Minneapolis-based medical device maker Vascular Solutions Inc. (VSI) agreed to pay $520,000 to resolve allegations it violated the False Claims Act by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval. The government alleged VSI knowingly promoted the device even though it 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 that failed to meet both safety and efficacy benchmarks. The allegations originated from a whistleblower lawsuit filed by DeSalle Bui, a former sales representative at VSI, under the qui tamprovisions of the False Claims Act. DOJ
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