Ivermectin Docs Pummel the FDA at the Fifth Circuit, but there are miles to go before we sleep.

Ivermectin Docs Pummel the FDA at the Fifth Circuit, but there are miles to go before we sleep.

To people supporting the use of Ivermectin and other off-label drugs for Covid, arguably the most galling thing about the mainstream Covid mafia’s PR campaign against Ivermectin was the false and outrageous moniker of it being horse paste. It is false becasue as everyone in the Covid mafia knows, Ivermectin is approved for use in humans.

The FDA and promoters of this false moniker obviously intentionally omitted this fact which makes it a bald-face lie. It is outrageous because in fact, some people have been forced to use the animal version because of the Covid mafia’s successful PR campaign to smear the drug, threaten and intimidate doctors from prescribing it, and dissuade most pharmacies from filling prescriptions for it. (Baby boomers out there might remember the comedian/activist Dick Gregory line about a bodily function and the olfactory sense.)

The people in government and the private sector who created or propagated this outragous lie should be held accountable. The Fifth Circuit’s decision in Apter v. HHS decided on September 1, 2023 was the very welcomed first judicial acknowledgement in this accountability project. But it surely won’t be the last, or to paraphase Robert Frost, there are miles to go before we sleep (x2).

To briefly recap the procedural posture: Three high-profile physicians, each of whom is a thought leader/activist advocating for these off-label treatments, filed a lawsuit against the FDA claiming that the FDA actions in recommending against the use of these drugs was beyond the agency’s statutory jurisidction (ultra vires). They argued they could sue using the federal administrative procedure act. They sought a declaration that the FDA’s recommendation was ultra vires and hence illegal and asked the court to force the FDA to cease recommending against the use of these drugs for Covid because it constituted the “practice of medicine” over which the FDA has no statutory jurisdiction. Here is a copy of the complaint. It’s very strong and clear. 3-22-cv-00184.

The FDA moved to dismiss based on soverign immunity. Sovereign governments cannot be sued by people unless the government gives permission to sue for specific claims (like under the federal tort claims act which allows people to sue the government for tortious conduct by government officials). It is an abstruse and complicated area of the law especially when it intersects with the federal admininstrative procedure act which is itself complicated. Throw in the concept of ultra vires (beyond the authority of the entity or official), and it becomes an excercise of conceptual gymnastics and hair-splitting.

Anyway, the Galveston District Court judge bought the FDA’s argument and dismissed the case. Here is the judge’s decision. apterdcorder.

And as you know, the Fifth Circuit reversed the district court holding that soverign immunnity did not apply. The panel remanded the case back to the district court to determine another technical threshold issue, specifically, whether the doctors had the legal “standing” to file the suit. I think the appellate court panel gave a big hint that it thinks the plaintiffs have standing because they stated that the same factors which led them to find that the FDA did not have sovereign immunity from this type of suit were applicable to a standing analysis. So good luck (in the sarcastic sense of the phrase) to the FDA making that argument to the district court. Here is the Fifth Circuit’s decision. 22-40802-CV0

For what it’s worth, I think the strongest part of the case is the misrepresentation/bold-face lies. I’m pretty clear that lying/misleading to the public is ultra vires, (but some would say it is quite common these Covid days in matters of public health, vaccines, mandates and drugs). But other than the lying, maybe it gets complicated. Can the FDA weigh into the controversy at all, the controversy being whether Ivermectin can be used off-label for Covid? Can it bring forth studies and limit them to one side of the issue? Or, is it required to say nothing despite being the agency that approves drugs, deals with post marketing surveillance, and in general has a mandate to protect the public health, as it relates to drugs, devices and vaccines.

The Fifth made a very bright line distinction between providing information and making a categorical recommendation against use, the latter being the practicing of medicine. It gets even more complicated because, unless I am mistaken, Ivermectin’s manufacturer has also recommended against its use for Covid. Is it also practicing medicine? (and fyi, manufacturers are prohibited from promoting off label use of their products, if that is relevant). I am just posing some questions. (I have others, but for a variety of reasons, I will not share them here and now.)

So what’s next?

That depends on what the FDA does. The Fifth slapped down the FDA pretty hard, and on what appears to be a case of first impression. If I were in charge of this case for the FDA, I’d go for a stay of the decision. The Fifth is very conservative and is in the middle of a couple major issues like abortion and the conceptually related Biden/Kennedy v. Missouri consolidated cases.

I think they need four justices to take a case. The three liberals plus one of the three who are now called moderate conservatives (The three arch conservatives are hooting with joy over the decision). Some number between 3 and 5 justices might not be as hard on the FDA as the Fifth Circuit panel (except for the lying thing, and yes I am having a hard time getting past that, and I hope all subsequent judges and decisions will keep the focus on that).

Assuming the district court gets the hint and denies the FDA’s standing challenge, to me what is going to be super interesting is the email and memo discovery surrounding the decision to omit mentioning the fact that Ivermectin is approved for human use. It’s like how they make sausage, you don’t want to know, but we do want to know which officials of the administrative state thought it was a good idea to mislead the public. I think it will be as revealatory as the discovery was in Biden v. Missouri.

But be advised: The Fifth Circuit’s decision won’t give people access to these off-lable treatments, but it is an important first step in the right direction. That direction being holding some of the other parts of the Covid mafia responsible for this misinformation, and maybe bringing in these players into one big lawsuit, and ultimately forcing the governments to allow access to off-label drugs based on the discretion and judgment of individual physicians. What a novel idea!

September 1st was a good day for this side of the issue. Hopefully, there will be more good days to come.

Thanks to the brave docs who brought the case, and kudos to the lawyers who made it happen. They are very (x10 (at least)) good!*

Rick Jaffe, Esq.

*I would be remiss in failing to mention that C. Boyden Grey (among other things, former white house counsel under the first president Bush) appeared in this case as one of the attorneys in his firm which handled this case. He died on May 21, 2023, and thus did not live to see this decision or the oral argument. But I have to believe that with his experience, he could read the tea leaves.

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