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Fed Joins Vascular Solutions Whistleblower Lawsuit

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The U.S. District Court in the Western District of Texas has unsealed a whistleblower lawsuit filed in 2010 by a former Vascular Solutions employee alleging off-label promotion and physician kickbacks for the Vari-Lase Short Kit used to treat patients with varicose veins.

Though a regulatory filing from August 16 says the company “believes the allegations are factually inaccurate and without merit,” it also said it “intends to both fully comply with the U.S. Attorney’s investigation and defend the litigation.” Vascular Solutions received a subpoena from the U.S. Attorney’s Office for the Western District of Texas, seeking information and documentation regarding the Vari-Lase Short Kit. The whistleblower lawsuit alleges the illegal marketing has cost the federal government more than $20 million.

It is illegal to promote a drug or medical device for treatments that have not been approved by the U.S. Food and Drug Association.

The regulatory filing reported that the Vari-Lase Short Kit generated nearly $410,000 in U.S. sales from 2007 to 2011, which equals about .01 percent of Vascular Solutions domestic revenue, Pioneer Press reports. disclaimer: This article: Fed Joins Vascular Solutions Whistleblower Lawsuit was posted on Monday, August 20th, 2012 at 8:12 pm at and is filed under Medical Device Lawsuits.

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