Court Opinion

ID: 9693841
Source: CourtListenerOpinion
Date Created: 2023-08-25 17:03:09.925923+00
Date Added: 2024-06-11T18:19:51.040113
License: Public Domain

O’HERN, J.,
dissenting.
Only one such as Anatole France1 could adequately capture the irony in the Court’s judgment. A sight-impaired woman has lost her claim that she was the unwitting subject of experimental eye surgery in part because she should have more carefully read the release form that she signed before undergoing the surgery. Ante at 72, 713 A.2d at 1028. In order to reach that result the Court has improperly fused the accrual of two separate claims and thereby avoids resolution of a factual dispute whether plaintiff was informed of the experimental nature of the eye surgery.
A
Must the claims of medical malpractice and lack of informed consent accrue simultaneously?
I have found no jurisdiction in which a subject of a medical experiment has had an informed consent claim dismissed without resolution of the question of when the patient had been informed of the experimental nature of the procedures involved. In Anderson v. George H. Lanier Memorial Hospital, 982 F.2d 1513, *781519 (11th Cir.1993), the medical provider argued that the nondisclosure claims were “intertwined with medical malpractice claims” and that the statute of limitations governing the malpractice claims should bar the informed consent claims. The court disagreed. It found the claim that the patients alleged was that the hospital “did not obtain their informed consent concerning an experimental procedure.” Id. at 1519. The court observed: “The appellants may have been put on notice that [the physician] negligently performed their eye surgeries. The appellants, however, were not placed on notice that they were the victims of an experimental procedure.” Id. at 1520. In Shadrick v. Coker, 963 S.W.2d 726 (Tenn.1998), an orthopedic patient was never told that a certain type of screw put in his back was experimental. He was well aware that the operation was unsuccessful. For over three years following removal of the screws, he continued to have pain in his back. Id. at 729. It was not until December 17, 1993, that he saw a television program (“20-20”) containing a segment on pedicle screws. He learned from that program that the screws were experimental and had not been approved by the Food and Drug Administration for use in the spine. The television show also informed him that such screws had been found to cause a number of problems to patients. Id. at 729. The Tennessee court observed that the cause of action based on the lack of informed consent “stems from the premise that a competent patient should be allowed to formulate an intelligent, informed decision about surgical or other treatment procedures the patient undertakes.” Id. at-731. It found that the cause of action based on the lack of informed consent did not accrue until the patient viewed the 1993 television program disclosing the experimental nature of the treatment. It reached that conclusion even though Mr. Shadrick knew when he woke up from the surgery that screws had been implanted without his consent, and even though he learned just a few months later that one of the screws had broken. Id. at 734; see also Barrett v. United States, 689 F.2d 324, 328-29 (2nd Cir.1982) (distinguishing claim based on negligent administration of a drug from claim based on concealment of fact that Army used decedent *79as a “human guinea pig,” and finding factual dispute as to when the latter claim accrued under the “diligence-discovery” rule).
The majority reasons that the statute of limitations should start running on both claims when injured parties know of their injuries and of facts sufficient to support the institution of either a medical malpractice or an informed consent claim. Ante at 71, 713 A.2d at 1027. The homogenization of the two claims is flawed.
It is shattering to think that a person who was essentially a guinea pig should be deprived of her cause of action based on absence of informed consent because she knew something was wrong with her eyes after the surgery. The majority reasons that “diligence requires an injured party, once he or she knows of one claim against the defendant, to investigate all other related claims.” Ante at 71, 713 A.2d at 1028. The proposition may be valid in other contexts, but its relevance to this case rests shakily on the unstated premise that plaintiffs malpractice and informed consent claims are inextricably related. I cannot accept that premise because the two claims share neither a legal nor a factual relationship. Legally, plaintiffs informed consent action derives from her rights of self-determination and personal integrity. Largey v. Rothman, 110 N.J. 204, 209, 540 A.2d 504 (1988). It is a dignitary tort. Unlike the malpractice claim, a plaintiff suing under the informed consent theory may prevail without proving physical damage. Lugenbuhl v. Dowling, 701 So.2d 447, 455 (La.1997). Factually, the informed consent action arises out of the alleged lack of disclosure prior to plaintiffs eye surgery. The malpractice claim on the other hand arises out of the operation itself. It is one thing to draw an inept surgeon. It is another thing to be treated as a human guinea pig.
A most unfortunate example of such experimental medicine is that of the Tuskegee volunteers. In that case, the federal government withheld treatment from 400 men suffering from syphilis. Researchers had discovered that penicillin treated syphilis effectively, but government health officials, interested in tracking the *80natural course of the disease, treated the unwitting participants with placebos. See generally James H. Jones, Bad Blood: The Tuskegee Syphilis Experiment (1981). Let us assume that the victims of the placebo treatment knew that their condition was worsening, knew that something was going dreadfully wrong. Would their cause of action based on a lack of informed consent accrue when they first believed that their treatment was not working or would it accrue when they learned that important information concerning their health choices had been withheld from them? I would certainly hope that it would be the latter.
I therefore would follow the panel of the Appellate Division that twice held that a cause of action for lack of informed consent to experimental medical treatment accrues when the plaintiff learns that the surgery was experimental, not when the plaintiff discovers that something is wrong with his or her physical condition. Baird v. American Med. Optics, 301 N.J.Super. 7, 11-12, 693 A.2d 904 (App.Div.), certif. granted, 151 N.J. 467, 700 A.2d 879 (1997); Lombardo v. Borsky, 298 N.J.Super. 658, 667, 690 A.2d 150 (App.Div.), certif. granted, 150 N.J. 28, 695 A.2d 671 (1997), appeal dismissed, 153 N.J. 44, 707 A.2d 149 (1998).2
*81B.
When did this patient become aware that she was the subject of a medical experiment?
The majority notes that plaintiff cannot establish a lack of informed consent because she signed a consent form that described the experimental nature of the intraocular lens (IOL).
Baird signed a detailed consent form that described the investigational status of the IOL. Although the Appellate Division concluded that “[i]t is undisputed that plaintiff was not aware the implanted lens was an experimental IOL until March 1991,” 301 N.J.Super. at 11, 693 A.2d 904, the record does not support that conclusion. Dr. Newman proceeded only after Baird signed a detailed consent form that described the investigational status of the IOL.
[Ante at 72, 713 A.2d 1028.]
Of course, if malpractice and informed consent accrue simultaneously, it is unnecessary to discuss when plaintiffs informed consent claim arose. A reader might conclude that the Court’s reference to the consent form arises from doubt about the fairness of its statute-of-limitations holding. Be that as it may, if the majority wishes to discuss the consent form that its holding renders moot, it should not draw incorrect inferences about the legal effect of that form. It is simply not the law of New Jersey that because a person has signed a form the person is bound by the form or informed of its contents. Dancy v. Popp, 114 N.J. 570, 572, 556 A.2d 312 (1989). Although a party is ordinarily bound by an instrument that he or she signs, she is not bound if there is evidence that she was misled or that provisions of the document were not adequately called to her attention. See John D. Calamari, Duty to Read — A Changing Concept, 43 Fordham L.Rev. 341, 342-49 (1974).
In this case plaintiff vigorously denies that she was aware of the investigational status of the IOL until many years after it was implanted, and she contends that her doctor made no effort to inform her that the implantation would be an experiment. There is a factual dispute on that issue. Because the dispute arises on a motion for summary judgment, and because as far as we can see *82there is no “single, unavoidable resolution of the alleged disputed issue of fact,” we would have to resolve the dispute in plaintiffs favor, had the court not erroneously dismissed her case on statute-of-limitations grounds. Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520, 540, 666 A.2d 146 (1995). Denying plaintiff the benefit of the doubt, as the majority suggests it would do, conflicts not only with our summary judgment law, but also with the spirit of the Medical Device Act (MDA). Senator Edward Kennedy, in introducing the MDA, explained to his colleagues that “the legislation is written so that the benefit of the doubt is always given to the consumer. After all it is the consumer who pays with his health and his life for medical device malfunctions.” 121 Cong. Rec. 10,688 (1975). Eleanor Baird is being asked to pay with her health for experimentation on the IOL.
Because plaintiffs informed consent claim is distinct from her treatment claim, plaintiff is entitled to a factual hearing on whether her doctor was reasonably diligent in determining whether plaintiff understood that she was to be a laboratory animal in the service of medical science — whether she understood that the development of the IOL was still in the “anything can happen” stage. Michael E. Petrella, License to Maim: Federal Pre-emption and the Medical Device Amendments of 1976, 6 Health Matrix 349 (1996). Her signature on the consent form would serve as evidence at that hearing. It might in fact prevent her from prevailing. But at the summary judgment stage, her signature should not serve to deny her the opportunity to prove her case, as the majority suggests it would. Her entitlement to a hearing seems elementary to me and is not too much to ask for a woman who has lost her eyesight in a case of experimental surgery.
STEIN, J., joins in this opinion.
For modification and remandment — Chief Justice PORITZ, and Justices HANDLER, POLLOCK, GARIBALDI, and COLEMAN — 5.
For affirmance — Justices O’HERN and STEIN — 2.

 It was he who reminded us of "the majestic equality of the laws, which forbid rich and poor alike to sleep under the bridges, to beg in the streets, and to steal their bread." Anatole France, Le Lys Rouge, in Five Works of Anatole France 91 (W. Stephens trans.1924) (1896).

 I would also agree with the result reached by a separate panel in Bennett v. Surgidev Corp., 311 N.J.Super. 567, 710 A.2d 1023 (App.Div. 1998). In that case, the patient, Sylvia Bennett, knew that the IOL was “not perfected" when she consented to its implantation in 1982; and she knew something was wrong with her eyes following the surgery. Yet Bennett did not file her complaint until July 1991, which was eighteen or nineteen months after a doctor told her that the lens in her eye was "defective.” Id. at 571, 710 A.2d 1023.
The appellate panel held that the informed consent claim was time-barred. Id. at 571, 710 A.2d 1023. That was an appropriate holding on the facts of that case, because Bennett knew that the IOL was "not perfected" at the time she consented to the procedure. Like the Bennett court, I see no difference between awareness that a device was "not perfected" and awareness that a device is "experimental.” Id. at 574, 710 A.2d 1023. However, I would not go as far as the Bennett court was prepared to go in equating knowledge that the IOL did not work with knowledge that the device was experimental. Ibid. If a hypothetical patient did not know that a medical device was experimental at the time she consented to its use, her informed consent claim should not accrue when the patient discovers, for example, a manufacturing defect in the device. The *81informed consent claim should not accrue until a patient discovers or should have discovered that she was denied the right to decide for herself whether to subject her body to medical experimentation.