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Orthopedic, legal semantics complicate the definition of‘complications’
The federal government weighs in on what constitutes a complication withits list of ‘never events’ — complications that should neveroccur.
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The current medical malpractice system has been subjected to harsh criticism. Typically this criticism has focused on judges, juries and attorneys whose perceived conduct has often inflamed the medical community.
Lost in the heated debate has been the justifiable criticism that judges, attorneys, physicians and expert witnesses often use words and phrases as shortcuts for reasoning. Little effort has been made to examine the precise meaning of highly descriptive words used in a medical malpractice context.
One such descriptive word is a “complication” of surgery. It is frequently used as a means towards a verdict that favors the defendant physician in a medical malpractice lawsuit, reasoning that the adverse outcome is “a known complication of the procedure.”
 B. Sonny Bal |
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How should the word “complication” be defined? In the strict sense, a complication means that an injury sustained during the course of surgery was unavoidable, regardless of how reasonable the surgical conduct happened to be. It has often been referred to as “inherent” in the procedure in that such an outcome can occur as an inherent component of the decision to undergo the procedure. While the concept of inherency is frequently used, one has to be careful in defining it. Inherency is not a simple idea; academic courses have been offered at universities where the sole subject is defining inherency.
Complications in the literature
The expression “complication” has developed into a different and much more controversial meaning in malpractice litigation. To some, the word “complication” encompasses errors leading to avoidable injuries that result from surgery. Defendants in malpractice claims frequently cite the medical literature to show the rate of injuries that occur with certain procedures — such as the rate of dural injuries during spinal surgeries — with the goal of having juries infer that the surgeon was not negligent.
In describing the complication rates, these articles rarely, if ever, differentiate between adverse outcomes that were the result of surgical negligence vs. those that were unavoidable. In fairness, perhaps such a distinction can never be made with the scientific precision that physicians are accustomed. Therefore, the admission into evidence of the “complication rate” of the procedure in question may have no evidentiary value to the jury, unless the article referred to also outlined all surgical injuries that were unavoidable. Scientific articles rarely, if ever, do so.
Surgical error
Certainly defense experts have expanded the definition of complications to embody surgical errors. A classic example of an expanded definition of “complication” can be seen in litigation involving laparoscopic cholecystectomies.
In laparoscopic cholecystectomies there have been a significant number of iatrogenically divided common bile ducts. Even though dividing the common duct frequently results from the surgeon confusing the common duct for the cystic duct, many general surgeons believe that this is an acceptable complication.
The reasoning is that patients are informed of the risk of bile duct injuries; that the biliary anatomy can have 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.
Patients who have their common bile ducts unintentionally divided during surgery, however, view this injury differently. They note that general surgeons are aware that variations of 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 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 and, if the cystic duct cannot be conclusively identified, by performing intraoperative cholangiography or converting to an open procedure.
Sciatic nerve injury after hip replacement is a comparable scenario; most orthopedic surgeons see a small risk of such as nearly inevitable even in the best of hands. Injured patients and their attorneys see it differently; they reason that if the complication can be avoided, as suggested in the literature, by diligent attention to the nerve, proper exposure, prudent placement of retractors, attention to leg lengths, and possible release of the gluteus maximum insertion of the femur as suggested by some authors, then why does sciatic injury occur at all after hip replacement? Is it simply one of those things that will happen no matter what the surgeon does in terms of using professional diligence?
“Never events”
Now, the federal government has decided to weigh in on the debate about what defines a complication. Recent Medicare regulations have designated certain device-related bloodstream infections, urinary tract infections and surgical infections after orthopedic and heart surgery as “never events.” In the opinion of the federal government, these are complications that should never occur. If they do, the reimbursements to hospitals for treatment of “never events” will be denied by the government. It is expected that the list of these Medicare “never events” will be expanded in the future.
What are the implications for medical malpractice litigation arising out of these complications that are now called “never events?” The answer to that question depends upon whether courts rule that plaintiffs can introduce, and juries can consider the federal government’s conclusion that the plaintiff has suffered a “never event.” The logical result will be that jurors will find for the plaintiff on the grounds that the infection would not have occurred with reasonable care and that any such infection is entirely the result of provider negligence.
There are three possible methods the courts could use to admit “never events” into evidence. First, courts almost universally have the discretion to allow juries to consider the medical literature on the basis that the literature is authoritative. Courts may find that the government’s conclusions are as reliable and authoritative as the medical literature and allow the jury to receive evidence of the federal government’s findings that the plaintiff suffered a “never event.”
Second, articles in the medical literature may reference these “never events.” Because the information contained in these articles can be received by the jury, this becomes a means by which “never events” are introduced into evidence.
Finally, there is a legal concept known as “judicial notice” which allows courts to take notice of laws and regulations and to instruct the jury on those laws and regulations. There remains the possibility that some courts may take “judicial notice” of the “never events.”
What do you think?
- Should a “complication” for liability purposes be limited to surgical injuries which are unavoidable even when the surgery is performed flawlessly?
- Can a surgical error ever be considered an “acceptable complication” since even the most competent surgeons make mistakes?
- Should juries be allowed to consider “never events” in their deliberations?
- If an article in the medical literature describes the rate of a particular injury associated with a surgical procedure, should the jury be allowed to consider the article if it does not also identify all injuries from the surgery that were unavoidable?
For more information:
- B. Sonny Bal, MD, 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.