Drug Product Liability (LAW-991-001)
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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 recent landmark decision in Wyeth v. Levine (2009). 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 the controlling 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 these 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 portion of opposing opening statements, based on the edited trial record they have been reviewing, which will then be combined and presented to a “jury” recruited from the D.C. area.
There is no prerequisite for this course.
Course Requirements: A “bench memo” due Week 8; a 6-7 page section of the final jury presentation due Week 12; class participation. No exam.
Textbooks and Other Materials
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First Class Readings
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