Vascular Solutions Settles Two Lawsuits

Minneapolis, Minn.-based Vascular Solutions Inc. has reached a settlement in its patent lawsuit with Boston Scientific Corporation relating to patents in the area of coronary guide extension catheters.

Vascular Solutions filed the original lawsuit in U.S. District Court for the District of Minnesota in May 2013, alleging that Boston Scientific infringed three of its patents related to rapid exchange guide extension technology by manufacturing and selling its Guidezilla guide extension catheter. Boston Scientific filed a counterclaim in July 2013, alleging that Vascular Solutions infringed a patent owned by Boston Scientific related to rapid exchange guide extension technology by manufacturing and selling its GuideLiner guide extension catheter. As part of the settlement agreement, all litigation between the two parties related to guide extension will be dismissed. The terms of the settlement are confidential.

In a separate settlement agreement, Vascular Solutions paid $520,000 to the U.S. Department of Justice (DOJ) for to resolve allegations that it caused false claims to be submitted to federal health programs by marketing a medical device for the ablation (or sealing) of perforator veins without FDA approval and despite the failure of its own clinical trial. However, the company still denies any guilt associated with these claims.

“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.”

“An agreement to settle this lawsuit was previously reached on January 22, 2014 and previously disclosed in the company’s public filings, with the only event occurring today being the long-delayed signing of the formal settlement agreement,” said company officials in a statement. “The terms of the settlement are that the company will make a payment of $520,000, the company will make no admission of fault or liability, and the U.S. Attorneys’ Office will dismiss the civil lawsuit with prejudice and release all civil claims brought against the company in the civil lawsuit. The press release issued today by the Department of Justice contains numerous allegations which the company continues to deny.”

According to the DOJ, Vascular Solutions’ Short Kit was approved only for the treatment of surface or superficial veins in the leg, which run near the surface of the body, and not for perforator veins, which connect the surface veins to deeper veins in the leg muscle.  The government alleged that the company knowingly promoted the Short Kit for the ablation of perforator veins even though the company had attempted to and failed to get FDA marketing clearance for ablation of this particular type of vein, and also that the company had conducted a clinical trial of the Short Kit for ablating perforator veins that failed to meet both safety and efficacy benchmarks.  As a result of this conduct, the government alleged that Vascular Solutions knowingly caused physicians and other purchasers of the Short Kit to submit false claims to federal health care programs for uses of the Kit that were not reimbursable.