A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted...more
6/6/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Oral Argument ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
The U.S. Department of Justice (DOJ) obtained more than $2.2 billion in civil False Claims Act (FCA) judgments and settlements in fiscal year (FY) 2022, the lowest such annual total since 2008 and a significant drop from a...more
2/10/2023
/ Business Litigation ,
Coronavirus/COVID-19 ,
Cybersecurity ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Qui Tam ,
Relators ,
Settlement ,
Whistleblowers ,
White Collar Crimes
The Department of Justice (DOJ) recovered more than $3 billion in settlements and judgments from civil cases involving the False Claims Act (FCA) in the fiscal year ending September 30, 2019, according to statistics released...more
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more
9/23/2015
/ Amarin ,
Commercial Speech ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs