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
We’re not surprised by the preemption ruling in In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, 2021 U.S. Dist. Lexis 100041 (D. Md. May 17, 2021), but that doesn’t makes us any less appalled.
First, here’s what happened.
This latest Birmingham Hip ruling was in preparation for
Now that all three parts of our 50-state survey examining the state of state law concerning allegations that a defendant can state a common-law cause of action where the allegedly liability creating conduct is failure to make a statutorily mandated report to a governmental agency has been published, we have consolidated all fifty states under
Now that all three parts of our 50-state survey examining the state of state law concerning allegations that a defendant can state a common-law cause of action where the allegedly liability creating conduct is failure to make a statutorily mandated report to a governmental agency has been published, we have consolidated all fifty states under
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
Not too long ago we discussed the decision in In re Allergan Biocell Textured Breast Implant Products Liability Litigation, 537 F. Supp.3d 679 (D.N.J. 2021) (“TBI”). TBI addressed quite a few topics, one of which was the first nationwide (or close to it) analysis of whether a given jurisdiction permitted, under state
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