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
Failure to Report
Mostly Good Preemption Decision Out of the District of Columbia
We write on a gorgeous spring day in suburban Philadelphia, with Passover imminent for us and Easter for many we love. Today’s decision contains more than enough “good” to sustain the positive vibe. Ward v. Zoll Lifevest Holdings LLC, 2021 WL 7907066 (D.D.C. Sept. 20, 2021) is a D.C. District case from last September…
Tipping the Scales on Failure to Report in Missouri
In our 50-state survey on failure to report claims, we described Missouri as an “up in the air” state, with courts on both sides of the issue failing to cite or consider prior significant precedent. Now the Eastern District of Missouri has weighed in bringing the issue a little closer to the ground.
In Schnulle…
First Circuit Asks Whether Massachusetts Recognizes a Duty to Report Adverse Events to the FDA
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…
FDA Reporting and Consumer Protection Issues Certified to Connecticut Supreme Court
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…
More MDL Madness – Defeating Preemption with Made-Up “State Law” Claims
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…
We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey (Part 3)
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…
We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey (Part 2)
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…
Gaming The System To Pursue Claims Against Generic Manufacturers
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…
We Report on FDA-Based Failure-To-Report Claims – A Fifty-State Survey
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…