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
Lanham Act
Collateral Litigation As A Deterrent Of Bogus Research?

From its start, the Blog has railed against certain expansions of traditional product liability that could have negative impacts on scientific progress and the availability of good medical products. Innovator liability, first described in Conte back in 2008, is a good example of a bad idea. Its offspring, the so-called duty to innovate…
D.Mass. Dumps Lanham Act claim because Statements about Drug Shortage are not Related to Qualities of the Product
First Circuit Revival of Action Against Compounder

In our first appellate oral argument we found ourselves in front of a very hot Ninth Circuit panel (that means lots of questions). We danced our hardest to affirm the district court’s denial of a criminal defendant’s motion to suppress. The problem was that the lower court had wandered onto shaky ground. We knew it.
The Intersection Between the Lanham Act and the FDCA

FDA’s exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation. 21 U.S.C. §337(a). That is the foundation on which prescription drug and device preemption is built. However, preemption is about the interplay between federal and state law requirements and where the latter must…
Thorny Questions Raised by Lanham Act Claim Better Left to FDA

It’s a Sunday night after an incredibly jam-packed weekend of activities. The family, mother, father and two teens, decide to end the weekend with a movie. A nice wind down before another hectic week begins. A few minutes in, the father remarks: don’t I know that actress from something else? To which mother offers –…
Court Dismisses Lanham Act Claims Brought By Device Manufacturer Against Competitor

A Vaudeville act is supposed to leave the audience wanting more. Not so a judicial decision. But that is what we have today: a decision whose result—the dismissal of Lanham Act claims brought by a device manufacturer against a competitor—is underexplained.
The plaintiff in Impact Applications, Inc., v. Concussion Management, LLC, 2021 WL 978823…