Supreme Court Associate Justice Samuel Alito speaks during the Federalist Society’s 40th Anniversary at Union Station in Washington, Monday, Nov. 10, 2022. ( AP Photo/Jose Luis Magana)
Supreme Court Justice Samuel Alito gave the nation’s highest bench two more days to consider the fate of abortion pill mifepristone. Hanging in the balance until midnight Friday are potentially profound consequences for the pharmaceutical industry and the federal Food and Drug Administration (FDA).
Mifepristone is one part of a two-drug combination used in the U.S. for medication abortions; the second drug, misoprostol, can be used on its own, but studies show it is less effective than using both drugs to end an early pregnancy. The drug is currently at the center of a rapidly-escalating legal battle that could reach well beyond abortion and potentially affect how all Americans obtain their medication.
A temporary pause on a first-of-its kind ruling
Last Friday, Alito issued a brief “administrative stay” of an order by the U.S. Court of Appeals for the Fifth Circuit. That ruling had blocked a portion of U.S. District Judge Matthew J. Kacsmaryk’s unprecedented directive that the FDA revoke its approval of mifepristone, which was granted back in 2000. The appellate court left in place the portion of Kacsmaryk’s order that reversed the FDA’s 2016 regulatory change to made mifepristone more widely and easily available.
The sweeping order from Kacsmaryk, a Donald Trump appointee, crossed paths with one issued by another federal judge, U.S. District Judge Thomas Rice, appointed by Barack Obama. Rice’s order, which directed the FDA to keep mifepristone on the market in several states, conflicted directly with Kacsmaryk’s ruling, which applied nationwide.
The Fifth Circuit’s ruling was appealed to the Supreme Court, and Alito’s temporary stay elicited a sigh of relief from many, as it kept mifepristone legal and available — a particularly significant status in a post-Dobbs world, where Roe v. Wade no longer applies and abortion access is no longer guaranteed.
That first stay expired Wednesday at midnight. Just short of the deadline, however, Alito extended the stay to give the justices two more days to consider their actions. That means two more days of mifepristone availability — but it might also bring the Court two days closer to a ruling that would upend the future of the pharmaceutical industry.
Strong-arming the FDA
A federal court has never ordered the FDA to revoke its authorization for medication that has been approved for decades — a reality that even counsel representing the right-wing advocacy group plaintiff in case before Kacsmaryk acknowledged.
According to the Washington Post, when attorney Erik Baptist was asked by if he could cite any example of a ruling, Baptist reportedly answered: “No, I can’t.” Baptist reportedly characterized the order against the FDA as one that “restore[s] proper policing power to the states.”
Not only did Kacsmaryk’s ruling commandeer the FDA against medical advice — the American Medical Association warned in a brief that reversal of mifepristone’s removal would cause “profound and irreparable harm to patients across the country” — but it spat in the face of longstanding legal norms in the context of separation of powers.
As 253 members of Congress explained in their amicus brief, Congress designated the FDA as “the expert federal agency with authority to review and approve drug applications,” and while it allowed limited judicial review of the FDA’s drug approvals, “it did not invite federal courts to substitute their judgment for the expert conclusions of FDA’s scientists.”
The FDA’s authority comes from a Congressional statute that was enacted in 1938. Since 1962, Congress has required that drugs be shown to be safe and effective before they can be sold in the United States. Given the legal framework of the FDA’s authority, courts are expected to defer to the agency’s decisions regarding drug approval.
In the case of mifepristone, an order revoking FDA approval is stunning not only in that it intrudes on the FDA’s autonomy, but also in that drug is not even newly approved. It has been approved and used for decades. Should the Supreme Court rule that Kacsmaryk had the authority to unilaterally demand the FDA change course on mifepristone, it could open the door for similar judicial interference with any and all drugs.
“Do no harm” to doctors themselves
The Supreme Court now has the chance to rethink another aspect of Kacsmaryk’s extraordinary ruling: the idea that doctors have redressable injury when a federal policy could somehow lead to their having to treat patients in a manner with which they disagree.
As with every case, the mifepristone plaintiffs — a group of anti-abortion doctors — are required to show that they have standing to bring the litigation. Standing is the requirement that before any federal court can hear any lawsuit that challenges a federal policy, plaintiffs must show that they have already suffered a concrete actual injury or that they will suffer a future injury that is not merely hypothetical, but “certainly impending.”
The Fifth Circuit devoted several pages of its mifepristone ruling to analyzing the plaintiff doctors’ rather attenuated argument on standing. The doctors argued that some patients who had taken mifepristone to terminate a pregnancy went on to suffer “torrential bleeding.” The doctors, though, were not asking that the court impute the women’s physical suffering onto them to create standing. Rather, they argued that caring for these patients was “emotionally taxing” to the point of affecting the doctors‘ “quality of life.” They also argued that in some cases, emergency physicians were forced to perform surgical abortions after patients experienced complications from taking mifepristone, and that doing so went against the doctors’ personal beliefs.
The Fifth Circuit took pains in its decision to say while the doctors in the case have suffered “a concrete, particularized injury,” that their holding was meant to be a narrow one that does not recognize doctor’s standing to challenge all FDA actions. Mifepristone approval, said the court, was “an exceedingly unusual regime.”
As the case remains on the Supreme Court’s docket, the justices face the chance to issue their own ruling on standing. Irrespective of the Fifth Circuit’s assurances, a finding that physicians have standing to challenge FDA regulations on the basis that complications resulting from use of an approved drug caused them harm could have wide applicability. Doctors — or even other professionals— who interface with patients who have taken anything from birth control pills to puberty blockers to antidepressant medications could base standing to challenge FDA regulations on a holding in favor of the mifepristone plaintiffs.
The Supreme Court’s ruling in Dobbs v. Jackson Women’s Health Organization was not unexpected. For years, many of the justices have been vocal about their feelings that Roe v. Wade was wrongly decided. The Court’s conservative wing has also been harshly critical of the “administrative state” in many contexts.
However, when it comes to standing, the conservative court has been unreceptive to crafty lawyering, generally refusing to widen the scope of what “harm” would be sufficient to support a lawsuit, even within the context of abortion. In 2022, the justices declined the opportunity to weigh in on a case about whether fetuses have standing to bring lawsuits in federal court.
The mifepristone litigation operates as a true test of priorities for the justices. Though a majority appeared to relish its chance to eradicate a federally-enshrined right to abortion, it may not be as willing to jettison foundational rules about what deserves to be on the federal docket.
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