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)
Misbranding
Ninth Circuit Holds No Scienter Required for Misbranding of Drugs
We don’t write a lot on criminal cases, but published opinions in the Ninth Circuit involving the Food Drug and Cosmetic Act always catch our eye. In United States v. Marschall, No. 22-30048, 2023 WL 6135771 (9th Cir. Sept. 20, 2023) (to be published in F.4th), the Ninth Circuit held last week that some…
Federal Law Expressly Preempts State-Law Misbranding Claims Predicated on Labeling Statements Approved By A Federal Agency
Today we report on Thornton v. Tyson Foods, Inc., — F.4th —-, 2022 WL 727628 (10th Cir. 2022)—a favorable express-preemption decision under the Federal Meat Inspection Act (FMIA), 21 U.S.C. §§ 601–695, that is directly applicable to medical-device cases. Although decided under a different statute, Thornton makes clear that the FDCA bars state-law claims…
Decision Dismissing Claims Against Generic Drug Manufacturer On Implied-Preemption Grounds Also Helpful In Other Contexts
Today’s post discusses a recent implied-preemption decision that is relevant beyond the generic-drug context in which it arose.
A bit of background first.
In Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. § 337(a)—which declares that all actions to enforce the FDCA “shall be by…
Zantac Chronicles II – The Prevalence of Preemption
Another of the recent significant decisions from the In re Zantac MDL, No. 2924, addressed preemption – mostly but not entirely involving defendants who manufactured generic versions of the drug. In re Zantac (Ranitidine) Products Liability Litigation, ___ F. Supp.3d ___, 2020 WL 7864213 (S.D. Fla. Dec. 31, 2020). For those who have not…