The Case for a "Strong" Regulatory Compliance Defense

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Federal administrative agencies have established safety standards or licensing procedures for airplanes, motor vehicles, pesticides, drugs, medical devices, and a variety of other products. At the same time, product sellers are subject to tort liability even though their products comply with applicable federal safety standards. Product sellers maintain that compliance with federal safety standards ought to protect them from liability under state tort law and have relied upon several legal principles to support this claim. The first, and most successful, theory is federal preemption. Under this concept, Congress may expressly or impliedly assert the primacy of federal law under the Supremacy Clause of the U.S. Constitution, thereby displacing competing (or even complementary) state regulation. So far, product manufacturers have successfully invoked the doctrine of preemption to defeat damage claims by injured consumers in connection with cigarette labeling, pesticide labeling, motor vehicle design, and medical device labeling and design.

The regulatory compliance defense is another concept that can limit tort liability. In its strong version, the regulatory compliance defense provides that a product is not defective if it meets applicable regulatory standards or requirements. However, very few jurisdictions recognize regulatory compliance as a complete defense to tort liability. Instead, most courts allow juries to take compliance with regulatory standards into account, but steadfastly refuse to treat federal safety standards as anything more than minimum standards.

Part I of this Article provides a brief overview of significant federal product safety legislation. Part II sets forth the argument that administrative agencies can regulate product safety more cheaply and effectively than tort law. The concept of federal preemption is discussed and critiqued in part III. Part IV focuses on the conventional treatment of regulatory compliance in products liability law and proposes a "strong" regulatory compliance defense that will foreclose most damage claims against product manufacturers who comply with federal safety standards. Finally, part V analyzes the effect such a proposal would have on product safety and the compensation of injured consumers. The Article concludes that the administrative cost savings that a strong regulatory compliance defense would achieve should more than offset any negative effects that the defense might have on product safety and victim compensation.

Original languageAmerican English
Pages (from-to)1210-1267
JournalMaryland Law Review
Issue number3
StatePublished - Jan 1 1996


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