On appeal from the Superior Court of New Jersey, Law Division, Middlesex County, L-8072-01.
Before Judges Lintner, Parker and Yannotti.
The opinion of the court was delivered by: Lintner, J.A.D.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Submitted November 29, 2004
Plaintiffs, James Paul Troxclair, Jr. (James), an infant by his father and guardian ad litem, James Paul Troxclair, and Heidi C. Troxclair and James Paul Troxclair, individually, appeal from two orders, one entered in April 2003, and the other in December 2003 dismissing their complaint, respectively, against defendants Eli Lilly and Company (Lilly) and Aventis Pasteur, Inc. (Aventis). Both orders were later certified as final for the purpose of appeal.*fn1 R. 4:42-2.
James was born on March 22, 1988. Between 1988 and 1992, he allegedly received vaccine injections containing thimerosal, a preservative containing mercury used in the manufacture of certain vaccines. The complaint, which was filed on August 21, 2001, alleged that James first began displaying symptoms of neurological damage consistent with mercury poisoning at fifteen months of age and was diagnosed as having mercury poisoning with related mental and physical problems less than one year prior to the filing date of the complaint. Aventis manufactured the vaccines administered to James*fn2 and Lilly was the manufacturer of thimerosal. Instead of answering the complaint, Lilly and Aventis filed motions to dismiss pursuant to R. 4:6-2(e), asserting that plaintiffs failed to state a claim upon which relief could be granted because they had not first pursued James's claim under the National Childhood Vaccine Injury Act, 42 U.S.C.A. §§ 300aa-1 to -34 (the Act).
On appeal, plaintiffs essentially contend that the trial judge erred in considering the motion under R. 4:6-2(e) because sufficient proof was presented to raise a factual question that the inclusion of thimerosal in the vaccines placed the cause of action outside of the Act. The motion judge correctly determined that the motions were properly brought under R. 4:6-2(e) as turning upon the preclusive application of the Act. We hold that the injuries allegedly caused by the use of thimerosal as a preservative in the vaccines administered to James are vaccine-related as a matter of law under the Act, and plaintiffs' failure, in the first instance, to file and prosecute a claim in the Federal Claims Court bars their State cause of action on behalf of James against the vaccine manufacturer. Accordingly, we affirm the order of dismissal in favor of Aventis. However, we reverse the order dismissing plaintiffs' complaint against Lilly and remand for further proceedings to permit the trial court to determine the status of Lilly as a manufacturer and whether the Act bars the action on James's behalf against the manufacturer of a component part as distinguished from the manufacturer of the vaccine itself.
In 1986, Congress enacted the Act, which"provides a federal no-fault system for compensating vaccine-related injuries or death by establishing a claim procedure involving the United States Court of Federal Claims and special masters." McDonald v. Lederle Labs., 341 N.J. Super. 369, 371 (App. Div. 2001). The Act was prompted by two concerns: 1) the costs of insurance and lawsuits had jeopardized the ability of vaccine manufacturers to supply needed vaccines; and 2) the delays, costs, and uncertainties of tort recovery in the courts served as obstacles to compensating victims of childhood vaccines. Owens v. Am. Home Products Corp., 203 F. Supp. 2d 748, 752 (S.D. Tex. 2002); McDonald, supra, 341 N.J. Super. at 377-78; see generally Shackil v. Lederle Labs., 116 N.J. 155, 181-86 (1989) (reviewing the history and purposes of the Act).
Thus, the Act establishes a procedure that a claimant must follow before resorting to a traditional tort action against manufacturers of injury-causing vaccines. The Act creates a National Vaccine Injury Compensation Program (the Program) to administer compensation for"vaccine-related injury or death." 42 U.S.C.A. § 300aa-10(a). A claimant must file a petition with the United States Court of Federal Claims, which adjudicates the claim via a special master, a system informally known as the Vaccine Court. Owens, supra, 203 F. Supp. 2d at 752. Filing the petition and obtaining a final adjudication by the Vaccine Court is a prerequisite to any civil action. 42 U.S.C.A. § 300aa-11(a)(2)(A). Indeed, if a claimant files a civil action in state or federal court before exhausting the Act's procedure,"the court shall dismiss the action." 42 U.S.C.A. § 300aa-11(a)(2)(B).
The Act is designed in part"to free manufacturers from the specter of large, uncertain tort liability, and thereby keep vaccine prices fairly low and keep manufactures [sic] in the market." Schafer v. Am. Cyanamid Co., 20 F.3d 1, 4 (1st Cir. 1994). The Act also benefits claimants. Besides providing a streamlined process of adjudication, a claimant is afforded a lower standard of proof,"under which individuals who suffer injuries within specified intervals after being administered a vaccine, benefit from a presumption that a vaccine caused those injuries." Owens, supra, 203 F. Supp. 2d at 752. Thus, Congress sought to afford"an injured party an expedited procedure, thus encouraging the use of the Program and discouraging utilization of the traditional tort-law avenues which... required proof of causation, injury, negligence and defect...." McDonald supra, 341 N.J. Super. at 378. A claimant who obtains an award under the Program may choose to accept it, thus waiving any further rights to file a tort action. 42 U.S.C.A. § 300aa-21(a). However, a claimant may decline the award and subsequently pursue the traditional tort remedies. Ibid.; see Owens, supra, 203 F. Supp. 2d at 753. If, as here, a timely petition in accordance with the Act is not filed with the Vaccine Court, a claimant is barred from later seeking recovery for injuries resulting from an adverse reaction to a vaccine in a state civil action. McDonald, supra, 341 N.J. Super. at 371-72.
42 U.S.C.A. § 300aa-11(a)(2)(A) provides in pertinent part:
No person may bring a civil action for damages in an amount greater than $1,000 or in an unspecified amount against a vaccine administrator or manufacturer in a State or Federal court for damages arising from a vaccine-related injury or death associated with the administration of a vaccine... unless a petition has been filed... for compensation under the Program for such injury or death.... (Emphasis added.) Thus, the Act precludes state or federal tort action where the injury is vaccine-related and damages are sought against a"vaccine administrator or manufacturer" until a claimant pursues his remedy under the Program. 42 U.S.C.A. § 300aa-33(3) further defines"manufacture" as meaning"to manufacture, import, process, or distribute a vaccine...." 42 U.S.C.A. § 300aa-33(5) defines"vaccine-related injury or death" as an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine.
The parties do not dispute that the vaccines administered to James are listed in the Vaccine Table. Rather, the dispute centers upon whether thimerosal is an adulterant or contaminant. Plaintiffs contend on appeal, as they did in response to defendants' motions, that the injuries are not vaccine-related because they result from the use of the preservative thimerosal, which was added to the vaccine and constituted an"adulterant or contaminant." In support of their contention, plaintiffs rely upon the affidavits of two experts, a biochemist, Boyd E. Haley, Ph.D., and a board certified toxicologist, Daniel T. Teitelbaum, M.D., both of whom concluded that thimerosal is considered by the medical and scientific community to be an adulterant and contaminant. Plaintiffs also relied upon a July 1999 report from the United States Food and Drug Administration (FDA) and the American Academy of Pediatrics, which announced that the mercury contained in thimerosal could cause exposure in excess of federal guidelines and recommended that vaccine manufacturers reduce or eliminate thimerosal from the vaccine supply as soon as possible. Thus, plaintiffs argue that they established through their experts a question of fact, which should not have been decided in a summary manner by motion. However, contrary to plaintiffs' contentions, the overwhelming federal authority holds that thimerosal is an ingredient used in the manufacture of certain vaccines and, therefore, any injuries caused by it are vaccine-related and subject to the restrictions of the Act. Moss v. Merck & Co., 381 F.3d 501, 503-04 (5th Cir. 2004); John & Jane Doe 2 v. Ortho-Clinical Diagnostics, Inc., 335 F. Supp. 2d 614, 622-23 (M.D.N.C. 2004); Laughter v. Aventis Pasteur, Inc., 291 F. Supp. 2d 406, 410 (M.D.N.C. 2003); Murphy v. Aventis Pasteur, Inc., 270 F. Supp. 2d 1368, 1375 (N.D.Ga. 2003); Blackmon v. Am. Home Prod. Corp., 267 F. Supp. 2d 667, 673-75 (S.D.Tex. 2002); Liu v. Aventis Pasteur, Inc., 219 F. Supp. 2d 762, 767 (W.D.Tex. 2002); Owens, supra, 203 F. Supp. 2d at 754-55; Wax v. Aventis Pasteur, Inc., 240 F. Supp. 2d 191, 194 (E.D.N.Y. 2002); Leroy v. Sec'y of Dep't of Health & Human Serv., No. 02-392V, 2002 WL 31730680 at *11 (Fed. Cl. Oct. 11, 2002); Cheskiewicz v. Aventis Pasteur, Inc., 843 A.2d 1258, 1265-66 (Pa. Super. 2004).
Initially, we note that on November 25, 2002, Congress passed the Homeland Security Act, Pub. L. 107-296 Title XVII §§ 1714 to 1717, which in part amended § 300aa-33, Paragraphs (3) and (5). Specifically, Paragraph ...