Jury Acquits Medical Device CEO Charged With FDA Crimes
On February 26, 2016, a jury in West Texas acquitted Minnesota-based medical device company Vascular Solutions, Inc., and its CEO, Howard Root, in a federal criminal case involving FDA alleged crimes. The indictment in the case charged Vascular Solutions and Mr. Root with misbranding and conspiracy based on allegations that Vascular Solutions marketed its Vari-Lase® device for off-label use and sought to conceal that activity from the FDA. The jury wholly rejected the government’s case and delivered a stunning defeat to the FDA and the Department of Justice (DOJ) by acquitting Vascular Solutions and Mr. Root on all counts.
