Tag: Enforcement
UK Publishes Guidance on Failure to Prevent Fraud: Companies Without “Reasonable Prevention Procedures” Could Be Held Criminally Liable
On 6 November 2024, the UK government published guidance in respect of the failure to prevent fraud offence, which was introduced in the Economic Crime and Corporate Transparency Act 2023 (ECCTA).Under this offence, companies may be held criminally liable if they did not have ‘reasonable prevention procedures’ in place when a fraudulent act was […]
DOJ to Launch New Whistleblower Rewards Program
On March 7, 2024, US Deputy Attorney General Lisa Monaco announced a new program that will financially reward whistleblowers who notify the Department of Justice (DOJ) of “significant” corporate misconduct. This announcement served as the kickoff of a 90-day “sprint” to develop a pilot program. The formal program launch will […]
Proceed With Caution: Federal Courts of Appeal Uphold Criminal Convictions for Misbranding Violations Under FDCA
Voluntary compliance may be the backbone of the Federal Food, Drug, and Cosmetic Act (FDCA), but when the US government believes that a company is unwilling or unable to achieve compliance, it will seek to enforce the FDCA both civilly and criminally. Two recent cases reaffirm that the federal government […]
DOJ Warns of Harsher Punishment for Crimes Committed Using Artificial Intelligence
On February 14, 2024, Deputy Attorney General Lisa Monaco announced that prosecutors would seek stricter sentences for crimes perpetrated using artificial intelligence (AI). Monaco also announced a new initiative – Justice AI – to study the effective use of AI in the justice system. Monaco’s comments are the latest confirmation […]
Featured in Law360: Landmark Product Safety Prosecution May Signal Sea Change
In November 2023, a jury convicted two corporate executives of conspiracy and failure to report information about defective residential dehumidifiers, as required by the Consumer Product Safety Act (CPSA). The jury verdict in U.S. v. Chu is the first-ever criminal conviction of corporate executives for failure to report under the […]
Online Service Providers: Obligations Under The UK’s Online Safety Act 2023
The UK’s Online Safety Act (OSA) 2023, which became law on 26 October 2023, imposes extensive new obligations on certain types of online service providers, requiring them to protect their users by identifying, mitigating, and managing risks relating to illegal and harmful content. The OSA applies to certain service providers […]
Parallel SEC, FDA Regulatory Enforcement: What Life Sciences Companies Should Know
Life sciences companies, take note: While parallel enforcement by the Securities and Exchange Commission (SEC) and the Food and Drug Administration (FDA) is not new, it appears to be gaining favor among regulators. Cooley partners Luke Cadigan and Sonia Nath recently co-authored an article in the Food and Drug Law […]
The Jury Has Spoken: Two Executives Convicted in Groundbreaking Consumer Product Safety Prosecution
Editor’s note: Authored by Daniel Grooms, Matt Howsare and Shawn Skolky, this article was originally published in Law360. In November 2023, a jury convicted two corporate executives of conspiracy and failure to report information about defective residential dehumidifiers, as required by the Consumer Product Safety Act.[1] The jury verdict in U.S. […]
DOJ Announces New Safe Harbor Policy for Voluntary Self-Disclosure in M&A
The Department of Justice continues to make clear that one of its principal corporate enforcement priorities is encouraging companies to voluntarily self-disclose misconduct. To that end, the DOJ recently announced its decision to decline to prosecute Lifecore Biomedical, a pharmaceutical and medical device manufacturer, despite evidence that employees of Lifecore’s […]
When Are Redactions Reasonable?
The long-running investigation by the Serious Fraud Office (SFO) into Eurasian Natural Resources Corporation (ENRC) has provided several points of instructive guidance during its lifetime – and that trend looks set to continue. The most recent matter before the High Court[1] examined certain redactions the SFO made to a report it […]