'FDA is not a Physician': Federal Appeals Court Sides with Doctors on Ivermectin for COVID-19
Dr. Mary Talley Bowden 'thrilled" the 5th Circuit rules that her lawsuit against the agency can continue
A federal appeals court on Friday gave three doctors the green light to pursue their lawsuit against the Food and Drug Administration (FDA) over using ivermectin off-label to treat COVID-19.
“It’s been David v Goliath from the start of this pandemic, and it’s finally a small win for David,” Dr. Mary Talley Bowden, one of the plaintiffs, told me Friday. “But there’s still a lot more work to do.” Bowden writes
.This is the fifth part of the series on this case. Catch up and get the original sources: lawsuit filed (June 2022), federal district court hearing (Nov. 2022), lawsuit dismissed and appealed (Dec. 2022) and 5th Circuit Appeal hearing (Aug. 2023)
Just weeks after hearing the case, the 5th Circuit reversed a district court’s dismissal on the grounds that the FDA has sovereign immunity. (The decision is at the bottom for paid subscribers to read.)
The ruling was written by U.S. Circuit Judge Don Willett, a Pres. Donald Trump appointee. He pointed to the FDA’s social media posts (below) about ivermectin that made it seem the medication was for farm animals.
The judge wrote:
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. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials.
Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.
Judge Willett also wrote that the social media messaging “traveled widely across legacy and online media.” He wrote:
Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.
Dr. Bowden said that she and her co-plaintiffs Dr. Paul E. Marik and Dr. Robert L. Apter are “thrilled with the decision which recognizes the FDA is not a doctor and does not have the authority to issue medical advice.”
During the hearing before the three-judge panel, Judge Jennifer Walker Elrod pressed the FDA’s lawyer hard on whether the agency’s social media posts were “commands.”
Finally, the FDA lawyer conceded, “FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.”
The doctors filed the suit in June 2022 for interfering with both their authority to prescribe an approved medication and the doctor-patient relationship.
“The court rejected the government’s attempt to assert sovereign immunity and avoid any accountability for its illegal actions, allowing our case to proceed,” Bowden said. “We look forward to continuing the fight.”