Endoscopic sinus surgery is one of the most litigated areas in otolaryngology. Physicians typically receive little education regarding medicolegal issues during training and may find themselves in an unfamiliar territory during litigation. This article reviews the scope of the problem and provides strategies to improve patient care and mitigate medicolegal risk in endoscopic sinus surgery.
Overview
“Few issues in health care spark as much ire and angst as medical malpractice litigation.” The current malpractice climate in the United States has fueled much debate and emotion on the part of attorneys as well as physicians. Physicians may feel pressure, real or perceived, to order additional testing or take additional steps to document for fear of litigation, adding to the cost of health care delivery.
Frivolous lawsuits comprise approximately 37% of malpractice cases, accounting for about 15% of the system’s cost. Studies have shown that the great majority of patients who sustain a medical injury as a result of negligence do not sue. However, lawsuits, whether appropriate or frivolous, are viewed as an assault on the character and competence of the physician. For psychologic, monetary, and patient safety reasons, the malpractice system has tremendous effect on physicians and society.
Functional endoscopic sinus surgery (FESS), due to its location adjacent to the orbit and beneath the skull base and its proximity to the optic nerve and carotid artery, is a procedure fraught with potentially catastrophic complications. Sinusitis is the most common diagnosis involved in otolaryngology lawsuits. From 1985 to 2005, rhinology claims represented 70% of the total indemnity compensation for otolaryngology claims.
Anatomy of a lawsuit
Malpractice law is part of personal-injury tort law. To win a lawsuit, the plaintiff must “prove that the defendant owed a duty of care to the plaintiff, that the defendant breached this duty by failing to adhere to the standard of care expected, and that this breach of duty caused an injury to the plaintiff.” Typically, the standard of care and causation must be determined by testimony of expert witness. In theory, the mere occurrence of a complication should not result in loss of a lawsuit, if the physician was following the standard of care. The reality, however, is that the occurrence of a disastrous injury is predictive of payment to the plaintiff regardless of whether the standard of care was met.
Anatomy of a lawsuit
Malpractice law is part of personal-injury tort law. To win a lawsuit, the plaintiff must “prove that the defendant owed a duty of care to the plaintiff, that the defendant breached this duty by failing to adhere to the standard of care expected, and that this breach of duty caused an injury to the plaintiff.” Typically, the standard of care and causation must be determined by testimony of expert witness. In theory, the mere occurrence of a complication should not result in loss of a lawsuit, if the physician was following the standard of care. The reality, however, is that the occurrence of a disastrous injury is predictive of payment to the plaintiff regardless of whether the standard of care was met.
Malpractice and rhinology
Endoscopic sinus surgery is one of the most litigated surgeries in otolaryngology. It can also be the most expensive in terms of judgments. The 3 most common complications listed in FESS lawsuits are intracranial complications (including cerebrospinal fluid [CSF] leak), orbital injury (including blindness), and anosmia ( Box 1 ).
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Intracranial complications (CSF leak, brain injury, meningitis, hemorrhage)
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Orbital injuries (blindness, diplopia)
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Anosmia
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Atrophic rhinitis
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Death
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Failure to diagnose or delayed diagnosis of cancer.
In Lynn-Macrae and colleagues’ review of 41 cases from 1989 to 2003, they found that the average award to plaintiffs in FESS cases was $751,000, with a range of $61,000 to $2.87 million. The highest awards were in cases of CSF leak, anosmia, blindness, wrongful death, and intractable pain. The following allegations were noted in Lynn-Macrae and colleagues’ review: 76% of cases alleged negligent technique; 37%, lack of informed consent; 5%, wrongful death; 27%, surgery not indicated; and 7%, failure to diagnose. Multiple allegations are often present within a case. About 41% of cases were won by plaintiff, whereas 56% of cases were successfully defended by the physician. Lydiatt and Sewell similarly found that in 62% of cases, the physician defendant won the case, with plaintiffs winning 23% of cases that went to court, whereas 15% of cases were settled. In the study by Lydiatt and Sewell, the median judgment was $650,000, with a median settlement of $575,000. The range of awards given was from $16,000 to $25 million. FESS complications, sinonasal cancer, and misdiagnosis were the most common cases seen in their analysis of sinonasal lawsuits.
Informed consent
Failure to obtain a patient’s informed consent before sinus surgery is malpractice. A patient has the legal right to consent, or refuse consent, to any recommended treatment or procedure and the right to sufficient information to make a knowledgeable and informed decision about a proposed procedure. Informed consent is not simply a form or the signature of the patient on the operative permit. It is the process of discussion between patient and provider as well as the documentation of that process and the patient’s agreement to proceed with treatment. Physicians must describe the recommended treatment or procedure and disclose the benefits, risks, potential complications, and alternatives to the proposed treatment, nontreatment, or procedure ( Box 2 ). The surgeon’s emphasis should be on the discussion with the patient, not just a signed piece of paper. Several studies have been published on informed consent in endoscopic sinus surgery.
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Patient’s diagnosis, if known
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Nature and purpose of proposed treatment
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Risks and benefits of treatment
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Alternatives
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Risks and benefits of alternative treatments
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Risks and benefits of not proceeding with the suggested treatment
Data from AMA Patient Physician Relationship Topics. Informed consent. Available at: http://www.ama-assn.org/ama/pub/physician-resources/legal-topics/patient-physicianrelationship-topics/informed-consent.shtml ; accessed January 10 2010.
The legal standard for informed consent is typically the reasonable patient or reasonable physician standard, outlined as follows: what would the typical physician discuss about the intervention (the reasonable physician standard) and what would the average patient need to know to make an informed decision (the reasonable patient standard). In the United States, the applicable legal standard for judging the adequacy of informed consent is determined at the state level. As to the reasonable patient standard, Vaughan and colleagues found that patients want to know not only the common risks and complications in FESS but also the rare, high-morbidity risks. FESS risks are outlined in Box 3 . Most otolaryngologists counsel patients regarding the risk of CSF leak and orbital injury, but Wolf and colleagues found that only 40% of otolaryngologists disclosed the risk of anosmia as a possible complication of FESS. Anosmia should be discussed as a potential risk during the informed consent process. Documentation of the extent of smell and taste should be done before performing FESS.
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Bleeding, infection, synechiae
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Lacrimal duct injury
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Atrophic rhinitis
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Skull base or intracranial injury: CSF leak, intracranial hemorrhage, brain damage, pneumocephalus, meningitis/abscess
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Orbital injury: blindness, diplopia, orbital hematoma, subcutaneous emphysema
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Anosmia or hyposmia
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Death, stroke, heart attack, or other unexpected problems associated with anesthesia
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Need for postoperative nasal endoscopy, debridement, and long-term care
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Potential need for future surgeries and medicines
A full and open discussion should take place with the patient and all questions should be answered. This process must be documented. Care should be taken to ensure that the patient understands the recommendations and risks associated with endoscopic sinus surgery. Questions such as “Do you understand? Should I draw you a diagram? Would you like me to repeat that? Do you have any other questions or concerns that we haven’t addressed?” can help the patient and guide the speed and level of detail that the surgeon provides. A preprinted handout for the patient to review may also generate questions ahead of time and be helpful as an adjunct to the consent discussion ( Fig. 1 ). It is advisable to have the patient sign the handout.
