Managing Whistlelbowers
10 For 10: Top Compliance Stories For the Week Ending August 23, 2025
Daily Compliance News: August 21, 2025, The Fabricated Evidence Edition
Adventure in Compliance: The Novels - The Valley of Fear, Whistleblowers and Corporate Compliance
Creativity and Compliance: Reinventing Compliance with Creativity: The Acteon I-Care Code
Moving Beyond the Usual Helpline Data
Podcast - Bring Out the Bad Stuff
Adventures in Compliance: The Novels - The Valley of Fear, Introduction and Compliance Lessons Learned
Episode 381 -- NAVEX's 2025 Annual Hotline Report
Compliance Tip of the Day: AI, Whistleblowing and a Culture of Speak Up
2 Gurus Talk Compliance: Episode 56 – The Grasshopper Edition
From the Editor’s Desk: Compliance Week’s Insights and Reflections from July to August 2025
Episode 379 -- Update on False Claims Act and Customs Evasion Liability
Everything Compliance: Episode 157, The Q2 2025 Great Women in Compliance Edition
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
Texas Alleges That Eli Lilly Patient Assistance Programs Violates AKS - The state of Texas and Health Choice Alliance, LLC filed a complaint alleging that pharmaceutical manufacturer Eli Lilly & Company, Inc. violated the...more
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
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
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
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
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
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
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
DOJ Reports Nearly $3 Billion in FCA Settlements, Judgments for FY 2024 - On January 15, the US Department of Justice (DOJ) reported that settlements and judgments under the False Claims Act (FCA) totaled more than $2.9...more
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
In a significant ruling, the Second Circuit Court of Appeals recently expanded the scope of the Anti-Kickback Statute (AKS).The Court joined other circuit courts across the country in adopting, for the first time, the...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
Pharmacies and Healthcare Providers May Be Impacted - A June 1st U.S. Supreme Court (SCOTUS) decision on two whistleblower cases may have far reaching consequences for pharmacies or healthcare providers that charge a discount...more
DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more
St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities. St. Jude was acquired by Abbott Laboratories in early 2017....more
In United States ex rel. Silver v. Omnicare, Inc., et al. (D.N.J. No. 11-cv-01326), a whistleblower relator consistently alleged that certain pharmaceutical service providers have engaged in an illegal kickback arrangement...more
This week the Department of Justice reported it recovered $3 billion from False Claims Act cases in 2019. Of that recovery amount, $2.1 billion resulted from whistleblower, or qui tam, actions. In addition, 633 new qui tam...more
On September 4, 2019 the Department of Justice (DOJ) announced a $15.4 million settlement with pharmaceutical company Mallinckrodt ARD LLC (Mallinckrodt) to resolve alleged violations of the Anti-Kickback Statute (AKS) in two...more
One of the reasons compliance officers and health care attorneys read fraud settlements is to identify issues the government is focused on. The cases the government decides to pursue are very indicative of the areas of fraud...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
Prompt Payment Discounts Not an Anti-Kickback Statute Violation - In United States of Am. et al. ex rel. Ruscher v. Omnicare, No. 15-20629, 2016 WL 6407128 (5th Cir. Oct. 28, 2016), the court of appeals affirmed summary...more
Charitable organizations can easily become enmeshed in Justice Department enforcement issues. We have seen charities used in FCPA cases as a means to funnel bribes to government officials, spouses or family members....more
Abbott Laboratories recently won a jury verdict in a high profile qui tam lawsuit alleging that Abbott “caused” health providers to submit false Medicare payment claims for off-label use of biliary stents. U.S. ex rel....more