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Bexis has already plugged the Reed Smith Life Sciences CLE programs this week, so we won’t replug  — except to remind you that Rachel Weil and the drudge/author of this post will tomorrow discuss the taxonomy and tactics of warning causation.  We talk in terms of taxonomy because there are so many interesting variations of the contents of the warning, the relevant audience, doctors who read, who didn’t read, who already know, and who would like to have known, as well as the rules and burdens of proof in jurisdictions around this great, over-warned country. 

It turns out that Kentucky offers some good pro-defense law on warning causation but, then again, there is some weird, unnerving stuff courtesy of the Sixth Circuit.  Tune in tomorrow for details.  In the meantime, we (obviously) have a preference for clear rules, even though the muddy areas are (obviously) where good lawyers can make a difference and earn their money.

There’s nothing wrong with being obvious.  In today’s case, Adamson v. Lupin Pharmaceuticals, Inc., 2022 WL 3448044 (W.D. Ky. Aug. 17, 2022), we get a blissfully clear and obvious ruling from a Kentucky court, and it is in our favorite legal area, preemption, to boot.  The plaintiff in Adamson alleged that he suffered from Stevens-Johnson Syndrome (SJS) — a serious disease that causes the top layer of the skin to die and shed — as a result of taking generic amlodipine besylate.  If you are one of those folks wrestling with hypertension, you might have some familiarity with amlodipine. 

The Adamson complaint included a messy mixture of claims for failure to warn, negligence, negligent misrepresentation, defective design, and breach of warranties.  The defendant moved to dismiss the complaint on the ground that all the claims were preempted by federal law.  The court agreed with the defendant, dismissed the complaint, and did not waste any time in doing so.

Continue Reading W.D. Kentucky Dismisses Amlodipine Claims on 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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Maybe we have been doing this too long.  Or maybe, like the prequels, spinoffs, and reboots that are so prevalent among streaming entertainment options, there is just a lot of repetition.  In serial product liability cases, we hope that repetition leads to consistency of results or at least predictable rules of the game.  Consider the

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If the concept behind Multidistrict Litigations is centralized, efficient management of common issues in large numbers of lawsuits, with remand of trial-ready cases, then MDLs are less than successful on those grounds, and certainly not successful enough to justify the asymmetric discovery and bad rulings (or nonrulings) that come as part and parcel of the

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If drugs and medical devices undergo a product life cycle, so do drug and medical device litigations. We are currently laboring in the relatively early stage of a Multidistrict Litigation, where the court seems terrified of making any substantive decisions. We get no rulings. Rather, the parties are forced to listen to lectures about the

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A long time ago in a law school relatively far away, we took torts as a first year law student.  Many of the cases about which we learned (or were supposed to have learned) were from even longer ago and we had no idea how much some of those old cases would inform our practice. 

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When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker.  It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo.  It means you’re starting in the power position.  Since the Supreme Court’s decision in Riegel v. Medtronic