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Cabiroy v. Scipione

In a medical malpractice case, the jury should have been permitted to consider patient's claim of negligence per se where defendant doctor violated FDA statutes and regulations classifying liquid injectable silicone as dangerous to the public.

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J. A44006/00

� 1 This is an appeal from a trial court order granting Appellee-Plaintiff’s request for post-trial relief and awarding a new trial. We affirm.

� 2 Appellee commenced this action alleging Appellant committed medical malpractice when he treated Appellee with injections of liquid silicone to cosmetically improve a nasal deformity. It was alleged that the silicone injections caused lumps to form on Appellee’s nose, which later had to be shaved off with a scalpel. It was established at trial that the FDA had never approved the use of liquid silicone for injections and that Appellee signed a consent form stating he understood that silicone injections were not FDA approved. At the close of Appellee’s case, the trial court granted Appellant’s motion for non-suit on the issue of negligence per se for violation of FDA statutes and regulations. The court also charged the jury that the FDA had no authority to regulate the practice of medicine by a physician treating a patient. The jury returned a verdict in favor of Appellant, in response to which Appellee filed post-trial motions. Appellee claimed the court erred in granting the non-suit on the issue of negligence per se and that the court’s charge to the jury on the lack of the FDA’s authority to regulate the practice of medicine was in error. The trial court accepted these arguments and ordered a new trial. This appeal followed.

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