Baltimore, Maryland – California-based medical device manufacturer NuVasive Inc. has agreed to pay the United States $13.5 million 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 CoRoent System for surgical uses that were not approved by the U.S. Food and Drug Administration (FDA).
The settlement further resolves allegations that NuVasive caused false claims by paying kickbacks to induce physicians to use the company’s CoRoent System.
The settlement was announced by United States Attorney for the District of Maryland Rod J. Rosenstein; Principal Deputy Assistant Attorney General Benjamin C. Mizer, of the Justice Department’s Civil Division; and Special Agent in Charge Nick DiGiulio of the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG); Inspector General Jon Rymer of the U.S. Department of Defense, Office of Inspector General; and Inspector General Patrick E. McFarland of the Office of Personnel Management – Office of Inspector General.
“Health care providers need to be free to make medical decisions without improper influence by material or incentives from manufacturers,” said U.S. Attorney Rod J. Rosenstein of the District of Maryland. “A medical device manufacturer violates the law if it knowingly causes physicians to use its products for purposes that are not medically reasonable and necessary and to bill federal health insurance programs.”
The United States alleged that between 2008 and 2013, NuVasive promoted the use of the CoRoent System for surgical uses that were not approved or cleared by the FDA, including for use in treating two complex spine deformities, severe scoliosis and severe spondylolisthesis. As a result of this conduct, the United States alleged that NuVasive caused physicians and hospitals to submit false claims to federal health care programs for certain spine surgeries that were not eligible for reimbursement.
The settlement agreement also resolves allegations that NuVasive knowingly offered and paid illegal remuneration to certain physicians to induce them to use the CoRoent System in spine fusion surgeries, in violation of the federal Anti-Kickback Statute. The illegal remuneration consisted of 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). SOLAS was allegedly created, funded and operated solely by NuVasive, despite its outward appearance of independence.
The civil settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act by Kevin Ryan, a former NuVasive sales representative (United States ex rel. Kevin Ryan v. NuVasive, Inc. (D. Md.).
NuVasive Inc. will pay $13.5 million to settle False Claims Act allegations. 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 CoRoent System for surgical uses that were not approved by the U.S. Food and Drug Administration (FDA). The settlement further resolves allegations that NuVasive caused false claims by paying kickbacks to induce physicians to use the company’s CoRoent System.
Defendant: NuVasive Inc.
Criminal Charges: False Claims Act
City and State: Baltimore, Maryland
Exact Date: N/A
Sentence or Outcome: $13.5 million settlement
Dollar Amounts: $13.5 million
Related Federal Cases
Key Facts
- State: Maryland
- Category: White Collar Crime
- Source: DOJ Press Release â†â€â€
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