In a long-awaited decision, on December 3, 2012, a divided panel (2–1) of the U.S. Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia, a former pharmaceutical sales representative for Jazz Pharmaceuticals whom a federal district court jury found guilty of conspiring to introduce a "misbranded" drug into interstate commerce in violation of the federal Food, Drug and Cosmetic Act ("FDCA"). A copy of the full opinion is available here. In this case, the majority held that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their employees for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug.
This Client Alert reviews the holding of the case and assesses the potential impact that this case may have for the industry.
Please see full alert below for more information.
Firefox recommends the PDF Plugin for Mac OS X for viewing PDF documents in your browser.
We can also show you Legal Updates using the Google Viewer; however, you will need to be logged into Google Docs to view them.
Please choose one of the above to proceed!
LOADING PDF: If there are any problems, click here to download the file.