Medical device preemption should be straightforward. The statute could not be clearer. Federal regulation supplants state laws that would impose requirements that are different from or in addition to the federal requirements. But the law has evolved into a bit of a mess, with misreadings of certain approval/clearance pathways and inventions of exceptions, such as
By their very nature, prescription only medical devices—particularly those that require surgical implantation—are complex products, the design and manufacture of which are not lay person knowledge. So, if you are going to claim such a device malfunctioned, you are going to have to prove it with expert evidence. This is a well-known legal concept. Yet
The plaintiff in Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), lost the bulk of her case recently, on a motion to dismiss no less. In this case involving surgical staples, strict liability and negligence claims (which, in New York, are “functionally synonymous,” id. at *18) for design and
Bergdoll v. Coopersurgical, Inc., 2025 U.S. Dist. LEXIS 38300 (W.D. Mo. March 4, 2025), is a good Class III medical device preemption decision. The device was a Filshie clip, which is used to perform tubal ligations. The claim in Bergdoll is the typical one that the clip migrated and caused adverse symptoms. Bergdoll is
Blair v. Abbvie Inc., 2025 WL. 57198 (W.D. Pa. Jan. 9, 2025), is, from the defense perspective, a favorable opinion dismissing (some with prejudice, some with leave to amend) all counts of the plaintiff’s complaint. The opinion is a bit odd, in a semi, unintentionally-ironic sort of way, because it faults the plaintiff for
There was a time when it seemed that half our posts were mixed bags of TwIqbal — product liability claims tested against the SCOTUS decisions in Twombly and Iqbal requiring pleadings to be substantive and plausible. Then things settled down for a bit. Did plaintiffs get smarter? Did courts resume tolerance for bare bones complaints?
This is from the non-Dechert part of the Blog.
Over the years, the Blog has had many, many posts related to the issue of whether Pennsylvania recognized any form of strict liability in product liability actions against prescription medical products. In addition to the fact that several of the principal authors of the Blog have
Today we discuss an excellent express preemption decision from the District of Arizona, Skinner v. Small Bone Innovations Inc., 2024 WL 3639296 (D. Ariz. Aug. 2, 2024).
This decision involved the Scandinavian Total Ankle Replacement device (“STAR”). The STAR® Ankle is a Class III medical device subject to the Medical Device Amendments’ express preemption provision, 21 U.S.C. § 360k(a). This was Plaintiff’s second bite at the apple: The Court had already granted Defendants’ motion to dismiss but with leave to amend to attempt to state a parallel claim. See Skinner v. Small Bone Innovations Inc., No. CV-23-01051-PHX-MTL, 2023 WL 6318014, at *6 (D. Ariz. Sept. 28, 2023). After striking out in round one, Plaintiff fared no better in round two.Continue Reading Slam-Dunk Express Preemption Decision from the District of Arizona
We have often characterized judicial options as mixed bags, and a recent example of such a mixed bag can be found in Muldoon v. DePuy Orthopaedics, Inc., 2024 U.S. Dist. LEXIS 130020 (N.D. Cal. July 23, 2024). The plaintiff claimed injuries from a ceramic-on-metal hip implant. He alleged that friction and wear caused the
The plaintiff in Pachecho v. Johnson & Johnson, 2024 WL 3260883 (M.D. Ga. Jul. 1, 2024), both over-pleaded her causes of action and under-pleaded their factual support (at least as to manufacturing defect). Both errors led the court do a little pruning. And while the cases continues, we hope in its uncluttered state, the