April 2016

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The revolution in personal jurisdiction touched off by Daimler AG v. Bauman, 134 S. Ct. 746 (2014) (“Bauman”), is in full swing. The favorable results obtained by numerous corporate defendants that have managed to “get out of Dodge” because they are not “at home” in Dodge are compiled in our Bauman cheat sheet (160 different cases, to date). The most important ones in the prescription medical product area are detailed in the posts under our personal jurisdiction topic heading. Bauman has become the most important tool we have to fight forum shopping by litigation tourist plaintiffs, since litigation tourists, as non-residents, cannot assert specific personal jurisdiction either.

Personal jurisdiction defenses, however, are waivable. They have to be pleaded and asserted at the outset of the litigation, or else the other side will argue – more persuasively, the more time that has passed – that a defendant has slept on its rights while other parties and the judicial system itself have expended valuable time and effort litigating in the plaintiffs’ forum of choice. Thus, corporate defendants have to act quickly to evaluate and raise Bauman-based jurisdictional defenses at the outset of the case. That can be difficult because, like everything in the law, lawyers have made things complicated.Continue Reading Bauman Personal Jurisdiction In-House Counsel Checklist

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When we examined Restatement (Second) of Torts §402A, comment k (1965), in our 2011 research post “Comment K, Some of the Way,” we remarked about how it said “a lot of things,” including: (1) that one can’t design away unavoidable risks, (2) that unavoidably unsafe products aren’t considered “unreasonably dangerous” for purposes of strict liability, and (3) that such products are “especially common” in the prescription medical product area. The first proposition suggests that design defect liability is incompatible with unavoidably unsafe product characteristics. The second indicates that unavoidably unsafe products shouldn’t be subject to strict liability. The third raises the issue of whether all prescription medical products should be considered unavoidably unsafe products – since their inherent risks are why they require a prescription in the first place.

We pointed out that some states, like California and Utah, prohibit design defect liability altogether, following that aspect of comment k. Others, like Pennsylvania, reject strict liability in the context of prescription medical products. Often, as is the case in Massachusetts, the status of negligent design liability is uncertain.

However, the most striking divide has always been between those states following a case-by case approach to determining whether a given product was “unreasonably dangerous” and those states that followed an “across-the-board” approach to comment k in the prescription medical product area. After adding everything up, we had to conclude in our blogpost that, despite its inherent inefficiency and tendency to second-guess the FDA, the case-by-case approach to comment k remained the majority rule.Continue Reading Comment K Case by Case – Falling Out of Favor?

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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