Spectranetics Corporation, a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages, as well $100,000 forfeiture to resolve claims against the company, the United States Department of Justice (DOJ) announced December 29, 2009.
The claims arise from allegations that the company illegally imported unapproved medical devices and provided them to physicians for use in patients; committed fraud in a clinical study by failing to comply with federal regulations; and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.
The company manufactures, distributes and sells certain medical lasers and peripheral devices for those lasers, such as lead wires that guide the lasers through vascular tissue and catheters that carry and contain the lasers inside the veins, including, specifically, the CVX-300 Medical Laser and the CliRpath Turbo Laser Catheter, the TURBO Elite Laser Ablation Catheter, and the TURBO-Booster Laser Guide Catheter, according to the DOJ.
To read the full press release, go to: http://www.justice.gov/opa/pr/2009/December/09-civ-1385.html.
For more information about qui tam and health care fraud, contact Nolan and Auerbach, PA.