The Department of Justice (DOJ) today announced that Vascular Solutions Inc. (VSI) agreed to pay $520,000 to resolve allegations that it caused the submission of false claims by marketing its medical device for uses not approved by the Food and Drug Administration (FDA) and not supported by a clinical trial.
VSI sells endovenous laser ablation medical devices that treat varicose veins by sealing the veins with laser energy. The government alleged that VSI knowingly promoted its Vari-Lase Short Kit medical device for unapproved uses after VSI attempted but failed to get FDA marketing clearance for the expanded uses and (ii) conducted a clinical trial that failed to satisfy safety and efficacy standards. The government further alleged that this marketing scheme caused physicians and other purchasers of the medical device to submit false claims to federal health care programs for medical device uses that were not reimbursable.
A former sales representative of VSI initiated the lawsuit by filing a qui tam whistleblower complaint under the qui tam provisions of the False Claims Act. His share of the recovery has not been determined.
Assistant Attorney General Stuart F. Delery warned that“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 press release is available at http://www.justice.gov/opa/pr/2014/July/14-civ-789.html