13 F.4th 531
6th Cir.2021Background
- FDA issued an Emergency Use Authorization (EUA) for hydroxychloroquine in March 2020 that authorized distribution from the federal stockpile only for hospitalized adult/adolescent COVID-19 patients when clinical trial participation was unavailable or infeasible.
- Association of American Physicians & Surgeons (AAPS) sued the FDA and related officials seeking declaratory and injunctive relief to broaden access; claims alleged violations of the Fifth Amendment (equal protection), the First Amendment (association), and the APA.
- AAPS alleged three injuries: it might cancel a conference (organizational injury), its physician members were prevented from prescribing hydroxychloroquine (associational standing), and members’ patients could not obtain the drug (third-party standing).
- The district court dismissed under Rule 12(b)(1) for lack of Article III standing; on appeal the Sixth Circuit reviewed de novo, applied Twombly/Iqbal plausibility standards to standing allegations, and addressed whether the complaint plausibly alleged member injuries traceable to the FDA.
- The Sixth Circuit held AAPS lacked standing: the EUA governed federal stockpile distribution (not physician prescribing), and AAPS’s allegations that state medical boards would discipline members were speculative and failed to show imminence, causation, or redressability; the organizational injury claim was abandoned on appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Associational standing (can AAPS sue for members?) | AAPS: EUA prevents members from prescribing hydroxychloroquine for prophylaxis/early treatment, so members are injured. | FDA: EUA only governs federal stockpile distribution and does not prohibit off‑label prescribing; no member injury pleaded. | No — AAPS failed to plausibly allege any member suffered a concrete, particularized injury or that relief would redress such an injury. |
| Indirect harm via state disciplinary actions (traceability and imminence) | AAPS: state medical boards relied on the EUA and members fear discipline for prescribing. | FDA: Allegations are speculative; no credible threat, no specific state board actions identified, and independent actors break causation. | No — threats were not certainly impending and causation to FDA was speculative. |
| Third‑party standing (can AAPS assert patients’ rights through members?) | AAPS: may assert patients’ rights via its physician members. | FDA: AAPS forfeited any organizational injury and cannot rest on members who lack standing. | No — because AAPS failed to show its members had Article III standing, it could not invoke third‑party standing for patients. |
| Pleading standard for standing allegations | AAPS: broad factual assertions about membership and harm suffice. | FDA: Standing elements must be plausibly pleaded under Twombly/Iqbal. | Twombly/Iqbal plausibility standard applies to standing; AAPS’s factual allegations were inadequate. |
Key Cases Cited
- Flast v. Cohen, 392 U.S. 83 (1968) (early Supreme Court discussion of broader standing doctrines)
- Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (Article III standing requires concrete and particularized injury, causation, redressability)
- Hunt v. Wash. State Apple Advert. Comm’n, 432 U.S. 333 (1977) (test for associational standing)
- TransUnion LLC v. Ramirez, 141 S. Ct. 2190 (2021) (injury‑in‑fact and historical practice guide Article III standing analysis)
- Warth v. Seldin, 422 U.S. 490 (1975) (association may sue for members only if members would have standing; redressability considerations)
- Summers v. Earth Island Inst., 555 U.S. 488 (2009) (limits on organizational standing where members’ injuries are not concretely alleged)
- Susan B. Anthony List v. Driehaus, 573 U.S. 149 (2014) (pre-enforcement credible‑threat doctrine for imminent injury)
- Clapper v. Amnesty Int’l USA, 568 U.S. 398 (2013) (speculative chains of causation to independent third parties do not establish standing)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (FDA’s regulatory scope distinguished from state regulation of medical practice)