Friter v. Iolab Corp.

• Decision Date: 01 May 1992
• Citation: 607 A.2d 1111,414 Pa.Super. 622
• Parties: Frederick FRITER and Sally Friter, Appellant, v. IOLAB CORPORATION, Johnson & Johnson, Inc., Robert Reinecke, M.D., Jerome Peters, M.D., Estate of Kenneth Michaile, M.D., Deceased, and Kenneth Michaile, M.D., Ltd., and Wills Eye Hospital.
• Court: Pennsylvania Superior Court

Page 1111

607 A.2d 1111

414 Pa.Super. 622

Frederick FRITER and Sally Friter, Appellant, v. IOLAB CORPORATION, Johnson & Johnson, Inc., Robert Reinecke,

M.D., Jerome Peters, M.D., Estate of Kenneth

Michaile, M.D., Deceased, and Kenneth

Michaile, M.D., Ltd., and

Wills Eye Hospital.

Superior Court of Pennsylvania.

Argued Sept. 18, 1991.

Filed May 1, 1992.

Gerald A. McHugh, Jr., Philadelphia, for appellant.

Stephen A. Ryan, Bala Cynwyd, for appellees.

Before JOHNSON, FORD ELLIOTT, and HESTER, JJ.

FORD ELLIOTT, Judge:

This is an appeal from the October 18, 1990 order of the Court of Common Pleas of Philadelphia County granting defendant Wills Eye Hospital's motion for judgment non obstante verdicto. We reverse.

On November 22, 1982, Dr. Kenneth Michaile implanted an Iolab Model 91Z anterior chamber intraocular lens into Frederick Friter's left eye following cataract surgery at Wills Eye Hospital. This particular intraocular lens rests behind the cornea and serves as a substitute lens after the opacified natural lens has been removed from the eye. At the time of Mr. Friter's surgery, this particular lens had not yet been approved for general use by the United States Food and Drug Administration (FDA), but rather was the subject of a clinical investigation to determine its safety.

Prior to Mr. Friter's surgery, Wills Eye Hospital had applied for and received approval to participate in a clinical study involving the Iolab Model 91Z lens. The hospital named Dr. Michaile, a member of its medical staff, to be one of its registered investigators with permission to implant the experimental lens. Both Dr. Michaile, as a registered investigator for Iolab, and Wills Eye Hospital, as an approved institution for conducting experimental studies, were bound by FDA regulations to obtain an informed consent from any patient undergoing experimental treatment. The special five-page consent form explained, among other things, the nature of the clinical investigation, the existence of known complications, and the fact that there were, as yet, undetermined complications.

Frederick Friter was never informed, prior to surgery, that he was about to become a participant in a clinical investigation, and that he was about to have an unapproved medical device implanted in the interior portion of his eye as a substitute for his natural lens. As a result of the surgical implantation of the Iolab 91Z lens, Mr. Friter suffered numerous complications, including filamentary keratitis, chronic and recurrent uveitis, damage to the corneal endothelium, hemorrhage, and the threat of loss of vision in the eye.

As a result of the damage caused to his eye, Frederick Friter, and his wife Sally, filed suit against the Estate of Kenneth Michaile, M.D., deceased, Kenneth Michaile, M.D., Ltd., and Wills Eye Hospital, seeking recovery for the injuries sustained by the unauthorized placement into his eye of an intraocular lens which had not yet been approved and was still under investigation by the FDA. At trial, the Friters asserted claims of battery against Dr. Michaile and Wills Eye Hospital for failing to obtain an informed consent prior to performing surgery on Mr. Friter's eye. A jury trial commenced in the court of the Honorable Murray C. Goldman on September 19, 1989. On September 28, 1989, the jury returned a verdict in favor of the Friters and awarded Mr. Friter 1.5 million dollars in damages, and Mrs. Friter $250,000 in damages.

Post-trial motions were subsequently filed on behalf of Dr. Michaile and Wills Eye Hospital. The Friters settled with the Michaile defendants. However, the trial court granted Wills Eye Hospital's motion for a judgment n.o.v. This timely appeal followed. Appellants now raise two issues for our consideration.

I. Did not the trial court erroneously enter judgment in favor of Wills Eye Hospital notwithstanding the jury's finding that Wills Eye Hospital had assumed the responsibility of supervising the obtaining of plaintiff's informed consent to surgery involving an unapproved medical device which was under investigation by the defendant hospital?

II. When a hospital agrees to conduct a clinical study of a medical device under investigation by the Food and Drug Administration and selects the surgeons who will carry out the study, and where the hospital admits that it was the hospital's responsibility to assure that all physicians who participated in the investigations were obtaining informed consent of their patients, is not the hospital liable for damages resulting from the surgeon's failure to obtain informed consent?

Appellee, in its counter-statement of the questions presented, has framed the issues as follows:

I. Did the trial court correctly refuse to allow the hospital to be held liable for the intentional battery of failing to obtain an informed consent?

II. Did the trial court correctly grant the hospital judgment n.o.v. where the law of this Commonwealth has never imposed a duty to obtain a patient's informed consent on a hospital?

III. Did the trial court correctly determine that, despite a hospital's involvement in a clinical investigation, a hospital cannot be held liable for the tort of intentional battery?

In essence, all five questions presented to this court for review focus upon the same central consideration: whether appellants, proceeding against the hospital under a theory of lack of informed consent, pled and proved facts sufficient to justify the jury's verdict against Wills Eye Hospital, given that this Commonwealth, heretofore, has never recognized an informed consent action against a hospital. It is that central question upon which this opinion will focus.

Instantly, we note that our standard of review when considering an appeal from an order granting a judgment n.o.v. is well settled.

In the review of the record in an appeal from an order of a trial court which has granted judgment n.o.v., we are required to consider the evidence and all reasonable inferences therefrom in the light most favorable to the verdict winner.

Lowry v. State Farm Insurance Co., 392 Pa.Super. 77, 80, 572 A.2d 700, 701 (1990). The entry of judgment n.o.v. will be reversed whenever the evidence favorable to the plaintiff, and the reasonable inferences therefrom, support plaintiff's theory of liability. Handfinger v. Philadelphia Gas Works, 439 Pa. 130, 266 A.2d 769 (1970). It is with this standard in mind that we address the merits of this case.

The gravamen of appellants' action against Wills Eye Hospital was that the hospital failed in its duty to ensure that a legally effective informed consent was obtained from Mr. Friter prior to his surgery. Historically, the doctrine of informed consent has been interpreted by appellate courts of this Commonwealth to apply only to surgeons who perform operations without first securing the informed consent of the patient. The unconsented to operation is considered a non-consensual touching, thus giving rise to an action by the patient for a "technical" battery. Doe v. Dyer-Goode, 389 Pa.Super. 151, 566 A.2d 889 (1989); Malloy v. Shanahan, 280 Pa.Super. 440, 421 A.2d 803 (1980). To date, a hospital has never been held liable to a patient under a theory of lack of informed consent. Appellee relies upon this well settled case law to support its position that the trial court's decision to grant the motion for judgment n.o.v. was correct. However, such reliance ignores the factual context in which these decisions rest. Indeed, were we to view this case as a traditional lack of informed consent action against a hospital, we would be constrained to follow precedent and affirm the trial court's order. A review of trial court cases which have addressed this issue demonstrates that two prevailing reasons are offered for relieving the hospital of liability.

The first reason offered is that Pennsylvania case law on informed consent is premised on a battery arising out of a medical procedure performed by a physician and therefore the duty to inform as to the risks associated with that procedure only runs as between doctor and patient. This "duty" analysis was summarized by the trial court in Margotta v. Lancaster General Hospital, 47 Pa. D. & C.3d 300 (1987).

Our research uncovered only one Pennsylvania case, Hurley v. Won, 9 [Pa.] D. & C.3d 796 (1979), which dealt specifically with a hospital's duty to obtain a patient's informed consent. Hurley at 798, held that there is no duty, in Pennsylvania, on a hospital to obtain consent from a patient prior to an operation.

....

Our research failed to uncover any Pennsylvania authority for imposing an independent duty on a non-physician to obtain a patient's informed consent. See, e.g. Smith v. Yohe, 412 Pa. 94, 194 A.2d 167 (1963); Gray v. Grunnagle, 423 Pa. 144, 223 A.2d 663 (1966); Cooper v. Roberts, 220 Pa.Super. 260, 286 A.2d 647 (1971) (allocatur refused); Malloy v. Shanahan, 280 Pa.Super. 440, 421 A.2d 803 (1980) (plurality decision); Boyer v. Smith, 345 Pa.Super. 66, 497 A.2d 646 (1985); and Festa v. Greenberg, 354 Pa.Super. 346, 511 A.2d 1371 (1986).

Accordingly, we agree with both parties that Pennsylvania does not recognize an independent duty on a non-physician to obtain a patient's informed consent. Absent the recognition of such a duty, we do not accept plaintiff's invitation to create such a duty. Under the current state of the law, it appears with certainty that plaintiff can not recover under Count II [informed consent].

Id. at 305-06.

As noted by the trial court in Margotta, Pennsylvania case law reflects the notion that heretofore it is only the physician who has been held liable under a theory of lack of informed consent, for it is the physician who has the duty to obtain the consent for a medical procedure which the physician performs. In the traditional surgical setting, this analysis is well founded. However, the facts of this case are quite different for we are not here addressing the duty owed by...