Not quite three years ago, we co-authored a chapter in a Digital Health guide put out by International Comparative Legal Guides. It bore the pithy title “Predicting Risk and Examining the Intersection of Traditional Principles of Product Liability Laws with Digital Health.” We continue to tinker with the principles of product liability law
Perhaps driven by fear of retribution for saying what you really think, an indirect method of communication has gained some popularity on the social media platforms of late. It goes like this: 1) a historical fact or spin on one is presented, such as on a past military conflict or a criminal conviction; and 2)
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
Some of us are old enough to remember when the Kessler-led FDA attacked off-label use of prescription medical products by using archaic language in the agency’s “intended use” regulations (21 C.F.R. §§201.128, 801.4) to claim that a regulated entity’s mere knowledge that its products were being used off-label by physicians meant that those products were
Today’s guest post is by Howard Dorfman, a old friend of the Blog, who is now continuing to think important thoughts as an Adjunct Professor at Seton Hall Law School. This post concerns potential product liability implications of the FDA’s decision to release so-called “complete response letters (“CRLs”), apparently as a matter of future
As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects. A lot of it also is of questionable accuracy, giving “the false impression that they reflect medical or governmental advice,” using phrases such as “consumer medical alert,” “health alert,”
It is not as if the Wednesday slot is reserved for flakey stuff, but we’ll confess a weakness for cases from the Ninth Circuit, where we clerked. A lot of craziness percolates up through federal courts out there. We also have a soft spot for cases that are not exactly in the product liability heartland
When a federal agency reverses course, the Supreme Court has a test to determine whether that agency action is impermissibly “arbitrary and capricious.” FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009), set the current APA standard for review of federal agency flipflops. While no “heightened standard” exists under the APA for reversals
Skrmetti (upholding Tennessee statute forbidding gender dysphoria treatments for minors) was the SCOTUS case that got the most publicity last week, but we drug and device lawyers will always perk up most when we see the High Court issue a ruling regarding the Food and Drug Administration (FDA). That is probably one reason (though surely
Today’s opinion, In re SoClean, Inc., Mktg., Sales Pracs., & Prods. Liab. Litig., No. 22-MC-00152-JFC, 2025 WL 974258 (Sp. Mstr. W.D. Pa. Mar. 20, 2025), involves a lot of case-specific discussion with little applicability to the broader readership of the Blog. But it also contains some general observations regarding invading the province of the FDA that are “so fresh and so clean” (if this litigation name takes you back, as it does us, to circa 2000 Outkast).Continue Reading Same Rule, Different Setting: Litigants Cannot Usurp the FDA’s Authority