Judge Rules on Lawsuit Against FDA Over Ivermectin

Judge Rules on Lawsuit Against FDA Over Ivermectin
The U.S. Food and Drug Administration in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)
Zachary Stieber

A federal judge on Dec. 6 agreed to throw out a lawsuit that was filed against the U.S. government over its repeated exhortations not to take ivermectin against COVID-19.

Plaintiffs, three doctors, said the FDA violated the Federal Food, Drug, and Cosmetic Act by its warnings against using ivermectin to treat COVID-19.
But the law does not support their case, U.S. District Judge Jeffrey Brown, a Trump appointee, said in a 20-page ruling.

"First, while § 396 limits the FDA’s powers as applied to medical devices, it does not do so in the context of drugs. As there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations," he said. "Further, it cannot be said that the FDA had no colorable basis of authority. The FDA is charged by Congress with protecting public health and ensuring that regulated medical products are safe and effective, among other things.

"The plaintiffs do not dispute that the FDA has the authority, generally, to make public statements in-line with these purposes. Although the FDA could have, and perhaps should have, been more prudent in their communications, they had at least a colorable basis in authority—and there is no statute saying otherwise," he added.

The doctors had pointed to six FDA statements, including a post on social media that said, "You are not a horse" and told people to "stop" taking ivermectin for COVID-19.

They had said the statements amounted to a "final agency action," which could trigger relief under the Administrative Procedure Act.

Brown disagreed, saying there was "no indication the FDA has adopted a legal position, no indication of any future liability on non-complying parties, and no establishment of safe harbors.

"While the plaintiffs allege that the FDA’s statements have incited third parties to investigate and fire the plaintiffs, the FDA’s statements do not state the FDA’s view of the law or create civil or criminal liability for noncompliance," he added.

He ruled in favor of the government's claim of sovereign immunity. The government can only be sued with its consent, and plaintiffs did not meet the exceptions they cited, according to the judge.

“We are conferring with our clients regarding an appeal to U.S. Court of Appeals for the Fifth Circuit. The improper actions of government agencies like the FDA leave many open legal questions that deserve a full public airing," Boyden Gray, a lawyer for the plaintiffs, told The Epoch Times in an emailed statement.

The FDA declined to comment.

Motion to Dismiss

The government filed its motion to dismiss in September, saying the doctors did not show injuries that are traceable to government officials, including the FDA.

Dr. Mary Bowden, Dr. Paul Marik, and Dr. Robert Apter said their complaint that the FDA "has unlawfully taken formal, unequivocal, and conclusory actions to prohibit or otherwise interfere with the use of ivermectin to treat COVID-19," and that the statements led to adverse action against them, including a rejection by pharmacists of ivermectin precriptions.

The doctors' practice of medicine "is affected by FDA statements regardless of whether the FDA can legally enforce them, because the practice of medicine has become highly driven by standards and guidelines" and employers of doctors increasingly look to the FDA, as do pharmacies.

The government also said that plaintiffs had not proven the statements were a final agency action because they could be updated in the future if and when new relevant information comes to light.

In their opposition, plaintiffs urged the judge against dismissing the case.

"Defendants suggest that because Plaintiffs have continued to prescribe ivermectin, they have not been harmed. But Plaintiffs’ ability to prescribe ivermectin in some cases does not negate the many times the FDA’s actions have interfered—and will continue to interfere— in others. Indeed, Defendants do not dispute that Plaintiffs have plausibly alleged 'interference' with the practice of medicine," they said.

Arguments in Court

Lawyers for the parties later appeared before Brown in a U.S. court in Texas.

Isaac Belfer, a government lawyer, said that statements such as "stop it" in reference to taking ivermectin against COVID-19 "were recommendations."

"They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Belfer said.

Jared Kelson, a lawyer for the plaintiffs, said that plaintiffs had made a sufficient case to get past the motion to dismiss.

“If the government is going to label ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out,” he said.

“The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine," he added later. "And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA."