Vascular Solutions vindicated in off-label marketing suit over varicose vein device

Vascular Solutions CEO Howard Root

Vascular Solutions ($VASC) is off the hook in a federal court case claiming that the company improperly marketed a device to treat varicose veins. But CEO Howard Root is still hopping mad about the former allegations and wants the Department of Justice (DOJ) to own up to its false claims about the company.

A jury in the Western District of Texas in San Antonio unanimously ruled not guilty on all charges against Vascular Solutions and Root over alleged "off-label" promotion of the company's Vari-Lase Short Kit. The ruling prompted Senior U.S. District Judge Royce Lamberth to submit an order to dismiss the case that is final and not subject to appeal.

But Root is not appeased. "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. "There is simply no excuse for abusive and dishonest conduct in any U.S. governmental agency, much less in the Department of Justice and our law enforcement agencies."

In 2013, grand jurors in the San Antonio court charged Root and Vascular Solutions with conspiracy and illegal promotion of its Vari-Lase Short Kit after a former employee filed a whistleblower suit against the company. Vascular's device was approved to treat varicose veins near the surface of the skin, but Root allegedly told sales teams to market the product for short vein segments deeper in the leg.

Throughout the proceedings, Vascular maintained its innocence. The company was "subjected to 5 years of attacks which forced us to hire 10 separate law firms at a cost of over $25 million to defend against a criminal prosecution that clearly was never warranted by the facts," Root said.

Plus, the case was only focused on one of the company's more than 100 medical devices that comprised 0.1% of its sales and never harmed patients. "To say that this prosecution was wrong-headed and disproportionate would be the understatement of the year," Root said.

Now Root wants the DOJ to issue a press release correcting its earlier claims about the company and its alleged off-label marketing. The agency should also think about changing its own practices to make sure that its claims aren't "based on false allegations made by a money-motivated disgruntled former employee," Root said.

"Vascular Solutions is fortunate to have had the financial strength and dedicated employees necessary not only to fight, but to win. Most other companies would have been destroyed before they even set foot in the courtroom," Root said. "In order to ensure that what happened to Vascular Solutions doesn't happen to a defenseless company or individual, changes need to be made in the personnel and culture at the Department of Justice."

- read the statement

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