Association of American Physicians & Surgeons v. Food & Drug Administration, 479 F.Supp.3d 570

In March 2020 FDA issued an Emergency Use Authorization (EUA) for hydroxychloroquine (HCQ) limited to supplies from the federal Strategic National Stockpile for hospitalized adult/adolescent COVID-19 patients when clinical trials were unavailable.
The EUA did not affect commercially available HCQ; AAPS acknowledged no commercial shortage.
The FDA revoked the EUA in June 2020, citing lack of efficacy and safety (cardiac adverse events), restricting use from the stockpile to clinical trials.
Plaintiff Association of American Physicians & Surgeons (AAPS) sued on behalf of members who allegedly wish to prescribe HCQ prophylactically, claiming FDA actions prompted state medical authorities to deter or discipline prescriptions and that AAPS suffered organizational injury (canceled/converted conference).
Defendants moved to dismiss for lack of standing; AAPS moved for a preliminary injunction. The court found AAPS’s alleged injuries attenuated, traceability to defendants weak, and redress unlikely, and therefore dismissed for lack of standing and denied the injunction.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Organizational standing (AAPS suing in its own right)	AAPS lost revenue/events (cancelled conference) and thus suffered injury traceable to FDA actions	Injuries stem from independent state actions and public-health restrictions; FDA did not affect commercial HCQ supply	Denied — injury not fairly traceable to defendants and not redressable by relief requested
Associational standing (on behalf of member physicians)	Members (e.g., John Doe) cannot prescribe/prosecute HCQ due to state boards relying on FDA; fear of retaliation	Members remain free to prescribe commercially available HCQ; traceability to federal defendants is indirect	Denied — members’ alleged injuries speculative, not concrete; causation and redressability fail
Third‑party standing (on behalf of patients)	Patients cannot obtain prophylactic HCQ because of state reliance on FDA; AAPS asserts patient interests	Third parties (patients) can litigate; AAPS lacks close relationship and hasn’t shown hindrance to patients suing	Denied — AAPS fails to show close relationship or hindrance; third‑party exception inapplicable
Preliminary injunction	Urgent relief needed to restore access to HCQ from stockpile and prevent chilling of prescribing	No standing; moreover APA/First Amendment claims face deferential review and other hurdles	Denied — preliminary relief unavailable because plaintiff lacks standing; merits not reached

Spokeo, Inc. v. Robins, 136 S. Ct. 1540 (2016) (standing: concrete and particularized injury requirement)
Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (standing: injury‑in‑fact, causation, redressability framework)
Warth v. Seldin, 422 U.S. 490 (1975) (associational standing principles)
Valley Forge Christian Coll. v. Americans United for Separation of Church & State, 454 U.S. 464 (1982) (traceability requirement for standing)
Friends of the Earth, Inc. v. Laidlaw Environmental Servs., 528 U.S. 167 (2000) (redressability: likely vs. speculative relief)
Hunt v. Washington State Apple Advertising Comm’n, 432 U.S. 333 (1977) (associational standing test)
Parsons v. United States Dep’t of Justice, 801 F.3d 701 (6th Cir. 2015) (Article III standing at pleading stage)
Crawford v. United States Dep’t of Treasury, 868 F.3d 438 (6th Cir. 2017) (limitations where injury results from independent third‑party actions)
Waskul v. Washtenaw Cty. Cmty. Mental Health, 900 F.3d 250 (6th Cir. 2018) (associational standing: at least one member must have standing)
Ass’n of Am. Physicians & Surgeons, Inc. v. Texas Medical Bd., 627 F.3d 547 (5th Cir. 2010) (contrasting associational‑standing facts where members suffered concrete, traceable injuries)