Extra Use Devices News Today

The Off-Label/Contraindicated-Use Theory The relator alleged “that Medtronic engaged in misbranding, mislabeling, and adulterating in violation of the Food, Drug, and Cosmetics Act (FDCA)” by marketing devices “without FDA approval or clearance for use in the cervical spine—an ‘off-label’ and indeed contraindicated use.” The Ninth Circuit rejected this theory because “the federal government does not distinguish between on-label and off-label uses in determining whether to pay fo...

The Ninth Circuit recently weighed in on the appeal of a False Claims Act lawsuit from a relator against Medtronic. In this case, the relator alleges that Medtronic, Inc.: ...