Drug Product Liability Litigation: Principles and Practice

Information Introduction

Section 1, Fall 24

Schedule Information

Enrollment: /18
Credits: 3
Days Time Room Start Date End Date


1300-1500 SL262

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 In re Fosamax (2019). 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. 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. As part of each class, we will also review the manner in which those issues were presented to a jury using the record of a recent pharma products trial. Over the last four weeks of the course, each student will prepare a different portion of a jury statement drawing on the trial transcript and related exhibits (actual internal documents and studies). Each student will prepare a script and slides summarizing their individual topic through an outline, rough draft, and final product (following comments from the instructor). The students will then compile the individual portions into a combined statement which will be delivered by the teams to a jury composed of residents from Charlottesville, much as practitioners do in actual jury research.

Course Requirements

Exam Information

Final Type (if any): None

Description: None

Written Work Product

A short “bench memo” due Week 7 (due directly to instructor, not via EXPO); a section of the final jury presentation; class participation. (N.B. The oral component of the jury presentation will not be graded -- only the individual written components will be evaluated.)

Other Work

Class participation expected.

Other Course Details

Prerequisites: Because the credits in this course count toward the JD Program Professional Skills requirement, JD candidates will be given enrollment priority for this class. Concurrencies: None

Exclusive With: Drug Product Liability Litigation Seminar (9294)

Laptops Allowed: Yes

First Day Attendance Required: No

Course Resources: To be announced.

Course Notes: This 3-credit class will meet concurrently in the same room with the 2-credit Drug Prod. Liab. Litigation Seminar (LAW 9294). The courses do, of course, have different work expectations.

Graduation Requirements

Satisfies Understanding Bias/Racism/Cross-Cultural Competency requirement: No

Satisfies Writing Requirement: No

Credits For Prof. Skills Requirement: Yes

Satisfies Professional Ethics: No

Additional Course Information

Schedule No.: 124817962

Modified Type: Simulation

Cross Listed: No

Waitlist Count: 0

Concentrations: Health Law , Law and Technology , Litigation and Dispute Resolution

Evaluation Portal Via LawWeb Opens: Friday, November 22, 12:01 AM

Evaluation Portal Via LawWeb Closes: Friday, December 06, 11:59 PM

Information reflected on this page was last refreshed at: Friday, July 19, 2024 - 7:02 AM *

*During open enrollment periods, live enrollment data may be found in SIS.