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

We offer a different take on preemption today.  We have discussed on any number of occasions how the FDA’s regulation of drug warnings preempts (or should preempt) state-law tort claims purporting to impose different or additional warnings.  But what if the alleged state-law duty is based on a public referendum or statute?  Does that make

There are some basic rules for medical product liability litigation, at least as we—and the vast majority of courts—see it.  One is that the manufacturer of the medical product that the plaintiff used and allegedly injured her is typically the right defendant.  Part of what a potential plaintiff is supposed to do during the statute