Firm Settles With DOJ Over Unapproved Medical DeviceDec 31, 2009 | Parker Waichman LLP
Spectranetics Corporation, a medical device manufacturer, located in Colorado Springs, Colorado, has agreed to pay the United States $4.9 million in civil damages and a $100,000 forfeiture to resolve claims against the company, the Justice Department just announced, said the United States Attorney’s Office District of Colorado.
The claims arise from allegations that Spectranetics illegally imported unapproved medical devices and provided them to physicians for use in patients, 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 Food and Drug Administration (FDA) approval or clearance.
Spectranetics manufactures, distributes, and sells certain medical lasers and related peripheral devices, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside veins. These include, specifically, said the Colorado US Attorney’s Office: The CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter.
Spectranetics entered into a civil settlement agreement and a non-prosecution agreement with the U.S. and 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, illegally importing unapproved medical devices from overseas manufacturers, distributing those devices for use in human patients, and failing to meet its reporting obligations to the U.S. Food and Drug Administration (FDA) regarding a study named “CORAL” (COronary graft Results after Atherectomy with Lasers) and another study in connection with these devices.
Under the terms of the non-prosecution agreement, Spectranetics accepted responsibility for its conduct, instituted remedial measures to prevent this conduct in the future, and will continue to cooperate in the ongoing criminal investigation. Because of this, Spectranetics will not be criminally prosecuted. Under the civil settlement agreement, the U.S. alleged that, as a result of its conduct, Spectranetics caused false Medicare claims to be submitted during times from 2003 to 2008. “It is important to hold those who submit false claims to Medicare responsible for their actions,” said U.S. Attorney David Gaouette. “Settlements such as this help to protect the integrity of the Medicare system.”
“The Department of Justice will be vigilant in pursuing cases against medical device companies that break the law and defraud taxpayers,” said Tony West, Assistant Attorney General for the Justice Department’s Civil Division.
“Our compliance agreement with Spectranetics holds the company and its executives accountable for violations of Federal health care program and FDA requirements,” said Daniel R. Levinson, Inspector General of the Department of Health and Human Services. “Records from Spectranetics’ clinical investigations will be audited by an Independent Review Organization to ensure compliance with FDA rules—including reporting of adverse events.”