“The Eighth Circuit’s decision [against preemption] not only threatens to undermine the public’s confidence in generic drugs; it threatens the long-term viability of the generic pharmaceutical industry in this country.”1

Introduction

More than a year ago, the United States Supreme Court, in Wyeth v. Levine, held that state law failure-to-warn claims against brand-name drug manufacturers are not automatically preempted by the Food Drug and Cosmetic Act (FDCA). Levine applies only to branded pharmaceuticals, and the Court did not address the implications of its holding for generic drug manufacturers. Before Levine, a number of courts found that failure-to-warn claims against generic manufacturers were preempted by the Hatch-Waxman amendments to the FDCA.

The reasoning: because generic manufacturers were required to maintain the “same” label as the branded drug, generic manufacturers could not initiate label changes independent of the branded manufacturer. Generic manufacturers therefore argued that state law failure-to-warn claims could not succeed when the generic manufacturer complied with the FDCA and used the last approved label for the brand-name equivalent drug.