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Gannon v. American Home Products

July 29, 2010


On appeal from the Superior Court of New Jersey, Law Division, Bergen County, Docket No. L-3443-03.

The opinion of the court was delivered by: Messano, J.A.D.



Argued December 8, 2009

Before Judges Grall, Messano and LeWinn.

Plaintiffs*fn1 Jamie and Rebecca Gannon appeal from the grant of summary judgment dismissing their complaint against defendants American Home Products Corporation (American), American Cyanamid Company (Cyanamid), and Lederle Laboratories (Lederle) (collectively, defendants). We have considered the arguments raised in light of the record and applicable legal standards. We reverse and remand for further proceedings consistent with this opinion.


Plaintiff's amended complaint, filed June 11, 2003, alleged that between September 1973 and August 1976, he was administered "five doses of Orimune trivalent vaccine," an oral polio vaccine, at the offices of his pediatrician in Pennsylvania. The complaint further alleged that American manufactured the Orimune vaccine that "caused cancer in plaintiff . . . ." The complaint named Cyanamid, "an owned subsidiary of" American, and Lederle "a wholly-owned division" of American and/or Cyanamid, as defendants.*fn2

Plaintiff contended that Orimune "was improperly manufactured and . . . contained contaminants, including . . . SV40," a simian virus. Plaintiff alleged that defendants "manufactured [the vaccine] without complying with the regulatory mandate and/or [their] report and application for the licensing of Orimune." Plaintiff sought damages, claiming that Orimune caused him to develop "an SV40 cancerous brain tumor." Defendants filed an answer generally denying plaintiff's claims.

Also in 2003, plaintiff filed a claim in the federal district court for the Eastern District of Pennsylvania, naming the United States as defendant, and seeking relief under the Federal Tort Claims Act, 28 U.S.C.A. §§ 2671-80. Plaintiff's claim . . . rest[ed] on the argument that the United States government negligently licensed Lederle to produce Orimune and to release it to the public. Plaintiff[] claim[ed] that the United States did not confirm the absence of SV40 at each stage of manufacture allegedly in violation of the federal regulations concerning the licensing, testing, and manufacture of live oral polio vaccine. [Gannon v. United States, 571 F. Supp. 2d 615, 616 (E.D. Pa. 2007), aff'd, 292 Fed. Appx. 170 (3d Cir. 2008).]

In January 2007, the federal district court commenced a bench trial on plaintiff's complaint. Ibid.

In June 2007, defendants moved in this case for summary judgment, essentially arguing that plaintiff had failed to identify Orimune as the specific oral polio vaccine that was administered to him decades earlier. In July, before the motion was argued, the federal district court issued its decision. The judge concluded that "[p]laintiff[] ha[d] failed to demonstrate . . . that SV40 causes cancer . . . in humans." Gannon, supra, 571 F. Supp. 2d at 640. Because "[p]laintiff[] . . . failed to meet [his] burden on the dispositive issues of general and specific causation[,]" the judge entered judgment "in favor of the United States." Id. at 641. Defendants then supplemented their pending motion for summary judgment in this case by forwarding a copy of the federal district court's decision to the motion judge. Defendants argued that "[p]ursuant to the doctrine of collateral estoppel, [p]laintiff[] [was] precluded . . . from relitigating the issues of causation on which the federal court ha[d] now ruled against [him]."

On February 14, 2008, the motion judge granted defendants' motion for summary judgment on two grounds. He concluded that "plaintiff[] . . . failed to establish a prima facie case as to product identification" because he could not identify who manufactured the vaccine that allegedly caused his cancer. The judge additionally determined that "plaintiff[] [was] precluded from re[]litigating all issues that were previously litigated and decided by the Federal Court . . . ." Since general and specific causation were issues decided by that court, the motion judge concluded that plaintiff was collaterally estopped in the present case from litigating those issues again. He dismissed plaintiff's complaint; this appeal followed.


Plaintiff first contends that the judge erred in granting summary judgment to defendants based upon the purported failure to identify their product as the vaccine that caused his cancer. He argues, in essence, that the record contained sufficient evidence such that an issue of disputed fact existed as to the identification of the vaccine administered to him, and, therefore, summary judgment should have been denied. We agree.

When reviewing a grant of "summary judgment, we [employ] the same standard[s] . . . [used] by the motion judge." Atl. Mut. Ins. Co. v. Hillside Bottling Co., 387 N.J. Super. 224, 230 (App. Div.) (citation omitted), certif. denied, 189 N.J. 104 (2006). In conducting our review of the motion record, we accord plaintiff the benefit of all the favorable evidence and inferences. See R. 4:46-2(c); Brill v. Guardian Life Ins. Co. of Am., 142 N.J. 520, 540 (1995).

It is well-settled that "in products-liability litigation, [a plaintiff] 'must demonstrate that his or her injuries were proximately caused by . . . defendant's . . . product.'" Vassallo v. Am. Coding & Marking Ink Co., 345 N.J. Super. 207, 214 (App. Div. 2001) (quoting Coffman v. Keene Corp., 133 N.J., 581, 594 (1993)). "[P]roof of causation-in-fact is ordinarily an indispensable ingredient of a prima facie case . . . ." Shackil v. Lederle Labs., 116 N.J. 155, 163 (1989); see also Namm v. Charles E. Frosst & Co., 178 N.J. Super. 19, 27 (App. Div. 1981) ("It is a fundamental principle of products liability law that a plaintiff must prove, as an essential element of his case, that the defendant manufacturer actually made the particular product which caused injury.") (quotation and citations omitted).

In this case, it is undisputed that defendant entities, along with Wyeth and Pfizer, were the only licensed manufacturers of the oral polio vaccine during the general time-frame at issue.*fn3 Plaintiff was born in 1973; his pediatrician was Dr. Frank Bender of Upper Darby, Pennsylvania. Dr. Bender's office manager was his daughter, Helen. By the time this litigation was filed, both had died and the office files could not be located.

Plaintiff's mother kept an "Immunization and Health Record" (the form). It indicated that plaintiff had received five doses of polio vaccine at Dr. Bender's office on specific dates between 1973 and 1976. The form was pre-printed and bore Lederle's name and corporate logo. Under a column denoting "Active Immunizations" was a line listing "Poliomyelitis Vaccine" and three possible vaccine types: "Poliovirus Vaccine, Live[;] Oral, Sabin Strains[;] Orimune(r) Trivalent." Five dates were handwritten in five boxes immediately to the right of this line signifying the dates that plaintiff's first through fifth doses of polio vaccine were administered. The form also indicated that plaintiff received a combined vaccination for diphtheria, tetanus, and pertusis (DPT) on the same dates.

Other lines appear on the form for "Chest X-ray," "Tuberculin Tests," and "Other," under a column denoted as "Screening and Diagnostic Tests." The following appears below the "Tuberculin Tests" line: "TINE TEST(r) (Rosenthal Lederle)"; "Mantoux Test"; and "Other." Handwritten next to the Tine test line was a date, "9/20/76," and the notation, "Neg."

Defendants produced a certification from David M. Standiford, who claimed to be district sales manager of the Philadelphia area between 1968 and 1979. Standiford identified the form as a "promotional" item given to doctors by his sales force, and it "w[as] not intended to be a doctor's official vaccination record." Indeed, immediately above Lederle's name and logo, the form provides that it "w[ould] be useful at school registration time," or "if you move," so that it could be "shown . . . to your new doctor." Standiford urged his sales representatives to distribute the forms "whether the particular doctor purchased Lederle products" or not.

Standiford identified Frank Blence as the Lederle sales representative who handled the Upper Darby area; Blence had since died. Standiford also recalled that "there was intense competition among manufacturers to sell vaccines, including oral polio vaccine[s]" during the 1970s. In his deposition, Standiford identified Lederle as the manufacturer of the Tine test for tuberculosis. He also testified that companies other than Lederle made a combined DPT vaccine at the time; but, he could not identify either Wyeth or Pfizer as one of those companies.

Dr. Bender's nurse, Mary Alexander, certified that she would administer the vaccine the doctor prescribed, and it would be noted on the patient's chart. Alexander claimed that the form was "not the standard medical form that [sh]e used internally in . . . [the] office[,]" and that it may have been plaintiff's own personal "vaccine booklet, . . . kept by [his] parents as proof of vaccinations for their child's school registration." In the office on the day of their visit, Helen would "record the vaccination[s] that [the patient] had received in the . . . vaccine booklet . . . ."

During deposition, Alexander identified Helen's handwriting on the form, including the dates plaintiff received his polio vaccines. Alexander "d[id] not know what brand or brands of oral polio vaccine we[re] used in . . . [Dr.] Bender's office to vaccinate patients in the 1970s[,]" and "c[ould not] identify based on [the form] what brand or brands of oral polio vaccine" plaintiff received.

In his written decision granting summary judgment, the motion judge concluded that "the only evidence that plaintiff[] c[ould] point to" regarding product identification was the form. He then framed the question presented as follows: "The issue is whether the [form's] reference to 'Orimune' . . . established that [plaintiff] received Orimune manufactured by Lederle rather than Wyeth's or Pfizer's oral polio vaccine." The judge further noted that the depositions of Alexander and Standiford "provided reasonable explanations for the lack of identification as to the vaccine administered to . . . plaintiff . . . ." He concluded that plaintiff "f[ound] no evidence to rebut . . . defendant[s'] contention" that he "failed to establish a prima facie case as to product identification . . . ."

We agree with plaintiff that in assessing the record on the issue of product identification, the judge misapplied the standard for summary judgment. Under that standard, a determination whether there exists a "genuine issue" of material fact that precludes summary judgment requires the motion judge to consider whether the competent evidential materials presented, when viewed in the light most favorable to the non-moving party, are sufficient to permit a rational factfinder to resolve the alleged disputed issue in favor of the non-moving party. The judge's function is not himself [or herself] to weigh the evidence and determine the truth of the matter but to determine whether there is a genuine issue for trial.

[Brill, supra, 142 N.J. at 540 (alteration in original) (quotations omitted).]

Only "[i]f there exists a single, unavoidable resolution of the alleged disputed issue of fact," in this case, whether plaintiff was administered Orimune, is "that issue . . . insufficient to constitute a 'genuine' issue of material ...

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