backRecently, industry has won significant victories in criminal and civil off-label promotion cases. On February 29, 2016, Vascular Solutions, Inc. (VSI) and the company’s CEO, Howard Root, were acquitted of all charges in a criminal case brought by the Department of Justice related to alleged off-label promotion of a medical device. In addition, Amarin Pharmaceuticals, Inc. and Pacira Pharmaceuticals, Inc. brought declaratory judgment actions against FDA seeking to make certain promotional claims without the threat of prosecution. Amarin and Pacira successfully resolved their lawsuits through favorable settlement agreements, and the companies are now free to make the claims at issue. These favorable outcomes demonstrate that litigation, both offensive and defensive, can be a powerful tool to protect the rights of manufacturers and to shape off-label policy. In this session, partners from King & Spalding who defended VSI will share key lessons learned and offer advice for how pharmaceutical and medical device companies can capitalize on recent industry victories in their future government interactions.
Program Speakers
- John Richter
- Jeffrey Bucholtz
- Lisa Dwyer
For more information, contact:
Glenda R. Smith
Senior Paralegal
King & Spalding LLP
1180 Peachtree Street NE
Atlanta, GA 30309
+1 404 572 3017 Direct
glendasmith@kslaw.com
The King & Spalding University e-Learn Series offers monthly one-hour interactive panel presentations. There is no expense to participants.