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

Abstract

This Article compares and contrasts the rocky reception the Restatement (Third) of Torts section 6(c)’s restrictive prescription product design standard has endured with the rise of an increasingly active judicial approach to preemption from the 1990s through the late 2000s. Preemption’s rise may have to some extent crested (at least for now) with Riegel v. Medtronic in 2008, and it showed signs of possible contraction (again, at least for now) with Wyeth v. Levine in 2009. The Article analyzes the effect of preemption’s rise in the 1990s and pre-Wyeth 2000s on developing a generally more restrictive approach to prescription product design defect claims, along with other prescription product defect claims. The article suggests that the restrictive tone of section 6(c) may have to some extent caught the “mood” of courts regarding prescription product design liability, even if the specific details of the unfamiliar standard have not found much traction. Indeed, some of the rationales provided for section 6(c) overlap with some of the rationales the Supreme Court employed in the 1990s and 2000s to support its increasingly aggressive use of preemption analysis in prescription products cases. Thus, the article concludes that the currents underlying section 6(c)’s restrictive tone for prescription product design liability may have found a “back door” in Supreme Court rulings such as Daubert and Riegel, despite most courts’ and commentators’ refusal to provide “front door” acceptance of the Restatement (Third)’s prescription product design defect standard. Further, the article contemplates whether Wyeth may represent the start of a contraction in preemption doctrine or whether its significance will be more limited.

Keywords: tort, restatement, Wyeth, Riegel, Altria, Daubert, Cipollone, products liability, prescription, defect, medical, FDA, design liability, pharmaceutical, preemption, design, warn, immunity, Supreme Court, manufacture