Some states seem stronger on FDA preemption than SCOTUS was in the Wyeth v. Levine decision. For example, Michigan, New Jersey, and Texas prevent or limit the ability of plaintiffs to sue over an FDA-approved drug, including attacks on the FDA-approved label. See, e.g., Texas Civ. Prac. & Rem. Code Ann. § 82.007. Sometimes those statutes afford plaintiffs an out under certain circumstances. Some of those outs make sense (e.g., if the medicine was sold after it had been ordered withdrawn by the FDA) and some do not (e.g., off-label use or promotion). The most controversial out allows plaintiffs to sue over an FDA-approved drug if the plaintiff can show that such approval happened only because the FDA had been hoodwinked. That translates into a claim of fraud on the FDA, and that, in turn, is preempted by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). If anyone is going to decide whether the FDA had been defrauded, it should be the FDA, not some state jury whipped into a frenzy by cherry-picked documents and reptilian rhetoric. Thus, the exception is null and void and the plaintiff is still out of luck.
That’s our position, of course. We could say that reasonable minds can disagree, but we don’t believe that for a second. When appellate courts come out on opposite sides as to whether a state fraud-on-the-FDA exception was preempted, we have no trouble saying that the courts holding preemption — Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (applying Texas law) (discussed here), and Aron v. Bristol-Myers Squibb, 2018 U.S. Dist. LEXIS 39146 (S.D.N.Y. Mar. 9, 2018) (applying Texas law) (discussed here) — were right, while the courts holding no preemption — Desiano v. Warner Lambert & Co., 467 F.3d 85, 95 (2d Cir. 2006) (applying Michigan law), aff’d by equally divided court, 552 U.S. 440 (2008), and Tigert v. Ranbaxy Pharmaceuticals, Inc., 2012 WL 6595806 (D.N.J. Dec. 18, 2012) (applying Texas law) — were wrong.
The plaintiff in Kumaritakis v. AstraZeneca Pharmaceuticals LP, 2020,WL 1024933 (Del. Super. Ct. March 2, 2020), was apparently spoiling for a fight on this issue. She claimed that she had been injured by taking an FDA-approved diabetes drug. Her causes of action included negligence and failure to warn. The parties agreed that Texas law governed, so the plaintiff ran smack against section 82.007. Right out of the chute, the plaintiff argued that the FDA fraud exception was not preempted. That should be a flat-out loser. And so it was in this case, but not for the reason you’d expect. The Delaware court was able to side-step the preemption point because the plaintiff never bothered to argue that any of the exceptions actually applied. Indeed, the plaintiff said she was not alleging that the defendant misrepresented or withheld information from the FDA.
Well, that was easy.
Why are we even writing about the Kumaritakis case? Isn’t this just an odd instance of a plaintiff shooting herself in the foot? What useful lesson emerges from this case? Well, one lesson might be to check whether the plaintiff has skipped a step or two in the rush to join issue on the most difficult or important legal dispute. (Think of so-called “parallel claim exception” cases in which plaintiffs never bothered to show any legitimate state law claim.)
There is another aspect of the Kumaritakis case that is interesting. The plaintiff also brought a cause of action for design defect She claimed that a safer design existed. Maybe so, but under FDA regulations, once a drug is approved “the manufacturer is prohibited from making any major changes in the ‘qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved application.’” Essentially, the plaintiff was singing that old Huey Lewis and the News song, “I Want a New Drug.” The court’s response was, “Yeah, well you’re not getting one until the FDA approves it.” The defendant could not change its medicine without FDA approval. That is straight-on impossibility preemption.
It seems to us that this sort of preemption is ineluctable and obvious, and should consign almost all pharma design defect claims to the litigation boneyard.