Criminal and Civil Liabilities for Off-Label Promotions of Drugs and Medical Devices


Morrison & Foerster LLP
12531 High Bluff Drive
San Diego, CA
Siobhan Guthrie
(415) 268-7103

To access this webinar, please go to

This program is being co-hosted with the San Diego Chapter of the Association of Corporate Counsel.

In recent years, the United States Department of Justice has made the investigation and prosecution of pharmaceutical and life sciences companies for unlawful promotion and marketing of products for off-label use a priority.  Companies such as Pfizer, Eli Lilly, Cephalon, Bristol Meyers, Serono, and Purdue Pharma have entered pleas of guilty and paid monumental civil and criminal fines (e.g. $425 million - $2.3 billion) for engaging in off-label marketing and promotion of products such as Bextra, Zyprexa, Oxycontin, Abilify, Gabitril, Actiq and Provigil, and Serostim.  Individual executives and employees also have been held responsible.  Morrison & Foerster has successfully defended companies and individuals in these cases at both the pre-indictment and trial stages as well as in civil lawsuits and regulatory actions. 

This program will cover:

  • Recent developments in the law and types of conduct and activities that the government is targeting 
  • Recent criminal and civil lawsuits, prosecutions, and settlements involving off-label communications 
  • Lessons companies and counsel can apply when designing compliance programs and defense strategies 
  • Red flags that companies should keep an eye out for 
  • Measures that companies can adopt to prevent and defend government investigations and prosecutions. 


  • Adam Hoffinger, Securities Litigation, Enforcement, and White-collar Defense Practice Group, Morrison & Foerster LLP (former Assistant U.S. Attorney)
  • James Huston, Product Liability and Trial Practice Groups, Morrison & Foerster LLP
  • Dr. Jae Hong Lee, Product Liability Practice Group, Morrison & Foerster LLP


11:30 AM – Noon Registration and Lunch
Noon – 1:00 PM   Program

There is no cost to attend this program.

Morrison & Foerster LLP has been certified by the New York State Continuing Legal Education Board as an Accredited Provider of continuing legal education in the State of New York.

This continuing legal education program has been approved in accordance with the requirements of the Continuing Legal Education Board for a maximum of 1.0 credit hours, of which 1.0 credit hours can be applied toward the Professional Practice requirement.




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