STORY FROM: Drugs & Medical Devices

GGMP Claims in Medtronic Neurostimulation System Action Preempted, N.Y. Federal Judge Rules

NEW YORK — A New York federal judge has awarded Medtronic Inc. summary judgment in a case involving its neurostimulation device, ruling that the plaintiff’s state law claims based upon the manufacturer’s alleged violation of the Current Good Manufacturing Practices are preempted.

In a Jan. 6 order, Judge Sandra L. Townes of the U.S. District Court for the Eastern District of New York explained that the plaintiff alleges violation of "vague and open-ended" CGMPs which have the potential to create varying standards that would be “different from, or in addition to” those required by federal law.

Mikhail Babayev sued Medronic ...

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