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
We start with some disclaimers. Not the usual disclaimers about which of the Blog authors’ respective firms deny responsibility for the post. We disclaim that we care much about the availability of cigarettes and vaping products, except insofar as litigation over them says something about litigation over medical products and the general interplay between state
Today’s case, Hartney v. Zoetis, Inc., 2025 WL 2924661 (D.N.J. Oct. 15, 2025), is about a canine medicine allegedly gone wrong. But lest you think the DDL blog has gone to the dogs, this case addresses issues such as preemption and learned intermediary that are key in cases with thumbed, supposedly sapient, biped plaintiffs.
Mind you
It’s twenty-four years post-Buckman and here we are still talking about the dismissal of cases premised on allegations that a manufacturer made misrepresentations to the FDA. Which means plaintiffs are still filing them. We thought Buckman was the legal equivalent of a big red “STOP” sign. But it seems not everyone got the message.
Today’s decision, Croci v. Zoll Medical Corp., 2025 WL 2307728 (S.D.N.Y. Aug. 11, 2025), is a straightforward, preemption-based 12(b)(6) dismissal of a complaint involving a Class III medical device. The case involves claims about a Life Vest, which is worn externally and monitors the wearer’s heart rate. The device is able to detect ventricular tachycardia and ventricular fibrillation, and it can deliver a therapeutic shock to restore the wearer’s heart rate to a normal rhythm. The complaint alleged that the decedent experienced problems with the Life Vest, and that a representative of the Life Vest’s manufacturer visited the decedent’s home to “desensitize the device.” Id. at *1. Shortly after the alleged visit from the representative, the decedent experienced a cardiac arrest and died.
Continue Reading PMA Preemption in the Southern District of New York