1. Case Site: United States v. Caronia, 703 F.3d 149 (2d. Cir. 2012) Case# 4.4 Page 118

2. Facts: FDA required that the prescription Xyrem carry a “black box” warning in 2002. A black box warning is the strictest warning placed on the labeling of the prescription drugs or drug products by the FDA. Having the black box warning around the warning indicates that an adverse reaction to this drug may cause death or serious injury. Alfred Caronia was convicted by the government for promoting Xyrem considering this medication was unapproved by the FDA.

3. Issues for the court to decide: Is the government’s prosecution of Caronia an unconstitutional violation of Caronia’s First Amendment right of free speech?

4. Analysis of this case: If free speech