Wednesday, September 30, 2009
Richard Cupp (Pepperdine) has posted to SSRN Preemption's Rise (and Bit of a Fall) as Products Liability Reform: Wyeth, Riegel, Altria, and the Restatement (Third)'s Prescription Product Design Defect Standard. Here is the abstract:
This Article is Professor Cupp's most recent contribution to the discussion of the Restatement (Third) of Torts and its standard for prescription product design defect claims, especially in light of the rising strength of the preemption doctrine and the recent Supreme Court cases of Riegel v. Medtronic and Wyeth v. Levine. Under the Restatement (Third)'s standard, outlined in section 6(c), a prescription product manufacturer may not be held liable in a prescription product design defect case unless no reasonable health care provider would have prescribed the product to any class of persons.
The Article begins by fleshing out section 6(c)'s standard of prescription product design defect liability and explaining why, in Professor Cupp's view, it is a "near-immunity" standard. The Article also briefly addresses the limited number of cases that cite the standard itself, explaining why many courts and commentators appear to not be in favor of it. Then, the Article discusses important recent Supreme Court preemption litigation. This discussion starts with the 1992 case of Cipollone v. Liggett Group, Inc., which was decided around the time formal work on the Restatement (Third) began, followed by three recent cases: Riegel, Wyeth, and Altria Group, Inc. v. Good. The Article then analyzes the Food and Drug Administration (FDA)'s shifting position on whether FDA approval should create preemption, which came to light during the most recent Bush administration. The Article continues by discussing whether section 6(c) reflected the mood of the courts in assessing prescription product design liability at the time of its drafting. This mood, as illustrated in the 1993 Supreme Court case of Daubert v. Merrell Dow Pharmaceuticals, reflected the tendency to favor restricting liability in prescription product design liability cases by employing an increasingly aggressive use of preemption analysis. In conclusion, the Article suggests that recent preemption decisions may parallel the Restatement (Third)'s disdain for prescription product design liability but acceptance of prescription product warning liability.