FLCCC Alliance Statement on the Settlement Reached in Case Against DHHS for Telling the Public to “Stop it” Regarding Taking Ivermectin to Prevent and Treat COVID-19

WASHINGTON, D.C. – A settlement has been reached between the Food and Drug Administration (FDA) and the plaintiffs in a groundbreaking case filed in federal court to decide if the FDA violated its authority as a federal health agency in telling the public to stop taking ivermectin, a safe, well-studied, and proven drug for the prevention and treatment of COVID-19.

In the settlement, the FDA agreed to remove website and social media posts that make statements about using ivermectin for COVID-19.

“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” said Paul E. Marik, M.D., FCCM, FCCP, a plaintiff in the case, chairman and chief scientific officer of the FLCCC Alliance (FLCCC) and former Chief, Pulmonary and Critical Care Medicine at Eastern Virginia Medical School.  “The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. 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.’”

“I couldn’t be prouder of Paul and our colleagues for taking a stand for all of us against a government health agency that overstepped its authority,” said Pierre Kory, M.D., M.P.A., president and chief medical officer of the FLCCC. “The FDA knew exactly what it was doing when it tweeted that ivermectin was for horses and that people should ‘stop it.’ I hope this case will serve as precedent the next time a federal health agency steps out of its authority and tries to practice medicine.”

The lawsuit, Apter et al. v. Dep’t. of Health and Human Services et al., was brought by Robert Apter, MD, Mary Talley Bowden, MD, and Paul E. Marik, MD, and first filed in the U.S. District Court on June 2, 2022. It 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 use of ivermectin to prevent and treat 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, not to use ivermectin, a drug that has received full FDA approval for human use. In September of last year, the U.S. Court of Appeals for the Fifth Circuit reversed the lower court’s dismissal of the lawsuit with a ruling that said the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.” The ruling goes on to say that 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 legal team’s work at Boyden Gray PLLC was exceptional,” Marik added. “My colleagues and I could not have asked for a better partner to represent us on this case. We are very grateful for their hard work.”

The settlement can be found here: https://covid19criticalcare.com/wp-content/uploads/2024/03/Stipulation-of-Dismissal.pdf

The FLCCC filed its amicus brief supporting the lawsuit in February of 2023. 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

About the FLCCC Alliance

The FLCCC Alliance was organized in March 2020 by a group of highly published, world renowned critical care physicians and scholars with the academic support of allied physicians from around the world. FLCCC’s goal is to research and develop lifesaving protocols for the prevention and treatment of COVID-19 in all stages of illness including the I-RECOVER protocols for “Long COVID” and Post Vaccine Syndrome. For more information: www.FLCCC.net