In the News

David Graham and Kevin Zielke Co-Author Chapter for Successful Partnering Between Inside and Outside Counsel

July 27, 2015

David P. Graham, Minneapolis-based senior counsel and leader of Dykema’s Food & Beverage Practice Group, and Kevin M. Zielke, Detroit-based member and leader of the firm’s Pharmaceutical Team, have authored a chapter in the Thomson Reuters Westlaw and the Association of Corporate Counsel (ACC) book, Successful Partnering Between Inside and Outside Counsel.

Graham and Zielke’s chapter, “Food & Drug Administration Regulated Institutions: Drug and Medical Device Companies,” discusses certain unique legal challenges medical device and drug companies face and how inside counsel can work with outside counsel to effectively manage legal risk. Topics include:

  • Evaluating and assessing legal matters
  • Evaluating and assessing legal risks
  • Choosing outside counsel
  • Partnering Strategies
  • Fraud and abuse risks
  • Relevant cases law and statutes—The False Claims Act
  • FDA Regulations—Clinical Trials
  • Litigation
  • Effective compliance program checklist
  • FDA inspection checklist
  • Pre-crisis period checklist
  • Crisis period checklist

For more information about this book, click here.