Court revives doctors’ lawsuit saying FDA overstepped its authority with anti-ivermectin campaign

Federal Appeals Court Resurrects Lawsuit by Doctors Alleging FDA Exceeded Authority in Anti-Ivermectin Campaign

In a recent development, a federal appeals court has given new life to a lawsuit filed by three medical professionals who contend that the Food and Drug Administration (FDA) went beyond its jurisdiction in a campaign opposing the utilization of the anti-parasite medication ivermectin as a treatment for COVID-19.

Ivermectin, a compound widely employed to address parasitic infections in livestock, has garnered attention as a potential COVID-19 treatment, particularly championed by conservative voices. Nevertheless, the FDA has refrained from granting approval for the utilization of ivermectin as a remedy for COVID-19 due to a lack of substantiated evidence from studies demonstrating its efficacy.

The FDA has not promptly responded to requests for commentary concerning this matter.

The recent ruling handed down by a panel of three judges from the 5th U.S. Circuit Court of Appeal in New Orleans, which transpired on Friday, scrutinized multiple facets of the FDA’s drive against the use of ivermectin as a COVID-19 treatment.

The verdict acknowledged the FDA’s reception of reports detailing instances wherein individuals necessitated hospitalization after self-administering ivermectin designated for animal use. However, the ruling contended that the campaign—characterized at times by the catchphrase “You are not a horse!”—habitually omitted the fact that the medication is also at times prescribed for human usage.

According to the ruling, the doctors are now permitted to proceed with their lawsuit, asserting that the FDA’s campaign exceeded the boundaries set by federal law. Judge Don Willett, composing the verdict on behalf of the panel which also consisted of Jennifer Walker Elrod and Edith Brown Clement, articulated, “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.” Willett elaborated that the doctors credibly argued that the FDA’s communications straddled the divide between informational and directive.

The trio of medical professionals—Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik—initiated the lawsuit during the preceding year. All three plaintiffs averred that their professional reputations sustained harm as a consequence of the FDA’s campaign. Notably, the ruling noted that Bowden forfeited her admitting privileges at a Texas hospital, while Marik alleged the loss of his positions at a medical school and a hospital due to his advocacy for the use of ivermectin.

The lawsuit, initially dismissed in December by U.S. District Judge Jeffrey Vincent Brown, was thwarted on grounds that the complaints failed to surmount the concept of “sovereign immunity,” a legal doctrine shielding government entities from numerous civil litigations related to their responsibilities. However, the appellate panel maintained that the alleged transgression of authority by the FDA opened the door for the litigation to proceed.

It’s noteworthy that Willett was nominated to the 5th Circuit by former President Donald Trump, whereas Clement and Elrod received their nominations from former President George W. Bush. Meanwhile, Brown’s nomination to the district court bench was attributed to President Trump.

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More about FDA Lawsuit Revival

• Federal appeals court revives lawsuit against FDA over anti-ivermectin campaign
• Ivermectin: Uses, safety, and COVID-19
• FDA’s authority and responsibilities
• Background on the doctors’ lawsuit
• 5th U.S. Circuit Court of Appeals