Vascular Solutions Inc. Agrees to Pay $520,000 in Medical Device Whistleblower Case By Tod Aronovitz | 08/06/14 | 0 Comment

Vascular Solutions Inc. (VSI) has agreed to a $520,000 settlement to resolve accusations that it caused false claims to be submitted to federal health programs as a result of marketing a medical device for treatment other than what the FDA approved, the Justice Department recently announced.

The allegations against the Minneapolis-based medical device company were raised in a medical device whistleblower lawsuit filed against VSI by a former sales representative, DeSalle Bui, under the qui tam provisions of the False Claims Act. Mr. Bui’s share of the settlement has not been determined yet.

The medical device whistleblower case centered on the off label marketing of a VSI product, the “Vari-Lase Short Kit.” The product, which is designed to treat vein segments that are shorter in length, had only been approved for treatment on surface or superficial veins in the leg running near the surface of the body. However the device was also supposedly being marketed to treat perforator veins, which connect surface veins to deeper veins in the leg muscle, and can cause varicose veins if they are not functioning properly.

The government alleged that VSI deliberately endorsed the “Short Kit” for the ablation (or sealing) of perforator veins even though the company failed to get FDA marketing clearance for ablation of perforators. VSI also allegedly failed to get the product to meet both safety and efficacy requirements for ablation of perforators when it conducted its own clinical trial.

As a result, the government contended 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 settlement should make it clear that the Department of Justice 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.

“Medical device manufacturers that ignore rules designed to protect patients in order to boost profits will be held accountable for their actions,” said Special Agent in Charge Mike Fields for the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), Dallas region. “We will continue to work with the Department of Justice to root out all forms of waste, fraud, and abuse in our federal health care programs.”

The lawsuit is captioned United States ex rel. DeSalle Bui v. Vascular Solutions, Inc., No. A10CA883-SS (W.D. Tex.).

How to Report Medicare Fraud

Healthcare professionals or medical billing employees who have knowledge of questionable Medicare billing practices or medical device claims can file a confidential legal claim under the False Claims Act. By acting as a “whistleblower” in what is known as a “qui tam” lawsuit, a private party may collect up to 30 percent of the amount recovered, depending on how the case is prosecuted.

ARONOVITZ LAW: Miami Whistleblower / Qui Tam Law Firm

The Miami Qui Tam law firm of ARONOVITZ LAW routinely works with whistleblowers to document Medicare fraud and other forms of fraud against the government. Contact Miami Whistleblower / Qui Tam lawyer Tod Aronovitz to discuss your case.