Last year we reported on Plourde v. Sorin Group USA, Inc., 2021 WL 736153 (D. Mass. 2021), which held that the plaintiff’s failure-to-warn claims were expressly preempted by 21 U.S.C. § 360k(a) because those claims were based on an alleged failure to report adverse events to the FDA and the plaintiff had not shown

We’ve commented extensively on COVID19related vaccination cases, because vaccines are prescription medical products.  We haven’t commented on another aspect of litigation intended to sabotage public health efforts to combat the COVID-19 pandemic – attacks on masking requirements − mostly because masks don’t require prescriptions.  The kind of masks involved in

Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies

“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

We’ll get to the recent Second Circuit decision, Ignacuinos v. Boehringer Ingelheim Pharms., Inc., — F.4th —-, 2021 WL 3438355 (2d Cir. 2021), in due course, but first some background.

One of our top ten decisions in 2018 was Gustavsen v. Alcon Labs., Inc., 903 F.3d 1 (1st Cir. 2018), an important implied-preemption