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This post sort of got away from us.  We started with the proposition that our prescription medical product clients frequently move to dismiss cases, and thus seek to get courts to take judicial notice of FDA-related documents in product liability litigation involving their products.  Judicial notice in cases involving FDA regulated products can be of great assistance on pleadings-based motions (Rule 12(b)(6) and judgment on the pleadings) because judicial notice is an exception to the usual limitation of such motions to what plaintiffs plead – or, equally importantly, fail to plead – in their complaints.  Not only do judicially noticeable documents fill in facts that plaintiffs deliberately omit, but they can also defeat contrary factual allegations that the documents establish are untrue.  This is an important exception to the Rule 12 mantra that challenged allegations are to be taken as true.  Instead, allegations in a complaint are not credited where contradicted by judicially noticeable documents.  E.g., Fuqua v. Santa Fe County Sheriff’s Office, ___ F.4th ___, 2025 WL 3072794, at *4 (10th Cir. Nov. 4, 2025); Jeffery v. City of New York, 113 F.4th 176, 179 (2d Cir. 2024); Clark v. Stone, 998 F.3d 287, 298 (6th Cir. 2021); Massey v. Ojaniit, 759 F.3d 343, 353 (4th Cir. 2014); Kaempe v. Myers, 367 F.3d 958, 963 (D.C. Cir. 2004); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001).  So judicial notice can overcome contrary pleadings.Continue Reading Getting Noticed – Receiving FDA-Related Judicial Notice

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You know it’s going to be an interesting ride when the appellate brief reads like a conspiracy theory starter pack. Which is how we read the issues raised on appeal in Thelen v. Somatics, LLC, — F4th –, 2025 WL 2749888 (11th Cir. Sep. 29, 2025):  erroneous entry of summary judgment on design…

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This is from the non-Dechert and non-RS side of the Blog.

We recently attended a successful Ph.D. thesis defense on the seemingly narrow issue of trap states in quantum dots.  This was held in a dark wood-paneled room in a large science building on the campus of a research institution generally known by a short…

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We could care less about almost everything in Driver v. Naranjo, 2024 WL 2869367 (S.D. Cal. June 6, 2024), which dismissed an overly litigious pro se prisoner’s product liability and other claims involving his purportedly forced use of a prescription drug.

But Driver’s first footnote raises an interesting question of judicial notice – whether notice can extend to the “characteristics” of prescription medical products. Driver held that “[t]he Court may take judicial notice of medical facts regarding prescription drugs, their active ingredients and effects.”  2024 WL 2869367, at *1 n.1.  The opinion cited two cases for that proposition, United States v. Howard, 381 F.3d 873, 880 & n.7 (9th Cir. 2004) (taking judicial notice of certain effects of a drug listed in the product warnings reprinted in the Physician’s Desk Reference (“PDR”)); and Lolli v. County of Orange, 351 F.3d 410, 419 (9th Cir. 2003) (“Well-known medical facts are the types of matters of which judicial notice may be taken.”) (citation omitted).Continue Reading Are Prescription Medical Product Characteristics Subject to Judicial Notice?

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As we discussed at length in this post, since the 1940s, the Pennsylvania Supreme Court and other courts applying Pennsylvania law have refused to subject prescription medical products to strict liability.  That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their…

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We’ve finished reading through the New Jersey Supreme Court’s unanimous decision in Hrymoc v. Ethicon, Inc., ___ A.3d ___, 2023 WL 4714042 (N.J. July 25, 2023) (which should really be captioned “McGinnis” because plaintiff Hrymoc settled, see n.1).  The good – really good – news is that an abusively obtained nuclear ($68 million+) verdict goes bye-bye.  That alone is grounds for celebration.Continue Reading Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
Learn more about this book