Misbranding Off-Label Promotion

News & Analysis as of

First Amendment And Off-Label Promotion – Prosecute What I Do, Not What I Say

On December 3, 2012, the United States Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia (“Caronia”), who had been tried and convicted of participating in an unlawful conspiracy to introduce a...more

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

Business Litigation Report -- April 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

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

Court Upholds Executive’s Conviction Stemming from Off-Label Drug Promotion

The U.S. Court of Appeals for the Ninth Circuit has upheld the wire fraud and misbranding convictions and sentence of InterMune Inc. founder W. Scott Harkonen. United States v. Harkonen, No. 11-10209 (9th Cir. March 4, 2013)....more

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

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

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 Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia

On December 3, 2012, a panel of three judges on the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce...more

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

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

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

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