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Recently, within the course of a couple of weeks, two different courts reached the same conclusion – that a plaintiff’s negligence per se claims, largely based on purported violations of the Food, Drug & Cosmetic Act (“FDCA”), failed to state a claim.  See Disarro v. Ezricare, LLC, 2023 WL 6619445 (M.D. Fla. Oct. 11, 2023), and Alcozar v. Orthopedic & Sports Medical Center, ___ N.E.3d ___, 2023 WL 6302337 (Ind. App. Sept. 28, 2023).  Another thing that these two opinions share is that neither of them relied on federal preemption in disposing of the FDCA-related negligence per se claims.Continue Reading Beating FDCA-Based Negligence Per Se Claims on Non-Preemption Grounds

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We defend drug and device manufacturers. Our cases involve drugs and devices. Not surprisingly, we tend to cite drug and device decisions. But there is no reason to ignore helpful decisions arising in other contexts. The case we report on today—Jimenez v. Holiday CVS, LLC, 2023 WL 4251176 (S.D. Fla. 2023)—is such a

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The case we discuss today, Doe v. Ladapo, 2023 WL 3833848 (N.D. Fla. 2023), appeared in our daily search results because it briefly addresses off-label use of prescription drugs. Invalidating a state statute that would have prohibited a particular off-label use, the court explained that “[o]ff-label use of drugs is commonplace” and the fact

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The defendants in Mixson v. C.R. Bard, Inc., ___ F. Supp.3d ___, (N.D. Fla. Sept. 16, 2022) (“Mixson I”), and Mixson v. C.R. Bard, Inc., 2022 WL 7581737 (N.D. Fla. Sept. 23, 2022) (“Mixson II”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results.Continue Reading Mixson Somewhat Mixed, But We’ll Take It

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A federal court applying Florida law has refused to dismiss fraud and misrepresentation claims brought by a patient against a medical-device manufacturer, rejecting the manufacturer’s contention that such claims are categorically barred by the learned-intermediary doctrine.

It is perhaps telling that the decision, Pirlein v. Ethicon, Inc., Med. Devices Rep. ¶ 24,799 (S.D. Fla.