A Texas jury has found Vascular Solutions and its CEO Howard Root not guilty of charges involving off-label promotion of its Vari-Lase Short Kit.
Prosecutors in United States of America v. Vascular Solutions, Inc., and Howard C. Root alleged the defendants had encouraged members of the sales force to speak to physicians about the off-label use of the Short Kit to treat varicose perforator veins in the leg. The cause was argued in the U.S. District Court for the Western District of Texas.
The Vari-Lase Short Kit was sold in the U.S. from October 2007 through July 2014 under an FDA 510(k) clearance.
An upcoming criminal trial remains scheduled for one of the company’s sales representatives on obstruction of justice charges. — Jonathon Shacat