Product Development Protocol? Preempted.


Just a note about Malbroux v. Jancuska, 2011 U.S. Dist. Lexis 96590 (W.D. La. Aug. 29, 2011), an otherwise forgettable opinion throwing out medical device claims on the basis of preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Malbroux is forgettable: (1) because it’s a pretty much routine application of Riegel to allegations that don’t even attempt to make any sort of violation claims, and (2) because the plaintiff was pro se, so he probably didn’t know he needed to in any event.

What’s interesting to us is the nature of the device as to which preemption was found. Rather than the usual pre-market approval, the device in Malbroux (an “Inflatable Penile Prosthesis” according to the complaint), was being marketed according to a “product development protocol.” The court found no material difference between that and PMA, and dismissed on express preemption grounds...

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