Happy Star Wars Day. May the Fourth be with you.

If all FDA approved medicines enjoyed the preemption protection that vaccines do, the DDL product liability litigation landscape would be leaner and less nonsensical. Flores v. Merck & Co., 2022 U.S. Dist. LEXIS 46442 (D. Nev. March 16, 2022), shows why that is so.

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

Have you ever heard of the “Presentment Clause” to the United States Constitution?  U.S. Const. Art. I §, cl. 2.  While we can’t say that we had never heard of it – we are aware of presidential vetoes, pocket vetoes, and such – we had never had occasion to consider it in the context of the legal work we do defending prescription medical product liability litigation.  That changed with In re Gardasil Products Liability Litigation, ___ F.4th ___, 2025 WL 2535105 (4th Cir. Sept. 4, 2025), which we recently discussed, here.Continue Reading Presenting the Presentment Clause

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