Don’t stop us if you’ve heard this before, because you have. (Here and here, for example). Wilson v. Coopersurgical, Inc., (S.D. Illinois Sept. 9, 2025), is yet another case from the Filshie Clip litigation illustrating the power of premarket approval (PMA) preemption. The defendant won dismissal on summary judgment after the case
We’ve blogged recently about good preemption decisions in the Filshie Clips litigation from the Southern District of Texas (per Bexis, “as good a PMA medical device preemption decision as a defendant has a right to expect”) and the Northern District of Georgia. Today we add another preemption win in the same litigation from the
The day before this post went live there was a retirement ceremony for Judge Jon P. McCalla, the federal district judge for whom we clerked three decades ago. After serving as an Army officer in the Vietnam War, Judge McCalla got his J.D. from Vanderbilt and clerked for Judge Bailey Brown of the Western District
If you’re a frequent visitor to the DDL blog, you’ll know all about products liability claims premised on defendants’ alleged failure to report adverse events to the FDA. You’ll also be acutely aware of what we think of such claims—they are flat-out preempted. Much to our dismay, not every court agrees with us. But recently
A federal judge in California filed an important OTC preemption decision earlier this month, and it’s important because it applied federal preemption to shut down (for now) one of the many recent benzene-related consumer class actions. The case is Daugherty v. Padagis US LLC, No. 24-cv-02066, 2025 WL 2243622 (N.D. Cal. Aug. 6, 2025)
Bexis is updating (probably for the last time) the preemption chapter of his drug and device product liability treatise, so expect blogposts like this on preemption-related topics.
Briefly, preemption in the prescription drug context is limited to implied preemption because, unlike medical devices, the FDCA lacks any preemption language applicable to those products. The
We don’t venture into politics here at the DDL Blog, but sometimes we have to call them like we see them. A divided panel of the Fourth Circuit filed an opinion last week upholding a state law that essentially prohibits the sale and use of an FDA-approved drug within that state for its FDA-approved intended
We’ve gleefully detailed the plaintiffs’ utter failure in the Zostavax MDL to establish causation. Now, the Gardasil MDL likewise seems well on the way to a place on the list (along with Bone Screw, Aredia/Zometa, Taxotere, and Zantac) of MDLs that plaintiffs’ counsel wish they’d given a miss. Maybe plaintiffs will
This is from the non-Dechert and non-RS portion of the Blog.
We used to post about defense wins in litigation over both branded and generic ranitidine fairly often. The MDL in the Southern District of Florida systematically knocked down all of plaintiffs’ theories based on the lack of legal support (e.g., preemption) and lack of
States cannot take over enforcement of federal requirements when Congress has entrusted that enforcement exclusively to the FDA. In Iowans for Alternatives to Smoking & Tobacco, Inc. v. Iowa Department of Revenue, No. 4:24-cv-00448, 2025 U.S. Dist. LEXIS 85732 (S.D. Iowa May 2, 2025), the state of Iowa enacted a law imposing penalties on