This section contains the nature of the case and procedural background.

Cafazzo (P) underwent surgery for implantation of a mandibular prothesis. Six years later it was discovered that the device was defective. The manufacturer is in bankruptcy, and unable to sustain liability. P sued the hospital (D), and the surgeon (D1) under strict products liability; the product was defectively designed and lacked any warning necessary to ensure safety. Ds' preliminary objections in the nature of a demurrer was granted by the trial court which concluded that P failed to state a claim cognizable under Pennsylvania law, and the Superior Court affirmed.

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