Apter v. Dep't of Health & Human Servs.

80 F.4th 579

Robert L. APTER; Mary Talley Bowden; and Paul E. Marik, Plaintiffs—Appellants, v. 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 capacityas Commissioner of Food and Drugs, Defendants—Appellees.

No. 22-40802

United States Court of Appeals, Fifth Circuit

FILED September 1, 2023

Appeal from the United States District Court for the Southern District of Texas, USDC No. 3:22-CV-184, Jeffrey Vincent Brown, U.S. District Judge Jared Kelson, R. Trent McCotter, Boyden Gray, P.L.L.C., Washington, DC, for Plaintiffs—Appellants.

Ashley Cheung Honold, U.S. Department of Justice, Civil Division, Appellate Section, Washington, DC, Oliver McDonald, U.S. Department of Justice, Consumer Protection Branch, Washington, DC, Daniel Bentele Hahs Tenny, Esq., U.S. Department of Justice, Civil Division, Washington, DC, for Defendants—Appellees.

Alan Dumoff, Attorney, Law Office of Alan Dumoff, Gaithersburg, MD, for Amicus Curiae Front Line Covid-19 Critical Care Alliance.

Andrew Layton Schlafly, Far Hills, NJ, for Amicus Curiae Association of American Physicians & Surgeons.

David Anthony Dalia, New Orleans, LA, for Amicus Curiae America's Frontline Doctors.

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 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 to proceed.

We REVERSE and REMAND.

I

A

Ivermectin is a drug. About eighteen months into the COVID-19 pandemic, the Food and Drug Administration released an informal "Consumer Update" titled "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19" ("Update"). The current version of the Update reads, in part (internal headings omitted):

COVID-19. We've been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it's perhaps not surprising that some consumers are turning to drugs not approved or authorized by the Food and Drug Administration . . . .

. . .

There seems to be a growing interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. Certain animal formulations of ivermectin such as pour-on, injectable, paste, and "drench," are approved in the U.S. to treat or prevent parasites in animals. For humans, ivermectin tablets are approved at very specific doses to treat some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea.

However, the FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.

• The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.

• Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.

• Taking large doses of ivermectin is dangerous.

• If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.

• Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.

. . . .

The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals. Ivermectin has not been shown to be safe or effective for these indications.

There's a lot of misinformation around, and you may have heard that it's okay to take large doses of ivermectin. It is not okay.

. . . .

Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can help determine the best option for you, based on your health history.¹

FDA also released a document titled "FAQ: COVID-19 and Ivermectin Intended for Animals" ("FAQ"). Together, the Update and the FAQ total about four pages. In addition to those releases, FDA also posted four items online between August 2021 and April 2022—one on its website, and three across social media. The website post reads, in part: "Q: Should I take ivermectin to prevent or treat COVID-19. A: No." The three social media posts are similar. They say, in full:

• "You are not a horse. You are not a cow. Seriously, y'all. Stop it."

• "You are not a horse. Stop it with the #ivermectin. It's not authorized for treating #COVID."

• "Hold your horses, y'all. Ivermectin may be trending, but it still isn't authorized or approved to treat COVID-19."

FDA included an image of a horse in each of the three social media posts. We refer to these six items as the "Posts" (that is: the Update, the FAQ, the website post, and the three social-media posts).

In an internal email, a member of FDA's communications team referred to the Posts as part of a new engagement strategy. The strategy played well, and media outlets nationwide ran headlines and stories emphasizing FDA's "horse" messages. Medical organizations also took note of the Posts, as did pharmacy boards and hospitals. Federal and state courts, too, began citing the Posts in cases involving ivermectin. All told, the Posts—and particularly the Update—saw citations in newspapers, magazines, digital media outlets, medical and professional advisories, legal complaints, and judicial opinions across the Nation.

The Plaintiffs-Appellants in this case are three Doctors who have prescribed the human version of ivermectin to thousands of patients suffering from the coronavirus. The Doctors allege that the Posts interfered with their individual "ability to exercise professional medical judgment in practicing medicine." The Doctors also allege that the Posts harmed their reputations. Further, Dr. Apter alleges that he was "referred to [two state medical boards] . . . for prescribing ivermectin to treat COVID-19," and that "[t]he referrals include copies of FDA's [Posts]." Dr. Apter and Dr. Bowden each say that pharmacies have refused to fill ivermectin prescriptions for their patients because of FDA's Posts. Dr. Bowden also lost her admitting privileges at a hospital after "tweeting about using ivermectin to treat patients with COVID-19." And Dr. Marik lost his positions at a medical school and at a hospital "for promoting the use of ivermectin."

B

The Doctors sued FDA, arguing that the Posts are ultra vires under FDA's enabling Act and unlawful under the APA.² The Doctors asked the district court to:

• set the Posts aside, and declare them unlawful;

• declare that FDA cannot interfere with the practice of medicine;

• declare that "FDA cannot issue statements or directives about how or whether health professionals should use ivermectin off-label to treat patients, and that such FDA actions have no legal effect and do not bind health professionals or patients"; and to

• enjoin FDA "from engaging in such actions."

FDA moved to dismiss the Doctors' complaint under Rule (12)(b)(1), invoking sovereign immunity and arguing that the Doctors lack standing to sue under Article III. While noting that "FDA could have, and perhaps should have, been more prudent in their communications," the district court nonetheless held that sovereign immunity protects FDA and the other defendants, and it therefore dismissed the suit.³

The district court first held that the Doctors cannot rely on the narrow ultra vires exception to sovereign immunity.⁴ The...