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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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The case we discuss today, Vaughan v. Biomat USA, Inc., 2022 WL 4329094 (N.D. Ill. 2022), is neither a medical-device nor a pharmaceutical case. Nor is it a product-liability case. It is, however, a preemption case that implicates two issues relevant to our world.

The plaintiffs sold blood plasma to the defendants. When they

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We are not the only ones who have pointed out that every new contraceptive for the last fifty years or so has been the subject of litigation and that it is not hard to see how the burden associated with such litigation, even if the manufacturer does well, discourages the development of new options.  This

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It has been just about two years since the Central District of California dismissed the claims in Nexus Pharmaceuticals, Inc. v. Central Admixture Pharmacy Services, Inc. as impermissible attempts to privately enforce the FDCA and therefore impliedly preempted.  We blogged about that decision back then.  At that time, we noted that while the case arose

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Nerds such as your friendly neighborhood DDL bloggers read legal decisions with excitement. We hardly seem alone in that regard, at least lately. Over the past several weeks, SCOTUS issued a series of major opinions on wedge issues, engendering widespread feelings of triumph or despair or exultation or fury. The “least dangerous branch” looks plenty

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Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.  Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon.  Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility.  Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  It wasn’t.  Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.”  Id. at *2.  Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 

Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix