Colacicco v Apotex Inc. and the Federal Preemption of State Tort Remedies for Health Injuries: Implications for Public Health Policy and Practice

This installment of Law and the Public’s Health reviews a federal appeals court decision in Colacicco v Apotex Inc.1 and considers its implications for public health policy and practice. The Colacicco decision is emblematic of a fundamental change in U.S. public health policy: the federal preemption of state laws permitting individuals to recover damages for health injuries in favor of a uniform national regulatory system with public health safety enforcement powers solely in the hands of a federal agency. If affirmed by the U.S. Supreme Court (and its 2008 decision in Riegel v Medtronic, Inc.2 suggests a decisive shift toward federal preemption of state tort laws as they affect the drug and device industries), this change would leave individuals who are injured by prescription drugs with no direct legal recourse. At a time when public confidence in the ability of the U.S. Food and Drug Administration (FDA) to keep the public safe is at an ebb as the result of several highly publicized regulatory failures,3,4 the Colacicco decision raises significant implications for the future of public health. This decision, coupled with a newly aggressive effort on the part of the FDA to expand its preemptive reach, is the subject of this column.