A settlement has been reached against medical device manufacturer NuVasive, Inc., in a false claims case that was filed by a whistleblower in the U.S. District Court for the District of Maryland in Baltimore under the False Claims Act. Learn more about the settlement, the manufacturer, and the False Claims Act, below.
False Claims Settlement Against Medical Device Manufacture NuVasive
NuVasive, Inc.
Medical device manufacturer NuVasive, Inc. manufactured the CoRoent System, which had been approved by the FDA for "treatment of minor spinal conditions involving the thoracic and lumbar spine," according to medicalmalpracticelawyers.com.
Allegations Against
The false claims lawsuit alleged:
- That between 2008-2013, Nuvasive had marketed the CoRoent System for uses that had not been approved by the FDA, "including for use in treating two complex spine deformities, severe scoliosis and severe spondylolisthesis," according to Justice.gov.
- "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."
- "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 bya 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."
False Claims Act
The lawsuit against NuVasive was filed under the False Claims Act, which "permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the government’s recovery." The suit was filed by a former NuVasive sales representative who blew the whistle on the medical device manufacturer. He will receive $2.2 million from the $13.5 million total of the settlement.