Apter v. Dept of Health & Human Svc, 80 F.4th 579

Background

During the COVID-19 pandemic the FDA published a four‑page Update, an FAQ, a website post, and three social‑media posts (the “Posts”) warning consumers not to use ivermectin to prevent or treat COVID‑19 (including the viral “You are not a horse” social posts).
Three physicians who prescribed human‑form ivermectin allege the Posts interfered with their medical practice, harmed reputations, prompted referrals to state medical boards, led pharmacies to refuse fills, and cost hospital/school positions.
The physicians sued FDA, HHS, and two officials (official‑capacity), alleging the Posts were ultra vires under the Federal Food, Drug, and Cosmetic Act and unlawful under the APA, seeking declaratory and injunctive relief.
The district court dismissed, holding sovereign immunity barred relief: (1) the ultra vires exception to immunity did not apply, and (2) the Posts were not final agency action under the APA. The court did not resolve Article III standing.
The Fifth Circuit reversed and remanded: it held the physicians may invoke the APA as a vehicle to bring ultra vires claims against the Agencies and Officials (overcoming sovereign immunity), but the Doctors’ standalone APA claim failed because the Posts are not final agency action. The case was remanded for further proceedings (including standing).

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether sovereign immunity is waived so plaintiffs can sue for ultra vires agency action	Plaintiffs: APA §702 permits using the APA as a vehicle to bring non‑statutory (ultra vires) claims against agencies and officials; Posts exceeded FDA authority	FDA: Ultra vires waiver is narrow; common‑law merits inquiry requires dismissal; FDA also claims Posts were merely informational	Held: Plaintiffs can invoke the APA to bring ultra vires claims; FDA identified no colorable statutory authority to justify giving medical advice, so ultra vires vehicle overcomes sovereign immunity
Whether the Posts constitute "agency action"/a rule under the APA	Plaintiffs: Posts are agency statements announcing a generally applicable principle (“Should not use ivermectin…”) and therefore are agency action/non‑substantive rules	FDA: Posts are informational, non‑directive, nonbinding statements that do not prescribe policy	Held: Posts are agency action (non‑substantive rule/policy statement) because they announce a general principle and include imperative language
Whether plaintiffs fall within the Act’s zone of interests for APA §702 review	Plaintiffs: As practicing physicians alleging interference with the practice of medicine and reputational/operational harms, they are at least arguably within the Act’s zone of interests (21 U.S.C. §396)	FDA: Plaintiffs’ interests are not the kind Congress intended to protect from agency communication; conflates APA claims types	Held: Zone‑of‑interests test is met at least arguably; plaintiffs’ interests are not marginal and fall within protections the Act contemplates
Whether the Posts are "final agency action" under APA (so a pure APA claim can proceed)	Plaintiffs: Posts had practical binding effects, were widely relied on by courts, hospitals, pharmacies, and boards, and thus produced legal consequences	FDA: Posts are non‑final, informational, tentative, and did not determine rights or obligations; lacking finality, §702 does not waive immunity for pure APA claim	Held: Posts are not final agency action — they did not determine rights or legal obligations — so the plaintiffs’ standalone APA claim fails (sovereign immunity bars relief under general APA provisions)

Key Cases Cited

Danos v. Jones, 652 F.3d 577 (5th Cir.) (common‑law ultra vires standard: must show action without any authority or without a colorable basis)
Larson v. Domestic & Foreign Commerce Corp., 337 U.S. 682 (U.S. 1949) (foundational ultra vires/sovereign immunity doctrine)
Pennhurst State School & Hospital v. Halderman, 465 U.S. 89 (U.S. 1984) (limits on remedies against state actors and discussion of ultra vires principle)
Match‑E‑Be‑Nash‑She‑Wish Band of Pottawatomi Indians v. Patchak, 567 U.S. 209 (U.S. 2012) (APA §702 waiver framing; zone‑of‑interests discussion)
Lujan v. National Wildlife Federation, 497 U.S. 871 (U.S. 1990) (standing and zone‑of‑interests principles)
Walmart Inc. v. U.S. Dep’t of Justice, 21 F.4th 300 (5th Cir. 2021) (scope of what constitutes an agency rule/guidance; non‑substantive rule analysis)
Alabama‑Coushatta Tribe of Tex. v. United States, 757 F.3d 484 (5th Cir. 2014) (distinguishing APA general waiver claims from non‑statutory causes of action)
Data Mktg. P’ship, LP v. U.S. Dep’t of Labor, 45 F.4th 846 (5th Cir. 2022) (finality test elements for agency action under APA)
Texas v. Equal Emp. Opportunity Comm’n, 933 F.3d 433 (5th Cir. 2019) (practical‑binding‑effect discussion in finality analysis)
Qureshi v. Holder, 663 F.3d 778 (5th Cir. 2011) (agency action and reviewability principles)
Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (U.S. 2001) (off‑label use definition and context on federal regulatory role)