Prerequisites: None

Exam Type: Any Day Take-home

Class participation (5%); mid-term (40%); final exam (15%); jury presentation (40%).

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 practitioner with 25 years of experience trying such cases, will consider the theory and practice of such litigation before and 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; jury selection strategies; and the problems in structuring mass tort settlements. 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. The final class will focus on the alternative ways vaccines and pandemic treatment drugs are regulated and litigated.

Note: There is also a two-credit version of this course. The three-credit version of the course will include all of the classes and materials in the two-credit version. In addition, the students who elect to take the three-credit version will review, in detail, the transcript of an actual trial of a drug product liability case. They will then each prepare a 4-5 page (with Powerpoints) section of competing statements they will present, in teams, to a jury composed of Cambridge residents (not members of the HLS community). The jurors, in turn, will provide their reactions, much as the jury research most sophisticated practitioners conduct prior to major product liability actions. The three-credit version will include additional class time to work as a team on the presentation. The presentation to the jurors will be a final (3 hour) class.