Recently, in United States ex rel. Hart v. McKesson Corp., the Second Circuit clarified the standard for acting “willfully” under the federal anti-kickback statute (AKS).
False Claims Act relator Adam Hart alleged that...more
The Supreme Court will hear argument next week in two consolidated cases that will decide what standard applies when a doctor asserts a good faith defense to a criminal prosecution for unlawful drug distribution. ...more
2/23/2022
/ Certiorari ,
Controlled Substances ,
Criminal Convictions ,
Criminal Prosecution ,
Drug & Alcohol Abuse ,
Drug Distribution ,
Enforcement Actions ,
Food & Drug Regulations ,
Good Faith ,
Opioid ,
Physicians ,
Prescription Drugs ,
SCOTUS
Novartis Pharmaceuticals Corp. agreed earlier this month to pay $678 million to settle an SDNY False Claims Act case. The SDNY alleged that Novartis violated the False Claims Act and the Anti-Kickback Statute by giving...more
Compound prescription drugs have increasingly become a target for DOJ health fraud enforcement activities. ...more
In United States ex rel. Wood v. Allergan, Inc., the Second Circuit addressed the issue of whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of an action or whether it can be cured by the...more
9/11/2018
/ Allergan Inc ,
Amended Complaints ,
Anti-Kickback Statute ,
False Claims Act (FCA) ,
First-to-File ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Pharmaceutical Industry ,
Prescription Drugs ,
Qui Tam ,
Stark Law
Last week, in United States v. Scully, the Second Circuit vacated the conviction of a distributor of pharmaceutical products on misbranding charges due to evidentiary issues surrounding his advice-of-counsel defense at trial....more
12/19/2017
/ Advice-of-Counsel Defense ,
Criminal Conspiracy ,
Criminal Convictions ,
Evidence ,
Food and Drug Administration (FDA) ,
Foreign-Made Goods ,
Legal Advice ,
Medical Devices ,
Misbranding ,
Pharmaceutical Industry ,
Prescription Drugs ,
Vacated
The Second Circuit recently agreed to accept an interlocutory appeal to decide the question whether a violation of the False Claims Act’s “first-to-file” rule compels dismissal of the complaint or whether it can be cured by...more
9/5/2017
/ Allergan Inc ,
Anti-Kickback Statute ,
False Claims Act (FCA) ,
First-to-File ,
Healthcare Fraud ,
Interlocutory Appeals ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Qui Tam