DOJ Intervenes in Vascular Solutions Whistleblower Lawsuit

Federal prosecutors have decided to intervene in a whistleblower lawsuit filed against Vascular Solutions, which alleges that the company illegally marketed its Vari-Lase medical device for unapproved uses. 

The complaint was originally brought by a former Vascular Solutions employee, Desalle Bui, claiming to have proof that the company promoted the Vari-Lase Short Kit for uses other than treating perforated veins, which is the only indication approved by the FDA.

The off-label marketing lawsuit alleges that Vascular Solutions’ illegal promotion has cost the government $20 million in Medicare and Medicaid reimbursements.

The Department of Justice had the option of intervening or letting the former employee stand alone. However, Vascular Solutions reported last week that the U.S. Attorney’s Office for the Western District of Texas has decided to take part in the case.

Under federal laws, manufacturers of drugs and medical devices are only allowed to promote their products for medical uses that have been approved by the FDA. However, doctors are permitted to prescribe drugs or medical devices for whatever uses they see fit once they are on the market.

The Vari-Lase is an endovenous laser system that has brought in about $410,0000 in sales for the company. It is used to treat varicose veigns and varicosities. However, the lawsuit claims that the company paid doctors kickbacks to get them to buy it and use it for other uses.

Under the qui tam provision of the False Claims Act, whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

The company has indicated that the lawsuit is without merit, but says it will comply with the investigation. The details of the lawsuit, first file in November 2010, were unsealed last week.