“They Said What?! I’ll Sue!” – Litigating Defamatory Claims – Speaking of Litigation Video Podcast
Impact of Mickey Mouse on public domain. The latest artificial intelligence and intellectual property cases - Thaler lost again. Nirvana Nevermind baby gets day in court. Tolkien estate and more.
(Podcast) The Briefing: IP Rights and the “Public Good” Exemption to California’s Anti-SLAPP Law: An Update
The Briefing: IP Rights and the “Public Good” Exemption to California’s Anti-SLAPP Law: An Update
Roundup of 2023 Entertainment Law Cases: Analysis SAG/AFTRA and WGA contracts, No Parody of Iconic Sneaker, AI Copyright Highlights China vs US law; SCOTUS Bad Spaniel and Warhol/Prince.
(Podcast) The Briefing: SCOTUS to Determine if USPTO Refusal to Register TRUMP TOO SMALL is Unconstitutional
The Briefing: SCOTUS to Determine if USPTO Refusal to Register TRUMP TOO SMALL is Unconstitutional
Podcast: The Briefing - Deepfakes vs Right of Publicity: Navigating the Intersection Between Free Speech and Protected Rights
The Briefing - Deepfakes vs Right of Publicity: Navigating the Intersection Between Free Speech and Protected Rights
Early Returns Law and Politics with Jan Baran: Bradley Smith – Deregulating Political Speech Through Campaign Finance
What's the Tea in L&E? Government Employers: Is it Free Speech or Just Freely Complaining?
“So Many First Amendment Violations, So Little Time” | Tom Leatherbury | Texas Appellate Law Podcast
JONES DAY PRESENTS®: Section 230: A Springboard to a First Amendment Discussion
SPECIAL EDITION: NEWS + VIEWS + TO DO’S | ERIN HIGGINS, CONN KAVANAUGH
Employment Law Now V-99- Vaccines, Masks, and Other Big Developments
Law Brief ®: Richard Schoenstein and Ian Rosenberg Discuss the Fight for Free Speech
Employment Law Now V-96- LOTS of Big Employment Law Developments
Law School Toolbox Podcast Episode 285: Listen and Learn -- First Amendment (Content-Neutral Restrictions)
Bar Exam Toolbox Podcast Episode 123: Listen and Learn -- First Amendment (Content-Neutral Restrictions)
A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more
This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more
Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more
Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more
To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more
The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more
It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more
In This Issue: - Can Experts Testify as to the Ethics or State of Mind of Corporate Defendants? - Patent Reform for Biotech Companies - United States v. Caronia and its Implications for Off-Label...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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