“You should’ve made a better medicine sooner” sounds like a complaint, but not a legal complaint. The FDA approves drugs if they are safe and effective; they needn’t be the best possible on the fastest schedule. If best-and-fastest were the criteria, the drug approval process would be crazy, sloppy, and frantic. Or maybe it would hardly ever be used.
Being immersed in defense-hack curmudgeon-dom, it’s in our nature to grouse about specious legal theories. That is especially true for legal theories that threaten to make us all less safe. If we drone on about preemption, it is because preemption protects the viability of FDA regulation. Preemption tells drug developers that if they play by the rules they can avoid expensive litigation. If the rules offer no such protection, the game might not be worth playing. Dilution and/or circumvention of preemption hobble innovation.
Few legal theories seem as batty and counterproductive as the litigation alleging that a life saving HIV drug should have been replaced sooner with a better version. A prescription drug containing tenofovir disoproxil fumarate (TDF) was approved in 2004 to treat HIV. TDF worked. The defendant made money off TDF. That’s all fine and good. Meanwhile, according to plaintiffs, the defendant sat on a better product, containing tenofovir alafenamide (TAF), and didn’t seek FDA approval of TAF for over a decade, waiting until shortly before the TDF patent would expire. We suppose, especially in this age of supreme cynicism and silly conspiracy suspicions, one could conjure up a sinister scenario if one really wanted to do so. Guess what? Some plaintiff lawyers really wanted to do so.
We have written about this litigation more than once. When California and New Jersey courts allowed design defect claims against the allegedly inferior HIV drug to proceed, our pens dripped with acid. When a Florida court held that the claims were preempted by Mensing, Bartlett, and Albrecht, we applauded judicial sanity. When a Hawaii court mostly, but not entirely, got it right, we mostly, but not entirely, nodded our heads,
Today’s case, sadly, leaves us shaking our heads. In disgust? In confusion? Yes and yes. In Johnson v. Gilead Sciences, Inc., 2022 WL 4439246 (E.D. Mo. Sept. 28, 2021), the class action complaint included a claim of unfair/deceptive practices under the Missouri Merchandising Practices Act (MMPA) and a claim of unjust enrichment. There was no claim of physical injury. There was no claim that the earlier drug, TDF, did not work. Rather, the plaintiffs alleged that the defendant extolled the virtues of TDF and underplayed its risks, delayed development of the superior drug (TAF), and thereby commanded artificially high prices for TDF. Under the MMPA, there was no need to allege product defect or that anyone relied on any misrepresentation. This class action is a money-grab, pure and simple. The defendant filed a motion to dismiss the complaint for failure to state a claim.
The defendant’s first argument was that the claims were preempted. But the Johnson court held that Mensing and Bartlett did not apply because the plaintiffs here were “neither alleging that the FDA-approved labeling or composition of TDF products were false or misleading” nor did the complaint pursue “product liability based causes of action.” The court conceived the case to be centered on the plaintiffs’ allegation that the defendant knew TDF was “less effective and more dangerous than it needed to be” before it sought approval by the FDA, “yet it sought FDA approval, nonetheless.” Huh? So the problem is simply in seeking approval? Remember how in the Bartlett case, SCOTUS rejected the stop-selling theory? Shouldn’t that reasoning also apply to a never-should-have-started-selling theory?
But wait. It gets weirder. Here is the Johnson court’s preemption analysis:
“Plaintiff is attacking Defendant’s preapproval conduct. Defendant cites to no federal law regulating a drug manufacturer’s conduct prior to seeking FDA approval, or identified any federal law that would have prevented it from developing and submitting for approval TAF drugs rather than or in addition to TDF-based drugs. Because allegedly fraudulent conduct before FDA-approval is not within the preemption scope, Defendant’s argument is unavailing, at this stage of the proceedings, the Court concludes Defendant could have independently complied with both state and federal law prior to submitting TDF drugs for FDA approval.”
It was the court, not us, who italicized the temporality terms. It is as if the court was trying too hard to make a point – one that made no sense. It was as if typeface and fonts could substitute for logic. In any event, the Johnson preemption discussion is a wrong-headed mess. We have criticized the preapproval vs. post-approval distinction before. It is far from self-evident that “conduct before FDA-approval is not within the preemption scope.” Can we, for a moment, retreat to first principles? The heart of preemption is that juries should not second-guess regulatory approvals or guess at what regulators might have done with other information. Obviously, the approval decision is based on things that happened preapproval. Here, the FDA approved TDF. If plaintiffs suggest that such approval was gained via fraud, such claim runs squarely into Buckman preemption, even if the plaintiffs say the victims of the fraud were patients, not the FDA. Either way, the claim depends on a showing that the defendant did not tell the FDA the whole truth. For reasons of competence and uniformity, that issue is for the FDA, not juries, to decide.
Moreover, the claim invites the jury to guess that the FDA would have approved the TAF drugs instead of the TDF drugs. How is that anything other than sheer speculation? The independence principle of Mensing and Bartlett, the need for drug and device innovators to be able to rely on regulatory actions meaning something, and the judicial role in preventing juries from straying well beyond their competence all warrant preemption of these ridiculous time-travel, hindsight claims.
The defendant also argued that the claims did not pass muster under the MMPA, because the defendant’s 2004 explanation of why it pursued TDF rather than TAF at that time was not in connection with the sale of TDF, was a forward-looking expression of opinion rather than a misstatement of fact, and could not, in any event, have been material to the plaintiffs’ purchase of TDF. Nor did the fraud allegations satisfy the heightened specificity requirement of Rule 9(b). All those arguments make sense to us. Would an HIV patient really forego an effective life-saving drug because he or she thought the manufacturer had a better one on the drawing board? Further, the plaintiff articulated no coherent theory of ascertainable loss. But the Johnson court emphasized that, in ruling on a 12(b)(6) motion to dismiss, it was forced to accept the truth of the pleadings. Sure, but if the TwIqbal plausibility analysis means anything at all, it means that the Johnson complaint, a bizarre exercise in counterfactual ingratitude regarding a life-saving use, should have been poured out of court.