Archive

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

May 28, 2014

Medical device manufacturer Medtronic Inc. agreed to pay $9.9M to resolve allegations under the False Claims Act that the company used various types of illegal kickbacks to induce physicians to use pacemakers and defibrillators made and sold by Medtronic. Among the the illegal inducements the government charged Medtronic with using were: 1) paying implanting physicians to speak at events intended to increase the flow of referral business; 2) developing marketing/business development plans for physicians at no cost; and 3) providing tickets to sporting events. The settlement stems from a whistleblower complaint filed by former Medtronic employee Adolfo Schroeder under the qui tam provisions of the False Claims Act. He will receive a whistleblower reward of approximately $1.73M. DOJ