July 28, 2014

Vascular Solutions Inc (VSI), a Minneapolis-based medical device maker, agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval.  Specifically, the government charged that VSI marketed and sold its “Vari-Lase Short Kit” for treating perforator veins (which run deep in the leg muscle) even though the FDA approved the device only for treating surface (or superficial) veins.  DeSalle Bui, a former sales representative of VSI, will receive a whistleblower award in an undisclosed amount.  DOJ

Tagged in: Drug and DME Pricing, FCA Federal, FDA Fraud, Medical Devices and DME, Off-Label and Unapproved Use, Whistleblower Case, Whistleblower Rewards,