Fall 2014
    Law No.: LAW8659
    Sched. No.: 114820937

Drug Product Liability Litigation: Principles and Practice*
Section 1
Grossi, Peter T.

Administrative Information:
During SIS enrollment, check on SIS for real-time enrollment numbers
Days, Times (Room):M, 1600-1800 (SL292)
Capacity:34 **This information is current as of 05/22/2015 06:14:34 AM**
Current Enrollment:34 **This information is current as of 05/22/2015 06:14:34 AM**

Course Description:

More product liability lawsuits are filed against prescription drug manufacturers than against all other industries combined. As one legal scholar put it, the pharmaceutical industry is now “in tobacco-land in terms of how much people hate it,” and drug product liability litigation is now a “growth industry.”

This course will consider the theory and practice of such lawsuits before, and now after, the Supreme Court’s landmark decisions in
Wyeth v. Levine (2009), Plia v. Mensing (2011), and Barnett v. Mutual Pharm. (2013). At the outset, we will focus on the similarities and differences between such litigation and other product liability cases, using the “Phen-Fen” cases tried by the instructor as a model, and on the special context of FDA regulation. We will then consider the legal principles governing such lawsuits, such as inadequate warning; the learned intermediary doctrine; and medical causation. As part of each class, we will review the manner in which those issues were presented to a jury using the edited record of a recent pharma products trial.

The course will also consider the practical application of those doctrines, including the problems when doctors are witnesses; discovery strategies; and techniques to present complex information to juries. For the final class, each student will prepare one short portion of an opening jury statement, based on the edited trial record they have been reviewing, which will then be combined and presented to a “jury” recruited from Charlottesville residents.

COURSE REQUIREMENT: A short “bench memo” due Week 7; a 1200-1500 word section of the final jury presentation due Week 11; class participation. (N.B. The oral component of the jury presentation will not be graded -- only the individual written components will be evaluated.)

This course is on the professional skills course list.