In a significant, albeit unpublished, decision, an intermediate appellate court in Pennsylvania has ruled that there is no recognized Pennsylvania common-law “duty” for prescription medical product manufacturers to send Dear Healthcare Provider (“DHCP”, a/k/a “Dear Doctor”) letters about label changes. Zitney v. Wyeth LLC, 2020 WL 6129173 (Pa. Super. Oct. 19, 2020).
Zitney arose
We don’t like class action tolling. We don’t think that plaintiffs should be rewarded for filing a meritless class action (or any other meritless act) with a potentially broad and lengthy exemption from the relevant statute of limitations. We particularly don’t like cross-jurisdictional class action tolling, which makes a state’s enforcement of its own statute
We have a long, 50-state survey post entitled “Don’t Forget About A Prescribing Physician’s Failure To Read Warnings,” about a subject as to which we feel strongly enough that we keep it updated on an ongoing basis. Its proposition is simple, and powerful: Under the learned intermediary rule, it is impossible to prove
For the better part of a decade, Bexis has participated in the Food & Drug Law Institute’s (“FDLI”) annual Top Food and Drug Cases project. For 2019, he wrote about (surprise!) Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019). These haven’t been discussed previously on the Blog because, due
The Pelvic Mesh MDLs are now all but over, with all but a few stragglers either settled or remanded. But the specious logic used in that litigation to overturn decades of precedent that had recognized compliance with FDA regulatory actions as relevant and admissible evidence, is still afoot to haunt medical device manufacturers. As we’ve
Today we have another guest post from friend-of-the-Blog, Dick Dean at Tucker Ellis. He’s familiar with the ongoing Pradaxa litigation and is pleased with the preemption pummeling Pradaxa plaintiffs have been receiving. Here’s his post about yet another favorable decision from the state-court Pradaxa proceedings in Connecticut. With decisions like this, who needs snap
When we last examined the FDA’s sporadic effort to update the archaic “intended use” regulations (primarily 21 C.F.R. §§201.128 (drugs), 801.4 (devices)), the 2017 bait-and-switch amendment to these regulations had been put on ice. That has led to the bizarre Westlaw “currentness” notice for these regulations:
<Text of section effective upon the effective date of
Like we did with Justices Gorsuch and Kavanaugh, when they were first nominated, we took a look at Judge Amy Coney Barrett’s record on preemption. There wasn’t much. She’s authored exactly one opinion that discussed preemption, and that involved “complete” preemption under the Labor Management Relations Act. Her opinion in Boogaard v. National Hockey
Anyone remember Monty Python’s first movie, before anyone had ever heard of them? Along with the dead parrot and the Lumberjack Song, “And Now For Something Completely Different” featured a formally dressed man, sitting at an unexceptional desk, both of the sort you might find in a British law firm of the era (early
Most of the controversy in the recent decision, Hill v. Bayer Corp., 2020 WL 5367334 (E.D. Mich. Sept. 8, 2020), revolved around whether the plaintiff could assert a cause of action for failure to report adverse product events to the FDA. Like the great majority of decisions (particularly since Conklin v. Medtronic, Inc.,