This article the Fifth Circuit Court of Appeals decision about ivermectin was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about vaccination’s social and legal policies. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable diseases. She is also a member of the Vaccines Working Group on Ethics and Policy.
On September 1, 2023, the federal Fifth Circuit Court of Appeals revived a lawsuit by three ivermectin-prescribing doctors – Drs. Robert Apter, Dr. Mary Talley Bowden, and Dr. Paul Marik – against the FDA’s online guidance document recommending against prescribing ivermectin for treating COVID-19 and FDA’s tweets on the topic.
The court decision on ivermectin is problematic legally and on policy grounds. Legally, the court did not interpret – or address at all – the statutory provision the FDA relied on for the posts, 21 U.S.C. 375(b), and ignored the jurisprudence interpreting it. Second, even if the court is right about the existence of a waiver to sovereign immunity, the court’s decision strongly suggests there is no actual claim under the Administrative Procedure Act (APA) here, so why not dismiss the case on that?
Policy-wise, the court decision is just as problematic, undercutting the FDA’s ability to offer expertise-based guidance about products they regulate (and providing information on why the FDA did not approve or authorize ivermectin for COVID-19 is strictly within that framework). But it is not as big a win for the doctors as COVID-19 misinformation spreaders online claim, since it seems to encourage the lower court to dismiss the case as not addressing a final agency action and/or lack of standing.
What happened?
Three doctors who, among other things, prescribe ivermectin for treating COVID-19 sued the FDA over a statement warning patients against using ivermectin that way and especially warning patients not to use the animal version of ivermectin. As a reminder, data does not support using ivermectin for COVID-19.
The statements included a “consumer update” titled “Why you should not use Ivermectin to Treat or Prevent COVID-19.” Among other things, the update said, as quoted at length in the court decision:
FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.
The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.
If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.
Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.
None of the statements in the update seem particularly problematic, but that is not the point.
In addition, the lawsuit targeted three “social media posts,” cited in the decision:
- “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.”
With an image of a horse. They went viral, and had quite a bit of success – it was an effective, good campaign.
The three doctors bringing the lawsuit have, as the lawsuit said, “prescribed the human version of ivermectin to thousands of patients suffering from the coronavirus.” At least two of the doctors found themselves before their state’s medical board regarding prescribing the drug – appropriately, in my view: disciplining doctors that prescribe treatments that do not work for a disease, and which have risks, is one of the jobs of a medical board. The plaintiffs would, of course, have their full procedural rights before the boards, including an opportunity to convince the board that the action was not negligent.
The district court dismissed the case in December 2022, finding that the FDA had not acted outside its authority and that the action was not final agency action.
The doctors appealed to the Fifth Circuit Court of Appeals, and a panel reversed the dismissal of the ivermectin lawsuit.
Why the court found the guidance document and tweets ultra vires, and why it’s wrong about ivermectin
The court’s decision is, as I set out, somewhat strange. The court’s claim that the FDA was acting without authority is problematic since it does not even try to interpret the source of authority the FDA relied on, and it completely ignored the fact that publishing this kind of statement is a longstanding practice for the FDA.
First, the court addresses whether sovereign immunity prevents the claim. Sovereign immunity means that the government can only be sued, in the United States, as permitted by law.
The ground the court used to find that the government agreed to be sued here is in section 702 of the Administrative Procedure Act, which allows lawsuits “seeking relief other than money damages and stating a claim that an agency or an officer or employee thereof acted or failed to act in an official capacity or under color of legal authority.”
Although we might be tempted to think that this waiver should only apply to valid claims under the Administrative Procedure Act, courts have interpreted this provision more broadly, including for allowing statutory authority claims (see the text around footnote 38, and the citations in footnote, here).
To qualify under the provision, the court explains, requires two things:
- “agency action” affecting the plaintiff in a specific way,” and
- “adverse effects” for the plaintiff.
The court addressed whether the FDA has statutory authority to publish the update and the tweets to address whether it acted ultra vires, or outside its statutory mandate, which would be illegal. The court found that the FDA acted outside its statutory authority because “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.” The basis here is that if an official is acting outside the official’s authority, action can be taken against the government. As the court points out, to show this,
[t]he complaint must allege facts sufficient to establish that the officer was acting ‘without any authority whatever,’ or without any ‘colorable basis for the exercise of authority.’
The court’s main premise was that the posts recommend and advise rather than contain information. The court said: “…the Posts contain syntax that is imperative rather than declaratory…” and that the FDA does not actually have the authority to issue advice.
The court said:
[the FDA claimed that] ‘FDA’s informational statements do not ‘direct’ consumers, or anyone else, to do or refrain from doing anything.’
Likewise, the FDA’s brief says that the Posts are “purely informational.”
At the same time, however, the FDA’s brief also concedes that the Posts “provided recommendations” and “advise[d] consumers.” Despite these concessions, FDA never points to any authority that allows it to issue recommendations or give medical advice.”
That’s about all the court says. The court appears wrong in several ways.
The provision that the FDA cited in its briefs as a source of authority, and that the Court of Appeals did not even cite (let alone interpret), is §705(b) of the Food, Drug, and Cosmetics Act, which is also cited as 21 U.S.C. 375(b). Section 375 is titled “publicity”, which should be a reminder that, as one scholar pointed out, “The FDA is one of the few federal agencies in government which is specifically required and authorized by law to use publicity.”
§375(b) provides:
“(b)Information regarding certain goods
The Secretary may also cause to be disseminated information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving, in the opinion of the Secretary imminent danger to health or gross deception of the consumer. Nothing in this section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department.”
A couple of points about this provision and why, given the statute, the distinction between recommendation and information cannot stand. I will go back to the medical advice below.
First, the last sentence talks about “collecting, reporting, and illustrating” results of investigations. That certainly seems to include conclusions based on the data collected: reporting on the result of an investigation that showed ivermectin is not effective for COVID-19 would naturally include a comment that it should not be used, and that seems to fit well within “reporting” the result of the investigation. Similarly, reporting that using the animal version – which has larger doses – involves substantial risks naturally should lead the FDA to conclude that people should not use the animal version. The authority to report seems to at least strongly imply permission to share operative conclusions of that reporting.
That conclusion is even more strongly supported by the conditions for disseminating such information: since the information should be disseminated “in situations involving, in the opinion of the Secretary, imminent danger to health or gross deception of the consumer,” the implication is that the goal of the dissemination is to prevent harm to the consumer, in which case, adding a bottom-line recommendation is implied and warranted. And as the FDA mentioned, people can be put in imminent danger if they consume horse ivermectin.
Second, there is a very long history of the FDA making such recommendations. There is a (limited) jurisprudence addressing §375(b), summarized by Levi Liu here. An early case, Hoxsey Cancer Clinic v. Folsom (1957), addressed the FDA’s warning against a fake cancer treatment – a remarkably similar situation to the warning against ivermectin, and even more specific to the plaintiff, which was using that treatment.
The court there – a district court – found that there is authority to issue the statement and that it was not a violation of due process to issue it without a hearing. The court pointed out that this is not an order, all the FDA is doing is “disseminating information and warning the public against the use of certain medicines and of a certain treatment for internal cancer.”
In fact, the Hoxsey court would have upheld the FDA’s power to issue the statement even without the explicit provision, as implied by the FDA’s general regulatory authority. §375(b) cements that authority, since, “[t] he only purpose of this statute is to place within the express scope of the duties of the Secretary something that was one of his implied functions.” (Hoxey)
Hoxey found the FDA had the authority to do that, authority cemented by the statute. It reads into the authority to summarize results the authority to draw natural conclusions and recommend what to do based on them. If that is correct, the tweets in the current case – reflecting the FDA’s general warning against using an animal product – fall straight within the authority to “illustrate” the points made, in line with the last sentence of the law.
Similarly, in 1974, in Ajay Nutrition Foods, Inc v. FDA, plaintiffs complained about publications of the FDA about the health food industry that “have resulted in the deprivation of property without due process of law and the wrongful and unlawful interference with the rights of the plaintiffs and the other members of the class to carry on a business.”
Plaintiffs allege that the class has been referred to as “nutrition quacks,” “food faddists,” and “health quacks,” and that the products that are produced have been referred to as “shotgun mixtures.” Further, plaintiffs claim that the FDA has sought to discredit certain fastly held tenets of health food enthusiasts.”
The court found that the statements “are consistent with and stem from … investigations that led to the proposed regulations,” and that as long as the statements are standard agency practice, they are allowed.
In other cases, too, the FDA’s issuing of statements warning against using products has not been questioned, though in a few the issuance of statements – such as when a company had already recalled its product – was criticized.
If anything, these posts are on stronger grounds than the statements addressed in those other cases: they did not target any specific company or doctor, they just gave a general recommendation to the public not to use ivermectin (in the consumer update) and especially not to use animal ivermectin (in the tweets). The three plaintiffs are certainly not mentioned in them, so the adverse publicity raised as a concern in the article linked above is not relevant here.
What about medical advice? While the posts certainly recommend courses of action, they do not provide any individualized advice. They are certainly not medical advice to a specific patient, and in fact, to patients prescribed ivermectin, the only advice is to follow their provider’s instructions. The FDA is not telling doctors not to prescribe ivermectin and has no way to step in between the doctor and the patients (see below about these doctors and the medical boards).
I would add that even if the tweets were advice, the advice “do not take animal medication” seems milquetoast. Yes, you should not take horse medication, generally – you’re not a horse. And?
On policy grounds, too, the Fifth Circuit’s interpretation of the FDA’s statutory authority is deeply flawed. It instructs that agencies cannot engage in plain-language summaries of the practical meaning of reports and information without explicit statutory interpretation.
The FDA is the regulator that approves products, and draws conclusions from the data. It should be able to speak about those conclusions to people in plain language, and that generally means “This is what you should do based on that.”
But the court seems to disallow that. That seems harmful and without any benefits. What about other agencies that issue guidance? The CDC, which has no governing statute, but which issues guidance as one of its primary roles, comes to mind. Is that now forbidden?
The other part of the analysis the court engages in looks at two issues. First, are the posts “agency action?” Here the court concludes that they are, classifying them as a rule. That appears problematic; the agency does not have the power to regulate consumers directly and tell them what to take – and in fact, it cannot, it cannot sanction consumers or do anything – and although the posts give the agency’s opinion on what consumers should do, what is the applicability? Where is the prescription? Rules, according to the provision the court (correctly) cites, are “designed to implement, interpret, or prescribe law or policy” (the next lines are not applicable).
Where is the implementation, interpretation, or prescription? This is an opinion with a recommendation that the FDA has no power to enforce. The court seems wrong in concluding the agency created a rule. Worse, making every such agency pronouncement a rule really broadens the scope of the term, and that actually has direct practical implications— rules, even non-legislative rules, are supposed to be published in the Federal Register, under §552 of the Administrative Procedures Act – so every agency statement needs to be published there? That’s not the way it works.
Second, the court addressed whether the doctors are within the “zone-of-interests” affected by the FDA’s statements, which is required to allow a claim against the government under §702 of the Administrative Procedures Act, as the court’s decision explains. The court found that this test is “not especially demanding,” and found the doctors’ interests “much more than marginal.”
I think the court should have been more careful here too. The doctors claimed to be affected in several specific ways, beyond generally claiming the posts “interfered” with their ability to exercise professional judgment and harmed their reputations. Allegedly they were referred to medical boards for prescribing ivermectin to treat COVID-19, pharmacies refused to fill their prescriptions of ivermectin, Dr. Bowden lost admitting privileges at a hospital for tweeting about using ivermectin on patients, and Dr. Marik lost positions at a medical school and hospital.
Here is where distinguishing the different posts might matter. The most visible campaign of the FDA was against the use of horse ivermectin – and the doctors were not using that. If they were prescribing horse ivermectin to patients, they should – and likely would – have faced all of the above had the FDA said nothing. But they probably were prescribing human ivermectin.
So the tweets were not relevant to them. The consumer update may have had an effect, but if the FDA made no recommendation and just said that the data did not show ivermectin to be effective against COVID-19 – information which it is expressly authorized to publish – that still could, and likely would, be used against the doctors. Medical boards, for example, could certainly act against doctors prescribing ineffective treatments to people, especially when there are effective treatments available. So what is their interest?
The Fifth Circuit seems to have gotten this decision very, very wrong.
What the court said about finality
In the last part of the decision, pp. 20-24, the court finds that the FDA’s posts and tweets are not “final” agency action, because they do not determine rights and obligations, lead to legal consequences, or reflect the FDA’s view of the law. The Fifth Circuit used this to say that the general provisions of the Administrative Procedure Act do not apply – but this is actually important to the decision itself, because if the FDA’s statements are not final agency action, where is the claim under the Administrative Procedure Act? Will this go back down just to be kicked out on lack of finality?
Standing
Finally, the court ends by saying it is not going to determine standing here. Standing requires that a person would have an “injury in fact” – a concrete or actual injury to a legally protected interest, a causal connection between the agency’s conduct and the injury, and a likelihood that the court’s favorable decision will address the injury.
It may appear that the court addressed standing in finding that the doctors were within the “zone of interests” – there is some language there suggesting that the standard is the same – but the decision also has language suggesting the standards are different: the writing is confusing on this. I think there is a real question here.
First, the FDA is not the only entity to have spoken out about ivermectin. And if the boards and pharmacies had no guidance from the FDA, they could look to private organizations saying the same – like the American Medical Association, the American Society of Health-System Pharmacists, and the American Pharmacists Association, which issued a statement on this that would not change if the FDA removed the recommendation language.
Further, if the FDA clearly has the authority to share information about ivermectin – like the information that the data does not support its effectiveness against COVID-19 – where is the redressability? Again, boards and others could use the information in the same way.
Sending the case back to be dismissed on standing and finality helps no one.
Conclusion of Court of Appeals decision on ivermectin
The Fifth Circuit Court of Appeals’ decision about ivermectin is legally wrong, ignoring the statutory authority of the FDA that could cover issuing recommendations in addition to information and is in tension with longstanding FDA practice upheld by the courts.
It is bad on policy grounds: it could make it harder for expert agencies to translate information into practical guidance people can use, and it could undermine the goal of Congress in setting up the FDA to issue such information, to protect people from imminent danger or fraud. All it does is give a talking point to doctors seeking to provide an ineffective treatment to COVID-19 patients for personal gain; it is not even clear it will be helpful to these doctors in their lawsuit, since the claims may well be dismissed on other grounds.
It is terrible all around.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
