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Medical device company pays $520,000 to settle off-label allegations

July 29th, 2014 | No Comments

On July 28, the Department of Justice announced that Vascular Solutions, Inc., a medical device company, has agreed to pay $520,000 to resolve allegations – originally brought by a whistleblower – that the company marketed a device for uses not approved by the FDA (“off-label” uses), and that these resulted in the submission of false claims to government health care programs. According to DOJ’s press release:

Vascular Solutions Inc. (VSI) has agreed to pay $520,000 to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval and despite the failure of its own clinical trial, the Justice Department announced today. VSI is a medical device company based in Minneapolis, Minnesota.

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VSI markets and sells medical devices that treat varicose veins by sealing the veins with laser energy (endovenous laser ablation). Their products include consoles, which generate the laser energy, and accessory kits. Kits include needles to access the veins, laser fibers that carry the laser energy, and sheaths that guide the laser fiber to the area to be ablated and protect the parts of veins not being ablated. In particular, VSI marketed and sold the “Vari-Lase Short Kit” medical device. The kit contained a sheath that was shorter than other kits, which made it easier to treat vein segments that were shorter in length.

VSI’s “Short Kit” was approved only for the treatment of surface or superficial veins in the leg, which run near the surface of the body, and not for perforator veins, which connect the surface veins to deeper veins in the leg muscle. The government alleged that VSI knowingly promoted the “Short Kit” for the ablation of perforator veins even though VSI had attempted to and failed to get FDA marketing clearance for ablation of this particular type of vein, and VSI had conducted a clinical trial of the “Short Kit” for ablating perforator veins that failed to meet both safety and efficacy benchmarks. As a result of this conduct, the government alleged that VSI knowingly caused physicians and other purchasers of the “Short Kit” to submit false claims to federal health care programs for uses of the “Short Kit” that were not reimbursable.

The Department announced that the qui tam suit had been filed by a former sales representative of the company, but that the relator’s share of the settlement had not yet been determined.

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