Hyman Phelps and McNamara
Firm Publications

Does FDA’s Per Se Prohibition Against Off-Label Promotion Have a Future? The Short Answer: No
April 2016

The Department of Justice’s (DOJ) recent criminal prosecution of Vascular Solutions, Inc. (VSI) ended in a spectacular loss for the government. The defense rested without calling even a single witness, but the jury
unanimously acquitted VSI and its chief executive officer of, among other things, misbranding products due to “off-label” promotion.

VSI’s Vari-Lase products were 510(k)-cleared by FDA for the ablation of supercial veins, but VSI allegedly promoted them outside the scope of clearance for use in perforator veins, which connect the supercial vein system to the deep vein system. Although this off-label promotion allegedly misbranded the product, the trial judge instructed the jury that such promotion is not per se illegal.

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If you have any questions regarding the above information, please contact:
Jeffrey K. Shapiro (202) 737-9633 jshapiro@hpm.com