STORY FROM: Drugs & Medical Devices

Pa. Federal Judge Dismisses Medtronic Brain Stimulator Action as Preempted

PHILADELPHIA — Strict liability and negligence claims in a lawsuit targeting Medtronic’s deep brain stimulator devices are expressly preempted because they seek to impose state law claims that are “different from, or in addition to” federal regulations, a Pennsylvania federal judge has ruled.

In a Dec. 16 order, Judge Gerald McHugh of the U.S. District Court for the Eastern District of Pennsylvania explained that because the Class III devices at issue underwent the Food and Drug Administration’s rigorous Premarket Approval process, claims challenging the devices’ design and warnings are preempted.

Edward Walls was implanted with two Activa deep brain stimulators ...

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