Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson1 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 a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices […]
Whistleblower Essentials for US Companies
Companies now face an increasingly complicated and evolving landscape of programs announced by prosecutors and regulators that give individuals a financial incentive to report corporate misconduct. In the last year, the US Department of Justice (DOJ) has established several such programs, which complement existing initiatives from the US Securities and […]
Federal Law Enforcement Recommends Encrypted and Ephemeral Messaging
In light of recent reports of cyberattacks on telecommunications companies, the FBI and the Cybersecurity and Infrastructure Security Agency (CISA) issued a series of reports and statements recommending secure communications, including using end-to-end encryption. At the same time, US regulators – including the Department of Justice (DOJ) and the Securities […]
SEC Announces FY2024 Enforcement Results, Including Record-Breaking Financial Remedies
The Securities and Exchange Commission (SEC) recently announced its enforcement results for fiscal year 2024, during which it obtained the highest amount of financial remedies in history at $8.2 billion, representing a 66% increase from FY2023. More than half of that amount is attributable to a $4.5 billion settlement following […]
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 Focuses on AI, Emerging Tech in Newly Issued Guidance Updates for Evaluating Corporate Compliance Programs
On September 23, 2024, the Criminal Division of the US Department of Justice (DOJ) issued an updated Evaluation of Corporate Compliance Programs (ECCP). The updated ECCP emphasizes that companies should address risks associated with new technologies, such as artificial intelligence (AI). The updated ECCP also highlights the importance of incentivizing […]
EDNY Launches New Whistleblower Non-Prosecution Pilot Program
On September 17, 2024, the US Attorney’s Office for the Eastern District of New York (EDNY) announced a new pilot program that offers non-prosecution agreements (typically referred to as NPAs) to individuals who voluntarily disclose information about certain corporate crimes to EDNY. Officials explained that the program, which took immediate […]
A Sword and A Shield: How SCOTUS Expert Testimony Rulings May Benefit Corporate Defendants
The US Supreme Court decided several criminal procedure cases during the 2023 – 2024 term – including Diaz v. United States, 144 S. Ct. 1727 (2024) and Smith v. Arizona, 144 S. Ct. 1785 (2024) – which have relevance and strategic value to corporate defense, despite being facially outside the […]
DOJ Launches New Incentive Program for Corporate Whistleblowers
The US Department of Justice has officially launched its whistleblower rewards pilot program, which offers financial incentives to individuals who report corporate misconduct to the DOJ and meet certain criteria. Deputy Assistant Attorney General Nicole Argentieri has made clear that the DOJ is attempting to break down barriers between whistleblowers […]
Federal Court Dismisses Bulk of SEC’s Complaint Against SolarWinds in Cyberattack Case
On July 18, 2024, US District Judge Paul Engelmayer of the Southern District of New York issued a detailed 107-page opinion and order dismissing most of the US Securities and Exchange Commission (SEC) case against SolarWinds and its chief information security officer (CISO). The SEC’s amended complaint alleged that SolarWinds and its […]