STORY FROM: Drugs & Medical Devices

Failure-To-Warn Claim Involving St. Jude Riata Leads Survive Preemption Analysis in Pa.

PHILADELPHIA — A claim accusing St. Jude Medical Inc. of failing to report adverse events involving its Riata defibrillation leads to the Food and Drug Administration are not expressly preempted because they seek to impose state law regulations that parallel federal law, a Pennsylvania federal judge has ruled.

In a July 12 order, Judge Michael M. Baylson of the U.S. District Court for the Eastern District of Pennsylvania further held that the negligent failure-to-warn claim is not impliedly preempted because it is “a traditional state failure-to-warn theory based on alleged non-compliance with federal regulations” and does not exist solely by ...

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