Friter v. Iolab Corp., 607 A.2d 1111 (Pa. Super. 1992)

Jan 01, 1989

OUTCOME: Iolab Corporation, my client, was dismissed at the summary judgment stage. At trial the plaintiff's won a substantial damages judgment, which was affirmed on appeal.

Established duty of an institution to obtain informed consent of patient when the institution is participating in clinical studies to determine safety and efficacy of medical device pursuant to FDA reg ... ulations. Iolab Corporation manufactured intra-ocular lenses and was granted investigation status by the FDA to conduct clinical studies at clinical sites, generally hospitals, to gather data showing the safety and efficacy of the device. As required by federal regulations, Iolab Corporation's evidence showed that it had provided extensive informed consent guidelines to all of the sites in its investigation, including the hospital in which the plaintiff's surgery took place. However, the hospital was unable to show that the patient was ever provided with this information. The court ruled, setting a narrow exception to the precedent only non-health care providers can be required to obtain informed consent. The appeals court ruled that when a Pennsylvania institution agrees to participate in a clinical study governed by federal regulations to determine the safety and efficacy of a medical device, that it, not only the surgeon, assumes the duty of obtaining the informed consent of the patient.