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Medical Device Manufacturer NuVasive Inc. to Pay $13.5 Million to settle False Claims Act Allegations

As a whistleblower law firm, we feel it’s our duty to keep you informed about the happenings in the False Claims Act world. So here’s another qui tam whistleblower case you might have missed:

In July of 2015, California-based medical device manufacturer NuVasive Inc. agreed to pay the United States a $13.5 million settlement to resolve allegations that the company caused health care providers to submit false claims to Medicare and other federal health care programs for spine surgeries by marketing the company’s CoRent System for surgical uses that were not approved by the U.S. Food and Drug Administration (FDA). The settlement also resolved allegations that NuVasive caused false claims by paying kickbacks to induce physicians to use the company’s CoRent System.

The United States alleged that between 2008 and 2013, NuVasive promoted the use of the CoRent System for surgical uses that were not approved or cleared by the FDA, including the use in treating two complex spine deformities, severe scoliosis and severe spondylolistheses. As a result of this conduct, the United States alleged that NuVasive caused the physicians and hospitals to submit false claims to federal health care programs for certain spine surgeries that were not eligible for reimbursement.

As far as Medicare fraud cases go, this is a particularly disturbing one. The laws put in place by the FDA are there to ensure that medical devices are safe and effective; if medical device manufacturers aren’t held accountable to those laws, that leaves the general public—those of us who would just believe that our doctors are using safe and approved devices—at risk. Furthermore, according to Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, “It is also 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.”

Cases such as these are often brought on thanks to whistleblower protection under the False Claims Act. In this case, former NuVasive sales representative Kevin Ryan stepped forward to file suit against his former employers on behalf of the United States. Mr. Ryan’s whistleblower reward will be approximately $2.2 million from the settlement