Photo of Susanna Moldoveanu

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

Photo of Eric Alexander

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

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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

Photo of Michelle Yeary

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 –