Three Texas doctors, Robert L. Apter, Mary Talley Bowden, and Paul E. Marik, filed a lawsuit against the Food and Drug Administration (FDA) in June 2022 regarding the FDA’s social media posts and directives advising against the use of Ivermectin for treating or preventing COVID-19. This legal action has resulted in a settlement between the doctors and the FDA.
One of the posts that centered around the lawsuit was one the FDA posted back in August 2021, referring to Ivermectin, and it said, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The three doctors argued in their lawsuit that the FDA violated practice of medicine law. They wrote in their lawsuit that the FDA cannot “limit or interfere with the authority of a health care practitioner to prescribe or administer drugs approved for human use for any condition or disease within a legitimate health care practitioner-patient relationship,” and that “The FDA has violated this prohibition by advising against the use of ivermectin to treat COVID-19, thereby restricting its off-label use and interfering with the practice of medicine.”
The lawsuit was initially dismissed by a Texas U.S. District Judge, but it was later overturned by the Texas Fifth Circuit Court of Appeals, which ruled that the “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 the FDA’s posts fell on the wrong side of the line between telling about and telling to. As such, the doctors can use the APA to assert their ultra vires claims against the agencies and the officials.”
The Court of Appeal ruling went on to say, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority. We REVERSE the district court’s judgment of dismissal, and we REMAND for further proceedings.”
The court documents show that as part of the settlement, the FDA has agreed to delete and refrain from republishing anything that mentions “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” on its Twitter, LinkedIn, Facebook, and Instagram accounts. Additionally, the FDA will remove the Consumer Update on its website titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”
You can review the settlement at the link below.
https://drive.google.com/file/d/1dYqJ6_2CF1O5CoHrcqMu0xKTmb6ASJyc/view?usp=sharing