Substantive Updates Part Three: Preparing for Increased Criminal and Civil Enforcement Against Life Sciences Companies – Off-Label, Individual Liability, and More

July 28, 2016 3:45pm

Jennifer Santos
Sr. Corporate Counsel
Vertex Pharmaceuticals (Boston, MA)

Lynn A. Neils
Baker Botts L.L.P. (New York, NY)

Shelly L. Goldklang
Assistant General Counsel
Johnson & Johnson

Yvonne M. Cristovici
Assistant General Counsel
Pfizer Inc (New York, NY)

Rupa Cornell
Senior Director

  • Recognizing the behaviors that may raise a red flag for government enforcers and trigger an enforcement action
  • Updates on the off-label promotion landscape post-Amarin and other First Amendment cases
  • Overview of the year’s top cases and CIAs in the life sciences realm
  • Analyzing the steady trend of staggering penalties and fines for life sciences manufacturers in these cases
  • Addressing the increased threat of individual liability for officers and directors after the Yates Memo
  • Practical considerations for in-house and law firm counsel when faced with an enforcement action