Grimy Times has learned that Vascular Solutions Inc. (VSI), a medical device company based in Minneapolis, Minnesota, 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 of perforator veins without FDA approval and despite the failure of its own clinical trial.
“The FDA approval process and clinical studies serve an important role in ensuring that federal health care participants receive devices that are medically appropriate and necessary,” said Assistant Attorney General Stuart F. Delery for the Justice Department’s Civil Division. “We will not permit companies to circumvent that process and put profits over patient safety.”
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.
The government alleged that VSI knowingly promoted the “Vari-Lase Short Kit” medical device 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.
“The settlement announced today should make it clear that the government will pursue companies that knowingly promote medical devices for unapproved uses, causing federal health care programs to pay for services that cannot be reimbursed,” said U.S. Attorney Robert Pitman for the Western District of Texas.
According to the government, the allegations resolved by today’s settlement were raised in a lawsuit filed against VSI by DeSalle Bui, a former sales representative at VSI, under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of false claims to bring civil actions on behalf of the government and to share in any recovery. Mr. Bui’s share of the settlement has not been determined.
The case was handled by the Commercial Litigation Branch of the Justice Department’s Civil Division, and the U.S. Attorney’s Office for the Western District of Texas. Assistance was provided by the Defense Health Agency, the Office of Personnel Management, and the HHS-OIG and Office of General Counsel. This settlement illustrates the government’s emphasis on combating health care fraud and marks another achievement for the Justice Department’s efforts to protect patients and taxpayers.”
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Key Facts
- State: Minnesota
- Category: White Collar Crime
- Source: DOJ Press Release ↗
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