We have covered several vaccine cases over the last few months, but Berenson v. Gottlieb et al., 2026 WL 3135334 (2d Cir. Oct. 20, 2026), is of a different sort. The plaintiff is a fairly famous writer who once worked
Drug & Device Law
The definitive source for intelligent commentary on the law that matters for drug and device product liability cases
Drug & Device Law is a blog published by the Drug & Device Law Blogging Team that focuses on legal issues surrounding prescription drugs and medical devices. It covers topics such as product liability litigation, regulatory compliance, FDA approval processes, preemption doctrines, class action lawsuits, and statutes of limitations relevant to drug and device manufacturers. The blog discusses court decisions involving manufacturing defects, failure to warn claims, fraudulent joinder and misjoinder, and pricing program litigation like the 340B drug pricing program. It also addresses procedural and jurisdictional issues in multidistrict litigation and state versus federal court matters related to drug and device law.
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Yesterday’s News, Today’s “Newly Acquired Information” — The First Circuit’s CBE Time Warp
Here is a question the First Circuit has now answered the wrong way — can a scientific paper published before the FDA approved a drug nonetheless qualify as “newly acquired information” that triggers a duty to change the warnings under…
False Claims Act Survives Constitutional Challenge in Eleventh Circuit
Last year we posted about the “Frontal Assault” on the constitutionality of the False Claims Act (“FCA”), mounted in United States ex rel. Zafirov v. Florida Medical Associates, LLC, 751 F. Supp.3d 1293 (M.D. Fla. 2024). We pointed out that…
Connecticut Court Torpedoes Multi-Plaintiff Joinder
Sometimes we get a little tired of plaintiffs’ antics in bringing multi-plaintiff complaints to defeat diversity jurisdiction or tilt the scales in their favor at trial. Federal courts are generally wise to this maneuver (see our prior posts here,…
Child-Resistant Packaging Preemption
Readers of this space know we pay close attention to how courts handle preemption in product cases. This week, we stumbled across a new-to-us variation, by virtue of the federal Poison Prevention Packaging Act (“PPPA”), 15 U.S.C. § 1471, et…
No Injury Action Against Fertility Treatment Gives Birth to Dismissal
No harm, no foul. And no case. That is the lesson of Klosowski v. FPG Labs, LLC, 2025 WL 2532500 (D. Del. Sept. 3, 2025). (Yes, the case is over a year old. But this bundle of joy just popped…
Nevada Court Exorcises Three Expert Reports
Johnny Cash sang about ghost riders in the sky. In a federal courtroom in Las Vegas earlier this month, we got the litigation version: ghost writers in the sky — specifically, in three different expert reports that all somehow said…
Informed Consent? Not in Our Sandbox!
There is still a lot of 2026 left, and the Blog has already published two posts discussing (among other things) informed consent claims brought against manufacturers of prescription medical products. The first post reviewed Graw v. Eli Lilly & Co.,…
Downstream Is Too Far: N.D. Illinois Dismisses School Districts’ Opioid Claims Against Marketing Vendors
A recent order from the Northern District of Illinois shows just how far public entities will go in trying to spread blame for opioid use and abuse, and in Baltimore City Board of School Commissioners v. Publicis Health, LLC, the…
There Is No Need To Feel Bad About Dismissing A Barred Case
As if our reputation as curmudgeonly and heartless defense lawyers needed burnishing, our post today gripes about how the Fifth Circuit affirmed the dismissal of two related cases brought by a decedent’s estate. This griping arguably ignores the sage advice…