The Path to the Supreme Court
On April 7, 2023, the Northern District of Texas blocked the FDA’s approval of the abortion pill mifepristone, along with all subsequent FDA actions that had expanded access to the drug, in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, No. 2:22-CV-223-Z, 668 F. Supp. 3d 507 (N.D. Tex. Apr. 7, 2023). The court’s ruling was scheduled to take effect nationwide on April 13, 2023.
Meanwhile, also on April 7, 2023, a federal district court in the Eastern District of Washington ordered the FDA to maintain the same approval and distribution standards in place for mifepristone in 18 states that sought increased access to mifepristone. See Washington v. FDA, No. 1:23-CV-3026-TOR (E.D. Wash. Apr. 7, 2023). In response to the Department of Justice’s request for clarification, the district court confirmed that it intended its ruling to preserve the post-market restrictions the FDA had approved as of January 2023.
The Department of Justice and Danco Laboratories (the manufacturer of the brand drug) both appealed to the U.S. Court of Appeals for the Fifth Circuit and filed a request for an emergency stay of the district court’s decision. The Fifth Circuit granted a partial stay of the order’s effect pending resolution of the appeal. See Alliance for Hippocratic Medicine v. FDA, No. 23-10362 (5th Cir. Apr. 12, 2023), ECF No. 183-2 (partial stay order).
The Fifth Circuit stayed the portion of the lower court’s decision that effectively unwound the FDA’s original approval of mifepristone in September 2000. The Fifth Circuit did so because, on abbreviated review, it determined that the plaintiffs’ challenge to the FDA’s approval nearly 23 years earlier was untimely.
When the FDA approved mifepristone in 2000, the FDA incorporated post-market restrictions to “assure safe use,” which included (1) limiting drug use through 49 days gestation, (2) requiring three in-person office visits, (3) requiring the supervision of a qualified physician, and (4) requiring the reporting of all adverse events from the drugs. See the Fifth Circuit’s April 12, 2023, partial stay order, slip op. at 4.
In 2016, the FDA approved changes to the 2000 restrictions to (1) increase the maximum gestational age to 70 days, (2) reduce the number of in-person office visits to one, (3) expand the prescribing and administration of mifepristone to additional healthcare providers who were not physicians, and (4) limit the adverse reporting requirement to fatal adverse events. In 2019, the FDA approved a generic version of mifepristone and imposed the same 2016 post-market restrictions. In 2021, the FDA announced its intent to exercise enforcement discretion during the COVID-19 pandemic to not require in-person dispensing requirements, and in January 2023, the FDA modified the restrictions, eliminating the in-person dispensing requirement.
In the April 12, 2023, stay, the Fifth Circuit left intact the lower court’s stay of everything but the 2000 approval and found unconvincing the FDA’s arguments about harm caused by allowing the district court’s unwinding of the post-2000 changes to the Risk Evaluation and Mitigation Strategy.
On August 16, 2023, a panel of the Fifth Circuit vacated in part and affirmed in part. The panel concluded that the challenge to the FDA’s 2000 approval likely is barred by the statute of limitations and vacated the portion of the order involving the 2019 generic approval because the plaintiffs did not provide evidence “that the 2019 Generic Approval contributed to any organizational injury.” Alliance for Hippocratic Medicine v. FDA, No. 23-10362, slip op. at 36 (5th Cir. Aug. 16, 2023). The panel affirmed the stay order regarding the 2016 amendments and the 2021 and 2023 elimination of the in-person dispensing requirement.
The Supreme Court’s Decision
The plaintiffs offered three theories of the alleged downstream effects of the 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 the FDA’s decision-making).
The Supreme Court held that all three were too speculative to support standing. Because the plaintiffs were “unregulated parties who seek to challenge the FDA’s regulation of others,” Alliance for Hippocratic Medicine, No. 23-235, slip op. at 13, the Supreme Court explained that determining causation is not a “mechanical exercise” and is instead a “question of degree.” Id. 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 the 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 doctors’ offices with follow-on injuries.” Id. 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 because of a rollback of power plant emissions standards by the Environmental Protection Agency and an emergency room 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. . . . [D]octors 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.” Id. at 19, 20.
For the advocacy injury theory, the Supreme Court explained that “an organization may not 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.” Id. 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.” Id. 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 the FDA, the Supreme Court did not rule out entirely the possibility of doctors’ alleged conscience injuries 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 healthcare practitioners 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, and individual users of parks. Alliance for Hippocratic Medicine, No. 23-235, slip op. at 12. Particularly given the growing number of challenges to agency regulations, 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.
