On appeal from Superior Court of New Jersey, Law Division, Bergen County, No. L-8470-01.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued September 30, 2009
Before Judges Wefing, Grall and Messano.
Plaintiffs appeal, pursuant to leave granted, from an order entered by the trial court. After reviewing the record in light of the contentions advanced on appeal, we reverse.
The matter has a complex background which must be set forth in some detail to adequately analyze the parties' contentions. This is the second time these parties have been before this court; we take the initial factual background from our earlier opinion, Rivard v. American Home Products, Inc., 391 N.J. Super. 129 (App. Div. 2007). Plaintiffs are the parents of Lindsay Rivard, who died in 1999 at the age of seven from a brain tumor diagnosed the year before her death. Id. at 139. Lindsay had received four doses of Orimune, an oral polio vaccine manufactured by defendants. She received her last dose in June 1997, and her tumor was diagnosed in November 1998; she died in October, 1999. Ibid. Plaintiffs filed suit in October 2001, alleging that the polio vaccine Lindsay had received had been contaminated with a monkey virus identified as SV40, which led to her brain tumor and subsequent death. Ibid.*fn1 In our earlier opinion, we summarized the development of Orimune.
In the early 1960's, the federal government licensed three manufacturers to make and market "live polio vaccines" from the material created by the developer of the first oral polio vaccine, Dr. Albert Sabin. The government granted one of these licenses to defendants American Cyanamid and its Lederle Laboratories.
Historically, the three types of polio virus, Type I, II, and III, were treated with different vaccines. Graham v. Am. Cyanamid Co., 350 F.3d 496, 500 (6th Cir. 2003), cert[if]. denied, 541 U.S. 990, 124 S.Ct. 2040, 158 L.Ed. 2d 495 (2004). In 1963, however, the federal government granted defendants a license to manufacture and sell a "trivalent vaccine" which worked against all three types of polio virus. Ibid. Defendants developed this vaccine and began distributing it, from the early 1960's until 1999, as Orimune, the vaccine at issue in this appeal. Ibid. See Campagna v. Am. Cyanamid, 337 N.J. Super. 530, 535-39 (App. Div.) (providing a comprehensive review of the development and licensure of the vaccine), certif. denied, 168 N.J. 294 (2001).
Orimune was derived from the original strains of polio virus that Dr. Sabin had developed. To derive the vaccine, defendants took a small amount of Dr. Sabin's strains and neutralized those strains for SV40, which was known to be in the Sabin strains. The neutralization process did not remove SV40 but instead was designed to destroy the virus's ability to infect living cells. The parties, in this case, vigorously contest whether neutralization of the original Sabin polio virus strains with SV40 antiserum sufficiently removed the virulent form of monkey virus from the resulting vaccine.
In any event, to make the vaccine, defendants then multiplied the polio virus contained in the small amount of the original neutralized strain in cultures of monkey kidney cells. The resulting virus was then harvested and pooled with others derived in similar fashion to form a larger volume that was designated as a "seed" to be used in vaccine production.
Defendants then took a small volume of seed, multiplied that virus by again inoculating it into cell cultures of monkey kidneys, harvesting the resulting virus and pooling several harvests of the same type of attenuated poliovirus together into a monopool. Monopool volumes of all three viruses where then "combined" into the trivalent "bulk vaccine lot," which defendants called Orimune.
Because monkey kidney cells were utilized in the production of the vaccine, after neutralization of the Sabin strains, plaintiffs also argue that by utilizing this technique, even though an approved Food and Drug Administration (FDA) production method, defendants further added SV40 to the vaccine.
Federal regulations required that tests be performed on the vaccines at various production stages. Graham, supra, 350 F.3d at 501. Regulations required that "[e]ach seed virus [as contrasted with the Sabin strains] used in manufacture shall be demonstrated to be free of extraneous microbial agents." 42 C.F.R. § 73.110(b)(3)(4) (1962). See In re Sabin Oral Polio Vaccine Prods. Liab. Litig., 743 F.Supp. 410, 420 n.16 (D. Md. 1990) (stating that § 73.110(b)(3) "applies only to seeds"), aff'd, 984 F.2d 124 (4th Cir. 1993). In addition, the regulations required testing to ensure that each viral harvest was SV40 free. See 42 C.F.R. §§ 73.113(d), 73.114(a)(5) (1962). Nevertheless, several courts have already concluded that at times in the past defendants and the government breached some of the pertinent federal regulations by releasing vaccines which ...