Alfred Caronia was a pharmaceutical sales representative convicted of a misdemeanor conspiracy to introduce a misbranded drug.

FORBES: Does Misdemeanor Misbranding Survive Caronia?

Caronia is game-changing if it becomes prevailing law because, for decades, the prohibition on off-label speech shaped how pharmaceutical companies did business.

FORBES: Does Misdemeanor Misbranding Survive Caronia?

David Trone, an analyst at Fox Pitt Kelton Cochran Caronia Waller, agrees.

FORBES: What's Ahead For Financials?

Justice chose its words carefully in its post-Caronia announcement of the Amgen settlement on Dec. 19 and navigated around the First Amendment decision.

FORBES: Off-Label Pharma Prosecutions Won't Be Silenced By First Amendment Decision

Two of the three judges on the appeals court panel agreed with Caronia that the conviction violated his free speech rights, and they vacated it.

FORBES: Off-Label Pharma Prosecutions Won't Be Silenced By First Amendment Decision

Caronia, legal challenges based on similar arguments are certain to arise in other circuits, and the Department of Justice will have to evaluate its position on future off-label prosecutions.

FORBES: Does Misdemeanor Misbranding Survive Caronia?

When promoting Xyrem, a prescription narcolepsy drug, Caronia made comments to a doctor about various uses of the drug that had not been approved by the Food and Drug Administration.

FORBES: Does Misdemeanor Misbranding Survive Caronia?

The Court of Appeals case involved the criminal conviction of a pharma sales rep, Alfred Caronia, for conspiracy to introduce a misbranded drug into interstate commerce in violation of the Federal Drug and Cosmetic Act.

FORBES: Off-Label Pharma Prosecutions Won't Be Silenced By First Amendment Decision

The Second Circuit agreed with Caronia and became the first court in the nation to hold that truthful and non-misleading off-label promotional speech is constitutionally protected under the First Amendment and, as a corollary, that off-label promotional speech would not constitute a criminal offense unless the speech was false or misleading.

FORBES: Does Misdemeanor Misbranding Survive Caronia?