Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability

Abstract

This essay, which is part of a symposium about the government standards defense for FDA-regulated products, generally argues in favor of the recognition of a rule that would make compliance with agency regulations conclusive evidence of non-defectiveness. Although they are not formally obligated to adopt such rules as particularizing the standard of care in tort litigation (at least absent federal preemption), judges should take them far more seriously than they do at present. As the decision-makers empowered by the citizenry to set safety standards, legislatures and regulatory agencies select levels of product risk that they deem appropriate, based on scientific, economic, and political considerations. But when the courts treat these standards as presumptively sub-optimal, they arrogate such important societal decisions for themselves. As a result, often unsophisticated jurors in different parts of the country will make their own judgments about appropriate prescription drug and medical device labeling and design, thereby second-guessing the far more expert, politically accountable, and uniform determinations made by the FDA in the course of promulgating a rule. When their arguments fail to move agency officials, consumer activists should not get to keep waging what they regard as the good fight in the more congenial arena of tort litigation, addressing their evidence to often receptive panels of jurors who are accountable to no one for decisions that have undoubted regulatory effects. If federal safety requirements appropriately set the standard of care (through a negligence per se instruction) when that helps plaintiffs (notwithstanding fears of regulatory obsolescence or ambiguity that are emphasized by opponents of the government standards defense), then compliance with those very same safety requirements should satisfy the standard of care in products liability cases even though that happens to help defendants.

JEL Classification: K13