STORY FROM: Drugs & Medical Devices

St. Jude Spinal Stimulator Case Survives Preemption Defense in Del. Federal Court

WILMINGTON, Del. — A Delaware federal judge has allowed the plaintiffs in a St. Jude spinal stimulator case to amend their failure-to-warn claim, ruling it is not preempted to the extent it alleges failure to notify the Food and Drug Administration of adverse events.

In a Feb. 1 order, Judge Mark Kearney of the U.S. District Court for the District of Delaware also allowed the negligent manufacturing claim to proceed, ruling that the plaintiffs have adequately alleged that St. Jude manufactured and/or sold a device that was adulterated or otherwise nonconforming with the FDA’s good manufacturing practices (GMP).

Kathleen Freed ...

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Reed Smith
Tybout Redfearn & Pell

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