The Star Tribune reports that a federal grand jury indicted Howard Root, CEO of Vascular Solutions, Inc. (VSI), on one felony count of conspiracy and eight misdemeanor charges of selling unapproved and adulterated medical devices. The same charges were also brought against VSI. According to its website, Minneapolis MN-based VSI makes medical devices for diagnostic and interventional vascular procedures.
According to the United States Department of Justice, the indictment alleges that VSI and Root ran an off-label promotion scheme to market VSI’s Vari-Lase product for the ablation of perforator veins, which connect superficial veins to deep veins. According to its 510(K) summary, the FDA cleared the Vari-Lase for treatment of superficial veins. As the Department of Justice notes, the FDA did not approve the Vari-Lase for treating perforator veins due to higher risks associated with perforator veins’ contact with deep veins. Yet, as stated by the indictment, VSI and Root continued to promote and sell Vari-Lase for treating perforator veins even after failing to obtain FDA approval.
The Department of Justice reports that VSI and Root continued off-label promotion of the Vari-Lase even after a whistleblower complained to Root in 2009 and the government told VSI about its investigation in 2011, and VSI and Root continued to deceive the FDA by using code words and misleading investigators. The Star Tribune states that Vari-Lase was eventually voluntarily pulled from the market in July 2014 when VSI agreed to pay $520,000 to resolve civil allegations related to the same alleged off-label promotion.
Following the indictment, VSI issued a press release stating that “[t]he indictment is the profoundly flawed product of government attorneys who have conducted a misguided and abusive investigation.” The case is now pending in the U.S. District Court for the Western District of Texas.