, 2006)

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Figure 20.6 Refractive surgery, 1995–2006

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experience by Abbott et al.2 These conclusions and the discussion they generated are discussed in detail in the literature review; the risk management section provides recommendations on how to minimize the risk of a lawsuit regardless of surgical volume and how to safely comanage patients.

Laser In Situ Keratomileusis In 1996, PRK became the first laser vision correction procedure to be approved by the FDA. Although it was deemed safe and effective, it never became popular with the general public because it was associated with significant discomfort and delayed visual recovery. Patients’ experiences with LASIK were different: the combination of minimal discomfort and rapid visual recovery provoked a “WOW!” reaction from patients who responded enthusiastically to the almost immediate improvement in their vision and near complete visual recovery by the morning after surgery. Bilateral simultaneous surgery became very popular, and the number of LASIK procedures escalated dramatically. Within a couple of years of its introduction in the United States in 1996–1997, more than a million LASIK procedures were being performed, and ophthalmologists began to advertise widely, and at times aggressively, in order to attract patients. Soon enough, stories of complications emerged, which is hardly surprising given that LASIK is a technologically more difficult procedure requiring more surgical skill than PRK. In addition, early microkeratomes were difficult to assemble, maintain, and use. Figure 20.1 details the OMIC claims incidence between 1995 and 2004, when LASIK claims rose from 7 in 1998 to a peak of 55 in 2002. This uptick in claims frequency correlates with the increases in both the number of LASIK procedures being performed and the number of ophthalmologists insured by OMIC, which rose from 1,700 members in 1996 to 2,968 insureds in 2002. A similar spike was noted in cataract claims over that time period. Figure 20.6 clarifies, however, that the LASIK frequency trend was short-lived. Although the number of policyholders continued to climb, LASIK claims kept decreasing; as of June 2006, there were only four. Figure 20.7 details the average indemnity payment per LASIK claim between 2001 and 2005, which ranged from $31,000 to $56,000—except for 2003. That year, there were 12 claims and a much higher average settlement of $156,000, largely due to two significant awards. In one case, a patient underwent bilateral simultaneous surgery and later developed corneal ectasia with irregular astigmatism, ghosting, and best-corrected visual acuity of 20/30. The patient’s topography indicated form fruste keratoconus. Most refractive surgeons consider this a contraindication to LASIK surgery. Photorefractive keratectomy might be an option if the surgeon provides the patient with information about the possible increased risk for postoperative problems associated with ectasia. The insured surgeon in this case, however, did not review the topography, disclose the presence of form fruste keratoconus to the patient, or have the patient sign a procedure-specific informed consent document. The case settled for $250,000.

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Average LASIK Settlement Settlements/ Ave. 2001

(3)

$ 31,667

2002

(6)

$ 58,333

2003 (12)

as of July 1, 2005 156,217

160000 140000 120000

90,831

100000

$ 156,217

80000 60000

2004

(5)

$ 35,400 40000

2005

(3)

$ 45,833 00000

58,333 31,667

45,833 35,400

20000 2001 2002 2003 2004 2005

all years

Figure 20.7 Average laser in situ keratomileusis settlements

That same year, another patient sustained a buttonhole flap complication in the first eye, allegedly resulting from a violent head movement during the microkeratome pass. The flap was repositioned without ablation of the bed, and surgery on the second eye was cancelled. The patient developed central corneal haze and irregular astigmatism with best-corrected vision of 20/40. As in the prior case, there were questions about the patient’s candidacy and the consent. No preoperative pachymetry was performed, and subsequent examinations revealed that the patient had a “thin” cornea. The patient’s consent for surgery must be both voluntary and informed. To the dismay of some surgeons, the legal standard is what a prudent layperson would need to know in order for the choice to be informed, not what the surgeon feels is necessary. The surgeon in question first met the patient on the day of surgery but did not document a discussion of the risks and benefits, so the plaintiff argued he was not informed. Moreover, the informed consent document was signed immediately before the procedure, allowing the plaintiff to argue that the consent was coerced instead of voluntary. As readers have no doubt surmised, the patient’s care was comanaged. In addition to limited contact before the surgery, the ophthalmologist examined the patient only on the first postoperative day; subsequent examinations were performed by the comanaging optometrist. Documentation problems surfaced, as no documentation of the head movement could be found. While both the surgeon and the operating room technician confirmed the incident during depositions, the other standard of care concerns led to a settlement of $450,000. In response to these cases, OMIC modified its refractive surgery underwriting requirements pertaining to the role the surgeon must play in determining patient candidacy and informed consent (see the risk management discussion at the end of the chapter). Figure 20.8 charts OMIC’s LASIK trials between 2000 and 2006. In five cases, the jury returned defense verdicts. The only two plaintiff verdicts occurred in 2006. In the first case, a loss of suction during the microkeratome pass led to

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Refractive Trials RK Progressive postoperative Defense verdit hyperopic shift LASIK-decentered flap Plaintiff Verdict LASIK-wrinkled flap Defense verdict PRK-decentration & abnormal Defense verdict healing LASIK-mild DLK postoperatively Defense verdict LASIK-topography suspect Plaintiff Verdict keratoconus? (Surgeon performed less than 100 procedures) LASIK-loss of suction Plaintiff Verdict Pupil not dilated when suction ring applied

217

$2,200

$944,000

$275,000

Figure 20.8 Trials involving laser in situ keratomileusis

a buttonhole flap. The surgeon responded correctly by replacing the flap without performing the laser ablation, and the patient had successful repeat LASIK several months later. A buttonhole flap is a known complication of LASIK and would normally be considered a maloccurrence rather than malpractice. A video of the procedure showed that after application of the suction ring, the pupil did not dilate and the tonometer indicated inadequate pressure. The plaintiff’s expert testified that both of these findings were indications of pseudosuction, which should have alerted the surgeon to abort the microkeratome pass. While the patient acknowledged an uncorrected visual acuity of 20/20, he continued to experience glare, halos, and loss of contrast sensitivity. The jury found in favor of the plaintiff and awarded damages of $275,000. The second trial resulted in OMIC’s highest award in a LASIK case and focused on patient selection. One plaintiff expert suspected the patient had form fruste keratoconus, even though he acknowledged that the corneal topography was within normal limits. The well-qualified defense experts all felt that the topography and pachymetry were normal and that the patient was indeed an appropriate candidate for the procedure, thus confirming the second opinion the surgeon had obtained prior to the procedure from a fellowship-trained corneal specialist and the supportive evaluation of OMIC’s Claims Committee. Despite the absence of indications of preexisting keratoconus, the patient developed ectasia after LASIK. This development is consistent, the defense argued, with the incidence of keratoconus in the general population, which is approximately 1 per 2,000. Indeed, this patient may well have developed keratoconus without LASIK. Some felt that the ectasia in this case may have been related to a thicker than expected flap, which resulted in a postablation residual bed of less than 250 mm. These technical issues were not the basis of the jury’s plaintiff verdict, however. Instead, as they explained in interviews after the trial, the members of the jury felt that the approximately 100 cases performed

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by the surgeon did not adequately prepare him to handle this case. They were not swayed by the expert testimony that this known complication could have happened to any surgeon and awarded the plaintiff $944,000, which, after the addition of pretrial interest, resulted in an indemnity payment of $983,772.

Recent Significant Nonophthalmic Mutual Insurance Company Laser In Situ Keratomileusis Awards Large awards in refractive surgery are usually granted for economic reasons involving lost earnings and significant health care bills, as happened in the OMIC ectasia case just discussed. The jury believed that the plaintiff, an attorney, lost past and future wages despite the fact that visual acuity was near normal with contact lenses following penetrating keratoplasty. There have been at least four recent multimillion dollar awards involving LASIK cases. Two of these focused on the adequacy of the informed consent of patients with large scotopic pupils, and two involved post-LASIK ectasia.

Pupil Size The first multimillion dollar award involved a commercial airline pilot. Despite obtaining an excellent uncorrected visual acuity, he was initially granted a jury award of $4,000,000 (less $600,000 for the 15% fault attributed to him) based on his contention that he would not have agreed to have the surgery if he realized that night time glare and halos could make it hazardous for him to fly at night. Admitting that the standard informed consent mentioned this as a possibility, the plaintiff questioned the accuracy of the measurements of his scotopic pupils and the size of the optical zone delivered by the laser, which were subsequently found to be larger than the original measurements. The expert witness for the plaintiff initially stated that because the true optical zone of the laser was smaller than the 6.5 mm pupil size measured during his independent medical examination, the patient should have been consented differently. The jury agreed that the pilot should have been informed that his larger than normal pupils increased his risk and might interfere with his ability to fly. The case was appealed. The trial court granted a new trial because the plaintiff’s key expert changed his testimony on the size of the optical zone after the verdict. The Court of Appeals overturned the new trial, and the case was settled pending the appeal.3 The other pupil-related case resulted in a jury verdict for the plaintiff for $3,002,950. The plaintiff’s scotopic pupils were measured by a technician to be 5.5 mm, but subsequent measurements were 7.5 mm. The patient had a non– wavefront-based treatment in 2001 with a 6.5 mm ablation diameter. The plaintiff’s position was that he should have been warned that because of his large pupils he was at increased risk for night vision disturbances.4

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Post–Laser In Situ Keratomileusis Ectasia The plaintiff in the first post-LASIK ectasia case was a stockbroker who claimed loss of past and future earnings despite having adequate visual acuity with hard contact lenses. Preoperative topography in this case showed signs of form fruste keratoconus according to the plaintiff’s expert, who opined that the patient should have been informed that the surgery was contraindicated. The patient’s procedure took place in a commercial laser center; the abnormal topography was apparently not discussed by either the surgeon or the comanaging optometrist. The jury found in favor of the plaintiff and awarded $7,250,000—$4,500,000 in lost wages and $2,750,000 for pain and suffering.5 In the other case, the topography, pachymetry, slit-lamp examination, and family history were all normal. The defendant was a fellowship trained, nationally recognized corneal expert, as were the defense experts, who testified that the surgeon had met the standard of care. Nevertheless, the jury awarded the plaintiff $3 million. As in one of the OMIC cases described earlier, this patient may have been the 1 in 2,000 who was destined to develop keratoconus. In both instances, the LASIK surgery may have accelerated the progression.6

Literature Review of Malpractice Issues in Refractive Surgery Dr. Richard Abbott, OMIC Board Member and Chairman of the OMIC Underwriting Committee, was the lead author of a paper based on his analysis of OMIC’s first 100 PRK and LASIK claims.7 Dr. Abbott concluded in the study2 that [T]he chances for incurring a malpractice claim or lawsuit correlates significantly with higher surgical volume and a history of a claim or lawsuit. Additional risk factors that increase in importance with high surgical volume include physician gender, advertising use, preoperative time spent with the patient and co-management with optometrists.

Not explicitly stated in the article, but clarified in a subsequent interview, his goal was to obtain data to drive OMIC’s underwriting and risk management protocols so the company could continue to proactively reduce the risk of refractive surgery.7 Associating surgical volume and comanagement with quality of care was challenged in discussions and articles that responded to the study. Some ophthalmologists argued that analyzing the incidence of lawsuits per cases performed would indicate that high volume surgeons had a lower risk of suits given their vast experience with the procedure.7–9 Indeed, low volume surgeons in one study were shown to have a higher number of complications.10 Moreover, they felt that despite the number of surgeries performed, they, along with their staff, did spend adequate “chair time” with each individual patient. Dr. Abbott clarified that the study did not look at the relative risk per case, but instead the overall higher number of cases when compared with low volume surgeons.7 While he agreed that surgeons with less experience do indeed have higher complication rates, he explained that whether they are sued

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depends for the most part on how they handled the complication. Comanagement was associated with higher risk in relation to the volume; it was not an independent variable. The greater risk is due to the complexity of comanagement itself, he stated.

How to Minimize the Likelihood of Refractive Surgery Lawsuits A lawsuit is a traumatic experience, both emotionally and financially. To help ophthalmologists avoid claims and their distressing impact, OMIC has developed risk reduction materials and made them available on its website for use by all ophthalmologists. Risk reduction consists of managing patient expectations and proactively comanaging patient care.

Manage Patient Expectations First, ophthalmologists need to manage patient expectations by careful advertising, prudent patient selection, and patient-friendly informed consent. Advertising, including patient brochures and videos, must be truthful and professional, as well as consistent with the information provided during the informed consent process. An explanation of the rules governing physician advertising and an advertising review form are available in the Risk Management Recommendations section at of OMIC’s website.11,12

Patient Selection: Pupil Size The importance of the scotopic pupil size in predicting night vision complaints is confusing. Two recent studies by Schallhorn et al.13 and Pop and Payette14 failed to find that large scotopic pupils were predictive of night vision complaints. Other reports15,16 indicate that large scotopic pupils are associated with an increase in higher order aberrations and night vision complaints. Rather than wait for more studies to resolve the issue, manufacturers have opted to advise patients. Thus the latest patient information brochures on wavefront-based surgery from both Visx and Alcon warn of a potential association between large scotopic pupils and night vision difficulty. From a risk management perspective, if a patient has an unusually large scotopic pupil (greater than 6.5 mm), it would be advisable to discuss the potential increased risk of night vision complaints. Prospective patients should understand that although in most cases these improve with time, some patients have prolonged difficulty and may require drops to reduce pupil size to help alleviate their symptoms.17,18 The patient’s vocation and hobbies may be significant factors to consider. The OMIC’s sample consent form for LASIK includes a discussion of this issue.19

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Patient Selection: Ectasia From a liability perspective, the main issue with post-LASIK ectasia is whether there were any abnormal findings in the preoperative evaluation that could be considered a contraindication to the surgery. In effect, the defensibility of the case can come down to the interpretation of the topography. If the inferior cornea 3 mm below the center of the pupil is more than 1.5D steeper than the superior cornea 3 mm above the pupil, this may indicate form fruste keratoconus. In borderline cases, other tests may be helpful, including pachymetry over the steep area to see if it is thinner inferiorly than centrally, dilated retinoscopy looking for scissoring of the light reflex, and manual keratometry looking for subtle distortion of the mires. The history can also be important. A positive family history of keratoconus or unstable refraction, particularly changes in the amount or axis of astigmatism, can increase the suspicion that the patient may actually have early keratoconus. Findings such as these should be discussed with the patient, and LASIK should not be performed. Photorefractive keratectomy with proper informed consent can be considered as a safer option, but there are also cases of ectasia reported following it as well.20 The other potential risk factor in post-LASIK ectasia is leaving a residual bed of less than 250 mm. During the preoperative evaluation, surgeons should be very aware of the corneal thickness, depth of the planned ablation, and estimated flap thickness. Because the thickness of the actual flap can be considerably thicker than planned, intraoperative subtraction pachymetry should be performed, especially in any case where the corneal thickness and ablation depth might leave a residual bed less than 250 mm. If the intraoperative pachymetry shows that the 250 mm rule could be violated, the flap should be replaced without the excimer ablation. To address the potential patient safety and liability issue of post-LASIK ectasia, OMIC modified its sample LASIK and PRK informed consent documents to address this issue.21

Informed Consent Two specific issues that may need to be discussed during the informed consent process have just been addressed. This topic is so important that another chapter of this book is devoted to the general subject of informed consent, and we here want to emphasize a few other aspects of the consent process for refractive surgery that deserve special emphasis. First, the timing of the consent is important. Ideally, the informed consent is initiated by the surgeon, but in reality this rarely happens in a busy refractive surgery practice. During the initial consultation the surgeon or a staff member should emphasize that PRK and LASIK are both surgeries and like all surgeries carry some risk. Many patients feel that because the surgery is performed with a laser it is not “real surgery.” Advertising that refers to “procedures,” excludes any mention of risks, and describes subsequent surgeries as “enhancements” instead of retreatment only reinforces this misconception.

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Infection and the rare possibility of significant loss of vision should be mentioned because patients understand that an infection is a possible complication of all surgical procedures. The staff should also explain and demonstrate that under- and overcorrections are always possible even if they can usually be improved by a retreatment. If the patient has anything unusual, such as large scotopic pupils, need for a high correction, high astigmatism, or borderline dry eye, the implications of these findings should be discussed and documented in the record. Unusual complications such as buttonhole flaps, haze, and irregular astigmatism are generally covered in the written informed consent. If a retreatment is indicated, informed consent for it should be obtained. See the OMIC sample retreatment consent form.22 The written consent form should be given to the patient to take home well before the surgery. The patient should be encouraged to read it with friends and/or family members and to call with any questions so that misapprehensions can be cleared up. It is also wise to put a note in the record that the risks and benefits of the procedure were discussed with the patient and all questions were answered, especially if the patient has any findings that indicate an increased risk for complications. If necessary, the consent can then be signed on the day of surgery provided (1) the surgeon has already had a consent discussion with the patient and (2) the patient has not received any sedation.

Proactively Comanage Patient Care Many cataract and refractive surgeons comanage patients. Ophthalmic claims experience indicates that this method of care delivery can increase patient safety and liability risks if not properly performed. “Comanagement of Ophthalmic Patients”22 is a useful resource. It addresses scope of practice issues, how to select and credential comanagers, training and protocols, informed consent for comanagement,23 communication, availability, and supervision. The driving principle should always be patient safety, as determined by the operating surgeon, who has the ultimate responsibility for determining the patient’s candidacy, obtaining the informed consent, and recognizing and managing complications.

Conclusion Once performed by only a minority of ophthalmologists and greeted with skepticism by doctors and patients alike, LASIK is now a household word, and many cataract surgeons who insert multifocal intraocular lenses are considering performing it for the first time as part of biopic treatment packages. Refractive surgeons can improve patient safety and reduce their liability exposure by keeping their skills current and by adopting the risk management measures gleaned from the claims experiences of their colleagues.

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References 1. ISRS/AAO Survey. 2. Abbott, RL, Ou RR, Bird M. Medical malpractice predictors for ophthalmologists performing LASIK and photorefractive keratectomy. Ophthalmology 2003;11:2137–2146. 3. Post v. University Physicians, Inc. 4. Larson v. Weis, M.D. and N. Refractive Surgery Ctr., 21 Nat. J.V.R.A. 4:C6 (Minn. Dist. 2006). 5. Maggie Haberman. He wins $7.25M In Botched Eye Surgery Suit. New York Daily News (July 31, 2005). 6. $3 million awarded for botched LASIK eye surgery. Lawyers USA, August 14, 2006, citing Gropack v. TLC Laser Eye Centers; June 28, 2006; Nassau County Supreme Court, Mineola, N.Y.; Judge Roy Mahon. 7. Smith SE. Deciphering medical malpractice predictors. Cataract Refract Surg Today 2004;4(2):45–53. 8. Donnenfeld ED. Surgical volume and patient care. Cataract Refract Surg Today 2004;4(2):54–56. 9. Hoffman J. Study turns up the “volume.” Ophthalmol Manage 2004;Apr:146–148. 10. Stulting RD, Carr JD, Thompson KP, et al. Complications of LASIK for the correction of myopia. Ophthalmology 1999;106:13–20. 11. Menke AM. Advertising medical services. Available at: http://www.omic.com/resources/ risk_man/forms/medical_office/AdvMedServices.rtf. 12. Menke AM. Review of advertisement for medical services. Available at: http://www.omic. com/resources/risk_man/forms/medical_office/AdvReviewForm.rtf. 13. Schallhorn SC, Kaupp SE, Tanzer DJ, et al. Pupil size and quality of vision after LASIK. Ophthalmology 2003;110:1606–1614. 14. Pop M, Payette Y, Risk factors for night vision complaints after LASIK for myopia. Ophthalmology 2004;111:3–10. 15. Chalita MR, Chavalia S, Xu M, et al. Wavefront analysis in post-LASIK eyes and its correlation with visual symptoms, refraction, and topography. Ophthalmology 2004; 447–453. 16. Maguen E, Schlanger J, Wong J, Salz J. Relationship between total aberrations (RMS) and pupil size in ametropic eyes with the LADAR wave system [abstr]. Invest Ophthalmol Vis Sci 2003;44E. 17. Randazzo A, Nizzola F, Rossetti L, et al. Pharmacologic management of night vision disturbances after refractive surgery, results of a randomized clinical trial. J Cataract Refract Surg 2005;31:1764–1772. 18. McDonald JE II, El Moatassem Kotb AM, Decker BB. Effect of brimonidine tartrate ophthalmic solution .02% on pupil size in normal eyes under different luminance conditions. J Cataract Refract Surg 2001;27:560–564. 19. Informed consent for LASIK. Available at: http://www.omic.com/products/bus_products/ downloads/forms/LASIKconsent121404.rtf. 20. Malecaze F, Coullet J, Calvas P, et al. Corneal ectasia after photorefractive keratectomy for low myopia. Ophthalmology 2006;113:742–746. 21. Informed consent for LASIK retreatment. Available at: http://www.omic.com/products/bus_ products/downloads/forms/LasikRetreatmentConsent.rtf. 22. Menke, Anne M. Comanagement of ophthalmic patients. Available at: http://www.omic.com/ resources/risk_man/forms/medical_office/Comanagement%20of%20Ophthalmic%20Patient s.rtf. 23. Consent for comanagement after eye surgery. Available at: http://www.omic.com/resources/ risk_man/forms/patient/ComanagementConsent.rtf.

Chapter 21

Retina and Vitreous Marvin F. Kraushar and Peter H. Morse

Vitreoretinal Risk Factors for Ophthalmologists Comprehensive ophthalmologists and vitreoretinal specialists must be particularly diligent when managing patients with vitreoretinal diseases. Practically every vitreoretinal diagnosis has the potential for severe visual impairment or blindness. It can be further expected that a significant number of patients will experience profound, irreversible visual loss as a result of their disease before or despite successful treatment. Our best efforts cannot prevent a percentage of the treatment we provide from being unsuccessful. The devastating visual prognosis of most of vitreoretinal diseases virtually ensures a poor visual result after failed treatment.1 Patient education regarding risks during the informed consent discussion thus acquires even greater significance when managing patients with these diseases. Mention should be made of the possibility of no visual improvement or further vision loss despite successful therapy. It is of paramount importance that an optimal physician–patient relationship is established and nurtured throughout the course of treatment. This is often difficult because of the abrupt manifestation of symptoms of many vitreoretinal diseases, such as central retinal artery occlusion, retinal tear, retinal detachment, endophthalmitis, and intraocular foreign bodies, which usually require expeditious treatment the day of the first visit. In these circumstances, there is insufficient time to establish as strong a relationship as would be possible prior to an elective procedure. Patient apprehension in such situations can make comprehension of pertinent details less reliable.

Vitreoretinal Specialist Consultations Vitreoretinal specialists are at risk for litigation by patients seen in consultation who feel they have an unsatisfactory result from previous treatment by a comprehensive ophthalmologist. A significant number of these patients sue the consultant despite receiving no treatment.1 Many of the initial diagnoses are complications of appropriate treatment by the referring physician. Common examples are retinal

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detachment with pseudophakia, endophthalmitis, retained lens fragments after cataract surgery, cystoid macular edema, suprachoroidal hemorrhage, and dislocated intraocular lenses. These patients may understandably harbor some inherent resentment before they encounter the vitreoretinal specialist.1 Some suits may be stimulated by a physician’s attempt to escape from an unfavorable result. This may cause erratic behavior on the part of the physician, varying from hostility to excessive apology. The litigation may also be comprehensive against all individuals and institutions having contact with the patient during the alleged mishap. Such suits often have the intention of dropping the claim against the vitreoretinal surgeon if during discovery it is demonstrated that he or she was not liable. Unfortunately, such a claim will cost the medical malpractice insurance company money to defend and if the expenses are too great the sum may be added to the vitreoretinal surgeon’s claim total and may thus affect future premiums.

Allegations Most claims for negligent diagnosis (failure or delay) of vitreoretinal disease are brought against comprehensive ophthalmologists. Although allegations of negligent diagnosis are the most common reason for litigation in other ophthalmic subspecialties and most other specialties,2–5 it is a relatively uncommon cause of litigation against vitreoretinal specialists.1,6 This is probably because of the greater experience of vitreoretinal consultants in the diagnosis of these problems and also because the patient is initially seen by a comprehensive ophthalmologist before the referral is made, thus alerting the consultant to the possible diagnosis. Most allegations against vitreoretinal specialists are for negligent treatment.1,6

Appointments Office staff must be well educated regarding symptoms of possible emergency situations to ensure that patients complaining of these symptoms are given prompt appointments. When in doubt, the staff should have clear instructions to speak with the physician. If a new or established patient with possible emergent symptoms calls the office and refuses a prompt appointment, the procedure for informed refusal should be followed. This means warning the patient of the risk of not being seen promptly and documenting the warning with a note in the record as well as sending written notice of the risk of not being seen by return receipt mail. Technically the physician–patient relationship is not established until the patient is seen by the doctor. However, in today’s litigious society, it is not difficult to imagine a clever attorney suing on behalf of a new patient calling about the sudden, recent onset of flashes and floaters, refusing a prompt appointment, and developing

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a retinal detachment. The same procedure should be followed for patients missing postoperative appointments or appointments for continuing therapy for cystoid macular edema, photodynamic therapy, and other diseases requiring subsequent treatment.

Diagnostic Problems Medications and Tests Documentation of informed refusal is indicated for patients who do not agree to bilateral pharmacologic mydriasis. Patients often use the excuse, “I have to go back to work when I leave the doctor’s office.” Bilateral intravenous fluorescein angiography may also be refused, and this also requires warning of risks with documentation. Warnings about the potential difficulties that may be encountered should be given and documented in the medical record when a patient leaves the office in a state of partial or complete pharmacologic mydriasis. The documentation can be easily accomplished by means of a check-off box or an ink stamp. Reversing drops and/or disposable tinted glasses can be helpful. Although ophthalmologists are well aware of the risk that these patients may suffer an injury because of a “slip and fall,” there is a new, more far-reaching risk about which to be concerned. A Massachusetts court ruling in 2006 involved a patient on hypoglycemic medication who suffered an episode of low blood sugar while driving and hit and injured a motorcyclist who eventually sued the physician. There was no documentation in the record of the physician warning his patient, the auto driver, regarding this risk. The court ruled the physician has a “special duty” when “an individual does something that creates or increases the risk that a person will harm a third party.”7 It seems reasonable to assume that this “special duty” may some day be applied to an ophthalmologist who fails to warn and to document the warning to a patient leaving the office after pupillary dilation regarding the risk of injuring a third party in an auto accident. Informed consent is appropriate and advised for intravenous fluorescein angiography, because significant problems can occur. It is of paramount importance that the tip of the needle be monitored by gentle palpation during injection of fluorescein to ensure that extravascular accumulation of dye is promptly diagnosed in time to stop the injection. There have been successful lawsuits against physicians because of skin sloughs from extravascular dye reactions that required plastic surgery. It is both appropriate and compassionate to include a warning about the postangiogram change in color of the skin and urine, which can be a shock to the uninformed patient or companion. Test results should be promptly reported to and discussed with the patient, and the conversation should be documented. This is a good risk prevention measure, and it also improves the physician–patient relationship.

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Retinal Tear/Detachment The most frequent error in the diagnosis of ocular diseases that leads to litigation is delay or failure to diagnose a retinal tear or detachment.2–4 These suits are usually against comprehensive ophthalmologists.6 Typical problems revealed by review of claims include failures to dilate the pupil for ophthalmoscopic examination of the ocular fundus, examine the peripheral retina including the ora serrata, to look for retinal pigment cells in the anterior vitreous, and to document the examination by making a drawing in the record. Attempting to convince a jury that a dilated ocular fundus examination was done merely by noting it in the chart in the absence of an actual drawing seriously risks jeopardizing the jury’s confidence and credibility in the ophthalmologist. A time-saving practice is to have a check list or ink stamp in the chart where the physician can indicate the pupil was dilated and what instruments were used for the examination, such as direct or indirect ophthalmoscope and slit lamp with contact or noncontact precorneal lenses. It is important to remember that the physician’s performance is measured against the standard of an average physician. Provided the appropriate diagnostic steps have been taken, missing a retinal break may be excusable. There have been claims of failure to diagnose a retinal detachment in a patient complaining of a progressing peripheral visual field defect and an apparently normal ocular fundus examination. If a visual field examination had been obtained, it would have alerted the physician to a flat or partial retinal detachment. A common example of a claim for failure to diagnose a retinal tear or detachment is that of a patient complaining of floaters and flashes of light who on examination has a posterior vitreous detachment with no apparent retinal breaks. Several weeks later the patient sees a second ophthalmologist because of persistent symptoms, and a retinal detachment is found. Under most circumstances it will be difficult for a plaintiff’s expert to say “within a reasonable degree of medical certainty” that there was a missed retinal break on the visit to the first physician, because the symptoms of a retinal tear and vitreous detachment can be similar. Furthermore, posterior vitreous detachment may be progressive, and the tear may occur at a later time than that of the initial symptoms. A retinal break may be present for many weeks before a detachment develops. If the flap of a horseshoe break in attached or detached retina is shriveled or if the posterior edge of the break is rolled, it is strongly suggestive that the break is not fresh. One or more demarcation lines in an inferior retinal detachment is a sign of chronicity. Intraretinal cysts are also indicative of a longstanding detachment. In the absence of these findings, dating the occurrence of a retinal tear cannot be accurate purely on the basis of symptoms. If the examiner is confident there is neither a tear nor a detachment, the patient should be told to return immediately if the symptoms increase, and this warning should be documented. The bottom line for risk prevention and for optimal patient care in this situation is as follows: if the examiner cannot feel completely confident in ruling out a tear or detachment in the eye of a symptomatic patient by means of the indirect ophthalmoscope with scleral depression, a contact or precorneal lens, and visual fields, the patient should be

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referred to a vitreoretinal specialist immediately. “A request for the opinion of another physician does not reflect badly on your competence. On the contrary, it shows your honesty in dealing with the situation and your concern for the patient’s welfare.”8

Endophthalmitis Practically all endophthalmitis claims are brought against cataract surgeons for failure or delay in diagnosis. Occasionally the operating vitreoretinal surgeon is also sued for negligent treatment of the endophthalmitis. Despite the myriad claims in the summons and complaint, these lawsuits almost always involve the allegation of a postoperative evening or late night telephone call by the patient to the surgeon or covering physician claiming that the patient made specific complaints that were consistent with endophthalmitis and that the physician failed to see the patient in a timely manner, thus depriving the patient of the opportunity for a better result. Some cases involve inadequate or no coverage when the primary physician is not available. In the final analysis it becomes a question of contradictory statements by the parties involved. The problem for the defense is almost always the failure of the on-call physician to document the conversation by the following morning. Very often no note is made in the record for several weeks or until the lawsuit is instituted at which time the on-call physician writes a lengthy document attempting to note every complaint of the patient and every patient response to the physician’s questions. Juries are understandably not likely to put much faith in a document written so long after the fact, because it is unreasonable for them to expect the physician’s recall can be so exquisitely accurate so long after the occurrence. The best and most powerful defense to an allegation of not seeing the patient is putting contemporaneous, detailed documentation in the chart by the following morning. It will probably discourage the plaintiff’s expert from advising a lawsuit, and it will certainly impress a jury favorably. It is logical to assume the reason many ophthalmologists do not remember to document these conversations is because they occur after office hours. The patient’s chart is unavailable, and often the patient complaints may seem minor. The telephone call may be from another physician’s patient with whom the on-call doctor is unfamiliar. Fortunately, when there is no reliable proof as to what was or was not said by either party, the jury tends to believe the ophthalmologist. Regardless of the severity of the injury, it is often difficult for the patient to prevail in these claims.

Choroidal Melanoma The frequency of claims for misdiagnosis of lesions resembling melanoma or failure to diagnose a malignant choroidal melanoma is significantly less than that of previous

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years because of modern diagnostic techniques. Suspicious lesions, such as nevi or subretinal hemorrhages, should be carefully documented and monitored. If there is any doubt as to the diagnosis, patients should be referred for vitreoretinal consultation. Photographs in the patient’s chart are helpful for comparison on subsequent examinations. A more detailed discussion on this topic is presented in Chapter 17.

Miscellaneous Claims of negligent diagnosis for prevalent vitreoretinal diseases, such as diabetic retinopathy, age-related macular degeneration, and retinal vascular disease, are uncommon.1

Medical Treatment Topical Medications Lawsuits involving treatment with topical medications are uncommon. The usual precautions, especially intraocular pressure monitoring and observation for cataract, should be taken and documented for prolonged treatment with corticosteroids. It is good practice not to prescribe antibiotics unless absolutely indicated. The appropriate tests should be ordered and the results documented for patients during extended therapy of any chronic problem if there is a risk of harmful local or systemic effects from the medication.

Periocular/Retrobulbar Medications The usual precautions should be observed when delivering any anesthetic or therapeutic medication by injection anywhere around the exterior of the eyeball. This is discussed in Chapters 10 and 13.

Intraocular Medications The recent off-label use of intravitreal corticosteroids for macular edema and antivasoproliferative or other drugs for choroidal neovascularization has raised new questions about medical ethics.9 Because the safety and efficacy of some of these medications have not been tested by well-designed clinical trials, an appropriate informed consent is indispensable with respect to ethics and risk prevention.

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Possible deleterious side effects, which may occur over a longer time, have also not been determined. This topic is covered in Chapter 13.

Laser Treatment for Diabetic Retinopathy Background diabetic retinopathy, or proliferative diabetic retinopathy, is the most common retinal problem treated with laser. Lawsuits by patients undergoing focal, grid, or panretinal laser have been brought for every possible reason, including failure to treat, delay in treatment, initially treating the incorrect eye, and negligent treatment. Suits have been initiated for continued vision loss following treatment, failure to improve vision, and alleged decreased vision due to negligent treatment.2 All of these allegations are indicative of the need for an effective informed consent discussion. Inadequate panretinal photocoagulation over an appropriate time interval allowing proliferative diabetic retinopathy to progress is not uncommon. Such delay may allow development of tractional retinal detachment and other complications requiring vitrectomy and unnecessary loss of vision that might have been obviated with adequate and timely treatment. Cases of a patient seeking the opinion of a second ophthalmologist following protracted neglect by the initial ophthalmologist have prompted attorneys to attempt to sue the second ophthalmologist because of the extensive advanced disease.

Laser and Medical Treatment of Age-Related Macular Degeneration Litigation has been brought by patients with age-related macular degeneration for many of the same reasons as for diabetic retinopathy. The poor visual prognosis for most cases of exudative age-related macular degeneration, problems unique to photodynamic therapy, and anti–vascular endothelial growth factor treatment with the frequent need for repeated treatment make an effective informed consent discussion essential for patient education. Many of the newer anti–vascular endothelial growth factor or off-label medications have shown a short-term relative benefit but no proven long-term success. What may seem a relative triumph in preservation or restoration of vision to the ophthalmologist may not represent useful vision to the patient and lead to dissatisfaction.

Laser Treatment of Arterial and Venous Retinal Vascular Diseases Litigation for laser treatment for retinal vascular disease is uncommon. This may be related to the relatively better visual prognosis of this group of diseases.

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Laser/Cryotherapy Treatment of Retinal Tears Failure or delay of treatment, negligent treatment, and improper choice between cryotherapy or laser has been alleged. It is important to discuss the choice of the therapeutic modality and the reason for not using others in the informed consent discussion.

Treatment of Central Retinal Artery Occlusion There have been lawsuits for delay or failure to treat as well as negligent treatment of central retinal artery occlusion (CRAO) despite the fact that there is significant controversy regarding the timing of intervention and the efficacy of the therapy. Accurate assessment of pretreatment visual acuity is not always dependable, because some patients are so shocked by the sudden, severe loss of vision they may assume the eye is blind and do not look for residual vision. Some patients with a patent cilioretinal artery may eventually discover an island of vision and falsely assume it is the result of treatment. For risk prevention purposes as well as for optimal patient care, it is advisable to go through the steps of treatment for most patients who have been symptomatic for less than 24 hours. There have been lawsuits alleging failure to diagnose cranial arteritis in elderly patients with CRAO. While CRAO has been reported secondary to pressure on the eyeball from improper facial support for patients undergoing spine surgery in the prone position, it can also occur in patients during lengthy prone positioning for surgery even with proper facial support. In these instances, if proptosis of the globe is noted in the recovery room the ophthalmologist has an opportunity for risk prevention by decompressing the orbit.10 Hypertensive patients often with diabetes mellitus or papilledema have developed CRAO and optic atrophy because the blood pressure was excessively lowered for prolonged periods during general anesthesia.

Treatment of Rhegmatogenous Retinal Detachment Allegations of delay in treatment of rhegmatogenous retinal detachment (RRD) can be problematic for the defense. Although there are pilot studies suggesting similar visual results in detachments repaired after 1 day and after 7–10 days of macular involvement, there are no data from randomized, controlled studies for compassionate reasons. The evidence-based data for this situation are not extensive. Furthermore, good fellow eye vision and the element of denial are but some of the confounding problems in patient awareness of the symptoms of retinal detachment and dating the actual onset of macular involvement. It appears advisable not to delay treatment any longer than is necessary not only for humanitarian reasons but also because it can be

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difficult to convince jurors, many of whom believe that most retinal detachments are emergencies that a longer delay did not affect deleteriously. Pneumatic retinopexy, scleral buckle, and pars plana vitrectomy are used to repair rhegmatogenous retinal detachments. Lawsuits have been brought for improper choice of technique. Patients have also sued for alleged improper choice of thermal reaction among diathermy, cryotherapy, and indirect laser. It is advisable to involve the patient in the choice of technique and the reasons for the surgeon’s choice. The negligent use of intraocular gas with vitrectomy has resulted in devastating loss of vision in some patients. This is usually caused by excessive postoperative intraocular pressure, which may occur if an expansile percentage of gas is prepared by mistake or if an excessive volume of gas is injected. Failure to evaluate the intraocular pressure at the conclusion of a fluid–gas exchange or following an intraocular air or gas injection may also allow dangerous elevation of the intraocular pressure. It is the surgeon’s responsibility to educate the patient receiving intraocular gas regarding head positioning, prohibition of air travel, and nitrous oxide use during anesthesia for emergency surgery. These warnings must be documented, preferably with a patient signature. Such documentation would have been a strong defense in a claim initiated by a patient who had a pneumatic retinopexy and lost light perception from obstruction of the central retinal artery during elective spine surgery with nitrous oxide anesthesia only 3 days later. The patient never told the vitreoretinal surgeon about the planned spine surgery. He never told the spine surgeon and the anesthesiologist about the gas, and they never asked. Contemporaneous documentation is often the difference between winning and losing these lawsuits. Patients requiring one or more pars plana vitrectomies for proliferative vitreoretinopathy can elicit great sympathy from a jury as they recall their multiple procedures, weeks of face-down positioning, pain, and suffering. These experiences in combination with a poor visual result and the unfortunate cosmetic appearance of a hypotonous eye can bring a large monetary award in the event of a plaintiff verdict for a claim of negligent surgery. For these reasons an effective informed consent is a sine qua non. A caring, sympathetic vitreoretinal surgeon can assuage the anxiety and resentment of most of these patients.

Pars Plana Vitrectomy for Problems Other than Rhegmatogenous Retinal Detachment Patients with more serious problems affecting vision, such as diabetic traction retinal detachment, choroidal neovascular membranes, acute retinal necrosis, and central retinal vein obstruction, typically have had poor vision for a significant period of time and thus may be relatively resigned to the state of monocular vision. If these patients participate in an effective informed consent discussion, litigation should be less likely in the event of minimal visual improvement or failed surgery. Patients experiencing poor monocular vision for only a brief period of time, as in endophthalmitis or

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rhegmatogenous retinal detachment, are understandably concerned and usually less prepared to cope with the concept of permanent monocular vision loss. These patients require all the caring the surgeon and staff have to offer. The necessarily abbreviated preoperative interval for development of the physician–patient relationship further compounds the problem. Patients with relatively good preoperative visual acuity, as often seen with epiretinal membranes, macular holes, retained lens fragments after cataract surgery, and subluxated intraocular lenses, can be expected to have higher expectations for good vision and greater disappointment if it is not achieved. Because these procedures are relatively more elective, informed consent is of paramount importance. Documentation of the significant risk of postoperative cataract formation in phakic patients is essential.

Treatment of Intraocular Tumors Treatment of intraocular tumors is discussed in Chapter 17.

Treatment of Retinopathy of Prematurity Retinopathy of prematurity has perhaps the highest risk of litigation of any vitreoretinal disease. A large number of these young patients will have little or no vision despite optimal treatment, and treatment failures are not uncommon. Furthermore, in many states the statute of limitations can run for 15 to 20+ years, and thus many physicians are at risk of litigation in their retirement. Because awards for malpractice claims have escalated dramatically over the years, it can be expected that the award for a claim closed 15 to 20 years after the treatment will exceed the upper limit of the physician’s insurance coverage by a significant margin. A classic example of this is an ophthalmologist who was the only retina surgeon to practice in his area in the late 1950s. He volunteered to see the premature infants at no charge, as at that time health insurance for newborns was uncommon. Three years before he retired he was sued by a patient who was about to reach the age of 21 at which time the statute of limitations was to expire. The lawsuit alleged negligence when the baby was born in 1961 at which time the typical insurance coverage was $10,000. The claim, 20 years later, was for 2 million dollars. The lawsuit was eventually dropped but not before the retina surgeon lost 35 pounds and practically all of his hair. When these considerations are combined with the facts that management of this disease is time consuming and few if any of these patients have insurance, it seems unjust that the treating physicians are not accorded some form of immunity from litigation. This is especially true when the alleged complication for which the ophthalmologist is being sued occurred some years after he or she last examined the patient. Litigation in the management of this condition is discussed in Chapter 19.

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Conclusion The poor visual prognosis for most vitreoretinal diseases carries a significant risk for reduced vision even with successful management. Vitreoretinal diseases are thus high risk diagnoses for both the patient and the treating physician. Effective risk management for the treatment of these patients begins with educating the patient through the process of informed consent, which should include the possibility of complications and of visual acuity that may be less than expected by the patient. A thorough explanation makes it more likely that the patient will be satisfied with or accept the final result. Complete contemporaneous documentation of warnings, prognoses, reciprocal patient responsibilities, and possible complications is powerful evidence in the event of litigation. If a competent, caring, sympathetic physician takes these steps, the risk of litigation will be effectively minimized.

References 1. Kraushar MF. Medical malpractice experiences of vitreoretinal specialists. Retina 2003;23:523–529. 2. Sorrel AL. Failure to diagnose is the No.1 allegation in liability lawsuits. AMA News 2006;49:8–9. 3. Kraushar MF, Turner M. Medical malpractice litigation in ophthalmology: the New Jersey experience. Ophthalmic Surg 1986;17:671–674. 4. Bettman JW. Ophthalmology: The Art, the Law and a Little Bit of Science. New York: Aesculapius; 1977:75. 5. Kraushar MF, Robb JH. Ophthalmic malpractice lawsuits with large monetary awards. Arch Ophthalmol 1996;114:333–337. 6. Kraushar MF. Medical malpractice litigation in the management of vitreoretinal diseases. Arch Ophthalmol 1987;105:187–190. 7. Arsenault v. McConarty, 21 Mass. L. Rptr, 2006;500. 8. Alton WG. Malpractice: A trial lawyer’s advice for physicians. Boston: Little, Brown; 1977:56. 9. Holekamp NM. The ethics of Avastin. Retina Times 2006;16:32. 10. Leibovitch I, Casson R, Laforest C, Dinesh S. Ischemic orbital compartment syndrome as a complication of spinal surgery in the prone position. Ophthalmology 2006;113:105–108.

Chapter 22

Uveitis C. Stephen Foster

Introduction The provision of good health care is the goal and raison d’etre of all physicians. Meeting the appropriate standard of care goes a long way towards achieving a good medical outcome. Compliance with the applicable standard of care also goes far toward building rapport and goodwill with one’s patients. Good care and goodwill are laudatory goals in and of themselves. Additionally, the achievement of these goals will stand the physician in good stead in those instances in which poor medical outcomes occur despite appropriate care. Poor medical results can and do occur because of the inexact nature of medicine. Disability and death cannot be avoided and occur without negligence despite the best efforts of physicians exercising their best judgment. The purpose of this chapter is to discuss ways to implement good care for the management of patients with uveitis and improve and build a meaningful physician–patient relationship. In so doing, brushes with the legal system (whether a claim, a lawsuit, or a Board of Registration in Medicine complaint) may incidentally be avoided.

Documentation The importance of completeness of documentation cannot be overstated. It is of paramount importance in the management of patients with uveitis. At the same time, not everything said or done can be documented. For instance, it would be impossible to document all negatives. It would, however, be judicious to document negatives that are significant to diagnosis such as a negative finding that causes one to lean toward a diagnosis that is benign and away from a diagnosis that is life threatening. As in many aspects of medicine, balancing and exercise of appropriate judgment are required. It is sometimes said that if it is not documented, it was not done. Obviously, this is not always the case. You will always be able to testify to what was done regardless

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of whether it was documented. Under the law, oral testimony and documentary evidence are theoretically entitled to equal weight. As a practical matter, however, documentation of treatment provided wins out in virtually all instances in which the plaintiff alleges treatment was not provided. Of all the things that can be a disadvantage to a physician who is accused of negligence, failure to adequately document in the patient’s medical record is by far the most commonly damning element. In the face of good documentation in the medical record, the sole argument then left to the complainant is that the record has been altered. Of course, one of the worst things that could ever be done from a medicolegal perspective is alteration of the record. This must never occur. Rather, the record should be well documented contemporaneously. If additional information is necessary and/or appropriate, the further documentation should be clearly labeled as an addendum.

Detailed Patient Questionnaire To properly treat your patient with uveitis, you must take a full and complete history. A detailed patient questionnaire allows you to learn more about your patient and permits further insightful questioning of the patient at the initial visit and/or subsequently. We have used an extensive questionnaire at the Massachusetts Eye Research and Surgery Institute with special customization for inflammatory disease that I designed many years ago, the use of which, along with follow-up questioning, provides by far the greatest source of diagnostic leads of any of our activities and also demonstrates to the patient our effort in eliciting further significant information. The more you know of the patient’s medical history and family medical history, the better the position from which you are able to consider various diagnoses and differential diagnoses and the better documented your records are regarding the quality of your patient care efforts. For instance, a family history of certain conditions may place the patient at greater risk for such conditions and require the ophthalmologist to discuss said greater risk when advising the patient of possible diagnoses and/or treatment options. For example, it is now clear that the child with juvenile idiopathic arthritis–associated uveitis has a greater risk of an especially stubborn course of disease if there is a family history of psoriasis. Knowing this, both doctor and parents may be motivated to advance such a child to steroidsparing immunomodulatory therapy sooner rather than later in an effort to induce a steroid-free durable remission and avoid development of cataract or glaucoma or vision loss from retinal damage from recurrent or chronic inflammation. A detailed questionnaire, history, and initial examination build the foundation on which future treatment rests. Time and effort spent at this stage are not only appropriate and indicated but help to establish the requisite rapport with the patient. While you are evaluating the patient for necessary care, the patient is likewise evaluating you and your manner of caring, noting, for example, that you have reviewed the questionnaire that they completed prior to their encounter with you

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and noting that the information there is important to you, stimulating you to inquire further into certain responses on the questionnaire.

Chief Complaint and History of Present Illness Three things are required at this point in documentation of the chief complaint and the history of the present illness: detail, detail, detail. The time of onset of presenting symptoms as well as any change in symptoms prior to the time of the first visit when the formulation of a diagnosis and treatment plan are developed may all be critical to diagnosis and treatment as well as defense of the critical diagnosis and treatment plan. Whether the signs and symptoms are bilateral and the intensity of the signs and symptoms may also prove determinative in the patient’s care as well as in the courtroom. The presence or lack of nonvisual complaints should also be documented where important to diagnosis or to exclusion of diagnosis. For instance, documentation that the physician inquired about the presence or lack of general malaise or the presence or lack of jaw claudication is important in that these symptoms may be significant to the diagnosis or exclusion of the diagnosis of giant cell arteritis.

Review of Systems: Use of a Questionnaire The written questionnaire or template is a wonderful starting point. A start, however, is all that it actually is. Questionnaires and templates are a beginning of the thought toward the goals of diagnosis and treatment, which are far down the road from these limited tools. In certain cases, the review of systems may not require questions beyond the routine of the questionnaire. By necessity, the questionnaire and template, however, cannot encompass all aspects of review of systems. Thought must be given on occasion to items not contained on the questionnaire or template. This, as well as the patient rapport building aspect of taking the medical history, is why it is important for the physician to be willing and eager to think beyond and outside the box of the questionnaire and template.

Medications All of the patient’s medications need to be documented. The patient’s medications may lead to questions regarding history that otherwise may never have been asked. Dosage and frequency must also be recorded. For instance, the adequacy of the medication to accomplish the desired goal can be properly assessed only if the dosage and frequency are known. Interaction of medications must also be considered before a medication can be appropriately prescribed by an ophthalmologist.

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Examination: Eye and Otherwise The record should reflect all aspects of the eyes that are examined. All other aspects of the examination should also be reflected in the records so as to document the findings considered by the ophthalmologist. For example, for the patient with a history of recurrent uveitis with a review of systems questionnaire indicating that the patient has an episodic itchy, scaly rash on leg or scalp or elbow may prompt the ophthalmologist to consider psoriasis as a possible entity associated with the patient’s uveitis. An examination of the patient’s fingernails may disclose tiny punctate pits; these should obviously be documented in the medical record. Even if nail pitting is not detected, documentation of that negative extraocular finding is equally worthy of documentation.

Formulation of a Differential Diagnosis It is important to document not only the leading diagnosis or impression but also the other diagnoses in the differential. Consideration should always be given to testing and/or follow up for any potential diagnosis that is life, limb, or vision threatening. Be prepared to justify why a test or follow up was not done to rule out these types of potential diagnoses. For instance, it may be that the potential diagnosis was so remote that further testing or examination was not indicated. For example, although the patient with uveitis and associated retinal vasculitis could have Wegener’s granulomatosis as the underlying cause of these findings (and antineutrophil cytoplasmic antibody testing is easy and appropriate to request), chest and sinus computed tomography scanning may represent overreaching defensive medical testing in the absence of any sinus or chest symptoms on review of medical systems in the mind of even the most prudent physician, and so he may choose not to do such testing.

Formulation of a Plan: Laboratory Tests, Referral, and Treatment The record needs to reflect what the ophthalmologist considered in formulating a plan. Documentation should reveal the thought process as to laboratory tests, referral, and treatment. If laboratory tests and/or referral were considered but not ordered for the time being, in certain cases it may be appropriate to document the reasons for delay or for not doing such at all. For example, the patient with uveitis with the greatest concentration of cellular activity in the vitreous might be considered potentially to have central nervous system–intraocular large cell lymphoma, with neurology consultation and vitreal biopsy as part of the plan if fluorescein angiography, electroretinography, and HLA-A29 testing do not disclose that the

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patient has all of the features that speak more strongly for the diagnosis of birdshot retinochoroidopathy. Thus, the risks and the expense to the patient of the more invasive testing are appropriately deferred until the noninvasive studies have been completed. However, the documentation has clearly demonstrated the physician’s thought processes and in particular that he has considered the possibility of lymphoma and plans to pursue that possibility in the event that the noninvasive studies are negative.

Diagnosis After consideration of the patient’s history, review of systems, examination, tests, and laboratory results, what is the most likely diagnosis? What are the other possible diagnoses in order of most likely to least likely? What is the worst case scenario? Are additional tests, follow-up examination, or referral indicated to attempt to avoid vision loss or worse? Does the record reflect your thought process? Can you defend your thought process from the record or otherwise? Asking yourself these questions now may avoid your being asked these questions later by the patient or a representative of the patient.

Advice to Patient In treating patients, the prudent and caring ophthalmologist should advise his patient of the differential diagnoses along with the signs and symptoms of such, particularly when a differential diagnosis may have devastating consequences. For instance, a patient may have what appears to be a comparatively benign condition, such as a retinal tear. The condition, however, may be a precursor to a detached retina. Accordingly, the patient must be fully advised as to the initial signs and symptoms of a detached retina in order that the patient may respond in a timely way to receive the necessary treatment and avoid vision loss.

Discussion of Potential Risks and Complications Often, the patient is anxious and overwhelmed by the potential diagnoses, treatment options, and possible outcomes. In these circumstances, the patient does not always hear and retain what is being discussed and/or “filters” the discussion in a light most positive for the patient’s prognosis. Given that lack of informed consent provides a separate and distinct basis for recovery against a physician, it is critical to document the treatment options, alternatives, and potential risks and complications.

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The Risk of Failure to Diagnose Failure to diagnose is a matter of major importance in medicolegal actions. Uveitis patients may have an infection that is difficult to diagnose until late in the course of disease (e.g., herpes simplex recurrent uveitis), or they may have cancer as the cause of the “uveitis,” with the highly lethal central nervous system– intraocular large cell lymphoma being the preeminent example of this “masquerade.” Documentation of consideration of such possibilities can go a long way in making clear that the ophthalmologist has not been negligent in his intellectual assessment of the patient. Referral of the patient, of course, sooner rather than later in the case of uveitis that is unusual, stubborn, and particularly chronic, that is recurrent, or that is producing damage that is a threat to vision is the other preferred practice pattern that can provide the patient the best standard of care.

Consideration of Referral to a Specialist If the diagnosis remains unclear or if it is clear but implicates the need for further specialization, refer the patient sooner rather than later. Seldom is a physician criticized solely for referral. Instead, the criticism comes if the referral has been delayed. Involving a specialist early avoids this potential basis of criticism but, more importantly, provides the patient with more specialized care while you may or may not remain directly involved in the patient’s care. Even if you may no longer see the patient, your continuing to seek or receive reports will avoid any basis for any claim for alleged abandonment that unfortunately can follow an abrupt cessation in care, particularly if the possibility of a poor outcome has been raised. Finally, be complete in the information provided to the specialist, including your potential diagnoses even though you believe the specialist has a greater ability than you to reach the appropriate diagnosis. This will avoid a claim that not all significant information was conveyed to the specialist.

The Risk of Failure to Timely Refer The risk of allegations of negligence as a consequence of failure to refer a patient with uveitis to a subspecialist who has done additional training in the form of ocular immunology or uveitis fellowship training may be underappreciated. Our experience1 and that of others2–6 indicate a surprising prevalence of referral after irreversible damage from chronic or recurrent intraocular inflammation has occurred, with a shocking onethird of patients blind in at least one eye at the time of the initial referral visit. This is especially disappointing in light of the fact that if the uveitis in these patients is then typically abolished (generally after steroid-sparing immunomodulatory therapy) it indicates the irrefutable fact that the uveitis was treatable and raises the argument that

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Table 22.1 Types of uveitis requiring early referral to an ocular immunologist Juvenile idiopathic arthritis–associated uveitis Steroid-dependent chronic uveitis Steroid-resistant uveitis Posterior uveitis Retinal vasculitis

within all probability vision in the now blind eye would have been salvaged had the patient been referred to the subspecialist earlier. Therefore, we believe that referral early in the course of the care of patients with the types of uveitis listed in Table 22.1 to an ocular immunologist/uveitis specialist demonstrates the comprehensive ophthalmologist’s high level of knowledge and high level of concern for his patient’s care. It also demonstrates his understanding of current preferred practice patterns, even if such referral means that the patient must travel some distance for what may turn out to simply be a one time consultation visit, following which the primary ophthalmologist can continue to care for the patient, with long distance collaboration with the consultant and possibly with comanagement with a local chemotherapist.

Communications with Other Physicians In communications with a primary care physician, a specialist, or other physician, it is critical that it is crystal clear what your and the other physician’s responsibilities are or will be. It should be stated without equivocation who is now responsible for each aspect of the patient’s care, including who will follow up on each of the various medical issues of the patient. Such delineation may involve partial responsibility and follow up by a number of physicians with overall responsibility and coordination perhaps resting primarily with one physician whether it is a primary care physician or possibly a specialist, such as an oncologist during a period of cancer treatment.

The Risk of Failing to Treat Properly Certain disorders have been discovered to have such poor long-term outcomes (eye or otherwise) with corticosteroid monotherapy that two learned uveitis societies, following evidence-based medicine and peer-reviewed literature review exercises, rendered the opinion that those disorders should be treated (or at the very least should be offered treatment) with immunomodulatory therapy.7 Such diseases include uveitis secondary to sympathetic ophthalmia, Vogt-Koyanagi-Harada disease, Adamantiades-Behcet disease with retinal involvement, and uveitis or retinal vasculitis caused by Wegener’s granulomatosis or by polyarteritis nodosa. We agree with these opinions. In fact, in some instances, such as with polyarteritis

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nodosa and Wegener’s granulomatosis, failure to offer such therapy is almost guaranteed to ensure the patient’s death from these potentially lethal diseases. Clearly, no doctor wants to be party to such outcomes, nor should he be willing to be party to blindness as an outcome either, when effective therapy, employed early in the course of the stubborn uveitis, is available.

The Risk of Treatment-Associated Complications Treatment-associated complications may also trigger litigation, with allegations of negligence. The potential side effects of immunomodulatory therapy are well known, and these risks are typically well managed by the ocular immunologist or other chemotherapist who monitors the patient on such therapy through frequent face-to-face encounters and hematologic and serologic monitoring. The ophthalmologist who is not specifically trained in such matters obviously must engage the services of an appropriate expert to manage this aspect of his patient’s care. However, the ophthalmologist himself is exposed to the risk of treatment-associated complications that could result in encounters with the legal system. Complications of topical corticosteroid therapy (cataract and glaucoma), of systemic corticosteroid therapy (osteoporosis, diabetes mellitus, hypertension, psychosis, myopathy, and even morbid obesity include but a few of the myriad and legendary potential and sometimes inescapable side effects of chronic systemic corticosteroid therapy), of intraocular injection therapy (endophthalmitis, retinal detachment, glaucoma, cataract), and of surgical therapy (the legendary complications of surgery on the “complicated” uveitic cataract) are all risk exposures for the ophthalmologist caring for the patient with uveitis. Most are avoidable with proper strategic planning and therapy choice, but, clearly, documentation of discussions with the patient regarding treatment options and the risk/benefit ratio of each approach is essential in risk management vis-à-vis malpractice litigation. Consider the following example. A patient with chronic, indolent posterior uveitis for many months was referred to a vitreoretinal specialist who found a previously undiagnosed metallic intraocular foreign body. The uveitis was responsive to only oral steroids. After surgical removal of the intraocular foreign body the uveitis persisted and the oral steroids were continued. The patient developed aseptic necrosis of the hip and sued for improper informed consent, claiming he was not advised of the risk of hip necrosis and would not have consented to the oral steroids had he been so advised. At trial the surgeon said that among the warnings he gave to the patient prior to surgery was the possibility of death from the anesthetic, the likelihood of which he felt was approximately 1 in 30,000. The plaintiff’s attorney then showed the jury the Physician’s Desk Reference, which estimated the risk of hip necrosis at 1 in 10,000. He admonished the vitreoretinal surgeon for failing to warn the patient of the risk of hip necrosis, which was three times more likely than anesthetic death. The jury found for the plaintiff and gave him a large award. The verdict was reversed on appeal by a second jury who felt that no reason-

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able patient would have refused the steroid therapy based on the significant risk of permanent severe vision loss and the relatively small risk of hip necrosis.

Documentation After a Poor Outcome As with the informed consent discussion, physician’s statements following a poor outcome are often misheard and misconstrued. Patients who have had a poor outcome resulting from a recognized complication of a procedure even with the best of care are understandably anxious and upset. Expressions of sorrow that a bad result has occurred can and should be made but with the awareness that this can be misunderstood as admissions of fault. Accordingly, it remains important to document completely what has been said. It is likewise as important to document the response of the patient, particularly when (after the outcome) the patient expresses prior understanding of possible risks, particularly the risk that materialized. A patient’s statement of gratitude for the care given, continued confidence despite the poor outcome, and/or a wish to continue care should also be documented. Unfortunately, such statements may later be denied, particularly if not documented.

Conclusion Medicine always has been and remains an inexact science. Guarantees cannot reasonably be given because poor outcomes occur unavoidably without negligence. Steps such as those suggested in this chapter can be taken, most importantly to improve patient care and, incidentally, to avoid involvement with the legal system.

References 1. Dana MR, Merayo-Lloves J, Schaumberg DA, et al. Visual outcomes prognosticators in juvenile rheumatoid arthritis associated uveitis. Ophthalmology 1997;104:236–244. 2. Rosenberg KD, Feuer WJ, Davis JL. Ocular complications of pediatric uveitis. Ophthalmology 2004;111:2299–2306. 3. Edelsten C, Reddy MA, Stanford MR, Graham EM. Visual loss associated with pediatric uveitis in English primary and referral centers. Am J Ophthalmol 2003;135:676–680. 4. Ozdal PC, Vianna RNG, Deschenes J. Visual outcomes of juvenile rheumatoid arthritis associated uveitis in adults. Ocular Immunol Inflamm 2005;13:133–138. 5. Kump LI, Cervantes RA, Androudi SN, et al. Visual outcomes in children with juvenile idiopathic arthritis associated uveitis. Ophthalmology 2006;113:1874–1877. 6. Zak M, Fledelhius H, Pedersen FK. Ocular complications and visual outcome in juvenile chronic arthritis: a 25 year follow-up study. Acta Ophthalmol Scand 2003;81:211–215. 7. Jabs D, Rosenbaum JT. Guidelines for the use of immunosuppressive drugs in patients’ ocular inflammatory disorders: recommendations of an expert panel. Am J Ophthalmol 2001;131:679.

Part 3

Personal and Business Considerations

Chapter 23

Physician and Defendant: Living and Coping with a Double Life Sara Charles

Introduction After a bad outcome and, later, as named defendants in civil litigation, physicians, unbeknownst to others, often begin to feel as though they are living a double life. They are concerned about their affected patient and continue to devote themselves to their work with patients as though nothing has happened, but, at another level, they are preoccupied with their own concerns about survival, protecting themselves against anxiety and hurt, and devoting their time to defending their good name. How can they manage their seemingly conflicted, but all too human, concerns, carry out their work, respond to the demands of the legal process, and emerge from the experience stronger and more self-assured professionals? To master this serious life stressor and maintain their integrity and equilibrium, physicians need to explore what the event means to them personally, recognize the emotions it generates, understand the reasons for these emotions so that they can distinguish what they can and cannot control, correct any distortions related to the event, and make changes that help them emerge as a confident and healthier person.

The Environment Surrounding a Medical Malpractice Charge Without a national campaign to focus their attention, the public quickly, if understandably, loses interest in and consciousness about the litigation crisis. Popular culture associates bad medical outcomes and malpractice suits with “bad doctors.” Thirty years into the medical malpractice litigation crisis, the general public has a subtler view of the crisis, understanding that bad outcomes may not necessarily result from substandard care. The public possesses greater sophistication about access to care, especially related to obstetrics1; the economic costs associated with the current system, including rising insurance premiums and defensive medicine1; the evidence that the tort system fails to achieve its goals for patients and society effectively2; and the emotional repercussions of bad outcomes for both patients and doctors.3–5

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Despite creative and consistent efforts to relieve or change it, however, the tort system governing medical malpractice remains essentially intact. The result is that laypersons and professionals continue to blame someone for bad outcomes. Additionally, questions arise frequently about the behavior of physicians after bad outcomes and how “truthful” they are in disclosing them to patients. In this littlechanged environment, professionals receive little sympathy and physicians sued for malpractice continue to feel isolated, misunderstood, and lacking in support.

Assessing the Meaning of the Event What does it mean to be charged with malpractice in today’s environment? Despite recent efforts to diminish the “culture of blame” within health care, physicians remain the principal targets of inquiry whenever a bad outcome occurs. Their immediate instinct is to question their own role in the outcome. Later, if publicly charged with malpractice, they examine themselves more deeply about potential culpability and its meaning within the context of their personal and professional lives. Irrational fears lurk in the background; they feel that they will suffer some form of personal, career-ending, or financial destruction. CBS commentator Andy Rooney gave voice to these fears after he was publicly accused of making discriminatory remarks: “It is not clear to me whether I have been destroyed or not but I know that a denial from anyone does not carry anywhere near the same weight as an accusation.”6 Typically, physicians embark upon concomitant complex psychological processes, known as appraisal,7 within the context of their own life history and circumstances by asking a series of questions: “What is this all about? How does this lawsuit make me feel about myself? How does this impact my feelings of competence and professionalism? Do I feel that the charges have some basis or are they totally fraudulent? How will this affect my work and my professional relationships? Will this lawsuit change my relationship with my family, impact my health, or alter my long-term ambitions or goals? Do I feel overwhelmed, seething with anger, or terribly misunderstood? Can I manage my feelings or do I feel they are out of control? Do I feel powerless or hopeless?” How we answer these questions gives us clues about the meaning and impact of the event on us. The answers also reveal how we can begin to cope.

Recognizing the Emotions Associated with the Event The meaning of the event that characterizes the source of threat or benefit of the experience has a direct impact on the physician’s subjective feelings. Internist Dr. Richard Allen, whose patient died suddenly from complications secondary to orthopedic surgery, described his experience both before and after litigation had been filed8:

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It’s like someone who has a malignancy in remission. You know the old term, “whistling by the graveyard?” You know it’s there and you try to suppress it. You put it in the back of your mind, in your subconscious but it always creeps back no matter what. . . . You know that someday it’s going to show up. . . . I was made aware that the family had contacted an attorney and the chart had been requested so at that point, I reported it to my malpractice carrier . . . so nothing more was heard, this is about 19 months before the actual suit was filed. [When it was filed] it was absolutely terrible. It was terrifying. It was depressing. I had acute anxiety. I actually went into atrial fibrillation.

Seen in the emergency room on the Saturday morning his fibrillation began, Dr. Allen was treated and back at work on Monday. Unbeknownst to his colleagues, Dr. Allen, swept up in a whirlpool of feelings, lived a double life as physician and defendant for the next 3 years. Dr. Allen possessed a capacity for self-observation and was able to identify “a conflict of emotions” that captured the meaning of this experience for him: a strong drive for self-preservation; a fear of being psychologically damaged by the event; fears about the limits of his liability and the amount of monetary damages that might eventually be assessed; guilt and anger for being involved in a case that was literally “out of his control,” especially because he was away on vacation when the surgery and its aftermath occurred; shame that his sense of honor was being impugned; anger that the orthopedic surgeon, who was also a friend of the patient, was not named in the suit; and feelings of anger and betrayal based on the belief that his associate was trying to incriminate him rather than accept any blame for his management of the case. The most distressing emotion was anger: “I was very angry. I’m sure the anger contributed to the surge of adrenaline that put me into atrial fibrillation.” This well-functioning physician, marginally involved in the sudden death of a patient and in subsequent litigation, reacted as any person does when he or she experiences a significant life event with all its attendant losses. A widower or recent divorcee, for example, not only loses a spouse but usually suffers a change in social and economic status. A physician involved in a serious adverse event, especially one that precipitates subsequent litigation, is no different. It takes time to adapt and respond to these real and potential losses. Dr. Allen, for example, later decided to settle mainly because he feared that his health would be comprised by the stress associated with a trial.

Understanding Emotional Reactions to Serious Life Events Understanding ourselves and our experiences equips us well to anticipate and master our reactions. Horowitz9 describes the normal phases by which individuals experience any major life event. For physicians involved in a bad outcome, especially a catastrophic event that later leads to a lawsuit, both the event and its consequences may be experienced as “major.” Initially there is an outcry—an overwhelming sense that, “no, this can’t happen, this can’t be true.” The magnitude of the event is literally too much to absorb so that we feel stunned or shocked and sometimes temporarily out of touch with our surroundings. We

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experience “distress” with feelings of confusion, anger, anxiety, or a range of other unpleasant and threatening emotions and symptoms. Distress is a normal, usually selflimited response of short duration, but in some persons the symptoms may persist. Gradually, we realize that what we feared has actually happened and changed our life. We are next aware of alternating periods of denial, during which we consciously or unconsciously put the event out of our minds, and intrusion, during which we experience unsolicited thoughts, feelings, and preoccupations associated with the event. We may feel calm and in good emotional balance when some seemingly innocuous stimulus generates a rush of memories and disruptive feelings. We then consciously push the unwanted thoughts and feelings to the background in order to resume our normal life. The closer in time that we are to the trauma, the more frequently we are bothered by these preoccupations and the more psychological energy we expend to control our thoughts and feelings. When we pass the emergency department that was the scene of the event, for example, we may feel overwhelmed with memories and negative feelings. As time passes these intrusions generally diminish as does our vulnerability to disruption. Because there is no “time” in the unconscious, whenever we are reminded of the event, it feels as though it is happening freshly. Dr. Laura West’s obstetric patient sustained a complicating adult respiratory distress syndrome and, after 85 days in the intensive care unit, suffered a cardiac arrest after being fed a fatty emulsion intravenously rather than through her port. Efforts to revive the young patient failed. It was devastating. It changed everything in my life. . . . I was a young doctor. I had this catastrophic event . . . everyday I questioned myself. I had graduated first in my med school class. . . . I had been the chief resident. . . . I was as well prepared and well trained as I could be but I doubted myself every day. . . . It was just agony. I had trouble closing abdomens. I thought the patient would bleed to death. I eventually got over that over time. . . . I was sued for, basically, wrongful death. . . . After four years of hell, the case was ultimately dismissed with prejudice. In other words, we had won. The case was going to go no further because I really hadn’t done anything wrong.10

Dr. West was clearly traumatized and plagued for years with periods of denial and intrusive thoughts about her role in the event and her feelings of competence. She would do her best to attend to all patients and their concerns and, in some sense, deny the reality of this catastrophic event. Every surgery, however, reminded her of her patient. Her sleep was interrupted constantly with concerns about her patients and how the lawsuit would play out. Her effort to keep her “double life” in balance was an “agony.” During these long years she was psychologically engaged in working through the experience, which uses psychological energy to put the event into some perspective and deal with its emotional repercussions. This hard work begins the process of healing. It takes time to absorb the facts associated with the event, especially if a bad outcome is due to a mistake. The physician needs to put the facts into perspective, make the necessary adaptations, and regain psychological equilibrium. It was during this time, for example, that Dr. Allen recognized the complexities of his relationship with his associate that led eventually to the dissolution of their partnership. He also accepted that, despite feeling it was unfair, he, not the orthopedic surgeon, had been sued. Although both Dr. Allen and Dr. West emerged

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from the experience as far more confident, competent, and mature clinicians, the psychological toll on them and their families was significant, and they experienced major changes in their personal and professional lives.

The Charge of Negligence and Physicians’ Reactions When an adverse event involves the threat of litigation or when litigation occurs, two major factors contribute to physicians’ emotional reactions: their own personality traits and the nature of tort law.

The Personality Traits of Physicians Ordinary people defend themselves against perceived threats by using obsessivecompulsive defense mechanisms that help them feel in better control. This is marked by a preoccupation with orderliness, perfectionism, and an excessive devotion to work and productivity. Gabbard11 identified a “triad” of associated obsessive-compulsive traits that physicians typically share: a vulnerability to doubt, a propensity to guilt feelings, and an exaggerated sense of responsibility. Physicians express their vulnerability to doubt by questioning whether they considered all the options in their diagnosis or treatment of their patient; they tend to feel guilty if they fail to meet their sometimes onerous perception of the professional standard of care; and they worry about whether they have done everything possible to help their patient even when the situation was entirely out of their control. Physicians do not readily balance these reactions, and this may lead to overwork, neglect of family obligations, and a drive for perfectionism that is incompatible with a healthy life. If used wisely, these personality characteristics contribute to the care of their patients. When physicians are sued, however, these same traits become the source of considerable distress. Feeling “out of control,” physicians may begin to doubt themselves, feel guilty, and think that they failed to “do enough.” All of these feed into the playbook of the plaintiff’s attorney.

Tort Law Medical malpractice claims are torts, in contrast to crimes, that seek a civil sanction, usually compensation. They require that a person or entity be accused of failing to meet the standard of care and, by so doing, cause the patient to sustain an injury that deserves compensation. This public allegation of failing to meet the standard of care against a person whose identity relies on meeting that standard sets off deeply felt psychological repercussions. The central psychological event of litigation is the

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11,631 (5.3%)

2,531 (1.2%)

565 (.3%)

1,501 (.7%)

No Payment Settled-Plaintiff

60,705 (27.9%)

Verdict-Defendant Verdict Plaintiff 140,744 (64.7%)

MediationDefendant Mediation-Plaintiff

Figure 23.1 Outcome of closed medical malpractice claims (1985–2006). (Physician Insurers Association of America (PIAA), Rockville, MD, with permission.)

public accusation of failure against a person who is already uniquely sensitive to the slightest suggestion of failure. Such persons experience legal action as a direct assault on their sense of integrity. It is helpful for physicians to recognize that in the tort system negligence must be charged if the patient is to achieve compensation: the accusation is merely the means to an end. Recent evidence suggests that neither goal of the tort system—the efficient and fair recompense for injured patients and the rooting out of incompetent doctors—is currently achieved.2 It is also helpful to know that almost 70% of the cases filed result in no payment to the plaintiff; that is, they are found to be groundless, dropped, dismissed, or result in a trial verdict in favor of the physician (Figure 23.1) Most physicians believe that the system is unfair and that there should be other means for patients to achieve justice for injury in the health care system. Nonetheless, until significant change in the system occurs, physicians will continue to be principle targets of such accusations. Impelled to restore their good name and demonstrate that these accusations are not only false but unwarranted, physicians feel estranged from the inherently adversarial legal world. They feel tethered to an unfamiliar but well-established legal process that in stark contrast to the fast-paced, decision-making cadence of medical practice seems frustrating, slow moving, and time consuming.

Identifying Areas of Control Physicians react in their own distinctive ways to a malpractice suit, and, in fact, to each suit filed against them. Their primary challenge is to understand what they can and cannot control so that they can transform what feels like a “double life” into one integrated whole in which they can function as responsible clinicians and successful defendants.

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Physicians have a great advantage in knowing their own strengths and weaknesses. If they can observe changes in their characteristic ways of thinking and behaving under stress, they can identify the sources of their distress and make necessary changes. Physicians overwhelmed with financial concerns, for example, find it is useful to review their current financial status, review or initiate long-term financial plans, and reassess their malpractice coverage and their potential for loss, along with other relevant issues. Well-versed in and comfortable with that knowledge, physicians are far better qualified to contribute to decisions about whether to settle or pursue the case. Although his health was his primary motivation in settling, the suit distressed Dr. Allen because of its impact on his relationship with his partner. He gained control by reviewing his financial status, confronting his partner about his role in the case, settling the case for a minimal amount, dissolving his partnership, and selling his practice to a local hospital. Depending on their own particular circumstances, physicians may allow themselves more leisure time, redistribute their time commitments to work and family, improve their office procedures, enhance their risk management strategies, and schedule the time necessary for preparation for depositions. They may implement other changes that help them feel in better control of their own lives and to profit from the support of others during this difficult period in their lives.

Correcting Distortions Relevant to the Experience One of the most difficult challenges for physicians after a bad outcome, especially after making a clear medical error or being sued for malpractice, is to face and accept their own humanity and its attendant vulnerabilities. To do this they need the help of family, friends, and colleagues who provide understanding, support, and a sense of safety. Physicians are thwarted in sharing their experiences by their own lawyers who warn them not to talk to anybody about their situation for fear that they might say something that suggests culpability and therefore jeopardizes the legal defense of the case. This is classic good legal advice, but it is not good psychological advice. It is true that doctors can talk with their lawyers, claims professionals, and others directly protected by the law, but often these resources are insufficient to provide that emotionally “safe” and comfortable place that they need. Many physicians can talk with their spouses, who are often knowledgeable and supportive, especially if they are physicians themselves. Others find that a trusted colleague or friend is the best resource.12 In conversations with these persons, physicians can discuss their personal feelings about the incident and the lawsuit but not the technical details of the case, thereby safeguarding the concerns of legal counsel. By talking about our experience with others and listening to their feedback, we can begin to gain some distance and perspective that gradually allows us to see a “true” picture of what really happened. After negative events in the medical setting, physicians almost always become central players in sentinel event reviews, mortality and morbidity conferences, and other forms of debriefing and investigation that review the technical details of the

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situation. Physicians do not always perceive these venues as “safe,” because they seek to find the responsible culprit so that sanctions can be initiated. The most successful investigations are conducted within an environment of understanding and support so that the participants can learn from the incident rather than feel intimated and therefore defensive and withholding about their behavior. Some observers suggest that delaying these sessions for a reasonable length of time so that those involved can achieve some perspective on the event is more useful than reviews scheduled when the participants are still suffering the emotional aftershocks of the incident.13 Physicians are also in need of support as they prepare to interact with aggrieved patients. Often the adverse event is totally unanticipated, and its details and causation may be cloudy or, in some circumstances, strikingly clear. In any case, physicians must put their emotional response “on hold” until they inform and respond to the patient’s and family’s totality of concerns. In preparation for this discussion, the primary physician may find it useful to consult with a risk manager or involved associate to achieve a proper perspective on the event. Generally speaking, the best approach to disclosure is to reveal as “much as the doctor knows” at the time. Risk managers, of course, will generally caution physicians about how they disclose what they know relative to culpability for the event. Patients and their families as well as physicians themselves can have deeply rewarding and healing experiences when disclosure after a bad outcome is sensitive, informative, and timely.

Emerging as a Stronger and Healthier Person Achieving a sense of perspective about and accepting the event and their role in it can strengthen physicians personally and make them better defendants. This can only be accomplished by hard work and with the help of other sensitive, trustworthy, and reliable persons. As one physician remarked, “I am acting in the best physical, mental, professional and spiritual shape possible in anticipation of this case moving forward.”14 Physicians following this approach improve their chances of integrating this experience into both their personal and professional lives.

References 1. American Medical Association. Medical Liability Reform—Now! July 19, 2006. Available at: http://www.ama-assn.org/go/mlrnow. Accessed September 26, 2007. 2. Miller D. Liability for Medical Malpractice: Issues and Evidence. A Joint Economic Committee Study. Jim Saxton, Vice Chairman. United States Congress, May 2004. 3. Gilbert SM. Wrongful death: a memoir. New York. W.W. Norton, 1997.

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4. Hilfiker D. Healing the Wounds: A Physician Looks at his Work. New York: Pantheon Books; 1985. 5. Charles SC, Kennedy EC. Defendant: A Psychiatrist on Trial for Medical Malpractice. New York: Vintage Books; 1986. 6. Gerard J. Callers besiege CBS over Andy Rooney. New York Times, February 10, 1990. 7. Lazarus RS, Folkman S. Stress, Appraisal and Coping. New York: Springer; 1984:22–25. 8. Charles SC, Frisch PF. Adverse Events, Stress and Litigation. New York: Oxford University Press; 2005:58, 94. 9. Horowitz MJ. Treatment of Stress Response Syndromes. Washington, DC: American Psychiatric Press; 2003. 10. Charles SC, Frisch PF. Adverse Events, Stress and Litigation. New York: Oxford University Press; 2005:20, 216. 11. Gabbard GO. The role of compulsiveness in the normal physician. JAMA 1985;254:2926–2929. 12. Berlinger N. After Harm: Medical Error and the Ethics of Forgiveness. Baltimore: The Johns Hopkins University Press; 2005:89. 13. Kenardy JA, Carr VJ. Debriefing post disaster: Follow-up after a major earthquake. In: Raphael B, Wilson JP, eds. Psychological Debriefing: Theory, Practice and Evidence. Cambridge, England: Cambridge University Press; 2000:174–181. 14. Anonymous surgeon. Physicians and Medical Malpractice Litigation. Report to the Council of Medical Specialty Societies. Chicago: Survey Research Laboratory, University of Illinois; 2003.

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Chapter 24

Medical Malpractice Insurance: Selection of Companies and Policies Eric S. Poe

Introduction One of the most important decisions a physician needs to make each year is which medical malpractice insurance policy to buy. The three fundamental areas that should influence the physician’s decision are: (1) the cost of the insurance, (2) the policy form, and (3) the financial condition of the insurance carrier. Generally, most physicians focus on only the cost of a policy, when all three topics should be given equal weight. Not being fully cognizant of the other two components would be similar to negotiating and purchasing a car without asking or determining whether the car even runs. How would you feel after negotiating a very low price for a car but later found out that it did not start? When considering that medical malpractice insurance protects a doctor’s personal assets, one would assume that physicians would pay attention to the other factors, but sadly it is often not until the insurance carrier either goes out of business or the physicians face additional unexpected burdening costs that they realize their mistakes.

The Cost of the Policy Traditionally, the cost of a medical malpractice policy can be evaluated by simply reading the invoice each year. The reality is, however, that the ultimate cost to a physician may actually depend on the policy form that the physician purchases as well.

The Policy Form Generally, there are only two types of professional liability insurance policies that are offered to physicians throughout the United States: (1) the occurrence-type policy and (2) the claims-made policy.

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In an occurrence-type policy, you are covered against any patient who sues you for medical malpractice as long as the incident occurred when you were insured with the carrier. This is similar to a typical auto insurance policy in which if you rear-end another car in December 2005 and you sell your car in January 2006, you are still covered against the claim even if the person does not file a lawsuit against you until June 2006, because the negligent act occurred when you had a policy in effect. In contrast, in a claims-made policy, you are covered against a person who sues you for medical malpractice if two conditions are met: if the incident occurred when you were insured with the carrier and if, at the time the lawsuit is filed, you are still insured with the carrier. In the example using auto insurance, if you were to be involved in the same accident described previously, you would not be covered, because at the time the lawsuit was filed against you, you were no longer insured with the insurance carrier. However, in a claims-made policy you can protect yourself against such a lawsuit, even if it was filed after you left the insurer, if you purchase a supplemental “endorsement,” often referred to as a tail. This optional tail endorsement typically costs two to three times the physicians’ prior year’s premium at the time they leave the insurance carrier. Often physicians can avoid this very costly tail if they meet one of three conditions: (1) if the physician dies during the policy (his estate does not need to purchase the tail endorsement); (2) if the physician becomes permanently disabled; or (3) if the physician is with the insurance carrier for at least the 5 previous years, is over 60 years old, and decides to permanently retire. If one of these conditions is met, often the insurer will provide the tail free of charge. Although the “free” tail endorsement is often considered a major benefit to the physician in a claims-made policy, it is also the most often misunderstood portion of the policy. First, a physician should realize that a claims-made policy was introduced by the medical malpractice industry to meet their needs, not to address the needs of the physician. Claims-made policies enable the insurer the ability to adjust their rates and premiums more quickly than an occurrence type policy. The primary benefit to physicians of the claims-made policy is the cost savings. In fact, the cost savings is typically what allures them to purchase the claims-made policy, as generally a claims-made policy will cost 35% of the cost of an occurrencetype policy in the initial year. However, the savings automatically diminish for the physician each year until the fifth year of the claims-made policy, when the cost becomes the same as the occurrence-type policy. In fact, the typical escalating costs in the claims-made policy provide that the claims-made policy will be 35% of the cost of the occurrence-type policy in the first year, 65% in the second year, to 80% in the third year, and will generally be 90% in the fourth year from the occurrencetype policy. Generally, physicians are unaware of the fact that the savings of the claims-made policy is predetermined by the insurance companies as the company has already filed for these escalating factors with their state’s department of insurance prior to issuing the policy. As stated earlier, the advantages of a claims-made policy to the insurance companies far outweigh those cost advantages to the physicians. One of the most important advantages to the insurance company is that it can raise rates to

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its policyholders at a more rapid pace, while ensuring that most physicians will be forced to pay those rate increases. For example, when any insurance company chooses to raise its rates, it typically has the fear that such a rate increase can cause its current policyholders to shop around and consequently leave their insurance company, which would hinder their projections to collect more total premiums. However, physicians faced with a rate increase in a claims-made policy are forced to purchase a very costly tail if they desire to leave the insurer. Historically, the most common problem with a claims-made policy is that most physicians anticipate receiving the “free” tail endorsement and therefore never set aside capital to purchase a tail; then, when faced with a rate increase, they have no choice but to absorb it. Renewing under such a circumstance also increases the physicians’ tail endorsement cost by that rate increase percentage as well. In fact, in 1982, the “claims-made” form of coverage for physicians was introduced in New York and several insurers began solely offering these policies to their physicians. As a result, a number of physicians were forced to close their businesses because they were faced with unaffordable and unpredictable rising tail costs by insurance companies. In 1991, as an “emergency measure,” the New York Insurance Department stated, “It has become apparent that there are medical malpractice situations where claims-made coverage has proven impractical or unworkable,” promulgating a regulation requiring that every insurer offer to physicians “occurrence-type” policies. The implementation of this regulation ended the “claims-made crisis” in New York. The main advantage of the traditional occurrence-type policy is rather simple: it provides physicians the freedom to choose different insurance coverage each year, without incurring any additional and unpredictable costs. The largest complaint by most physicians is the unpredictable nature of the costs associated with medical malpractice insurance, and, by purchasing an occurrence-type policy, physicians are capable of ensuring that they can afford to shop for other insurance if their rates increase substantially.

Common Misconceptions About the Free Tail Without question, the largest misconception for physicians is related to the conditions that provide for the “free” tail endorsement. Most physicians believe that with a claims-made policy the insured is entitled to free tail endorsement coverage after 5 years with the carrier. Typically, they believe they can simply remain with the carrier for 5 years, and, because they are over 60 years of age, a free tail endorsement will be provided. Unfortunately, they do not foresee the scenarios in which they will not qualify because of intervening factors. First, the physician fails to realize that remaining with the insurance carrier for 5 years is not their unilateral decision. In other words, the insured does not always have the option to remain with the carrier for 5 years. Physicians are often nonrenewed by their insurance company before reaching that 5-year mark. The

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nonrenewal rights by an insurance company are generally very broad, and physicians can often be nonrenewed simply because they were named in a lawsuit during the year. Also, it is a realistic possibility that a physician’s insurance company will cease issuing policies in the state a physician practices. If this occurs, a physician will have no option in many cases but to purchase a tail. Furthermore, physicians must realize that the 5-year requirements along with being 60 years old are not the only scenarios beyond their control, because the free tail endorsement also requires that the physician retire as well. The retirement requirement means never seeing a patient again. Unless physicians have saved up two to three times their prior year’s insurance premium to purchase a tail when they are cancelled or not renewed, they can be in a very precarious position. Remember, each malpractice policy is governed by contract law and is simply a one-year contract with no guarantee of future coverage beyond that policy term. Agents and brokers, who are paid a considerable commission, typically 10% of a physicians’ policy cost each year, attempt to persuade physicians to purchase a claimsmade policy despite its inherent pitfalls by telling a physician that he or she can always buy “nose” or “prior acts” coverage with a new insurance company instead of paying an exiting tail endorsement. Unfortunately, the truth is that some insurance companies do not offer “nose” coverage or typically termed “prior acts” coverage for incidents that occurred prior to the purchase of their policy. Furthermore, even if such coverage is available through the new insurer, it must be paid up front—as in occurrence-type policies—and the costly tail endorsement must still be paid upon leaving the new insurance company. More frightening is the fact that the definition of the “rates in effect at the time” when a physician wishes to endorse the policy has been a topic of debate that has put many physician groups into a dangerous situation. Therefore, if a physician chooses to purchase a claims-made policy, or has no choice but to purchase such a policy because of the availability in his or her state, he or she should understand the inherent pitfalls associated with such a policy. Physicians, at the very least, should evaluate each insurance company through its track record of rate increases over time in order to assess the likelihood of another rate increase. This information can be obtained rather easily by calling the respective state department of insurance. Physicians should also make sure they understand the conditions of the claims-made policy provisions and not rely solely on verbal explanations. When the time arrives and a physician is faced with costs and invoices that were not adequately explained to them, only their policy language will protect them. Also, as a precaution, a physician should always set aside the appropriate amount of capital equal to their tail cost to avoid having to face closing their practice to an unexpected retirement or financing a loan to pay for an unanticipated costly tail endorsement.

Consent to Settle Clause In addition to the need for physicians to analyze what type of policy they choose to purchase, they also must identify the meaningful clauses contained in the policy

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language. One of the most common clauses found in medical malpractice policies is the “consent to settle” clause. The purpose of introducing the consent to settle clause in the 1990s was to attract physicians by providing them the illusion that they will possess the peace of mind to know that the insurance company will not be capable of settling a lawsuit without their consent. Although the clause seems simple enough in description, its practical application is far more complex. First, a physician must dispel the notion that an insurance company’s claims manager or executive officer will settle frivolous claims simply because the defense attorney costs are higher than the settlement offer. The reasons are simple. Generally, most medical malpractice lawsuits are generated and taken by a few large plaintiff attorney law firms within that state, and, if an insurance company or claims manager gains the reputation of settling claims without merit, they will most certainly increase the number of claims filed against them in the future. Second, unless odd circumstances exist, such as an insurance company placed under rehabilitation, an insurance company has the same interest in not paying out for lawsuits that have no merit. Although there may be physicians who may insist that they have been involved in a past scenario whereby their insurance company settled a lawsuit without merit, one must realize that the viewpoint of a highly trained physician and that of an experienced trial attorney can be vastly different. First, physicians accused of medical malpractice feel their management of the patient was not a deviation from the standard of care, and, although this may be clear in their minds, an experienced defense attorney realizes it is not whether this is a fact but whether he or she can prove this to a sympathetic jury. Many times the only evidence to protect a physician are illegible notes in medical records and disputed testimony. Physicians may believe their defense against the claim is strong, but an experienced defense attorney, and an even more experienced claims manager who has seen the disposition of hundreds of medical malpractice claims, may be of the opinion that indicates the true risk of taking the case to trial. The primary reason why a consent to settle clause is rendered meaningless to a physician is because it may expose physicians to their greatest risk, as one of the greatest protections for physicians when they go to trial is their ability to sue their insurance carrier for acting in “bad faith” by not settling the claim prior to a jury verdict. Physicians must understand that insurance companies have a fiduciary duty to their policyholders to prevent their policyholders from exposure of their own personal assets. This responsibility means that if an insurance company has the ability to settle a case below the policy limit of the physician prior to a jury verdict and fails to do so, when it “should have reasonably known” that a jury verdict could expose a physician to its own personal assets, it can be held liable for “bad faith” against its policyholder. Although the standard of what constitutes a “bad faith” claim against an insurance company may vary from state to state due to the state’s case law, this is generally the standard adopted by many courts. For example, let us say a physician who buys a $1 million liability limit is being sued by a patient plaintiff for medical malpractice. After discovery, the plaintiff’s attorney offers to settle the claim for the policy limits of $1 million. In response,

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despite reasonable evidence to support that the physician could be liable for negligence, the insurance company refuses to settle the claim and proceeds to trial. At trial, the jury finds in favor of the plaintiff for a judgment of $3 million. Because plaintiff attorneys would much rather seek the insurance company’s “deep pockets” of capital than the limited personal assets of the physician in order to recover the excess of $2 million not covered by the insurance policy – they will approach the physician and offer to settle the excess $2 million claim in exchange for the “bad faith” rights of the physician against the medical malpractice insurance company. In summary, when or if a physician refuses to settle a claim that the medical malpractice insurance company wishes to settle, they will tear down their final wall of protection against a plaintiff’s attack on their personal assets.

What Policy Limits to Choose One of the most common questions asked by physicians is, “How much insurance is enough?” If you take the necessary steps to protect yours assets, the minimum permitted by your licensing board or the state regulation is likely sufficient. In fact, there is more evidence to suggest that when physicians purchase high policy limits, they may be causing more medical malpractice lawsuits against themselves. The reason this occurs is because, during discovery, it is within the plaintiff’s rights to find out what each physician being sued has for medical malpractice insurance and the policy limits of that policy. The plaintiff’s attorneys ask this primarily to determine which insurance company faces the largest exposure associated with the malpractice claim. An example commonly found is when a “failure to diagnose” claim is made against an obstetrician as well as the radiologist. Typically, obstetricians carry the minimum limits required by most states, which is a $1 million per occurrence policy, while radiologists typically carry the higher limits of at least $3 million per occurrence. If a plaintiff’s attorney can make any allegation of malpractice that would associate the injury to the radiologist, he or she would be exposing the medical malpractice insurer for the radiologist to a possible $3 million loss. The tremendous trial experience of insurance claims managers who see the high policy limits at stake will be more likely to settle the claim at a higher value than if the policy limit were lower. In essence, higher policy limits can actually create a larger “target” for the plaintiff’s attorney to seek. Those physicians who believe they should purchase higher policy limits because of jury verdicts or settlements discussed in the newspapers should understand that settlements are typically always below the policy limit. When one reads of a settlement in the newspaper of $2 million for a medical malpractice case, it is most likely because the limits of the policies associated with that medical malpractice case were either $2 million or below. More importantly, plaintiff’s attorneys also have their interests to protect. When one considers that 80% of all medical malpractice cases that go to trial are won by the defense, it should not be a surprise that a plaintiff’s attorney would also have an apprehension of going to trial.

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The Financial Condition of the Insurance Company Issuing the Policy Too often in recent history, insolvent medical malpractice insurers have placed physicians’ personal assets at risk. Physicians commonly are misled to believe an insurance carrier is more stable simply because of its size. However, the reality is that most medical malpractice insurers that have gone insolvent (similar to declaring a bankruptcy) or that have discontinued writing policies have been the nation’s largest carriers. One could argue that there is more data to support the theory that in the field of medical malpractice insurance, larger could actually mean riskier. The following medical malpractice insurance carriers were recently deemed insolvent or ceased operations: PHICO Insurance Company: The nation’s eighth largest malpractice insurance company was declared insolvent and placed in liquidation in 2001 by the Commonwealth of Pennsylvania. St. Paul: The nation’s largest malpractice insurance company in 2001 exited the insurance market in 2002. MIIX Group, Inc.: The nation’s seventh largest malpractice insurance company in 2002 discontinued issuing policies in 2002. At the time, MIIX executives stated publicly it had sufficient assets to pay losses. In 2004, it was placed into rehabilitation by the state of New Jersey and found to be deficient to pay losses by over $300 million surplus. Medical Liability Mutual Insurance Company: The current largest medical malpractice insurance company was downgraded to a B– rating by A.M. Best in 2004, and is now currently requesting to be not rated and not to participate in the rating process. Reliance Insurance: This company was deemed insolvent in 2001. The biggest misconception about larger insurance carriers is that, because they have large stated assets, they are financially secure. However, assets alone should not be used as a strong indication of financial strength in the insurance industry. Unlike typical unregulated businesses, insurance carriers collect premiums well in advance, assuming liabilities into the future. For example, in the medical malpractice insurance field, insurance companies do not pay the majority of the claims until years after the policy is written. Therefore, insurance carriers will accumulate capital at the start of each policy, which is stated as assets. Consequently, insurance carriers reserve a portion of this capital to pay for claims that will be paid in the future, and these potential claims are considered possible liabilities, or “loss reserves.” In summary, if one were to determine financial strength based on assets of an insurance carrier, it would be similar to determining a person’s wealth without looking at the person’s liabilities. How financially secure is an insurance company with $100 million of assets if it has over $110 million in possible liabilities to pay? Therefore, assets alone should not be relied on as an accurate barometer when trying to assess financial stability because they do not illustrate how much capital

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the insurance carrier has available for a possible “cushion” if losses are worse than anticipated. In fact, financial strength ratings by rating bureaus such as A.M. Best and Weiss are chiefly based on the level of “cushion,” termed surplus, each insurance carrier maintains in relation to the amount of premiums it collects. The larger the surplus an insurance carrier maintains in ratio to how much it collects every year is more accurate at measuring an insurance carrier’s financial strength. This “premium to surplus ratio” is the most significant measure of financial strength, as it measures an insurance carrier’s ability to pay for claims, even if its predictions for losses are inaccurate. In addition, rating bureaus further determine their ratings of financial stability and strength by analyzing an insurer’s historical track record of predicting its losses. Obviously, if an insurer has a track record of setting insufficient capital aside for its claims, the accuracy of how much surplus it truly maintains can be considered questionable. For example, an insurer can systematically and purposefully under-reserve for its existing claims in order to increase its publicly reported surplus in the short term. Therefore, the historical track record of an insurer’s ability to set accurate reserves is typically what determines the credibility of the insurer’s stated surplus. Regardless of the type of company, prospective policyholders should evaluate the financial and operating strength of the company. One way to do this is to review the company’s A.M. Best rating. A.M. Best is an independent rating agency that evaluates the adequacy of reserves, soundness of investments, control of expenses, and capital and surplus sufficiency of companies. If a medical malpractice insurance carrier has completed 5 years of operation, it is eligible for rating by A.M. Best. A.M. Best has been publishing its opinion on the financial strengths of insurance companies since 1899. You can find the rating of your insurance carrier on their website at www.ambest.com. Another way to evaluate a company is to look at its annual report. The report will give some important financial data that should be considered by a physician before selecting an insurance carrier. First, however, you need to understand the basic terms related to analyzing an insurance company: Surplus: It is important that an insurance company have sufficient financial resources to meet all current as well as expected future claims. Surplus is the sum of items shown on a company’s balance sheet under the heading “policyholder surplus.” Surplus represents the amount by which assets exceed liabilities and is the net worth of the company. Loss reserves: Establishing loss reserves is complex. There are two classes of claim reserves: indemnity reserves and expense reserves. Expense reserves are further classified as allocated loss adjustment expense (ALAE) reserves and unallocated loss adjustment expense (ULAE) reserves. The incurred losses is the money set aside to pay present and future claims as well as defense attorney fees or expert witness fees (ALAE) and in-house claims operations (ULAE). You should examine how accurately your insurer has been setting its loss reserves in the past by looking at its “reserve development” in A.M. Best’s full rating report.

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Loss reserves to surplus ratio: The ratio of loss reserves (including reserves for loss adjustment expenses) to surplus (R/S) indicates the company’s ability to cover unanticipated reserve deficiencies. Industry regulators recommend that this ratio not exceed 4:1. Although these terms may seem intimidating, your understanding of them can make the difference between choosing a financially reputable and strong insurer or putting your personal assets at risk.

Conclusion Physicians have much more to worry about now than in the past regarding medical malpractice insurance. They no longer can afford to rely on their agent or broker, who may have a strong financial interest in their choice of medical malpractice insurer. Physicians spend countless hours keeping abreast of developing medical techniques, drugs, and treatments each year; unfortunately, keeping abreast of their medical malpractice insurance company also needs to be added to this list. Not spending at least a few hours a year analyzing your medical malpractice insurance can cost you your personal assets in the future.

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Index

A AAO (American Academy of Ophthalmology), 103, 132, 209, 213 Abandonment, pediatric ophthalmology relating to, 203 Acanthamoeba, 126, 129 Accidental injection intra-arterial, 97 intravenous, 97 Acetazolamide, 133, 176 Acquired immunodeficiency syndrome. See AIDS Administration of anesthesia, for ophthalmic plastic surgery, 198–199 of medication, update of, 133 Adverse events, revelation of, conundrum of apology and apology inadequate, 88 structure and effect of, 87 behavior, modification of, 85 conclusion to, 88 introduction to, 85 offense, gravity of, 86 ordinary courtesies relating to, 86 risk, prevention of, 86–87 Advice for medical expert, 45–46 to patient, regarding uveitis, 241 Agency for Healthcare Research and Quality. See AHRQ Age-related macular degeneration, laser and medical treatment for, 231 AHRQ (Agency for Healthcare Research and Quality), 143 AIDS (acquired immunodeficiency syndrome), 181 Allegations, 5

Allergies, drugs for, 133 Amaurosis, 95 American Academy of Ophthalmology. See AAO American Board of Ophthalmology, 55 American Glaucoma Society, 144 Ancillary tests, emergencies relating to, 152 Anesthesia, 91–101 accidental intra-arterial injection, 97 accidental intravenous injection, 97 amaurosis, 95 brainstem, 96–97 complications of, 91 general complications of, 98 IOP, 93, 94, 99 MH, 99 for globe penetration or perforation, 93–95, 159 issues of, in cataract surgery, 115–116 local, general considerations of complications of, 92–93 risk factors, 92 systemic toxicity, 93 myotoxicity, 97–98 oculocardiac reflex, 97 for ophthalmic plastic surgery, 198–199 optic nerve, atrophy of, 95–96 optic nerve sheath, penetration of, 96 retrobulbar hemorrhage, 93, 94, 95, 96 summary about, 99–100 topical, 92 Anesthesiologists, 91 Angle closure and other glaucomas, 159 Anterior vitrectomy, 119, 123 Antibiotics, 132 intracameral steroids and antibiotics, 112 topical, 141 Anticholinergic drugs, 141

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270 Anticoagulation, cataract surgery and, 112 Aphakic bullous keratopathy, 119 Apology conundrum of, 85–88 inadequate, 88 structure and effect of, 87 Appeal, trial relating to, 62 Areas of control, identified by physician/ defendant, 254–255 Arterial and venous retinal vascular diseases, laser treatment of, 231 Arteritis, giant cell, 154–155 Assumption, of risk, 167 Atrophy optic, 172–174 of optic nerve, 95–96 Attendance, at trial, 57–58 Attorney. See also Defense attorney; Plaintiff’s attorney selection of, 50 Attorney-physician-insurance company relationship, 50 Avastin, 138

B Battery, 66 Behavior, modification of, 85 Benefits, alternatives and, of informed consent, 70–71 Bilateral cataract surgery, 113 Bilateral optic disc edema, 174–176 Billing records, 33 Bioequivalent drug products, 136 Biopsy, 181 Bleeding corneal transplant relating to, 123 ophthalmic plastic surgery associated with, 199 Blephamide drops, 128 Blepharitis, 181 Blepharoplasty, 189, 197 Brainstem anesthesia, 96–97 Bupivacaine, 92 Burns, chemical, 153

C Cancer, 193 Carcinoma, squamous cell, 181 Cardozo, Benjamin, 65 Case analysis, plaintiff’s attorney relating to, 29–32

Index Cataract surgery anesthetic issues in, 115–116 anticoagulation and, 112 complications of, 103–104 conclusions about, 116–117 considerations specific to, 107–109 elective refractive surgical procedures, involving lens extraction, 110–111 endophthalmitis, 107–109 general risk management issues about, 105–107 high expectations relating to, 103 infection relating to, 108 informed consent for, 106 introduction to, 103–104 new technology for, general considerations for adoption of, 114–115 OMIC relating to, 105, 111, 116 pharmacologic agents, off-label use of, relating to, 111 postoperative treatment of, 108 in presence, of ocular and systemic diseases, 113–114 refractive surgery claims v., 210 risk prevention relating to, 104–105 second eye, monocular patient, and same-day bilateral, 113 specific drugs used off-label during, 112 volume of, 103 Cefazolin, 120 Cellulitis, orbital, 157–158 Central or branch retinal artery occlusions, 154. See also CRAO Central retinal artery compression or occlusion. See CRAO Certified Registered Nurse Anesthetist. See CRNA Charge to jury, 62 of negligence, reactions to, 253 Charts, 35 medical records and, drugs relating to, 134 Chemical burns, 153 Childbearing potential, women with, drugs for, 139–140 Choroidal hemorrhage, after surgery, 122–124 Choroidal melanoma, 229–230 Chronic uveitis, 114 Ciprofloxacine eye drops, 136 Claims-made policy, 259–261 Client intake by paralegal, 29 by plaintiff’s attorney, 29–30 Cocaine, 92

Index Cochrane Collaboration, 132 Cochrane Database of Systemic Reviews, 132 Codefendants, 8 Comanaging patients, 137, 222 Company issuing policy, financial condition of, 265–267 Comparative v. contributory negligence, 25 Compensatory damages, 24 Complaints, 51, 239 Conjunctival melanomas, 181 Conjunctivitis, 181 Consent form, 72–73 Consent, informed. See Informed consent Consent material, presentation of, 69–70 Consent to settle clause, 262–264 Consultant jury, hiring of, 36 for pediatric ophthalmology, 204 vitreoretinal specialist, 225–226 Contact lenses. See Cornea: external disease and contact lenses Contributory negligence, 25 Conundrum of apology, 85–88 Cornea: external disease and contact lenses choroidal hemorrhage, after surgery, 122–124 introduction to, 119 litigation emergency room and, 124–129 eye banks and, 124 postoperative endophthalmitis, 119–121 suture removal, 121–122 Corneal laceration, 189 Corneal surgery claims. See Refractive corneal surgery claims Corneal transplant, 119–121 bleeding relating to, 123 Coumadin relating to, 123 emergent situations after, 121 postoperative instructions regarding, 121 Corneal ulcer, descemetocele, or perforation, 159 Corneoscleral lacerations, 156 Corticosteroids, 132, 141 Cosmetic disfigurement, 189 Cosmetic facial surgery, 196–198 Cost, of medical malpractice insurance, 259 Coumadin, 112, 123 Countersuits, 63 Courtesies, adverse events relating to, 86 Courthouse conduct, 58 Covering physician, 6 Cranial nerve palsies, 158

271 CRAO (central retinal artery compression or occlusion), 93, 94, 99, 232 Criteria, for medical expert, 42 CRNA (Certified Registered Nurse Anesthetist), 91, 96, 97, 100, 116 Cross-examination of defendant physician, 17 defense attorney’s styles of dramatic questioner, 17–18 ingratiating questioner, 18 prepared questioner, 18 Cryotherapy treatment, for retinal tears, 232 Curriculum vitae, 33 Cyclomydril, 142

D Damages, 24, 29–30 Daubert v. Merrill Dow Pharmaceuticals, 509 U.S. 579 (1993), 37 Decision to proceed, by plaintiff’s attorney, 31–32 Defendant case of, 14–15 settlements and, 56 Defendant physician cross-examination of, 17 expertise of, 16 jury’s reaction to, 15–17 testimony of, 15–17 Defense attorney codefendants working with, 8 comparative v. contributory negligence relating to, 25 cross-examination styles of, 17–18 damages relating to, 24 defendant physician’s testimony relating to, 15–17 defendant’s case relating to, 14–15 defense expert’s testimony relating to, 18–19 defense helped by, 7 deposition preparation by, 7–8 deposition testimony and trial testimony, differences between, 9–10 Good Samaritan Laws relating to, 23–24 hiring own attorney v., 21–22 joint and several liability relating to, 24–25 jury relating to judge and, roles of, 11 judge v., 10 selection of, 11–12 opening statements of, 12

272 Defense attorney (cont.) physician-patient relationship relating to, 22–23 physician’s testifying questions relating to, 9 plaintiff’s case relating to, 13–14 settlement negotiations relating to, 19 statute of limitations relating to, 19–21 summations relating to, 19 Defense expert, testimony of, 18–19 Denial, as emotional reaction, 252 Deponent, 53–54 Deposition examination before trial as, 53–56 preparation for, 7–8, 34 transcript of, 55 videotape of, 34 Deposition testimony and trial testimony, differences between, 9–10 Descemetocele, 159 Diabetic retinopathy, laser treatment for, 231 Diagnosis, uveitis relating to, 240, 241, 242 Diagnostic problems, with retina and vitreous, 227–230 Diclofenac, 136 Differential diagnosis, uveitis relating to, 240 Dilantin, 29 Discovery rule, 20–21 Discovery, the process of examination before trial (depositions), 53–56 expert’s report, 53 interrogatories, 53 records, review of, 52–53 Discussant and discussion, informed consent regarding, 70 Discussion discussant and, informed consent relating to, 70 of potential risks and complications of uveitis, 241 of risks, 79 Diseases arterial and venous retinal vascular, 231 external and contact lenses, cornea relating to. See Cornea: external disease and contact lenses Graves’, 193–194 orbital, 157 prostate, 114 systemic and ocular, cataract surgery in presence of, 113–114 Documentation drug prescriptions relating to, 133–134 of emergencies, 152

Index of informed consent, 73 medical records and, 79–82 after poor outcome regarding uveitis, 215, 237–238 Documents, 35 Double life, of physician/defendant, 249, 251, 252, 254 Doubt, as emotional reaction, 253 Dramatic questioner, 17–18 Drug interaction, awareness of, 133 Drug Price Competition and Patent Term Restoration Act of 1984, 136 Drugs. See also FDA; INDs; Medication; Off-label drugs anticholinergic, 141 avoiding medication errors or claims in prescribing of, 131–132 for allergies, 133 charts and medical records relating to, 134 drug interaction, awareness of, 133 in handling drug samples, 135–136 medication administration, update of, 133 in medication refills, 135 necessary documentation relating to, 133–134 for needle to eye, 142–143 for pupil dilation, 145 in written prescriptions, 134–135 conclusions about, 145–146 generic eye medication, use of, 136–137 in lawsuits against ophthalmologists, 132 off-label use, during cataract surgery, 111, 112 OMIC relating to, 138, 145 patient counseling regarding, 144–145 patient’s compliance with, improvement of, 144 in PDR, 132 prescribed by ophthalmologists investigational, 138 marijuana, 139 for nursing women, 140–141 off-label, 137–138 for pediatric populations, 141–142 when comanaging patients with other specialists, 137 for women with childbearing potential and pregnant women, 139–140 prescriptions for, documentation relating to, 133–134 problem, magnitude of, 131 samples of, errors in handling of, 135–136 use of, legal affect’s on one’s practice, 143–144 Dysmorphia, 196

Index E Ectasia. See Refractive corneal surgery claims Edema bilateral optic disc, 174–176 of optic nerve heads, 155 Effect, of apology, 87 Elective refractive surgical procedures, involving lens extraction, 110–111 Emergencies ancillary tests relating to, 152 angle closure and other glaucomas, 159 central or branch retinal artery occlusions, 154 chemical burns, 153 communication relating to, 151 conclusions about, 160 corneal ulcer, descemetocele, or perforation, 159 cranial nerve palsies, 158 documentation regarding, 152 emotional issues relating to, 150–151 endophthalmitis, 157 examination, 151 giant cell arteritis, 154–155 globe, rupture of, 156 history relating to, 151 immunocompromised patients, problems with, 160 intraocular foreign bodies, 156–157, 195 introduction to, 149 iridocyclitis, 159–160 lacerations corneoscleral, 156 lid, 155 light and floaters, flashes of, 159 optic nerve heads, edema of, 155 orbital cellulitis, 157–158 orbital disease, 157 orbital fractures, 158 orbital hemorrhage, 158 physician-patient relationship, 149–150 responsibility relating to, 150 RRD, 159 special case situations, 152 Emergency room, litigation and, 124–129 Emergent situations, after corneal transplant, 121 Emotional issues, emergencies relating to, 150–151 Emotional reactions, to serious life events, 250–254 Emotions, medical malpractice charge relating to, 250–251

273 Endophthalmitis, 107–109, 229 as emergency, 157 postoperative, 119–121 Epithelial tumors, 181 Errors common, in evaluation of giant cell arteritis, 178 optic atrophy, 174 papilledema, 176 toxic optic neuropathy, 179 in handling, of drug samples, 135–136 Evidence-based practice, 132 Examination. See also Cross-examination before trial (depositions), 53–56 for uveitis, 240 Expert. See also Defense expert, testimony of; Medical expert medical opinion of, basis of, 42 report of, discovery relating to, 53 Expertise, of defendant physician, 16 Expert witness credentials of, 35 selection of, 52 trial judge and, 37–39 of unethical plaintiff, retribution for, 63–64 External disease and contact lenses, cornea relating to. See Cornea: external disease and contact lenses Eye generic medication for, 136–137 needle to, drug errors in, 142–143 right v. left, in pediatric ophthalmology, 204–205 second, monocular patient, same-day bilateral cataract surgery and, 113 Eye banks, litigation and, 124 Eye drops, ciprofloxacine, 136 Eyelid surgery, functional, 192–193

F Facial fracture repair, 195 Facial surgery, cosmetic, 196–198 Facial trauma, 195–196 Failure risk of, to diagnose uveitis, 242 serious life events relating to feelings of, 253–254 FDA (Food and Drug Administration), 111, 212, 215 drugs and, 135, 137, 138, 139, 142 glaucoma and, 168, 169 pediatric ophthalmology and, 205, 206 Fee-for-service arrangement, 191

274

Index

Financial condition, of company issuing policy loss reserves relating to, 266 loss reserves to surplus ratio relating to, 267 misconceptions about, 265 rating bureaus relating to, 266 surplus relating to, 266 Floaters, flashes of, 159 5-fluorouracil, 138 Food and Drug Administration. See FDA Fracture repair, facial, 195 Fractures, orbital, 158 Free tail endorsement, common misconceptions about, 260, 261–262 Frye v. United States, 293 F. 1013 (D.C. Cir. 1923), 37–40 Fuchs’ dystrophy, 122 Functional eyelid surgery, 192–193

H Health Insurance Portability and Accountability Act. See HIPAA Hemorrhage choroidal, 122–124 orbital, 158 retrobulbar, 93, 94, 95, 96 Herpes simplex virus infection, 121, 128 HIPAA (Health Insurance Portability and Accountability Act), 48 Hippocrates, 65 Hiring of attorney, 21–22 of jury consultant, 36 HIV (human immunodeficiency virus), 181, 182 Human immunodeficiency virus. See HIV Hyaluronidase, 93

G Gatekeeper role, of trial judge, 37, 42 General anesthesia complications of, 98 IOP, 93, 94, 99 MH, 99 Generic eye medication, use of, 136–137 Gentamycin, 94, 120 Giant cell arteritis, 154–155, 177 common errors in evaluation of, 178 Glaucoma, 114, 159 FDA and, 168, 169 introduction to, 163 management of, 163–164 noncompliant patient with, 168 options in, 166 as neuropathy, of optic nerve, 163 pediatric, 165–166 primary congenital, 166 research for, physician’s professional interests and, 168 risk factors for, 164–165 treatment of nontraditional, 167 technology in, 168–170 Globe penetration or perforation of, 93–95, 159 rupture of, 156 Goldmann perimetry, 172, 178 Good Samaritan Laws, 23–24 Good Samaritans, 28 Graves’ disease, 193–194 Gravity, of offense, 86 Guilt, as emotional reaction, 253

I Immature retina, 207 Immunocompromised patients, problems with, 160 Inadequate apology, 88 INDs (investigational new drugs), 138 Infections cataract surgery relating to, 108 herpes simplex virus, 121, 128 mycobacterium avium intracellulare, 178 pseudomonas, 125, 126 Informed consent, 227 for cataract surgery, 106 conclusion about, 74–75 definition of, 66–67 exceptions to, 68–69 history of, 65–66 indications for, 68 informed refusal, 74 lawsuit standard for lack of, 69 for ophthalmic plastic surgery, 188–190 process of consent form, 72–73 consent material, presentation of, 69–70 discussant and discussion, 70 documentation, 73 patient, questions for and by, 71–72 risks, benefits, alternatives, 70–71 setting during, 70 purposes of, 67–68 for refractive corneal surgery, 221–222 as risk prevention strategies, 79 Informed refusal, 74

Index Ingratiating questioner, 18 Injection, accidental intra-arterial, 97 intravenous, 97 Injury, nature and extent of, 29 INR (international normalized ratio), 112 Insurance. See Medical malpractice; OMIC Insurance company-attorney-physician relationship, 50 International normalized ratio. See INR International Society of Refractive Surgeons of the AAO. See ISRS/AAO Interrogatories, 32–34 Intra-arterial injection, accidental, 97 Intracameral lidocaine, 112 Intracameral steroids and antibiotics, 112 Intraocular foreign bodies, 156–157, 195 Intraocular lens exchange, 122 Intraocular lymphoma, 183, 184 Intraocular medications, 230–231 Intraocular pressure. See IOP Intraocular tumors and lesions, 182 Intravenous injection, accidental, 97 Intravitreal triamcinolone acetonide, 137 Investigational new drugs. See INDs IOP (intraocular pressure), 93, 94, 99 Iridocyclitis, 159–160 ISRS/AAO (International Society of Refractive Surgeons of the AAO), 214

275

J Joint and several liability, 24–25 Judge jury and, roles of, 11 jury v., 10 trial, 37–39, 42 Jury to defendant physician, reaction of, 15–17 deliberations of, verdict and, 62 judge and, roles of, 11 judge v., 10 selection of, 11–12, 58 Jury consultant, hiring of, 36 Justice Department, U.S., 139

L Laboratory tests, referral, and treatment plan, for uveitis, 240–241 Lacerations, 155, 156 Lacrimal surgery, 187, 193–194 Laser. See LASIK; Retina and vitreous, medical treatment for Laser-assisted in situ keratomileusis. See LASIK Laser skin resurfacing techniques, 197–198 Laser trabeculoplasty, 164, 166, 168 LASIK (laser-assisted in situ keratomileusis), 209, 210, 211, 214, 215–219 Lawsuits. See also Countersuits; Medical malpractice; Prelawsuit activities informed consent relating to, 69 against ophthalmologists, drugs relating to, 132 Legal effect’s, on practice, drug use relating to, 143–144 Legible medical record, importance of, 105–106 Lens, contact. See Cornea: external disease and contact lenses Lens exchange, intraocular, 122 Lens extraction, elective refractive surgical procedures involving, 110–111 Lens implantation, 110 Lesions and tumors, intraocular tumors, 182 Liability, 29 joint and several, 24–25 vicarious, 5–6 Lid lacerations, 155 Lidocaine, 92 Light and floaters, flashes of, 159 Literature review, of refractive corneal surgery malpractice claims, 219–220 Litigation emergency room and, 124–129 eye banks and, 124 Litigious patient, identifying and managing of, 82–83 Local anesthesia, 92–93 Loss reserves, 266 to surplus ratio, 267

K Keratectomy. See PRK Keratitis, 128 Keratotomy. See Refractive corneal surgery claims

M Macular degeneration, age-related, laser and medical treatment for, 231 Malignant hyperthermia. See MH Maloccurrence, 5

276 Malpractice. See Medical malpractice Malpractice claims, of refractive corneal surgery, literature of, 219–220 Management, of glaucoma, 163–164 noncompliant patient with, 168 options in, 166 Manage patient expectations, for refractive corneal surgery, 220 Marijuana, 139 Medical expert advice for, 45–46 basis for expert opinion of, 42 criteria for, 42 introduction to, 41 minefields for, 44–45 needed for, 41 process of, 42–43 testimony of, 43–44 Medical malpractice basic terminology for allegations, 5 introduction to, 3 maloccurrence, 5 medical misadventure, 5 negligence, 4 proximate cause, 4–5 respected minority, 5 standard of care, 3–4 tort, 4 vicarious liability, 5–6 charges of assessing meaning of, 250 correcting distortions relevant to, 255–256 emotions associated with, 250–251 environment surrounding, 249–250 claims, outcomes of, 254 insurance for company issuing policy, financial condition of, 265–267 conclusion to, 267 consent to settle clause, 262–264 cost of, 259 free tail, common misconceptions about, 260, 261–262 introduction to, 259 policy form, 259–261 policy limits, choosing of, 264 suit, sequence of events in attorney, selection of, 50 complaint, 51 countersuits, 63 discovery, the process of, 52–56 expert witness, selection of, 52

Index narrative summary, 51–52 patients’ suits relating to, 47 physician-attorney-insurance company relationship, 50 prelawsuit activities, 47–49 settlement, 56–57 summons, 49 trial, 57–62 unethical plaintiff’s expert witness, retribution for, 63–64 Medical misadventure, 5 Medical records, 33 charts and, drugs relating to, 134 collection and review of, 30–31 documentation and, 79–82 legible, importance of, 105–106 request for, 48 Medication. See also Drugs; Retina and vitreous, medical treatment for administration of, update of, 133 errors in, avoidance of, 131–132 for ophthalmic plastic surgery, 198–199 refills of, avoiding errors in, 135 tests and, for retina and vitreous, 227 for uveitis, 239 Melanomas choroidal, 229–230 conjunctival, 181 uveal, 183 MH (malignant hyperthermia), 99 Minefields, for medical expert, 44–45 Misconceptions, about free tail endorsement, 260, 261–262 Mitomycin-C, 138 Models, 35 Modification, of behavior, 85 Monocular patient, second eye, same-day bilateral cataract surgery and, 113 Mortality and Morbidity Rounds on Web. See Web M&M Mycobacterium avium intracellulare infection, 178 Mydriacyl, 142 Myotoxicity, 97–98

N Nadbath block, 92 NAION (nonarteritic anterior ischemic optic neuropathy), 173 Narrative summary, 51–52 Nasolacrimal duct obstruction, 194 National Board of Medical Examiners, 33 National Practitioner Data Bank, 33

Index National Registry of Drug-Induced Ocular Side Effects, 140 Needle to eye, drug errors in, 142–143 Negligence, 4 charge of, reactions to, 253 comparative, 25 contributory, 25 Negotiations, settlement, 19 Neuroophthalmology claim types from cases of, 171–179 introduction to, 171 Neuropathy, of optic nerve, 163 Nonarteritic anterior ischemic optic neuropathy. See NAION Noncompliant patient, with glaucoma, 168 Nonophthalmic laser in situ keratomileusis, 218–219 Nontraditional glaucoma, treatment of, 167 Novel treatment, for pediatric ophthalmology, 205 Nursing women, drugs prescribed for, 140–141

O Occlusions. See Central or branch retinal artery occlusions Occurrence-type policy, 259–261 Ocular and facial trauma, 195–196 and systemic diseases, cataract surgery in presence of, 113–114 Oculocardiac reflex, 97 Offense, gravity of, 86 Off-label drugs prescribed by ophthalmologists, 137–138 prescribed for pediatric ophthalmology, 205–206 Off-label pharmacologic agents, used during cataract surgery, 111, 112 OMIC (Ophthalmic Mutual Insurance Company), 119 cataract surgery relating to, 105, 111, 116 drugs relating to, 138, 145 neuroophthalmology relating to, 171 refractive corneal surgery claims statistics of, 209–212 statistics of, for refractive corneal surgery claims, 209–212 Oncology, 181–185 Opening statements, 12, 59 Operative report, 106–107

277 Ophthalmic Mutual Insurance Company. See OMIC Ophthalmic plastic surgery anesthesia administration and medication for, 198–199 bleeding associated with, 199 conclusions about, 199–200 cosmetic facial surgery, 196–198 functional eyelid surgery, 192–193 handling disappointment with, 190–191 informed consent for, 188–190 ocular and facial trauma, 195–196 orbit and lacrimal surgery, 193–194 paralytic agents used for, 197 risks of, 187 special considerations for, 187–188 Ophthalmic subspecialty claims by, 210 risk management on, 89 settlement by average, 211 total, 212 Ophthalmologists. See also Drugs risk prevention strategies of, 83–84 vitreoretinal risk factors for, 225 Optic atrophy, 172–174 common errors in evaluation of, 174 Optic nerve atrophy of, 95–96 dysfunction of, 182 neuropathy of, 163 Optic nerve heads, edema of, 155 Optic nerve sheath, penetration of, 96 Orbital cellulitis, 157–158 Orbital disease, 157 Orbital fractures, 158 Orbital hemorrhage, 158 Orbital tumefactions, 182 Orbit and lacrimal surgery, 193–194

P Papilledema, 175, 176 common errors in evaluation of, 176 Paralegal, client intake by, 29 Paralytic agents, 197 Pars plana vitrectomy, for problems other than RRD, 233–234 Patients comanaging of, drugs relating to, 137, 222 counseling of, regarding drugs, 144–145 drug compliance of, improvement of, 144 immunocompromised, problems with, 160

278 Patients (cont.) informed consent questions for and by, 71–72 litigious, identifying and managing of, 82–83 manage expectations of, for refractive corneal surgery, 220 monocular, second eye, same-day bilateral cataract surgery and, 113 noncompliant, with glaucoma, 168 and physician relationship, 22–23, 27, 48, 78–79, 149–150, 190–191, 203 postoperative instructions to, 107 prudent, 71 suits of, 47 trauma, 195 uveitis relating to, 238–239, 241 PDR (Physicians’ Desk Reference), 132, 244 Pediatric glaucoma, 165–166 Pediatric ophthalmology abandonment relating to, 203 consultant relating to, 204 FDA and, 205, 206 final thoughts about, 207–208 introduction to, 201 novel treatment for, 205 off-label prescribing for, 205–206 physician and patient relationship during, 203 promises about, 203 right eye v. left eye, 204–205 ROP, 206–207 third parties relating to, 202 unaccompanied minor relating to, 201–202 Pediatric populations, drugs prescribed for, 141–142 Penetration of globe, 93–95 of optic nerve sheath, 96 Perforation, of globe, 93–95, 159 Periocular/retrobulbar medications, 230 PERLA (pupils equal in size, react to light and accommodation), 152 PERRLA (pupils equal, round, and reactive to light and accommodation), 172, 173, 177 Personal counsel, 22 Personal feelings, about serious life events, 255 Personality traits, of physician/defendant, 253 Pharmacologic agents, off-label use of, for cataract surgery, 111, 112

Index Phenylephrine, 141, 142 Photorefractive keratectomy. See PRK Physician covering, 6 defendant, testimony of, 15–17 opinions of, 8 and patient relationship, 22–23, 27, 48 during emergencies, 149–150 during pediatric ophthalmology, 203 during plastic surgery, 190–191 risk prevention strategies relating to, 78–79 research for glaucoma and, 168 testifying questions of, 9 uveitis communications with other, 243 Physician and defendant. See also Defendant physician areas of control identified by, 254–255 charge of negligence, reactions to, 253 double life of, 249, 251, 252, 254 emerging as stronger and healthier person, 256 introduction to, 249 medical malpractice charge assessing meaning of, 250 correcting distortions relevant to, 255–256 emotions associated with, 250–251 environment surrounding, 249–250 personality traits of, 253 serious life events, understanding emotional reactions to, 250–254 support needed by, 256 tort law relating to, 253–254 trial testimony of, 60–61 Physician-attorney-insurance company relationship, 50 Physician Insurers Association of America. See PIAA Physicians’ Desk Reference. See PDR PIAA (Physician Insurers Association of America), 131, 135, 144 Plaintiff case of, 13–14 settlements and, 56 unethical, expert witness of, retribution for, 63–64 Plaintiff’s attorney case analysis relating to client intake-history and damages, 29–30 decision to proceed, 31–32 external, 31 injury, nature and extent of, 29

Index liability, 29 medical records-collection and review, 30–31 conclusion of, 36 depositions relating to, 34 interrogatories relating to, 32–34 introduction to, 27–29 trial preparation by, 34–36, 49 Plaquenil, 137 Policy form, for medical malpractice insurance claims-made, 259–261 free tail endorsement as part of, 260, 261–262 occurrence-type, 259–261 Policy limits, choosing of, 264 Post-laser in situ keratomileusis ectasia, 219 Postoperative endophthalmitis, 119–121 Postoperative instructions corneal transplant regarding, 121 to patients, 107 Postoperative treatment, of cataract surgery, 108 Potential risks and complications, of uveitis, discussion of, 241 Practice of Medical Exemption, 206 Predeposition conference, 54 Prednisolone acetate 1%, 136 Pregnant women, drugs prescribed for, 139–140 Prelawsuit activities, 47–49 Prepared questioner, 18 Prescriptions. See Drugs Pretrial mock trial, 36 Prevention, of risks. See also Risk prevention adverse events relating to, 86–87 Primary congenital glaucoma, 166 Private detectives, 13–14 PRK (photorefractive keratectomy), 209, 214–215 Proactively comanage patient care, for refractive corneal surgery, 222 Problem, of drugs, magnitude of, 131 Proparacaine, 92 Prostate disease, 114 Proximate cause, 4–5 Prudent patient, 71 Pseudomonas infection, 125, 126 Ptosis surgery, 190, 191, 192 Pulsed neodymium-YAG laser, 168–169 Punitive damages, 24 Pupil dilation, drugs for, 145

279 Pupils equal, round, and reactive to light and accommodation. See PERRLA Pupil size LASIK relating to, 218 refractive corneal surgery relating to, 220

Q Questionnaire, patient, regarding uveitis, 238–239

R Radial keratotomy. See RK RAPD (relative afferent papillary defect), 173 Rating bureaus, 266 Records billing, 33 medical. See Medical records review of, 52–53 Referral, to specialist, regarding uveitis, 242 Refills, in medication, avoiding errors in, 135 Refractive corneal surgery claims conclusion to, 222 introduction to, 209 LASIK, 215–218 nonophthalmic, 218–219 post-laser in situ keratomileusis ectasia, 219 pupil size relating to, 218 literature review of malpractice issues in, 219–220 minimize likelihood of ectasia relating to, 221 informed consent relating to, 221–222 manage patient expectations, 220 proactively comanage patient care, 222 pupil size relating to, 220 OMIC statistics relating to, 209–212 PRK, 209, 214–215 RK, 209, 212–213 Refractive surgery 1989-2002, 213 1995-2006, 214 cataract surgery claims v., 210 elective, 110–111 LASIK, 209 PRK, 209, 214–215 RK, 209 Relative afferent papillary defect. See RAPD Research for glaucoma, physician’s professional interests and, 168

280 Respected minority, 5 Responsibility emergencies relating to, 150 serious life events relating to sense of, 253 Retina and vitreous allegations relating to, 226 appointments relating to, 226–227 conclusions about, 235 diagnostic problems choroidal melanoma, 229–230 endophthalmitis, 229 medications and tests, 227 retinal tear/detachment, 228–229 vitreoretinal risk factors, for ophthalmologists, 225 vitreoretinal specialist consultations, 225–226 Retina and vitreous, medical treatment for age-related macular degeneration, laser and medical treatment for, 231 arterial and venous retinal vascular diseases, laser treatment of, 231 CRAO, 232 diabetic retinopathy, laser treatment for, 231 intraocular medications, 230–231 periocular/retrobulbar medications, 230 retinal tears, laser/cryotherapy treatment of, 232 retinopathy of prematurity, 234 RRD, 232–233 pars plana vitrectomy for problems other than, 233–234 topical medications, 230 Retina, immature, 207 Retinal artery occlusions, central or branch, 154. See also CRAO Retinal tear and detachment, 228–229 laser/cryotherapy treatment of, 232 Retinal vascular diseases, arterial and venous, laser treatment of, 231 Retinopathy diabetic, laser treatment for, 231 of prematurity. See ROP Retribution, for unethical plaintiff’s expert witness, 63–64 Retrobulbar block, 93 Retrobulbar hemorrhage, 93, 94, 95, 96 Retrobulbar/periocular medications, 230 Rhegmatogenous retinal detachment. See RRD Right eye v. left eye, in pediatric ophthalmology, 204–205

Index Risk assumption of, 167 benefits, alternatives, of informed consent, 70–71 complications and, about uveitis, 241 discussion of, 79 of failure, uveitis relating to, 241–245 of ophthalmic plastic surgery, 187 prevention of, adverse events relating to, 86–87 Risk factors for glaucoma, 164–165 of local anesthesia, 92 vitreoretinal, 225 Risk management issues, about cataract surgery, 105–107 Risk management, on ophthalmic subspecialties and related fields, 89 Risk management support, 212 Risk prevention, 47 cataract surgery relating to, 104–105 effective strategies of discussion of risks, 79 documentation and medical records, 79–82 good results of, 77–78 informed consent relating to, 79 introduction to, 77 litigious patient, identifying and managing of, 82–83 opportunities for perceptive ophthalmologists, 83–84 physician-patient relationship relating to, 78–79 RK (radial keratotomy), 209, 212–213, 214 ROP (retinopathy of prematurity), 206–207, 234 RRD (rhegmatogenous retinal detachment), 159, 232–234 Rush, Benjamin, 65

S Same-day bilateral cataract surgery, second eye, monocular patient and, 113 Selection of attorney, 50 of expert witness, 52 of jury, 11–12, 58

Index Serious life events, understanding emotional reactions to appraisal of, 250 denial, 252 exaggerated sense of responsibility, 253 failure relating to, 253–254 guilt, 253 intrusion, 252 outcry relating to, 251 personal feelings about, 255 working through, 252 Serum TSH (thyroid stimulating hormone) level, 182 Settlements, 56–57 defendants and, 56 negotiations of, 19 plaintiffs and, 56 Squamous cell carcinoma, 181 Standard of care, 3–4 of lawsuit, informed consent relating to, 69 Stare decisis, 65 State v. Cavallo, 88 N.J. 508 (1982), 38 Statute of limitations, 19–21, 32 Steroids intracameral, 112 topical, 128 Structure and effect, of apology, 87 Subpoena duces tecum, 48 Sufficient disclosure, 189 Summations, 19 Summons, 49 Support physician/defendant in need of, 256 risk management, 212 Supreme Court, U.S., 37, 139 Surgery. See also Cataract surgery; Ophthalmic plastic surgery choroidal hemorrhage after, 122–124 Surplus, 266 Suture removal, 121–122 Systemic and ocular diseases, cataract surgery in presence of, 113–114 Systemic toxicity, 93

T Technology in glaucoma treatment, 168–170 new, for cataract surgery, 114–115 Terminology. See Medical malpractice Testimony. See also Trial testimony of defendant physician, 15–17 of defense expert, 18–19 of medical expert, 43–44

281 Tests ancillary, emergencies relating to, 152 laboratory, referral, and treatment plan, for uveitis, 240–241 for retina and vitreous, 227 Tetracaine, 92 Third parties, pediatric ophthalmology relating to, 202 Thyroid orbitopathy, 182 Timolol gel-forming solution, 137 Timoptic-XE, 137 TobraDex, 128 Topical anesthesia, 92 Topical antibiotics, 141 Topical β-blocker, 140, 142 Topical medications, for retina and vitreous, 230 Topical steroids, 128 Tort/tort law, 4, 253–254 Toxicity, systemic, 93 Toxic optic neuropathy, common errors in evaluation of, 179 Transcript, of deposition, 55 Transplant, corneal. See Corneal transplant Trauma, facial, 195–196 Trauma patient, 195 Trial, 57–62 appeal relating to, 62 attendance at, 57–58 courthouse conduct at, 58 examination before, 53–56 jury relating to charge to, 62 deliberations of, verdict and, 62 selection of, 11–12, 58 opening statements at, 59 plaintiff’s attorney’s preparation for, 34–36, 49 charts, 35 documents, 35 jury consultant, hiring of, 36 models, 35 pretrial mock trial, 36 summations at, 61 Trial judge expert witnesses and, 37–39 function of, 38 gatekeeper role of, 37, 42 hearings and, 37 Trial testimony deposition testimony and, differences between, 9–10 of others, 59–60 of physician defendant, 60–61 Truman v. Thomas, 74

282 Tumors epithelial, 181 intraocular, 182

U Ulcer, corneal, descemetocele, or perforation, 159 Unaccompanied minor, pediatric ophthalmology relating to, 201–202 Underwriting requirements, 212 Unethical plaintiff’s expert witness, retribution for, 63–64 Unilateral or bilateral proptosis, 182 United States Pharmacopeial Convention. See USPC United States v. Addison, 498 F.2d 741 (D.C. Cir 1994), 38 USPC (United States Pharmacopeial Convention), 144 Uveal melanoma, 183 Uveitis advice to patient regarding, 241 chief complaint and history of, 239 chronic, 114 communications with other physicians regarding, 243 conclusion to, 245 detailed patient questionnaire regarding, 238–239 diagnosis of, 241 differential diagnosis relating to, 240 documentation, after poor outcome regarding, 215 documentation regarding, 237–238 examination for, 240 introduction to, 237 laboratory tests, referral, and treatment plan for, 240–241 medications for, 239

Index potential risks and complications, discussion of, 241 referral to specialist regarding, 242 risk of failure to diagnose, 242 in proper treatment, 243–244 to timely refer, 242–243 in treatment-associated complications, 244–245

V Vasocidin, 128 Venous and arterial retinal vascular diseases, laser treatment of, 231 Verdict, jury deliberations and, 62 Vicarious liability, 5–6 Videotape, of deposition, 34 Vitrectomies, 119, 123, 184, 233–234 Vitreoretinal risk factors, for ophthalmologists, 225 Vitreoretinal specialist consultations, 225–226 Vitreous. See Retina and vitreous

W Warfarin sodium, 133 Web M&M (Mortality and Morbidity Rounds on Web), 143 Women with childbearing potential, drugs for, 139–140 nursing, drugs prescribed for, 140–141 pregnant, drugs for, 139–140 Written prescriptions, errors in, 134–135

X Xylocaine 2%, 94