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108 F.4th 1163
9th Cir.
2024
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Background

  • The State of Washington, joined by 17 other states and D.C., sued the FDA, challenging "safe-use" restrictions on the abortion drug mifepristone imposed by the agency’s 2023 Risk Evaluation and Mitigation Strategy (REMS).
  • The plaintiff states argued that the FDA’s remaining restrictions (provider certification and patient documentation), and the underlying REMS framework itself, unnecessarily limited access to mifepristone.
  • Idaho and a coalition of six other states sought to intervene in the lawsuit, aiming to reimpose prior, stricter REMS requirements—especially the in-person dispensing rule that FDA had removed.
  • The district court granted a partial injunction for plaintiff states (sustaining mifepristone access) and denied Idaho’s motion to intervene, finding Idaho sought fundamentally different relief.
  • On appeal, the Ninth Circuit reviewed whether Idaho had Article III standing to intervene for separate relief (reimposing restrictions) and whether the denial of permissive intervention was correct.

Issues

Issue Plaintiff's Argument (Washington) Defendant's Argument (FDA) Held
Must an intervenor seeking different relief show standing? Yes, Idaho seeks different relief and must show standing. Yes, same position as plaintiffs. Yes, Idaho must independently establish Article III standing.
Does Idaho have standing based on Medicaid costs? N/A Idaho argued costs are too indirect. No, injury is too speculative/attenuated; increased state spending is not a cognizable Article III injury.
Does elimination of in-person dispensing harm Idaho’s sovereignty? N/A Idaho argued harm to law enforcement authority. No, because Idaho can still enforce its own laws; federal REMS does not preempt or nullify state enforcement.
Does Idaho have parens patriae standing based on health/fetal life? N/A Idaho argued quasi-sovereign interest. No, state cannot sue the federal government as parens patriae for citizen interests; only federal gov’t is sovereign.

Key Cases Cited

  • Town of Chester v. Laroe Estates, Inc., 581 U.S. 433 (2017) (intervenors seeking different relief must show independent Article III standing)
  • Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (Article III standing requirements)
  • United States v. Texas, 599 U.S. 670 (2023) (standing requirements for states; limits on standing based on indirect effects of federal policy)
  • Alliance for Hippocratic Medicine v. FDA, 602 U.S. 367 (2024) (standing and causation requirements applied to FDA mifepristone regulation challenges)
  • Massachusetts v. EPA, 549 U.S. 497 (2007) (state quasi-sovereign interests must concern the state as a whole, not individual citizens)
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Case Details

Case Name: State of Washington v. Fda
Court Name: Court of Appeals for the Ninth Circuit
Date Published: Jul 24, 2024
Citations: 108 F.4th 1163; 23-35294
Docket Number: 23-35294
Court Abbreviation: 9th Cir.
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    State of Washington v. Fda, 108 F.4th 1163