Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced revisions to its voluntary “Code on Interactions with Health Care Professionals” (HCPs), which will take effect January 1, 2022. These revisions...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
On June 18, the Third Circuit affirmed a District of Delaware decision dismissing a False Claims Act (FCA) case against Medco Health Solutions, Inc. because the relator was not an original source of the information underlying...more
One year after the Supreme Court changed the False Claims Act landscape, FCA litigants continue to grapple with the “demanding” materiality standard set forth in Universal Health Services v. United States ex rel Escobar. Now...more
A recent circuit court decision will be a welcome development for False Claims Act defendants because it reinforces a significant pleading hurdle for claims to proceed, with the court citing lack of government intervention as...more