2nd Circuit Overturns Conviction Against Sales Rep for Off-Label Promotion



DOCUMENTS
  • Opinion


NEW YORK — The 2nd Circuit U.S. Court of Appeals has overturned the conviction against a Jazz Pharmaceutical (NASDAQ: JAZZ) sales representative for promoting Xyrem for off-label use, ruling that the conviction violated the salesman’s First Amendment rights.

On Dec. 3, the appellate court found that the U.S. Government prosecuted the salesman for mere off-label promotion, which is, in fact, legal under the Food, Drug and Cosmetic Act.

The government argued that Caronia was not prosecuted for his speech and that his promotion of Xyrem for off-label use served merely as “evidence of intent,” or evidence that the “off-label …






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