Medicolegal Issues
Data on liability claims offer bright spots for ObGyns— and sobering statistics
Twenty-five years of claims data from the Physician Insurers Association of America suggest that things are improving in obstetrics and gynecology...
From the gynecologic perspective, however, it is of paramount importance to address the patient’s postoperative vaginal pain and determine the best management approach. In this case the TOT, and its association with a 21.5% complication rate, including reported vaginal extrusion, introduces a whole new set of concerns.1 The TOT use in itself raises the question of liability on the part of the surgeon. This mesh has more than 150 associated complications, including obturator nerve injuries, extensive blood loss, and ischiorectal fossa abscesses.2 Once a device comes upon the radar screen of the US Food and Drug Administration for significant complications, where does that leave the clinician in regard to litigation? Let’s look to our legal colleagues for their insight and expertise.
Legal considerations
Given the facts in this case, it is not surprising that it resulted in a defense verdict. The majority of cases filed are ultimately disposed of in favor of the medical defendants, and the majority of medical malpractice cases that go to trial result in defense verdicts.
Medical malpractice, or “professional negligence,” consists of a claim that a medical professional had a duty of care to the patient, a breach of that duty, injury to the patient, and a causal connection (“causation”) between the breach of duty and the injury. It is the obligation of the plaintiff to prove the elements of negligence by a preponderance of the evidence.
Were the surgeon’s actions in line with other surgeons’ expected actions? The issue of the breach of the duty of care essentially is the question of whether the physician acted similarly to a reasonably careful practitioner of the same specialty under the same circumstances. Doctors are not held to a standard of perfection. That is, not every injury or bad outcome is negligence—only those injuries that result from actions, or inactions, that were not within the level of care acceptable in the profession.
Why would this patient file a lawsuit? The injury was not trivial (it had both pain and cost associated with it), but it was not catastrophic, and the negligence was going to be difficult to prove. Furthermore, lawsuits are expensive in terms of time, energy, and emotional commitment—few people file them for the fun of it. We can only speculate on the answer to the question but, frequently, such claims are a search for the answer to “What happened, and why?” or a reaction to feeling ignored or disrespected. There is little in the case facts that we have to work with to indicate what the communication was between the gynecologist and the patient and her family. The statement of facts, however, leaves the impression that communication deteriorated as the postoperative pain endured.
Some additional areas of potential claims for liability in this case include:
- The explanation for the needle breaking during surgery is unclear from the brief statement of case facts. There might be malpractice liability if the surgeon was unreasonable in how the needle was used, used the wrong needle, or ignored defects in the needle.
- The surgeon tried unsuccessfully to retrieve the needle during the original surgery. If the surgeon’s failure to retrieve the needle was because of inadequate training, lack of care or the like, it might be seen as the “cause” of the patient’s injuries.
- The fact that a second surgeon was able to remove the needle tip, which resolved the patient’s pain, may raise the question of whether the first surgeon’s decision not to seek to remove it in response to the continuing pain was reasonable. If the first surgeon did not want to remove the needle tip, a question might be raised about whether that surgeon should have referred the patient to another surgeon. (The patient ultimately found another surgeon on her own.)
- Regarding use of TOT: A 21.5% complication rate ordinarily would be a significant factor to consider in a decision to use the tape. Physicians are responsible for keeping up with current developments in the devices and pharmaceuticals they use. Therefore, if information on the complication rate was available, the surgeon’s documentation should reflect the basis for choosing to use the tape. More important, the surgeon should document a conversation with the patient about the risks and benefits of using the TOT and the discussion of alternatives to its use.
What factors could have tipped the case toward the defense?
The defense verdict indicates that the jury determined there was no negligence, or that the patient could not prove any of these potential bases of liability. As noted above, what may have helped the defense is the fact that the surgeon documented the details of the informed consent conversation, including that “discussion was carried out regarding” the tape. The informed consent process is an important opportunity for communication with the patient, and a chance to make sure that expectations are reasonable. Liability for the failure of informed consent is not common. When something has gone wrong, however, it can matter whether the problem was something mentioned in the informed consent process. In addition, it was positive that postoperatively the patient was informed of the broken needle—although it is not clear who informed her about it.