In a significant, albeit unpublished, decision, an intermediate appellate court in Pennsylvania has ruled that there is no recognized Pennsylvania common-law “duty” for prescription medical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
Consider this an addendum to the “Adequate Warnings Should be Enough” post that Bexis wrote back in February. What makes a warning “adequate”? Insistence on truth and completeness is of little help. One does not have to be one of history’s all-time villains to ask what is truth, and it is just as legitimate to
This year has seen a lot – and most of it would not fall into the positive category. The pandemic; severe wildfires in the U.S. and Australia; record setting tropical storms in the Atlantic; social unrest over police brutality; explosion in Beirut. Unfortunately, we could go on. Even more unfortunate is the fact that all
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
The issue of product recalls rears its head a lot in our medical device practice. Or non-recalls, to be more precise. In the unsavory world of plaintiff solicitation, we have seen, over and over again, that plaintiff firms and their “phone banks” recruit potential plaintiffs by telling them that devices that remain in their bodies
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
Kelly v. Ethicon, Inc., 2020 U.S. Dist. LEXIS 191665 (N.D. Iowa Oct. 16, 2020), is a remanded pelvic mesh case. The complaint included the usual panoply of causes of action for negligence, strict liability, fraud, and breach of warranty. Failure to warn, as usual, was central to the plaintiff’s case.
During the years while
It’s a unique relationship based largely on knowledge and trust. Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient. Knowledge that often develops overtime through trust. Patients want and need to be able to trust their doctors. Sometimes patients share information with
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