Fraud, Failure to Notify of Adverse Event Claims Not Preempted, Calif. Federal Judge Rules

SAN JOSE, Calif. — Fraud claims and a portion of failure-to-warn claims brought against Medtronic Inc. in connection with its Infuse bone grafting device are not expressly preempted because they seek to impose requirements that are parallel to those imposed under federal law, a California federal judge has ruled.

In a May 13 order, Judge Lucy Koh of the U.S. District Court for the Northern District of California further held that the claims are not expressly preempted because they exist independently of the Food, Drug and Cosmetic Act. However, the failure-to-warn claims based on overpromotion and deceptive off-label promotion are …