Ninth Circuit Weighs In On Fraud-On-The-FDA Theory, Marketing Devices For Off-Label Use, And Kickbacks

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.:

• Engaged in “fraud-on-the-FDA” when obtaining clearance for several devices used in spinal fusion surgeries;
• Engaged in unlawful marketing of the devices for off-label and contraindicated use; and
• Paid illegal kickbacks to physicians to induce physicians to order such devices in violation of the federal Anti-Kickback Statute.

The Ninth Circuit reversed the district court, in part, for the fraud-on-the-FDA allegation, and affirmed the district court’s dismissal of the unlawful marketing and kickback allegations.

Source:

• Morrison Foerster: Ninth Circuit Weighs In On Fraud-On-The-FDA Theory, Marketing Devices For Off-Label Use, And Kickbacks