On March 18, the Advanced Medical Technology Association (AdvaMed) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code or Code), last revised January 1, 2020. The new version...more
A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more
9/17/2020
/ Criminalization ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Free Speech ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Strict Liability ,
White Collar Crimes
The Northern District of Illinois is the latest court to grant a defendant’s motion to dismiss in a False Claims Act (FCA) case, after the relator failed to meet the substantial pleading burden established in the U.S. Supreme...more
3/22/2019
/ False Billing ,
False Claims Act (FCA) ,
FRCP 9(b) ,
Healthcare Fraud ,
Hospira ,
Materiality ,
Medical Devices ,
Medicare ,
Motion to Dismiss ,
Pfizer ,
Relators ,
Universal Health Services Inc v United States ex rel Escobar