FDA-Based Failure-to-Report Claims State Law Survey

Summary

Attorneys representing drug and medical device companies that manufacture and sell products regulated by the Food and Drug Administration (FDA) are regularly called upon to advise their clients about liability risks associated with their products. This practice note provides information that will help life sciences attorneys understand fundamental issues related to failure-to-warn claims predicated on violations of the reporting requirements of the Food, Drug, and Cosmetic Act (FDCA). After summarizing the legal landscape surrounding FDCA-based failure-to-warn claims, this practice note provides a state-by-state analysis of related common-law duties. This practice note identifies states that recognize FDCA-based failure-to-report claims as a cause of action and provides valuable insight into the case law of those that do not.