Death of an FDA Prosecution: Post-Mortem on the U.S. v. Howard Root Acquittal
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 alleged FDA 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. This case is notable not only for its outcome, but also because it involved two of the hottest topics in criminal enforcement in the health care industry: the legality of off-label promotion, and DOJ’s new focus on bringing criminal charges against health care industry executives. The jury’s verdict was a significant setback for the government on both fronts.
On March 29, Fredrikson & Byron presented an insider’s view of the case and its subsequent acquittal. The program was moderated by Joseph T. Dixon, III and featured panelists John W. Lundquist, Dulce J. Foster and Kevin C. Riach, who represented Howard Root at trial, as well as Mr. Root himself. The panel discussed the team’s approach to defending against these alleged FDA crimes, shared their experiences at trial and explored how Mr. Root successfully met the challenges of running a public company while under indictment. The program highlighted how the government’s failure to obtain a conviction represents yet another nail in the coffin of its theory of criminal off-label promotion.