Recent legal and political False Claims Act (“FCA”) developments signal a potentially turbulent time for the defense of investigations and lawsuits brought under the FCA...more
3/12/2025
/ Anti-Kickback Statute ,
Appeals ,
Constitutional Challenges ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
SCOTUS ,
Trump Administration ,
Whistleblowers
On October 4, 2023, the Department of Justice’s (“DOJ”) Deputy Attorney General Lisa Monaco announced a new “Mergers & Acquisitions Safe Harbor Policy” (“M&A Safe Harbor Policy” or “Policy”) for companies that voluntarily...more
10/19/2023
/ Acquisitions ,
Corporate Misconduct ,
Department of Justice (DOJ) ,
Disclosure ,
Disgorgement ,
Individual Accountability ,
Mergers ,
Remediation ,
Restitution ,
Safe Harbors ,
Self-Disclosure Requirements ,
Sensitive Business Information
On March 2, 2023 and March 3, 2023, in a pair of speeches by Deputy Attorney General (DAG) Lisa Monaco and Criminal Division Assistant Attorney General (AAG) Kenneth Polite, the U.S. Department of Justice (DOJ) announced...more
3/14/2023
/ Clawbacks ,
Compliance ,
Corporate Crimes ,
Corporate Integrity Agreement ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement ,
Executive Compensation ,
National Security ,
OIG ,
Plea Agreements ,
Securities and Exchange Commission (SEC) ,
Self-Disclosure Requirements
As disruption from the COVID-19 pandemic continues, pharmaceutical and medical device companies have been working hard to keep FDA-regulated clinical trials on track. Everyone involved in clinical trials should be acutely...more
12/14/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Data Integrity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry