“What’s it to you?” The future of challenges to FDA decision making after the Supreme Court’s mifepristone decision

On June 13, 2024, the US Supreme Court reversed and remanded the decision of the US Court of Appeals for the Fifth Circuit that would have severely restricted the FDA-approved use of mifepristone to terminate pregnancies. See FDA v. Alliance for Hippocratic Medicine, 602 U.S. __ (2024).

In a 9-0 decision written by Justice Brett Kavanaugh, the Court held that the plaintiffs – several pro-life doctors and associations – did not have standing to advance “plaintiffs’ desire to make a drug less available for others.” Slip Op. at 1. Grounding its reasoning in separation-of-powers principles, the Court cautioned that courts do not have jurisdiction to review government decisions with which individuals may disagree if those individuals do not have a personal stake sufficient to confer standing.

While the lower court opinions dealt with several complex issues related to the plaintiffs’ goal of unwinding FDA’s approval of mifepristone in 2000 and FDA’s subsequent decisions that expanded access, the Supreme Court’s decision focused only on the legal issue of standing. (For more about the lower court decisions, see DLA Piper’s prior alerts here, here, and here.)

The decision

Plaintiffs offered three theories of the alleged downstream effects of FDA’s relaxed regulation of mifepristone:

• Conscience injuries (alleging treatment to women suffering complications from abortions violated doctors’ consciences)
• Economic injuries (alleging doctors’ diversion of resources to treat mifepristone complications), and
• Advocacy injuries (alleging injuries to the medical associations themselves in having to challenge FDA’s decision making).

The Court held that all three were too speculative to support standing. Because the plaintiffs were “unregulated parties who seek to challenge FDA’s regulation of others,” Slip Op. at 13, the Supreme Court explained that determining causation is not a “mechanical exercise” and is instead a “question of degree.” Slip Op. at 11.

The Supreme Court’s ruling on the alleged economic and advocacy injuries was direct and broad.

For the economic theory, the plaintiff doctors argued that FDA’s actions would cause them monetary and related injuries due to resources and time diverted from other patients to treat patients with mifepristone complications, as well as increased risk of liability and increased insurance costs. Rejecting this theory, the Supreme Court explained that “the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might then show up at emergency rooms or in doctor’s offices with follow-on injuries.” Slip Op. at 18. The Court took care to give examples of the implications of allowing the plaintiffs’ theory to stand (including a doctor suing to treat more asthma patients due to EPA rolling back power plant emissions standards and an ER doctor suing to treat more car accident victims due to a speed limit increase). The Supreme Court explained the “chain of causation is simply too attenuated . . . doctors have never had standing to challenge FDA’s drug approvals simply on the theory that use of the drugs by others may cause more visits to doctors.” Slip Op. at 19-20.

For the advocacy injury theory, the Supreme Court explained that “an organization cannot establish standing based on the ‘intensity of the litigant’s interest’ or because of strong opposition to the government’s conduct,” and that “an organization cannot spend its way into standing simply by expending money to gather information and advocate against the defendant’s action.” Slip Op. at 21-22. Justice Clarence Thomas also concurred separately to invite future challenges to associational standing, highlighting some of the problems with this form of standing in extending the limits of the judicial case-or-controversy requirement past an individual harm, in expanding the remedy of universal injunctions, and in subverting the class action mechanism.

However, with respect to conscience injuries as a basis for standing, the opinion was notably narrower, recognizing that this sort of injury could confer standing but that the plaintiffs here had not identified “any instances where a doctor was required, notwithstanding conscience objections, to perform an abortion or provide other abortion-related treatment that violated the doctor’s conscience.” Slip. Op. at 15. See also id. at 15-16 (“In other words, none of the doctors’ declarations says anything like the following: ‘Here is the treatment I provided, here is how it violated my conscience, and here is why the conscience protections were unavailable to me.’”). This absence of injury stems from federal protections afforded to healthcare personnel who object to providing abortions, sterilization, and other health services involving certain federal funds. See generally 42 U.S.C. § 300a-7.

Key takeaways

The Supreme Court’s opinion has important takeaways for future FDA challenges, as well as other government and agency challenges. With respect to FDA, the Supreme Court did not rule out entirely the possibility of doctors’ alleged conscience injury conferring standing. There remains the possibility of invoking standing on this basis in areas where federal law does not offer the same protections to healthcare practitioners with conscience objections, and those objections garner sufficient support to mount a future legal challenge. Such focus areas might include vaccines, products used to provide care to transgendered persons, and drugs granted accelerated approval. In these areas, it may be possible for a healthcare practitioner to acknowledge the treatment they provided, explain how it violated their conscience, and explain why the conscience protections were unavailable to them.

With respect to broader agency and government challenges, the Court highlighted several past decisions in which regulations of others affect the “unregulated plaintiff” in such a way as to confer standing; examples include downstream economic injuries to suppliers or customers further down a supply chain, or individual users of parks. Slip Op. at 12. Particularly given the growing number of challenges to agency regulations – many of which still have yet to be decided this term – the Court’s discussion of standing is unlikely to deter future challenges to agency regulations by those with more concrete downstream economic injuries tied to the agency action.

For more information, please contact the authors.