Vascular Solutions and its CEO Howard Root face a federal grand jury indictment in western Texas alleging the Maple Grove, MN-based company's sales force promoted off-label use of a laser ablation device for treating varicose veins. The Vari-Lase products were cleared by the FDA only for the treatment of superficial veins, but Root and VSI led a sales campaign from 2007 until 2014 that sold them for the ablation of "perforator" veins, which connect the superficial vein system to the deep vein system, the U.S. Justice department said Thursday in announcing the indictment. Root and VSI are each charged with one count of conspiracy and eight counts of introducing adulterated and misbranded medical devices into interstate commerce. "These charges involve a deceptive sales campaign led by the CEO of a public company," acting Assistant Attorney General Joyce R. Branda, of DOJ's Civil Division, said in a the news release. Vascular Solutions responded with a statement that described the indictment as the "profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation." "Without the company being able to present any information to the grand jury, today's action is not surprising. It is, however, fundamentally wrong and profoundly unjust," the company said. Branda, though, pointed out that the Vascular Solutions sales campaign "persisted in the face of FDA warnings, a whistleblower's complaint to the CEO and a failed clinical trial showing that the device was less safe and less effective than a product that had already been approved." In July 2014, Vascular Solutions agreed to pay $520,000 to resolve allegations that it caused false claims to be submitted to federal health programs by marketing the Vari-Lase devices for treating perforator veins, though the company did not admit any fault or liability. "We will take action to hold corporations and their leaders responsible when they violate laws intended to protect public health," Branda said. In announcing the indictment, federal prosecutors claimed Root authorized the sales campaign after Vascular Solutions failed to obtain FDA authorization to sell the Vari-Lase system for ablation of perforator veins--and that sales continued even after a whistleblower complained to Root in 2009 and the government told the company about its investigation in 2011. Vascular Solutions and Root allegedly sought to deceive the FDA by teaching the sales force to say the now-discontinued Vari-Lase "Short Kit" was intended for "short vein segments" or "short veins"--which was apparently a kind of code word to the health providers that the kit could be used to treat perforator veins. "We vehemently disagree with both allegations: we did not engage in any illegal off-label promotion of the Short Kit, nor did we engage in any false or misleading conduct," the Vascular Solutions statement said. Vascular Solutions pointed out that Short Kit sales over seven years were $534,000, just 0.1% of sales. The company claims that two-thirds of its sales representatives never sold even a single Short Kit, and the Short Kit has never been the subject of any reported serious adverse event in any patient. "The discrepancy between the insignificance of our Short Kit product and the severity of the government's actions in this matter is simply astonishing," the company concluded. John Erb, chairman of the Board of Vascular Solutions, added that Root is staying in his job, and that the board supports management's handling of the case.
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