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FDA v. Alliance for Hippocratic Medicine
602 U.S. 367
SCOTUS
2024
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Background

  • In 2000, the FDA approved mifepristone (Mifeprex) for terminating early pregnancies, with specific restrictions.
  • FDA relaxed those restrictions in 2016 (expanded use to 10 weeks, fewer in-person visits, broader prescriber pool) and again in 2021 (eliminating initial in-person visit).
  • Several pro-life medical associations and doctors sued, seeking to overturn FDA’s 2016 and 2021 regulatory changes.
  • The district court sided with plaintiffs, blocking mifepristone’s approval; the Fifth Circuit limited relief but agreed on standing.
  • The Supreme Court granted certiorari to decide whether plaintiffs had Article III standing to challenge FDA’s actions.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Standing: Injury-in-Fact Plaintiffs suffer conscience and economic injuries from relaxed FDA regulations Plaintiffs are not directly regulated; no concrete or particularized injury No standing; injuries are too speculative/attenuated
Conscience Protections FDA’s changes may compel pro-life doctors to participate in abortions Federal law protects doctors from being forced to perform or assist in abortions Conscience laws break the causal chain; no standing
Organizational Standing Medical groups claim injury by diverting resources to counter FDA’s actions Resource expenditure alone, without direct injury, does not create standing No standing; can’t spend way into federal court
Third-Party/Associational Standing Doctors/associations may sue on behalf of patients/members Plaintiffs must still show personal injury to themselves, not just members No standing; doctrine not satisfied in these circumstances

Key Cases Cited

  • Lujan v. Defenders of Wildlife, 504 U.S. 555 (Article III standing requirements: injury, causation, redressability)
  • Valley Forge Christian College v. Americans United for Separation of Church & State, 454 U.S. 464 (Generalized grievances and standing)
  • Allen v. Wright, 468 U.S. 737 (Standing: personal stake and separation of powers)
  • Simon v. Eastern Kentucky Welfare Rights Org., 426 U.S. 26 (Causation in standing for third-party government regulation)
  • Summers v. Earth Island Institute, 555 U.S. 488 (Concrete injury is required for standing)
  • TransUnion LLC v. Ramirez, 594 U.S. 413 (Concrete and particularized injury necessary for standing)
  • Schlesinger v. Reservists Comm. to Stop the War, 418 U.S. 208 (No standing just because otherwise nobody could challenge)
  • Sierra Club v. Morton, 405 U.S. 727 (Abstract interest in problem insufficient for standing)
Read the full case

Case Details

Case Name: FDA v. Alliance for Hippocratic Medicine
Court Name: Supreme Court of the United States
Date Published: Jun 13, 2024
Citation: 602 U.S. 367
Docket Number: 23-235
Court Abbreviation: SCOTUS