August 29, 2014
August 29, 2014 — It is a violation of the federal False Claims Act for a medical provider to bill Medicare or any other government healthcare program for a medical device that has not been approved by the FDA for the particular use for which it was prescribed. Under the qui tam provisions of the statute, insider employees are encouraged to notify the government of such Medicare billing violations
by filing a whistleblower lawsuit. Tipsters are eligible for a substantial portion of the government’s recovery.
Minnesota Medical Device Company Allegedly Marketed Device For Unapproved Use On Perforator Veins
Vascular Solutions Inc. (VSI), a Minnesota medical device company, has settled False Claims Act allegations raised in a whistleblower lawsuit. DeSalle Bui, who was formerly employed with VSI as a sales representative, alleged that VSI caused false claims for reimbursement to be filed with federally funded healthcare programs. In particular, VSI allegedly marketed a medical device used to seal perforator veins that had not been approved by the FDA and that failed in the company’s own clinical trial.
It will cost VSI $520,000 to settle the whistleblower lawsuit
. Mr. Bui’s portion of the recovery has not been decided.
VSI sells medical devices designed to treat varicose veins by sealing them off with laser energy. The device uses a console to create the laser energy and an accessory kit. The kit includes needles to penetrate the veins, laser fibers that transport the laser energy and sheaths that guide the laser fiber to the vein being treated. One of VSI’s medical devices was the “Vari-Lase Short Kit,” which contained a short sheath that made it easier to seal off shorter vein segments.
The “Short Kit” had been approved for use only on superficial veins and not on perforator veins, which run from the surface veins to veins deep within the leg muscle. VSI reportedly marketed the “Short Kit” to seal off perforator veins in addition to surface veins. This was despite the fact that the FDA had refused to give VSI clearance to market the short kit for perforator veins. Indeed, when VSI held a clinical trial of the “Short Kit,” the kit was shown to be neither safe nor effective for perforator veins.
As a matter of patient safety, government healthcare programs do not reimburse providers for medical devices that have not been approved by the FDA. According to the Justice Department, VSI intentionally caused doctors and other health care providers to purchase the “Short Kit” for treating perforator veins and then to file false claims for reimbursement to federal health care programs for use of the kit. In so doing, VSA violated the federal False Claims Act.
False Claims Act Lawsuits Redress Abuse
While Waters & Kraus did not handle this particular case involving medical devices, we are representing whistleblowers in similar lawsuits. If you have comparable claims against a different medical device maker or medical provider, email us
or call our qui tam attorneys at 855.784.0268 to learn more about our practice and how we can work together to notify the government about fraud and abuse. Our qui tam lawyers, like Michael Armitage
and Gary Paul
in the firm’s California office, are committed to advancing and protecting informants’ interests in whistleblower lawsuits.