The Department of Justice announced that Spectranetics Corporation, a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages plus a $100,000.00 forfeiture to resolve various claims against the company. Spectranetics sells certain types of medical lasers and peripheral devices for those lasers. The claims against Spectranetics arose from allegations that the company engaged in several inappropriate acts from 2003 to 2008, specifically:
- illegally importing unapproved medical devices and then providing them to physicians for use in patients;
- conducting a clinical study in a manner that failed to comply with applicable federal regulations, and
- promoting certain products for procedures for which Spectranetics had yet to receive FDA approval.
In order to resolve the many serious allegations against it, the company agreed to a civil monetary settlement, and also entered into a non-prosecution agreement to avoid criminal charges by the United States as well as a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. As a part of the non-prosecution agreement, Spectranetics has accepted responsibility for its misconduct and instituted remedial measures to prevent similar conduct in the future. The civil settlement agreement resolves allegations that Spectranetics caused false and fraudulent claims to be submitted to Medicare throughout the time its improper conduct was ongoing.
Going forward, the company will cooperate with the Department of Justice’s ongoing criminal investigation into related matters. Spectranetics will also be required to submit records from its clinical investigations to an independent review organization to be audited to ensure compliance with FDA regulations. The settlement is thus designed to protect the integrity of the Medicare system, the health of patients nationwide, and the interests of all taxpayers.
The Department of Justice’s press release can be found at: http://www.justice.gov/opa/pr/2009/December/09-civ-1385.html