Speaking Engagement

Off-Label Promotion of Drugs and Medical Devices - Criminal and Civil Liabilities 2010

PLI Webcast

05 Oct 2010 01:30 p.m. - 03:45 p.m.

PLI California Center
685 Market Street
San Francisco, CA 94105

Why You Should Attend

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. Our panel 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.

What You Will Learn

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

Who Should Attend

In-house counsel in the pharmaceutical and device industries
Attorneys who practice in the following areas:
- healthcare
- pharmaceutical
- product liability
- FDA regulatory law
- food and drug law
- government investigations
- white-collar
Corporate directors and officers
Regulatory and compliance officers
Risk managers
Ethics officers


Adam S. Hoffinger, Morrison & Foerster LLP (former Assistant U.S. Attorney)
Dr. Jae Hong Lee, Morrison & Foerster LLP (Physician)

For more information about the live webcast, please click here

PLI will provide CLE credit.




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