Off-Label Promotion Claims to Proceed Against Medtronic in Calif. Infuse Bone Graft Case

SACRAMENTO, Calif. — Claims asserted in a lawsuit concerning Infuse Bone Graft device may proceed against Medtronic to the extent that they allege fraudulent and negligent promotion for off-label uses, because they seek to impose state-law requirements that are parallel to those imposed by federal law, a California federal judge has ruled.

However, in the Nov 20 order, Senior Judge Anthony W. Ishii of the U.S. District Court for the Eastern District of California dismissed the failure-to-warn claim to the extent it alleges overpromotion of the Infuse device and misrepresentation during off-label promotion, ruling that these theories challenge the device’s …