Federal Preemption of State Law Remedies in the American Pharmaceutical Industry

Federal preemption - addressed within the United States Constitution’s Supremacy Clause - is the legal doctrine pursuant to which federal law supersedes state law. As it pertains to the American pharmaceutical industry, the Food and Drug Administration (FDA) supersedes state tort laws regarding the regulation of pharmaceutical research, development, and distribution. However, federal preemption within the pharmaceutical industry has engendered conflicts between pharmaceutical manufacturers and consumers in pursuit of state law remedies after becoming injured by the administration of a generic pharmaceutical. An exploration of the brand name pharmaceutical regulatory process and the generic pharmaceutical regulatory process implemented by the FDA within this thesis highlights the abbreviated pathway offered to generic pharmaceutical manufacturers to lower the cost of production. Brand name pharmaceutical manufacturers must satisfy arduous FDA regulatory requirements for the approval of a brand name pharmaceutical - sometimes taking up to 15 years. Conversely, generic pharmaceutical manufacturers must prove bioequivalence - biochemical equivalence - among other things, in order to be granted industry entry. This process can take as little as 6 months. As a result of this disparate regulatory landscape between brand name pharmaceuticals and generic pharmaceuticals, consumers may be led to believe that generic pharmaceuticals offer no legal recourse in the event that they produce inimical effects. Examples of this occur in the Supreme Court cases PLIVA v. Mensing (2011), and Merck Sharp & Dohme Corp. v. Albrecht (2019). In contrast, the Supreme Court case Wyeth v. Levine (2009) and the state court case Franzman v. Wyeth (2015) are examples of consumers’ state tort law claims proceeding, as their claims were not barred on the basis of federal preemption. These cases emphasize manufacturer liability for failure to comply with FDA regulatory requirements. The comparison between brand name pharmaceuticals and generic pharmaceuticals underscores the complexities of federal preemption, and its success in upholding safety and efficacy standards implemented by the FDA.