Drug Product Liability Litigation

More product liability lawsuits are files against prescription drug manufacturers than against all other industries combined. As one scholar put it, the pharmaceutical 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 be a practitioner with 30 years of experience trying such cases, will consider the theory and practice of such litigation before and after the Supreme Court' 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"; in adequate warning; learned intermediary; medical causation; and various forms of damage. We will discuss these issues both in their classic formations in a single lawsuit, but also in the way those principles are applied in mass pharmaceutical litigation where there may be several thousand claimants and multiple jury trial.

The course will also consider the practical application of these doctrines, including the special evidentiary problems when doctors are witnesses; trial 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.