Off-Label Use

Business Litigation Report -- April 2013

by Quinn Emanuel Urquhart & Sullivan, LLP on 4/15/2013

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

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

Appeals Court Rejects Drug Company Executive’s First Amendment Defense and Upholds Wire Fraud Conviction

by King & Spalding on 3/14/2013

A three-judge panel of the U.S. Court of Appeals for the Ninth Circuit, in a recent unpublished opinion, upheld the conviction and sentencing of former InterMune, Inc. executive Scott Harkonen for wire fraud. In 2009, a jury...more

Ninth Circuit Affirms Prosecution for Off-label Marketing

by Lane Powell PC - White Collar Criminal... on 3/13/2013

Over the past two years, courts began to recognize that at least some off-label marketing is protected lawful commercial speech under the First Amendment. Specifically, the Second Circuit in New York in a case called United...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

Class Certification Denied In Recent Consumer Products False Advertising Cases

by Nicole Skolout | BakerHostetler on 2/14/2013

In a number of recent district court decisions from across the country, courts have denied requests to certify nationwide or statewide classes in cases involving consumer products. These decisions could prove helpful in...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

Business News Digest - January 2013

by David G. Adams, James Y. Boland, Jana del-Cerro, Todd A. Harrison, Ronald M. Jacobs, Claudia A. Lewis, Dismas Locaria, Alexandra Megaris, Lindsay B. Meyer, Lawrence H. Norton, more +Jonathan L. Pompan, Andrew D. Price, Matthew R. Rabinowitz, Ralph S. Tyler, D. E. Wilson, Jr. | Venable LLP on 1/8/2013

In this issue: - Could Your Affiliate’s Activities Subject Your Company to the New Iran Reporting Requirements? - New York Attorney General Proposes New Rules Requiring Nonprofits Funding Political Communications 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

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

GMC Decides Not to Relax Its Guidelines to Permit Broader Prescribing of Off-Label and Unlicensed Medicines, Including on...

by James R.M. Killick | White & Case LLP on 12/11/2012

Introduction - Across Europe, as public budgets are tightened, there is pressure to lower spending on prescription medicines. These well-understandable budgetary pressures have led to some controversial suggestions,...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

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