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?
Attorney General (AG) Pam Bondi has issued a memorandum titled “Preventing the Mutilation of American Children” (the Memo) to select Component Heads of the Department of Justice (DOJ). Released on April 22, 2025, the Memo...more
Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...more
Q: If you had 30 seconds to describe your practice, what would you say? A: I am a partner in AGG’s Litigation & Dispute Resolution practice, focusing on government investigations, white-collar defense, and commercial...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
In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more
The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more
We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more
Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more
DOJ Secures Plea in $50 Million Medicare Fraud and Kickback Scheme - On April 26, the US Department of Justice (DOJ) announced that Manishkumar Patel pleaded guilty to charges related to a $50 million health care fraud and...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
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more
Ultragenyx to Pay $6 Million To Settle False Claims Act Case - Ultragenyx Pharmaceutical Inc. recently agreed to pay $6 million to settle a qui tam action filed under the False Claims Act (FCA). Ultragenyx manufactures a...more
Social media usage worldwide is showing no signs of slowing as it permeates all aspects of our daily lives. Originally published in Law360 - September 11, 2023....more
On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more
Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more
On June 14, 2023, a federal jury found that a Georgia physician knowingly violated the False Claims Act following a two-week trial on allegations that he made false claims to the Medicare Program. Now, despite just $1.1...more
We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more
Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more