In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment” as it “will now force the FDA to reconsider the way it deals with how companies market their products.” The editorial also raises questions about how pharmaceutical and medical device companies might face future inquiries by the FDA and DOJ on the issue of off-label marketing.
King & Spalding's Michael Pauzé, John Richter, and Robert Hur, all former DOJ prosecutors, defended VSI at trial, which the WSJ characterized as an attempt by the Justice Department to criminalize “honest behavior,” namely, providing wholly truthful and non-misleading information about the unapproved use of a medical device. Also supporting the defense of VSI were Jeff Bucholtz and others from King & Spalding's National Appellate practice and the firm's FDA & Life Sciences practice group.
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