Today we are talking about the decision in Govea v. Medtronic, Inc., 2025 WL 3467214 (C.D. Cal. Nov. 26, 2025). Plaintiff claimed the case was about off-label promotion. But thanks to the court taking judicial notice of PMA supplements, it’s mainly a case about on-label use and a plaintiff who waited far too long
There’s a certain romance to the idea that if one courthouse door closes, another—perhaps with better lighting and more favorable precedent—must surely be open somewhere else. But as one group of particularly determined preemption refugees recently learned, civil procedure is not a game of judicial Whac-A-Mole.
The story begins in Utah, where 50 plaintiffs brought
There is a special kind of optimism—some might call it magical thinking—that animates the modern failure-to-warn claim against prescription drug manufacturers. It goes something like this: Yes, the FDA-approved label warned about the exact risk that happened to me, but the manufacturer still failed to warn.
Which is a pretty accurate summary of plaintiff’s argument
There are two main issues that make the eyes of your dutiful Drug and Device Law bloggers well up in frustration over In re Taxotere (Docetaxel) Eye Inj. Prods. Liab. Litig., No. 3023, 2025 U.S. Dist. LEXIS 233514, 2025 WL 3442731 (E.D. La. Dec. 1, 2025).
The first is a gut-level, “this is an
It’s the most wonderful time of year, or at least Sirius channel 79 keeps telling us that. Too much food, too much drink, too much family, and not quite enough presents. Or, at least, not enough of the right presents. Or, maybe, lots of those veritable mixed bags. You know – a six pack of
Today’s guest post is from Dechert’s Chris McKeon who updates us on a rare application of the political question doctrine. As always, our guest posters deserve 100% of the praise (and any of blame) for their posts. Not that we expect the latter.
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In our earlier post, we explored whether the political question
As we’ve pointed out elsewhere, particularly in our duty to test cheat sheet, most states do not recognize any sort of separate negligence or strict liability claim for “duty to test” or “failure to test” separate and apart from the more usual sort of product liability claims involving the design and warnings of products. So defendants looking to file motions to dismiss against testing-based counts of their opponents’ complaints could do worse than to check out our cheat sheet.
Manufacturers of FDA pre-market approved medical devices, however, have a second option. They can also go after testing-based claims on preemption, because claims that manufacturers of such devices should have done more or different testing than the FDA considers necessary for approval are either “different from or in addition to” the FDA’s PMA criteria. Indeed, the seminal express preemption case, Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), recognized that express preemption under 21 U.S.C. §360k(a) extends to “tort law, applied by juries under a negligence or strict-liability standard,” such as state tort claims alleging “negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of [a PMA device],” id. at 320, although the dismissed testing claims were not separately discussed by the Supreme Court in Riegel.Continue Reading PMA Preemption of Negligent Testing Claims
We have been mulling over Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) and federal preemption.
Yes, we need a life, but let’s put that aside for the moment.
In particular, we’ve been reviewing a rash of complaints where plaintiffs contend that the FDA’s decisions about whether to grant or deny premarket approval
We’ve blogged a lot recently about preemption and the dismissal of complaints alleging that certain over the counter products, including acne medications, sunscreens, antiperspirants, expectorants, and shampoos contain benzene. Almost a year ago we blogged about the dismissal of an OTC case involving medicated shampoo that allowed plaintiff leave to amend. Today’s decision, Pineda v. Lake Consumer Products, Inc., 2025 WL 2698991 (E.D. Pa. Sept. 22, 2025), is a mixed bag that addresses plaintiff’s amended complaint. It’s about coal-tar shampoos, which are known to include benzene and are subject to an FDA monograph that recognizes the naturally occurring presence of benzene in coal tar. Yet, shockingly, plaintiff filed a class action claiming she would not have purchased the shampoos had she known they contained benzene.Continue Reading OTC Preemption Letdown in the Eastern District of Pennsylvania
It feels like 20 years ago when we were doing almost monthly fen-phen diet drug trials in the Philadelphia Court of Common Pleas. The old timey-air-conditioning units in City Hall, along with subways rumbling underfoot, occasionally drowned out the testimony of plaintiff experts taking both scientific studies and internal company documents out of context. That