Richter Wins Federal Jury Trial in Key Off-Label Marketing Case

John Richter

John Richter

NAFUSA life member John C. Richter won a unanimous federal jury verdict of not guilty on behalf of client Vascular Solutions, Inc. (VSI) and CEO Howard Root regarding allegations of “off-label” promotion of Vari-Lase Short Kit. With Friday’s verdict, Senior U.S. District Judge Royce Lamberth—sitting by designation in the Western District of Texas—dismissed the case, which cannot be appealed.

The verdict vindicates the company and Root, who fought the allegations in and outside court at great cost for almost five years. The allegations advanced by prosecutors at trial concerned whether VSI and Root engaged in a promotional campaign to encourage members of the company’s sales force to speak to physicians about the use of the Short Kit to treat varicose perforator veins in the leg and whether that use was outside the Short Kit’s FDA-cleared labeled indications for use and therefore an “off-label” use.  The government’s case lasted three weeks.  The defense rested without calling a witness.  After a day-and-a-half of deliberations, the jury unanimously rejected all of the prosecutors’ allegations.

Richter, a King & Spalding partner and former U.S. Attorney for the Western  District of Oklahoma and Acting Assistant Attorney General in charge of the Criminal Division, was joined by Michael Pauzé and Robert Hur in trying the case.  Pauzé and Hur are both former Assistant U.S. Attorneys. NAFUSA member Johnny Sutton, former U.S. Attorney for the Western District of Texas, served as local counsel for VSI on the case.

“We are gratified that after five years of investigation and three weeks of trial, the jury completely exonerated our client, Vascular Solutions, and its CEO Howard Root,” said Richter. “The verdict vindicates the First Amendment right of life sciences companies to provide truthful information about their products.”