“You are not a horse.” Sound familiar? If you remember seeing this message a couple of years ago, you probably caught one of the Food and Drug Administration’s (FDA) social media campaigns about COVID-19. In the middle of the pandemic, the FDA thought it would be effective to make funny posts urging people not to take a drug called ivermectin to treat COVID-19.
But a lot of doctors didn’t find it so cute. A couple of doctors had been recommending ivermectin to treat the coronavirus since its onset in 2020. But after the FDA’s public health campaign, those doctors faced consequences at work for their use of this drug. They then took the FDA to court, and now, the suit has just settled. Let’s look at the case that made the feds get off their high horse.
FDA Says “Neigh” to Ivermectin
In the wake of the pandemic, the FDA had discovered that some people were treating their COVID symptoms using the animal version of a drug called ivermectin. The agency released a consumer update titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” It stated that certain animal formulations of ivermectin (pour-on, injectable, paste, and “drench”) are approved to treat or prevent parasites in animals within the country. But for American humans, ivermectin tablets are approved only at very specific doses, and they’re meant to treat things like certain parasitic worms, while there are topical versions for things like head lice and rosacea.
The feds reminded the public in the update that it had not authorized or approved ivermectin for use in connection with the coronavirus, either treating it or preventing it — both for humans and animals. Clinical trials were still being conducted about its use for COVID-19. The FDA reiterated: “Currently available data do not show ivermectin is effective against COVID-19.”
The FDA also reminded Americans that animal ivermectin products are very different from those approved for humans, and doubled down on its stance that the use of animal ivermectin for the prevention or treatment of COVID-19 in humans is “dangerous.” It warned: “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.” For those whose health care provider had written them an ivermectin prescription, the FDA urged them to only fill it through a “legitimate source such as a pharmacy,” and take it “exactly as prescribed”
Nonetheless, the agency received multiple reports of people self-medicating with ivermectin that was purportedly intended for livestock, and needing medical attention afterwards.
Feds Horse Around on Social Media
Eager to dispel the practice of using ivermectin designed for livestock, the FDA decided to launch a humor social media campaign comparing humans to horses. On its website and across social media platforms, the FDA posted the following messages accompanied by pictures of horses:
“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.”
The agency’s “engagement strategy” worked too well. The posts basically went viral, with media outlets across the country running headlines about the FDA’s “horse messages.” Importantly, key players in the medical profession saw the campaign. Hospitals, medical organizations and pharmacy boards (as well as courts ruling on ivermectin) took note of the posts.
But while the human version of ivermectin hadn’t been (and still isn’t) approved by the FDA for treating COVID, doctors had been prescribing it off-label for this very purpose. In particular, three doctors in Texas who had prescribed the human version of ivermectin to thousands of their patients decided to sue the FDA for their public health campaign. Each of these doctors claimed that the FDA’s messages interfered with their own individual medical practice.
FDA Is Not a Physician
The FDA claimed sovereign immunity, an issue that made its way through the federal court system and was up before the Fifth Circuit Court of Appeals last fall. The Circuit court ruled that sovereign immunity didn’t apply in this case, and the doctors could proceed with their lawsuit.
But the language of the opinion unrelated to sovereign immunity is arguably more interesting. While the Fifth Circuit acknowledged that while some people reported being hospitalized from self-medicating with ivermectin intended for animals, the FDA’s messaging campaign left out the fact that the drug was sometimes also prescribed for humans. And importantly, the court commented on the real heart of the issue: that it’s not the FDA’s place to tell physicians how to practice.
The Fifth Circuit opinion read: “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.”
A Settlement Reigns in the Horseplay
Recently, attorneys for the plaintiff doctors announced that they had settled with the FDA. One of those doctors stated: “Today’s settlement with the FDA is a major win for the doctor-patient relationship. It vindicates our position that the FDA overstepped its regulatory authority by trying to dictate appropriate medical care.”
The details of the settlement haven’t been released, but for now, it looks like there are two lessons everyone can learn from this story: (1) the FDA is not a physician, and (2) you are not a horse.
Related Resources
Medical Malpractice (FindLaw’s Learn About the Law)
Personal Injury Lawyers and Dangerous Drug and Medical Device Lawsuits (FindLaw’s Guide to Hiring Lawyers)
Answers to Your Legal Questions About COVID-19 (FindLaw’s Learn About the Law)
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