Medical device maker NuVasive Inc. will pay $13.5 million to settle a lawsuit alleging violations of the False Claims Act (FCA). The company was accused of promoting off-label uses of spinal fusion products for Medicare patients and dispensing kickbacks through a supposedly independent medical society. The settlement between the U.S. Department of Justice and California-based NuVasive, which also was accused of defrauding Medicaid and Tricare, includes a $2.2 million award to a whistleblower. A onetime sales representative Kevin J. Ryan filed the FCA suit in 2012 in Maryland federal court. The whistleblower will receive another $230,000 for attorneys’ fees, expenses and costs.
NuVasive marketed from 2008 through 2013 its CoRoent devices for uses not approved by the U.S. Food and Drug Administration (FDA). Those uses included spinal fusion surgeries involving more than two contiguous levels of the spine, procedures targeting the thoracic region of the spine and treatments for severe scoliosis and spondylolisthesis. During the same time period, NuVasive allegedly disguised kickbacks to doctors as speaker fees and expenses related to events sponsored by the Society for Lateral Access Surgery (SOLAS). The group was misleadingly portrayed as independent. “Despite its outward appearance of independence, SOLAS was created, operated and funded solely by NuVasive,” the settlement agreement said. Nick DiGiulio of the Office of Inspector General at the U.S. Department of Health and Human Services, stated:
Settlements such as the one entered into today by NuVasive send a message to the medical device industry that such practices will be closely monitored.
I am convinced that if the drug manufacturers had to fear strong regulation by the government, there would be very few FCA lawsuits. However, the drug industry knows that the FDA is underfunded and understaffed and as a result incapable of doing its regulatory function adequately. Therefore, the FCA will continue to be in full use and that’s a good thing. Hopefully, Congress will eventually realize that it makes “good sense” to give the FDA the help it so badly needs.