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More product liability lawsuits are filed against prescription drug manufacturers than against all other industries combined. As one 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 a "growth industry." This course, which will be taught by a practioner with 25 years of experience trying such cases, will consider the theory and practice of such litigation before, and now after, the Supreme Court's landmark decision in Wyeth v. Levine.
At the outset, we will focus on the similarities and differences between pharma cases and other product liability cases, using the "Phen-Fen" (Diet Drug) cases tried by the instructor as a model, and on the special context of FDA regulation. We will then consider the legal doctrines governing such lawsuits, such as "failure to test"; inadequate warning; learned intermediary; medical causation; and various forms of damages. We will discuss these issues both in their classic formulations in a single lawsuit, but also in the way those principles are applied in the context of a mass pharmaceutical litigation where there may be several thousand individual claimants and multiple jury trials.
The course will also consider the practical application of these doctrines, including the special evidentiary problems when doctors are witnesses; discovery tactics where regulatory agencies are involved; techniques to present complex scientific material to juries; approaches to trial examination; and jury selection strategies. Again, we will review both the legal principles governing these issues and the way they are often mutated in the context of mass claims and trials.
Course Requirements: Class participation (20%); short mid-term "bench memorandum" in mid-October (40%); take-home final exam (open book) in mid-November (40%).
Note: The course will meet on September 10, 11, 17 and 18; October 1, 2, 8, 16, 22, 23, 29 and 30.
© 2013 The President and Fellows of Harvard College. All rights reserved.
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