The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more
n June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief is...more
8/23/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Health Insurance ,
Healthcare ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Scienter ,
SCOTUS ,
Subjective Standard ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
On June 1, 2023, the U.S. Supreme Court unanimously settled a long-standing dispute over a subjective versus objective standard for scienter under the False Claims Act (FCA), holding that a defendant’s own subjective belief...more
8/23/2023
/ False Billing ,
False Claims Act (FCA) ,
Healthcare ,
Medicaid ,
Medicare ,
Objective Unreasonableness Standard ,
Pharmacies ,
Prescription Drugs ,
Qui Tam ,
Reasonableness Factors ,
Scienter ,
US ex rel Tracy Schutte et al v SuperValu Inc et al