Misbranding, First Amendment | JD Supra Law News

Business Litigation Report -- April 2013

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/15/2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

The First Amendment and Off-Label Promotion: United States v. Caronia

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/11/2013

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

by John L. Brownlee, William F. Gould, Timothy J. Taylor | Holland & Knight LLP on 2/1/2013

After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more

FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

by Ellyn L. Sternfield | Mintz Levin - Health Law on 1/30/2013

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...more

Second Circuit Jettisons Criminal Conviction for Pharma Rep Convicted for Off-Label Promotion

by Christopher R. Hall, Gregory G. Schwab | Saul Ewing LLP on 12/20/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the conviction of a pharmaceutical sales representative convicted for misbranding in violation of the federal Food, Drug and Cosmetic...more

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

by Jeffrey L. Bornstein, Michael R. Gordon, Leanne E. Hartmann, Michael H. Hinckle, Steven M. Kowal, Megan C. Lambert, Suzan Onel, Michael D. Ricciuti, Mark A. Rush, Paul W. Shaw | K&L Gates LLP on 12/17/2012

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

by Fuerst Ittleman David & Joseph, PL on 12/17/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

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Misbranding › First Amendment