Misbranding

FDCA Express Preemption Victory in Benecol Misbranding Class Action

by Maya Ingram, Claudia Vetesi | Morrison & Foerster - Private Surgeon... on 5/17/2013

A recent Third Circuit case brings good news for defendants making express preemption arguments under the Food, Drug and Cosmetic Act (FDCA) in misbranding class actions. Last week, the court affirmed the dismissal of a...more

Energy Drink Regulatory Update: Monster Sues City of San Francisco in Federal Court, City Fires Back in California State Court

by Fuerst Ittleman David & Joseph, PL on 5/16/2013

The FDA announced that it is conducting an investigation into the use of caffeine in foods and beverages. Since the FDA’s announcement, the energy drink industry has continued to receive significant media attention. On May 6,...more

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

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

“All Natural” Suit Against AriZona Iced Tea: Class Decertified and Suit Tossed

by Rebekah Kaufman, Claudia Vetesi | Morrison & Foerster - Private Surgeon... on 4/10/2013

In the world of food misbranding class actions, few cases have yet made it to the merits stage. Companies defending against these claims should accordingly take note of AriZona Iced Tea’s recent win in Ries v. AriZona...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

False Press Release Leads To Exclusion From Federal Programs

by Robert Rose | Sheppard Mullin Richter & Hampton LLP on 2/20/2013

Dr. Harkonen was the CEO of InterMune, Inc, a pharmaceutical company that developed, marketed and sold drugs for lung and liver diseases, including Actimmune. In 2002, the FDA had approved Actimmune to treat only two...more

It’s a BRAND New World: Update on ICANN’s Expanded gTLD Program

by Judith Harris, Brad Newberg | Reed Smith on 2/5/2013

You have likely heard by now that the Internet is about to get substantially bigger and more complex, with potentially treacherous consequences for brand owners. This past fall, we wrote a chapter covering this issue 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

FDA Will Not Appeal Second Circuit Decision in U.S. v. Caronia

by Ellyn L. Sternfield | Mintz Levin - Health Law on 1/30/2013

After the Second Circuit’s split decision in U.S. v. Caronia, holding that truthful off-label marketing is protected under the First Amendment and thus cannot be prosecuted under the misbranding provisions of the Food Drug...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

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

Second Circuit Jettisons Criminal Conviction for Pharma Rep Convicted for Off-Label Promotion

by Christopher R. Hall, Gregory G. Schwab | Saul Ewing LLP on 12/20/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit overturned the conviction of a pharmaceutical sales representative convicted for misbranding in violation of the federal Food, Drug and Cosmetic...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

United States v. Caronia: Second Circuit Rules Manufacturers Cannot Be Criminally Prosecuted for Off-Label Promotion of Drugs...

by Fuerst Ittleman David & Joseph, PL on 12/17/2012

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued a landmark decision in United States v. Caronia, holding that “the government cannot prosecute pharmaceutical manufacturers and their...more

9th Circuit’s POM Wonderful Ruling Could Influence Food Class Actions

by Morrison & Foerster LLP on 8/8/2012

Originally published in Washington Legal Foundation on August 3, 2012. Class action lawyers looking for a shakedown have gone on a food binge. They have focused on the food industry and the ever-obliging federal court...more

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