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February 29, 2016

King & Spalding Wins Federal Jury Trial in Key Off-Label Marketing Case on Behalf of Vascular Solutions Inc.

WASHINGTON, D.C., Feb. 29, 2016 — King & Spalding won a unanimous federal jury verdict of not guilty on behalf of its client Vascular Solutions, Inc. (VSI), and the company’s founder and CEO, Howard Root, in the U.S. District Court for the Western District of Texas. VSI and Mr. Root were charged with conspiracy and other federal offenses in connection with the so-called “off-label” promotion of a medical device used to cure varicose veins. With Friday’s verdict, U.S. District Judge Royce Lamberth—sitting by designation in the Western District of Texas—entirely dismissed the case, which now cannot be appealed. The verdict vindicates the VSI and Mr. Root, who fought the allegations at great cost for several years.

At trial, federal prosecutors alleged that VSI and Mr. Root presided over a promotional campaign to encourage doctors to use of the company’s Vari-Lase products to treat varicose veins in a manner that was outside of the device’s FDA clearance. Following more than three weeks of trial, and a day and a half of deliberations, the jury unanimously exonerated VSI and Mr. Root.

King & Spalding Washington, D.C., partners Michael Pauzé and John Richter served as lead counsel in the case.

“We are gratified that after five years of investigation and three weeks of trial, the jury completely exonerated our client, Vascular Solutions, and its founder and CEO Howard Root,” said Pauzé and Richter in a joint statement. “The verdict vindicates the First Amendment right of life sciences companies to provide health care professionals with truthful information about their products.”

More information on this case can be found on VSI’s site, here.

For healthcare clients who are faced with the need to litigate, King & Spalding offers the unusual combination of lawyers who have deep healthcare expertise and lawyers who also routinely try high-exposure and mission critical cases. Our healthcare and product liability litigators are trained to litigate in court, before juries, in administrative proceedings, before arbitration panels and in various appellate forums. King & Spalding’s product liability practice was named 2015 Practice Group of the Year by Law360.

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