Washington, DC – In a matter critical to stopping federal overreach into the practice of medicine, Boyden Gray PLLC welcomes a decision from the U.S. Court of Appeals for the Fifth Circuit in Apter v. Dep’t of Health and Human Services, rejecting the government’s blanket assertion of sovereign immunity and allowing the case to proceed. The Washington-based firm represents the physicians who brought this complaint, seeking to hold the FDA accountable for its illegal crusade against the off-label use of ivermectin to treat or prevent COVID-19. In its Friday evening (Sept. 1) decision, the court found that medical advice is “beyond FDA’s statutory authority,” even in “tweet-sized doses.”
“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” said Jared Kelson, Counsel at Boyden Gray PLLC. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”
The Fifth Circuit held that the “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” Additionally, the court emphasized that the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.”
Boyden Gray PLLC provides clients with strategic counsel, regulatory engagement, and impact litigation on the most difficult issues across law, public policy, and politics. The firm advises clients—including corporations, shareholders, trade associations, and workers—across a range of sectors, including energy, financial services, healthcare, and nonprofit. Its attorneys are all experienced litigators, and the firm regularly represents clients before federal trial and appellate courts, including parties and amici before the Supreme Court of the United States.