Medtronic wins another PMA-preemption-based dismissal. The cite: Walker v. Medtronic, Inc., C.A. No.
An alleged deviation from manufacturing performance specifications for a device that has received premarket approval is not the same thing as noncompliance with the FDA or its regulations. To hold otherwise would make a manufacturer an insurer of its product. Indeed, premarket approval does not guarantee that a device is completely safe.
One other thing – The plaintiff also tried to wave around some FDA warning letters, but the court readily saw through that, as the letters had nothing to do with pump at issue in the case. Slip op. at 3-4 n.1. We see that a lot on motions to dismiss, but this case was decided on summary judgment. That plaintiffs, even after discovery, made the same lousy arguments based on irrelevant warning letters says to us that allowing discovery on that issue serves no purpose. The warning letters are all on the FDA’s website and their applicability to a plaintiff’s specific device is a yes/no question. If the plaintiffs are just going to make the same arguments, with or without discovery, let’s call it “judicial notice” and get it over with on a motion to dismiss.