Last week, the Fifth Circuit Court of Appeals reversed a lower court’s ruling that had said sovereign immunity protects the Food and Drug Administration from any liability for telling the public to stop taking Ivermectin, a drug that is relatively safe when used correctly, well-studied, and has been used by many for the prevention and treatment of Covid-19.
Judges Clement, Elrod, and Willett wrote, “FDA argues that the Twitter posts are ‘informational statements’ that cannot qualify as rules because they ‘do not ‘direct’ consumers, or anyone else, to do or refrain from doing anything.’ We are not convinced.”
“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,” said Pierre Kory, M.D., M.P.A., president and chief medical officer of the Front Line COVID-19 Critical Care Alliance.
“The FDA’s campaign against ivermectin continues to be used as an excuse by hospitals to deny access to a lifesaving treatment and weaponized by medical boards to threaten the licenses of doctors who stray from the mainstream to prescribe a drug that has been proven in controlled trials to safely treat hundreds of thousands of patients around the world,” he said.
The lawsuit, Apter et al v. Dep’t. of Health and Human Services, was brought by Robert Apter, MD, Mary Talley Bowden, MD, and FLCCC co-founder, Paul E. Marik, MD, and first filed in the U.S. District Court on June 2, 2022.
The lawsuit stated that the FDA acted outside of its authority and illegally interfered with the doctors’ ability to practice medicine with an aggressive effort to stop the prescribing of ivermectin for the prevention and treatment of COVID-19. The case was later dismissed by the court citing that the FDA had “sovereign immunity,” giving the agency absolute protection from any wrongdoing or harm in directing the public, including health professionals and patients, to not use ivermectin, a drug that has received full FDA approval for human use. Earlier this year, Apter et al filed an appeal in the U.S. Court of Appeals for the Fifth Circuit requesting the Court reverse the lower court’s dismissal of the lawsuit.
The Court’s reversal was issued last week with the ruling stating, 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 FDA’s Posts fell on the wrong side of the line between telling about and telling to.”
The ruling goes on to say the “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”
And finally, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”
“The work of the legal team at Boyden Gray has been nothing short of superb,” Kory added. “We are very fortunate to have them on the side of our doctors in this case.”
It’s certain the federal government will appeal to the U.S. Supreme Court.
The Fifth Circuit Court’s ruling can be found here: https://covid19criticalcare.com/wp-content/uploads/2023/09/Apter-Reversal-22-40802_Documents.pdf
The FLCCC filed its amicus brief in support of the lawsuit in February of this year. A copy of the brief can be found here: https://covid19criticalcare.com/wp-content/uploads/2023/02/FLCCC-Apter-v-HHS-Amicus-2-13-23-FINAL.pdf
