United States v. Alcon Laboratories

Alcon Laboratories (defendant) manufactured a prescription antiemetic drug, WANS, that had been used under medical supervision in various dosage strengths for 25 years without Food and Drug Administration (FDA) concern until the FDA’s Neurologic Drugs Advisory Committee sent a letter outlining concerns about a lack of evidence of safety and efficacy for some of the drug’ components and reports of adverse and even fatal reactions in children who were treated with drugs containing the same component. The FDA notified Alcon that it considered Alcon’s marketing of WANS to be in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and asked for a reply within 10 days. Alcon responded with proposed revised labeling that the FDA called an improvement but not a substitute for scientific evidence. Alcon continued to manufacture WANS, and the FDA instituted a seizure action in federal court and by court order seized a large quantity of WANS. Alcon continued to manufacture WANS, and the FDA instituted further action and sought a temporary restraining order (TRO) and preliminary and permanent injunctions. The district court denied the TRO and consolidated the injunctive and seizure actions. Nothing further happened for two years until the FDA instituted a second seizure action and again confiscated large quantities of WANS. That seizure action was consolidated with the previous actions. Thereafter, the district court issued an order enjoining the FDA from instituting any further seizure actions against Alcon or WANS in any forum and neutralizing its prior seizures pending further administrative proceedings and remanded the matter back to the agency. The FDA appealed.