Cabiroy v. Scipione

Rule of Law:

Under Pennsylvania law, a physician's violation of FDA statutes prohibiting the distribution of adulterated or misbranded medical devices constitutes negligence per se, as these statutes are intended to protect individual patients from the harm of unapproved treatments.

Facts:

• In 1989, the Appellant doctor treated the Appellee for a nasal deformity.
• The doctor administered injections of liquid silicone into the Appellee's nose to improve its cosmetic appearance.
• The doctor had obtained the liquid silicone from a deceased colleague in an unsealed, non-sterile, 8-ounce glass bottle that lacked a manufacturer's label.
• At the time of treatment, the FDA classified liquid injectable silicone as a Class III device and had never approved it for injection into humans.
• The doctor advised the Appellee that the substance was not FDA-approved but administered the injections anyway.
• Following the procedure, lumps formed on the Appellee's nose.
• The Appellee required surgery to have the lumps shaved off with a scalpel.

Procedural Posture:

• Appellee sued Appellant in the trial court for medical malpractice, alleging both negligence and negligence per se.
• The trial court granted Appellant's motion for non-suit specifically on the issue of negligence per se.
• The trial court instructed the jury that the FDA had no authority to regulate the practice of medicine.
• The jury returned a verdict in favor of the Appellant.
• Appellee filed post-trial motions arguing the court erred in granting the non-suit and giving the jury instruction.
• The trial court granted the post-trial motions and ordered a new trial.
• Appellant appealed the order granting a new trial to the Superior Court of Pennsylvania.