Free Speech, Off-Label Use | JD Supra Law News

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

by King & Spalding on 3/14/2013

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

Ninth Circuit Affirms Conviction in Harkonen, Rejects the Defendant’s “Off-Label” First Amendment Challenge

by Vernon Francis, Thomas Lee | Dechert LLP on 3/13/2013

On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen,1 a case in which the CEO of a pharmaceutical company was prosecuted for transmitting...more

White Collar Watch - February 2013

by Andrea P. Brockway, Justin Ettelson, Christopher R. Hall, Patrick Hromisin, Adam Isenberg, Nicholas J. Nastasi, Scott Patterson, Gregory G. Schwab, Nicholas C. Stewart | Saul Ewing LLP on 2/22/2013

In This Issue: - New HIPAA “Megarule” Broadens Enforcement - Government Declines to Seek Rehearing of Landmark Off-Label Speech Decision - Seizure of Rothstein Ponzi Assets Highlights Tension Between...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

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

by Aileen Mcgill | Patterson Belknap Webb & Tyler LLP on 1/17/2013

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

Network Interference: A Legal Guide to the Commercial Risks and Rewards of the Social Media Phenomenon (2nd Edition)

by Reed Smith on 1/9/2013

In October 2009, we published the first edition of this White Paper, focusing primarily on social media issues in the United States. The response was overwhelming and far beyond our expectation — clients, friends, press and...more

Telling People They Can Use A Drug In A Way Different Than How The FDA Says They Can Use A Drug Is Not A Crime, Says the Second...

by Matthew G. Kaiser | The Kaiser Law Firm PLLC on 1/3/2013

Alfred Caronia was a sales rep for a pharmaceutical company. And, despite what you might think by reading some of the literature, being a pharmaceutical sales rep is not a crime. It's even more emphatically not a crime after...more

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

by King & Spalding on 12/22/2012

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

Advertising News & Analysis – December 13, 2012

by David G. Adams, Emilio W. Cividanes, Todd A. Harrison, Stuart P. Ingis, Jeffrey D. Knowles, Claudia A. Lewis, Amy Ralph Mudge, Jonathan L. Pompan, Andrew D. Price, Matthew R. Rabinowitz, more +Randal M. Shaheen, Ralph S. Tyler | Venable LLP on 12/17/2012

In this issue: - It’s Easier Being Green - Off-Label Marketing Protected by First Amendment - Understanding New Restrictions on Advertising GI Bill Benefits - FTC Looks at "The Big Picture" - Upcoming...more

Second Circuit Rules That Certain Speech Regarding the Off-Label Use of Drugs Is Protected Under the U.S. Constitution

by Stuart M. Gerson, David C. Gibbons, Wendy C. Goldstein, Daniel G. Gottlieb, Benjamin S. Martin, Natasha F. Thoren | Epstein Becker & Green, P.C. on 12/13/2012

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...more

Short Wins - Off-Label Drug Use And the First Amendment In The Second Circuit; Machine Guns And Grenades In The Eighth Circuit

by The Kaiser Law Firm PLLC on 12/12/2012

It's an odd week for wins in the federal appellate courts. The Second Circuit ruled that the First Amendment protects (some kinds of) promotional activity for off-label use of drugs. Any time the First Amendment is...more

Second Circuit Rules that Pharma Rep's Promotion of Drug for Off-Label Use is Protected Speech

by S. Jeanine Conley | BakerHostetler on 12/11/2012

The Second Circuit's December 3, 2012 decision in United States v. Caronia, No. 09-5006-CR, could cause a sea change in the growing number of prosecutions brought by the government to prevent the off-label promotion of drugs...more

Does Misdemeanor Misbranding Survive Caronia?

by Jonathan Sack | Morvillo Abramowitz Grand Iason & Anello P.C.... on 12/11/2012

The Court of Appeals for the Second Circuit sent shockwaves through the pharmaceutical industry with its decision in United States v. Caronia. Alfred Caronia was a pharmaceutical sales representative convicted of a...more

Court’s Ruling about Off-Label Drug Promotion Defies Reason

by Patrick Malone & Associates P.C. | DC Injury... on 12/10/2012

Last week a federal appeals court made a ruling that chips away at a fundamental aspect of the FDA's gatekeeping function with new drugs. The court tossed a conviction of a drug sales representative who was promoting drugs...more

Second Circuit Holds that Criminal Penalties for Pharmaceutical Sales Representative’s Off-Label Promotion Violate the First...

by Robin A. Linsenmayer | Orrick, Herrington & Sutcliffe LLP on 12/8/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued an opinion that stands to transform the regulatory landscape in which pharmaceutical and medical device companies operate. In recent...more

Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion

by Dechert LLP on 12/7/2012

In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to...more

Second Circuit Delivers Blow to Off-Label Promotion Prosecutions in U.S. v. Caronia

by Demme Doufekias, Adam S. Hoffinger, Robert A. Salerno | Morrison & Foerster LLP on 12/6/2012

In a much-anticipated decision, a federal court of appeals has ruled that the government cannot criminally prosecute pharmaceutical manufacturers and their representatives under the Food, Drug and Cosmetics Act (“FDCA”) for...more

Off Label Marketing – First Amendment Challenge Ruling

by Ellyn L. Sternfield | Mintz Levin - Health Law on 12/6/2012

The U.S. Court of Appeals for the 2nd Circuit upheld a First Amendment challenge to the federal prosecution of pharmaceutical salesperson Alfred Caronia for off-label marketing, http://www.ca2.uscourts.gov/decisions. Given...more

‘Off-Label’ FDA Cases Can Run Afoul of First Amendment, Appeals Court Holds

by Jeff Ifrah on 12/6/2012

A recent decision by the U.S. Court of Appeals for the Second Circuit may significantly curtail enforcement efforts relating to the so-called “off-label” use of drugs approved by the Food and Drug Administration for specific...more

Second Circuit Rules Off-Label Prosecution Violates First Amendment

by Michael Volkov on 12/6/2012

The US Court of Appeals for the Second Circuit, in a decision issued on December 3, 2012, in United States v. Caronia, threw out a criminal conviction of the defendant Alfred Caronia, a pharmaceutical sales person, for an...more

Second Circuit Vacates Conviction Against Sales Representative for Off-Label Promotion

by Ara Beth Gershengorn | Foley Hoag LLP on 12/5/2012

The Second Circuit, New York’s federal court of appeals, this week issued its long-awaited decision in United States v. Caronia and vacated the conviction of a pharmaceutical sales representative for off-label promotion. In a...more

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

by John T. Bentivoglio, Jennifer L. Bragg, David B. Leland, Michael K. Loucks, Gregory M. Luce | Skadden, Arps, Slate, Meagher & Flom LLP on 12/5/2012

In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more

Second Circuit Holds First Amendment Bars Conviction Based Solely on Off-Label Promotion of FDA-Approved Drug

by Ropes & Gray LLP on 12/4/2012

In its long-awaited decision in United States v. Caronia, the Second Circuit ruled today that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful,...more

Second Circuit Court of Appeals Issues Blow Against Off-Label Promotion Enforcement

by Dechert LLP on 12/4/2012

In a split decision today, a panel of the Second Circuit Court of Appeals overturned ? on First Amendment grounds ? the criminal conviction of a pharmaceutical sales representative who had promoted Jazz Pharmaceutical’s Xyrem...more

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Free Speech › Off-Label Use