FDA v. Alliance for Hippocratic Medicine
602 U.S. 367 (2024)
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Rule of Law:
A plaintiff seeking to challenge a government agency's regulation of a third party must demonstrate a concrete and particularized injury in fact that is fairly traceable to the agency's action. An ideological, moral, or policy objection, or an injury that is speculative or attenuated, is insufficient to establish Article III standing.
Facts:
- In 2000, the Food and Drug Administration (FDA) approved the new drug application for mifepristone to terminate pregnancies up to seven weeks, imposing several restrictions on its use and distribution.
- The 2000 restrictions required that only doctors could prescribe mifepristone and that patients make three in-person visits to the doctor.
- In 2016, the FDA relaxed some restrictions, deeming mifepristone safe for use up to ten weeks of pregnancy, allowing non-physician healthcare providers to prescribe it, and reducing the required in-person visits from three to one.
- In 2019, the FDA approved an application for generic mifepristone, applying the same relaxed conditions of use established in 2016.
- In 2021, the FDA announced that, based on experience gained during the COVID-19 pandemic, it would no longer enforce the requirement for an in-person visit to receive the drug.
- The plaintiff doctors and medical associations are pro-life, oppose elective abortion, and do not themselves prescribe or use mifepristone.
Procedural Posture:
- Four pro-life medical associations and several individual doctors sued the Food and Drug Administration (FDA) in the U.S. District Court for the Northern District of Texas (a federal trial court).
- Danco Laboratories, the sponsor of Mifeprex, intervened as a defendant.
- The plaintiffs moved for a preliminary injunction, which the District Court granted, effectively enjoining the FDA's approval of mifepristone and ordering it off the market.
- The FDA and Danco (appellants) appealed to the U.S. Court of Appeals for the Fifth Circuit (an intermediate appellate court) and sought an emergency stay of the District Court's order.
- The Fifth Circuit granted the stay in part, allowing mifepristone to remain available but only under the more restrictive, pre-2016 regulations.
- The FDA and Danco then applied to the U.S. Supreme Court for a full stay of the District Court's order, which the Supreme Court granted, thereby keeping mifepristone available under the current 2016 and 2021 rules pending the appeal.
- The Fifth Circuit later issued its decision on the merits of the appeal, affirming in part and concluding that the plaintiffs were likely to succeed in their challenge to the FDA's 2016 and 2021 actions.
- The U.S. Supreme Court granted certiorari to review the Fifth Circuit's judgment concerning the 2016 and 2021 FDA actions.
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Issue:
Do pro-life medical associations and individual doctors have Article III standing to challenge the Food and Drug Administration's actions that relaxed the regulatory requirements for the abortion drug mifepristone?
Opinions:
Majority - Kavanaugh, J.
No. The plaintiff doctors and medical associations lack Article III standing because they have failed to demonstrate any cognizable injury in fact that is fairly traceable to the FDA's challenged actions. A plaintiff's desire to make a drug less available for others does not establish standing to sue. The Court rejected three primary standing theories: 1) The alleged 'conscience injury' fails because federal conscience protection laws definitively shield doctors from being required to perform abortions or provide treatment that violates their beliefs, thus breaking the chain of causation. 2) The alleged 'economic injuries'—such as diverting time and resources or facing increased liability insurance costs—are too speculative and attenuated, and the Court declined to create a novel 'doctor standing' doctrine that would allow physicians to challenge any general public safety regulation. 3) The associations' claim of 'organizational standing' fails because an organization cannot manufacture standing by expending resources to oppose a government action it dislikes; this is different from cases like Havens Realty, where the defendant's conduct directly impaired the organization's ability to carry out its core mission.
Concurring - Thomas, J.
No. While joining the Court's opinion in full, this concurrence questions the constitutional foundation of 'associational standing' itself. Associational standing, like third-party standing, allows a plaintiff to sue based on injuries to others rather than themselves, which appears to conflict with the traditional understanding of Article III's case-or-controversy requirement. This doctrine creates a mismatch where the plaintiff association has no injury to redress, distorts traditional remedial principles, and subverts procedural mechanisms like class actions. In an appropriate future case, the Court should re-examine whether associational standing is consistent with the Constitution's limits on judicial power.
Analysis:
This unanimous decision significantly reinforces the stringent requirements for Article III standing, particularly for plaintiffs challenging the government's regulation of third parties. By explicitly rejecting a 'doctor standing' theory, the Court foreclosed a potential new avenue for litigation where healthcare professionals could challenge a wide range of public health and safety regulations. The ruling effectively channels ideological and policy-based disputes away from the judiciary and back to the political and legislative branches. It underscores that federal courts are not forums for generalized grievances, thereby limiting the ability of interest groups to challenge government actions without demonstrating a direct, personal, and concrete harm.
