On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more
7/9/2025
/ Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medical Devices ,
Medicare
Key Points -
- The U.S. Department of Justice (DOJ) will resume investigations and enforcement actions under the Foreign Corrupt Practices Act (FCPA), prioritizing, in part, FCPA actions involving cartels and transnational...more
Matthew Galeotti’s recent memorandum as head of the Department of Justice’s (DOJ’s) Criminal Division echoes the Trump administration’s “America First” priorities. It directs the Criminal Division to “strike an appropriate...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
5/16/2025
/ Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fraud ,
Fraud and Abuse ,
Government Agencies ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Pharmaceutical Industry ,
White Collar Crimes
Key Points -
- A new memo suggests DOJ will continue to prosecute white collar fraud and crimes.
- DOJ identified 10 “high-impact” areas of focus, prioritizing crimes that cause harm to government programs, citizens, and...more
On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more
On February 10, 2025, President Donald Trump signed an executive order directing the U.S. attorney general, Pam Bondi, to pause Foreign Corrupt Practices Act (FCPA) actions for 180 days until she issues revised FCPA...more
2/13/2025
/ Anti-Corruption ,
Compliance ,
Corruption ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Executive Orders ,
Foreign Corrupt Practices Act (FCPA) ,
Securities and Exchange Commission (SEC) ,
Trump Administration ,
Whistleblower Protection Policies ,
Whistleblowers ,
White Collar Crimes
The U.S. government’s recent complaint in a relator-filed case under the False Claims Act (FCA):
- Marks the first FCA suit in which the Department of Justice (DOJ) has intervened since launching its ongoing Civil...more
Two recent settlements under the False Claims Act (FCA):
- Signal enhanced risk around cybersecurity for recipients of federal funds.
- Underscore the need to assess compliance with cybersecurity requirements and...more
On April 15, 2024, the Department of Justice’s (DOJ’s) Criminal Division unveiled a new Pilot Program on Voluntary Self-Disclosures for Individuals that offers non-prosecution agreements (NPAs) to individuals who voluntarily...more
4/24/2024
/ Anti-Corruption ,
Anti-Money Laundering ,
Corporate Crimes ,
Corporate Governance ,
Corporate Misconduct ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Pilot Programs ,
Financial Institutions ,
Financial Services Industry ,
Non-Prosecution Agreements ,
Self-Disclosure Requirements ,
Voluntary Disclosure ,
Whistleblower Awards ,
Whistleblowers ,
White Collar Crimes
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
3/25/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Information Technologies ,
Life Sciences ,
OIG ,
Personal Information ,
Pharmaceutical Industry ,
Regulatory Reform
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
11/3/2023
/ Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Hospitals ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
OCR ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
Telehealth ,
Tracking Systems
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
6/8/2023
/ Clawbacks ,
Compensation ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
New Regulations ,
OIG ,
Self-Disclosure Requirements
DOJ Increases Resources To Investigate and Prosecute Sanctions Evasion and Export Control Violations -
On March 2, 2023, during a keynote speech at the American Bar Association’s annual White Collar Crime National...more
3/17/2023
/ Anti-Corruption ,
Bureau of Industry and Security (BIS) ,
Compliance ,
Corporate Entities ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Economic Sanctions ,
EU ,
Export Controls ,
Exports ,
Financial Institutions ,
Foreign Corrupt Practices Act (FCPA) ,
International Trade ,
Office of Foreign Assets Control (OFAC) ,
Russia ,
Self-Disclosure Requirements ,
U.S. Commerce Department ,
U.S. Treasury ,
UK ,
Voluntary Disclosure
On February 22, 2023, the Department of Justice (DOJ) adopted a new policy that establishes a national standard for voluntary self-disclosure credit in corporate criminal enforcement actions brought by U.S. Attorneys’ Offices...more
On January 17, 2023, the U.S. Department of Justice (DOJ) announced revisions to the Criminal Division’s Corporate Enforcement Policy. The revisions follow Deputy Attorney General (DAG) Lisa Monaco’s September 2022...more
1/24/2023
/ Anti-Corruption ,
Anti-Money Laundering ,
Commodities ,
Corporate Governance ,
Corporate Misconduct ,
Cross-Border ,
Department of Justice (DOJ) ,
Economic Sanctions ,
Enforcement Actions ,
False Claims Act (FCA) ,
Investigations ,
Securities and Exchange Commission (SEC) ,
Self-Reporting ,
White Collar Crimes
In a recently published memorandum, Deputy Attorney General (DAG) Lisa Monaco announced important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. In the...more
This quarter’s issue includes summaries and associated court opinions of selected cases principally decided between July and October 2020.
Class Certification
- Cryptocurrency – Definition of a Security
- Derivative...more
12/11/2020
/ Breach of Duty ,
Class Action ,
Class Certification ,
Cryptocurrency ,
Department of Justice (DOJ) ,
Derivative Suit ,
EBITDA ,
Enforcement Actions ,
Excessive Fees ,
Fiduciary Duty ,
Insider Trading ,
Investment Company Act of 1940 ,
Loss Causation ,
Material Misrepresentation ,
Material Misstatements ,
Mergers ,
Pleading Standards ,
PSLRA ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
Securities Litigation ,
Standing ,
Whistleblowers
Former U.S. attorney Jessie K. Liu recently joined Skadden from her role overseeing the U.S. Attorney’s Office in Washington, D.C., which is not only the largest in the country but also home to one of the busiest Civil...more
On July 3, 2020, the U.S. Department of Justice (DOJ) and U.S. Securities and Exchange Commission (SEC) jointly released the second edition of the “Resource Guide to the U.S. Foreign Corrupt Practices Act,” which was...more
7/17/2020
/ Accounting Controls ,
Acquisitions ,
Co-Conspirators ,
Compliance ,
Conspiracies ,
Department of Justice (DOJ) ,
Disgorgement ,
Due Diligence ,
FCPA Resource Guide ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Official ,
Instrumentality ,
Intent ,
Meals-Gifts-and Entertainment Rules ,
Mergers ,
Publicly-Traded Companies ,
Securities and Exchange Commission (SEC) ,
Third Party Payments ,
Travel
Although U.S.-China bilateral tensions eased to a degree earlier this year with the signing of an interim trade agreement, fundamental differences remained. These differences — such as the role that China’s industrial policy...more
4/2/2020
/ Bilateral Agreements ,
China ,
China Initiative ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Disclosure Requirements ,
Failure To Disclose ,
False Statements ,
Mail Fraud ,
Trump Administration ,
US Trade Policies ,
Wire Fraud
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more
10/3/2019
/ Anti-Money Laundering ,
Appeals ,
Blocking Statutes ,
Bribery ,
CFTC ,
China ,
CLOUD Act ,
Communication Restrictions ,
Compliance ,
Conspiracies ,
Cooperation Agreement ,
Crime (Overseas Production Orders) Act 2019 (the COPO Act) ,
Criminal Prosecution ,
Cross-Border Transactions ,
Cryptocurrency ,
Cybersecurity ,
Deferred Prosecution Agreements ,
Denial of Certiorari ,
Department of Justice (DOJ) ,
Deutsche Bank ,
Disclosure ,
Dodd-Frank ,
Economic Sanctions ,
Enforcement Actions ,
EU ,
EURIBOR ,
Exports ,
Extradition ,
Extraterritoriality Rules ,
Financial Conduct Authority (FCA) ,
Financial Records ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Exchanges ,
France ,
Fraud ,
General Data Protection Regulation (GDPR) ,
Government Investigations ,
Hackers ,
Hungary ,
Imports ,
India ,
Indictments ,
Information Sharing ,
Iran Sanctions ,
Israel ,
Lithuania ,
Money Laundering ,
Morrison v National Australia Bank ,
Multinationals ,
Office of Foreign Assets Control (OFAC) ,
Opioid ,
Pharmaceutical Industry ,
Popular ,
Rate-Rigging ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Serious Fraud Office (SFO) ,
Spoofing ,
Subpoenas ,
Swiss Supreme Court ,
Switzerland ,
Tax Crimes ,
Tax Evasion ,
Tax Treaty ,
Turkey ,
UK ,
United States ,
Venezuela ,
Wal-Mart
The ongoing trade tensions between the U.S. and China have caused some U.S. companies to become increasingly concerned that the Chinese authorities may subject their local operations to closer scrutiny, leading these...more
1/23/2019
/ Attorney-Client Privilege ,
China ,
Compliance ,
Criminal Investigations ,
Cross-Border Transactions ,
Department of Justice (DOJ) ,
Foreign Corrupt Practices Act (FCPA) ,
Foreign Jurisdictions ,
Government Investigations ,
Internal Investigations ,
Joint Venture ,
Local Rules ,
Mobile Apps ,
Privacy Laws ,
Remediation ,
Risk Assessment ,
Risk Mitigation
This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including DOJ guidance on the use of corporate monitors in criminal...more
1/7/2019
/ Anti-Bribery ,
Anti-Corruption ,
Anti-Money Laundering ,
Appeals ,
Attorney-Client Privilege ,
Brazil ,
Bribery ,
BSA/AML ,
China ,
Corporate Counsel ,
Criminal Conspiracy ,
Criminal Convictions ,
Criminal Investigations ,
Cross-Border ,
Cryptocurrency ,
Cyber Attacks ,
Cybersecurity ,
Data Privacy ,
Data Protection Acts ,
Department of Justice (DOJ) ,
Enforcement Actions ,
EU ,
Exports ,
Extraterritoriality Rules ,
FATCA ,
Financial Crimes ,
Foreign Corrupt Practices Act (FCPA) ,
Forex ,
France ,
Government Investigations ,
Guilty Pleas ,
Hackers ,
Imports ,
International Litigation ,
Iran ,
Legal Professional Privilege ,
Libor ,
Litigation Privilege ,
Market Manipulation ,
Money Laundering ,
Multi-Jurisdictional Litigation ,
Multinationals ,
NYDFS ,
Privileged Communication ,
Russia ,
Sanction Violations ,
Securities and Exchange Commission (SEC) ,
Securities Fraud ,
SFO ,
Spoofing ,
Tax Fraud ,
Traders ,
UK ,
Unexplained Wealth Orders (UWOs) ,
United Arab Emirates (UAE) ,
Yates Memorandum
On November 29, 2018, in a speech at the 35th International Conference on the Foreign Corrupt Practices Act, U.S. Deputy Attorney General Rod Rosenstein announced the Department of Justice’s (DOJ or the Department) revised...more