SHORT HILLS, N.J., July 28, 2014 /PRNewswire/ -- Stone & Magnanini LLP today announced a $520,000 settlement of off-label marketing and fraud claims between the United States Department of Justice ("DOJ") and Vascular Solutions, Inc. ("VSI"). The settlement covers fraud in connection with the marketing of various medical devices for endovenous laser ablation of varicose veins for unapproved uses.
Stone & Magnanini, a firm with a history of representing whistleblowers in groundbreaking settlements, represented DeSalle Bui, a conscientious employee who blew the whistle on VSI's fraudulent conduct back in 2010. Following Mr. Bui's filing, DOJ intervened in the case and the Stone & Magnanini team worked with the Government lawyers to aggressively litigate and ultimately settle this case.
"It is courageous citizens like Mr. Bui, the whistleblower in this case, who, at great risk and personal sacrifice, protect our citizens and health care system and keep medical companies like VSI honest," Magnanini stated. "We applaud the Government's actions, in particular attorneys Charles Biro, Lamine Hendrix and John LoCurto in this case and we encourage other whistleblowers who know about pharmaceutical and medical fraud to come forward and prevent future harm to patients."
The settlement agreement states that VSI knowingly promoted the Vari-Lase Short Kit for the ablation of perforator veins even though VSI had attempted and failed to obtain FDA clearance, had conducted a clinical trial that failed to meet both safety and efficacy benchmarks and knew, deliberately ignored, or recklessly disregarded that Medicare and TRICARE programs did not cover such procedures. VSI marketed and sold directly to health care providers throughout the United States the Vari-Lase Short Kit and laser consoles and related accessories, from June 2007 through January 2014. VSI also allegedly made false marketing statements about the safety and effectiveness and paid illegal kickbacks to physicians to promote their products and caused health care providers to submit false claims. The significance of this settlement is that because of Mr. Bui's integrity and bravery, the Government was able to recover multiples of damages of the amounts it paid for the products because of VSI's illegal marketing.
Stone & Magnanini, which was recognized as one of the top ten boutique law firms in the country by the National Law Journal, represents whistleblowers in False Claims Act cases as well as cases filed under IRS, SEC and other whistleblower statutes. The firm has assisted its clients and the government in recovering several billion dollars from health care companies including GlaxoSmithKline, McKesson, Inc., Forest Laboratories, Bristol-Myers Squibb, Cephalon and Medco. The firm also just last year assisted the Government in a $2.2 billion settlement against Johnson & Johnson and Janssen Pharmaceuticals, Inc. Stone & Magnanini's attorneys have been involved in the largest FCA cases and have assisted the Government in collecting over $6 billion and are currently fighting on behalf of whistleblowers everywhere in the litigating the case of the United States ex rel. Carter v. Halliburton, et al., at the Supreme Court.
SOURCE Stone & Magnanini LLP