Cabiroy v. Scipione

Frank Cabiroy (plaintiff) was treated by Dr. Richard Scipione (defendant) with liquid-silicone injections to cosmetically improve a nasal deformity. The bottle of liquid silicone Dr. Scipione used was not sealed, sterile, or labeled. The injections caused lumps to form on Cabiroy’s nose, which later needed to be removed with a scalpel. Cabiroy sued Dr. Scipione for medical malpractice. The Food, Drug, and Cosmetic Act (FDCA) gave the federal Food and Drug Administration (FDA) comprehensive jurisdiction over all devices intended for human use. Devices were classified as Class I, II, or III based on their potential danger to the public. Class III devices were the most heavily regulated and must have undergone an extensive application process before they obtained FDA approval. Liquid injectible silicone was a Class III device. The FDCA also stated that the receipt in interstate commerce of any drug, device, or cosmetic that is auldutered or misbranded is prohibited. It was established at trial that the FDA had not approved the use of liquid silicone for injections. Cabiroy sought to establish that Dr. Scipione was negligent per se for violating the FDA’s provisions and the FDCA statute that prohibited the receipt in interstate commerce of any drug or device that is adulterated or mislabeled. Dr. Scipione moved for nonsuit on the issue of negligence per se. The court granted the motion, and the jury found in favor of Dr. Scipione. Cabiroy filed post-trial motions claiming that the court erred in granting the nonsuit on the issue of negligence per se. The trial court accepted this argument and ordered a new trial. Dr. Scipione appealed, challenging the grounds on which a new trial was granted.