August 01, 2010
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Document to manage complications and avoid litigation

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Complications are inevitable in the course of any high-risk venture, such as elective orthopedic surgery. Adverse events can occur and compromise the outcome of surgery despite the flawless execution of a procedure. Such complications are deemed to be intrinsic, or inherent to the procedure itself; these occur at a regular frequency even when performed expertly by the best of surgeons. Examples of such complications include: nerve injuries for which there is no explanation; deep vein thrombosis/pulmonary emboli (DVT/PE) problems despite the use of a multimodal anticoagulation regimen; cardiac arrest despite a comprehensive cardiac evaluation before surgery; cerebrovascular accident; and a myriad of similar, unpleasant events.

Avoidable complications

On the other hand there are complications that we recognize as avoidable. At best, these serve as reminders to be careful, or to institute safety measures, or changes in institutional or personal protocols to avoid recurrence. These complications occur with less frequency with increased surgeon experience, learning, and wisdom. Examples could include a transient peroneal palsy following a knee replacement traced to a tight bandage, urinary retention from a misplaced Foley catheter, or surgeon carelessness leading to a vascular injury that requires repair. When such complications occur from a lack of due diligence, they can serve as a wake-up call to exercise more caution, or establish new protocols, or improve existing safety guidelines, in order to lessen the odds of recurrence.

From a medicolegal standpoint, one of the most daunting tasks in malpractice litigation is determining what constitutes a “complication” that excuses orthopedic surgeons from liability. This topic is of everyday interest to surgeons, and while difficult to tackle, it is of keen importance. Previous articles in this column have addressed this important topic and its related nuances several times; this article is a recapitulation of the key concepts and insights that could help surgeons understand and manage complications in order to mitigate the risk of litigation.

Defining complication

Lawrence H. Brenner, JD
Lawrence H. Brenner
B. Sonny Bal, MD, JD, MBA
B. Sonny Bal

The term complication means different things to different people. Plaintiffs’ attorneys interpret complication to mean those surgical injuries which are unavoidable no matter how much care is used to prevent them. There is a tendency for defendants to have a much broader definition of a complication than plaintiffs. The broadest definition utilized by defendants is that if an injury is known to occur, and recognized as such in the peer-reviewed literature, then it must constitute an excusable complication. In other words, the complication was simply expected, ie, it was an inherent component of the risk proposition that the patient signed up for, whether or not the patient is now surprised by its occurrence. Accordingly, there is little purpose in inquiring about the etiology of such a complication, since it happens as a matter of chance.

Often defendants cite articles from the literature that document the rate at which injuries occur and, therefore, seek to be excused from liability on the grounds that since the same or similar injury occurred in the case being litigated, the patient suffered an acceptable complication. Examples include the unexpected and unpleasant sciatic nerve palsy after a perfectly executed total hip replacement, the inexplicable deep infection despite the use of preoperative antibiotics and meticulous sterile technique, or a peroneal palsy discovered after an otherwise satisfactory knee replacement.

Unfortunately, most of the literature fails to differentiate which of the documented percentage of injuries were either unavoidable or caused by careless surgery. The majority of literature concerns itself with reporting the incidence of complications in a limited set of patients, with speculation about why a complication might have manifested itself in the study population.

Clearly, a more discreet set of analytical tools needs to be developed to differentiate a negligent from non-negligent complication of orthopedic surgery. Aside from the obvious utility of such a differentiation to the judicial system, the educational value in training surgeons is indisputable.

Evaluating complications

A model of evaluating complications involves peripheral nerve injuries which are uncommon surgical complications, but frequently implicated in orthopedic professional liability lawsuits. While no bright light separates the negligent from the non-negligent nerve injury, two principles can help guide the analysis of when an orthopedic surgeon is, or is not liable, for a nerve injury that is discovered following an elective orthopedic procedure such as a total hip or knee replacement. These two principles relate to awareness and action on the part of the surgeon. The questions that flow from these principles are: Was the surgeon aware of the increased potential for injury to the nerve because of the proximity to the operative site, or because of some patient-specific variable(s); and if the surgeon was aware of the risk of injury to a nerve, were actions taken to mitigate that risk?

Three facets of complication

In evaluating the complications of surgery, it is also important to note that litigation almost always focuses on three facets of the complication, namely: the occurrence, the detection and the management.

Often it is more difficult for the plaintiff to establish negligence in the occurrence of the complication than it is to establish negligence in the detection and management of the complication. Therefore, the fact that a complication occurred is not, in itself, actionable conduct; the plaintiff filing a lawsuit will usually have delved deeper to find other related evidence to characterize conduct as actionable.

It follows, therefore, that when a complication such as a nerve palsy occurs following an otherwise uneventful primary hip or knee replacement proper documentation should address the following: early recognition of the complication or unexpected outcome by the surgeon; documentation of the processes and routines that were in place to avoid such a complication; a systematic exclusion of the factors that are known to result in the complication; and a plan to manage the complication in a timely and competent manner, with further documentation that such a plan was indeed executed.

Perspective

The documentation can be a major contributing factor in either avoiding or reducing the number of malpractice lawsuits filed against orthopedic surgeons for complications such as the previously mentioned peripheral nerve injury. In creating a comprehensive record, the orthopedic surgeon should review the differential reasons why a nerve injury may have occurred in the particular patient.

The perspective of the operating orthopedic surgeon documented in a timely manner is important. Each of the potential reasons for the complication should be excluded, and the most probable reason clearly identified and addressed with a treatment plan. The surgeon should address the possible reasons for the outcome in the record in a timely, direct and forthright manner.

The surgeon is best situated to recognize the complication, understand and identify the most likely reason for its occurrence, and devise a treatment plan. While doing this, he or she should ensure the factual information is accurately documented and avoid creating a “defensive record” that explains the injury in a manner that cannot be reconciled with surgical common sense. In other words, the documentation should be credible, from the perspective of objective peer review of the record, rather than a defensive tool meant to insulate oneself from over-zealous plaintiffs’ attorneys.

An outline of the routine procedures and processes that were in place to ensure the safety of the patient can be critical in avoiding litigation. Much of the documentation might address those actions that are so routine to most surgeons that one may not think about documenting them. For example, during the procedure itself, most surgeons position retractors carefully to protect the anatomic sites where major nerves and vessels are encountered. In difficult cases with aberrant anatomy or previous surgical dissection, the adjacent nerves may even be identified and dissected for a direct visualization and protection. If so, the circumstances encountered and steps taken should be documented.

Duty of care

While this article speaks of documentation, in reality, the differentiation between culpable vs. benign conduct really turns on the legal element of “duty of care” that is the foundation of tort law. The surgeon owes a duty of professional care to the patient; the applicable standard is measured by peer testimony. Peer testimony is facilitated by the firsthand impressions of the surgeon documented in the medical record. Absent such documentation, a potential plaintiff is free to argue that the surgeon failed to meet a duty of professional care and in essence, speculatively fill in the blanks that really should have been addressed by the surgeon.

Even before the operation, a surgeon may have a protocol for safe positioning of the patient, proper insertion of the various catheters, and a mnemonic for ensuring correct surgery site; while these steps may become automated, their documentation is nonetheless a powerful defense against an allegation of negligence. These, and related steps, should become an integral part of a professional routine, just like a preflight check.

While many of us might take routine preoperative preparation for granted, it is important to document what the routines were and the fact that they were followed carefully. If this information is missing in the records, the inference may be improperly drawn that appropriate steps were not taken, for example, to protect the nerve from injury.

More importantly, the documentation process is a subtle reminder that these steps need to be taken, and reinforces the surgeon’s desire to take every reasonable step to avoid a complication, to understand the mechanism of the injury if it occurs, to detect the injury as early as possible, and to develop a management plan to allow the patient the optimal opportunity for recovery.

  • B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
  • Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.