Rivard v. American Home Products, Inc.

917 A.2d 286, 391 N.J. Super. 129
CourtNew Jersey Superior Court Appellate Division
DecidedMarch 8, 2007
StatusPublished
Cited by14 cases

This text of 917 A.2d 286 (Rivard v. American Home Products, Inc.) is published on Counsel Stack Legal Research, covering New Jersey Superior Court Appellate Division primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Rivard v. American Home Products, Inc., 917 A.2d 286, 391 N.J. Super. 129 (N.J. Ct. App. 2007).

Opinion

917 A.2d 286 (2007)
391 N.J. Super. 129

David RIVARD, as Administrator of the Estate of Lindsay M. Rivard, Deceased, and David Rivard and Diane Rivard, as the Parents and Natural Guardians of Lindsay M. Rivard, Deceased, Plaintiffs-Respondents,
v.
AMERICAN HOME PRODUCTS, INC., American Cyanamid Company and Lederle Laboratories, a Division of American Cyanamid, Defendants-Appellants (Two Cases).

Superior Court of New Jersey, Appellate Division.

Argued December 20, 2006.
Decided March 8, 2007.

*291 Roger W. Yoerges, of the District of Columbia bar, admitted pro hac vice, argued the cause for appellants (Porzio, Bromberg & Newman, Morristown, and Mr. Yoerges, attorneys; Kenneth R. Meyer, Morristown, of counsel; Mr. Yoerges, on the brief).

Donald S. MacLachlan, and Stanley P. Kops, of the Pennsylvania bar, admitted pro hac vice, Bala Cymwyd, PA, argued the cause for respondents (Breslin & Breslin, Hackensack, Mr. MacLachlan, and Mr. Kops, attorneys; Angelo A. Bello, Hackensack, of counsel; Mr. Bello and Mr. Kops, on the brief).

Edward Himmelfarb, Washington, DC and Elizabeth H. Saindon, Rockville, MD, argued the cause for amicus curiae, United States of America (Christopher J. Christie, United States Attorney, attorney; Neil R. Gallagher, Assistant United States Attorney, on the brief).

Before Judges LEFELT, PARRILLO and SAPP-PETERSON.

The opinion of the court was delivered by

LEFELT, P.J.A.D.

Lindsay Rivard ingested an oral polio vaccine called Orimune from which she allegedly developed a brain tumor and died at seven years of age. Plaintiffs David Rivard, as administrator of the estate of his deceased daughter; and David and his wife, Diane, as Lindsay's parents filed a complaint in State court against defendants American Home Products, Inc.,[1] as the manufacturer of Orimune, and American Home's related or subsidiary companies American Cyanamid and Lederle Laboratories. Plaintiffs alleged, among other things, negligence, strict liability, failure to warn, and fraud in the manufacture and testing of the vaccine received by Lindsay. More specifically, plaintiffs asserted in part that defendants failed to adequately test for and remove a monkey virus known as SV40 from the vaccine. This allegedly caused Lindsay's brain tumor.

Lindsay Rivard was born in 1992 and received Orimune on four occasions between that year and June 1997. In November 1998, she was diagnosed with medulla blastoma, a brain tumor from which she died on October 7, 1999. One of plaintiffs' experts confirmed that molecular tests performed on Lindsay's tumor tissue found the presence of SV40 DNA. Another of plaintiffs' experts also found SV40 in the "tumor cells" but not in the "adjacent non-malignant *292 brain tissue." That expert concluded that this finding "provide[d] powerful evidence that the virus played a role in the causation of the tumor."

These appeals present three issues. The first and second issues, for which the Supreme Court had granted defendants leave to appeal, question whether plaintiffs may, as ordered by the trial court on summary judgment, sue the vaccine manufacturer in State court without first proceeding in the federal Vaccine Court pursuant to the National Childhood Vaccine Injury Act, 42 U.S.C.A. §§ 300aa-1 to -34 (the Act); and whether summary judgment was properly denied defendants, vaccine manufacturers. The third issue, for which we had granted leave to appeal, asks whether discovery of numerous defense documents was properly ordered by the trial court despite allegations of attorney-client and work product privileges.

We reverse the trial court and remand for entry of an order dismissing those portions of the action seeking damages arising from a vaccine-related death, which must in the first instance be brought before the Vaccine Court, directing plaintiffs to exhaust their remedies before the Vaccine Court, and staying the remaining State claims pending the Vaccine Court resolution. In addition, we affirm the trial court's denial of summary judgment to defendants and affirm the trial court's discovery order.

I.

A.

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. 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, 767 A.2d 996 (App.Div.) (providing a comprehensive review of the development and licensure of the vaccine), certif. denied, 168 N.J. 294, 773 A.2d 1158 (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.

*293 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 were 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).

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917 A.2d 286, 391 N.J. Super. 129, Counsel Stack Legal Research, https://law.counselstack.com/opinion/rivard-v-american-home-products-inc-njsuperctappdiv-2007.