Big Win Against FDA in 5th Circuit

submitted by penelopepnortneyBecome ungovernable from self.WayOfTheBern

Robert Barnes posted this decision from the US Court of Appeals for the Fifth Circuit. This was a suit against the FDA by Doctors Robert Apter, Mary Bowden and Paul Marik (the last two participated in Sen. Ron Johnson's Covid 19 panel discussion). It was appealed to this court after being dismissed by the District Court for the Southern District of Texas as having no standing. The appeals court disagreed, said that the appelants did in fact have standing, and remanded it back to the district court "for further proceedings".

Here's some highlights from the appeals court's decision (bold added):

“You are not a horse.”

Or so the Food and Drug Administration (“FDA”) alerted millions of Americans via social media, midway through the COVID-19 pandemic. The agency had discerned that some people were treating their symptoms using the animal version of a drug called ivermectin. FDA decided to target that practice via the “horse” message—and others like it. The messaging traveled widely across legacy and online media. Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.

The Doctors sued FDA and the Department of Health and Human Services (together, the “Agencies”)... The Doctors argue that FDA’s “horse” message and similar public statements (together, the “Posts”) violate FDA’s enabling act (“Act”) and the Administrative Procedure Act (“APA”). The district court held that sovereign immunity protects the Agencies and the Officials, and it dismissed the suit. We disagree.

FDA is not a physician. 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.

About eighteen months into the COVID–19 pandemic, the Food and Drug Administration released an informal “Consumer Update” titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19”

FDA also posted four items online between August 2021 and April 2022—one on its website, and three across social media. The website post reads, in part: “Q: Should I take ivermectin to prevent or treat COVID-19. A: No.” The three social media posts are similar. They say, in full:

• “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

• “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.”

• “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

FDA included an image of a horse in each of the three social media posts.

The Plaintiffs–Appellants in this case are three Doctors who have prescribed the human version of ivermectin to thousands of patients suffering from the coronavirus. The Doctors allege that the Posts interfered with their individual “ability to exercise professional medical judgment in practicing medicine.”

The Doctors also allege that the Posts harmed their reputations. Further, Dr. Apter alleges that he was “referred to [two state medical boards] . . for prescribing ivermectin to treat COVID-19,” and that “[t]he referrals include copies of FDA’s [Posts].” Dr. Apter and Dr. Bowden each say that pharmacies have refused to fill ivermectin prescriptions for their patients because of FDA’s Posts. Dr. Bowden also lost her admitting privileges at a hospital after “tweeting about using ivermectin to treat patients with COVID-19.” And Dr. Marik lost his positions at a medical school and at a hospital “for promoting the use of ivermectin.”

At common law, “[t]he ultra vires exception to sovereign immunity. . . provides that ‘where the officer’s powers are limited by statute, his actions beyond those limitations are considered individual and not sovereign actions.’”

The argument proceeds along these lines: (1) FDA cannot act without express statutory authority, (2) FDA does not have express authority to recommend against off-label uses of drugs approved for human use, (3) the Posts recommend against ivermectin, therefore (4) the Posts are beyond FDA’s authority.

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[–]3andfro 4 insightful - 1 fun4 insightful - 0 fun5 insightful - 1 fun -  (2 children)

FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.

This is the crux, with sound legal reasoning applied at the appellate level. Bravo. I hope to see equally sound judgment (pun intended) at every subsequent step of this lawsuit.

Pharmacies, hospitals, and state medical boards that behaved as if the FDA had authority it did not should take note. EDIT: They were happy to pass the buck to the FDA on IVM. Doubtful they'd expose themselves on IVM or other off-label use of a product approved for humans without the cover of a federal higher authority that's now been deemed to have exceeded its authority.

[–]penelopepnortneyBecome ungovernable[S] 2 insightful - 1 fun2 insightful - 0 fun3 insightful - 1 fun -  (1 child)

If there aren't already lawsuits against those entities, there should be. With the pharmacies, wasn't it already established that they could not refuse to fill a legitimate prescription, that if a pharmacist demurred on grounds of conscience (e.g., RU-86) that the pharmacy had to make another pharmacist available to fill it? The hospital suit should be brought by families who had to see their relatives die in isolation, and there are nurses who spoke at Johnson's panel discussion about the fact that these patients weren't receiving even basic care like adequate food and liquids. Families also reported that their relatives' primary physicians were prohibited from administering ivermectin when that's what the patient/family wanted, and there was even at least one case where the family got a court order to force the hospital to allow it and the hospital still stood in the way, at least long enough that it became moot as the patient died (this happened to the father of one of the doctors who spoke at Johnson's hearing). As for the medical boards that pulled or threatened to pull doctors' licenses, they also acted well beyond their authority. You know it's bad when a critical care doctor of over 30 years says you should avoid going to the hospital if you get Covid, period, as Dr. Marik did.

[–]3andfro 3 insightful - 1 fun3 insightful - 0 fun4 insightful - 1 fun -  (0 children)

Many "shoulds" here I agree with, alongside a backdrop of an ocean of fear and still-believed misinfo from on high. What pharmacists could do was refer to state medical boards physicians who prescribed IVM with a COVID code, in some cases triggering review panels that jeopardized the prescriber's license. A very real chilling effect, regardless of whether it might in time have been found illegal. State med boards apply a standard of "community standards of care" in such cases, and IVM remains unrecognized in the US medical community as an acceptable standard of care for COVID. Removing FDA authority as a shield for such actions might be enough to stop them. We can hope.

[–]Centaurea 5 insightful - 1 fun5 insightful - 0 fun6 insightful - 1 fun -  (5 children)

It will be interesting to see what SCOTUS does with this case once it finally makes its way to them.

(That will probably take a while, because the Appeals Court has now sent it back to the District Court for discovery, trial, etc. This "standing" issue came up at a very early stage in the process. What the appellate court has done is reinstate the lawsuit, which the District Court had dismissed on procedural grounds.)

[–]penelopepnortneyBecome ungovernable[S] 5 insightful - 1 fun5 insightful - 0 fun6 insightful - 1 fun -  (4 children)

You did a much better job of summarizing it, thank you. I think the potential impact comes from the fact that it established the FDA exceeded its authority and by doing so it effectively interfered with doctors' ability to practice medicine and with the doctor-client relationship, it made ivermectin inaccessible to patients who wanted and needed it because pharmacies refused to fill their legal prescriptions. Who knows the full extent of the harms their interference caused, and with this court decision that they acted beyond their statutory authority, what liability they could rightly be subject to as a result. Couldn't happen to a better set of criminals.

[–]NetweaselContinuing the struggle 3 insightful - 1 fun3 insightful - 0 fun4 insightful - 1 fun -  (3 children)

it established the FDA exceeded its authority and by doing so it effectively interfered with doctors' ability to practice medicine

So what was the argument that Standing to Sue did not exist? Just a decree that it did not, or was there stated reasoning? Because that right there clearly looks like Standing....

Unauthorized actions by the Defendant leading to direct, measureable losses by the Plaintiff... that's pretty much Standing.

[–]penelopepnortneyBecome ungovernable[S] 3 insightful - 1 fun3 insightful - 0 fun4 insightful - 1 fun -  (2 children)

The first court accepted the FDA's assertion they had the authority to do what they did, this is what the court of appeals ruled against: "It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise." So what they did was not protected by sovereign immunity.

[–]NetweaselContinuing the struggle 3 insightful - 1 fun3 insightful - 0 fun4 insightful - 1 fun -  (1 child)

So their "they don't have standing" argument was one of sovereign immunity?

[–]penelopepnortneyBecome ungovernable[S] 3 insightful - 1 fun3 insightful - 0 fun4 insightful - 1 fun -  (0 children)

Yes.