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Sometimes there are decisions that we begin to read with an expectation—perhaps based on a thumbnail from Bexis—that we will have a strong impression.  Not surprisingly, the expected impression is usually negative.  This was the case with Apter v. HHS, No. 22-40802, 2023 U.S. App. LEXIS 23401 (5th Cir. Sept. 1, 2023), which concerned

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We’ve finished reading through the New Jersey Supreme Court’s unanimous decision in Hrymoc v. Ethicon, Inc., ___ A.3d ___, 2023 WL 4714042 (N.J. July 25, 2023) (which should really be captioned “McGinnis” because plaintiff Hrymoc settled, see n.1).  The good – really good – news is that an abusively obtained nuclear ($68 million+) verdict goes bye-bye.  That alone is grounds for celebration.Continue Reading Perfect Defense §510(k) Compliance Win in New Jersey May Be Pyrrhic

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A plaintiff lawyer recently filed a case against our client in North Carolina.  He has made a settlement demand that any rational observer would regard as ambitious to the point of outrageous.  Despite that crazy number, we are on fairly friendly terms with the plaintiff lawyer. We jawbone at each other in a generally good

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Last November, we offered well-deserved criticisms of a really bad MDL-wide preemption decision in In re Acetaminophen − ASD-ADHD Products Liability Litigation, MDL No. 3043, 2022 WL 17348351 (S.D.N.Y. Nov. 14, 2022) (“ASD-ADHD I”).  One of its huge gaffes was not citing the Supreme Court’s decision in Merck Sharp & Dohme Corp.

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Lawyers really like to be right.  This dive into the latest on reproductive rights in the context of challenges to FDA’s regulation of a prescription medication is an instance where we wish we had not been right with some of our predictions.  Back when the Dobbs decision had been leaked but not yet issued, we

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A federal judge in DC has reminded us that the government does not operate in secret, at least not always and usually not completely in connection with prescription drug approval.  The case is Vanda Pharmaceuticals, Inc. v. FDA, No. 22-cv-938, 2023 U.S. Dist. LEXIS 51853 (D.D.C. Mar. 27, 2023), and the plaintiff was a