As we discussed in our recent 50-state survey on failure-to-report claims, plaintiff-side allegations seeking to predicate “warning” liability on a defendant’s allegedly failing to comply with FDCA adverse event reporting claims are “relatively new.”  That’s because, like so many other novel claims we’ve seen lately, it’s a transparent dodge to avoid preemption.  We said

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

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

This time out of Massachusetts.  And in an opinion authored by a female judge.  This isn’t something we would normally take the time to point out, but as we embark on the 39th Women’s History Month, the combination of Massachusetts and a female judge stood out to us.  After all, Massachusetts was home to

Another of the recent significant decisions from the In re Zantac MDL, No. 2924, addressed preemption – mostly but not entirely involving defendants who manufactured generic versions of the drug.  In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864213 (S.D. Fla. Dec. 31, 2020).  For those who have not