What Attorneys Need to Know About Informed Consent

    obstetrics and gynecology expert witnessThis article is authored by a leading obstetrics and gynecology expert witness. He is a member of both the American College of Obstetricians and Gynecologists and he was previously associate professor of obstetrics and gynecology at the Geisel School of Medicine at Dartmouth.

    A patient has arrived from out of town to see a prominent surgeon. She has a medical problem for which there are both medical and surgical treatment options. After consultation with the surgeon the patient is interested in surgery. The surgeon offers to perform the case the next day and consents the patient in his office. The next day the surgery is performed and after a brief hospital recovery the patient returns to her hometown. The patient later learns more about the non-surgical treatment options for her condition and feels the surgeon did not adequately inform her of prior to her surgery.

    Another patient visits a different surgeon for the same medical problem. After consultation with this surgeon a surgical approach is again pursued. The surgeon’s office arranges all the necessary pre-operative clearances and schedules the procedure to occur about 1 month later. The surgical consent is, however, not completed in the office due to an oversight. The surgeon meets the patient in the preoperative area; her intravenous lines are inserted and she is gowned for surgery. The surgeon performs the consent for the procedure. As before the patient later learns more about the non-surgical treatment options for her condition and feels the surgeon did not adequately inform her of prior to her surgery.

    Do these women have a basis for their complaint with regard to their surgical informed consent?

    Informed consent is a relative new concept in medicine. From an ethical perspective there are a minimum of three elements: (1) disclosure, (2) competency, and (3) choice. In many ways the legal concerns of informed consent focus on disclosure while the ethical concerns of informed consent focus on competency. Both disciplines seek to improve the likelihood a patient’s choice is consistent with the “facts” of the medical case and the patient’s “values” in regard to those facts. But precisely what defines adequate disclosure or competency is very unclear. In both of the highlighted cases it could be argued disclosure was satisfied insofar as a consent document was signed.

    Being competent of a body of knowledge is tricky business. In coaching my son’s baseball team I am very aware of the assenting nods or “yeah, I got it,” claims regarding some teaching point only to later find these claims of competency to be clearly misguided. The issue in the highlighted cases is that in each the competency is tainted by a compelling situation. Could the women in these cases walk away and reflect on their treatment options? If you knew that in the first case the physician was paid on productivity and that that surgeon was having a slow month (after all OR time was available the next day) would that affect your sense of whether the disclosure was balanced?

    Dartmouth researchers have classified care into three categories: (1) Evidence-based care, (2) Preference-based care, and (3) Supply-sensitive care. Evidence-based care is care that has known benefit for a given clinical condition. Taking an ACE inhibitor if you’re a diabetic has good evidence to support this practice and to not do this risks injury. Preference-based care is care that may have evidence to recommend it but that evidence shows no preference for one approach over another. Mastectomy or lumpectomy for treating breast cancer would be an example of preference-based care – there is no known difference in outcomes with either treatment approach.

    The last category of care dominates Medicare spending according the to folks at Dartmouth. Supply-sensitive care is care that is dictated by the supply of care available. In other words the more cardiologists you have in a community the more stress tests or angiograms will be performed. Supply-sensitive care is the antithesis of “value” given this sort of care maximizes neither outcomes nor cost. Supply-sensitive care is also ethically problematic given the driver of the care would appear to be outside of the patient.

    There is no reason to expect the Midwest or the South to have more gynecologic disease to explain why there are as much as twice as many hysterectomies done in these areas of the United States relative to New England. To be fair this sort of discrepancy may not be all about the physicians. Patients may clearly drive a preference for more care that is facilitated or endorsed by physicians. Nevertheless, irrespective of who is driving who, the “facts” of the medical case likely do not align with the evidence and competency is questionable.

    Like much of life, both margin and mission compel medicine. Doing “good” has to at least break-even. Margin can, however, become the mission. Without any mal-intent the surgeons in our two cases may merely seek to facilitate patient convenience and “margin” for the hospital. That said the mission focus, to ensure each patient has the best chance to make a fact and value congruent choice regarding their care, could override convenience and moderate a margin focus. Moral hazards abound but in the fiduciary relationship that exists between patient and clinician, the clinician’s power is constrained by duties toward beneficence and non-maleficence. In both examples those duties could be questioned.