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A jury should have been allowed to consider a claim of negligence per se against a doctor who allegedly violated FDA regulations by injecting silicone into a patient’s nose, Pennsylvania’s Superior Court has ruled. The three-judge panel in Cabiroy v. Scipione found that defendant Dr. C. Richard Scipione owed a duty to plaintiff Frank Cabiroy and that he breached that duty. According to the opinion written by Judge Joseph Del Sole, Cabiroy sued Scipione after the doctor treated Cabiroy’s nasal deformity with silicone injections. The silicone injections allegedly caused lumps to form on Cabiroy’s nose, which later had to be shaved off with a scalpel. At trial, it was established that the FDA had not approved the use of silicone injections and that Cabiroy had signed a consent form stating he understood that. The Philadelphia Common Pleas Court granted Scipione’s motion for summary judgment on the issue of negligence per se for violating the FDA’s guidelines. The court then instructed the jury that the FDA does not have the authority to regulate a physician’s treatment of a patient. The jury returned a verdict for Scipione, and Cabiroy filed post-trial motions. The trial court ordered a new trial, and Scipione appealed to the Superior Court. On appeal, Scipione first argued the trial court was wrong in finding that the jury should have been allowed to consider the claim of negligence per se. Del Sole explained that the concept of negligence per se establishes a duty and the breach of that duty where a person violates “an applicable statute, ordinance or regulation designed to prevent a public harm.” Once a plaintiff proves negligence per se, he or she cannot recover unless he or she proves the negligence was the proximate cause of the injury, Del Sole said. Pertinent to Cabiroy’s case were the Medical Device Amendments to the Food, Drug and Cosmetic Act, which gave the FDA jurisdiction over any “devices intended for human use.” Under the MDA, liquid injectable silicone is classified as a Class III device, which are the most heavily regulated and must either undergo an intense pre-market approval process or must be shown to be substantially similar to a device already on the market. Del Sole said Scipione was up front with Cabiroy that silicone injections were not yet FDA-approved but that he told the patient he believed they would be approved soon. “[Scipione] testified that he received his supply of liquid injectable silicone from a Richard Webster, M.D., now deceased,” Del Sole said. “[Scipione] testified that he believed it to be medical-grade silicone which was used for the injection, although it was housed in an eight-ounce glass bottle which was not sealed, or sterile, and which did not bear a manufacturer’s label.” Cabiroy based his lawsuit, therefore, on a violation of 21 U.S.C. Section 331, which prohibits “the receipt in interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise.” Del Sole said it was Cabiroy’s job to establish whether the statute was intended to protect a group of individuals rather than the public at large and whether the statute clearly applied to Scipione’s conduct. Scipione argued that the trial court failed to consider whom the MDA was meant to protect. Del Sole said it was clear the MDA was meant to protect a class of individuals. “We conclude that although no private cause of action is set forth in the act, it was certainly designed to protect a particular class of individuals — those such as [Cabiroy] who may be receiving some type of drug or devices,” Del Sole wrote. The trial court was therefore correct to reverse its prior ruling, he said. “In this case the statute was designed to protect an individual such as [Cabiroy] from being administered a non-labeled, non-sterile unapproved drug to avoid unexpected negative results,” Del Sole said. “Through proof of such violation, [Cabiroy] proved as a matter of law the first two elements of his cause of action, the duty and the breach of duty. This, coupled with any evidence presented on causation and damages, were matters for the jury’s consideration.” Turning to the jury instruction issue, Del Sole said the trial court accepted Cabiroy’s contention that its instruction gave the jury the impression that a doctor can give a patient any drug he or she wants. The trial court noted that the original instruction was given before the state supreme court’s decision in Southard v. Temple University Hospital, from 1999. The court in Southard said that the FDA “minimally” regulates the practice of medicine in several ways, such as by requiring that a medical device be approved for at least one use before a doctor can use it for another use. Del Sole said Scipione would have the court “discount” that statement because it was contained in a footnote. “This we decline to do. Doctors do not have sole and absolute discretion in treating their patients,” Del Sole said. Judge Justin M. Johnson joined the opinion. Judge Phyllis Beck concurred in the result.

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