This week’s Department of Justice “Catch of the Week” goes to California-based medical device manufacturer NuVasive Inc. Yesterday, the company agreed to pay $13.5 million to resolve charges it improperly promoted the company’s CoRoent System for spine surgeries for uses not approved by the Food and Drug Administration. The settlement also resolves allegations NuVasive paid illegal kickbacks to induce physicians to use the company’s CoRoent System. See DOJ Press Release.
According to the government, between 2008 and 2013, NuVasive promoted the use of the CoRoent System for surgical uses not approved or cleared by the FDA, including for use in treating two complex spine deformities, severe scoliosis and severe spondylolisthesis. The government alleged this conduct violated the False Claims Act by causing physicians and hospitals to submit false claims to Medicare and other federal health care programs for certain spine surgeries that were not eligible for reimbursement.
The government further alleged NuVasive violated the federal Anti-Kickback Statute by providing illegal remuneration to physicians to induce them to use the CoRoent System in spine fusion surgeries. This included promotional speaker fees, honoraria and expenses relating to physicians’ attendance at events sponsored by a group known as the Society of Lateral Access Surgery (SOLAS), which was allegedly created, funded and operated solely by NuVasive.
In announcing the settlement, US Attorney Rod J. Rosenstein of the District of Maryland stressed that that “[h]ealth care providers need to be free to make medical decisions without improper influence by material or incentives from manufacturers.” Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, echoed this sentiment: “It is  imperative that manufacturers not improperly influence the selection of medical devices in order to ensure that these decisions are based on the needs and interests of patients, not on a physician’s own financial interests.”
The government’s allegations originated in a whistleblower lawsuit filed by former NuVasive sales representative Kevin Ryan under the qui tam provisions of the False Claims Act. He will receive a whistleblower reward of approximately $2.2 million.
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