## Facts

- Frank Cabiroy sought cosmetic correction of a nasal deformity from C. Richard Scipione, M.D.
- Dr. Scipione injected liquid silicone into Cabiroy’s nose; the silicone was described as coming from a bottle that was not sealed, sterile, or labeled.
- Cabiroy developed lumps on his nose that later required surgical removal.
- Evidence at trial indicated liquid injectable silicone was treated as a Class III medical device under the federal Food, Drug, and Cosmetic Act (FDCA) and that the FDA had not approved liquid injectable silicone for cosmetic injections.
- Cabiroy alleged that Dr. Scipione’s use of non-approved silicone and use of an adulterated or misbranded product violated the FDCA and FDA regulations and constituted negligence per se, in addition to ordinary negligence.

## Issues

1. Whether alleged violations of the FDCA and FDA regulations may serve as the predicate for negligence per se in a Pennsylvania medical malpractice action against a physician.
2. Whether the trial court erred by granting a new trial after concluding it had wrongly entered a compulsory nonsuit on Cabiroy’s FDCA-based negligence per se theory.

## Decision

- The Superior Court of Pennsylvania reversed the order granting a new trial.
- The court reinstated the jury’s defense verdict for Dr. Scipione.
- The court held the trial court correctly entered a compulsory nonsuit on negligence per se because the FDCA and related FDA regulations did not authorize private enforcement through a state tort negligence per se theory in this context.
- Because the nonsuit was legally proper, the post-trial grant of a new trial rested on legal error.

## Legal Principles

- Under Pennsylvania law, negligence per se requires a statute or regulation that clearly sets a standard of conduct, is intended to protect a defined class of persons from a defined type of harm, and is appropriate to use as the civil standard of care.
- The FDCA is enforced by federal authorities and does not create a private cause of action; courts should not permit state-law negligence per se theories that effectively convert FDCA provisions into private enforcement mechanisms.
- Federal regulatory requirements may, in some cases, be considered as evidence relevant to the standard of care, but a claimed regulatory violation does not automatically establish breach as negligence per se in physician malpractice litigation.
- A new trial may not be granted based on an asserted legal error when the challenged trial ruling was correct as a matter of law.

## Conclusion

The court held that FDCA and FDA device-approval and labeling provisions could not be used to impose negligence per se on a physician in this malpractice case, so the original nonsuit on that theory was proper and the trial court’s post-verdict order granting a new trial was reversed in favor of reinstating the defense verdict.


Cabiroy v. Scipione, 767 A.2d 1078 (Pa. Super. Ct. 2001)