A life sciences company from Minnesota was forced to spend $25 million in legal costs and endangered future federal dealings in order to prove its innocence – an “extraordinary” move for a publicly traded business pursued by the Department of Justice, according to its attorney.
At first, the DOJ’s Civil Division accused Vascular Solutions of marketing its Vari-Lase Short Kit, which treats veins deep in the leg, when the FDA had only approved the device for treatment of veins closer to the skin’s surface.
The company maintained the plain language of the FDA approval gave authorization to treat a general category of varicose veins, as all varicose veins include perforator varicose veins.
At first, the DOJ’s Civil Division accused Vascular Solutions of marketing its Vari-Lase Short Kit, which treats veins deep in the leg, when the FDA had only approved the device for treatment of veins closer to the skin’s surface.
The company maintained the plain language of the FDA approval gave authorization to treat a general category of varicose veins, as all varicose veins include perforator varicose veins.
