We have now been monitoring litigation involving tenofovir-based HIV remedy for a while now. We reported a couple of weeks in the past on oral argument within the California Courtroom of Attraction, the place the events debated a novel “obligation to innovate” underneath California legislation. We additionally gave you our view on the 2019 order that many say kickstarted these circumstances, Holley v. Gilead Sciences, Inc., 379 F. Supp. 3d 809 (N.D. Cal. 2019). Though couched in numerous phrases, the plaintiffs’ core allegation in these circumstances is that the defendant ought to have marketed one other drug as a substitute of the one which the plaintiffs used, or at the very least that the defendant ought to have marketed the choice drug earlier. We blogged on related circumstances right here, right here, and right here.
As we defined right here, “hindsight” claims like these shouldn’t be allowed. A declare that the defendant “by no means ought to have offered” a drug needs to be preempted, the identical as “stop-selling” claims, since state legislation shouldn’t be allowed to penalize the introduction of a drug to market when federal legislation expressly approved it. A plaintiff additionally shouldn’t be allowed to carry out a completely different product instead design. One drug is just not another design for a distinct drug any greater than a motorbike is another design for an vehicle. You get the thought.
The Holley case has now proceeded to abstract judgment, and the result’s equally unsatisfying for the protection. To summarize, the medicine at situation are life-saving antiretroviral medicine used to deal with sufferers with HIV. The defendant has developed a number of medicine used to deal with or forestall an infection with the AIDS virus, together with a number of containing tenofovir disoproxil fumarate (“TDF”) as an lively ingredient. The plaintiffs in Holley declare that the defendants ought to have supplied a distinct drug as a substitute, one based mostly on tenofovir alafenamide (“TAF”), which the defendant had underneath growth and delivered to market about 10 years later. Each medicine stay available on the market, and physicians can and do prescribe both, relying on their sufferers’ wants.
On abstract judgment, the district court docket dominated once more that federal legislation doesn’t preempt the plaintiffs’ claims. We nonetheless disagree with this conclusion and imagine the district court docket’s characterization of the plaintiffs’ claims solely reinforces our view: “[Plaintiffs] allege that the TDF medicine they consumed had been faulty as a result of [Defendant] failed to think about TAF as a safer various and that, as a substitute of looking for approval for the TDF medicine, [Defendant] ought to have supplied a distinct formulation for FDA approval.” Holley v. Gilead Sciences, Inc., No. 18-cv-06972, 2023 WL 6390598, at *3 (N.D. Cal. Sept. 28, 2023).
Taking the district court docket’s personal gloss at face worth, these are claims that the defendant by no means ought to have marketed TDF medicine and may have offered TAF medicine as a substitute. It is a “by no means ought to have offered” declare that’s preempted underneath such authorities as Yates v. Ortho-McNeil-Janssen Prescribed drugs, Inc., 808 F.3d 281 (sixth Cir. 2015), and the Supreme Courtroom’s opinion in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2471 (2013). It makes no distinction in our view that the FDA finally permitted TAF-based medicine. It’s undisputed that, on the time the FDA permitted the primary TDF-based drug, the plaintiff’s proposed “various” was not permitted, and wouldn’t be permitted for an additional 10+ years.
The district court docket made quite a few different rulings as properly, and we are going to notice a couple of right here. First, the court docket dominated that strict legal responsibility design defect claims usually are not allowed underneath the legal guidelines of a number of states, together with the one state for which that was contested, Alabama. Id. at *3-*4.
Second, for the states that apply a risk-utility check, the court docket denied abstract judgment on design defect claims, regardless that the plaintiffs’ consultants had not supplied opinions weighing the danger and advantages of the TDF medicine that the plaintiffs used. As an alternative, the plaintiffs’ consultants had supplied opinions that TDF was related to kidney damage and that TAF medicine had been safer. Id. at *4-*5. We query whether or not these opinions had been ample for the claims to outlive abstract judgment, primarily as a result of a risk-benefit evaluation ought to weigh specific product’s dangers and advantages—not the product’s dangers weighed in opposition to the dangers of a distinct product. Tylenol is tougher on the liver than ibuprofen, however that doesn’t imply Tylenol is flawed, or say something about how Tylenol’s liver threat weighs in opposition to its advantages. A comparability of TDF in opposition to a distinct drug is equally uninformative, and unprecedented.
Third, the district court docket dominated that the plaintiffs’ “put up approval” failure to warn declare was preempted, however that its “pre-approval” failure to warn declare was not. On the previous, the court docket granted abstract judgment, noting that federal legislation preempted a “post-approval” failure to warn declare except the plaintiff might produce “newly acquired data.” Such data would have allowed the defendant unilaterally to vary its product label underneath the FDA’s “modifications being effected” guidelines, thus avoiding preemption. The plaintiffs’ submission of inside research, case studies, and scientific literature did not present “newly acquired” data—the FDA was already conscious of all of it. Id. at *7.
The court docket, nonetheless, denied abstract judgment on “pre-approval” failure to warn, which isn’t actually a failure to warn declare in any respect. It’s only a declare that the defendant ought to have proposed to the FDA a distinct warning than what the FDA permitted. When it that approach, we can’t reconcile an order discovering that “post-approval” failure to warn is preempted with an order discovering that “pre-approval” failure to warn is just not. The plaintiffs’ failure to determine “newly acquired data” ought to lead to preemption of all warnings-based claims. And, if there was materials data current on the time of approval (i.e., not newly acquired) that the FDA wanted and that the defendant withheld, that will be fraud on the FDA, which is preempted underneath Buckman in any occasion.
The district court docket made different rulings, however these are the highlights (or lowlights). These circumstances are attention-grabbing due to the novel and, in our view, tenuous foundation on which they’re being introduced. Hindsight is 20/20.