Caseflicks

Supreme Court of the United States • 2024

FDA v. Alliance for Hippocratic Medicine

602 U.S. 367

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Takeaway

In short, this case holds that ideological opposition to FDA’s regulation of a drug, plus speculative downstream burdens on doctors or advocacy expenditures by organizations, does not satisfy Article III standing.

Background

FDA approved mifepristone, marketed as Mifeprex, in 2000 for medication abortion up to seven weeks of pregnancy and imposed conditions on prescribing and distribution. In 2016, FDA expanded use through ten weeks, permitted certain nonphysician providers to prescribe the drug, reduced the required in-person visits from three to one, and altered adverse-event reporting requirements. FDA approved generic mifepristone in 2019. In 2021, after experience during the COVID-19 pandemic, FDA announced it would no longer enforce the remaining in-person dispensing requirement.

Four pro-life medical associations and several doctors sued under the Administrative Procedure Act. They sought to rescind FDA’s approval of mifepristone or, at minimum, invalidate the 2016 and 2021 actions. The District Court found standing and effectively ordered mifepristone removed from the market. The Fifth Circuit concluded that plaintiffs had standing, rejected their challenges to the 2000 approval and 2019 generic approval, but held plaintiffs likely to succeed against the 2016 and 2021 changes. The Supreme Court stayed the lower-court relief, granted review of the 2016 and 2021 actions, and reversed because the plaintiffs lacked Article III standing.

Issues

Issue #1

Whether the plaintiff doctors had Article III standing based on the possibility that FDA’s relaxed mifepristone rules would force them to provide abortion-related care contrary to conscience.

Holding

No. The doctors did not show that FDA’s 2016 and 2021 actions would likely cause a concrete conscience injury.

Reasoning

Article III requires a plaintiff to show a concrete, particularized, actual or imminent injury; that the defendant likely caused that injury; and that requested relief would likely redress it. The injury and causation requirements are especially demanding where, as here, an unregulated plaintiff challenges the government’s regulation of other people. The plaintiff doctors neither prescribe nor use mifepristone, and FDA did not direct them to do or refrain from doing anything.

A conscience-based injury could qualify as a concrete injury if a doctor were likely to be compelled to perform an abortion or provide treatment contrary to conscience. But the asserted causal chain was broken by federal conscience protections, including the Church Amendments, which protect medical personnel who refuse to participate in abortion or other care that conflicts with their religious beliefs or moral convictions.

The record did not identify any instance since mifepristone’s 2000 approval in which a plaintiff doctor, despite asserting a conscience objection, had been forced to perform an abortion or provide abortion-related treatment. The doctors’ declarations did not establish that they personally gave objectionable treatment, invoked conscience protections unsuccessfully, or faced a hospital’s refusal to accommodate an objection.

EMTALA did not supply the missing injury. The Court accepted the Government’s position that EMTALA imposes duties on hospitals rather than requiring individual emergency-room doctors to perform abortions over conscience objections. Doctors may simply refuse participation, and federal law protects them from repercussions for that refusal. Thus, the prospect of a compelled-conscience violation was too speculative to establish standing.

Issue #2

Whether the plaintiff doctors had standing based on alleged economic and professional burdens from treating patients with mifepristone complications.

Holding

No. The alleged diversion of time and resources, increased liability exposure, and increased insurance costs were too speculative and attenuated to be fairly traceable to FDA’s actions.

Reasoning

The doctors did not present evidence that the 2016 and 2021 regulatory changes caused more patients with mifepristone complications to seek treatment from them, or that treating such patients diverted their resources from other work. They likewise identified no past lawsuits or increased insurance costs arising from treatment of mifepristone complications, and offered no persuasive basis to conclude that such harms were likely in the future.

The Court rejected the proposed theory as an unprecedented form of generalized “doctor standing.” A doctor cannot challenge a government’s loosening of public-safety rules merely because the change may eventually result in more patients requiring medical care. Otherwise, doctors could challenge emissions rules because of possible asthma cases, speed limits because of possible crash injuries, or drug approvals because of side effects.

The causal connection was especially inadequate in the FDA context. Virtually every drug entails risks, complications, or side effects that can generate later medical visits. Allowing health-care providers to challenge FDA decisions simply because other people’s use of a drug might create downstream treatment needs would make standing effectively limitless and conflict with Article III’s case-or-controversy limit.

Issue #3

Whether the plaintiff medical associations had organizational standing because they spent resources studying mifepristone, petitioning FDA, and educating the public in opposition to FDA’s actions.

Holding

No. An organization cannot create standing by voluntarily spending money to oppose government action that has not itself caused the organization a concrete injury.

Reasoning

Organizations, like individuals, must establish injury in fact, causation, and redressability. The associations’ strong opposition to abortion and to FDA’s mifepristone policies did not itself constitute an injury. Article III does not permit a lawsuit based solely on the intensity or duration of an organization’s interest in a policy issue.

The associations claimed that FDA’s actions caused them to conduct research, file citizen petitions, and undertake advocacy and public education. But those were self-chosen expenditures made to oppose FDA’s policy, not injuries directly inflicted by FDA. An organization cannot manufacture standing by spending resources to gather information or advocate against an action it dislikes.

Havens Realty Corp. v. Coleman did not support a broader rule. In Havens, the defendant’s racial-steering practices directly impaired the plaintiff organization’s housing-counseling service, which was an operational activity of the organization. FDA’s actions did not similarly interfere with the associations’ own services or advocacy operations. Nor could the possibility that no other plaintiff might have standing justify relaxing Article III’s requirements; some disputes must be resolved through political and democratic processes rather than federal litigation.

Concurrences

Justice Thomas

Reasoning

Justice Thomas joined the Court’s opinion because existing standing precedent required rejection of the doctors’ asserted injuries. He wrote separately, however, to argue that the Court’s third-party-standing doctrine is itself mistaken. In his view, a plaintiff cannot establish an Article III case or controversy by asserting another person’s rights, even when the plaintiff has a close relationship with that person and the rights-holder faces obstacles to suing.

He also questioned the related doctrine of associational standing, under which an association may sue based on injuries to its members. That doctrine appears to depart from the traditional understanding that a litigant must assert an injury to its own rights. The Alliance’s claim illustrated the concern: it sought to rely on injuries to doctors who belonged to its member associations, placing the assertedly injured persons two steps removed from the party before the Court.

Justice Thomas further argued that associational standing creates redressability and remedial problems. The association itself has no injury to redress, while the injured members are not parties; an injunction directed only to the association would not remedy the members’ injuries, while broader relief may exceed traditional equitable authority. He also noted tensions with class-action requirements and preclusion principles.

Although he believed the Court should reconsider whether associational standing can be reconciled with Article III, Justice Thomas did not call for resolution of that question here. No party had directly challenged the doctrine, and rejecting it was unnecessary because the plaintiffs lacked standing under the Court’s existing rules.