United States Court of Appeals for the Fifth Circuit United States Court of Appeals Fifth Circuit

____________ FILED September 1, 2023 No. 22-40802 Lyle W. Cayce ____________ Clerk

Robert L. Apter; Mary Talley Bowden; and Paul E. Marik,

Plaintiffs—Appellants,

versus

Department of Health & Human Services; Xavier Becerra, in his official capacity as Secretary of Health and Human Services; Food & Drug Administration; Robert M. Califf, in his official capacity as Commissioner of Food and Drugs,

Defendants—Appellees. ______________________________

Appeal from the United States District Court for the Southern District of Texas USDC No. 3:22-CV-184 ______________________________

Before Clement, Elrod, and Willett, Circuit Judges. Don R. Willett, Circuit Judge: “You are not a horse.” Or so the Food and Drug Administration (“FDA”) alerted millions of Americans via social media, midway through the COVID-19 pandemic. The agency had discerned that some people were treating their symptoms using the animal version of a drug called ivermectin. FDA decided to target that practice via the “horse” message—and others like it. The messaging Case: 22-40802 Document: 00516882138 Page: 2 Date Filed: 09/01/2023

No. 22-40802

traveled widely across legacy and online media. Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose. The Appellants are three medical Doctors who prescribed the human version of ivermectin to thousands of their patients. Each Doctor says that FDA’s messaging interfered with their own individual medical practice. The Doctors sued FDA and the Department of Health and Human Services (together, the “Agencies”). They also sued two governmental employees in their official capacities (the “Officials”). The Doctors argue that FDA’s “horse” message and similar public statements (together, the “Posts”) violate FDA’s enabling act (“Act”) and the Administrative Procedure Act (“APA”). The district court held that sovereign immunity protects the Agencies and the Officials, and it dismissed the suit. We disagree. First, the Doctors can use the APA to bypass sovereign immunity and assert their ultra vires claims against the Agencies and the Officials. FDA is not a physician. Thus, assuming FDA is correct that we must consider the merits to some degree even at the pleading stage, the Posts that issue medical advice to consumers are plausibly ultra vires. The Posts are plausibly agency action, too, because they publicly announce the general principle that consumers should not use ivermectin to treat the coronavirus, and because the Doctors fall within the Act’s zone of interests. Second, because the Doctors can use the APA for their ultra vires claims, we need not consider the common-law version of that doctrine. Third, however, the Doctors’ pure APA claim cannot go forward. That is because the Posts do not determine legal rights and thus lack the finality. Even though this last theory fails, the Doctors’ first theory is enough to allow this suit