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
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 June 1, 2023, the U.S. Supreme Court issued its highly anticipated decision in the consolidated cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc., Nos. 21-1326 &...more
6/12/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
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
Over the course of a year beginning in March 2020, starting with the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), the U.S. government has approved trillions of dollars in relief funds in efforts to keep the...more
While much of the corporate legal world has been focused on the effects of the COVID-19 pandemic, a little-noticed case working its way through the federal courts in Washington, D.C. threatens to whittle down the scope of...more
5/29/2020
/ Attorney-Client Privilege ,
Auditors ,
Corporate Counsel ,
Corporate Investigations ,
Disclosure Requirements ,
Discovery ,
Document Productions ,
Enforcement Actions ,
False Claims Act (FCA) ,
Interlocutory Appeals ,
Internal Investigations ,
Mandamus Petitions ,
Motion to Compel ,
Popular ,
Privilege Waivers ,
Regulatory Agencies ,
Risk Management ,
Securities and Exchange Commission (SEC) ,
Securities Violations ,
Work-Product Doctrine
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
3/30/2018
/ Acquisitions ,
Anti-Kickback Statute ,
Biotechnology ,
Charitable Donations ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Donations ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Life Sciences ,
Materiality ,
Medical Devices ,
Medicare ,
Off-Label Promotion ,
OIG ,
Park Doctrine ,
Patient Assistance Programs ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Promotional Items ,
Split of Authority ,
Universal Health Services Inc v United States ex rel Escobar ,
Warning Letters ,
Whistleblowers