To resolve allegations relating to its medical devices
The US Justice Department has reported that Spectranetics has agreed to pay $4.9m in civil damages plus a $100,000 forfeiture to resolve claims against the company. The claims arise from allegations that the company illegally imported unapproved medical devices and provided them to physicians, conducted a clinical study in a manner that failed to comply with federal regulations, and promoted certain products for procedures for which the company had not received FDA approval or clearance.
In order to resolve this matter, Spectranetics has entered into a civil settlement agreement and a non-prosecution agreement with the US. The company also entered into a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services.
According to the non-prosecution agreement, officers and employees who acted on behalf of the company engaged in multiple areas of wrongdoing. Specifically, Spectranetics illegally imported unapproved medical devices from overseas manufacturers and distributed those devices for use in human patients, and failed to meet its reporting obligations to FDA regarding a study named ‘CORAL’ (COronary graft Results after Atherectomy with Lasers).
Under the terms of the non-prosecution agreement, Spectranetics has accepted responsibility for its conduct, has instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing investigation. As a result, Spectranetics will not be criminally prosecuted for this conduct.
David Gaouette, US Attorney, said: “It is important to hold those who submit false claims to Medicare responsible for their actions. Settlements such as this help to protect the integrity of the Medicare system.”
Tony West, assistant attorney general of Civil Division at Justice Department, said: “The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers.”
Daniel Levinson, inspector general of Department of Health and Human Services, said: “Our compliance agreement with Spectranetics holds the company and its executives accountable for violations of Federal health care program and FDA requirements. Records from Spectranetics’ clinical investigations will be audited by an Independent Review Organization to ensure compliance with FDA rules – including reporting of adverse events.”