Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
9/9/2021
/ Criminal Investigations ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Falsified Documents ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Product Defects ,
Qui Tam ,
Whistleblowers
Enforcement in Life Sciences Series:
Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers -
Recent settlements between the U.S. Department of Justice (DOJ) and a range of...more
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
8/24/2020
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fines ,
Health Care Providers ,
Incentive Compensation ,
Life Sciences ,
Marketing ,
Novartis ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Popular ,
Qui Tam ,
Risk Assessment ,
Risk Mitigation ,
Salespersons ,
Settlement Agreements ,
Speaker Programs
On December 6, 2016, the Supreme Court of the United States ruled unanimously in State Farm Fire and Casualty Co. v. United States ex rel. Rigsby that violations of the False Claims Act’s (FCA) seal requirement do not require...more
On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States ex rel. Escobar1 (Escobar) unanimously upheld the implied certification theory of False Claims Act (FCA) liability and strengthened...more
11/7/2016
/ Appeals ,
Conditions of Payment ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud ,
Government Knowledge Defense ,
Material Misrepresentation ,
Materiality ,
Motion to Dismiss ,
Pleading Standards ,
Qui Tam ,
Scienter ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar
On May 26, 2015, the U.S. Supreme Court issued a rare unanimous decision in a False Claims Act (FCA) case that cuts both ways for the health care industry. In an opinion authored by Justice Samuel Alito, the Court held in...more