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

The SCOTUS decision in the Wyeth v. Levine case created much mischief in the field of preemption. The Court’s sloppy overstatement of the significance and availability of the Changes Being Effected (CBE) process breathed new life into prescription drug failure to warn cases that should have been safely interred at the pleadings stage. As bad

We’re old enough that we remember the pre-Daubert Bendectin litigation.  Bendectin was the only FDA-approved drug indicated for nausea and vomiting from pregnancy.  Yellow journalism (the National Enquirer) and scientific fraud (deliberately falsified scientific data) fanned a birth defect scare, which led to an avalanche of factually baseless litigation – Daubert was