(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 October 10, 2001 -- Decided August 20, 2002
STEIN, J., writing for a majority of the Court.
In this appeal, the Court considers whether the plaintiffs' expert's opinion, determined by the trial court to be
scientifically unreliable, properly was excluded from evidence.
During the spring of 1975, and in response to an outbreak of measles and rubella of near epidemic proportions in
Burlington County, Burlington County health officials, with the cooperation of the Riverside Board of Education and the
New Jersey Department of Health, organized and operated a free immunization clinic at Riverside High School. On April
18, 1975, Debra Wright, a senior at Riverside, was given a rubella vaccine at the clinic. Debra either was pregnant with her
daughter, Delisha, or soon to become pregnant when she received the vaccine.
In 1973 and 1974, the product information provided for the rubella vaccine specifically recommended that
pregnant women not be given the vaccine. The product information also recommended that women of child-bearing age
not be considered for vaccination unless there was no possibility of pregnancy at the time of the injection or in the
following two to three months. Riverside agents maintained that it was standard practice to counsel all females of
childbearing age about the risks of vaccination and to refrain from inoculating any female who was pregnant or sexually
active.
In October 1992, Debra Wright filed a complaint alleging that the rubella vaccination that had been administered
to her caused an infection in her fetus, which caused her daughter to develop Congenital Rubella Syndrome (CRS). She
further asserted negligence on the part of the defendants for failing to ascertain prior to her vaccination whether Debra was
pregnant or sexually active. Finally, Wright alleged that she was not informed that she should not be vaccinated if she
were pregnant because the vaccine could cause severe birth defects to an unborn child.
During the course of discovery, Wright submitted two reports of her medical expert, Dr. George Huggins. In his
reports, Dr. Huggins concluded that it could be determined within a reasonable degree of medical certainty that Delisha
suffers from CRS as a result of the rubella immunization that Debra received in April 1975. He also concluded that the
program and care givers significantly deviated from the standard of care at that time because they did not determine the
pregnancy status or the possibility of pregnancy in Delisha's mother.
Dr. Huggins subsequently was deposed by defendants' counsel. During the course of his deposition, Dr. Huggins
testified essentially that basic studies show that the rubella vaccine is a live attenuated vaccine, and that when it is injected
into an individual, it replicates and causes a mild infection in that particular individual, stimulating the immune system to
develop antibodies to the virus. He further testified that it is known that in humans, the virus in the vaccine crosses the
placenta and enters the developing fetus and/or embryo. Dr. Huggins then testified that whenever there is documentation
of infection by a virus that is known to be a teratogen (a drug, virus, or agent that can cause congenital malformation), it
was reasonable to conclude “that there is proximate cause that the virus that was injected into the individual indeed did
cause the rubella syndrome.”
Following Dr. Huggins' deposition, defendants moved for summary judgment, noting the absence of any medical
support or scientific evidence confirming that there is a causal connection between the rubella vaccination and CRS, thus
rendering Dr. Huggins' opinion scientifically unreliable and inadmissible. Without conducting an evidentiary hearing on
the issue of admissibility of expert's opinion, the trial court determined that Dr. Huggins had failed to proffer a
scientifically acceptable basis for his opinion that the rubella immunization Debra Wright received in April 1975 caused
Delisha to develop CRS. Thus, the trial court held that Dr. Huggins' opinion was inadmissible. Because plaintiffs Wright
and Kemp were unable to prove their prima facie case without Dr. Huggins' report and opinion, the trial court granted
defendants' motion for summary judgment dismissing the complaint.
In an unpublished opinion, the Appellate Division affirmed. Quoting Rubanick v. Witco Chemical Corp.,
125 N.J. 421 (1991), the Appellate Division observed that Dr. Huggins' opinion was not sufficiently reliable because it was not
based on a “sound, adequately-founded scientific methodology involving data and information of the type reasonably relied
on by experts in the scientific field.” The panel further noted that Dr. Huggins himself had acknowledged that “no study,
report, medical journal, treatise, epidemiological or toxicology data, or other recognized authority has demonstrated a
correlation between attenuated rubella vaccines and congenital rubella syndrome in a child born with congenital rubella
syndrome.” The panel concluded that because Dr. Huggins could identify no such data or scientific study, it could not be
said that his opinion was founded on a scientifically tested and accepted methodology recognized by the medical
community.
The Supreme Court granted plaintiffs' petition for certification.
HELD: The trial court committed plain error when it determined that plaintiffs' expert's opinion was scientifically
unreliable, excluded that expert's opinion, and dismissed the plaintiffs' complaint, without first conducting an evidentiary
hearing to determine the reliability of the expert's testimony.
1. New Jersey Rule of Evidence 702, which governs the admission of expert testimony, requires that: (1) the intended
testimony concern a subject matter that is beyond the ken of the average juror; (2) the field testified to be at a state of the
art such that an expert's testimony could be sufficiently reliable; and (3) the witness have sufficient expertise to offer the
intended testimony. (pp. 16-17)
2. In the past, in order to meet the requirement that the expert's testimony was sufficiently reliable in the field of scientific
research, the proponent of the testimony was required to demonstrate that the expert's opinion or theory was generally
accepted within the scientific community. However, the Supreme Court relaxed the standard for admissibility of scientific
evidence in toxic tort cases due to the extraordinary and unique burdens plaintiffs faced when they sought to prove medical
causation. Thus, the Court held in Rubanick that a theory of causation that had not yet reached general acceptance in the
scientific community may be found to be sufficiently reliable if it is based on a sound, adequately-founded scientific
methodology involving data and information of the type reasonably relied on by experts in the scientific field. (pp. 17-20)
3. When a trial court is faced with a not yet generally accepted theory of causation, a Rule 104 hearing would allow it to
assess whether the expert's opinion is based on scientifically sound reasoning or unsubstantiated personal beliefs couched
in scientific terminology. (pp. 20-22)
4. Other courts have recognized that the most efficient procedure to determining the reliability of expert testimony is
through an in limine hearing. Failure to hold such a hearing may constitute an abuse of discretion, particularly when a
ruling on admissibility of expert opinion/scientific evidence turns on factual issues in the summary judgment context. (pp.
22-25)
5. The more relaxed standard of Rubanick applies to the causation issue in this case, and the proper inquiry is whether Dr.
Huggins' opinion that the rubella vaccination caused Delisha's CRS is based on a “sound, adequately-founded scientific
methodology involving data and information of the type reasonably relied on by experts in the scientific field.” Thus, on
remand, the trial court must ascertain whether the scientific medical community accepts the process by which Dr. Huggins
arrived at his conclusion as one that is consistent with sound scientific principles. (pp. 25-26)
6. Although plaintiffs did not adequately verify Dr. Huggins' methodology as a scientifically sound analytical method
accepted and used by other experts in the same field, the lack of a Rule 104 hearing may have adversely affected plaintiffs'
ability to present their expert's testimony in its best light. (pp. 27-29)
7. Although plaintiffs did not request a Rule 104 hearing, it was plain error for the trial court not to conduct an evidentiary
hearing in order to determine the reliability of plaintiffs' expert testimony. In cases in which the scientific reliability of an
expert's opinion is challenged and the court's ruling on admissibility may be dispositive of the merits, the sounder practice
is to afford the proponent of the expert's opinion an opportunity to prove its admissibility at a Rule 104 hearing. (pp. 29-
30)
Judgment of the Appellate Division is REVERSED and the matter is REMANDED to the trial court for a Rule
104 hearing in order to determine the reliability and admissibility of Dr. Huggins' expert opinion.
CHIEF JUSTICE PORITZ has filed a separate dissenting opinion in which JUSTICES VERNIERO and
LaVECCHIA join. Although Chief Justice Poritz agrees that the more relaxed standard of Rubanick should be applied not
only in the toxic tort context but whenever a medical cause-effect relationship has not been confirmed by the scientific
community but compelling evidence nevertheless suggests that such a relationship exists, she does not believe that
plaintiffs in this case have put forward any such compelling evidence. To the contrary, she noted that even Dr. Huggins
admitted that no case has been documented demonstrating that the vaccine causes CRS. For that reason, Justice Poritz
believes that the trial court properly performed its “gatekeeper function” when it ruled that there was no scientific basis for
the opinion offered by plaintiffs' expert, and would affirm the judgment of the Appellate Division.
JUSTICES COLEMAN, LONG, and ZAZZALI join in JUSTICE STEIN's opinion. CHIEF JUSTICE
PORITZ has filed a separate dissenting opinion in which JUSTICES VERNIERO and LaVECCHIA join.
SUPREME COURT OF NEW JERSEY
A-
80 September Term 2000
DELISHA KEMP, a minor, by her
parent and natural guardian, DEBRA
WRIGHT, and DEBRA WRIGHT, in her
own right,
Plaintiffs-Appellants,
v.
STATE OF NEW JERSEY, COUNTY OF
BURLINGTON, RIVERSIDE BOARD OF
EDUCATION and RIVERSIDE HIGH
SCHOOL,
Defendants-Respondents,
and
JOHN DOES MANUFACTURERS (1-10);
RICHARD ROES DISTRIBUTORS (1-10);
and ROBERT DOES (1-10) (fictitious
names) individually, jointly,
severally, and/or in the
alternative,
Defendants.
Argued October 10, 2001 -- Decided August 20, 2002
On certification to the Superior Court,
Appellate Division.
David K. Cuneo argued the cause for
appellants (Cuneo & Hensler, attorneys).
Glenn R. Jones, Deputy Attorney General,
argued the cause for respondent State of New
Jersey (John J. Farmer, Jr., Attorney
General of New Jersey, attorney; Michael J.
Haas, Assistant Attorney General, of
counsel; Karen L. Jordan, Deputy Attorney
General, on the brief).
Timothy E. Annin argued the cause for
respondent County of Burlington.
Frank G. Basile argued the cause for
respondents Riverside Board of Education and
Riverside High School (Basile & Testa,
attorneys; Mr. Basile and Renee E. Scrocca,
on the brief).
The opinion of the Court was delivered by
STEIN, J.
In this appeal we consider whether plaintiffs' expert's
opinion, determined by the trial court to be scientifically
unreliable, properly was excluded from evidence. Plaintiffs,
Delisha Kemp (Delisha), a minor, by her mother and guardian,
Debra Wright (Debra), and Debra Wright individually, appeal from
the judgment of the Appellate Division affirming the trial
court's grant of summary judgment dismissing their personal
injury action against defendants State of New Jersey, Burlington
County and Riverside Board of Education (Riverside).
Plaintiffs allege in their complaint that defendants
negligently had administered a rubella virus vaccine to Debra
while she was pregnant with Delisha, claiming that the vaccine
caused Delisha to develop Congenital Rubella Syndrome (CRS). The
trial court determined that plaintiffs' medical expert's opinion,
elicited in the course of defendants' deposition of the expert,
that concluded that the rubella vaccine was the proximate cause
of Delisha's CRS condition could not be presented to the jury
because it was scientifically unreliable. Because the expert's
testimony was essential to plaintiffs' prima facie case, the
trial court granted defendants' motion for summary judgment. The
Appellate Division affirmed. Although we agree with the courts
below that the expert's opinion in its present form is not
admissible, we now reverse and remand to the Law Division to
conduct a N.J.R.E. 104 hearing and redetermine the admissibility
of the expert's testimony.
A
In 1973 and 1974, the product information provided for the rubella vaccine specifically recommended that pregnant women not be given the vaccine. The product information also recommended that women of child-bearing age not be considered for vaccination unless there was no possibility of pregnancy at the time of the injection or in the following two to three months. Defendants state that the standard practice at the Riverside High School clinic was to counsel all females of childbearing age about the risks of vaccination and to refrain from inoculating any female who was pregnant or sexually active. They also assert that a pre-vaccination screening was conducted during which students were questioned about the status of their sexual activity.
In October 1992, plaintiffs filed a complaint alleging that the rubella vaccination that defendants administered to Debra caused an infection in the fetus resulting in Delisha's CRS. The plaintiffs further alleged that defendants were negligent in failing to ascertain prior to her vaccination whether Debra was pregnant or sexually active. In addition, plaintiffs alleged that Debra was not informed that she should not be vaccinated if she were pregnant because the vaccine could cause severe birth defects to an unborn child.
At an early state of the litigation, the Law Division dismissed plaintiffs' complaint, holding that defendants were immune from suit pursuant to the provisions of the Tort Claims Act, N.J.S.A. 59:1-1 to N.J.S.A. 59:13-10. The Appellate Division affirmed. However, this Court reversed the judgment of the Appellate Division and reinstated plaintiffs' complaint. Kemp v. State, 147 N.J. 294, 297 (1997).
Defendants subsequently moved again for summary judgment, asserting on the basis of their deposition of plaintiffs' expert that plaintiffs had failed to provide a scientifically reliable medical expert report to demonstrate that the rubella vaccination was the cause of Delisha's CRS. Defendants claimed that the report submitted by plaintiffs' medical expert constituted a net opinion, was scientifically unreliable and thus inadmissible. The trial court, without conducting an evidentiary hearing on the issue of the admissibility of expert's opinion, determined that plaintiffs' expert, Dr. George Huggins, failed to proffer a scientifically acceptable basis for his opinion that the rubella immunization Debra received in April 1975 caused Delisha to develop CRS. Accordingly, the trial court held that Dr. Huggins' opinion was inadmissible. Because plaintiffs were unable to prove their prima facie case without Dr. Huggins' report, the court granted defendants' motion for summary judgment dismissing plaintiffs' complaint. Plaintiffs' motion for reconsideration was denied.
In an unpublished opinion, the Appellate Division affirmed the ruling of the trial court that Dr. Huggins' opinion was inadmissible. The Appellate Division, quoting Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991), observed that “Dr. Huggins' opinion that a causal relation exists is not sufficiently reliable because it is not 'based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.'” The court continued:
Indeed it can be said that he applied no methodology at all in reaching his conclusion. He acknowledges that no study, report, medical journal, treatise, epidemiological or toxicology data, or other recognized authority has demonstrated a correlation between attenuated rubella vaccines and congenital rubella syndrome in a child born with congenital rubella syndrome. His opinion has not been the subject of peer review or adopted by any recognized scientific disciplines. Because he could identify no such data or scientific study, it cannot be said that his opinion is founded on a scientifically tested and accepted methodology recognized by the medical community.
We granted plaintiffs' petition for certification. Kemp v. State, 167 N.J. 635 (2001).
During discovery, Dr. Huggins submitted two reports on behalf of plaintiffs dated October 22, 1990, and November 6, 1990, and was deposed by defendants' counsel on June 13, 1997. Dr. Huggins concluded in his reports that it could be determined within a reasonable degree of medical certainty that Delisha suffers from CRS as a result of the rubella immunization that Debra received in April 1975. He also concluded that “[b]ecause the program and care givers did not determine the pregnancy status or the possibility of pregnancy in Delisha Kemp's mother, in my opinion, they significantly deviated from standard of care at that time.”
Dr. Huggins explained in his report and testified at his deposition that his methodology included a review of Debra's obstetrical admission records from Burlington County Memorial Hospital where Delisha was born. He also reviewed several medical reports by various doctors, including a cardiologist, a neurologist and an ophthalmologist, each of whom had evaluated Delisha's condition after her birth. Dr. Huggins testified during his deposition that those medical reports established that Delisha has a “constellation of mental retardation, microcephaly, cardiac abnormalities, cataracts, hearing loss, which is compatible with rubella syndrome,” and that Delisha has what is medically recognized and diagnosed as CRS. Dr. Huggins also testified that the rubella vaccine, which is a live attenuated virus, is capable of crossing the placenta and entering the developing fetus or embryo. Dr. Huggins explained that that attribute of the vaccine has been established through scientific studies that confirm the presence of the attenuated rubella virus in the fetal tissue of the offspring of women who did not carry to term and who had received the rubella inoculations during pregnancy, or within three months of becoming pregnant. During his deposition Dr. Huggins testified:
We know from basic studies . . . that the rubella vaccine is a live attenuated vaccine, and that when it's injected into an individual it replicates and causes a mild infection in that particular individual, which is what stimulates the immune system to develop antibodies to the virus. We know that in humans this virus in the vaccine crosses the placenta and enters the developing fetus and/or embryo. And there have been basic studies done in the laboratory which have documented the presence of the virus in placenta and in fetal tissue. Whenever there is documentation of infection by a virus that is known to be a teratogen [drug, virus or agent that can cause congenital malformation], it's reasonable to conclude that if a recognized syndrome develops in someone who's been given the vaccine early in pregnancy, that there is proximate cause that the virus that was injected into the individual indeed did cause the rubella syndrome.
Dr. Huggins further testified that there is no medical evidence that Debra contracted the wild Rubella virus before or during her pregnancy. Dr. Huggins points out that “[t]here is no indication in the medical records of a clinical rubella infection during pregnancy.” Dr. Huggins concluded that the only documented exposure of Delisha in utero to the live rubella virus was the rubella vaccine that Debra received immediately before or during her pregnancy.
Dr. Huggins referred to the recommendation of the FDA proscribing the administration of the rubella vaccine in early pregnancy to avoid the risk of infecting the fetus. In addition, Dr. Huggins testified that when the vaccine was first administered it was recommended that pregnant women who were inadvertently inoculated should consider aborting the fetus. He acknowledged that there are some physicians who now believe that inadvertent inoculation of a pregnant woman is not an absolute indication for abortion.
During Dr. Huggins' deposition defendants' counsel identified and referred to two editions of the Red Book, published by the American Academy of Pediatrics. The 1994 edition stated that abortion ordinarily is not indicated to interrupt pregnancy when a pregnant woman has received a rubella vaccination. Defendants' counsel pointed out that the 1997 edition contained a revised statement to the effect that rubella vaccination during pregnancy is not an indication for interruption of pregnancy.
Defendants argue that Dr. Huggins did not arrive at his conclusion using an accepted scientific methodology. They note the absence of any medical support or scientific evidence confirming that there is a causal connection between the rubella vaccination and CRS. The trial court and the Appellate Division also noted the absence of medical studies or reports establishing a causal connection between rubella vaccination during pregnancy and CRS. Furthermore, defendants argue that it is well established that the wild rubella virus, if contracted by a pregnant woman, can cause CRS and that Debra was exposed to the wild rubella virus during the rubella outbreak. Defendants also claim that studies conducted by the Center for Disease Control (CDC) confirm that the attenuated virus does not cause CRS.
The CDC findings are summarized and explained in an article entitled “Fetal Risk Associated with Rubella Vaccine: An Update.” Sandra W. Bart, et al., “Fetal Risk Associated with Rubella Vaccine: An Update,” 7 Reviews of Infectious Diseases 95 (Supp. Mar.-Apr. 1985). That article states that in 1970, at a symposium held by the National Institute of Health, data was presented indicating the ability of the rubella vaccine virus to cross the placenta and infect the developing fetus, leading to concerns about teratogenicity.See footnote 11 In order to monitor the risks to the fetus after exposure to the attenuated rubella virus, the CDC maintained a register of women who received rubella vaccinations shortly before or after they became pregnant. The women were then observed to determine the outcome of their pregnancies. Significantly, the data was obtained by means of a passive reporting system, in which reports were submitted voluntarily by physicians, patients and state and local health departments. The CDC recognized that that method of reporting increased the likelihood that the data collected might be incomplete.
Reported women were classified into one of three categories of immune status: 1) susceptible - seronegativity (negative reaction to serological test) for rubella antibody documented within one year of vaccination; 2) immune - seropositivity (positive reaction to serological test) before or within two weeks after vaccination; and 3) unknown immune status. Between 1971 and April 1979, the CDC received reports concerning 149 susceptible pregnant women who received the Cendehill or HPV-77 strain of vaccine, and also received reports from 1979 to 1983 concerning 157 susceptible pregnant women who received the RA 27/3 vaccine. (In 1979, the RA27/3 vaccine was introduced and replaced the Cendehill and HPV-77 vaccines. Because Debra was vaccinated in 1975, we assume that she received either the Cendehill or HPV-77 strain of vaccine.) Of those 149 susceptible women who were vaccinated with Cendehill or HPV-77, the outcome of the pregnancies (live birth, stillbirth, or abortion) was known and reported for 143 of the women. Out of the 143 women, 94 (65.7%) delivered living infants. Three of those infants had “laboratory evidence of subclinical rubella infection at birth.”See footnote 22 Id. at 98. However, subsequent reports revealed that they were all growing and developing normally at least two years after their births. Of the 157 susceptible pregnant women who received the RA27/3 vaccine, 119 women delivered 121 living infants. One of those infants had “laboratory evidence of subclinical rubella infection” but subsequent reports also revealed that the infant was developing normally. Ibid.
The CDC concluded that because no infants with CRS were born to 214 susceptible mothers (94 who received the Cendehill or HPV- 77 vaccines, 119 who received the RA27/3 vaccine and one who received a vaccine of unknown strain), “the observed risk to date is zero.” Id. at 101 (emphasis added). Nevertheless, the CDC suggested that “[t]he occurrence of any congenital defect after maternal vaccination during pregnancy deserves careful analysis and follow-up.” Ibid. In addition, the CDC noted that the available data on the RA27/3 vaccine seems to indicate a lower, almost negligible, potential risk of CRS to the developing fetus for women who received that vaccine compared to the greater risk for women who received the Cendehill or HP-77 vaccines prior to April 1979. The CDC added that “[h]owever, because of the theoretical - albeit minimal-risks of CRS, women known to be pregnant should not be vaccinated” and that “[r]easonable precautions before vaccination include asking women if they are pregnant.” Ibid.
Finally, a summary of the report appearing at the beginning of the article states:
One hundred nineteen women susceptible to rubella received RA27/3 vaccine, 94 received either Cendehill or HPV-77, and one received a vaccine of unknown strain in the three months before or after their estimated date of conception. They gave birth to 216 living infants [including two sets of twins] free of abnormalities compatible with the congenital rubella syndrome(CRS). The maximum theoretical risk for CRS for these infants was 1.7%. Four of these infants born to susceptible women had laboratory evidence of subclinical infection (three after receiving Cendehill or HPV-77 vaccines and one after receiving RA27/3 vaccine) but were normal at birth and at subsequent follow-up examinations. Rubella virus was isolated from the products of conception for only 3% (1 of 32) of cases involving susceptible women who received RA27/3 vaccine; the reported rate of virus isolation for Cendehill and HPV-77 vaccine is 20%. The available data indicate that if vaccination occurs within three months of conception, the risk is negligible. However, since the actual risk may not be zero, women known to be pregnant should not be vaccinated, and conception should be avoided for three months after vaccination.
During his deposition, Dr. Huggins acknowledged that the CDC
found no evidence of CRS in any of the babies born to mothers who
had received the vaccine during pregnancy. Dr. Huggins also
criticized the CDC studies, stating that the studies are
inconclusive and that the medical community still advises against
rubella vaccination during pregnancy. Specifically, Dr. Huggins
testified that the CDC studies are misleading and incomplete
because the conclusions are based on a passive reporting system
that permits the possibility of significant under-reporting,
noting that the CDC did not independently corroborate any of the
information sent to them. Dr. Huggins also observed that there
was an incomplete follow-up for purposes of the study of the
eight infants reported to have a subclinical rubella infection at
birth. Therefore, Dr. Huggins asserts that the CDC study does
not disprove a causal connection between rubella vaccination
during pregnancy and CRS, but rather indicates only that the
study found no reported cases.
Finally, Dr. Huggins concedes that Delisha's CRS would be
the first reported case in the medical history and literature of
rubella in which the inoculation of a pregnant woman caused the
child to develop CRS. Dr. Huggins also acknowledged that there
are no medical studies confirming that the attenuated virus,
although capable of crossing the placenta, also can cause the CRS
condition in the offspring of vaccinated pregnant women.
A
If scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education may testify thereto in the form of an opinion or otherwise.
In the past, in order to meet that requirement the proponent of the expert testimony was required to demonstrate that the expert's opinion or theory was generally accepted within the scientific community. Rubanick v. Witco Chemical Corp., 125 N.J. 421, 432 (1991)(citing Kelly, supra, 97 N.J. at 210). In a relatively new field of scientific research there were three ways a proponent of expert testimony could prove general acceptance: “(1) the testimony of knowledgeable experts; (2) authoritative scientific literature; and (3) persuasive judicial decisions which acknowledge such general acceptance of expert testimony.” Ibid. (citation omitted).
However, in order to gain general acceptance in the scientific community, the expert's opinion or theory had to satisfy an extraordinarily “high level of proof based on prolonged, controlled, consistent, and validated experience.” Rubanick, supra, 125 N.J. at 436. Therefore, this Court relaxed the standard for admissibility of scientific evidence due to the “extraordinary and unique burdens” plaintiffs faced when they sought to prove medical causation in toxic tort cases. Id. at 433. “[P]laintiffs in toxic-tort litigation, despite strong and indeed compelling indicators that they have been tortiously harmed by toxic exposure, may never recover if required to await general acceptance by the scientific community of a reasonable, but as yet not certain, theory of causation.” Id. at 434.
In Rubanick, the Court noted that other courts also had taken a more flexible approach to the admission of causation theories in toxic tort litigation. For example, in Ferebee v. Chevron Chemical Co., 736 F.2d 1529 (1984), the Court of Appeals for the District of Columbia stated:
[A] cause-effect relationship need not be clearly established by animal or epidemiological studies before a doctor can testify that, in his opinion, such a relationship exists. As long as the basic methodology employed to reach such a conclusion is sound, . . . products liability law does not preclude recovery until a "statistically significant" number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies of the chemical.
[Rubanick, supra, 125 N.J. at 439
(quoting Ferebee, supra, 736 F.2d 1529,
1535-36)(emphasis added).]
The United States Supreme Court in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 587, 113 S. Ct. 2786, 2793, 125 L. Ed.2d 469, 479 (1993), also has relaxed the standard for the admissibility of expert scientific evidence. The Court determined that the “general acceptance” test developed at common law had been superseded by the Federal Rules of Evidence. Ibid. The Supreme Court stressed that a proffer of expert scientific testimony requires the trial court, at an evidentiary hearing, to assess “whether the reasoning or methodology underlying the testimony is scientifically valid and [] whether that reasoning or methodology properly can be applied to the facts in issue.” Id. at 592-93, 113 S. Ct. at 2796, 125 L. Ed. 2d at 482. The Court added that the inquiry is a “flexible one,” and that its focus must be “solely on principles and methodology, not on the conclusions that they generate.” Id. at 594-95, 113 S. Ct. at 2797, 125 L. Ed. 2d at 484. Recently, in Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 141, 119 S. Ct. 1167, 1171, 143 L. Ed. 2d 238 (1999), the Court expanded application of the Daubert holding to testimony based on technical and other specialized knowledge.
When the qualifications of a person to be a witness, or the admissibility of evidence, . . . is subject to a condition, and the fulfillment of the condition is in issue, that issue is to be determined by the judge. . . The judge may hear and determine such matters out of the presence or hearing of the jury.
In the course of the Rule 104 hearing, an expert must be able to identify the factual basis for his conclusion, explain his methodology, and demonstrate that both the factual basis and underlying methodology are scientifically reliable. Id. at 417. The court's role is to “determine whether the expert's opinion is derived from a sound and well-founded methodology that is supported by some expert consensus in the appropriate field.” Id. at 417 (citing Rubanick, supra, 125 N.J. at 449-50). Support for an expert's methodology may be found in professional journals, texts, conferences, symposia, or judicial opinions accepting the methodology. Ibid. (citation omitted). Courts also may consider testimony from other experts in the field who use similar methodologies. Rubanick, supra, 125 N.J. at 449-50.
In both Rubanick, supra, 125 N.J. at 424, and Landrigan, supra, 127 N.J. at 411, the trial courts had conducted evidentiary hearings in order to determine the admissibility of expert testimony. However, in both cases the trial courts had applied the “general acceptance” standard in determining the admissibility of scientific evidence. Ibid. Applying that standard, the courts excluded expert testimony proffered by plaintiffs resulting in a summary judgment in Rubanick and a directed verdict in Landrigan in favor of defendants. Ibid. We reversed and remanded both matters for the court to conduct another evidentiary hearing and to reconsider the experts' testimony applying the less stringent standard set forth in Rubanick. Rubanick, supra, 125 N.J. at 454; Landrigan, supra, 127 N.J. at 428 (citing In re Paoli Railroad Yard PCB Litigation, 916 F.2d 829, 835 (3d Cir. 1990), where Court of Appeals set aside directed verdict and remanded to trial court to conduct another evidentiary hearing in accordance with Rubanick inquiry.).
We also note that the Third Circuit has “long stressed the importance of in limine hearings under Rule 104(a) in making the reliability determination required under Rule 702 and Daubert.” Padillas v. Stork-Gamco, Inc., 186 F.3d 412, 417 (1999). That court has recognized that the most efficient procedure for determining the reliability of expert testimony is an in limine hearing. Ibid. (citing United States v. Downing, 753 F.2d 1224, 1241 (3d Cir. 1985). However, an in limine hearing is not “required whenever a Daubert objection is raised to a proffer of expert testimony.” Id. at 418.
Whether to hold one rests in the sound discretion of the district court. But when the ruling on admissibility turns on factual issues, as it does here, at least in the summary judgment context, failure to hold such a hearing may be an abuse of discretion.
The trial court in Padillas held that the expert's report was inadmissible because, among other reasons, the expert did “not set forth in his report the methodology by which he made his determinations in this case.” Padillas, supra, 186 F. 3d at 416. The Third Circuit however, did not determine or address whether the trial court had abused its discretion in holding the expert report inadmissible. Rather, that court was concerned with the process the trial court afforded to the proponent of the expert's report, holding that failure to hold an in limine hearing was an abuse of discretion. Id. at 418. The court observed that the “district court's analysis of the [expert's report] does not establish that [the expert did] not have 'good grounds' for his opinions,” but rather that they were not sufficiently explained and the “reasons and foundations for them inadequately and perhaps confusingly explicated.” Ibid.
Although the plaintiff in Padillas had not requested a hearing, the Court of Appeals determined that that omission was immaterial, in part because the trial court “has an independent responsibility for the proper management of complex litigation,” and also because the plaintiff bears the burden of establishing admissibility and deserves to have the opportunity to be heard on the critical issues of scientific reliability and validity. Id. at 417 (citation omitted). The court stated that if the trial court were concerned about the admissibility of the evidence, it should have allowed the plaintiff the opportunity to respond to the court's concerns by conducting an in limine hearing. Id. at 418. Therefore, the Third Circuit reversed the summary judgment in favor of the defendant and remanded to the trial court to conduct an in limine hearing. Ibid.
A
The obstacles plaintiffs generally confront concerning reasonable but unconfirmed theories of medical causation are not confined to toxic tort litigation. Several other varieties of tort litigation exist in which a medical cause-effect relationship has not been confirmed by the scientific community but compelling evidence nevertheless suggests that such a relationship exists. The same concerns arise in those cases, as in toxic tort litigation, if a plaintiff is barred from recovery because a novel or relatively new scientific theory of causation has not, as yet, satisfied the “extraordinarily high level of proof” required in order to gain “general acceptance” in the scientific community. Rubanick, supra, 125 N.J. at 436. We conclude that the Rubanick standard applies to the causation issue in this case, and that the proper inquiry is whether Dr. Huggins' opinion that the rubella vaccination caused Delisha's CRS is based on a “sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field.” Id. at 449.
Accordingly, the trial court on remand must ascertain whether the scientific medical community accepts the process by which Dr. Huggins arrived at his conclusion as one that is consistent with sound scientific principles. It is his analysis and reasoning process (applied to the facts of this case) that is at issue in determining whether his testimony is scientifically reliable.
Dr. Huggins' testified during his deposition that his opinion was based on studies that show the existence of the attenuated virus in the fetuses of inoculated pregnant women, as well as the medical recommendation to avoid the inoculation of pregnant women with the rubella vaccine. He also reviewed Debra's and Delisha's medical records. He testified that he ruled out the possibility that Debra's contraction of the wild rubella virus during the outbreak of measles in 1975 was the cause of Delisha's CRS, instead of the attenuated virus in the vaccine, because the medical records he examined did not indicate that Debra had clinical symptoms of rubella. He testified that he based his conclusion that Debra's vaccination with the rubella vaccine caused Delisha's CRS on numerous factors, including Debra's and Delisha's medical records, the CDC study, scientific evidence that the virus in the vaccine was capable of crossing the placenta, and his own extensive medical and scientific experience.
Our review of Dr. Huggins' deposition testimony, however, reveals that Dr. Huggins did not attempt to demonstrate or verify that the scientific methodology he used in concluding that the rubella vaccination caused Delisha to develop CRS was consistent with that used by other qualified medical and scientific experts. Dr. Huggins did not establish that his analysis and methodology is comparable to that used by other experts in the medical community in reaching analogous opinions, or that other experts in the field would rely on similar studies, data and medical records in considering whether the rubella vaccine could cause CRS. Nor did he refer to analogous conclusions with regard to comparable viruses by other experts in the field, based on similar studies and clinical data. In short, the record reveals that plaintiffs failed to demonstrate that their expert's methodology was scientifically sound.
However, we are persuaded that the lack of a Rule 104 hearing may adversely have affected plaintiffs' ability to present their expert's testimony in its best light. Because Dr. Huggins' testimony was taken only at defendants' deposition, the trial court did not have the benefit of an orderly and comprehensive presentation of his expert testimony elicited by plaintiffs counsel. Rather, Dr. Huggins' deposition afforded defendants' counsel the opportunity to challenge and cast doubt on the reliability of his opinion. We are not satisfied that the record of that deposition fairly reflects the more balanced and complete presentation of his opinion that a Rule 104 hearing would have afforded.
Although the parties did not request a Rule 104 hearing, we hold that it was plain error for the trial court not to conduct an evidentiary hearing in order to determine the reliability of plaintiffs' expert testimony. We fully agree with the Third Circuit's observation in In re Paoli, supra, 916 F. 2d at 854 (internal citations omitted):
The adversarial process upon which our legal system is based assumes that a fact finder will give the parties an adequate opportunity to be heard; if it does not, it cannot find facts reliably. Thus, the detailed factual record requirement, firmly entrenched in our jurisprudence, requires adequate process at the evidentiary stage, particularly when a summary judgment may flow from it.
Moreover, although the need for a hearing is remitted to the
trial court's discretion, in cases in which the scientific
reliability of an expert's opinion is challenged and the court's
ruling on admissibility may be dispositive of the merits, the
sounder practice is to afford the proponent of the expert's
opinion an opportunity to prove its admissibility at a Rule 104
hearing.
JUSTICES COLEMAN, LONG, and ZAZZALI join in JUSTICE STEIN's opinion. CHIEF JUSTICE PORITZ filed a separate dissenting opinion in which JUSTICES VERNIERO and LaVECCHIA join.
A- 80 September Term 2000
DELISHA KEMP, a minor, by her
parent and natural guardian, DEBRA
WRIGHT, and DEBRA WRIGHT, in her
own right,
Plaintiffs-Appellants,
v.
STATE OF NEW JERSEY, COUNTY OF
BURLINGTON, RIVERSIDE BOARD OF
EDUCATION and RIVERSIDE HIGH
SCHOOL,
Defendants-Respondents,
and
JOHN DOES MANUFACTURERS (1-10);
RICHARD ROES DISTRIBUTORS (1-10);
and ROBERT DOES (1-10) (fictitious
names) individually, jointly,
severally, and/or in the
alternative,
Defendants.
PORITZ, C.J., dissenting.
In my view, the trial court properly performed its
“gatekeeper function” when it ruled that there was no scientific
basis for the opinion offered by plaintiffs' expert, Dr. Huggins.
Ordinarily, when the trial court is “'faced with a not generally
accepted theory of causation,'” a Rule 104 hearing is appropriate
“'to assess the soundness of the proffered methodology.'” Ante
at ___ (slip op. at 20) (citation omitted). In this case, Dr.
Huggins' theory has been considered by the scientific community
and no basis for a causal connection between the rubella vaccine
and Congenital Rubella Syndrome has been found. I would not
remand this case on the slender proffer rejected by the trial
court, but would instead affirm the well-reasoned decision of the
Appellate Division upholding the trial court's grant of summary
judgment dismissing plaintiffs' complaint.
I agree with the majority that the more relaxed standard of
Rubanick v. Witco Chem. Corp.,
125 N.J. 421, 449 (1991), should
be applied not only in the toxic tort context but whenever “a
medical cause-effect relationship has not been confirmed by the
scientific community but compelling evidence nevertheless
suggests that such a relationship exists.” Ante at ___ (slip op.
at 26). The problem here is that plaintiffs have not put forward
anything resembling compelling evidence. It is not contested
that live attenuated vaccine passes through the placenta to the
fetus or that the wild virus can cause Congenital Rubella
Syndrome. Dr. Huggins admits, however, that no case has been
documented demonstrating that the vaccine causes Congenital
Rubella Syndrome. Indeed, there are substantial studies
indicating an “observed risk . . . [of] zero” from vaccination.
Sandra W. Bart, et al., Fetal Risk Associated with Rubella
Vaccine: An Update” 7 Reviews of Infectious Diseases 95, 101
(Supp. Mar.-Apr. 1985). Because the studies are based on
voluntary reporting, plaintiffs' expert claims there may be
significant underreporting that could affect the results.
Nonetheless, he can point to no documented link in any of the
literature to support his theory.
Most troubling, plaintiffs' expert admits that because there
was a rubella epidemic (hence the county's vaccination program),
the mother “could have had a high probability of exposure” to the
wild virus. Based on a lack of medical records indicating a
“clinical rubella infection during pregnancy,” the expert
concludes “with a reasonable degree of medical certainty” that
the immunization caused the syndrome. Yet, it is uncontroverted
that many people who are infected with the rubella virus are
essentially asymptomatic. In the facts as presented, the
expert's conclusion simply cannot withstand scrutiny.
The Rubanick standard is now an important part of our
jurisprudence. In Landrigan v. Celotex Corp.,
127 N.J. 404
(1992), we reaffirmed and further explained its application. We
also focused on the need for a sufficient demonstration of
reliability so that the trial courts can exercise their
discretion to exclude unreliable opinions. See id. at 417
(holding that “experts . . . must be able to identify the factual
bases for their conclusions, explain their methodology, and
demonstrate that both the factual bases and the methodology are
scientifically reliable”). We must allow the trial courts to act
as gatekeepers in such cases. See Gen. Elec. Co. v. Joiner,
522 U.S. 136, 141-42,
118 S. Ct. 512, 517,
139 L. Ed.2d 508, 516
(1997) (affirming that district courts, performing their
“gatekeeper” role under Federal Rules of Evidence, must ensure
that admitted scientific evidence is reliable). Without that
discretion, we have no standard at all.
For the reasons stated, I would affirm the judgment of the
Appellate Division.
Justices Verniero and LaVecchia join in this opinion.
NO. A-80 SEPTEMBER TERM 2000
ON APPEAL FROM
ON CERTIFICATION TO Appellate Division, Superior Court
DELISHA KEMP, a minor, by her
parent and natural guardian, DEBRA
WRIGHT, and DEBRA WRIGHT, in her
own right,
Plaintiffs-Appellants,
v.
STATE OF NEW JERSEY, COUNTY OF
BURLINGTON, RIVERSIDE BOARD OF
EDUCATION and RIVERSIDE HIGH
SCHOOL,
Defendants-Respondents.
DECIDED August 20, 2002
Chief Justice Poritz PRESIDING
OPINION BY Justice Stein
CONCURRING OPINION BY
DISSENTING OPINION BY Chief Justice Poritz
Footnote: 1 1A teratogen is “[a]nything that adversely affects normal cellular development in the embryo or fetus. Known teratogens include certain chemicals, some therapeutic and illicit drugs, radiation, and intrauterine viral infections.” Taber's Cyclopedic Medical Dictionary, Clayton L. Thomas, M.D., M.P.H. (18th ed. 1997). Footnote: 2 2A total of eight infants born to women who had received Cendehill or HPV-77 vaccinations, including those classified as immune and immune status unknown in addition to susceptible, had laboratory evidence of subclinical rubella infection at birth but were all developing normally in follow-up reports. Three of those infants were born to susceptible mothers.