Podcast: The Briefing - Is Linda Fairstein’s Portrayal in Netflix’s “When They See Us” Fair?
The Briefing: Is Linda Fairstein’s Portrayal in Netflix’s “When They See Us” Fair?
Podcast - The Briefing by the IP Law Blog: Defamation by Docudrama – Inventing Anna
The Briefing by the IP Law Blog: Defamation by Docudrama – Inventing Anna
Law Brief®: Joel Rosner and Richard Schoenstein Discuss Palin vs. The Times
Negative Online Reviews and Reputation Management: Tips for Health Care Practices and Providers
Deepfakes and Disinformation: The World of Manipulated Media
The Briefing by the IP Law Blog: “Inspired By” Characters – Defamation Lawsuit Part II
Williams Mullen's COVID-19 Comeback Plan: Preparing Today for Tomorrow's PPP Audit
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more
Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more
In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more
Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more
For a little over a year, the Office of Prescription Drug Promotion (OPDP) sent no untitled letters. OPDP ended this untitled letter hiatus this summer when it sent two untitled letters—one in June and another in August—and a...more
How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District...more
On March 1, 2023, Judge Jesse Furman of the United States District Court for the Southern District of New York granted a motion to dismiss a putative class action against a pharmaceutical company (the “Company”) and its...more
Northern District of Illinois Grants Motion for Partial Reconsideration of Summary Judgment Decision Regarding Whether Former Walgreens CFO’s Statements Were Actionable; Securities Fraud Claims Against Chicken Producer for...more
In the case that tested the limits of the “fake it till you make it” approach to a startup business, on January 3, 2022, a jury in the U.S. District Court for the Northern District of California convicted Elizabeth Holmes,...more
Delaware Federal Court Dismisses Shareholder Derivative Suit Concerning Lack of Board Diversity; California Federal Court Dismisses Shareholder Class Action Against Sorrento Therapeutics Regarding COVID-19 Treatment; Delaware...more
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more
Report on Research Compliance 18, no. 7 (July 2021) - In a review of more than 500 NIH awards, the HHS Office of Inspector General (OIG) found that about one-fifth were funded “out of rank order,” and for more than a...more
In late 2019, Gustav Eyler, the Director of the U.S. Department of Justice’s (“DOJ”) Consumer Protection Branch (“CPB”), cited fraudulent data in clinical research trials for new drugs and medical devices as a topic of “major...more
On June 10, 2020, the Ninth Circuit, in Vicky Nguyen v. Endologix, Inc., et al., affirmed in a published decision the district court’s dismissal with prejudice of a putative securities fraud class action because plaintiff...more
California Federal Court Denies Motion to Dismiss Securities Class Action Arising from Uber’s IPO; S.D.N.Y. Dismisses Ponzi Scheme Action Against HSBC Hong Kong for Lack of Personal Jurisdiction; Delaware Court of Chancery...more
Securities Class Action Against Swiss-Based Company Dismissed On Forum Non Conveniens Grounds; Second Circuit Finds Strong Inference of “Conscious Recklessness” In Allegations And Reverses Dismissal of Securities Suit Against...more
DOJ’s aggressive enforcement of the opioid industry is a striking example of the power of federal prosecutors when focused on an industry. Once prioritized for enforcement, DOJ has quickly brought together prosecutors and...more
This update provides an overview of key regulatory developments in the past three months relevant to companies listed, or planning to list, on The Stock Exchange of Hong Kong Limited (HKEx), and their advisers. In particular,...more
In the wake of recent unexpected changes in the way that companies do business, the goods and services that consumers demand, and the accompanying market volatility, plaintiffs have begun filing securities fraud complaints...more
On February 3, 2020, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued a joint statement announcing their plans to collaborate in promoting competitive biological product markets and...more
Summer is winding down, and Fall texted to say she is on her way. This means that Pro Te: Solutio is returning for its third edition of 2019. As always, our authors have taken the time to research and address current issues...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more