A former Maryland sales agent for a medical device manufacturer will receive $2.2 million from the $13.5 million False Claims Act settlement recently reached between the U.S. government and the medical device manufacturer. The former sales agent had filed a federal lawsuit under the False Claims Act in the U.S. District Court for the District of Maryland in Baltimore during September 2012, after which the United States intervened as a party. The False Claims Act permits private parties to file suit on behalf of the United States for false claims and obtain a portion of the government’s recovery.
It was alleged that the medical device manufacturer’s spinal device was illegally marketed to physicians for off-label uses at various Maryland hospitals, which caused federal health care programs such as Medicare and Medicaid to wrongfully pay millions in reimbursements. It was further alleged that the medical device manufacturer paid illegal kickbacks to physicians to induce them to use its spinal device, in violation of the federal Anti-Kickback Statute. The former sales agent handled the marketing and sales of the spinal devices to Maryland hospitals between 2010 and 2012.
The FDA had approved the spinal device for treatment of minor spinal conditions involving the thoracic and lumbar spine but the medical device manufacturer allegedly marketed the spinal device for treatment of severe spinal conditions, such as severe spondylolisthesis and severe scoliosis, between 2008 and 2013, for which the spinal device had not been approved. The Maryland whistleblower brought to the attention of the U.S. Department of Justice his concern that the medical device was being marketed for inappropriate uses.
The Maryland federal whistleblower case is captioned United States ex rel. Kevin J. Ryan v. NuVasive Inc., Case No. 1:12-CV-02683-WDQ.
In announcing the settlement on July 30, 2015, the U.S. Attorney of the District of Maryland stated, “Health care providers need to be free to make medical decisions without improper influence by material or incentives from manufacturers. 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 head of the U.S. Justice Department’s Civil Division stated, “The Justice Department is committed to holding medical device manufacturers accountable, which includes requiring that they follow all laws designed to ensure that medical devices are safe and effective. 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.”
If you have information regarding false claims having been submitted to Medicare, Medicaid, other federal health care programs, or to other federal agencies/programs, and the information is not publically known and no actions have been taken by the government with regard to recovering the false claims, you should promptly seek to consult with a False Claims Act attorney (also known as qui tam attorneys) in Maryland or in your U.S. state who may investigate the basis of your False Claims Act allegations and who may assist you in bringing a qui tam lawsuit on behalf of the United States, if appropriate, for which you may be entitled to receive a portion of the recovery received by the U.S. government.
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