Association of American Physicians & Surgeons v. Food & Drug Administration — W.D. Mich., No. 1:20-cv-00493

Case summary

The Association of American Physicians & Surgeons filed a complaint for declaratory and injunctive relief on June 2, 2020 in the U.S. District Court for the Western District of Michigan, Southern Division, No. 1:20-cv-00493, against the Food and Drug Administration, the Biomedical Advanced Research & Development Authority, the Department of Health and Human Services and their officers in their official capacities. The complaint challenges the FDA's restrictions on the use of hydroxychloroquine distributed from the Strategic National Stockpile to treat COVID-19, under the equal protection component of the Due Process Clause, section 564 of the Federal Food, Drug, and Cosmetic Act and the Administrative Procedure Act. On August 14, 2020 Chief Judge Robert J. Jonker granted the defendants' motion to dismiss, denied the preliminary injunction and entered judgment for the defendants, dismissing all claims for lack of standing.

Case at a glance

What does the complaint allege?

That the FDA's restrictions on the use of hydroxychloroquine from the Strategic National Stockpile to treat COVID-19 are arbitrary, irrational and unjustifiable, and that AAPS members have suffered injury in the form of the denial by the FDA of access to the drug for members to prescribe to patients, causing economic injury by interfering with their ability to care for patients who have COVID-19 or are at risk of it. The complaint pleads claims under the Fifth Amendment's equal-protection component, the Federal Food, Drug and Cosmetic Act and the Administrative Procedure Act.

What did the court decide?

That AAPS lacks standing under any of the theories it articulated, because the causal connections between the alleged injuries and the actions complained of are attenuated and general. The opinion records that hydroxychloroquine is commercially available and physicians are free to prescribe it for off-label uses absent contrary direction by state medical authorities, and that nothing in the Emergency Use Authorization or its revocation had any direct impact on the drug's availability in the commercial market. The court granted the defense motion, denied the preliminary injunction and dismissed the case.

What measure was at issue?

The opinion records that in March 2020 the FDA approved an Emergency Use Authorization for hydroxychloroquine permitting healthcare providers to prescribe the drug distributed from the federal Strategic National Stockpile to treat COVID-19, limited to adults and adolescents already hospitalised with COVID-19 for whom clinical trials were unavailable, and that approximately three months later the FDA revoked the authorization, restricting distribution from the stockpile to use only in clinical trials.