Lake v. FDA

Norman Lake (plaintiff) invented a nose clip called the Inductive Nasal Device (IND), which Lake claimed could cure colds and allergies. In 1979, Lake sought approval for the IND from the Food and Drug Administration (FDA) (defendant). The IND was automatically classified as a Class III device under the Food, Drug, and Cosmetic Act (FDCA). Class III devices could be marketed only if the FDA granted a premarket-approval application (PMA) for the device. The FDA denied Lake’s PMA because no clinical trials had been conducted for the IND, and the FDA was not convinced that the IND was an effective cold and allergy cure. Lake then petitioned to reclassify the IND as a Class I device under the FDCA. Class I devices included (1) devices for which general statutory controls provided reasonable assurance that the device was safe and effective or (2) devices for which insufficient information was available to determine that the statutory controls would assure the device’s safety and effectiveness, provided the device was not meant for use in supporting or sustaining human life, and the device did not pose a potential unreasonable risk of illness or injury. The FDA denied Lake’s reclassification petition. Lake challenged the FDA’s decision in federal district court. Lake contended that Class I devices should include devices that were unproven to be safe and effective but were not unreasonably risky. The FDA moved for summary judgment, asserting that the lack of scientific evidence regarding the IND’s safety and efficacy presented an unreasonable risk of illness and injury and thus precluded reclassification.