According to an article in the Star Tribune, a Texas grand jury has charged Howard Root, CEO of Vascular Solutions, with conspiring to sell a varicose-vein treatment device for unapproved uses. Prosecutors claim that Vascular Solutions marketed a device called the Vari-Lase to seal off veins deep in the leg, although the Food and Drug Administration (FDA) approved the device for the treatment of superficial blood vessels only. The Vari-Lase was pulled from the market over the summer after Vascular Solutions settled a civil whistleblower lawsuit alleging the same off-label marketing issue as the new criminal case.
“These charges involve a deceptive sales campaign led by the CEO of a public company,” said Joyce Branda, acting assistant attorney general for the Justice Department Civil Division. “We will take action to hold corporations and their leaders responsible when they violate laws intended to protect public health.”
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