State of Louisiana et al. v. Food and Drug Administration et al.

Docket No.
6:25-cv-01491
District Court
Louisiana Western

Goal

  • Compel agency action
  • Declaration that agency action is unlawful
  • Vacate agency action

Issues

Why This Matters:

In 2023, the FDA revised the Risk Evaluation and Mitigation Strategy for mifepristone to, among other changes, remove a requirement that the medication be dispensed in-person in a medical facility. This revision allowed prescribers to send, and their patients to receive, the medication by mail. Plaintiffs challenge the FDA’s revision as arbitrary and capricious, an abuse of discretion, and contrary to law in violation of the Administrative Procedure Act. Reinstating the in-person dispensing requirement, which has not been in effect since 2020, would create a serious barrier for women seeking reproductive care.

Potential Impact:

Unnecessary restrictions on safe and effective drugs can create obstacles for doctors to promote medically appropriate care and jeopardize the health and safety of patients.

News And Analysis (2)

42 Major Filings

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Related Litigation

Current Status

Briefing is ongoing

Important Date

Defendant Supplemental Briefing Due

Legal Issues

Administrative Procedure Act - Arbitrary and Capricious, Administrative Procedure Act - Contrary to Law

Amicus Briefs for Plaintiff(s)

Family Research Council et al.; Women Injured by Abortion et al.; American Association of Pro-Life Gynecologists and Obstetricians et al.; Women and Families Harmed by Mifepristone et al.; The American Center for Law & Justice; Ethics and Public Policy Center; Senator Bill Cassidy, M.D. et al.; State of Nebraska et al.; Advancing American Freedom et al.; Concerned Women for America; Dr. Calum Miller;  Heartbeat International; Students for Life of America

Amicus Briefs for Defendant(s)

IGH PLLC et al.; National Domestic Violence Hotline et al.; Reproductive Health, Rights, and Justice Organizations; Former Commissioners and Acting Commissioners of the U.S. Food and Drug Administration; State of New York et al.; Former U.S. Department of Justice Officials; Disability Rights Education and Defense Fund et al.; American College of Obstetricians & Gynecologists et al.; Medical Students for Choice

Topic(s)

Medication Abortion

Date Filed
October 6, 2025
Case Type
Civil
Court Type
District Court
Court
Louisiana Western
Judge
Joseph, David C. Appointed By: Donald Trump
Plaintiff(s)
State of Louisiana; Rosalie Markezich
Lead Counsel For Plaintiff(s)
Government; Johnson, Siebeneicher & Ingram
Defendant(s)
Food and Drug Administration; Martin A. Makary; George F. Tidmarsh; Department of Health and Human Services; Robert F. Kennedy Jr.
Lead Counsel for Defendant(s)
Government
Intervenors
Danco Laboratories, LLC; GenBioPro, Inc.