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

When last we tuned into the In re Incretin-Based Therapies (“Incretin”) multi-district litigation, the Ninth Circuit had just undone a preemption-based dismissal – but only on procedural grounds.  As we discussed, here, the Ninth Circuit avoided the merits, but ruled that the MDL court had erred in “rel[ying] on Buckman [Co.

The drive from our home to the Delaware courthouse takes no more time than the drive to the Philly courthouse. But those two courthouses are worlds apart. The Philadelphia Court of Common Pleas is plaintiffs’ heaven. Most judges there think everything should go to a jury, and most jurors there think heaps of money should

Today’s post discusses a recent implied-preemption decision that is relevant beyond the generic-drug context in which it arose.

A bit of background first.

In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. § 337(a)—which declares that all actions to enforce the FDCA “shall be by