Mifepristone Lawsuit Highlights Medicine and Law’s Complex Relationship
Image courtesy of cottonbro studio.
By Colten Maertens-Pizzo
In episode 112 of Bioethics on Air, “Chemical Abortion and the Courts,” Joe Zalot interviews Elizabeth Kirk on the complexity of the April 2023 federal court cases dealing with the chemical abortion drug mifepristone. Kirk serves as the director of the Center for Law and the Human Person at the Columbus School of Law at the Catholic University of America, and she is an associate scholar at the Charlotte Lozier Institute, a research organization that advises the pro-life movement. As an attorney and scholar, she is highly qualified to explain the complexities of Alliance for Hippocratic Medicine v. FDA, the strikingly convoluted case challenging the legality of mifepristone’s initial approval by the US Food and Drug Administration.
Hippocratic Medicine involves four health care organizations and four individual doctors “suing the FDA for illegally approving the chemical abortion drug mifepristone and failing to protect consumers.” Their overarching argument is that “the FDA has put politics above the health and safety mandate” under which the FDA ordinarily functions. This case is especially complicated because the plaintiffs challenged the FDA’s reasoning, which calls into question how the agency uses its expertise. When courts review agency action, they typically defer to the agency’s expertise on the subject matter and are allowed to overrule agency action only if it is unlawful or deemed arbitrary and capricious.
The plaintiffs claim that the FDA acted both unlawfully and arbitrarily. The FDA initially approved mifepristone under a regulation meant for “accelerated approval of drugs that are ordered towards serious, life-threatening illnesses and that … [provide] a serious benefit.” Against this provision, the plaintiffs argue that pregnancy is not a life-threatening illness. Regarding the second provision, the plaintiffs claim that the studies used to demonstrate the drug’s safety are, in fact, “arbitrary and capricious” precisely because they do not match the “conditions under which the [FDA] allowed the drug to be prescribed in the real world.”
Kirk explains that the plaintiffs also identified three problematic changes to previously established safeguards for the drug, which took effect beginning in 2016. First, two of the three previously required in-person medical visits for using the drug were eliminated. Second, non-physicians were allowed prescribe mifepristone. Third, the requirement to report nonfatal adverse effects was removed. These changes paved the way for the FDA to approve a telemedicine-based approach to prescribing the drug. Ironically, even the FDA admits, according to the plaintiffs, “that [the initial] studies weren’t adequate to establish safety” for this approach. However, this case is even more complex.
In 2002 the plaintiffs filed a citizen’s petition against the FDA, challenging the initial approval of mifepristone. Another was filed in 2016 in response to the aforementioned changes. The FDA did not respond to the initial petition for sixteen years yet claimed, in Kirk’s words, that the plaintiffs “waited too long to bring this lawsuit.” To the contrary, by waiting more than a decade, the FDA effectively stonewalled the petition and forced a lawsuit years after the ordinary window for bringing one. Furthermore, the defendants employed a “respect the agency, follow the science, only the FDA has the expertise” style of argument, which is inherently flawed. As the plaintiffs counter, we should not follow the FDA when it makes unreasonable decisions that fail to follow the law.
According to Kirk, in the original hearing in Amarillo, Texas, the judge concluded that “the plaintiffs had demonstrated they were likely to succeed on their claim that the FDA has exceeded its authority by approving mifepristone in 2000.” The judge followed by suspending the original approval and all subsequent actions. He allowed for a seven-day stay of his orders. However, on the same day, another judge in a separate court responded to a different case put forth by seventeen states who claimed that the FDA had imposed reasonable restrictions on mifepristone. That judge ordered the FDA to maintain the availability of the drug in those states in contradiction to the Texas stay. Although a separate case, that judge’s timing was highly inappropriate because of the confusion it elicited.
Anyone paying attention to the legal news in April 2023 would have recognized that the challenges posed to the FDA on mifepristone’s initial approval had turned into a convoluted mess of multiplying court challenges. Hippocratic Medicine is a technically complex case because “no court can fully address the underlying merits of the plaintiff’s claim.” Nevertheless, as Kirk notes, the FDA made these claims into a game of political baseball that would become only increasingly legally complex.
The Texas case was appealed by the federal government to the Fifth Circuit Court. A three-judge panel held an emergency hearing to issue a temporary judgment to hold until a full hearing could be arranged. The emergency panel upheld the Texas ruling with respect to the changes made since 2016 but stayed the ruling on the initial approval. The emergency panel agreed that the removal of safeguards was problematic, because it was analogous to a situation, as Kirk summarizes, where “we did the study of safety of an automobile with airbags and seatbelts, but then when the car was sold to the public, it didn’t include seatbelts.” By allowing some of the initial ruling to remain in place, the appeals court complicated an already convoluted case with “appeals within appeals.”
In response to the Fifth Circuit ruling, the federal government appealed to the Supreme Court, which decided to stay the previous court orders, ending the full appeal of the Texas ruling. However, the ruling was not unanimous, as Justices Samuel Alito and Clarence Thomas dissented. Alito’s dissent is telling of the political baseball surrounding this case, especially where he points out how the usual criticisms about shadow dockets—emergency processes to stay lower court decisions— were set aside for this case. As Kirk suggests, any future rulings will continue to be mired by political complexity, especially because “the case will likely be appealed back to the Supreme Court.”
Colten Maertens-Pizzo works for the Archdiocese of Chicago Catholic School System.