On appeal from Superior Court of New Jersey, Law Division, Bergen County, L-12795-94.
Before Judges Petrella, Braithwaite and Wells.
The opinion of the court was delivered by: Braithwaite, J.A.D.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Plaintiff John Scott Campagna ("John") was born on June 27, 1979. On December 8, 1979, John's mother, plaintiff Irene Edson, took him to the office of Dr. Charlotorn Locharernkul, who vaccinated John against polio by giving him Orimune OPV, an oral polio vaccine, manufactured by defendant American Cyanamid Company. Shortly thereafter, John was hospitalized with a high fever and a paralyzed left leg. He was discharged from the hospital with a diagnosis of "poliomyelitus, meningoencephalitis and left leg paralysis." In 1994, John, through his guardian ad litem and legal guardian Linda Greco, and his mother commenced this products' liability action against defendant seeking damages, alleging that the vaccine was defective because it did not comply with federal regulations and asserting that defendant failed to adequately warn of the dangers presented by the non-compliant vaccine.
Defendant filed an answer denying the material allegations of the complaint and asserting affirmative defenses. Following discovery, defendant moved for summary judgment, contending that there were deficiencies in plaintiffs' proofs and that there was a lack of proof "that any regulatory violation was a proximate cause of [John's] injuries." With respect to plaintiffs' failure-to-warn claim, defendant asserted that plaintiffs' proofs were deficient and that plaintiffs could not prove that an "allegedly inadequate warning was a proximate cause of [John's doctor's] decision to administer" the Orimune OPV to John. For purposes of the motion, defendant assumed that John's injuries were the result of poliomyelitus.
Plaintiffs opposed defendant's motion. Plaintiffs also cross- moved, seeking summary judgment on their failure-to-warn claim. The motions were argued on October 21, 1998. The motion judge denied defendant's motion, concluding that plaintiffs had raised genuine issues of material fact. The judge also denied plaintiffs' cross-motion, determining that the motion had not been properly filed and that defendant did not have "appropriate time within which to prepare a response or prepare for oral argument."
Thereafter, on March 18, 1999, defendant moved for reconsideration. At the time, the original motion judge was unavailable due to maternity leave. The motion was carried until the judge's return. The reconsideration motion was heard on June 30, 1999. During the motion for reconsideration, defendant told the judge that, for the purposes of that motion, she could "assume that every dose of vaccine ever manufactured was administered to John Campagna with respect to the legal issue we are raising now and that is whether the existence of one or two grade 3-3 monkeys has correlated any increased risk of vaccine- associated polio."
The motion judge granted defendant's motion for reconsideration. On the defective-product claim, the judge determined that, even if she found that the vaccine administered to plaintiff "did not satisfy the [FDA's] regulatory standard," plaintiffs would still have to prove proximate cause. According to the judge, plaintiffs had "not presented proof that any of the regulatory violations that they alleged [had occurred] had any effect on the safety of defendant's vaccine or on its propensity to cause vaccine-associated polio." Expanding on that point, the judge found that plaintiffs had not presented proof that "the alleged non-compliance [with Food and Drug Administration vaccine- manufacturing regulations] made the subject vaccine in question any less safe . . . [than] the vaccine produced in compliance with the federal mandate." Thus, the judge concluded that plaintiffs had failed to provide proof of proximate causation to support their product-defect claim.
As to plaintiffs' failure-to-warn claim, the judge concluded that plaintiffs had failed to overcome the rebuttable presumption contained in N.J.S.A. 2A:58C-4, that a warning or instruction is adequate if approved by the Food and Drug Administration ("FDA"). Further, the motion judge held that even if she found that defendant's warning on the package insert was inadequate, and that defendant had thus breached its duty to warn John's physician, plaintiffs would still have the burden of proving proximate cause. The judge ruled that plaintiffs had failed to submit proof "that a different warning would have altered John's doctor's decision to administer [the oral vaccine] to plaintiff."
Plaintiffs now appeal and, although they raise a number of points, essentially assert that the motion judge erred in granting summary judgment to defendant. We agree that the motion judge erred in concluding that plaintiffs failed to establish proximate cause in both their product-defect and failure-to-warn claims. We also conclude that the motion judge erred in ruling that plaintiffs failed to rebut the statutory presumption of N.J.S.A. 2C:58C-8. We, therefore, reverse the summary judgment granted to defendant and remand for further proceedings. We also reject plaintiffs' contention that we grant judgment to them on their failure-to-warn claim.
II. Historical and Technical Background of Polio Vaccination
Poliomyelitus, more commonly known as "polio," is a disease of the central nervous system that manifests itself in three forms or types. Type 1 polio can only be caused by a Type 1 polio virus; Type 2, only by a Type 2 polio virus; and Type 3, only by a Type 3 polio virus. In re Sabin Oral Polio Vaccine Prods. Liab. Litigation, 763 F. Supp. 811, 814 (D. Md. 1991), aff'd, 984 F.2d 124 (4th Cir. 1993).*fn1
In 1955, Dr. Jonas Salk developed a vaccine that protected against all three types of poliovirus. Sabin II, supra, 763 F. Supp. at 814. To induce immunity, Salk's vaccine utilized poliovirus that had been killed or "inactivated" and thus was referred to as an "inactivated polio vaccine" or "IPV". Ibid. While the Salk vaccine substantially decreased the incidence of polio infection, it did not eliminate the disease. Ibid. In the late 1950s, thousands of persons in the United States continued to contract the disease. Ibid.
In response to this continuing problem, the Surgeon General of the United States formed a committee in 1958 to determine the feasibility of developing an oral polio vaccine or "OPV". Ibid. An OPV has advantages over an IPV in that it is less costly and can be administered orally, rather than through a series of shots and booster shots. An OPV has an inherent risk, however. To induce immunity, an OPV utilizes attenuated or weakened poliovirus to mildly infect the person vaccinated. Ibid. The use of such living, though weakened, viruses to stimulate immunity, carries with it the risk that the person vaccinated or a person in close contact with the person vaccinated may develop a polio infection. Ibid.
Pursuant to federal law, a vaccine manufacturer must obtain a product license prior to marketing its particular brand of OPV. Berkovitz v. United States, 486 U.S. 531, 540, 108 S. Ct. 1954, 1961, 100 L. Ed. 2d 531, 543 (1988). In order to become eligible for such a license, the manufacturer must first make a sample of the vaccine for testing and for submission to the Division of Biological Standards ("DBS").*fn2 Ibid.; 21 C.F.R. §§ 601.2, 601.4 (1992). Since 1979, defendant has been the only licensed manufacturer of OPV in the United States.
There are three phases to the production of an OPV. Sabin I, supra, 743 F. Supp. at 413. First, a "strain" of a type of attenuated poliovirus is obtained by passage of the wild type of that virus through an animal host. Ibid. A portion of the resulting strain is then inoculated into monkey kidney cell cultures, thus producing a "seed" of the particular type of virus. Ibid. "Pools" of vaccine are then made from this seed type, and separate production "lots" of that type of vaccine are derived from these pools. Ibid.; Berkovitz, supra, 486 U.S. at 541, 108 S. Ct. at 1961, 100 L. Ed. 2d at 543.
At this stage of production, vaccine pools contain only one of the three types of OPV (Type 1 vaccine, Type 2 vaccine, or Type 3 vaccine) and are referred to as "monovalent" pools or "monopools." Sabin I, supra, 743 F. Supp. at 413 n.4. To obtain a dose of vaccine that immunizes against all three types of polio, separate lots of Type 1, Type 2, and Type 3 vaccine are commingled to produce a single "trivalent" pool from which a trivalent vaccine may be derived. Ibid. Defendant's OPV, Orimune OPV, is a trivalent vaccine that provides immunity against all three types of polio. Significantly, from 1965 to 1983, a period that included the time of plaintiff's OPV vaccination in 1979, Orimune's Type 3 vaccine component was derived from Seed 45 B 85. This is the same seed that was implicated in the Sabin and Berkovitz cases. Sabin II, supra, 763 F. Supp. at 821; Sabin I, supra, 743 F. Supp. at 413 n.6. In order to qualify for licensure, an OPV, like defendant's Orimune OPV, had to pass a monkey neurovirulence test. 21 C.F.R. §§ 601.4, 610.1, 630.17 (1992); Berkovitz, supra, 486 U.S. at 546, 108 S. Ct. at 1963, 100 L. Ed. 2d at 546; Sabin II, supra, 763 F. Supp. at 815. "Neurovirulence is the capacity of an infectious agent to produce pathologic effects on the central nervous system." Berkovitz, supra, 486 U.S. at 545 n.9, 108 S. Ct. at 1962 n.9, 100 L. Ed. 2d at 545 n.9.
The monkey neurovirulence test requires that a specific number of monkeys be injected with varying concentrations of vaccine from the monopool to be tested. Sabin II, supra, 763 F. Supp. at 815. Some of the monkeys receive the injection intrathalamically at the stem of the brain, while others are injected at the base of the spine. Ibid. The monkeys are kept under observation for a set period and then destroyed so that a pathological examination can be performed on tissue taken from their brains, spinal cords, and lumbar spines to study the effect of the injected test material. Ibid.
The test results from the monkeys are then arrayed as number scores of "0," where no polio lesions are observed in a monkey's tissues, to "4," where severe lesions are present. Id. at 815-16. Two scores are provided for each monkey, reflecting the presence or absence of lesions at the point of injection (the "severity" score), and the presence or absence of lesions at the relevant point most distant from the point of injection (the "spread" score). Id. at 816. Thus, for a monkey injected intrathalamically, the tissue taken from its brain stem provides the severity score, while the tissue taken from its lumbar spine provides the spread score. Ibid. Each monkey is then assigned a single-number, "final neurovirulence grade" which is the higher of the severity or spread scores that it received. Ibid.
The test results for a particular vaccine monopool are then compared to the results obtained from monkeys similarly injected with a reference virus. Id. at 815. Because Type 1 vaccine had proved to be the safest in clinical field trials, it was selected as the reference virus for all three types of OPV to be tested. Ibid. A product license could only be issued if the tested vaccine monopool proved to be no more neurovirulent than the reference virus. Ibid.; 21 C.F.R. §§ 601.4, 630.17 (1992). However, problems soon arose because the Type 3 vaccine pools proved to be "hotter" than the Type 1 ...