Committee of Dental Amalgam Manufacturers v. Stratton

California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) required consumer warnings for any products and services involving identified chemicals known to pose a health risk. California identified mercury as a product that causes reproductive harm. Because mercury is a component part of dental amalgam, Proposition 65 required consumer warnings for dental amalgam. A group of dental amalgam manufacturers sued the state, alleging that Proposition 65 was preempted under the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA), which did not impose a warning requirement on dental amalgam. Under an explicit preemption provision in the MDA, state requirements are only preempted if the Food and Drug Administration (FDA) has established specific counterpart regulations or there are regulations applicable to a specific device. The district court, not finding any specific FDA regulations relating to dental amalgam, nevertheless held that Proposition 65 was preempted under the MDA and granted summary judgment to the manufacturers. In so doing, the district court specifically found that the MDA provisions were specific enough to trigger preemption and the fact that the FDA had not imposed any reproductive toxicity requirements on dental mercury was itself preemptive. The state appealed.