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Another Slam Dunk Infuse Win — Preemption and More
Law360
October 5, 2016

If you have any interest in the topic of preemption in Pre-Market 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.

The most recent Infuse victory strikes a blow at each and every attempt by plaintiffs to circumvent, dodge, sidestep and elude preemption and pleadings standards. And with each bypass blocked, the plaintiffs’ claims had nowhere to go.

Read "Another Slam Dunk Infuse Win — Preemption and More."