Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
The Seventh Circuit affirmed the dismissal of a False Claims Act (FCA) retaliation suit against AbbVie Inc. (formerly Allergan) brought by former sales representative Jeffrey Lewis. In the complaint, Lewis alleged he was...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
On April 7, 2016, following a three-week trial and after only three hours of deliberations, a federal jury in Dallas, Texas found that Abbott Laboratories had not violated the False Claims Act (FCA) when it marketed bile duct...more
The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more