## Facts

- In 1986, Albert F. Cafazzo underwent surgery at a hospital operated by Central Medical Health Services, Inc., where Dr. Norman Stern implanted a mandibular prosthesis manufactured by Vitek, Inc.
- In 1992, the prosthesis was discovered to be defective.
- Cafazzo and his wife sued the hospital entities and Dr. Stern on a strict products liability theory, alleging the defendants provided and placed the implant into the stream of commerce and that it was defectively designed and inadequately warned.
- The plaintiffs did not plead negligence; they sought to treat the hospital and surgeon as “sellers” of the implant under Restatement (Second) of Torts § 402A.
- Vitek, Inc. was not sued because it was in bankruptcy.

## Issues

1. Whether a hospital and a physician may be treated as “sellers” under Restatement (Second) of Torts § 402A and held strictly liable for a defective medical device supplied incident to medical services.
2. Whether charging for, or supplying, an implant as part of surgery converts a medical-services transaction into a product sale for strict liability purposes.

## Decision

- The Pennsylvania Supreme Court affirmed the dismissal of the strict liability complaint.
- The Court held that a hospital and a physician providing medical treatment are not “sellers” of a medical device that is incidentally supplied and implanted during the provision of medical services.
- Because § 402A applies to entities engaged in the business of selling products, strict products liability did not apply to the defendants on the pleaded facts.

## Legal Principles

- Restatement (Second) of Torts § 402A strict liability generally applies only to those “engaged in the business of selling” the product at issue.
- The patient–hospital–physician relationship is principally a service relationship; the controlling inquiry is the nature of what is being done (medical treatment), not how charges are itemized.
- Medical providers do not become product sellers merely because they supply, select, or implant a device during treatment, even if the patient is billed for the device.
- Courts should not extend strict liability in a way that makes hospitals and physicians insurers for defects in products used in treatment, which they do not design or manufacture and are not marketing as retailers.

## Conclusion

The court refused to extend § 402A strict products liability to hospitals and physicians for defects in medical devices supplied as part of medical treatment, holding that such providers are service renderers rather than product sellers and are therefore not strictly liable on that theory.


Cafazzo v. Cent. Med. Health Servs., Inc., 668 A.2d 521 (Pa. 1995)