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Complications: Acceptable or not?
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In the film, Rashomon, director Akira Kurosawa presents the theme that truth, in an individual’s experience and perception, is relative. The film tells the tale of a samurai and his wife, who are attacked by a bandit. The bandit kills the husband and then engages in sexual relations with the wife.
The story is told from three perspectives — wife, bandit and deceased husband (via a mystic). Each tale seems to be an objective version of the events.
Rashomon may be an excellent allegory for the conflicting views of what constitutes an act of professional negligence. Both surgeons and patients relate to an adverse surgical event in different, but seemingly “objective” ways. This is particularly true in orthopedic surgery, where the patient’s goal and expectation is to regain function.
When patients do not regain function, but rather become worse because of surgically related complications, they often perceive the orthopedic surgeon as negligent. Orthopedic surgeons, highly trained and possessing sophisticated skills are, in turn, likely to perceive intraoperative injuries as unavoidable and inherent risks of surgery.
B. Sonny Bal
In the objective worlds of both the orthopedic surgeon and the patient, there are times when each sees himself or herself as the victim: the patient as the victim of professional negligence and the orthopedic surgeon as the victim of an unfair lawsuit.
Acceptable complication
Nowhere is the Rashomonic view more evident than in the debate about what constitutes an “acceptable complication” of surgery. When plaintiffs and defendants in professional liability lawsuits offer different views on whether a surgical injury was or was not acceptable, the question invariably arises — acceptable to whom? Is it acceptable to the medical community, to the injured patient or to society? Is it acceptable because the particular risk was in the informed consent, thereby absolving the surgeon of liability?
This conflict is reflected in the question sometimes posed by plaintiffs’ attorneys when cross-examining defense expert witnesses: “When you refer to standard of care, are you referring to minimally acceptable care, average care or the care that you would want to receive for yourself or a loved one?” Turning to a particular procedure as an example, the large number of professional negligence cases has occurred since the introduction of laparoscopic cholecystectomies reflects the relative views of surgeons and patients regarding the acceptability of surgical injuries.
In this example, there was an increase in the number of patients whose common or hepatic ducts were unintentionally divided during surgery. These bile duct injuries led to professional liability lawsuits. The question that arose in these early lawsuits was: “Is dividing the common duct during the performance of a laparoscopic cholecystectomy an ‘acceptable complication’ of that procedure?”
Even though dividing the common duct frequently results from the surgeon confusing the common duct for the cystic duct, many general surgeons believe that is an acceptable complication. They reason patients are informed of the risk of bile duct injuries, that the biliary anatomy has many unexpected variations that are difficult to differentiate, and that even the most competent general surgeons have unintentionally divided the common duct. Moreover, some surgical errors are anticipated and will inevitably occur. To insist (for liability purposes) that a general surgeon will never mistakenly divide the common duct, is to create a standard of care that demands infallibility.
Patient view
Patients who have their common bile ducts unintentionally divided, however, view this injury much differently. They note that general surgeons are aware that variations or anomalies are common in the biliary anatomy. The surgeon should be aware that variations or anomalies are common in the biliary anatomy. The surgeon should be aware of these variations and take the utmost care to avoid mistaking the common duct for the cystic duct. Because the cystic duct is the only structure that enters the gallbladder, unintentionally dividing the common duct can always be avoided if the general surgeon conclusively identifies the cystic duct before dividing any structure. If the cystic duct cannot be conclusively identified, the should perform intraoperative cholangiography or convert to an open procedure.
Patients argue that excusing surgical mistakes (by dismissing them as acceptable complications) because other surgeons have made the same mistake results in a form of rhetorical immunity from liability. Patients are also troubled by the logic that if a surgical complication is deemed acceptable because it is known to occur, then apparently, the more frequently an injury occurs, the more acceptable it must be. This logic would inevitably lead to a decrease in patient safety in their eyes, because the more common a surgical mistake, the more liability protection is afforded to a surgeon.
Lawrence H. Brenner
It may well be that the term “acceptable complication” has entered the vocabulary of professional negligence litigation because it acts as a substitute for reasoning through the more difficult liability questions posed by surgical complications. Should surgeons be held liable for all avoidable injuries that occur during surgery? Does the standard of care allow for any surgical error? If so, how do we differentiate acceptable surgical errors from unacceptable surgical errors?
A related issue is the interpretation of data documenting the rate of surgical injury. For example, spinal surgery results in dural injuries in 1% to 2% of cases. What inferences are we to draw form this data? Is this the rate below which surgeons cannot avoid injury, despite the utmost care utilized during the performance of surgery? Do these data represent the rate of negligence during spinal surgical procedures? Perhaps there is no inference that may be drawn from these data that sheds light on whether a complication is acceptable.
Risk management principles
No bright line separates an acceptable orthopedic surgery complication from on that is unacceptable. Moreover, it is extremely difficult to develop legal principles to uniformly distinguish between negligent and non-negligent surgical injuries.
Nevertheless, the following risk management principles should help orthopedic surgeons reduce the risk of patient injury and, if injury does occur, persuade a judge or jury it was an acceptable complication for which the surgeon should not be held liable. Moreover, these can serve as guidelines in determining when a surgical injury is the result of a violation of the standard of care.
- Make certain that you are aware of the significant complications of the surgery you propose to perform (and document it). At the most basic level, if you are not aware of the complications associated with the procedure — especially those that are known to occur with some degree of frequency, you cannot take the expected actions to avoid them. Excessive bone removal during hallux valgus surgery can lead to hallux varus deformity. If you are unaware that bone removal during hallux valgus can result in hallux varus, you are unlikely to be mindful of this complication as you remove bone. Therefore, you may not be sufficiently careful in its removal or properly gauge the amount of bone to be removed.
- Take appropriate actions to prevent or minimize injury associated with the occurrence of known complications (and document those actions). Simply because something is a recognized complication does not mean the surgeon can be reckless or careless in trying to avoid its occurrence. An extreme example might be failing to place appropriate padding around a patient on the OR table. There is a risk that even with padding the patient will sustain a neuropraxia, but failing to adequately pad the patient would be difficult to justify.
In a recent liability case, a patient filed an action arising from injury to his paraspinal muscles and permanent lumbosacral nerve root damage as a result of inadequate padding during a prolonged surgical procedure. Similarly, if you do not take reasonable actions to prevent or limit an intraoperative injury or complication, it is far more difficult to persuade a jury that your conduct was reasonable and diligent (and therefore, that complication was acceptable).
- Objectively assess your proficiency and competency to perform complex orthopedic surgical procedures. Be realistic about the difficulty and whether you have the appropriate skills to perform it. The testimony of an orthopedic expert medical witness who has performed many similar cases may be more persuasive to a judge or jury than that of an orthopedic surgeon possessing limited experience with it.
Consider the following case scenario: A patient undergoing total elbow arthroplasty sustains an intraoperative fracture. This could happen to a surgeon regardless of his or her experience in performing the procedure. Whether true or not, the psychological presumption may well be that the person who has the greater experience will have exercised all reasonable care while the person without the experience may not have exercised the same care.
If you have limited experience in performing a procedure (but elect to perform it), you must be especially mindful of the previous two risk management principles and document both an awareness of significant complications as well as the actions taken to minimize the risk of occurrence.
For more information:
B. Sonny Bal, MD, JD, MBA; and Lawrence H. Brenner, JD, are partners in the law firm of BalBrenner/Orthopedic Law Center and are the exclusive providers of loss prevention, risk management and quality improvement services for the Orthopedic Physician’s Insurance Company. Brenner can be reached at lbrenner@balbrenner.com.
Disclosures: Bal and Brenner report no relevant financial disclosures.