On certification to the Superior Court, Appellate Division.
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.
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 During the spring of 1975, an outbreak of measles and rubella of near epidemic proportions occurred in Burlington County. In response, 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, a senior at the high school, was given a rubella vaccine at the clinic. Debra either was pregnant or soon to become pregnant when she received the vaccine. On December 28, 1975, she gave birth to Delisha. Delisha was born with CRS and is currently afflicted with severe birth defects that require continuing medical treatment.
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 ...