The 9th U.S. Circuit Court of Appeals revived a lawsuit April 2 accusing Medtronic of violating the False Claims Act by misrepresenting select spine devices to the FDA for clearance.
Four details:
1. The initial lawsuit was filed in 2015 by the Dan Abrams Company, the U.S. and several states alleging Medtronic represented certain spine devices that could only be used in the cervical spine as being applicable to the thoracolumbar spine in an FDA clearance application as a class 2 device. The devices needed FDA clearance to receive Medicare reimbursement.
2. The Central District Court of California ruled in favor of Medtronic in 2019, and the plaintiffs appealed. The circuit court reversed the district court's decision related to the spine devices that can only be used in the cervical spine.
"[The plaintiffs'] claims that Medtronic knew that cervical [vertebral body replacements] posed different questions of safety to its previously approved devices, and if Medtronic disclosed that the devices were intended for use in the cervical spine, then the FDA may have required Class III approval," states a memorandum from the circuit court. "These considerations — intended use, similarly to a predicate device, and different questions about safety — are precisely those that the FDA considers in granting Class II certification."
3. The circuit court affirmed the district court's decision to dismiss the plaintiffs' allegations against Medtronic over the off-label use of its spine devices. The federal government allows physicians to use devices off-label if it is medically necessary and reasonable, according to the memorandum.
4. The lawsuit also claimed Medtronic violated the Anti-Kickback Statute by offering rebates to hospitals for using the devices and paying costs for physicians to promote the devices. The appeals court agreed with the district court's decision that Medtronic did not violate the statute with its actions.