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Case Detail


United States v. Caronia
Case Date:
4/22/2010
Project Name:
On January 23, 2013, the federal government announced that it would not pursue an appeal from a landmark appeals court decision that affirmed commercial speech rights and overturned the conviction of a drug salesman alleged to have promoted an FDA-approved pharmaceutical for an off-label use (that is, a use not strictly conforming to the uses specified on the FDA-approved labeling). The decision to abandon an appeal marked another victory for WLF, which played a lead role in overturning the conviction. The December 2012 decision by the U.S. Court of Appeals for the Second Circuit agreed with WLF that the First Amendment broadly protects the right of individuals to speak truthfully about off-label uses of FDA-approved products, even in a commercial context. Prosecutors initially sought and obtained an extension of time within which to seek a rehearing in the appeals court. However, FDA announced on January 23 that it has decided to abandon all appeals.
Case Status:
Victory. Government abandoned appeals.
More Information and Downloads:
4/22/2010: Download the Brief
12/3/2012: Download Appeals Court Decision
Press Release: Court Urged to Overturn Conviction for Speech on Off-Label Drug Use
Litigation Update: Court Overturns Conviction For Speech On Off-Label Drug Uses
Litigation Update: U.S. Abandons Appeal From Decision Affirming Off-Label Speech Rights