Way before we were lawyers, we read a good chunk of the writings of James Herriot, the nom de plume of a rural English veterinarian who chronicled his exploits in helping All Creatures Great and Small (the title of a movie and TV series about him). The veneration of his seemingly altruistic and tireless work made sense in a house with a range of critters. We did not become vets, though; we became lawyers, specifically lawyers who represent drug and device companies. So, when we recently saw a news account of a litigation between a vet and the Texas State Board of Veterinary Examiners over the vet’s dispensation of a range of advice over the internet, our minds turned to the regulation of truthful statements about off-label uses of prescription medical products, not to how his advice might have helped people and their animals or even something seasonally appropriate like the ailments of flying reindeer. Sad, perhaps, but true.
We tracked down the decision referenced in that news story, read a bit more about the case, and decided that the decision was, in fact, Blogworthy. As a semi-aside, we can recommend the Twitter account belonging to the First Amendment, which largely posts about bad legal takes from non-lawyers, political hacks, and lawyers without much grounding in constitutional law. The posts often consist of “[Doing what was suggested below] would violate me.” We chuckle on the inside. But we did take con law (from a future acting Solicitor General), so we know the big issue in cases involving freedom of speech or other express rights from the Bill of Rights is the level of scrutiny that should be applied. A law, as written or applied, may fail the strict scrutiny test, but pass easier tests. In addition, there can be disputes about whether what someone did, or what the law is attempting to limit, criminalize, regulate, etc., is speech in the first place.
That brings us to Hines v. Quillivan, No. 1:18-CV-155, 2021 WL 5833886 (S.D. Tex. Dec. 9, 2021). Dr. Hines is the vet and he sued individual members of the Texas Board of Veterinary Examiners to get declaratory and injunctive relief that he could keep doing what he had been doing without fear of criminal charges, disciplinary proceedings, fines, and such. From the decision and elsewhere, we see that Dr. Hines, while licensed in Texas, had been retired from active practice (apparently secondary to disability) for several years and had been offering a range of advice to pet owners around the world (which is broader than Texas, despite what some may think) through the wonders of the internet since 2012. It appears that some portion of his advice was free and some portion was for pay; he also engaged in other communications, like consoling a pet owner for a pet’s death or illness. At some point, he was told he could not do this anymore, because Texas had a law requiring a physical examination of the animal in connection with providing veterinary care. He sued, the case was dismissed, the Fifth Circuit reversed and remanded, and the case was back before the trial court to decide a motion to dismiss consistent with TwIqbal. Really, the cite above is to the district judge’s review of the magistrate’s report and recommendation that the motion to dismiss should be denied, but that is a de novo review so we are splitting fur here.
On remand, the issue was framed as whether the defendants’ application of the requirement of a physical examination “regulate[s] only speech, restrict[s] speech only incidentally to their regulation of non-expressive professional conduct, or regulate[s] only non-expressive conduct.” Id. at *2. Because the plaintiff’s constitutional challenge was to the requirement as applied to him, the court “does not consider the general purpose of the law, but whether Hines’s actions that triggered the Defendants’ disciplinary procedures constitute speech of conduct.” Id. The defendants argued that strict scrutiny should not apply because they were primarily regulating conduct with, at most, only an incidental burden on free speech rights. The Supreme Court’s decision in Holder v. Humanitarian Law Project, 561 U.S. 1 (2011) (called “HLP” in the decision and here), set the relevant tests. Rather than get into the facts of HLP, we will focus on the application to allegations in Dr. Hines’s complaint. His communications with pet owners included the following:
He consoled distressed pet owners, recommended that pet owners seek immediate veterinary care because an animal’s symptoms indicated a serious medical condition, clarified information that other veterinarians had provided to pet owners, helped pet owners “decide how to proceed when local veterinarians had provided conflicting diagnoses”, and generally pointed them to relevant information on the internet. Hines never prescribed medication or rendered any diagnosis. At times, if he discovered an error in a prescription that a pet owner received, he would provide guidance to the pet owner so that she could visit her local veterinarian to ask that the prescription be corrected.
Id. at *3 (citations and footnote omitted). There was no hint (and certainly not in the complaint) that any of what the plaintiff said or wrote was false, misleading, or even bad advice. There was no discussion that a different standard might apply to what might have been considered commercial speech.
Pause, if you will. Imagine that the electronic communications detailed above came from a drug company. It responded to doctors who had reached out with questions about caring for their patients or went looking for information on the company’s website. The doctors were directed to sources of information, like published studies, and provided general information about the diagnosis and treatment of disease states without mentions of the company’s specific prescription drugs. Maybe knowledgeable doctors were available to answer questions (while being compensated by the company). Maybe some of the information, if the doctor went looking for it, related to the off-label use of the company’s drugs (and maybe its competitors’ too). Assume there was nothing false or misleading in the information provided by the company, including about the off-label use.
Historically, FDA treated almost all of the discussion of off-label use as improper off-label promotion that it could regulate and even refer for criminal prosecution. It took years of litigation for truthful and non-misleading statements about off-label uses to be treated as protected speech rather than potentially prosecutable conduct. (See here, here , here , and here for a sampling.) Even after the Amarin settlement, clear statements from FDA recognizing the role of First Amendment protections in commercial speech from drug and device companies are hard to find.
Back to Hines, right after the examples of the plaintiff’s communications, the court concluded “[t]hese alleged actions by Hines constitute speech, and not conduct.” Id. The plaintiff alleged that, because of the Board’s application of its policy to him, he was now unable to console pet owners or disseminate general information without personally conducting a physical examination of the pet. “In short, the overwhelming majority of what Hines sought to do, but which the Defendants prohibited him from doing unless he satisfied the Physical Examination Requirement, constituted speech and in no manner could be characterized as conduct.” Id.
The application to plaintiff was also content-based. The content of his communications had to be evaluated to determine if he was engaging in veterinary practice as defined by the applicable Texas law or doing something else with his communications (e.g., providing general information not targeted an individual patient). “This distinction squarely meets the definition of a content-based regulation, as defined in HLP.” Id. That meant strict scrutiny applied and the defendants did not even contend they could withstand strict scrutiny. The motion to dismiss was denied on the case continued.
Return to the hypothetical above about truthful, non-misleading information about off-label use provided by a drug company. Under the analysis in HLP and Hines, it sounds like any attempted regulation by FDA would be triggered by speech. To determine if the statements are about off-label use, are truthful, and/or are misleading, FDA would need to consider the content. Could FDA’s regulation of these statements pass constitutional muster if the company raised its First Amendment rights to free speech and strict scrutiny applied? Any litigation would get past the motion to dismiss stage and FDA would be spending a lot of time in court. It is hard to see how such attempted regulation would advance FDA’s public health goals.