News & Analysis as of

Free Speech Marketing

Social Links: Proposed legislation to outlaw “catfishing” & protect young Web users; blockchain technology’s impact on marketing

The government in Indonesia has warned the world’s biggest social media providers that they risk being banned in that country if they don’t block pornography and other content deemed obscene....more

Social Links: Can media companies be liable for their talents’ social media posts?; a trade group for social influencers; a...

A defamation suit brought by one reality television star against another—and naming Discovery Communications as a defendant—could determine to what extent (if any) media companies may be held responsible for what their talent...more

Social Links: Burger King ad triggers Google Assistant devices; suits allege infringement of copyrights in content posted to...

Without Google’s permission, Burger King ended one of its television commercials with a statement designed to automatically cause Google Assistant devices to read a list of the Whopper’s ingredients out loud. Having passed...more

Advertising Law - August 2016 #3

ANA, 4As Battle Over Transparency Guidance - Two industry groups are engaging in a public battle over transparency. The dispute began when a joint task force was formed between the American Association of...more

Status Updates: Appeals court upholds anti-cyberbullying law; better marketing through neural networks; restaurant owner turns the...

Cruel intentions. Laws seeking to regulate speech on the Internet must be narrowly drafted to avoid running afoul of the First Amendment, and limiting such a law’s applicability to intentional attempts to cause damage usually...more

HIPAA Marketing Rules Prompt First Amendment Challenge

In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug...more

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

by King & Spalding on

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 Dechert LLP on

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

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

by Holland & Knight LLP on

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

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

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

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

by King & Spalding on

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

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

by Epstein Becker & Green on

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

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

by BakerHostetler on

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

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

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...

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

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 Morrison & Foerster LLP on

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

Socially Aware: The Social Media Law Update -- Vol. 3, Issue 5 -- December 2012

by Morrison & Foerster LLP on

In this issue of Socially Aware, our Burton Award-winning guide to the law and business of social media, we examine why social media marketing strategies should be concerned with clearing more than just copyrights; we revisit...more

Off Label Marketing – First Amendment Challenge Ruling

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 Ifrah PLLC on

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

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

by Ropes & Gray LLP on

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

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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