No, a court didn’t rule that the FDA broke the law with advisory warning against using ivermectin for COVID-19

In June 2022, the U.S. Food and Drug Administration (FDA)’s consumer advisory and social media posts advising consumers not to take ivermectin for COVID-19 became embroiled in a lawsuit.

The lawsuit’s settlement in late March 2024 became the subject of numerous social media posts and articles that began circulating.

Tweets by DC Draino (also known as Roger O’Handley) and Erin Elizabeth—both known sources of health misinformation with large followings—claimed that a court found the FDA had broken the law and was now forced to remove its posts about ivermectin.

Pierre Kory, a physician who has promoted using ivermectin to treat COVID-19 since 2020, similarly claimed that the lawsuit’s outcome showed the FDA’s posts were “illegal”.

The language used in other posts implied that the FDA lost the case. Mary Talley Bowden, an ear, nose and throat specialist and one of the physicians who filed the lawsuit, tweeted “The FDA Loses Its War On Ivermectin”. In her bio on X (formerly Twitter), she repeated the claim (“Sued FDA for interfering with DR-PT and relationship and WON!”).

The Gateway Pundit, a source of misinformation and conspiracy theories, echoed Bowden’s language in its article about the case.

However, these posts and articles are misleading. They misrepresent the outcome and implications of the lawsuit, as we will explain below.

How the lawsuit started and how it concluded

The lawsuit was first filed in June 2022 by three physicians who had been prescribing ivermectin for COVID-19 to patients—Bowden, Paul Marik, and Robert Apter.

Ivermectin is approved by the FDA for treating parasitic infections in people. In fact, two scientists won the Nobel Prize in Physiology or Medicine in 2015 for their discovery of ivermectin’s antiparasitic activity.

Ivermectin isn’t approved for treating COVID-19, but physicians can prescribe a drug “off-label”, meaning the drug can be used to treat a condition other than the one it’s been approved for.

Bowden, Marik, and Apter argued that the FDA’s consumer advisory—titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19”—and social media posts sharing the advisory, illegally interfered with their practice of medicine. They alleged that the FDA advisory had harmed them.

Notably, the complaint clarified that “[t]his case is not about whether ivermectin is an effective treatment for COVID-19. It’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process”. This piece of information becomes relevant later on, as we will see.

The case was initially dismissed by a federal judge in Texas. But in September 2023, an appeals court overturned the ruling, allowing the case to proceed.

On 21 March 2024, the court announced that the lawsuit was dismissed following a settlement between the three physicians and the FDA. Namely, the three agreed to dismiss the case if the FDA agreed to remove the consumer advisory and to delete social media posts associated with the consumer advisory.

The Stipulation of Dismissal specifies that these actions don’t constitute “an admission or evidence of any issue of fact or law, wrongdoing, misconduct, or liability on the part of any party to this litigation”.

An FDA spokesperson told The Epoch Times that it chose to settle “rather than [continue] to litigate over statements that are between two and nearly four years old”.

As the above shows, the FDA didn’t lose the lawsuit and the outcome doesn’t mean it broke the law, contrary to claims by DC Draino, Elizabeth, and Kory.

In addition, the Stipulation of Dismissal notes that while the FDA has agreed to remove the current advisory and social media posts, it still retains the right to publish a revised version of the advisory.

The lawsuit has no bearing on ivermectin’s ability to treat COVID-19

Although the lawsuit specified it wasn’t arguing about ivermectin’s effectiveness at treating COVID-19, some have chosen to conflate the lawsuit with evidence of ivermectin’s effectiveness against COVID-19.

Indeed, when the lawsuit was first filed in June 2022, some social media posts claimed that it meant the FDA had reversed its position on ivermectin, implying the drug was effective against COVID-19 after all. An earlier Science Feedback review documented these claims and explained how they misrepresented the proceedings of the case.

In the wake of the settlement, these claims are being revived.

For example, Marik told The Epoch Times that “We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA’”.

The Vigilant Fox, an account on X/Twitter that has repeatedly spread COVID-19 misinformation, claimed “Lawsuit Drops Bombshell on FDA’s Orwellian Lie About Ivermectin” and that “the FDA has to remove ALL social media content and consumer advisories on ivermectin usage”.

In the same vein, the headline of an article on the settlement from the anti-vaccine organization Children’s Health Defense claimed the FDA had “Blood on Its Hands”.

Jessica Rose, a scientist who has spread vaccine misinformation, tweeted “So if the FDA were lying about IVM to the point we’re they’ve been ordered to remove their lies from social media, one must ask: What else were they lying about?”

But these claims are misleading and aren’t substantiated by the outcome of the lawsuit.

Dorit Reiss, a professor of law at the University of California Law San Francisco, who discussed the legal ramifications of the lawsuit in this article, refuted the misinformation:

“First, there is no indication the FDA was even wrong on Ivermectin, let alone lying. There is no court decision saying that, there is no good basis to argue it. Second, the FDA was not ordered to remove anything. It offered, as a settlement to avoid bothering with a case that it – wrongly, in my view – considered too small to be worth more effort.”

Ivermectin remains unapproved and unauthorized by the FDA for treating COVID-19, although its ability to treat parasitic infections in people is recognized.

While some studies reported that ivermectin could benefit COVID-19 patients, these studies have generally been found to contain limitations that affect their reliability. Science Feedback covered some of these studies in its reviews (see here and here). BBC Reality Check also published a report about the flawed—and in some cases, fraudulent—studies about ivermectin.

Some, like the Gateway Pundit, attempted to bolster their claims of ivermectin’s effectiveness against COVID-19 by citing the website c19ivm.org. The website purportedly claims to show more than a hundred studies showing ivermectin is effective against COVID-19.

However, CovidAnalysis, the entity that runs the website, has already been documented to commit significant errors in its analyses of alleged COVID-19 treatments. Science Feedback covered some of these problems in these reviews. The flaws in CovidAnalysis’ analyses have also been highlighted by Ars Technica and Science-Based Medicine.

Well-performed randomized clinical trials haven’t found evidence that ivermectin is associated with improved outcomes in COVID-19^[1-3].

Most recently, the PRINCIPLE trial, which has been running in the U.K. for a few years, published its findings on ivermectin’s impact on recovery from COVID-19 and COVID-19-related hospitalization or death^[4].

The authors reported:

“Ivermectin for COVID-19 is unlikely to provide clinically meaningful improvement in recovery, hospital admissions, or longer-term outcomes. Further trials of ivermectin for SARS-Cov-2 infection in vaccinated community populations appear unwarranted.”

Conclusion

The FDA agreed to settle a lawsuit related to its advisory warning people not to take ivermectin for COVID-19. As part of the settlement, the FDA agreed to remove the advisory and related social media posts. However, it still retains the right to publish a revised version of the advisory and to post about the revised version on social media.

Claims that a court found the FDA broke the law with its ivermectin advisory or that it lost the case are inaccurate and misrepresent the outcome of the case. Furthermore, the outcome also has no bearing on whether ivermectin is effective for COVID-19. Multiple clinical trials have detected no meaningful benefit from treating COVID-19 with ivermectin.

REFERENCES

• 1 – Lim et al. (2022) Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities: The I-TECH Randomized Clinical Trial. JAMA Internal Medicine.
• 2 – Reis et al. (2022) Effect of Early Treatment with Ivermectin among Patients with Covid-19. New England Journal of Medicine.
• 3 – Naggie et al. (2022) Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA.
• 4 – Hayward et al. (2024) Ivermectin for COVID-19 in adults in the community (PRINCIPLE): an open, randomised, controlled, adaptive platform trial of short- and longer-term outcomes. Journal of Infection.