Pharmaceuticals are subject to what are, in effect, two overlapping and often conflicting regimes for overseeing drug safety: mandatory regulation by the U.S. Food and Drug Administration and lawsuits seeking billions of dollars in damages in the common-law state tort system. This dual system is both irrational and destructive, particularly insofar as it discourages innovation, raises drug prices, and denies patients access to many medicines that are reasonably safe and effective.

   The FDA’s regulatory regime, while imperfect in many respects, is nonetheless better suited to weighing the benefits and risks of new medicines than state courts, which may consider liability for harm only to the particular plaintiffs before them. State tort litigation thereby exacerbates the effects of the FDA’s biases and raises consumer prices. In many instances, state tort law directly contradicts the FDA’s considered decisions. Product-liability directives can vary from state to state—indeed, from courtroom to courtroom—and jurors’ decisions are impaired by a lack of expertise, hindsight bias, and rules that prohibit the very kind of social cost-benefit analysis that the FDA is obliged to employ. Public policy reforms should focus on providing just compensation for victims while minimizing waste, containing costs, and ensuring that the public has access to a wide array of safe medical products. This goal can be accomplished most effectively by allowing for federal preemption of state courts in drug and medical device litigation along with administrative compensation modeled after the Vaccine Injury Compensation Program.