Medical Device Company Settles with US Department of Justice

Spectranetics, a Colorado-based medical device manufacturer, has settled its dispute with the US Justice Department. The medical device company has agreed to pay the government $4.9 million in civil damages and a $100,000 forfeiture to resolve claims that Spectranetics illegally imported and distributed unapproved medical devices to doctors in the United States. Other allegations include conducting a clinical study that was not in compliance with federal regulations and marketing products for purposes not approved by the FDA.
The civil settlement resulted in an investigation dating back to 2003 and concerned the submission of false Medicare claims.
Spectranetics, which manufactures lasers, lead wires, and other peripheral medical devices, avoids criminal prosecution by agreeing to pay the civil penalty. In addition, the settlement includes an admission of wrongdoing on the part of the company, an agreement to implement remedial measures so that such illegal activity is not repeated, and continued cooperation in the ongoing criminal investigation.