STORY FROM: Drugs & Medical Devices

Warning Claim in Medtronic Pain Pump Case Preempted, Ala. Federal Judge Rules

BIRMINGHAM, Ala. — Failure-to-warn claims asserted against Medtronic in a pain pump action are preempted because they improperly seek to hold the manufacturer liable for failing to make disclosures to the Food and Drug Administration, an Alabama federal judge has ruled.

In a July 22 order, Judge Abdul Kallon of the U.S. District Court for the Northern District of Alabama explained that only the FDA can bring a cause of action for a manufacturer’s failure to make disclosures to the FDA as required by the Medical Device Amendments.

The judge also dismissed the plaintiff’s negligent misrepresentation claim as inadequately pled. ...

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