STORY FROM: Drugs & Medical Devices

Ariz. Appeals Court Reinstates Failure-to-Warn Claims in Medtronic Pain Pump Action

PHOENIX — Failure-to-warn claims in a Medtronic SynchroMed II pain pump action are not preempted because the state law requirements on which they are based parallel federal requirements that require a manufacturer to notify the FDA of adverse events, an Arizona appeals court has ruled.

Hoever, in an Oct. 19 opinion, the Arizona Court of Appeals, Division 1, affirmed that the plaintiffs’ claims of design defect, manufacturing defect, and breach of express warranty are preempted because they challenge the FDA’s approval of the SynchroMed II’s design and manufacturing specifications.

Raymond Conklin was surgically implanted with a Medtronic SychroMed II infusion ...

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