Ninth Circuit Rules On False Claims Act Suit Involving Off-Label Use of Medical Devices

The United States Court of Appeals for the Ninth Circuit recently considered an Order of the Central District of California dismissing a qui tam False Claims Act suit against a medical device manufacturer based on allegations that it: (1) marketed devices used in spinal fusion surgeries for an off-label and contraindicated use; (2) fraudulently obtained FDA clearance; and (3) violated the Anti-Kickback Statute by entering into rebate agreements with hospitals and providing remuneration to physicians. The Ninth Circuit affirmed the dismissal of the FCA claims based on first and third theories of liability. It partially affirmed and partially reversed the dismissal of the claims based on the second theory. The case is Dan Abrams Co. v. Medtronic Inc.

Source:

• Arnall Golden Gregory: Ninth Circuit Rules False Claims Act Suit Involving Off-Label Use of Medical Devices