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Appeals Court: Doctors Can Sue FDA for Condemning Ivermectin as a COVID-19 Treatment, Resulting Reputational Harm
Legal Insurrection ^ | September 10, 2023 | Terance Kible

Posted on 09/11/2023 6:42:00 AM PDT by Chad C. Mulligan

federal appeals court allowed three doctors to sue the FDA over a series of website and social media posts condemning ivermectin as a treatment for COVID-19. The doctors alleged the FDA exceeded its authority by offering medical advice and “that FDA’s messaging interfered with their own individual medical practice.”

The lawsuit stems from a series of FDA posts advising consumers not to take horse ivermectin but failing to acknowledge the existence of a human ivermectin formulation, including one tweet advising consumers, “Hold your horses, y’all”:

The trial court dismissed the doctors’ lawsuit after finding sovereign immunity barred their three claims. The appeals court reversed on one claim, finding plausible the argument the FDA exceeded its statutory authority by offering medical advice instead of medical information:

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. . . . Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority. (emphasis original)

The FDA argued its posts were purely informational, which the appeals court rejected:

On the contrary, all six of the Posts contain syntax that is imperative rather than declaratory (for example: “Stop it,” “Stop it with the #ivermectin,” and “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”) For that reason, we are unable to draw any analytical distinction between FDA making the Posts versus FDA telling Americans to “Stop it” with acetaminophen or antibiotics.

The firm Boyden Gray, which represents the doctors, issued a press release praising the decision:

(Excerpt) Read more at legalinsurrection.com ...


TOPICS: Constitution/Conservatism; Culture/Society; Government; News/Current Events
KEYWORDS: covid; fda; ivermectin; lawsuit
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To: exDemMom

I will disagree with you.

Could post lots of “antidotal” or meta analysis data but for brevity will relate to you an interaction with a patient in my store. This person has had long COVID for a long time. First, was told there was no reason for the patient’s brain fog, fibromyalgia like symptoms, headaches, etc. Finally, long COVID became an accepted diagnosis. No one would treat this person because the treatment was unacceptable except by the FLCCC protocols. The dad had all during this time tried to get his child to try some “ horse paste.” After a spinal tap and increasingly suicidal ideation, this person came to the breaking point of “I’m dead if I do and dead if I don’t” and called the dad. Remember, the news was presented that if you take horse paste, you’re going to end up in the ER.

After one week of therapy, this person had turned around 180 degrees. No suicide thoughts, body was starting to not hurt, could think again, felt 90 percent their self not 60, and more to the point had hope that wellness was achievable.

My question for you is… Will you go and tell this person the what they experienced was only a bs psychosomatic experience and nothing of the past 1.5 years was real and the turn around is a false expression of a non-possibility?

Just wondering…


21 posted on 09/11/2023 8:12:14 AM PDT by Texaspeptoman (Even cannibals... get fed up with people sometimes.)
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To: exDemMom

“There is no evidence”

Obviously you don’t pay attention.


22 posted on 09/11/2023 8:30:28 AM PDT by Revel
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To: Chad C. Mulligan

What about the covered countermeasures crap?

Doctors could always prescribe Ivermectin.

Their health systems stopped them, and doctors submitted, because since Deep State refused to include Ivermectin as a covered countermeasure, no liability protection accrued to its prescription.

These doctors are being too cute by half.

They could have prescribed it anyway.

They chose to knuckle under


23 posted on 09/11/2023 8:39:14 AM PDT by mewzilla (Never give up; never surrender!)
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To: exDemMom

There are scientific papers, peer reviewed, going back to at least 2012 on Ivermectin’s anti-viral properties.


24 posted on 09/11/2023 8:41:08 AM PDT by mewzilla (Never give up; never surrender!)
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To: Texaspeptoman

I took the “horse paste” version of Ivermectin as well. I trusted this more than pills purchased from India from sources that I was not sure were legit. I took less than half of the dosage recommended by those advocating for the pills. I didn’t experience any bad side effects but it also didn’t cause an immediate recovery.


25 posted on 09/11/2023 8:41:49 AM PDT by fireman15 (Irritating people are the grit from which we fashion our pearl. I provide the grit. You're Welcome.)
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To: Chad C. Mulligan

Following my previous post, I did a little research into these doctors.

It is as I thought. Paul Marik is associated with a charlatan group “FLCCC” that recommends anything but tested and accepted treatment protocols. For example, among its many questionable recommendations for early Covid treatment, it lists fluvoxamine, which is a psychoactive drug meant for treatment of obsessive-compulsive disorder (as well as the old charlatan standbys ivermectin (IM) and hydroxychloroquine (HC) and a bunch of supplements). Is Covid, then, a psychiatric disorder related to OCD? I don’t think so.

The FLCCC also recommends a “MATH+” protocol for hospitalized patients which actually does list antiviral medication (but not a specific antiviral) buried in the other questionable recommendations. Of note, Malik and two others published a case study on the MATH+ protocol in a reputable medical journal, but it was retracted. The sponsoring hospital reviewed the data from the study and found that Malik and colleagues had referenced 191 patients in the study, but only 73 were actually treated with the MATH+ protocol. And among those 73, the death rate from Covid was actually 28%—which is at the high end of mortality rates reported in the medical literature.
https://journals.sagepub.com/doi/pdf/10.1177/0885066620973585

The Texas Medical Board recently filed a complaint against Mary Bowden for ethical lapses including prescribing medications (notably, IM and HC) to patients she had never examined and who were under the care of another physician. Her admitting privileges at Houston Methodist hospital had previously been suspended because she had been telling patients that vaccines don’t work and that the hospital would not treat unvaccinated patients. (Which is ridiculous. There is a lot more profit in treating the unvaccinated because they get a lot sicker and require more staff and resources to treat. Ka-ching!)
https://www.houstonpublicmedia.org/articles/news/health-science/2023/06/09/454104/texas-medical-board-complaint-mary-bowden-houston-doctor-prescription-patient-confidentiality-violations/ (Note: this page requires a free subscription to read.)

I could not find much on Robert Apter, other than about his involvement in the lawsuit filed back in Jun 2022.

Last, as for the lawsuit itself, I found this at the Boyden Gray website:
https://boydengray.com/complaint-in-apter-v-hhs-no-322-cv-184-s-d-tx-june-2-2022-2/
This page contains a non-functional link prefaced by “Setting up fake worker failed: “Cannot load script at [web address].” Presumably, this should link to the lawsuit filed Jun 2, 2022.

The fact that most of the lawsuit has already been dismissed and that only the part citing what the plaintiffs claim is language by the FDA overstepping its regulatory boundaries is going forward means that the plaintiffs have already lost the substantive issue of the lawsuit. The FDA actually *is* allowed to state the correct usage protocols of the drugs that it approves. This is not the FDA acting as a physician; this is the FDA providing the information to physicians and patients (because, otherwise, how would they know?).

Here is an entire FDA web page describing the use of the Pfizer vaccine:
https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/pfizer-biontech-covid-19-vaccines

This page also contains links to various approval documents granted to Pfizer by the FDA. While antivax charlatans love to claim that the FDA is keeping the data secret, it is all there if you care to read all the memoranda and follow all the links. The 45 page decision memorandum dated April 18, 2023 summarizes studies and provides links to detailed study reviews, such as this 74 page study description https://www.fda.gov/media/159393/download. The FDA does not provide the raw data, which would probably be meaningless to anyone who is not a professional involved in clinical studies, but Pfizer stores that data and the FDA reviewed it.


26 posted on 09/11/2023 9:02:11 AM PDT by exDemMom (Dr. exDemMom, infectious disease and vaccines research specialist.)
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To: exDemMom

Your entire post needs to be labeled FAKE NEWS.


27 posted on 09/11/2023 9:40:08 AM PDT by Jane Long (What we were told was a conspiracy theory in ‘20 is now fact. Land of the sheep, home of the knaves)
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To: exDemMom

Your “research” is likely FRAUDci funded.

NO THANKS and NO SALE.


28 posted on 09/11/2023 9:40:38 AM PDT by Jane Long (What we were told was a conspiracy theory in ‘20 is now fact. Land of the sheep, home of the knaves)
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To: mewzilla

There are scientific papers, peer reviewed, going back to at least 2012 on Ivermectin’s anti-viral properties.


The plants/$hills could care less about that fact.


29 posted on 09/11/2023 9:41:31 AM PDT by Jane Long (What we were told was a conspiracy theory in ‘20 is now fact. Land of the sheep, home of the knaves)
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To: exDemMom

Ivermectin clearly has demonstrated anti-viral activity in vitro and just barely missed clinical significance in a big trial in covid patients. The hazard ratio was quite in favor of ivermectin.


30 posted on 09/11/2023 1:27:43 PM PDT by mtrott
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To: exDemMom

Try reading the article.


31 posted on 09/11/2023 2:21:26 PM PDT by Jacquerie (ArticleVBlog.com)
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To: exDemMom

Bookmarked for later.


32 posted on 11/19/2023 7:17:53 PM PST by grey_whiskers ( The opinions are solely those of the author and are subject to change without notice.)
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