Podcast - “I Lied Like a Dog!”
Sittenfeld v. United States – Campaign Contributions as Crimes?
Podcast - Persistence and Determination
Episode 377 -- Refocusing Due Diligence on Cartels and TCOs
10 For 10: Top Compliance Stories For the Week Ending, July 12, 2025
RICO Section 1962(b): Acquisition or Maintenance of Control Over Legitimate Enterprises — RICO Report Podcast
Podcast - The Seeds of Corruption
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Episode 374 -- Justice Department Resumes FCPA Enforcement with New, Focused Guidance
Daily Compliance News: June 16, 2025, The Golden Share Edition
The JustPod: Defending the "Evil Genius:" A Conversation with Leonard Ambrose
The Presumption of Innocence Podcast: Episode 62 - The Tragic Toll of Conspiracy Theories: The Seth Rich Story
SBR-Author’s Podcast: The Unseen Life of an Undercover Agent: A Conversation with Charlie Spillers
Podcast - "Ready for Trial?"
Podcast - The Law as a Force for Change
The JustPod: A Discussion with Defense Counsel Rocco Cipparone and Angie Levy on January 6 Prosecutions
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
The JustPod: A murder-for-hire allegation, public corruption trial, and notable acquittal
Podcast - Every Case Is a New World
The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more
The May 12, 2025, memo from the head of the Department of Justice’s (DOJ’s) Criminal Division highlights 10 “high-impact” areas as the focus of DOJ’s criminal enforcement efforts. (See our May 14, 2025, client alert “In a New...more
In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more
I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
In a speech on September 15, 2022, Deputy Attorney General (DAG) Lisa Monaco announced several important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. These...more
What is an FDA Warning Letter? Did you receive an FDA warning letter? If so, then there are critical steps you can take today to prepare and to be able to respond promptly to the warning letter. The FDA will issue a...more
Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns....more
In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with colleague Justin Danilewitz, a litigator in the Firm’s White Collar and Government...more
Compliance Today (February 2021) - Purdue Pharma LP pleaded guilty to three felony offenses: “one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two...more
On May 1, 2020, Blue Bell Creameries L.P. (Blue Bell) agreed to plead guilty to charges that it distributed contaminated ice cream products that were linked to a 2015 listeriosis outbreak. The Blue Bell outbreak made...more
In an important set of criminal prosecutions for food safety violations, the Justice Department recently announced resolutions with Blue Bell Creameries and Chipotle Mexican Grill....more
Two core principles of American criminal liability are: (1) a crime does not occur unless the accused has both criminal intent (mens rea) and commits a criminal act (actus reus); and (2) the intent and the act must occur at...more
On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more
Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more
The Trump administration is urging the U.S. Supreme Court not to review the prison sentences given to Quality Egg LLC executives for their role in failing to prevent a national salmonella outbreak. This move indicates that...more
A recent Eighth Circuit decision that two corporate officers must serve jail time for failing to prevent the distribution of contaminated eggs despite the fact that they did not know the eggs were infected reaffirms...more
In 2014, Las Vegas urologist, Dr. Michael Kaplan, was convicted by a federal jury for reusing single-use plastic needle guides during prostate biopsies. He was convicted of conspiracy to commit adulteration in violation of...more
On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...more
Last Thursday, July 7, 2016, a divided panel of the U.S. Court of Appeals for the 8th Circuit upheld a three-month jail sentence against Austin “Jack” DeCoster and his son Peter, the CEO and COO respectively of Quality Egg...more
Over the last ten to twenty years, we have witnessed the expansion of federal criminal prosecution of health and safety matters. Environmental and food and drug regulatory enforcement has been supplemented by aggressive...more
As we enter 2016, adulterated food-related investigations are leading the headlines—and should be leading companies in the food and beverage industry to ask what they can do to prevent and prepare for a potential outbreak on...more
On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more