Episode 379 -- Update on False Claims Act and Customs Evasion Liability
10 For 10: Top Compliance Stories For the Week Ending July 19, 2025
2 Gurus Talk Compliance: Episode 55 – The From Worse to Worser Edition
Daily Compliance News: July 18, 2025, The Don’t Alter Docs Edition
Blowing the Whistle: What Employers Should Know About DEI & the False Claims Act
When DEI Meets the FCA: What Employers Need to Know About the DOJ’s Civil Rights Fraud Initiative
FCPA Compliance Report: Stay the Course: Ellen Lafferty on Navigating Anti-Corruption Compliance in 2025
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
Compliance into the Weeds: Boeing’s New Safety Initiatives and Compliance Reforms
Upping Your Game: Crowd - Sourcing Risk Management Intelligence with AI
10 For 10: Top Compliance Stories For the Week Ending June 21, 2025
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
Daily Compliance News: June 16, 2025, The Golden Share Edition
Daily Compliance News: June 13, 2025. The All Boeing Edition
Enforcement Priorities of the Second Trump Administration: The False Claims Act
Episode 372 -- DOJ Applies False Claims Act to Tariff and Trade Violations
FCPA Compliance Report: Revolutionizing Speak Up: Ariel D. Weindling on Enhancing Whistleblower Systems
2 Gurus Talk Compliance: Episode 53 – The AI as a Whistleblower Edition
Hospice Insights Podcast - Still Number One: Healthcare Fraud Remains Central in DOJ’s White Collar Enforcement Plan
A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the US False Claims Act (FCA) is unconstitutional. This case, now before the Court of Appeals for the...more
On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...more
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
Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more
The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more
The Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the relaunch of a Working Group to enhance enforcement of the False Claims Act (FCA) across the healthcare and life...more
Whistleblower Watch is a comprehensive source for all False Claims Act (FCA) news and information. Every quarter, Cozen O’Connor will provide in-house counsel and compliance professionals with a summary of the most notable...more
On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more
On May 12, 2025, the Head of the US Department of Justice’s Criminal Division, Matthew R. Galeotti (“Galeotti”), announced DOJ’s first ever White-Collar Enforcement Plan (the “Plan”), which directs prosecutors to: (1) focus...more
The U.S. Attorney’s Office for the Southern District of New York last week announced the resolution of two significant False Claims Act (FCA) cases—one from a large settlement and the other the result of a jury verdict after...more
The Administration for Market Regulation of Shanghai recently finalized penalties totaling RMB 223 million (approx. $31 million) against three pharmaceutical companies for colluding to fix prices and divide markets for...more
A circuit split over the causation standard under the federal Anti-Kickback Statute (AKS) could grow wider after a recent Northern District of Illinois (NDIL) decision. In United States ex rel. Jeffrey Wilkerson & Larry...more
Walgreens to Pay $300 Million to Settle DOJ Claims Over Invalid Opioid Prescriptions - Walgreens Boots Alliance has agreed to pay more than $300 million to resolve allegations brought by the US Department of Justice (DOJ)...more
On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more
The Supreme Court’s decision in Wisconsin Bell v. United States ex rel. Todd Heath clarifies what constitutes a “claim” under the federal False Claims Act (FCA). ...more
Welcome to the Winter 2025 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
On February 18, 2025, in United States v. Regeneron Pharmaceuticals, the First Circuit held that to establish civil liability under the False Claims Act (“FCA”) premised on violations of the Anti-Kickback Statute (“AKS”), the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more
In a much-anticipated decision, the First Circuit unanimously ruled the government and relators must prove that a violation of the federal Anti-Kickback Statute (AKS) was the “but-for” cause of a false claim under the False...more
On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more
In a closely watched appeal, the U.S. Court of Appeals for the First Circuit ruled on February 18 that to satisfy the causation requirement in False Claims Act (FCA) actions based on alleged Anti-Kickback Statute (AKS)...more
On February 18, 2025, the First Circuit joined a growing list of circuit courts to hold that “but-for causation” is the correct causation standard in most False Claims Act (FCA) cases premised on alleged violations of the...more
On Feb. 18, in U.S. v. Regeneron Pharmaceuticals, the First Circuit Court of Appeals joined the Sixth Circuit and the Eighth Circuit in holding that, for purposes of establishing that a claim for payment of items or services...more
Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more
The U.S. Department of Justice (DOJ) and 18 state attorneys general (AG) announced a settlement with Boston-based QOL Medical, LLC (QOL) and its CEO, Frederick Cooper, to resolve allegations that the company provided unlawful...more