The U.S. Supreme Court clarified the standard for a defendant's state of mind in False Claims Act ("FCA") cases, holding that a defendant acts "knowingly"—which the FCA defines also to include deliberate ignorance and...more
Health care industry participants frequently operate under nuanced legal frameworks that apply to the receipt of government funds. A breach of these regulations can open the door to draconian liability under the FCA even when...more
2/14/2022
/ False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Liability ,
Qui Tam ,
Regulatory Standards ,
Regulatory Violations ,
Relators ,
Scienter ,
Statutory Interpretation
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ("FDA") approved license in order to ensure their products are safe for consumption. Until the...more
The Situation: In Spay v. CVS Caremark Corp., the Third Circuit became the latest court of appeals to hold that, in False Claims Act litigation, scienter can be lacking when the government has knowledge of "the facts...more
11/28/2017
/ Acquiescence ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
False Statements ,
Government Knowledge Defense ,
Material Misstatements ,
Materiality ,
Medicare Part D ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar