Why Failure-to-Market Claims Are Preempted Under Federal Law

A California appellate court invented out of whole cloth a new and troubling theory of tort liability. Specifically, the court held that drug companies have a duty to develop and bring to market drugs that are supposedly safer and more effective than another, FDA-approved drug the company sells already. The claim rested on factual premises contradicted by all publicly available information, the acceptance of which could seriously disrupt the FDA approval process. This disruption gives rise to an issue the parties did not raise on appeal and that the appeals court never addressed, notwithstanding the complex, comprehensive statutes governing drug approval: these state tort law claims are preempted under theories of both field and conflict (including obstacle) preemption. This White Paper explains why it is imperative for the federal government and private parties to advance these preemption arguments, and why the courts should accept them.