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
Great Women in Compliance: From Hotline to Headline: The DOJ’s Whistleblower Awards Reboot with Mary Inman and Liz Soltan
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
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
Government investigations are an ever-present reality for companies operating in FDA-regulated industries. Whether you're in pharmaceuticals, medical devices, biologics, laboratories, food, cosmetics, veterinary, or cannabis,...more
As seen in the previous article, whistleblowing cases regularly make the news headlines. And while some of the names of the reporters or the cases are well known, it’s worthwhile to take a closer look at the people behind the...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
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
The giant drug maker Abbott and the federal Food and Drug Administration both should hang their heads in shame as more information becomes public as to how they left millions of vulnerable infants hungry and put kids’ health...more
We invite you to enjoy a review of the food and beverage industry with bite size articles ranging from regulatory and real estate trends to litigation and M&A happenings. The past two years have seen significant changes...more
US Supreme Court Requests Solicitor General’s Views in FCA Rule 9(b) Context - On May 16, 2022, the US Supreme Court requested a brief from the US Solicitor General on the level particularly required by Federal Rule of...more
Denver jury acquits DaVita, former CEO, of all charges in antitrust trial - After two days of deliberations, a Denver jury found DaVita and former CEO Kent Thiry not guilty of all charges relating to charges they...more
In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more
Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more
2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more
Breaking News- New Leadership at the FTC- •President Joseph R. Biden designated Federal Trade Commission (“FTC”) Commissioner Rebecca Kelly Slaughter as Acting Chair of the FTC . •As Commissioner, Chairwoman...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
Announcements by both Pfizer and Moderna that their trial COVID-19 vaccines appear to be over 90% effective have led to a surge of interest by everyone, employers included, about exactly when and how a vaccine will save us...more
COVID-19- Bipartisan Group of Attorneys General Seeks to Expand Production of Antiviral Drug- A bipartisan group of 34 AGs, led by California AG Xavier Becerra and Louisiana AG Jeff Landry, sent a letter urging the U.S....more
While gearing up to get trillions of dollars into the economy, the government was also setting in place the mechanism to investigate and prosecute fraud related to these programs. The CARES Act was signed into law on March...more
LEGISLATION, REGULATIONS & STANDARDS - France to Ban Mass Culling of Male Chicks - France’s agriculture minister has reportedly announced that the country will prohibit the mass culling of male chicks shortly after they...more
Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which...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 October 1, 2018, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery issued a 246-page post-trial opinion in Akorn, Inc. v. Fresenius Kabi AG, C.A. No. 2018-0300-JTL, that denied the seller’s (Akorn) request...more
In a 246-page post-trial decision issued this week, the Delaware Court of Chancery ruled that a buyer could terminate a $4.75 billion public company acquisition because of material adverse effects that had occurred at the...more