Not too long ago we commented on the President of the United States promoting the unproven off-label use of a prescription drug, hydroxychloroquine, for treatment of COVID-19, on nationwide TV, in the presence of the Commissioner of the FDA, no less.  As we pointed out in the prior post, this drug has serious potential side effects – life threatening cardiovascular disorders.

Now, it’s gotten worse.  A president at least has authority over anything the federal government does – that’s within the job description.  But now we see news that the Federal Trade Advisor – who is not a doctor and whose office has no responsibility (where have we heard that before?) for anything related to medical practice went on several television shows touting the same unproven, potentially dangerous off-label use.

That got us thinking, what happens when these serious potential side effects inevitably occur?  As per our first COVID 19 post, the “manufacture, distribution, administration, or use of medical countermeasures” treating COVID-19 have all been immunized from liability.

What about Navarro’s statements?

Well, he’s a government official using his position to get attention to engage in off-label promotion.  The first place to look would be the Federal Torts Claims Act, which governs governmental liability for the alleged torts of federal government officials, as opposed to individual liability.  The FTCA extends to:

[C]ivil actions on claims against the United States, for money damages . . . for injury or loss of property, or personal injury or death caused by the negligent or wrongful act or omission of any employee of the Government while acting within the scope of his office or employment, under circumstances where the United States, if a private person, would be liable to the claimant in accordance with the law of the place where the act or omission occurred.

28 U.S.C. §1346(b)(1) (emphasis added).

We highlighted what we see as the biggest question, is Navarro “acting within the scope of his office or employment”?  On the Blog, we don’t do the plaintiffs’ research for them, but just observing what is going on, we tend to doubt it.  If we represented the government in civil litigation, we would certainly be arguing that the scope of waiver of sovereign immunity conferred by the FTCA doesn’t cover a Federal Trade Advisor who is not even a medical doctor, going on a non-government news program to advocate for an unproven medical treatment.  That seems rather far afield from the duties of that position.

The second limit in §1346(b)(1) is whether a “private person” can be sued on a similar legal theory in the relevant jurisdiction.  As Trade Advisor, Navarro did not have had an obligation to speak on COVID-19 treatment, but once he undertook to function analogously to a drug sales representative, he had the same obligation as anybody else to avoid negligence.  That’s something we’ve discussed before.

And speaking of things we’ve discussed before, how about off-label promotion?  Many courts have addressed whether, and when, false or misleading off-label promotion can be prosecuted by injured persons under state law.  This issue had arisen repeatedly against our clients – FDA regulated entities − and the dividing line has been, that there is no claim based merely on the fact of off-label promotion, but to the extent a plaintiff can plausibly assert (under either a warning, warranty, misrepresentation or fraud theory) that the off-label promotion is also false and misleading, most courts have concluded that a viable state law cause of action exists.

When plaintiffs join off-label promotion allegations and state-law claims asserting that something in the content of said promotion is false or misleading, such false off-label promotion claims usually have been held to state “parallel” claims that escape preemption, because (for one thing) an action exists under existing (non-FDCA) state law:

As to [plaintiff’s] theory [] that Defendants made misrepresentations and omissions in promoting off-label use . . . the court joins those courts determining that such claim is . . . moored in traditional state common law that exists independently from [federal law].

Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1037 (D. Haw. 2014) (quoting Houston v. Medtronic, Inc., 957 F. Supp.2d 1166, 1179 (C.D. Cal. 2013)).  We litigated whether these claims were preempted for years – believe us, there are lots of cases like this.  We beat almost all of them, but mostly on the facts (or lack thereof), rather than on this particular ground.

But preemption arises from prescription medical product labeling being governed by the FDCA – and Navarro’s off-label promotion is not governed by the FDCA – so he wouldn’t have a preemption defense.  He might have a First Amendment defense (and so, more plausibly, would the TV stations), but another principle we’ve advocated fairly frequently on this Blog is that the First Amendment only protects truthful off-label promotion.  So once again we’re back to the same question.  Would courts be able to find that Navarro’s advocacy of the off-label use of hydroxychloroquine for treatment of COVID-19 was “truthful” and not “misleading” as a matter of law, or would juries get to decide that issue?

So far, we’ve only addressed the FTCA in this post.  If Navarro were to be found to be acting outside the scope of his employment in this respect, a plaintiff could not sue the federal government.  But the flip side of “scope of employment” would be liability in a personal capacity for engaging in false off-label promotion.  We’ve never seen such a case (except as forum-shopping devices, not brought for their merits), and it’s outside the scope of what this Blog covers, so we aren’t going to speculate on that one.  But the answer may lie in what happened to non-government claims in the 704 cases that our Westlaw search of FTCA cases mentioning “scope of employment” provision of §1346(b)(1) pulled up.

Who knows, we might find out.  There are very few possible non-immune defendants should persons be injured by the off-label use of hydroxychloroquine to treat COVID-19, and we know from our preemption cases that, in such circumstances, the other side has shown quite a bit of creativity.