STORY FROM: Drugs & Medical Devices

Claims Based on Failure to Submit Adverse Event Reports Preempted, Ariz. High Court Rules

PHOENIX — State law failure-to-warn claims based upon a medical device manufacturer’s failure to submit adverse event reports to the FDA are preempted because they seek to enforce the FDCA, which only the federal government may do, the Arizona Supreme Court has ruled.

In a Dec. 18 opinion, the Arizona Supreme Court overturned an appellate court’s reinstatement of a failure-to-warn claim in a Medtronic pain pump action, ruling that the claim is impliedly preempted pursuant to Buckman Co. v. Plaintiffs’ Legal Committee.

After injuring his hip years ago, Raymond Conklin experienced chronic pain. In 2008, a physician surgically implanted him ...

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