Case docket

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

Association of American Physicians & Surgeons v. Food & Drug Administration — 15 court filings in the archive from U.S. District Court for the Western District of Michigan, Southern Division, filed between June 2, 2020 and August 14, 2020. Among them: 4 motions, 2 declarations and 1 complaint.

Case facts

Court	U.S. District Court for the Western District of Michigan, Southern Division
Filings	15 public filings
Filed	2020-06-02 – 2020-08-14
Document types	motions (4), declarations (2), complaint (1), memorandum or brief (1), judgment (1), opinion (1)
Original PDFs	15 of 15

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

Parties	Plaintiff: Association of American Physicians & Surgeons, a non-profit membership organization of physicians incorporated in Indiana and headquartered in Tucson, Arizona. Defendants: Food & Drug Administration; Stephen M. Hahn, Commissioner of Food & Drugs; Biomedical Advanced Research & Development Authority; Gary L. Disbrow, Acting Director of BARDA; Department of Health & Human Services; and Alex Azar, Secretary of Health & Human Services, the individuals all in their official capacities
Court and docket	U.S. District Court for the Western District of Michigan, Southern Division, No. 1:20-cv-00493 (Chief Judge Robert J. Jonker); the mandamus petition is U.S. Court of Appeals for the Sixth Circuit, No. 20-1743
Program	Not named in the filings on this page. The measure at issue is the Emergency Use Authorization for hydroxychloroquine from the Strategic National Stockpile and its revocation
Claims	Declaratory and injunctive relief for violations of the equal protection component of the Due Process Clause of the Fifth Amendment, section 564 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3, and the Administrative Procedure Act, 5 U.S.C. §§ 701-706, with jurisdiction pleaded under 28 U.S.C. § 1331 and the Declaratory Judgment Act
Disposition or status	Dismissed for lack of standing. The opinion and order of August 14, 2020 granted the defendants' motion to dismiss under Rules 12(b)(1) and 12(b)(6), denied the plaintiff's motion for a preliminary injunction and dismissed the case; judgment was entered the same day in favor of the defendants, dismissing all claims for lack of standing
Status checked	2026-09-23 · against DOJ press releases through 2026-09-22; court docket not yet read

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.

Summary written from the documents on this page; every sentence is sourced.

Filings

15 public filings from this case, in filing-date order.

2020-06-02Complaint — AAPS v. FDAComplaint · PDF
2020-06-22CDC HCQ Fact Sheet (Exhibit 12) — AAPS v. FDA
2020-06-22Declaration of Jane Orient, M.D. (Exhibit 1) — AAPS v. FDADeclaration
2020-06-22Declaration of Jeremy Snavely (Exhibit 2) — AAPS v. FDADeclaration
2020-06-22Memorandum in Support of PI Motion — AAPS v. FDA (W.D. Mich.)Memorandum or brief
2020-06-22Motion for Preliminary Injunction — AAPS v. FDA (W.D. Mich.)Motion
2020-07-10Combined Memo: MTD and Opposition to PI — AAPS v. FDAPDF
2020-07-10Motion to Dismiss — AAPS v. FDAMotion
2020-07-20Combined Reply in Support of PI / Opposition to MTD — AAPS v. FDAPDF
2020-07-20Joseph Declaration and Michigan LARA Exhibits (Exhibit 1 to Reply) — AAPS v. FDAPDF
2020-07-20Second Declaration of Jeremy Snavely (Exhibit 2 to Reply) — AAPS v. FDA (W.D. Mich.)
2020-07-30Motion to Expedite Hearing — AAPS v. FDAMotion
2020-08-10Petition for Writ of Mandamus — AAPS v. FDAMotion
2020-08-14Judgment — AAPS v. FDAJudgment
2020-08-14Opinion and Order — AAPS v. FDAOpinion