Drug Product Liability Litigation: Principles & Practice

Section 1, Fall 15

Schedule Information

Enrollment: 32/32
Credits: 3

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 Requirements

Exam Info:
Midterm Type (if any):
Description: None

Final Type (if any):
Description:

Written Work Product
Written Work Product:

Other Work

Other Course Details
Prerequisites: None Concurrencies: None
Mutually Exclusive With:
Laptops Allowed: Yes
First Day Attendance Required: No
Course Notes:

Graduation Requirements

*Satisfies Writing Requirement: No
**Credits For Prof. Skills Requirement: Yes
Satisfies Professional Ethics: No

*Yes means professor requires everyone in the course to submit a substantial research paper (which is the requirement standard in Academic Policies), so no paperwork required to be submitted to SRO. No means student must timely submit paperwork to SRO if intending to use a paper in this course to satisfy the 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.

General Information

Schedule No.
115819826
Law No.
LAW8659
Modified Type
Seminar
Cross Listed: No
Cross-Listed Course Mnemonic:
Public Syllabus Link: None
Evaluation Portal Via LawWeb Opens:
Evaluation Portal Via LawWeb Closes: