Law360, New York ( October 5, 2016, 11:23 AM EDT) -- If you have any interest in the topic of preemption in premarket approved (PMA) medical devices that were used in an off-label manner, just take a look at cases involving Medtronic's Infuse. There are dozens, and almost all are complete victories for the defense. What occasionally survives are fraud or misrepresentation claims, although they have a tough time meeting the heightened pleading standard of Rule 9(b), or failure to warn claims where a court recognizes failure to submit adverse events to the Food and Drug Administration as parallel to a state law duty to warn physicians....
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