Episode 379 -- Update on False Claims Act and Customs Evasion Liability
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?
The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized...more
The Department of Justice’s decision to shutter the Consumer Protection Branch (“CPB”) by September 30, 2025, is sending shockwaves across multiple industries. Known for its unique dual mandate to pursue both civil and...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more
There are many junctures in the U.S. healthcare system that enable fraudulent activities, and one of the biggest has to do with pharmaceutical companies. The U.S. Food and Drug Administration (FDA) and the Department of...more
Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more
This is the first post in this year’s series examining important trends in white collar law and investigations. Join us in the weeks ahead as we provide updates on new developments and emerging trends in a number of white...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
The United States Department of Justice announced that Affordable Healthcare Solutions, LLC has pleaded guilty and was sentenced to Receiving Adulterated Devices in Interstate Commerce and Delivery for Pay with Intent to...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
DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more
The U.S. Department of Justice (DOJ) recovered more than $2.2 billion in settlements and judgments from civil cases under the False Claims Act (FCA) in the fiscal year ending September 30, 2020. This is a drop of more than...more
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
On November 16, 2020, OIG issued a significant Special Fraud Alert that warns about certain “inherent” fraud and abuse risks raised by speaker programs sponsored by pharmaceutical and medical device companies. OIG expressed...more
Exploring the Implications of HHS-OIG’s Special Fraud Alert and Groundbreaking Novartis CIA Requirements on Compliance Program Policies and Controls that Govern Speaker Programs - A Special Fraud Alert issued by the U.S....more
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on November 16, warning that speaker programs organized by pharmaceutical and medical device companies pose...more
In struggling to address the evolving COVID-19 pandemic, the United States and many other countries continue to face major shortages of Personal Protective Equipment (PPE), such as N95 masks, gowns and other vital materials...more
The U.S. Department of Health and Human Services (HHS) and Department of Justice (DOJ) have released the 2019 annual report for their Health Care Fraud and Abuse Control Program. The government recovered almost $3.6 billion,...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
Podiatrist Sentenced to Prison for Fraudulent Billing Scheme - On July 19, 2019, a New York podiatrist was sentenced to 366 days in prison, assessed a $50,000 fine, ordered to pay $869,651 in restitution and forfeit...more
The FCA began as a response to procurement fraud by military contractors during the Civil War. In the intervening years, its reach has extended and increasingly the government is using the FCA as a tool in the context of...more
Last month, we reported on a Massachusetts federal court jury’s decision to acquit the former CEO of Warner Chilcott in one of the first prosecutions of a health care executive following the Department of Justice’s (“DOJ”)...more
Last week, the Civil Division of the U.S. Department of Justice (DOJ) filed an indictment charging Vascular Solutions Inc. (VSI) and its CEO Howard Root with (1) selling medical devices without the approval of the U.S. Food...more