Drug and Device Product Liability Litigation Strategy

Thousands of lawsuits continue to be filed in federal and state courts each year to seek recovery from manufacturers of pharmaceuticals and medical devices. These lawsuits include individual actions, actions consolidated into federal multidistrict litigation, multi-plaintiff cases, and class actions. As drug and device litigation remains as active as ever, companies that develop new drugs and devices continue to face significant and often costly product liability litigation in the United States.

This new and revised edition of Drug & Device Product Liability Litigation Strategy provides detailed background, discussion, and strategic guidance to those practicing in this field. The book offers lawyers a detailed analysis of the full range of issues involved in drug and device litigation, including pre-litigation counselling, document preservation and discovery, consolidation and mass joinder, multidistrict litigation, class action litigation, admissibility of expert testimony, dispositive and pre-trial motion practice, jury selection, and trial. This second edition not only contains thorough revisions to reflect recent changes in the legal landscape following key court decisions and statutory developments in areas such as preemption, admissibility of expert testimony, the learned intermediary doctrine, and innovator liability, but also contains new analyses of issues such as personal jurisdiction, pre-litigation counselling, and the amended Federal Rules of Civil Procedure. It is an indispensable guide to lawyers handling cases in this high-stake, high-profile, and rapidly evolving area.

Mark Herrmann, Vice President and Chief Counsel, Litigation at Aon Corporation,David B. Alden, Partner, Jones Day,Geoffrey M. Drake, Partner, King and Spalding's Tort Litigation and Environmental Group

Mark Herrmann is Vice President and Chief Counsel - Litigation at Aon Corporation, which is the world's leading insurance and reinsurance broker. Before joining Aon, he was a partner at Jones Day, where his practice focused on the defense of class action and mass tort litigation, including pharmaceutical and medical device cases. He clerked for Judge Dorothy W. Nelson of the United States Court of Appeals for the Ninth Circuit and graduated from The University of Michigan Law School (J.D. 1983) and Princeton University (A.B. 1979).



David B. Alden is a partner in Jones Day's Cleveland office, where his practice focuses on products liability litigation, including pharmaceutical and medical device cases; securities and accounting fraud litigation; and issues relating to the attorney-client privilege and work product protection.


Geoffrey M. Drake is a partner in King and Spalding's Tort Litigation and Environmental Group, where he represents companies in high-exposure product liability, personal injury, toxic tort, commercial and whistleblower litigation, as well as internal and external government investigations. He is also a member of the Next Generation Advisory Board for Emory University's Institute for Complex Litigation and Mass Claims.

1. Introduction
2. The FDA's Regulation of Prescription Drugs and Devices
3. Pre-litigation Counseling
4. Legal Issues & Theories
5. Consolidated Proceedings
6. Aggregated Proceedings - Class Actions
7. Aggregated Proceedings - Multidistrict Litigation
8. Fact Discovery
9. Expert Retention and Discovery
10. Expert Testimony, Rule 702, And Daubert
11. Preemption
12. The Learned Intermediary Doctrine
13. Motions In Limine
14. Jury Selection
15. The Trial Of A Drug Or Device Case
Index