Howard Root, the former CEO of medical device company Vascular Solutions, warned InsideSources that an overzealous government prosecution “can happen to anyone.”
Root was prosecuted by Department of Justice attorneys for allegedly marketing an FDA-approved device, which made up only 0.1 percent of the company’s sales, for unapproved uses. Root and Vascular Solutions were eventually acquitted on all counts after spending $25 million over five years fighting the investigation. He said the matter was a product of an “incredibly powerful culture” rooted in “money motivation.”
ILR’s Faces of Lawsuit Abuse campaign released a video on Root’s story last year. You can view that video here.