Drug Product Liability Litigation: Principles and Practice

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.