There is a good deal of emerging literature concerning the new automated multi-arrays utilizing peripheral blood samples for the identification of genetic abnormalities. Testing for 100 or more occult genetic disorders can now be rapidly processed by automated machinery with highly reproducible and reliable results.
O’Grady: There is a good deal of emerging literature concerning the new automated multi-arrays utilizing peripheral blood samples for the identification of genetic abnormalities. Testing for 100 or more occult genetic disorders can now be rapidly processed by automated machinery with highly reproducible and reliable results. With this type of testing, routine surveillance for many potentially important genetic conditions - many of which are recessive - can be performed at low cost. So, given the availability of this innovation which is now being marketed to clinicians, what does the standard of care dictate regarding implementing such surveillance tests into our practice? Is not performing the test, or at least, not offering the test a deviation from a care standard? If testing using these new arrays is currently not the standard, how do practitioners know when, if ever, the transition to becoming the standard of care is made?
Giordano: These are interesting questions, and not easily answered. You have to remember in most scenarios, the law does not determine the standard of care. Instead, the standard of care is determined by the professionals in the field of practice. It is for this reason that expert witnesses are required to testify pertaining to the duty that was owed. Generally speaking, malpractice in its truest sense is either failing to do something that the average qualified practitioner would have done under the particular circumstances, or conversely undertaking an action that the average qualified practitioner would not have done. So the standard of care is not supposed to be determined by “outsiders” so to speak, meaning that plaintiff’s lawyers and juries do not impose their will as to what they think the standard of care ought to be, but instead determine the standard based upon the testimony of expert witnesses. In the setting of multi-array genetic testing, the question then is when, if ever, does it become accepted within the specialty of ob/gyn that the average qualified practitioner should be ordering such testing and in what circumstances? So even if the testing is reliable and cost-effective, but if it’s not embraced by the field as something that should be offered by practitioners, then failing to do so should not be malpractice.
O’Grady: But it seems that with the availability of information that is accessible, advances in medicine can be rapidly transmitted throughout the medical world, especially given the of access to new information via the web, e-journals, and in light of the many CME programs now available on line. Doesn’t this create a burden upon physician to incorporate such advancements more expeditiously?
Giordano: There is a duty that physicians and other health care physicians must stay current with literature and advancements in the field. And certainly, the age of information technology has allowed for advancements in medical technology to become widespread very quickly. But information and/or knowledge does not necessarily mean that the standard of care changes with the knowledge. It requires acceptance and a collective movement towards its implementation. Furthermore, except in a situation of like universal screening, the definition of the standard of care generally includes reference to a physician’s judgment in a given clinical circumstance. Thus, from my perspective the basis for determining the standard of care is pretty much a mirror image of the practitioner’s medical decision-making process--employing sound medical judgment given the known clinical facts with consideration given to the advancements in the field.
I recently tried an interesting case involving Topamax, a medication for migraine headaches. In rare instances the drug can cause acute angle glaucoma. A cautionary statement was included in the PDR regarding this complication. However, there had been relatively few cases. Glaucoma specialists in large referral centers were seeing the complication and the discussion was slowly making its way into the specialty journals. However, the risk was not, and probably still is not, something that is well known by internists nor was it described at the time in online prescribing resources like UpToDate. In that case, the plaintiff’s expert was not allowed to argue what the standard of care should have been given what was known at the time. Instead, he was constrained to discuss the standard of care applicable to internists at the time based upon what should have been known by the average qualified primary care physician. The expert had to establish not what primary care physicians as a body of providers should have been doing, but instead what they were doing. And to that you again look to the treatises and promulgations by learned bodies and other evidence to support the testimony. Unfortunately, even without evidence to support his propositions, this did not stop the plaintiff’s expert from giving an opinion that the doctor was negligent, however thankfully the jury did not agree with him.
O’Grady: But the problem for practitioners it seems is that those of us who follow the pronouncements of ACOG and other learned bodies believe that they are often quite slow in making or changing their recommendations and pronouncements - and even much slower in weighing in on the advances reported in the literature. So, if ACOG or other “learned bodies” do not currently suggest such testing, cannot this simply be characterized as misplaced conservatism? After all, as I understand it ACOG does not determine the standard of care for many conditions.
Giordano: Again, the law is not supposed to lead the discussion, practitioners are. The legal principle presupposes that the collective wisdom within a specialty will implement those practices that are in the best interests of patients. So in determining the standard of care, statements by learned bodies are considered, but they are not “authoritative,” just as articles that comprise the medical literature may support either the plaintiff or defendant’s expert articulations. Many ob/gyn cases are tried without reference to ACOG guidelines or medical literature and thus convincing the jury rests upon solely the credibility of the evidence and testimony of experts. But when either side can rely upon pronouncements, or literature that is unequivocal, even though it may not be determinative of the standard care, it can often be pretty presumptive evidence. From a practice perspective though, the thing is, for the reasons you stated, practitioners cannot presume that because a learned body has not made a recommendation, that the standard of care still won’t require the practice.
O’Grady: It seems like there is a large area of gray that could be exploited by an expert who is a “hired gun.” If the law does not establish the standard of care, nor does ACOG or learned treatises, then couldn’t an expert be called to testify that something is the standard of care, when it really isn’t. For instance, rely upon the studies about the reliability of multi-array testing, and then if it is true that it’s economically feasible, testify that the standard of care requires prenatal screening. He can clearly establish that the lack of any comment by ACOG, or other promulgation of a learned body does not negate the standard of care. So one expert can establish the standard of care and call upon the defendant to negate it, correct?
Giordano: It is true, that the standard of care in a given circumstance, or the timing of when something is generally accepted as being the standard, is often subjective. Hopefully when the respective expert takes the information and assimilates it with the clinical situation to provide opinions as to whether there has been a deviation from the standard of care, they do that in a principled manner implementing sound medical reasoning and evidence based medicine. Unfortunately, this is not always the case with experts, and can be exploited by a “hired gun.” But there are some safeguards in place that try to keep out opinions that aren’t evidence-based. Most importantly though, although health care professionals are often distrusting of juries, a strong majority of the jury verdicts favor them. I think the case I described above is just one example of that.
O’Grady: I am not sure that you are ever going to get health care professionals to trust the jury system, but perhaps that is a conversation for another day.