Criminal Law, Commercial Law & Contracts, Constitutional Law

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

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

by Christopher R. Hall, Gregory G. Schwab | Saul Ewing LLP on 3/25/2013

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

Casinos Go Virtual

by Peter Hahn | Pillsbury Social Media, Entertainment &... on 3/12/2013

In late February 2013 the New Jersey Legislature passed legislation allowing on-line wagering, subject to certain limitations. This legislation was signed into law by Governor Chris Christie. Under the new law, licensed...more

Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

by David Douglass | Sheppard Mullin Richter & Hampton LLP on 3/8/2013

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and...more

New Jersey One-Gun Law Upheld, Setting a Precedent

by Lawyers.com on 2/13/2013

This article first appeared on the Huffington Post. New Jersey’s law that limits handgun purchases to one per month was just upheld by the 3rd U.S. Circuit Court of Appeals, creating a federal law foundation for other...more

DOJ Plans to Intervene in N.J. Sports-Betting Case

by Jeff Ifrah on 1/23/2013

The U.S. Department of Justice announced on January 22, 2013, that it plans to intervene in the lawsuit brought by the four major professional sports leagues and the NCAA challenging a New Jersey state law that legalized...more

War Over Gun Controls Explodes Nationwide

by Aaron Kase | Lawyers.com on 1/12/2013

Vice President Joe Biden met this week with government officials, victims of gun violence, retailers, media executives and firearm advocates on both sides of the issue as part of a task force designed to look for ways to...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

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

Federal Court Tosses Illinois Concealed Carry Ban

by Aaron Kase | Lawyers.com on 12/14/2012

The 7th U.S. Circuit Court of Appeals yesterday threw out an Illinois law banning concealed handguns, which had been the nation’s only blanket law against concealed carry. Lawmakers will have 180 days to rewrite the...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

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

Fraternal Order of Police Urges Congress to Update the Wire Act -- Letter to US Congressional Leaders (November 26, 2012)

by Ian Imrich on 11/26/2012

A Brief History of the Fraternal Order of Police [From the FOP website]: In 1915, the life of a policeman was bleak. In many communities they were forced to work 12 hour days, 365 days a year. Police officers didn't like...more

Morvillo Abramowitz Grand Iason & Anello P.C....

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Criminal Law › Commercial Law & Contracts › Constitutional Law