“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)
In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more
U.S. health officials have taken the first concrete step toward implementing the vision set out in the “American Patients First” blueprint published by President Trump and Health and Human Services (HHS) Secretary Alex Azar...more
The US Food & Drug Administration (FDA) serves as the gatekeeper between pharmaceutical companies and the public they serve, including governing how medications are promoted and advertised. Pharmaceutical companies want to go...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
Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more
This is the second post in our California Ballot 2016 series – providing the “nutshell” versions of each of the 17 state-wide measures voters must decide in November. Please refer to our first post in the series: Props 51-56,...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
The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more
The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more
FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....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
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
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...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
On September 11, 2013, HHS stated in a joint motion filed in the case of Adheris, Inc. v. Sebelius, No. 1:13-cv-1342 (D.D.C.), that it plans to issue guidance on a HIPAA regulation related to prescription drug refill...more
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
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