Title: Canesi v. Wilson
Citation: N/A
Docket Number: a-46-97
State: new-jersey
Issuer: new-jersey Supreme Court
Date: June 17, 1999

(This syllabus is not part of the opinion of the Court. It has been prepared by the Office of the Clerk for the convenience of the reader. It has been neither reviewed nor approved by the Supreme Court. Please note that, in the interests of brevity, portions of any opinion may not have been summarized). HANDLER, J., writing for a majority Court. The issue posed on this appeal is whether it is necessary to establish medical causation in a wrongful birth action that involves the prescription of drugs without adequate warning of the fetal risks posed by those drugs. On July, 1, 1991, twenty-nine-year-old Melissa Canesi visited Dr. James A. Wilson, an obstetrician/gynecologist, because she had missed her period and wanted to determine whether she was pregnant. A urinalysis yielded the same negative results that a home pregnancy test had. Dr. Wilson prescribed Provera, a drug designed to induce menstruation. Dr. Wilson did not inform Canesi about the side effects and contraindications of Provera. At the time, the Physicians' Desk Reference (PDR) warned that if a woman was or became pregnant while on Provera, she should be informed that there was a risk that the fetus would suffer from congenital abnormalities, including limb reduction, and a risk that she would retain a defective ovum instead of spontaneously aborting it. The Provera did not induce menstruation. On July 15, Dr. Wilson gave Canesi a blood serum test that resulted in positive for pregnancy. When Canesi learned she was pregnant with twins, she asked Dr. Wilson if her taking the Provera could have any deleterious effects on either the fetuses or the course of her pregnancy. Dr. Wilson told her not to worry. Because Dr. Wilson was not a participating doctor in her health insurance plan, Canesi sought prenatal care from Dr. Ronald Loewe. She told Dr. Loewe of her pregnancy with twins and of her ingestion of Provera. Dr. Loewe also told her not to be concerned that she had taken the drug. Canesi had problems during her pregnancy. She began spotting, one of the fetal twins died, and amniocentesis revealed excessive amniotic fluid, an indication that the remaining fetus might be suffering from an abnormality. On March 18, 1992, Brandon Canesi was born with the congenital impairment of bilateral limb reduction. Canesi and her husband sued Drs. Loewe and Wilson, alleging that Dr. Wilson was negligent in failing to diagnose Canesi's pregnancy in a timely manner, that both doctors were negligent for failing to inform her of the effect her ingestion of Provera would have on her fetus and for "otherwise" negligently caring for and treating her. Canesi claimed that had she known of the risk of congenital defects generally, or limb reduction specifically, that Provera posed to her remaining fetus, or if she had been told that she was at an increased risk of retaining a defective ovum, she would have terminated her pregnancy. Also included in the complaint was a claim brought on behalf of Brandon, alleging that Provera caused his bilateral limb reduction and that the doctors were negligent in prescribing the drug to his mother without warning of this risk. Drs. Wilson and Loewe moved for summary judgment, dismissing the complaint against them. They noted that the Canesis had failed to present any expert testimony that Provera caused fetal limb reduction, and that the latest edition of the PDR no longer contained a warning that Provera was even associated with this defect. Construing the cause of action to involve the lack of informed consent, the doctors contended that because the Canesis could not prove medical causation, as a matter of law, the physicians could not be found liable. The trial court granted the doctors' motion, reasoning that a plaintiff who alleges that her physician's malpractice consists of a failure to disclose material risks of a prescribed drug must prove that the drug caused the harm that materialized. The Appellate Division affirmed, determining that even if Canesi's claim was considered a wrongful birth action based on the lost opportunity to terminate pregnancy, the Canesis still must establish the taking of Provera caused Brandon's limb reduction. The Supreme Court granted certification. HELD: It is not necessary to establish medical causation in a wrongful birth action that involves prescription of drugs without adequate warning of the fetal risks posed by those drugs. 1. A wrongful birth action is based on a woman's right to determine for herself whether or not to continue or terminate her pregnancy; it consists of the parents' lost opportunity to make the personal decision of whether or not to give birth to a child who might have birth defects. The doctor's duty of disclosure must be sufficient to enable the mother to make an informed and meaningful decision concerning whether or not to continue the pregnancy. Plaintiffs need not prove that the doctor's negligence caused the defect. Rather, they must prove that their emotional and economic injuries were proximately caused by the doctor's negligence in depriving them of the decision to decide whether or not to terminate a pregnacy of a child with a potential congenital defect. (pp. 6-10) 2. In an informed consent case, the plaintiff must prove that an undisclosed risk was medically accepted and material, that a reasonably prudent person in the patient's condition would not have undergone the treatment if aware of the risk, and that the risk came to fruition. The doctor's duty of disclosure focuses not on the "reasonable physician" standard, but on the material risks a prudent patient would want to know before making a medical decision. In addition, the plaintiff must prove medical causation, that is, a causal connection between the undisclosed risk and the injury ultimately sustained. (pp. 10-14) 3. Informed consent and wrongful birth causes of action, although similar, have important differences. In an informed consent case, the plaintiff must demonstrate proximate cause by proving that the undisclosed risk actually materialized and was medically caused by the treatment. In a wrongful birth case, the plaintiff need not prove that the doctor's negligence was the medical cause of the child's birth defect. Rather, the test of proximate cause is satisfied by showing that an undisclosed fetal risk was material to a woman in the plaintiff's position; the risk materialized, was reasonably forseeable and not remote in relation to the doctor's negigence; and, had plaintiff known of that risk, she would have terminated her pregnancy. (pp. 14-15) 4. The Canesis presented insufficient proof of a causal relationship between Provera and the defect suffered by Brandon. That failure of proof also supports summary judgment in favor of Drs. Wilson and Loewe to the extent the Canesis sought damages in the nature of a claim for wrongful life based on their allegation that the drug caused Brandon's defect. Similarly, the evidence was insufficient to establish medical causation in support of the allegation that Provera caused the retention of a defective ovum, leading eventually to Brandon's birth and congenital defect. (pp. 15-17) 5. The physician's duty to disclose in a wrongful birth case is limited by what risks a reasonably prudent patient in the plaintiff's position would consider material to her decision. There was sufficient evidence to enable a jury to determine that the doctors breached their duty of disclosure. There was also sufficient evidence to establish proximate cause. The dissent, by insisting that medical causation is a requirement, unduly burdens a patient's wrongful birth claim that does not seek recovery for the congenital impairment. (pp. 17-28) 6. There is sufficient evidence in the record for the jury to determine that the doctors' inadequate disclosure deprived the Canesis of their right to decide for themselves whether to give birth to a child who might be afflicted with a physical abnormality. In addition, the Canesis have sufficiently shown that the resulting birth defect was reasonably forseeable and not too remote in relation to their doctors' negligence and, had the doctors not been negligent, the pregnancy would have been terminated. (pp. 28-32) Judgment of the Appellate Division is AFFIRMED IN PART and REVERSED IN PART and the matter is REMANDED to the trial court to proceed in accordance with the opinion. JUSTICE O'HERN, concurring, is of the view that the dissent sets up an argument that does not exist and then proceeds to refute it. This case is about the eventual manifestation of a specific defect about which the doctors had an acknowledged duty to warn. The Court's opinion does not create an open-ended liability for obstetricians whenever a birth defect occurs. JUSTICE POLLOCK, dissenting, is of the view that the cause of action created by the majority subjects physicians to liability for failing to warn about the adverse effects of a drug that are not causally linked to the claimed defect. By breaking that link, the majority has unleashed a cause of action that knows no bounds. CHIEF JUSTICE PORITZ and JUSTICES O'HERN, GARIBALDI, STEIN and COLEMAN join in JUSTICE HANDLER'S opinion. JUSTICE O'HERN has filed a separate concurring opinion. JUSTICE POLLOCK has filed a separate dissenting opinion. BRANDON CANESI, a minor by his parents Melissa and Sebastian Canesi as Guardian Ad Litem, MELISSA and SEBASTIAN CANESI, Individually, Plaintiffs-Appellants, v. JAMES A. WILSON, M.D. and RONALD LOEWE, M.D., Defendants-Respondents, and JOHN DOE PHYSICIAN (2-10) and JOHN DOE DRUG MANUFACTURER (1-10), Defendants. Argued November 3, 1997 -- Decided June 17, 1999 On certification to the Superior Court, Appellate Division, whose opinion is reported at 295 N.J. Super. 354 (1996). Jay L. Hundertmark argued the cause for appellants (Valore Law Offices, attorneys). Robert E. Paarz argued the cause for respondent James A. Wilson, M.D.(Paarz, Master, Koernig, Crammer, O'Brien &amp; Bishop, attorneys; Mary Ann C. O'Brien, on the letter in lieu of brief). Donald J. Grasso argued the cause for respondent Ronald Loewe, M.D. (Orlovsky, Grasso &amp; Bolger, attorneys; Nina M.C. Halpin on the letter in lieu of brief). The opinion of the Court was delivered by HANDLER, J. In this medical malpractice case, parents brought suit against two obstetricians after their child was born with the congenital defect of bilateral limb reduction. The parents' principal allegation was that the doctors were negligent in failing to warn them that a drug prescribed for the plaintiff mother posed the specific risk of fetal limb reduction and that the prescribed drug caused this defect. They also alleged other acts of negligence, including the failure to warn of general, unspecified fetal risks posed by the prescribed drug, and to take diagnostic measures during the mother's pregnancy that would have disclosed the presence of a fetal defect. They assert that as a result of defendants' negligence they were deprived of their right as parents to decide whether or not to terminate the pregnancy, they would have terminated the pregnancy had they been warned, and they are entitled to the damages allowable in a wrongful birth cause of action. The doctors, focusing on the parents' allegation that the prescribed drug caused their child's birth defect, characterize plaintiffs' claims as based on the doctrine of informed consent and contend, accordingly, that they cannot be found liable because the parents cannot prove medical causation, that is, that the drug was the medical cause of the child's congenital impairment. In light of the contentions of the parties and the determinations of the lower courts, the basic issue that must be addressed is whether it is necessary to establish medical causation in a wrongful birth action that involves the prescription of drugs without adequate warning of the fetal risks posed by those drugs. [Kathy Seward Northern, Procreative Torts: Enhancing the Common-Law Protection for Reproductive Autonomy, 1 998 U. Ill. L. Rev. 489, 533.] The physician's obligation, therefore, does not "compel disclosure of every risk . . . to any [pregnant] patient[,]" but rather only "material risks" to a reasonable patient." Largey, supra, 110 N.J. at 213. E.g., Jones v. United States, 933 F. Supp. 894, 902 (N.D. Cal. 1996) (holding that military physicians did not have duty to disclose to patient that penicillin they had prescribed for her could interfere with effectiveness of her birth control pills because existence of such drug interaction was unproven and danger of interference occurring appeared to be extremely remote), aff'd, 127 F.3d 1154 (9th Cir. 1997), cert. denied, __ U.S. __, 118 S. Ct. 2359, 141 L. Ed. 2d 728 (1998); Munro v. Regents of the Univ. of Cal., 263 Cal. Rptr. 878, 882 (Cal. Ct. App. 1990) (noting that "it is medically impossible to screen all patients for all known genetic abnormalities"); Smith v. Cote, 513 A.2d 341, 347 (N.H. 1986) (holding that physician is not required "to identify and disclose every chance, no matter how remote, of the occurrence of every possible birth 'defect,' no matter how insignificant"). Although the duty of disclosure in wrongful birth cases serves to protect the individual's right of self-determination and personal autonomy, because that duty is premised on principles of civil tort law, the scope of disclosure in a wrongful birth context is not coextensive with or measured by the woman's constitutional right to decide the fate of her pregnancy. Cf. Roe v. Wade, 410 U.S. 113, 93 S. Ct. 705, 35 L. Ed. 2d 147 (1973) (holding that woman has constitutionally protected right to determine for any reason or no reason to terminate her pregnancy). The physician's duty to warn is thus limited by what risks a reasonably prudent patient in the plaintiff's position would consider material to her decision.See footnote 5 These constraints serve to place reasonable bounds on the extent of disclosure required by doctors and, so bounded, the standard comports with basic considerations of fairness and public policy that are relevant in determining the scope of a duty of care and the extent of liability that may be placed on the medical profession. E.g., Carey v. Lovett, 132 N.J. 44, 58-60 (1993). Applying the standard governing the duty of disclosure, we consider whether the evidence in this case, viewed most favorably for plaintiffs, was sufficient to enable a jury to determine that defendants violated the duty owed plaintiffs. We note preliminarily that the defendant doctors' concession of negligence or breach of duty was made only for the limited purpose of the summary judgment motion below so that the trial court could determine whether plaintiffs had satisfied the test of proximate causation in the context of a claim based on the principles of informed consent doctrine. That concession, therefore, does not extend to the determination of plaintiffs' wrongful birth claim. Plaintiffs contend that the PDR, which contained specific warnings that Provera could cause bilateral limb reduction, the retention of a defective ovum, and general genetic anomalies, constituted evidence of the standard of care governing the doctors' duty of disclosure. In determining what constitutes a medically accepted risk when defining a doctor's duty to warn, we have recognized that the PDR, standing alone, is not and should not be the touchstone of what risks a physician must reveal to his or her patient. See Morlino v. Medical Ctr. of Ocean County, 152 N.J. 563, 580 (1998) (holding that because PDR warnings are written "for many reasons including compliance with FDA requirements, advertisement, the provision of useful information to physicians, and an attempt to limit the manufacturer's liability[,]" PDR warning alone does not establish physician's duty of care). Thus, the fact that the PDR contained warnings of the general and specific risks Provera posed to the fetus is not, of itself, sufficient evidence to establish a standard of care. Plaintiffs, however, do not rely solely on the PDR to establish the standard of care. They present additional evidence that fetal deformity was a medically accepted risk of which they should have been informed. Dr. William Vilensky, one of plaintiffs' experts, noted in his report that the standard of care required that, under circumstances such as were present in this case, the patient be informed of the PDR warnings. Similarly, Dr. Deborah Consoli, plaintiffs' second expert, testified that in 1991 the medical community was split concerning whether Provera caused limb reduction and that she, therefore, informed her patients of the risk. Moreover, both defendant doctors had actual knowledge of plaintiff's personal concern about having taken Provera while pregnant. The doctors, however, did not explain to plaintiff whether there were any risks posed by or associated with the ingestion of Provera that were recognized by the medical community or a substantial segment thereof, or whether those risks were remote or likely, or could result in severe or mild impairments. Instead, the doctors dismissed her personal concerns and told her "not to worry." In addition, plaintiff exhibited other "maternal indicators."See footnote 6 The record discloses evidence that plaintiff was spotting, one of the fetal twins died in utero, and an amniocentesis revealed polyhydramnios,See footnote 7 which is a possible indicator of fetal abnormality. Defendants' own expert admitted that there were signs that "suggested that this was an abnormal pregnancy." Plaintiffs' evidence also showed that a diagnostic procedure that could have detected whether the potential defect had in fact materialized was available and yet was not utilized until so late in the pregnancy that detection was unlikely.See footnote 8 Defendants did not inform plaintiffs of the availability of this diagnostic test nor did they administer that test during the critical period of her pregnancy. As her pregnancy progressed and more maternal risks appeared, the evidence would sustain the determination that Dr. Loewe, instead of keeping plaintiff properly apprised of the status of her pregnancy, chose to keep her in the dark. Given these maternal indicators, the doctors should have known that a reasonable prudent patient in this woman's position would have likely attached significance to the risks associated with Provera.See footnote 9 In sum, there was sufficient evidence to enable a jury to determine that defendants breached their duty of disclosure. The evidence, we find, was also sufficient to establish proximate cause. The dissent accuses the Court of "eliminat[ing] proximate cause" altogether, or, alternatively, "redefin[ing] it beyond recognition." Post at (slip op. at 10-11). That simply is not the case. Legal or proximate cause is clearly an essential element of a wrongful birth cause of action. Medical causation, however, is not. The dissent, by insisting that medical causation is a requirement, unduly burdens a patient's wrongful birth claim that does not seek recovery for the congenital impairment. There is sound authority explaining why medical causation is not a requirement in wrongful birth causes of action. The failure to establish medical causation of the child's injury historically was viewed as a ground warranting the dismissal of wrongful birth actions. Stephanie S. Gold, Note, An Equality Approach to Wrongful Birth Statutes, 65 Fordham L. Rev. 1005, 1013 (1996). In order to prove causation, a plaintiff had to prove that the physician caused the anomaly in the child. Ibid; Anthony Jackson, Action for Wrongful Life, Wrongful Pregnancy, and Wrongful Birth in the United States and England, 17 Loy. L.A. Int'l &amp; Comp. L.J. 535, 560 (1995). Over time, however, it was recognized that the nature of the tort of wrongful birth does not depend on whether a defendant caused the injury or harm to the child. Rather, the appropriate inquiry was viewed as whether the defendant's negligence was the proximate cause of the parents' loss of the option to make an informed and meaningful decision either to terminate the pregnancy or to give birth to a potentially defective child. Brenda L. Kimble, Wrongful Birth: A Practitioner's Guide to a New Arrival, 55 Ala. Law. 84, 88 (1994). Today, "most courts [] recognize the distinction between causing [a birth defect] and causing the parents to lose the option to terminate the pregnancy, [and] the latter causation standard is widely accepted in jurisdictions recognizing wrongful birth actions." Gold, supra, at 1013 (citing Robak, supra, 658 F.2d at 477; Keel, supra, 624 So. 2d at 1027). The appropriate proximate cause question, therefore, is not whether the doctor's negligence caused the fetal defect; the congenital harm suffered by the child is expressly not compensable. Rather, the determination to be made is whether the doctors' inadequate disclosure deprived the parents of their deeply personal right to decide for themselves whether to give birth to a child who could possibly be afflicted with a physical abnormality. There is sufficient evidence in the record of this case to enable a jury to make that determination. In addition, in establishing proximate cause for wrongful birth, plaintiffs must show that the resulting birth defect was reasonably foreseeable, that is, not too remote in relation to defendants' negligence, and that had defendants not been negligent, the pregnancy would have been terminated. See, e.g., Berman, supra, 80 N.J. at 426 (imposing liability for wrongful birth on premise that proximate cause was met where plaintiff, once notified that her child, if born, would have been afflicted with Down's Syndrome, would have terminated pregnancy); Haymon v. Wilkerson, 535 A.2d 880, 882 (D.C. 1987) (holding that plaintiff must establish that had she learned of impairment during her pregnancy, she would have terminated pregnancy); Proffitt v. Bartolo, 412 N.W.2d 232, 237 (Mich. Ct. App. 1987) (holding that plaintiff satisfies causation by showing that in absence of defendant's negligence, she would have obtained abortion); Smith, supra, 513 A.2d at 347 (holding that chain of causation is not too remote where plaintiff claims she would have aborted fetus had she learned of impairment). The record reveals sufficient evidence to support the determination of proximate cause under that standard. The evidence indicates that defendants' negligence consisted of a combination of the failure to warn and the failure to diagnose. As a result, there existed the unwarned and undetected risks of fetal deformity -- "congenital anomalies" (according to the PDR) -- including bilateral limb reduction. Further, the record discloses that plaintiff hadspecific concerns about her treatment and condition and had indicated that, when faced in an earlier pregnancy with the possibility of a defective fetus, she in fact did have an abortion. Such evidence would support the determination that the risks to which plaintiff was exposed were material and that she would have terminated her pregnancy had those risks been communicated to her or had they been diagnosed. The dissent follows the Appellate Division's reasoning that in the absence of a requirement of "medical causation" in a wrongful birth case, such as this, plaintiffs might recover for a "chance occurrence," 295 N.J. Super. at 364, leading to its assertion that doctors will be made guarantors against birth defects. Post at __ (slip op. at 17-18). That position is inaccurate and exaggerated. In voicing that concern, the dissent relies on our own wrongful birth cases, noting the apparent factual connection between the undisclosed and undiagnosed risks and the congenital defect that occurred. Post at (slip op. at 11). The dissent suggests, therefore, that these cases require that the malpractice be a medical cause or a cause-in-fact of the child's birth defect. These decisions, however, do not require proof that the doctor's malpractice constitutes the medical cause of the child's defect, only that the defect was a foreseeable risk posed by the malpractice.See footnote 10 These cases present the circumstance of a factual similarity or parallel between the unwarned or undetected risk and the birth defect that eventuated. That circumstance serves only to support the finding that the resulting birth defect was not too remote in relation to the doctor's omission as an element of proximate cause. These cases do not require that the omission be causally related to the defect. The circumstance of the similarity between the unwarned and undetected risk and the ultimate defect was not used to establish medical causation, which, we acknowledge, it does not do; nor was it invoked as a substitute for medical causation, which, we repeat, is not required. Rather, the circumstance is one that is relevant to the jury's determination of legal or proximate cause: whether the birth of a child with a defect was a material risk that was reasonably foreseeable and was itself a result that was not too remote in relation to the doctor's failure to apprise the parents of that risk during the pregnancy. Finally, we turn to the issue of the sufficiency of the evidence relating to damages. As noted, a woman asserting a wrongful birth claim who proves that she herself would have had an abortion if apprised of the risk of fetal defect is entitled to damages consisting of both the special medical expenses attributable to raising a child with a congenital impairment, see Schroeder, supra, 87 N.J. at 70, and the emotional injury attributable to the deprivation of "the option to accept or reject a parental relationship with the child[,]" Berman, supra, 80 N.J. at 433. Defendants' motion for summary judgment and the rulings of the lower court sustaining that motion did not purport to determine or foreclose those claims for damages. BRANDON CANESI, a minor by his parents Melissa and Sebastian Canesi as Guardian Ad Litem, MELISSA and SEBASTIAN CANESI, Individually, Plaintiffs-Appellants, v. JAMES A. WILSON, M.D. and RONALD LOEWE, M.D., Defendants-Respondents, and JOHN DOE PHYSICIAN (2-10) and JOHN DOE DRUG MANUFACTURER (1-10), Defendants. O'HERN, J., concurring. In formal logic, the technique of setting up an argument that does not exist and then refuting that misrepresented argument is called the straw man fallacy. See Douglas Walton, A Pragmatic Theory of Fallacy 57 (1995). The straw man technique is fallacious because it leads to irrelevancies and because it precludes the development and resolution of the true issues of contention. See Madsen Pirie, The Book of the Fallacy 160 (1985). [Philip M. Nichols, Realism, Liberalism, Values, and the World Trade Organization, 17 U. Pa. J. Int'l Econ. L. 851, 882, n.20 (Fall 1996).] In this case our dissenting member has set up an argument that does not exist and then has proceeded to refute it. The false premise of the dissent is contained in its first sentence: The majority holds that a physician who fails to warn a pregnant woman of a potential adverse effect of a prescribed drug virtually insures that her child will be born without birth defects from any cause. Post at __, Pollock, J., dissenting (slip op. at 1). Not so. This case concerns the eventual manifestation of the specific defect about which the physician had an acknowledged duty to warn his patient. The Court's opinion does not create an open-ended liability for obstetricians whenever a birth defect occurs. For liability to be imposed, the birth defect must be parallel to the undisclosed material risk concerning which the physician had a duty to warn, taking into account the maternal indicators of the patient. Ante at ____, Handler, J. (slip op. at 13-14). We would not sustain a cause of action, for example, if Brandon had been born with a hereditary hip dislocation, a condition totally unrelated to the unwarned risk. Considering the maternal indicators of this patient, she should have been warned that taking Provera during early pregnancy posed the risk of congenital anomalies, including congenital heart defect and limb reduction. Ante at ___, Handler, J. (slip op. at 25-26). Recall that this patient specifically inquired about the risks of having taken Provera during early pregnancy and was told not to worry. Ante at ___, Handler. J. (slip op. at 24). When the birth defect that occurs is the very one about which warning should have been given, it cannot fairly be charged that the Court has eliminated proximate cause from a wrongful birth analysis. Post at __, Pollock, J., dissenting (slip op. at 22). It may be that science is unable to establish to a reasonable degree of medical certainty that Provera was the cause in fact of Brandon's condition. That does not detract from the reality that the risk was one about which the patient should have been warned and that was the risk that eventuated. Science still cannot pinpoint the cause of cancer. Yet, men and women will want to avoid the risk of cancer by avoiding those substances that are believed to increase the risk of its occurrence. So too Melissa Canesi was entitled to know if certain substances were believed to pose or increase a risk that her child would be born with a limb reduction. Even if the extent of the risk is not scientifically certain, some women will simply not risk ingesting a substance that could have such side effects. Consider, for example, the recent debate about silicone breast implants. Although frequently associated with the incidence of cancer, a definitive link has not been established to the satisfaction of many scientists. Science Panel Members Explain Methodologies, According to Deposition Transcripts, 7 No. 12 Mealy's Litig. Rep.: Breast Implants 4 (May 13, 1999). In suits over silicone breast implants, . . . some argue that evidence of causation is lacking, but that does not mean a causal link does not exist. It means that we might not have found it yet because the scientific process is limited by its theories, its tools and time. Roman M. Silberfeld, Scientific Law of Unintended Consequences, Nat'l L. J., Jan. 19, 1998, at A22. Persistent scientific debate would not relieve a physician performing a breast implant procedure of a duty to warn a patient that the risk existed. In short, this case is not about a birth defect unrelated to the physician's breach of the duty to warn. This case is about the occurrence of one of the very risks about which there was a legal duty to warn. It is not as though the record established that there was some other cause, genetic or environmental, that caused the defect. However difficult it may be to prove the etiology, Brandon's birth defect appears to have been a case of the unwarned risk coming to pass. SUPREME COURT OF NEW JERSEY A- 46 September Term 1997 BRANDON CANESI, a minor by his parents Melissa and Sebastian Canesi as Guardian Ad Litem, MELISSA and SEBASTIAN CANESI, Individually, Plaintiffs-Appellants, v. JAMES A. WILSON, M.D. and RONALD LOEWE, M.D., Defendants-Respondents, and JOHN DOE PHYSICIAN (2-10) and JOHN DOE DRUG MANUFACTURER (1-10), Defendants. POLLOCK, J., dissenting. The majority holds that a physician who fails to warn a pregnant woman of a potential adverse effect of a prescribed drug virtually insures that her child will be born without birth defects from any cause. I respectfully dissent. Under the majority opinion, the parents of a child born with congenital defects may maintain a wrongful birth action against physicians who failed to warn the mother of the potential adverse effects of a drug that did not cause the defects. The import of the holding is that the parents need not prove that the drug was the proximate cause of the birth defects that give rise to the action. All the mother need prove is that she would have aborted the fetus if apprised of potential risks, even if the risks never materialized. Both the reasoning and the result of the majority opinion are flawed. The PDR still warns against taking Provera during the first four months of pregnancy. According to the PDR, if a pregnant woman is exposed to Provera, she should be apprised of two potential risks: possible genital abnormalities in the fetus and possible delay in spontaneous abortion of defective fertilized ova. Neither of those two potential risks eventuated in this case. On March 18, 1992, Canesi gave birth to plaintiff Brandon Canesi, who was born with bilateral limb reduction of the hands. Canesi and her husband (jointly described as the Canesis"), filed a wrongful birth action in which they claimed that Drs. Wilson and Loewe, by failing to warn of the risks that Provera posed to a fetus, had deprived them of the right to abort Brandon. The Canesis claimed that Provera had caused Brandon's limb reduction and that the two doctors had been negligent in failing to warn them of the limb reduction risk. In a separate count, which is not before us, the Canesis asserted a claim on Brandon's behalf for his wrongful life. The Law Division granted the doctors' motion for summary judgment, reasoning that the Canesis had failed to establish that Provera had caused Brandon's limb reduction or that the ingestion of Provera was related in any way to the defect. The trial judge also observed that expert testimony was required to support a claim that Canesi's fertilized ova were defective or that Provera caused a delay in her spontaneous abortion of one of them. In the absence of any supporting expert testimony, the trial court correctly discounted those claims. The Appellate Division likewise found that the record contained no evidence that Provera had caused or increased the risk of limb reduction. 295 N.J. Super. 354, 359-60 (App. Div. 1996). The court stated: [I]t is clear in this case that if the fetus had been aborted because of the concerns expressed in the PDR, it would have been based on a medical premise now found to be fallacious. Id. at 362. Assuming that the doctors' failure to warn that Provera could cause limb reduction defects constituted a breach of their duty of care, the point remains that to establish a cause of action, plaintiffs must prove that Provera caused the defect. The concurrence acknowledges that "[w]e would not sustain a cause of action, for example, if Brandon had been born with a hereditary hip dislocation, a condition totally unrelated to the unwarned risk." Id. at (slip op. at 2). The reason that the concurrence would not impose liability is that Provera does not cause hip dislocations. Medical science, including plaintiffs' experts, now accepts that Provera does not cause limb reduction defects. The PDR's former warning of the risk of such defects, even if relevant on the issue of the doctors' duty to warn, should not suffice, in light of current medical knowledge, to establish causation. If proximate cause is to remain an element of the cause of action, the failure to warn should not lead to the imposition of liability for limb reduction defects any more than it should for the hypothetical hip dislocation. Apparently, the concurrence also would shift the burden of proof on causation from plaintiffs to the doctors. The concurrence states, "This case is about the occurrence of one of the very risks about which there was a legal duty to warn. It is not as though the record established that there was some other cause, genetic or environmental, that caused the defect." Id. at (slip op. at 4). Implicit in the comment that the record does not establish another cause for the birth defect is the premise that the doctors were obligated to establish such a cause. The logic of the concurrence is that absent proof of another cause, the doctors are liable for the cause asserted by plaintiffs. Thus, the concurrence would shift the burden of proof on causation from plaintiffs to defendants. The determination of proximate cause necessarily involves public policy considerations. Prosser &amp; Keeton on Torts, supra, 42. As Justice Handler has stated: In considering the standards that govern an appropriate duty of care and limitations of liability in [the context of health care], we must be especially mindful of the principles of sound public policy that are informed by perceptions of fairness and balance. We therefore insist that an immediate, close and clear involvement or connection be present between a person suffering emotional distress [the claimed injury] and the conduct of the professional health care providers whose fault has contributed to [the event that precipitated the emotional distress]. Absent any supporting expert testimony, the trial court correctly found that the physicians' breach of their duty of care was not causally related to the birth defect: It was argued that [the case] goes to a jury because the prescribing of Provera to a pregnant woman increased the risk that if she was carrying an abnormal fetus, that such fetus would be retained rather than spontaneously aborted [defective ovum argument] . . . . There is no testimony to that in the case. . . . And that brings us to the issue, which is really the heart of the argument. Number 2, that the failure to inform and warn Mrs. Canesi once they knew she was pregnant, that the taking of Provera during the early stages of her pregnancy posed potential risk to the fetus[,] thus depriving her of the opportunity to make a reasoned determination as to whether the pregnancy should be terminated or not. . . . That is the real issue in this case and that's the issue that gave me a lot of concern . . . . I view that as an argument that would extend the parameters of current and existing law or would fly in the face of current existing law. The cases that I've read cited by both parties with respect to failure to warn [including Berman and Procanik] all, without exception, involve failure to warn of risks which ultimately involve the patient suffering from one of the very risks that she was not warned about. There hasn't been one case in the reported decisions that has deviated from that concept. This would be that case. In plaintiffs' motion for reconsideration, their attorney again differentiated wrongful birth and informed consent claims. Their attorney repeated that the omitted warnings should have included not only the possibility of limb reduction defects, but of fetal abnormalities in general. Plaintiffs raised the same arguments in the Appellate Division, contending that they need not prove that Provera caused Canesi's ovum to be defective. They did not address the need to show that an ovum was defective or that Provera caused Canesi to retain it. In this Court, plaintiffs likewise have failed to claim that Canesi's fertilized ova were defective or that Provera delayed her spontaneous abortion of one of them. Like the trial court, the Appellate Division rejected plaintiffs' wrongful birth claim for lack of proof of proximate cause: [W]e are convinced that plaintiffs' cause of action cannot exist unless it is demonstrated that the undisclosed harm or risk actually occurred and that defendant's negligence was a proximate cause of the condition complained of. We do not believe that legal acceptance of plaintiffs' theory of causation is appropriate or desirable. Plaintiffs' theory would impose liability for a failure to warn or to obtain informed consent without regard to whether the ultimate consequence in fact related to the condition of which the doctor failed to warn or inform the patient. Because Brandon's deformity is not related to the drug to which the warning pertained, we hold, as a matter of law, that legal or proximate causation between the consequences of the birth and the failure to warn, resulting in a lost opportunity to abort, may not be found. To hold otherwise would lead to a multitude of tort claims based on chance occurrences, rather than legally definable causal relationships. Missing from the majority's quotation, however, is the remainder of the paragraph: Like most of the other courts that have considered this cause of action, we hold that the parents of a genetically or congenitally defective child may maintain an action for its wrongful birth if the birth was the result of the negligent failure of the attending prenatal physician to discover and inform them of the existence of fetal defects. NO. A-46 BRANDON CANESI, etc., et al., Plaintiffs-Appellants, v. JAMES A. WILSON, M.D., et al., Defendants-Respondents, and JOHN DOE PHYSICIAN (2-10), et al., Defendants. DECIDED Perhaps the strongest consideration that influences our decision in favor of the "prudent patient" standard lies in the notion that the physician's duty of disclosure "arises from phenomena apart from medical custom and practice": the patient's right of self-determination. The foundation for the physician's duty to disclose in the first place is found in the idea that "it is the prerogative of the patient, not the physician, to determine for himself the direction in which his interests seem to lie." [Largey, supra, 110 N.J. at 214 (quoting Canterbury, supra, 464 F.2d at 781, 784, 786-87, 789).] --------------- FOOTNOTES --------------- In this case, the unwarned risk was that Provera might cause birth defects. Provera, however, was not the cause of Brandon Canesi's limb reduction, the only defect that materialized. In fact, Provera did not cause any birth defects. [Post at (slip op. at 7) (emphasis added).] The dissent also implies that our holding in this case would support a finding of liability in a wrongful birth case in which the eventual harm was completely different from and unrelated to the bases for the physician's negligence. That characterization of our holding is inaccurate. This record clearly demonstrates a sufficient connection or parallel between the various allegations of physician negligence and the resulting harm to the infant, and warrants submission of plaintiff's wrongful birth claim to a jury.