FDA Policy/General

Appeals Court Reverses Ivermectin Suit Dismissal

The 5th Circuit Court of Appeals has reversed a Texas federal court’s decision dismissing a suit filed by three doctors against FDA and HHS challenging the agencies’ messaging advising against using ivermectin to treat Covid-19. The appeals court sent the case back to the Texas federal court for further proceedings.

In addition to suing the agency, the doctors also sued HHS secretary Xavier Becerra and FDA commissioner Robert Califf in their official capacities.

The court says that when the agency issued its “You Are Not a Horse” and similar messaging to caution people not to use the veterinary drug ivermectin to treat Covid-19, it did not mention there is a human version of the drug. The doctors who filed the suit said they had prescribed the human form of the drug to thousands of their patients and the FDA messaging interfered with their individual medical practice.

The doctors argued that the messages violated the FDA enabling act and the Administrative Procedure Act (APA). The district court dismissed the case, saying that sovereign immunity protects the agencies and officials. But the appeals court disagreed.

The 5th Circuit said the doctors can use the APA to bypass sovereign immunity and assert their ultra vires (beyond legal authority) claims against the agencies and officials. “FDA is not a physician,” the court writes. “Thus, assuming FDA is correct that we must consider the merits to some degree even at the pleading stage, the posts that issue medical advice to consumers are plausibly ultra vires. The posts are plausibly agency action, too, because they publicly announce the general principle that consumers should not use ivermectin to treat the coronavirus.”

Since the court is allowing the case to proceed based on the doctors’ first argument, it said there was no need for it to consider the doctor’s common-law theory. It did, however, reject their pure APA claim because the FDA messages did not determine legal rights and thus lacked the finality needed for final administrative action to be challenged under the APA.

In its ruling, the 5th Circuit says FDA “can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” Thus, it says, the doctors can use the APA to assert their ultra vires claims against the defendants.

“FDA is not a physician,” the appeals court decision concludes. “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.”

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