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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’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug.  Wilkins v. Genzyme Corp., 2022 WL 4237528 (D. Mass. Sept. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug.  Fortunately, in Wilkins, those claims (several theories alleging essentially the same thing) did not state a claim.Continue Reading No Liability for Not Manufacturing a Product

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Two weeks ago we blogged about the Georgia Supreme Court’s not-quite embrace of the apex doctrine limiting depositions of organization big-shots.  In National Collegiate Athletic Association v. Finnerty, 2022 WL 2815848 (Indiana July 19, 2022), the Indiana Supreme Court did something similar.   The Finnerty case was brought on behalf of college athletes against the…

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Still more Zantac MDL dismissal orders.

Today’s installment grants dismissal of the plaintiffs’ medical monitoring claims, and also sheds some light on the questionable factual basis of everything being asserted in this MDL.  As we’ve pointed out in our prior posts (such as this one), plaintiffs allege that the active ingredient in this drug…

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If hard cases make bad law, big cases make really bad law. No cases are bigger than product liability multidistrict litigations. Some have populations dwarfing the towns where many of you were raised. Perhaps it is the high stakes involved, or perhaps it is the judicial obsession with settling many thousands of cases ASAP, but…

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Uncertainty plagues American litigation and accounts for the frequent analogy to a lottery. The same case tried before two different juries will produce two very different results. Within the same jurisdiction, a plaintiff might ring the bell this week, but get zeroed out the next. Factor in different jurisdictions, and the possibilities will wander all…

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If, like this blogger, you had small children in the early 2000s, subconsciously you may have read today’s title with a Scottish brogue.  That’s because it might recall a scene from Shrek where Mike Myers (Shrek) and Eddie Murphy (Donkey) are having a philosophical conversation about the many and varied attributes of ogres.  “Ogres are…

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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