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Failure to Warn

200 published works

  1. Drug & Device Law

    California District Court Punts on Learned Intermediary Causation Post-Himes

    By Susanna Moldoveanu, Adaeze Ashiedu

    We posted earlier this year about the failure to warn causation decision from the California Supreme Court in Himes v. Somatics, 549 P.3d 916 (Cal. 2024), and the potential parade…

  2. Drug & Device Law

    Failure-to-Warn Claim Implicating Class II Medical Device that Received De Novo Classification Held Expressly Preempted on Facts Presented

    By Andrew Tauber

    [This post is from the non-Reed Smith side of the blog.] Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case…

  3. Drug & Device Law

    Has Albrecht Been Undone?

    By Eric Alexander

    We do not mean the German Renaissance painter and thinker Albrecht Dürer.  His work, while a poor cousin to that of some famous contemporaries to the south, remains as is. …

  4. Inside Class Actions

    California Supreme Court Decision Highlights Potential Class Certification Defenses for Manufacturers of Prescription Drugs & Medical Devices

    By Alyssa McGraw, Andrew Soukup

    A recent decision by the California Supreme Court underscores why courts should be hesitant to grant class certification in cases in which the learned intermediary doctrine applies.   In Himes…

  5. Drug & Device Law

    California Supreme Court Hears Argument On Learned Intermediary Doctrine

    By Steven Boranian

    We observed oral argument the other day before the California Supreme Court in Himes v. Somatics, a case that places California’s learned intermediary doctrine squarely in the spotlight.  A learned…

  6. Drug & Device Law

    . . . Try, Try Again; But Enough is Enough

    By Michelle Yeary

    Is what the court finally had to tell plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2023 U.S. Dist. LEXIS 166742 (C.D. Cal. Sep. 19, 2023) in dismissing his second amended…

  7. Manufacturing Industry Advisor

    Seventh Circuit Finds the Duty to Warn Can Extend to Packaging Manufactured by Another Company

    By Gregory N. Heinen

    Can a company be found liable for failure to warn about hazards of another company’s product used in packaging for its own product?  What about when the company wasn’t warned…

  8. Drug & Device Law

    This Failure-to-Warn Decision Isn’t Just Cosmetic

    By Andrew Tauber

    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…

  9. Drug & Device Law

    Med-Mal Plaintiff Expert Standard of Care Opinion Unnecessary Due to FDA Warnings

    By Stephen McConnell

    Law school taught us that design defect, manufacturing defect, and failure to warn are the big troika of product liability theories.  Real life practice taught us that failure to warn…

  10. Mass Tort Defense

    Federal Court Declines to Certify, Predicts Adoption of Learned Intermediary Rule

    By Sean Wajert

    Better late than never. We missed last month the decision in Costa v. Johnson & Johnson, No. CV 17-452 WES, 2023 WL 2662903, at *3 (D.R.I. Mar. 28, 2023), a…