This week’s Department of Justice “catch of the week” goes to Vascular Solutions Inc (VSI). On Monday, the Minneapolis-based medical device maker agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval. Specifically, the government charged that VSI marketed and sold its “Vari-Lase Short Kit” for treating perforator veins (which run deep in the leg muscle) even though the FDA approved the device only for treating surface (or superficial) veins. See DOJ press release.
According to the government, VSI knowingly promoted the “Short Kit” for the sealing (or ablation) of perforator veins even though VSI had attempted to and failed to get FDA marketing clearance for treating this particular type of vein. Furthermore, VSI had conducted a clinical trial of the device for sealing these veins which failed to meet both safety and efficacy benchmarks. The government alleged that VSI’s misconduct caused physicians and other purchasers of the “Short Kit” to submit false claims to federal health care programs for uses of the device that were not reimbursable.
In announcing the settlement, DOJ Civil Chief Stuart Delery made clear the government’s commitment to ensuring medical device manufactures comply with all FDA standards and approvals: “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. We will not permit companies to circumvent that process and put profits over patient safety.”
The government’s allegations against VSI originated in a lawsuit filed by former VSI sales representative DeSalle Bui under the qui tam, or whistleblower, provisions of the False Claims Act. Mr. Bui’s share of the settlement has not yet been determined.
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