Reporting Claims Reinstated in Infuse Suit; Off-Label Promotion Claim Not Preempted

A man allegedly harmed by off-label use of Medtronic Inc.'s Infuse bone growth product may pursue claims under California law based on the company’s alleged failure to report adverse events to the Food and Drug Administration, a California appeals court held Jan. 27 (Coleman v. Medtronic, Inc., Cal. Ct. App., B243609).

These claims weren’t preempted because they were based on California law duties that paralleled Medtronic’s federal obligations. The claims were adequately pleaded, the California Court of Appeal, Second Appellate District, also said, reversing a trial court decision and reinstating plaintiff John Coleman’s claims.

The court upheld ...