United States v. Universal Management Services, Inc.
United States Court of Appeals for the Sixth Circuit
191 F.3d 750 (1999)
- Written by Mary Phelan D'Isa, JD
Facts
Universal Management Services, Inc. (UMS) (defendant) sold and distributed pain-relieving devices known as the Stimulator and the Extender without approval from the Food and Drug Administration (FDA). The devices, which essentially consisted of electric gas grill igniters equipped with finger grips and extensions, were advertised to relieve numerous kinds of pain when the devices delivered electric currents to acupressure points on the body. UMS sold 800,000 for $88.30 each, at a cost of one dollar per unit. In May of 1995, the FDA had more than $1.2 million worth of the devices seized under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA) and informed UMS that if distribution of the devices continued without FDA approval, further action would be taken. Distribution did not end, and the FDA sought and was granted a permanent injunction preventing UMS from further distributing the devices and an order requiring UMS to offer full refunds to customers who had purchased devices after the May 1995 seizure. The district court found that restitution was a proper remedy under the FDCA. UMS appealed and argued that restitution was not a permitted remedy under the FDCA and even if it was, restitution was not appropriate in this case.
Rule of Law
Issue
Holding and Reasoning (Suhrheinrich, J.)
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