Under Fed. R. Evid. 9(b), “[i]n alleging fraud or mistake, a party must state with particularity the circumstances constituting fraud or mistake.”  In our sphere, federal courts are quite variable in how they apply this standard when deciding 12(b)(6) motions.  In particular, MDLs seem to have an unfortunate habit of allowing general allegations to support

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

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