Vascular Solutions faces whistleblower suit over off-label product use

The federal government has joined a whistleblower lawsuit against Maple Grove-based Vascular Solutions alleging that the company improperly promoted a medical device for uses not specified on the product label.

The whistleblower lawsuit claims that the alleged “off-label” promotion and other activities resulted in $20 million in damages to the federal government, according to the regulatory filing Thursday, Aug. 16.

“The company believes the allegations are factually inaccurate and without merit,” Vascular Solutions said in the filing, which also disclosed that the company has received a subpoena from the U.S. Attorney’s Office for the Western District of Texas.

“The company intends to both fully comply with the U.S. Attorney’s investigation and defend the litigation,” the company said.

Earlier this week, the U.S. District Court in the Western District of Texas unsealed the whistleblower lawsuit, which was originally filed under seal by a former Vascular Solutions employee in November 2010. The lawsuit alleges both off-label promotion of a device called Vari-Lase Short Kit as well as company-provided kickbacks to physicians.

Vari-Lase Short Kit is used by doctors treating patients with varicose veins. Between 2007 and 2011, the product generated about $410,000 in U.S. sales, which was about 0.1 percent of the company’s domestic revenue, according to the regulatory filing.

The company makes catheter products used in medical procedures to diagnose and treat problems in the vascular system.