Drug Product Liability Litigation: Principles and Practice

Section 1, Fall 22

Schedule Information

Enrollment: 17/17
Credits: 3
Days* Time Room Start Date End Date
  • M
  • 1300-1500
  • SL268
09/05/2022 12/05/2022
*“R” means Thursday

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 Info:
Final Type (if any): None
Description: None

Written Work Product
Written Work Product: A short “bench memo” due Week 7; 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
Mutually 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 Writing Requirement: No
**Credits For Prof. Skills Requirement: Yes
Satisfies Professional Ethics: No

*If “Yes,” then students are required to submit a substantial research paper in this course, which means students do not need to submit any form to SRO for this paper to meet their upper-level writing requirement. If “No,” then students must submit a “special request” e-form to SRO (available via LawWeb) no later than five weeks after the start of the term for a paper in this class to be counted toward the upper-level writing requirement.

**Yes indicates course credits count towards UVA Law’s Prof. Skills graduation requirement, not necessarily a skills requirements for any particular state bar.

Schedule No.
Law No.
Modified Type
Cross Listed: No
Cross-Listed Course Mnemonic:
Public Syllabus Link: None
Evaluation Portal Via LawWeb Opens: Wednesday, November 30, 12:01 AM
Evaluation Portal Via LawWeb Closes: Friday, December 09, 11:59 PM