Judge rules FDA actions against ivermectin within its authority: No exceptions to ‘sovereign immunity’
The King can do no wrong
This is the post that Medium found to be “extreme content” that is “controversial” and “suspect.” My account there was suspended because of this article. Personally, I think they didn’t like the graphic.
On December 6, Texas U.S. District Judge Jeffrey V. Brown dismissed the complaint filed against the FDA over its coercive actions to rebrand ivermectin as horse paste, giving the agency free rein to continue telling medical professionals and the public alike to “stop it with the ivermectin.”
Judge Brown’s order to toss out the case, which was filed this past summer by three front-line covid doctors, Paul Marik, Robert Apter and Mary Bowden, was the upshot of a hearing conducted at the beginning of November in which an attorney from the Department of Justice Consumer Protection branch who represented the FDA argued for dismissal of the lawsuit.
As reported at RESCUE, the lawsuit, filed against both the FDA and the Department of Health and Human Services, didn’t involve discussion of the amazing anti-viral properties of ivermectin or how this Nobel-prize winning drug has successfully saved the lives of covid patients around the world. The case instead exposed how the FDA had abused its authority and voice, disregarding long-standing laws that prohibit it from interfering with “the practice of medicine.”
In the November hearing before Judge Brown at the Galveston Federal Courthouse, a variety of legal arguments aimed at stopping the lawsuit were presented, including a claim that the FDA’s numerous posts and statements urging that ivermectin be avoided as a covid treatment did not represent a “decision-making process” by the agency and “did not say you may not do it…(that) it’s prohibited or it’s unlawful.” As for the agency’s viral Tweets and other posts, those were merely insignificant suggestions that used “informal conversational language,” the DOJ attorney argued.
But the one big hurdle that the plaintiffs were unable to overcome is a citizen’s lack of standing to sue a federal agency without its permission, what’s called “sovereign immunity,” taken from the British common-law principle that in essence the “king can do no wrong.” While there are exceptions to sovereign immunity that conceivably could have allowed the case to move forward, Judge Brown considered none of them acceptable.
“Although the FDA could have, and perhaps should have, been more prudent in their communications,” Brown wrote in his decision, “they had at least a colorable basis in authority — and there is no statute saying otherwise.” He added that the lawsuit “fails to allege an ultra vires act (to exceed the scope of power allowed the FDA) that would vest this court with subject-matter jurisdiction in the face of the defendants’ sovereign immunity.”
Unfortunately, the FDA’s abuse of power in this case was almost a litmus test to show how far a federal agency can go to achieve its ends.
In a series of hokey and confusing but highly persuasive social media posts, many showing photos of horses, the agency successfully convinced a large segment of the public to believe that ivermectin is exclusively a veterinary drug used to deworm horses and farm animals.
Approved for human use in 1996, ivermectin was discovered to be a powerful covid treatment during the height of the pandemic and was quite legally and properly being prescribed as an “off-label” treatment by doctors. Then in mid-2021 the FDA started its social media campaign, which had a “devastating effect” according to Dr. Marik, one of the plaintiffs in the lawsuit. “It basically shut down ivermectin,” he told me.
All three plaintiffs suffered serious setbacks to their reputations and careers in medicine due to the FDA’s attack on ivermectin. Dr. Marik, for example, cites the FDA Tweets as being the “beginning of my decline” at Eastern Virginia Medical School in Norfolk, Virginia, where he was a professor of medicine and chief of pulmonary and critical care for over ten years.
The FDA’s guidelines state that “doctors are allowed to prescribe FDA approved drugs at their own discretion,” Marik said. “They are violating their own policy. The FDA is not in the business of telling doctors how to practice medicine,” he added.
But whatever “business” the FDA was in prior to covid, is no more.
The extraordinary escalation of FDA powers that allowed it to authorize Pharma to manufacture, ship and advertise unapproved drugs and vaccines through the emergency use authorization (EUA) is a cash cow that must be protected at all costs.
The emergency use authorization according to the “FDA’s own rules is predicated on the fact that there is no effective therapy,” said Marik. “If the NIH had accepted ivermectin when we petitioned them as an effective treatment, the EUA for the vaccines would have been null and void.”
The EUA is still needed for a variety of covid-related devices, drugs and vaccines, including the Moderna and Pfizer “bivalent” booster (authorized with no human trials), which was permitted under an EUA allowing it to be given to babies as young as six months in a three-dose series. The pandemic was the first time an EUA was used for experimental new vaccines.
Although Judge Brown said in his opinion and order that the “FDA’s statements” do not impose “criminal liability” for not complying with its messaging, it’s clear that in the real world outside of the courtroom, the FDA’s webpages, farm photos and scare language regarding ivermectin did the job of curtailing its use just as effectively as any official action by the agency.
The D.C. public policy firm of Boyden Gray & Associates, which filed the complaint for Marik, Apter and Bowden said in a statement via email: “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.”
Dr. Marik said he was “disappointed,” adding that it “seems like sovereign immunity means you can’t hold any government agency accountable for illegal activity.”
In the meantime, however, the FDA has continued to use a variety of similarly contrived Tweets for its “MemeMonday,” such as a popular Internet image of a child named Chloe Clem giving a side-eyed look to her parents after being told she was going to Disney World to illustrate the line, “You’re not boosted yet?”
Judge rules FDA actions against ivermectin within its authority: No exceptions to ‘sovereign immunity’
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