Appeals Court: Doctors Can Sue FDA for Condemning Ivermectin as a COVID-19 Treatment, Resulting Reputational Harm

Appeals Court: Doctors Can Sue FDA for Condemning Ivermectin as a COVID-19 Treatment, Resulting Reputational Harm

A federal appeals court allowed three doctors to sue the FDA over a series of website and social media posts condemning ivermectin as a treatment for COVID-19. The doctors alleged the FDA exceeded its authority by offering medical advice and “that FDA’s messaging interfered with their own individual medical practice.”

The lawsuit stems from a series of FDA posts advising consumers not to take horse ivermectin but failing to acknowledge the existence of a human ivermectin formulation, including one tweet advising consumers, “Hold your horses, y’all”:

Hold your horses, y'all. Ivermectin may be trending, but it still isn't authorized or approved to treat COVID-19. https://t.co/TWb75xYEY4

— U.S. FDA (@US_FDA) April 26, 2022

The trial court dismissed the doctors’ lawsuit after finding sovereign immunity barred their three claims. The appeals court reversed on one claim, finding plausible the argument the FDA exceeded its statutory authority by offering medical advice instead of medical information:

FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. . . . Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority. (emphasis original)

The FDA argued its posts were purely informational, which the appeals court rejected:

On the contrary, all six of the Posts contain syntax that is imperative rather than declaratory (for example: “Stop it,” “Stop it with the #ivermectin,” and “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”) For that reason, we are unable to draw any analytical distinction between FDA making the Posts versus FDA telling Americans to “Stop it” with acetaminophen or antibiotics.

The firm Boyden Gray, which represents the doctors, issued a press release praising the decision:

In a matter critical to stopping federal overreach into the practice of medicine, Boyden Gray PLLC welcomes a decision from the U.S. Court of Appeals for the Fifth Circuit . . . rejecting the government’s blanket assertion of sovereign immunity and allowing the case to proceed.

The Front Line Covid-19 Critical Care Alliance (FLCCC), which submitted a brief supporting the doctors, also praised the decision.

“We are very pleased with this development and extremely proud of our colleagues for taking a stand against a government health agency that is clearly overstepping its authority,” FLCCC president and chief medical officer Dr. Pierre Kory said in the press release.

The doctors prescribed human ivermectin to their COVID-19 and alleged the FDA’s “horse” messaging and recommendation against off-label ivermectin use harmed them professionally.

Dr. Robert Apter alleges he was twice referred to state medical boards for prescribing ivermectin off-label, with the referrals citing the FDA’s posts.

Dr. Apter and Dr. Mary Bowden allege pharmacies refused to fill their ivermectin prescriptions because of the FDA’s posts. Dr. Bowden claims she lost admitting privileges at a hospital after tweeting about using ivermectin to treat COVID-19.

Dr. Paul Marik, co-leader of FLCCC, alleges he lost positions at a medical school and hospital “for promoting the use of ivermectin.”

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