Off-Label Enforcement Developments (Vascular Solutions, Inc. Acquittal and Amarin Settlement)

Two important cases involving the permissible scope of speech regarding off-label marketing recently resolved in ways that should bolster efforts by drug and device manufacturers to secure their First Amendment rights to make truthful, non-misleading statements about potential off-label uses of their products. First, in a closely watched case in federal court in Texas, a jury acquitted a medical device manufacturer and its CEO of all charges, which included numerous off-label-related allegations. Second, the Food and Drug Administration ("FDA") settled a First Amendment lawsuit filed against it by a drug manufacturer, preserving a significant win that the manufacturer achieved earlier in the case.

Vascular Solutions, Inc. Acquittal

On February 26, 2016, a jury in the United States District Court for the Western District of Texas returned acquittals across the board in a case involving allegations that a medical device manufacturer engaged in off-label promotion. In United States v. Vascular Solutions, Inc., Cr. No. 14-926 (W.D. Tex.), a jury found Vascular Solutions, Inc. ("VSI"), and its chief executive officer, Howard Root, not guilty of all charges.

VSI manufactures the Vari-Lase device, a laser console that is used to treat varicose veins by ablation, meaning to dissipate them with intense heat. The FDA cleared the Vari-Lase device for treatment of superficial veins, but doctors sometimes used the device off-label to treat perforator veins, the short veins that connect the superficial and deep vein systems. VSI unsuccessfully sought FDA clearance for use of the Vari-Lase device to treat perforator veins and developed a special Vari-Lase "Short Kit" that, according to the government, was designed to make it easier to treat perforator veins.

The Department of Justice ("DOJ") charged VSI and Root in federal court in San Antonio with conspiracy to distribute misbranded and adulterated medical devices, and with distributing misbranded and adulterated medical devices, in violation of the Food, Drug, and Cosmetic Act ("FDCA"). DOJ alleged that VSI unlawfully distributed and promoted the Vari-Lase device, including the Short Kit, for a new intended (i.e., off-label) use to treat perforator veins; additionally, DOJ alleged that VSI misrepresented clinical data about the safety and effectiveness of the product for perforator vein ablation and misinformed doctors that Medicare and private payers would cover perforator vein procedures.

A...