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.
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