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Medical Devices › Pharmaceutical Industry › Misbranding

Troutman Pepper

Did Congress Intend to Criminalize Off-Label Promotion? One District Judge Suggests the Issue Is Ripe for Review

Troutman Pepper on

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

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - July 2020

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more

Farrell Fritz, P.C.

Second Circuit Vacates Conviction of Pharmaceutical Distributor on Advice-of-Counsel Defense

Farrell Fritz, P.C. on

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

Cadwalader, Wickersham & Taft LLP

The Responsible Corporate Officer Doctrine in the Wake of DeCoster

Cadwalader, Wickersham & Taft LLP on

Executive Summary: The most important Park doctrine case in over forty years may be heading to the Supreme Court – but not if the federal government has its way. The Responsible Corporate Officer doctrine (“RCO doctrine”),...more

Wilson Sonsini Goodrich & Rosati

Federal Government Continues to Bring Actions Against Pharmaceutical and Medical Device Companies and Individuals for Alleged...

Wilson Sonsini Goodrich & Rosati on

The Office of Inspector General (OIG) for the Department of Health and Human Services recently released its Semiannual Report to Congress. Through the first three quarters of 2015, OIG announced recoveries of $3.35 billion...more

Morgan Lewis

Practical Implications from Amarin

Morgan Lewis on

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

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