Last summer, I wrote about the Medical Question Doctrine, the theory that federal courts should defer to physicians on medical-legal questions. The relevance of my piece has resurfaced, now that Texas district court Judge Matthew Kacsmaryk issued a nationwide injunction prohibiting the FDA’s mifepristone approval.
Mifepristone is a one of two medications used for medical abortions. Mifepristone “blocks a hormone called progesterone that is needed for a pregnancy to continue.” The drug itself was first approved in 2000, and its approval was audited and validated in 2008. Mifepristone is effective and safe: the drug is 80% successful and sends fewer people to the ER than Tylenol and Viagra. In fact, only 24 out of nearly 3.7 million individuals who took mifepristone experienced a fatal side effect – and 6 of those cases coincided with alcohol and drug use. This puts the fatality rate of mifepristone at .00065%. Even compared to surgical abortion, medical abortion is indistinguishable with regards to safety and effectiveness.
On a tenuous legal theory and even more strained medical analysis, Judge Kacsmaryk stayed the initial and subsequent mifepristone approvals by the FDA. In essence, Judge Kacsmaryk paused legal distribution and prescription of mifepristone (with a seven-day grace period). Judge Kacsmaryk’s decision rested on the administrative complaint that the FDA had improperly approved the drug and that patients and doctors may experience injuries from using mifepristone.
In response to this decision, legal scholars, newspapers, and the United States President have criticized the decision for adopting radical, conspiracy-like reasoning that badly misconstrues reproductive medicine (and administrative law). In making his decision, Judge Kacsmaryk relies on a new theory of standing, a dormant 1873 statute, and an unprecedented remedy.
Last year, I suggested that the Medical Question Doctrine ought to consider “[1] the breadth of science on the policy, [2] the good faith justification by the physician, [3] the interest convergence of industry in pushing the treatment, [4] the effectiveness of the treatment in past experimentation, and [5] the interests of the state in regulating the treatment.” While none of these factors are dispositive, the Medical Question Doctrine prioritizes dereference to the individual physician rather than substitute the physician’s expertise for the Court’s.
In contrast to these careful considerations, Judge Kacsmaryk’s nationwide remedy contravenes the particularized, case-specific reasoning that physicians use when prescribing treatment. Of course, subsequent FDA regulations had gone further, permitting a prescription without a doctor’s visit. However, Judge Kacsmaryk’s remedy prevented a prescription, even with informed consent (as the initial approval permitted). More than just a contempt for abortion, this decision joins a series of nationwide remedies that demonstrate serious misgivings about expertise and agency judgement. Broadly, this means that a court without medical training can override the best medical judgement of physicians, even when that physician believes that such a treatment may be the most effective medication.
This is especially troubling when the American Medicine Association Code of Medical Ethics requires that physicians “[k]eep[] current with best care practices.” What happens when Federal Judges prohibit the use of best medical treatments? How can doctors conform with their ethical duties when judges intervene into the medical practice? Even for a Court skeptical of the administrative state, the local and particular nature of medical practice should warrant greater deference to physicians who have the most amount of information and knowledge on a particular topic. As I’ve noted before, the US Congress has only had 27 physicians elected to office since 2005, so it is difficult to understand why politicians or judges without medical training should be left to unquestionably dictate best care practices.
While this article does not advocate “Chevron for Doctors,” it does require that a court consider its own expertise on the difficult decisions doctors are forced to make and defer to their on-the-ground training (much in the same way courts will defer to police officers when evaluating qualified immunity claims). Once again, the Supreme Court will be presented with an opportunity to recognize its limits. Rather than succumb to conspiracies about the “Clinton Administration,” the Supreme Court should commit to local decision making; not by politicians and judges who do not understand complex medical procedures, but by doctors who are on the ground making these decisions.