Two New PMA Preemption Cases


You all know we love preemption. So, when two favorable medical device preemption decisions are entered on the same day, well that’s a two-fer we can’t wait to blog about. In both cases, plaintiffs tried to plead and argue their way around PMA preemption – unsuccessfully. Here is the spin plaintiffs tried and why it didn’t work.

Bentzley v. Medtronic, Inc., 2011 U.S. Dist. Lexis 136570 (E.D. Pa. Nov. 28, 2011): This one involves an insulin and glucose monitoring system. The system includes a sensor/transmitter and a pump that work together to monitor the patient’s glucose levels and administer insulin automatically and continuously. Id. at *2. Plaintiff alleged that his system malfunctioned and failed to administer the correct dosage of insulin and the reason for the malfunction was that it was exposed to high-strength electromagnetic fields during his employment. Id. at *7-8. This is a known risk with this particular system and one that prompted a Class 2 Recall a year before the system was implanted in plaintiff, including the addition of warning information in the systems shipped to new customers. Id.

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