2 Gurus Talk Compliance: Episode 55 – The From Worse to Worser Edition
Daily Compliance News: July 17, 2025, The COSO Yanked Edition
Podcast - Persistence and Determination
Episode 377 -- Refocusing Due Diligence on Cartels and TCOs
Blowing the Whistle: What Employers Should Know About DEI & the False Claims Act
Regulatory Ramblings: Episode 73 - Geopolitical Risk: Thai Tensions / Sanctions, Tariffs & FCPA Enforcement in Asia
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
Episode 376 -- DOJ's Unicat Settlement and the Future Look of Trade Enforcement Actions
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Current Regulatory, Legislative, and Litigation Developments on ADA Website Accessibility for Consumer Finance Digital Platforms — The Consumer Finance Podcast
Podcast - How Do You Define Success?
Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
10 For 10: Top Compliance Stories For the Week Ending June 21, 2025
2 Gurus Talk Compliance – Episode 54 – The FCPA is Back On Edition
Understanding the DOJ's Recent Corporate Enforcement Policy Changes
Compliance Tip of the Day – New FCPA Enforcement Memo – What Does it Mean?
Daily Compliance News: June 17, 2025, The JBS Goes Public Edition
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
All Things Investigations: Navigating New DOJ Directives - Declinations, Cooperation, and Whistleblower Programs with Mike DeBernardis and Katherine Taylor
Johnson & Johnson Challenges the Constitutionality of FCA $1.6 Billion Verdict - Following a record $1.6 billion jury verdict for off-label promotion of HIV drugs Prezista and Intelence, Johnson & Johnson (J&J) subsidiary...more
On March 14, 2025, a three-judge panel of the U.S. Court of Appeals for the Fourth Circuit lifted a nationwide preliminary injunction that previously halted parts of two DEI-related executive orders signed by President Donald...more
A panel of the United States Court of Appeals for the Fourth Circuit lifted a nationwide injunction, allowing the Trump administration to resume implementation of a pair of executive orders targeting diversity, equity, and...more
What, exactly, is “illegal” Diversity, Equity and Inclusion (“DEI”)? As we previously reported, two recent Executive Orders (“EO”) prohibit “illegal” DEI practices that violate longstanding civil rights laws, but fail to...more
On February 21, 2025, a federal court in Maryland issued a nationwide preliminary injunction temporarily blocking the administration from carrying out key provisions in two of President Trump’s Executive Orders on Diversity,...more
On February 21, 2025, the U.S. District Court for the District of Maryland issued a preliminary injunction that significantly impacts two of President Trump’s executive orders targeting Diversity, Equity, and Inclusion (DEI)...more
A federal district court in Maryland issued a preliminary nationwide injunction on February 21 that temporarily halts enforcement of elements of Executive Orders 14151 and 14173. Most notably for federal contractors and...more
On Friday, the U.S. District Court for the District of Maryland issued a preliminary injunction against several provisions of two executive orders signed by President Trump that sought to dismantle diversity, equity, and...more
On Friday, February 21, 2025, the United States District Court for the District of Maryland issued a preliminary injunction against key provisions of executive orders issued by President Trump that are aimed at curtailing the...more
On Feb. 21, 2025, the federal district court for the District of Maryland issued a preliminary injunction partially enjoining two of President Trump’s executive orders: Ending Radical and Wasteful Government DEI Programs and...more
On February 21, a federal court in Maryland preliminarily enjoined three components of Executive Order (EO) 14151 (Ending Radical and Wasteful Government DEI Programs and Preferencing) and Executive Order 14173 (Ending...more
On February 20, 2024, a Federal District Court in Baltimore preliminarily stopped the Trump DEI Executive Orders from going into effect until further legal proceedings occur. This abrupt halt of the Executive Orders will...more
On February 21, 2025, a federal court preliminarily blocked the Trump administration from enforcing key provisions of the recent executive orders (EOs) to eliminate “illegal” diversity, equity, and inclusion (DEI) programs...more
On February 21, 2025, a federal district court in Maryland issued a nationwide injunction, temporarily preventing enforcement of three key provisions of President Trump’s executive orders targeting DEI programs. Specifically,...more
In our prior Baker Donelson Client Alert, we examined the labor and employment implications of Attorney General Pam Bondi's Ending Illegal DEI and DEIA Discrimination & Preferences memorandum. This alert focuses on the...more
On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...more
For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...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