(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).
Argued November 3, 1997 -- Decided June 17, 1999
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.
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.
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 & 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 & 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.
On July 1, 1991, plaintiff Melissa Canesi, then twenty-nine years old, consulted defendant Dr. James A. Wilson, a specialist in obstetrics and gynecology, concerned that she might be pregnant because she had been amenorrheic for eleven days. A urinalysis yielded the same results as a home pregnancy test had: plaintiff was not pregnant. Thereafter, Dr. Wilson prescribed for plaintiff Provera, a progestational agent designed to induce menstruation. Dr. Wilson did not provide any information to plaintiff concerning the potential side effects and contraindications of the drug. At the time, the Physicians' Desk Reference (PDR) warned that if a woman was or became pregnant while taking Provera, she should be advised that there was a risk that the fetus would suffer from congenital anomalies, including limb reduction, and a risk that she would retain a defective ovum instead of spontaneously aborting it.
Provera did not succeed in inducing menstruation and, on July 15, Dr. Wilson gave plaintiff a blood serum test to determine if she was pregnant. This time, the test was positive. Upon learning that she was pregnant with twins, plaintiff asked Dr. Wilson if her ingestion of Provera would have a deleterious impact on the fetuses or the course of her pregnancy. Dr. Wilson told plaintiff not to worry.
Because Dr. Wilson was not a participating physician in plaintiff's health insurance plan, she needed to look elsewhere for pregnancy care. On July 25, she saw Dr. Ronald Loewe for the first time and informed him both of her pregnancy and of the fact that she had taken Provera. Dr. Loewe told her that she should not be concerned that she had taken the drug.
Plaintiff's pregnancy was not without incident. She began spotting, one of the fetal twins died, and an amniocentesis revealed excessive amniotic fluid, an indication that the remaining fetus might be suffering from an abnormality. On March 18, 1992, plaintiff gave birth to a boy, Brandon, who had the congenital impairment of bilateral limb reduction.
Plaintiff, together with her husband Sebastian, sued Drs. Wilson and Loewe, alleging that Dr. Wilson was negligent for failing to diagnose her pregnancy in a timely manner, and 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. Plaintiff claimed that had she known of the risk of congenital defects generally, or limb reduction specifically, that Provera posed to her remaining fetus, or had she been told that she was at an increased risk of retaining a defective ovum, she would have terminated her pregnancy. Being kept ignorant of these risks, she asserted, deprived her of the personal choice of determining whether or not to terminate her pregnancy. The complaint also included a claim brought on behalf of Brandon. That claim alleged that Provera caused his bilateral limb reduction and that defendants were negligent in prescribing the drug to his mother without warning of this risk.
Defendants moved for summary judgment. They pointed out that not only did plaintiffs fail to present any expert testimony that Provera caused fetal limb reduction, but the latest edition of the PDR no longer contained a warning that Provera was even associated with this defect.See footnote 1 Construing the cause of action essentially to be one involving the lack of informed consent, the defendants contended that, because plaintiffs could not prove medical causation, i.e., that Provera had actually caused Brandon's limb reduction, defendants, as a matter of law, could not be found liable.
The trial court granted defendants' motion, noting 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 in fact caused the harm that materialized. The Appellate Division affirmed. 295 N.J. Super. 354 (1996). The court determined that even if plaintiffs' claim was denominated a wrongful birth action based on the lost opportunity to terminate the pregnancy, plaintiffs still "must establish that the taking of Provera caused Brandon's limb reduction abnormalities." Id. at 362.
The Court granted plaintiffs' petition for certification. 149 N.J. 139 (1997).
A wrongful birth cause of action is predicated on a woman's right to determine for herself whether or not to continue or terminate her pregnancy. Persons "have a right of their own either to accept or reject a parental relationship, and the deprivation of that right by the negligent misconduct of another creates a cause of action in the parents." Schroeder v. Perkel, 87 N.J. 53, 66 (1981). The right protects a distinctively personal interest. See Hummel v. Reiss, 129 N.J. 118, 136 (1992) (Handler, J., dissenting) (noting that because decision to terminate pregnancy "involve[s] profound moral and personal issues," it is one that "only [the patient] could make").
The violation of the interest in self-determination that undergirds a wrongful birth cause of action 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. Schroeder, supra, 87 N.J. at 66. The claim in a wrongful birth action can arise when a physician fails to provide adequate genetic counselling, see id. at 63, fails to detect a discoverable fetal defect or to inform the parents thereof, see Berman v. Allan, 80 N.J. 421 (1979), fails to interpret test results properly, see Procanik v. Cillo, 97 N.J. 339 (1984), or fails to warn of a child being born with a defect, see Harbeson v. Parke-Davis, Inc., 656 P.2d 483, 491 (Wash. 1983); see also Williams v. University of Chicago Hosp., 688 N.E.2d 130, 133 (Ill. 1997) (stating that in wrongful birth actions, parents allege that they would not have carried fetus "to term if it had not been for the defendant's negligence in prenatal testing, genetic prognosticating, or counseling [them] as to the likelihood of giving birth to a physically or mentally impaired child") (internal quotation and citation omitted)).
Because the patient's protectable interest is the personal right of self-determination, the doctor's duty of disclosure must be sufficient to enable her to make an informed and meaningful decision concerning whether or not to continue the pregnancy.
Compensable damages in a wrongful birth case include the emotional injury of the parents caused by the deprivation of "the option to accept or reject a parental relationship with the child. . . ." Berman, supra, 80 N.J. at 433. These damages also include the special medical expenses attributable to raising a child with a congenital impairment. See Schroeder, supra, 87 N.J. at 70. Damages, however, do not encompass the birth defect or congenital impairment itself. See Berman, supra, 80 N.J. at 429-30 (stating that plaintiff may not recover compensable damages for existence per se of child in impaired state).
Because in a wrongful birth action damages for the birth defect itself are not recoverable, the parents are not required to prove that the doctor's negligence caused the defect. See Keel v. Banach, 624 So.2d 1022, 1029 (Ala. 1993) ("The nature of the tort of wrongful birth has nothing to do with whether a defendant caused the injury or harm to the child, but, rather, with whether the defendant's negligence was the proximate cause of the parents' being deprived of the option of . . . making an informed and meaningful decision either to terminate the pregnancy or to give birth to a potentially defective child."); Robak v. United States, 658 F.2d 471, 477 (7th Cir. 1981) (stating that causation in wrongful birth action "is not based on the injuries to the fetus but on defendant's failure to diagnose [plaintiff's medical condition] and inform her of the consequences [to her pregnancy]"); see also Provenzano v. Integrated Genetics, 22 F.Supp.2d 406, 417 (D.N.J. 1998) (acknowledging in wrongful birth case, medical causation not required because "cause of [the child's] genetic condition is not at issue"; rather "[t]he alleged injury is [the child's] very birth"); discussion infra at __ (slip op. at 26-32). Because the cognizable harm is the emotional and economic injury suffered by the parents, they must prove that these injuries were proximately caused by the doctor's negligence in depriving them of the opportunity to decide whether or not to become parents of a child with a congenital defect.See footnote 2 E.g., Procanik, supra, 97 N.J. at 342.
Like a cause of action for wrongful birth, a claim based on the doctrine of informed consent is predicated on the patient's right to self-determination. The doctrine of informed consent is rooted in the premise that "every human being of adult years and sound mind has a right to determine what shall be done with his own body." Canterbury v. Spence, 464 F.2d 772, 780 (D.C. Cir.), cert. denied, 409 U.S. 1064, 93 S. Ct. 560, 34 L. Ed.2d 518 (1972) (internal quotation and citation omitted); see also Baird v. American Med. Optics, 155 N.J. 54, 79 (1998) (O'Hern, J., dissenting) (observing that informed consent is "dignitary tort" preserving patient's "rights of self-determination and personal integrity"). Informed consent doctrine requires a plaintiff to prove that the 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. See Canterbury, supra, 464 F. 2d at 791.
Informed consent doctrine imposes on the physician a duty to disclose "such information as will enable the patient to make an evaluation of the nature of the treatment and of any attendant substantial risks, as well as of available options in the form of alternative therapies." Largey v. Rothman, 110 N.J. 204, 208 (1988). That duty of disclosure rejects the "reasonable physician" standard and focuses on the material risks a "prudent patient" would want to know before making a medical decision.See footnote 3
In informed consent cases, proximate cause requires the plaintiff to prove that a reasonably prudent patient in the plaintiff's position would have declined to undergo the treatment if apprised of the risks that the defendant negligently failed to disclose. Id. at 215-16. In addition, because damages in informed consent cases include the harm or physical injury to the patient, there must be medical causation, that is, a causal connection between the undisclosed risk and the injury ultimately sustained. Grasser v. Kitzis, 230 N.J. Super. 216, 221-22 (App. Div. 1988) (noting that in informed consent cases where plaintiff suffers injury during surgery, plaintiff establishes proximate causation by making two showings: (1) prudent patient would have refused consent if full and adequate disclosure had been made, and (2) injury suffered was related to operation and did not occur spontaneously or by independent means); see also Canterbury, supra, 464 F. 2d at 790 (noting that "[a]n unrevealed risk that should have been made known must materialize, for otherwise the omission, however unpardonable, is legally without consequence").
These principles apply in informed consent cases that involve the prescription of drugs. Hence, the test of proximate cause in such cases requires that the plaintiff establish a causal relation between the prescribed drug about which she was inadequately warned and the harm that materialized. See, e.g., Niemiera v. Schneider, 114 N.J. 550, 554 (1989) (stating in failure-to-warn medical malpractice case involving administration of vaccine, "fundamental underlying question" is whether vaccine "was the cause of" plaintiff's brain damage); Eppel v. Fredericks, 610 N.Y.S.2d 254 (App. Div. 1994) (holding that in order to establish prima facie case for failure to procure informed consent, plaintiff must establish, among other things, that prescribed drug about which she received inadequate warning was proximate cause of her injury). That test of medical causation is applicable in an informed consent case even though the harm that materializes is a birth defect. Ramon v. Farr, 770 P.2d 131, 137 (Utah 1989) (finding that plaintiff failed to establish that child's serious birth defects were caused by doctor's negligent use of anesthesia).
In sum, the informed consent and wrongful birth causes of action are similar in that both require the physician to disclose those medically accepted risks that a reasonably prudent patient in the plaintiff's position would deem material to her decision. What is or is not a medically accepted risk is informed by what the physician knows or ought to know of the patient's history and condition. These causes of action, however, have important differences. They encompass different compensable harms and measures of damages. In both causes of action, the plaintiff must prove not only that a reasonably prudent patient in her position, if apprised of all material risks, would have elected a different course of treatment or care. In an informed consent case, the plaintiff must additionally meet a two-pronged test of proximate causation: she must prove that the undisclosed risk actually materialized and that it was medically caused by the treatment. In a wrongful birth case, on the other hand, a plaintiff need not prove that the doctor's negligence was the medical cause of her child's birth defect. Rather, the test of proximate causation is satisfied by showing that an undisclosed fetal risk was material to a woman in her position; the risk materialized, was reasonably foreseeable and not remote in relation to the doctor's negligence; and, had plaintiff known of that risk, she would have terminated her pregnancy. The emotional distress and economic loss resulting form this lost opportunity to decide for herself whether or not to terminate the pregnancy constitute plaintiff's damages.
This analysis frames and directs our inquiry into whether plaintiffs have pleaded and proffered evidence sufficient to establish a basis for liability.
That inquiry is initially complicated by the allegations and claims presented by plaintiffs' complaint. On the one hand, plaintiffs' complaint alleges a causal connection between the prescribed Provera and Brandon's birth defect and contains a claim for damages for the defect itself.See footnote 4 That comports with a claim based on informed consent. On the other hand, plaintiffs, in different counts and in response to defendants' motion for summary judgment, disclaim damages for the defect itself and insist that they seek to recover only for their injuries as parents, i.e., their own mental and emotional anguish at having lost the opportunity to decide for themselves whether or not to terminate the pregnancy and the special expenses incurred in rearing a child with an impairment. Those claims are typically embraced by a wrongful birth cause of action.
It is not entirely clear whether the only claim the lower courts considered was that seeking to recover damages for the child's impaired condition based on the causal connection between the ingestion of Provera and the birth defect. That claim, regardless of whether it is denominated as one based on informed consent, was properly foreclosed by summary judgment. The record discloses that plaintiffs presented insufficient proof of a causal relationship between the drug and the defect that afflicts their son. That failure of proof would also support summary judgment in favor of defendants to the extent plaintiffs sought damages in the nature of a claim for wrongful life based on their allegation that the drug caused the defect. Similarly, the evidence was insufficient to establish medical causation in support of plaintiffs' additional allegation that Provera caused the retention of a defective ovum, leading eventually to the birth of their child with the congenital defect. 295 N.J. Super. at 359.
The question remains, however, whether summary judgment was properly entered on the wrongful birth claim. Plaintiffs tried unsuccessfully at the hearings on the summary judgment motion to argue that they had a wrongful birth claim apart from and in addition to their claims based on the allegation that Provera posed the specific risk of bilateral limb reduction and in fact caused that defect. They asserted that they did not restrict their claims only to the specific fetal risk of bilateral limb reduction allegedly posed by Provera and that they did not seek damages only for the impairment suffered by their child; therefore, they were entitled to recover on other grounds that were not dependent on medical causation between the prescribed drug and the resulting birth defect.
Among those "other independent grounds of liability" was defendants' negligent failure "to inform and warn" plaintiffs "that the drug manufacturers issued clear warnings that Provera should not be taken during the first four months of pregnancy" and that the PDR required warnings of general "congenital anomalies, and that this negligence, together with other negligent acts, deprived them of the opportunity to terminate the pregnancy. Plaintiffs' attorney summarized this position. While acknowledging that he had "some big problems on the causation" issue, he contended, citing the wrongful-birth decisions of Berman and Procanik, supra, that he need not prove causation because he was alleging wrongful birth arising from the failure to warn and other negligent acts. He expressly argued that the doctors should have warned plaintiffs and that in failing to do so
[t]hey didn't give her her chance, all[] they had to do was say, "Provera has the possibility of (a) causing fetal abnormalities, generically; (b) of retaining an abnormal fetus rather than spontaneously aborting it; (c) [and] that [there were] indications of mild polyhydramnios[] an indication of fetal abnormality," and [their] failure to tell her [of those things] deprived her of her right to abort.
"This particular claim," plaintiffs insisted, "is not the more typical case of a failure to obtain informed consent." Although aware of this argument, the trial court did not determine whether plaintiffs' contentions based on a wrongful birth claim fell beyond the scope of defendants' motion for summary judgment and whether the evidence was sufficient to support a wrongful birth claim. The record provides an adequate basis for making that determination.
The initial analysis based on the record must focus on whether defendants breached a duty. As previously noted, the duty of disclosure in a wrongful birth case is grounded in the right of self-determination. Supra at __ (slip op. at 7-8). The doctor's duty is to communicate to the patient enough material information to allow her to make an “informed choice concerning the continuation of pregnancy.” Alan B. Handler, Individual Worth, 17 Hofstra L. Rev. 493, 496 n.23 (1989); see Hummel, supra, 129 N.J. at 134 (Handler, J., dissenting) (patients must "be told about and understand the available options and have all the relevant information necessary to make" a meaningful decision). The test of "materiality" in a wrongful birth case is "whether a 'reasonable patient,' in what the physician knows or should know to be the patient's position, would be 'likely to attach significance to the risk or cluster of risks' in deciding whether to forego the [pregnancy or to bring the fetus to term]." Bennet v. Surgidev Corp., 311 N.J. Super. 567, 573 (App. Div. 1998) (citing Largey, supra, 110 N.J. at 211-12 (quoting Cantebury, supra, 464 F. 2d at 787)). See Procanik, supra, 97 N.J. at 364 (Handler, J., concurring and dissenting) (indicating physician's general duty of disclosure encompasses material information relating to continuation of pregnancy); Carolyn Lee Brown, Genetic Malpractice: Avoiding Liability, 54 U. Cin. L. Rev. 857 (1986) (noting in wrongful birth cases importance of condition of individual patient and that "the facts of a given case will play a large part in determining the reasonableness of the physician's response").
The "prudent-patient" standard applicable to a claim for negligent interference with procreative autonomy contemplates a fully informed patient:
A physician or counselor could reasonably be expected to ascertain enough of a patient's background, [and] her reasons for seeking pregnancy [] counseling . . . to assess what information might be useful to the patient's deliberative process and then to discuss that information with her. The standard only requires physicians and counselors to make reasonable efforts. They need not be mind readers, as long as they reasonably attend to the circumstances of their individual patients. . . . The reasonably prudent patient standard thus takes into account each woman's unique circumstances.
[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 & 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.
We affirm in part and reverse in part and remand to the trial court to proceed in accordance with this opinion.
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.
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.
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.
Because this appeal arises from the grant of summary judgment for defendants, plaintiffs' version of the facts and all favorable inferences that may be drawn therefrom are assumed to be true. See Brill v. Guardian Life Ins. Co., 142 N.J. 520, 523 (1995); Pierce v. Ortho Pharm. Corp., 84 N.J. 58, 65 (1980). So viewed, the facts support the following summary.
In June 1991, Melissa Canesi (Canesi) was twenty-nine years old, married, and the mother of one child. When she missed her menstrual period that month, she feared that she might be pregnant.
A home pregnancy test indicated that Canesi was not pregnant. She nonetheless consulted defendant, Dr. James Wilson, on July 1, 1991. For the purpose of this appeal, Canesi concedes that she did not become pregnant until shortly after that date.
Dr. Wilson administered a urinalysis pregnancy test, which indicated that Canesi was not pregnant. To restart her menstrual cycle, Dr. Wilson prescribed ten Provera tablets, to be taken one per day. After taking eight of the tablets without success, Canesi again consulted Dr. Wilson.
On July 15, Dr. Wilson administered a blood serum test, which indicated that Canesi was pregnant; in fact she was carrying twins. Although Canesi expressed to Dr. Wilson a concern about the use of drugs during her pregnancy, he told her not to worry. On two prior occasions, Canesi had aborted pregnancies, once because of a concern about the side effects of painkillers and x-rays administered in connection with a broken leg.
Because Dr. Wilson was not a participating physician in Canesi's health plan, she next consulted Dr. Ronald Loewe. On July 25, Canesi told Dr. Loewe that she was pregnant and that she had taken Provera. Like Dr. Wilson, Dr. Loewe told Canesi that she need not be concerned about the drug. For reasons unrelated to the ingestion of Provera, Canesi experienced spotting and mild polyhydramnios (the presence of excessive amniotic fluid) during her pregnancy. One of the two fetuses that she was carrying died and was spontaneously aborted.
When Canesi consulted the two doctors in 1991, the medical profession was divided over the effects of Provera during pregnancy. In that year, the drug manufacturer, Upjohn, included in the Physicians' Desk Reference (PDR) a warning that the use of Provera was “not recommended” during the first four months of pregnancy. The warning stated that if a pregnant woman took Provera during that time, she should be told of the risk to her fetus of congenital anomalies, including possible “limb reduction defects,” and the risk of delay in the spontaneous abortion of defective fertilized ova. For the purpose of this appeal, both doctors concede that they had a duty to warn Canesi of those risks. They further concede that they did not warn her.
Subsequent scientific research revealed that Provera neither causes nor increases the risk of limb reduction defects. Consequently, in 1993, Upjohn deleted its warning about those defects from the PDR.
Consistent with the elimination of the warning, defendants' expert, Dr. A.F. Haney, Professor of Obstetrics and Gynecology at Duke University Medical Center, found “no scientific basis for limb reduction with exposure to progestins,” such as Provera. Dr. Haney explained that early reports of an “association” between Provera and limb reduction defects were based on “very bad epidemiology.” He concluded:
When careful analysis was performed, it became very obvious there was no scientific information whatsoever to support any association of limb reduction with progestins of any kind. . . . As a consequence, this patient and her family have been [misled] into thinking there is some potential association. It's certainly understandable for them [to] try and find a cause for their child's anomaly. The one thing that can clearly be said is that this is not related to the 10 days of Provera she took during [the] luteal phase of her conceptive cycle.
Plaintiffs' experts, Dr. William Vilensky and Dr. Deborah P. Consoli, likewise declined to attest to any connection between Provera and limb reduction defects. Specifically, Dr. Vilensky testified that he could not render any opinion about a causal relationship. Dr. Consoli, after conceding that current medical knowledge does not support a causal connection, stated that she no longer warned her own patients that Provera potentially could cause limb reduction. She testified that the warning was unnecessary
[b]ecause I think overall, I think medical-leg