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Is the concept of an “accepted complication”-or the identified limitations of medical science-a shield to malpractice claims? Kevin Giordano, Esq. and John O’Grady, MD, explore liability risks of diagnostic laparoscopy.
Physicians performing laparoscopic surgery recognize that if they do enough procedures, they will eventually encounter complications. This is because all surgical procedures involve an inherent risk. Physicians also recognize that when performing an exploratory laparoscopy, some pathology may not be visualized at the time the procedure is performed. In this two-part series, John O’Grady, MD, and Kevin Giordano, Esq., explore whether the concept of an “accepted complication”-or the identified limitations of medical science-shields a physician from malpractice claims. Further, is a malpractice claim ever justified as the legal penalty for an observed complication, regardless of cause?
Part 1: Diagnostic Laparoscopy
John O’Grady, MD: Let us take the case of a physician who performs a laparoscopy for a suspected ectopic pregnancy. A preoperative evaluation is performed, presumably with laboratory evaluation. In the operating room the clinician visualizes the pelvis in the usual manner and decides that no pathology is present. The procedure is then terminated. There are no apparent operative complications. However, on subsequent follow-up the patient turns out to have an ectopic anyway. She is displeased and seeks legal redress There are complex issues of follow-up in such cases that we will address later.
Several clinical scenarios might lead to such an outcome. My question is, legally, does the failure to have diagnosed the problem (i.e. visualized and treated the ectopic at the time of the initial surgery) mean that there was malpractice-assuming that the laparoscopy was performed for standard indications in the usual fashion and without a surgical complication?
Kevin Giordano, Esq.: The answer to your specific question is no. In law, a patient must prove some departure from good and accepted practice in order to be successful and recover a monetary award. Rarely in the malpractice setting does the mere occurrence of a bad outcome by itself mean that there has been medical malpractice. So in the setting of laparoscopic surgery, a misdiagnosis or a complication arising from the procedure, although that may form the basis of a claim, does not in and of itself mean that there has been malpractice. You need to examine the particular circumstances and determine whether there has been good surgical technique in the case, proper medical evaluation before the surgery, and often most importantly, appropriate follow-up care.
John O’Grady, MD: Well, the concern among physicians is that our society often plays the blame game. If the patient develops a complication, you must have done something wrong.
Kevin Giordano, Esq.: Of course you worry about the physician who has apparently followed accepted practice and yet is found negligent at trial. Unfortunately, such outcomes are possible. However, despite what may be common perception, such outcomes are really not the norm, even in the most sympathetic of cases. The mere fact that some harm occurs that arises out of medical care does not mean that there is malpractice. Conversely, it does not that mean that every time an injury occurs that arises out of something that was inevitable or unavoidable, it never represents malpractice. Perhaps the original event, or miss, itself was inevitable or unavoidable, but doctors may have to anticipate such clinical outcomes and takes steps to minimize any exacerbation of the problem. Ultimately it is the unique clinical circumstances that are critical.
John O’Grady, MD: Well, my example derives from a recent experience. A patient had symptoms suggestive of an ectopic. She had a positive serum HCG, albeit at low titer. The transvaginal ultrasound study was equivocal for an adnexal mass (limited visualization), fluid was noted in the cul de sac and the patient complained of abdominal pain. She also reported an uncertain last menstrual period. Further, when the uterus was visualized, no intrauterine gestational sac was noted. Inevitably, while no discrete adnexal masses were observed, the exam was reported as “difficult.” The radiologist, appropriately enough, reported that “an ectopic cannot be excluded.”
In this setting, the obstetrician judged that there was some risk of ectopic gestation or other occult pathology. A diagnostic laparoscopy was performed, driven primarily, I believe, by the symptoms. The medical record was unclear if the patient wished to continue the gestation if it was intrauterine.
Kevin Giordano, Esq.: Ok, so the indications for doing the procedure were apparently within the range of what a clinician would consider “appropriate” under the specific circumstances of the case. The obstetrician-as dictated by the standard of care-performed the right test under clinical circumstances to rule out an ectopic pregnancy, which was perceived as the primary risk. So, what is the explanation for why the ectopic pregnancy was missed and complications of internal hemorrhage subsequently occurred?
John O’Grady, MD: In retrospect, at the time of the original surgery it was simply too early to make the diagnosis. Thus, the ultrasound and the laparoscopy could neither confirm nor entirely exclude either an ectopic or an intrauterine pregnancy. The problem here is multifaceted, and the ultrasonic and laboratory diagnosis of ectopic vs. intrauterine gestation is not always secure. As an example, we have learned to our sorrow that the previously established “discriminatory zone” for HCG concentrations and visualization of the fetal sac is not always reliable. Also, there were other problems in this case to consider. No concomitant curettage was performed at the time of the laparoscopy. Nonetheless, the diagnosis of an intrauterine pregnancy with miscarriage was made after the negative laproscopic visualization. While there was a judgment issue in initiating the surgery, the more important problem became how closely the physician followed the patient’s signs, symptoms, and HCG levels after the procedure. Further, it was unclear from the record if the patient had been warned of the possibility that there could be either an intrauterine or an ectopic pregnancy unidentified by either the original ultrasound examination or the supposedly definitive laparoscopy.
Kevin Giordano, Esq.: So the first issue is whether the failure to make the diagnosis by laparoscope is malpractice. Although there are always exceptions, I think most individuals and most juries can understand that there are limitations to the science of medicine. The defense position would be that even in the best of hands, an ectopic pregnancy may not be evident as it is simply “too early” to make the diagnosis in some instances. Now certainly, it is very helpful if those limitations have been discussed with the patient, especially when as in this case where follow-up care is important. That said, we cannot stop the analysis there. In this specific case, fault may lie in that the clinician should have anticipated the possibility of a “negative” exploration. If so, then preparation of the patient preoperatively and careful evaluation postoperatively becomes critical. Post-op follow-up responsibilities cannot be shirked in the setting where there is significant risk of a false negative. So the issue is whether, armed with the knowledge that the original exploratory laparoscopy and the other tests performed all had limitations, what should the average practicing obstetrician to do in this setting? Thus, this should be the focus of what is the applicable standard of care.
John O’Grady, MD: As a physician, my opinion is that moving to a laparoscopy was acceptable in this case given the signs and symptoms and the equivocal nature of the preoperative data. The issue is what should have happened next, following the grossly unremarkable surgical exploration, and is more problematic for the clinician. The problem is that when a pregnancy is missed under such circumstances, it can proceed as either a normal gestation or as an ectopic. Unfortunately, in the case I encountered, serial study of HCG concentrations or other laboratory testing was not performed and the woman was followed clinically until she finally presented with an acute hemoperitoneum from ectopic rupture. There apparently was no consideration for the use of methotrexate as it was interpreted that a spontaneous abortion had occurred and that the original laparoscopy had excluded an ectopic.
Kevin Giordano, Esq.: So from a legal perspective, in our situation, the OB did not consider the potential limitations of both the surgical procedure and the other testing that was performed. The physician went about his business believing that pathology was “ruled out” when in fact the pathology was still present, but merely unseen. Therein lies the problem with defending this case.
In my own experience pertaining to laparoscopic procedures, malpractice cases arise because although the physician has ample indication to do the original surgery and adheres to all the proper surgical techniques, there is either an intraoperative complication or, as in this case, there is a failure to identify important pathology (i.e., a “false negative” exploration). The potential liability issues do not necessarily relate to the occurrence of an injury or the failure to make an accurate preoperative diagnosis, but center around the fact that the complication was not recognized in a timely fashion, or that the surgeon did not recognize the diagnostic limitations of the procedure and/or testing and failed to follow up appropriately.
John O’Grady, MD: So if in our scenario, the patient turns out to have an ectopic and gets into serious trouble three or four weeks later, you are saying that the failure to diagnosis at the time of the laparoscopic procedure may not be malpractice because proper technique was adhered to and because at that time the true diagnosis could not made.
However, that does not resolve the issue for the woman. The pregnancy is still ongoing and given the limitations of the procedure, the clinician’s potential liability rests in what should be common knowledge: that the procedure and tests that were performed did not exclude a pregnancy.