Vascular Solutions Cleared Of “Off-Label” Charges

CEO Howard Root was accused of personally coaching sales staff to market unapproved uses of the company's medical devices to physicians.

A federal jury in Texas on Friday cleared Maple Grove-based Vascular Solutions of all charges regarding alleged “off-label” promotions of one of its products.
The medical device company and CEO Howard Root faced criminal indictment charges from a grand jury of one count of conspiracy to sell misbranded devices, four counts of selling misbranded devices and four counts of selling adulterated devices.
Charges stem from the company’s Vari-Lase Short Kit, which was sold from 2007 to 2014 to treat varicose veins. The U.S. Department of Justice alleged that Root personally trained Vascular Solutions’ sales staff to market the products to physicians for treatment of perforator varicose veins that are located deeper in the legs—something the DOJ said wasn’t approved by the FDA.
Lawyers for Vascular Solutions argued that the Short Kit was approved to generally treat varicose veins, which included those deeper in the leg. The company said it spent $25 million fighting the charges. They had 20 witnesses lined up, but they ended up not choosing to call any of them.
The company said that the outcome of the case is not subject to appeal.
“The company and I are vindicated by today’s verdict, but outraged by the obscene legal process we were forced to endure,” Root said in a statement. “Vascular Solutions is fortunate to have had the financial strength and dedicated employees necessary to not only fight, but to win. Most other companies would have been destroyed before they even set foot in the courtroom.”
Other medical device companies have closely watched the case as a possible precedent on how they can market their products. The Star Tribune notes that several companies have argued in recent years that the FDA lacks the legal authority to prohibit them from telling doctors truthful information about off-label and unapproved uses of medical devices.