Shackil v. Lederle Laboratories

561 A.2d 511, 116 N.J. 155, 1989 N.J. LEXIS 101

• Court: Supreme Court of New Jersey
• Decided: July 31, 1989
• Status: Published

Opinions

The opinion of the Court was delivered by

CLIFFORD, J.

This is a medical-malpractice and products-liability action arising out of the 1972 inoculation of the infant plaintiff with a combined diphtheria-pertussis-tetanus vaccine, commonly known as DPT vaccine. Despite extensive discovery, plaintiffs were unable to identify the manufacturer of the DPT vaccine administered to the infant plaintiff. The issue is whether, in the context of childhood vaccinations, New Jersey should substitute for the element of causation-in-fact a theory of “market share” liability, thereby shifting to defendant manufacturers the burden of proof on the issue of causation.

We conclude that the imposition of a theory of collective liability in this case would frustrate overarching public-policy and public-health considerations by threatening the continued availability of needed drugs and impairing the prospects of the development of safer vaccines. Moreover, we are satisfied that an alternative compensation scheme established by Congress, entitled the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.A. §§ 300aa-1 to -34 (West Supp.1988), will fulfill in large measure the goal of providing compensatory relief to vaccine-injured plaintiffs.

We therefore reverse the judgment of the Appellate Division and reinstate summary judgment in favor of defendant manufacturers.

I

Underlying this appeal is a profound human tragedy. On October 24, 1972, two days before her second birthday, plaintiff Deanna Marrero was given a final “booster” shot of a DPT vaccine by Dr. Feld, defendant pediatrician. Plaintiff Clara Morgan Shackil, the child’s mother, noticed that within twenty-four hours of the inoculation Deanna displayed symptoms of extreme pain. The rapid deterioration of her condition resulted in the loss of her then-acquired verbal, motor, and mental capacities. Deanna, now eighteen years of age, has been diagnosed as having chronic encephalopathy and severe retardation. She is institutionalized and requires constant care.

In April 1985, thirteen years after the inoculation that allegedly caused plaintiff’s condition, Deanna Marrero and her parents brought suit against Dr. Feld and Lederle Laboratories, one of the manufacturers of DPT during 1971-72. The complaint asserted theories of negligence, breach of warranty, misrepresentation, and strict liability based on design defect. Plaintiffs’ delay in filing suit was occasioned by the fact that it was not until 1984 that Mrs. Shackil became aware of the linkage between brain damage and the pertussis portion of the DPT vaccine.

Largely because of the extensive time that had elapsed between the inoculation and the lawsuit, plaintiffs were unable to establish that Lederle Laboratories in fact manufactured the vaccine that caused Deanna’s injuries. The pediatrician, Dr. Feld, retained no records that would have revealed the brand name of the vaccine administered, and his pharmacist is no longer alive. In his deposition, Dr. Feld testified that he had used Lederle’s vaccine “for the most part”; however, he also indicated that on occasion he had used DPT vaccines manufactured by Eli Lilly, Wyeth Laboratories, Parke-Davis, and Pit-man-Moore. Dr. Feld did not mention the name of National Drug Company, the only remaining manufacturer of DPT at the time of Deanna’s inoculation.

Plaintiffs amended their complaint to include the additional manufacturers referred to in Dr. Feld’s deposition but not National Drug Company. After several months of discovery, however, plaintiffs were still unable to identify the manufacturer of the vaccine administered to Deanna. Consequently, defendants Lederle, Eli Lilly, Wyeth, and Parke-Davis moved for summary judgment based on plaintiffs’ failure to satisfy an essential element of a prima facie case — the identity of the manufacturer and distributor of the DPT dosage.

Relying on Namm v. Charles E. Frosst & Co., 178 N.J.Super. 19 (App.Div.1981), the trial court granted defendant manufacturers’ motions for summary judgment and entered orders dismissing the complaints as to those defendants. The Appellate Division granted leave to appeal and reversed. Shackil v. Lederle Laboratories, 219 N.J.Super. 601 (1987).

In the Appellate Division the case produced three opinions, two leading to a reversal and remand, and one to an affirmance. The lead opinion explained that although the trial court was correct in relying on Namm to dismiss the complaint, the Appellate Division’s role was “to determine what the Supreme Court would do if faced with the problem before us.” 219 N.J.Super. at 621. The lead opinion held that the rejection of collective liability theories, “which have been developed in states with views of tort law similar to our own[,] would be an unwarranted deviation from what we believe to be a course already charted by our Supreme Court.” Ibid.

The lead opinion examined and summarized the current theories of concert of action, alternative liability, enterprise liability, and market-share liability, id. at 622-30, as do we, infra at 162-164. According to the lead opinion a “risk-modified market share” approach was most aptly suited to the circumstances of this case. Under that approach

[a] plaintiff should first demonstrate that the specific manufacturer of a defective product proven to have caused the injury cannot be identified, and join the manufacturers of a substantial share of the relevant market, defined as all who could have distributed the product to the plaintiff. Once this has been accomplished, the burden is placed on the defendants to exculpate themselves by proving either non-participation, possession of a reduced market share or that their product engendered a lower risk. Our aim should be to determine the percentage of the potential risk to the plaintiff caused by each manufacturer of the product, and in this respect our resolution of this issue departs somewhat from a pure market share analysis. [Id. at 630-31.]

Under the lead opinion, on remand the trial court was to impose risk-modified market-share liability as a substitute for the causation-in-fact requirement “only if the standards to which plaintiffs seek to hold defendants have not been preempted by federal regulation, and if plaintiffs otherwise demonstrate that the product, with its recognized utility, was indeed defective, given the existing technology when it was manufactured and distributed.” Id. at 634 (citing Feldman v. Lederle Laboratories, 97 N.J. 429, 452 (1984)).

A second opinion, concurring in the judgment of remand and not foreclosing the availability of market-share liability, agreed that reliance on Namm, supra, 178 N.J.Super. 19, would be misplaced," and that a remand would appropriately “permit development of an adequate record from which the Supreme Court can review the matter in the context of specific factfinding.” 219 N.J.Super. at 640-41. The concurring member added that the remand should determine as well whether the recently-enacted products-liability legislation, N.J.S.A. 2A:58C-1 to -7, applied to the case, and if not, whether any policies embodied in the new legislation were nonetheless relevant to the analysis.

The dissenting member of the Appellate Division panel reasoned that in the absence of “amendatory legislation,” an intermediate appellate court should not depart from “traditional concepts and basic principles,” 219 N.J.Super. at 642, but should leave such a decision to a court of last resort. Moreover, the dissenter below concluded that the collective-liability theory adopted by the lead opinion was not administratively sound and would “add to the cost of the end product and discourage the production of needed drugs and commodities.” Id. at 643. Finally, any decision supporting collective liability in this case was inappropriate in light of the legislature’s recent enactment of a products-liability statute, and placed the legislature in “the position of having to react to what may well be unwarranted judicial fiat.” Id. at 643.

We granted leave to appeal, 109 N.J. 519, 520 (1987), and have permitted the participation of various amici. Our primary focus is on whether plaintiffs have demonstrated that a theory of market-share liability should be applied to the facts of this case to allow plaintiffs’ claims against defendant manufacturers to proceed. Because this appeal emanates from a motion for summary judgment, we must construe the pleadings and papers in the light most favorable to the nonmoving party, in this case the plaintiffs. E.g., Ruvolo v. American Casualty Co., 39 N.J. 490, 499 (1963); Judson v. Peoples Bank & Trust Co. of Westfield, 17 N.J. 67, 75 (1954). Therefore, we will assume that the vaccines manufactured by defendants were defectively designed and that Deanna’s injuries were directly caused by a DPT inoculation and not from a hereditary immunological or neurological disorder, issues that would potentially surface at later stages of this litigation. See, e.g., Niemiera v. Schneider, 114 N.J. 550, 554 (1989) (noting possibility of independent cause of plaintiffs’ injuries, unrelated to DPT inoculation); Feldman v. Lederle Laboratories, supra, 97 N.J. at 429 (whether a prescription drug is “unavoidably unsafe,” and therefore subject to § 402A of the Restatement (Second) of Torts comment k protection, is to be determined on a case-by-case basis).

II

At the center of this appeal is the traditional element of causation-in-fact, “that reasonable connection between the act or omission of the defendant and the damages which plaintiff has suffered.” W. Keeton, D. Dobbs, R. Keeton & D. Owen, Prosser & Keeton on the Law of Torts § 41 at 263 (5th ed. 1984) [hereinafter Prosser & Keeton\ The purpose of the causation-in-fact requirement, besides assigning blameworthiness to culpable parties, is to limit the scope of potential liability and thereby encourage useful activity that would otherwise be deterred if there were excessive exposure to liability. Fischer, “Products Liability — An Analysis of Market Share Liability,” 34 Vand.L.Rev. 1623, 1628-29 (1981) (citing W. Prosser, Handbook of the Law of Torts 237, 239 (4th ed. 1971)). Although proof of causation-in-fact is ordinarily an indispensable ingredient of a prima facie case, exceptions have nevertheless arisen that have allowed plaintiffs to shift to defendant or a group of defendants the burden of proof on the causation issue. Those exceptions include “concert of action,” with its offspring, “enterprise liability”; alternative liability; and market-share liability. In fact, the theory that we are urged to adopt in this case, modified market-share liability, is essentially an extension of the alternative-liability theory. The concert-of-action exception nevertheless warrants brief comment.

The theory of “concert of action” derives from the criminal concept of aiding and abetting. Ryan v. Eli Lilly & Co., 514 F.Supp. 1004, 1015 (D.S.C.1981). It allocates responsibility among parties who “in pursuance of a common plan or design to commit a tortious act, actively take part in it, or further it by cooperation or request, or * * * lend aid or encouragement to the wrongdoers, or ratify and adopt the wrongdoer’s acts done for their benefit * * Prosser & Keeton, supra, § 46 at 323. The clearest example of “concerted action” liability is the drag race in which two drivers agree to race and one collides with and injures a third party. Both drivers are jointly and severally liable for the injury to the third party even though only one driver inflicted the harm. Restatement (Second) of Torts § 876 at 315 (1982). Some courts have applied the theory of “concert of action” in the context of DES, a synthetic drug that was prescribed for pregnant women to prevent miscarriage and was later proven to be linked to cellular abnormalities. See, e.g., Abel v. Eli Lilly & Co., 418 Mich. 311, 336-39, 343 N.W.2d 164, 176 (holding all DES manufacturers jointly and severally liable if unable to exculpate themselves), cert. den. sub nom. E.R. Squibb & Sons v. Abel, 469 U.S. 833, 105 S.Ct. 123, 83 L.Ed.2d 65 (1984); Bichler v. Eli Lilly & Co., 55 N.Y.2d 571, 450 N.Y.S.2d 776, 436 N.E.2d 182 (1982) (because DES manufacturer made no motion to dismiss the complaint for failure to state a cause of action, “concerted action” theory became controlling law of case), overruled, Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 541 N.Y.S.2d 941, 945, 539 N.E.2d 1069, 1073 (N.Y.1989). But see Ryan v. Eli Lilly & Co., supra, 514 F.Supp. 1004 (rejecting application of concert-of-action theory of liability against DES manufacturers). Moreover, an extension of this theory, called “enterprise liability,” was developed in the context of the blasting-cap industry in Hall v. E.I. du Pont de Nemours & Co., 345 F.Supp. 353 (E.D.N.Y.1972). As explained in the lead opinion below, “[t]he enterprise or industry-wide liability theory imposes liability on all members of an industry [that] has produced a product causing a particular harm. The defendants then have the opportunity to exculpate themselves.” 219 N.J.Super. at 624. In Hall the court allowed a relaxation of the traditional burden of proving causation because defendants, six blasting-cap manufacturers and their industry trade association “exercise[d] actual collective control over a particular risk-creating product * * 345 F.Supp. at 376.

Without embarking on an analysis of the merits in or the inherent problems of applying concert-of-action theory to prescription drugs, we are persuaded that the theory is not applicable to this case. There are no allegations that the manufacturers of DPT had a “tacit understanding” or “common plan” to produce a defective product or not to conduct adequate tests on the vaccine. Indeed, unlike the producers of DES, for example, each of the manufacturers involved in this case made the DPT vaccine by a different process, protected by patent or trade secret. Each process was separately licensed by the Food and Drug Administration (FDA) under established guidelines for the production of the vaccine. 21 C.F.R. § 620.1 to 620.6 (1988); see, e.g., Jones by Jones v. Lederle Laboratories, 695 F.Supp. 700, 703-04 (E.D.N.Y.1988). In addition, each lot of the DPT vaccine was separately tested by the office of Biologies Research and Reviews, a division of the FDA. 21 C.F.R. 620.6 (1988). Application of “concert of action” to this case “would [therefore] expand the doctrine far beyond its intended scope and would render virtually any manufacturer liable for the defective products of an entire industry, even if it could be demonstrated that the product which caused the injury was not 'made by the defendant.” Sindell v. Abbott Laboratories, 26 Cal.3d 588, 605, 163 Cal.Rptr. 132, 141, 607 P.2d 924, 933 cert. den., 449 U.S. 912, 101 S.Ct. 286, 66 L.Ed.2d 140 (1980); accord Hymowitz v. Eli Lilly & Co., supra, 73 N.Y.2d 487, 541 N.Y.S.2d at 945, 539 N.E.2d at 1073; Martin v. Abbott Laboratories, 102 Wash.2d 581, 598, 689 P.2d 368, 379 (1984).

A second exception to the causation-in-fact requirement, termed “alternative liability,” was developed by the California Supreme Court in Summers v. Tice, 33 Cal.2d 80, 199 P.2d 1 (1948). The opinion in that case is essentially the starting point for any analysis of market-share liability. In Summers, two hunters fired their guns in the direction of plaintiff, whose eye was severely injured as a result of one of the gunshots. At trial, plaintiff established that both defendants were negligent; however, plaintiff was unable to identify which shot hit him. The trial court nevertheless concluded that the negligence of both defendants was the legal cause of the injury and that therefore both were responsible for the result. On appeal, the Supreme Court of California upheld the trial court’s relaxation of the causation-in-fact requirement, reasoning that because both defendants were negligent in respect of the plaintiff, it would be unjust to require the victim to isolate the guilty defendant. Id. at 88, 199 P.2d at 3. Consequently, the burden was shifted to each defendant to exculpate himself, on the failure of which he would incur liability for the entire damages. See, e.g., Restatement (Second) of Torts § 433B(3) (1965) (codifying theory in Summers).

“Alternative liability” is not applicable where not all of the culpable defendants have been joined in the action. See Sindell v. Abbott Laboratories, supra, 26 Cal.3d at 602, 163 Cal.Rptr. at 139, 607 P.2d at 931. That impediment to “alternative liability” has not deterred courts from fashioning a separate theory, denominated “market share liability,” which embodies the concept of “alternative liability” while eliminating the necessity of joining all possible tortfeasors and the requirement of contemporaneous negligent acts. The seminal market-share case is Sindell v. Abbott Laboratories, supra, 26 Cal.3d 588, 163 Cal.Rptr. 132, 607 P.2d 924, a class-action suit based on design defect, brought against the manufacturers of the drug DES for injuries sustained in útero. Because of the latent nature of the injury and the,fact that the drug was produced by approximately two hundred manufacturers from a generic formula that was prescribed interchangeably, plaintiffs were unable to identify the manufacturer who actually produced the injury-causing product. The California Supreme Court held that the inability to identify a defendant was not fatal to plaintiffs cause of action, provided plaintiff join as defendants a “substantial share” of manufacturers who produced or supplied “the DES which her mother might have taken.” Id. at 612, 163 Cal.Rptr. 145, 607 P.2d at 937. The burden would then shift to the defendant manufacturers to demonstrate that they could not have produced the DES ingested by plaintiffs mother. Any manufacturer that could not exculpate itself would be held liable “for the proportion of the judgment represented by its share of the market” of DES. Ibid.

Two important policy considerations supported the Sindell court’s decision to apply market-share liability. The first, “most persuasive” consideration was the one addressed in Summers:

[A]s between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury. Here, as in Summers, plaintiff is not at fault in failing to provide evidence of causation, and although' the absence of such evidence is not attributable to the defendants either, their conduct in marketing a drug the effects of which are delayed for many years played a significant role in creating the unavailability of proof. [Id. at 610-11, 163 Cal.Rptr. at 144, 607 P.2d at 936.]

The second consideration was that a DES manufacturer was in a better position to insure against the risk of injury; “thus, holding it liable for defects and failure to warn of harmful effects will provide an incentive to product safety.” Id. at 611, 163 Cal.Rptr. at 144, 607 P.2d at 936.

The market-share theory announced in Sindell was subsequently adopted, with modifications, by three states’ highest courts. See Hymowitz v. Eli Lilly & Co., supra, 73 N.Y.2d 487, 541 N.Y.S.2d 941, 539 N.E.2d 1069 (N.Y.1989) (adopting market-share theory of liability in which DES defendants are liable in proportion to their share in national market irrespective of proof that they did not cause the injury); Martin v. Abbott Laboratories, supra, 102 Wash.2d 581, 689 P.2d 368 (adopting “modified market share” liability, in which plaintiff must join only one defendant who produced or marketed injury-causing product; burden is then shifted to defendant to prove its percentage share of market and thereby lower presumptive equal share of market); Collins v. Eli Lilly & Co., 116 Wis.2d 166, 342 N.W.2d 37 (adopting modified market-share theory of liability in which each DES defendant is liable in proportion to its “respective contribution” to the result, as measured by various factors), cert. den., 469 U.S. 826, 105 S.Ct. 107, 83 L.Ed.2d 51 (1984); see also Smith v. Eli Lilly & Co., 173 Ill.App.3d 1, 122 Ill.Dec. 835, 527 N.E.2d 333 (1988) (adopting theory of liability enunciated in Martin, supra, in context of DES). But see Mulcahy v. Eli Lilly & Co., 386 N.W.2d 67, 76 (Iowa 1986) (rejecting market share theory in DES context on policy grounds and categorizing approach as more appropriately within the legislative domain); Zafft v. Eli Lilly & Co., 676 S.W.2d 241, 247 (Mo.1984) (rejecting market-share-liability approach in DES context on grounds that the theory would discourage desired pharmaceutical research and development and would provide little incentive to produce safer products). In addition, two federal courts have made the “bold foray[ ] into terra incognita,” Tidler v. Eli Lilly & Co., 851 F.2d 418 (D.C.Cir.1988), and allowed DES diversity claims to proceed under the market-share theory. See McCormack v. Abbott Laboratories, 617 F.Supp. 1521 (D.Mass.1985) (allowing DES claim to proceed under Massachusetts law); McElhaney v. Eli Lilly & Co., 564 F.Supp. 265, 269-71 (D.S.D.1983) (holding that because under South Dakota law plaintiff is not required to identify which of defendant-DES manufacturers produced injury-causing product, burden on causation issue is shifted to defendants). But see Tidler v. Eli Lilly & Co., supra, 851 F.2d 418 (refusing to apply market-share liability to DES manufacturers under the laws of Maryland and District of Columbia because neither state recognizes “non-identification” theories); Mizell v. Eli Lilly & Co., 526 F.Supp. 589 (D.S.C.1981) (holding that the application of Sindell market-share liability against DES manufacturers would violate public policy of South Carolina).

Despite its limited acceptance, the Sindell decision left several issues unanswered. See, e.g., Sindell, supra, 26 Cal.3d at 615, 163 Cal.Rptr. at 147, 607 P.2d at 939 (Richardson, J., dissenting) (noting absence of any guidance regarding “substantial share” of the relevant market). Among them was the question of whether market-share liability was intended to, apply to claims other than DES. That issue has frequently arisen in the context of asbestos litigation, where in most cases market-share liability is held inapplicable for public-policy reasons, see, e.g., Thompson v. Johns-Manville Corp., 714 F.2d 581 (5th Cir.1983) (refusing to apply “market share” liability in diversity case because it represents “radical departure[ ] from traditional theories of tort liability,” id. at 583), and because

products containing asbestos are not uniformly harmful — many products contain different degrees of asbestos. Thus “the total risk created by any manufacturer would be a function of both its share of the market and the relative harmfulness of its products”; but a company’s market share could not be adjusted for the latter relation. [Starling v. Seaboard Coast Line R.R. Co., 533 F.Supp. 183, 191 (S.D.Ga.1982) (citation omitted).].

See also Mullen v. Armstrong World Indus. Inc., 200 Cal.App.3d 250, 246 Cal.Rptr. 32 (Ct.App.1988) (rejecting the application of “market share” liability against the manufacturers of asbestos products because of diverse nature of products); Goldman v. Johns-Manville Sales Corp., 33 Ohio St.3d 40, 514 N.E.2d 691 (1987) (refusing to apply Sindell to asbestos products on grounds that there was a difference between risks associated with asbestos and that it would be inherently unfair to hold companies accountable for market share); cf. Blackston v. Shook & Fletcher Insulation Co., 764 F.2d 1480 (11th Cir.1985) (holding that “significant policy reasons” favor retention of proximate cause as an essential element of cause of action in asbestos litigation).

At present, there are three reported cases addressing the question of whether to apply a theory of market-share liability to a vaccine case. Of these three only one involves the theory urged in this case, that is, that the vaccine is defectively designed. Thus, in Senn v. Merrell-Dow Pharmaceuticals, Inc., 305 Or. 256, 751 P.2d 215 (1988), the Oregon Supreme Court rejected a theory of market-share liability against two DPT manufacturers in the context of a design-defect claim on grounds that the “adoption of any theory of alternative liability requires a profound change in fundamental tort principles,” which was perceived as more properly in the domain of the legislature. Id. at 271, 751 P.2d 223.

The other two cases involve the imposition of market-share liability in respect of a vaccine based on a manufacturing defect, a theory not relied on in this case. Nevertheless, those cases warrant our attention. In Sheffield v. Eli Lilly & Co., supra, 144 Cal.App.3d 583, 192 Cal.Rptr. 870, plaintiffs claim against the manufacturers of the Salk polio vaccine was summarily dismissed for failure to identify the defendant who had supplied the injury-causing vaccine. Plaintiffs appealed, urging the application of market-share liability.

The California Court of Appeals held that the rationale of Sindell was inapplicable for several reasons. First, the alleged defect related to the method in which the vaccine was processed (the “infectivity potential of the virus” had not been destroyed) and not to the design of the product, as was the case in Sindell. Id. at 594, 192 Cal.Rptr. at 876. The court explained:

Here, unlike Sindell, the injuries did not result from the use of a drug generally defective when used for the purpose it was marketed, but because some manufacturer made and distributed a defective product. The product that allegedly injured plaintiffs was itself not a unit of a total generic pharmaceutical product but a deviant defective vaccine. [Ibid.]

The court reasoned that it would be unfair to hold four innocent manufacturers responsible for an injury caused by the one tortfeasor who manufactured the defective dosage. Id. at 599, 192 Cal.Rptr. at 880; cf. Brown v. Superior Court of California, 44 Cal.3d 1049, 245 Cal.Rptr. 412, 751 P.2d 470 (1988) (holding that market-share theory of liability was inapplicable to fraud and breach-of-warranty claims).

The second reason why Sindell was inapplicable to the polio-vaccine context of Sheffield was that the “delay in discovering the alleged causation was in no way related to the nature of the defective product or any other act or omission of the unknown tortfeasor,” again unlike Sindell, where the “delay was occasioned because the potential for harm was latent and did not manifest itself for many years.” Id. 144 Cal.App.3d at 594, 192 Cal.Rptr. at 877.

Finally, the Sheffield court was of the view that an application of Sindell to the facts of the case would subvert the important public policy of encouraging swift production and marketing of new pharmaceutical products. Id. at 597-98, 192 Cal.Rptr. at 878-79. Specifically, the court noted that if market-share liability had been generally prevalent during the development of the poliomyelitis vaccine, manufacturers would have been reluctant to proceed, with the distribution of the vaccine, and consequently thousands of polio sufferers would not have been saved by the Salk vaccine program.' Id. at 599, 192 Cal.Rptr. at 880.

If Sheffield clarifies the question of whether market-share liability is applicable to vaccines that are defective because of manufacturing flaws, then the decision in Morris v. Parke, Davis & Co., 667 F.Supp. 1332, (C.D.Cal.1987) beclouds it. In Morris, a federal district court in California reasoned that Sheffield’s prohibition against the application of market-share liability was limited to only one type of manufacturing defect: that involving one unit that deviates from ostensibly identical units. Id. at 1341. Sheffield was inapplicable, according to the Morris court, to manufacturing defects shared by an industry “resulting from common (perhaps for reasons of economy) substandard means of production, storage and transportation or marketing.” Id. at 1342. The court then went on to impose market-share liability on the manufacturers of DPT vaccines insofar as their vaccines contained this second type of manufacturing defect.

The court in Morris therefore focused only on the first point made in Sheffield: that market share liability was inappropriate for a manufacturing defect case. As a consequence, the court managed to elude the other two grounds on which Sheffield was premised: the fact that the delay in discovering the defect was unrelated to the nature of DPT, and the important public policy considerations attendant on expanding liability to needed pharmaceutical products. See Sheffield v. Eli Lilly & Co., supra, 144 Cal.App.3d at 594, 192 Cal.Rptr. at 876-77.

Moreover, we are not convinced that the Morris court was correct in. classifying the defect as stemming from the manufacturing process. See Cepeda v. Cumberland Eng’g Co., Inc., 76 N.J. 152, 169 (1978) (pointing up the distinction between manufacturing defects and defects of design). Although the court in Morris later stated that it was “irrelevant * * * whether the defect which caused the plaintiffs injuries is common to the products of all the defendant manufacturers because it was a design defect or because it was a manufacturing defect [shared by an industry],” 667 F.Supp. at 1342, that statement is at odds with the court’s earlier pronouncement that plaintiff’s design-defect claims had been dismissed on grounds that comment k of the Restatement (Second) of Torts § 402A was applicable. Id. at 1334 n. 1. As such, the analysis in Morris lacks persuasive force.

We digress from a general overview of collective-liability precedent briefly to examine New Jersey case law. With the exception of the Appellate Division lead opinion in this case, there is no New Jersey decision that has expressly adopted concert of action, alternative liability, or market-share liability in the context of a products-liability action. Although in Ferrigno v. Eli Lilly & Co., 175 N.J.Super. 551 (Law Div.1980), a trial court held that alternative liability based on a percentage-share apportionment was permissible in DES cases, the complaint was subsequently dismissed following the Appellate Division’s opinion in Namm v. Charles E. Frosst & Co., supra, 178 N.J.Super. 19, which refused to adopt a theory of collective liability in a DES action.

The parties to this appeal appear to accept the proposition that this Court impliedly adopted a theory of alternative liability in NOPCO Chemical Div. v. Blaw-Knox Co., 59 N.J. 274 (1971), and Anderson v. Somberg, 67 N.J. 291, cert. den., 423 U.S. 929, 96 S.Ct. 279, 46 L.Ed.2d 258 (1975), by allowing recovery without proof of a precise causative agent. In NOPCO, supra, 59 N.J. 274 a transportation-bailment case, a commercial drying machine was delivered in damaged condition to plaintiff’s place of business, and plaintiff sued the manufacturer, the carriers, and bailees “who successively, but unconnectedly, handled [the machine] until it reached its final destination.” Id. at 278 (emphasis added). However, because of the complex nature of the transportation and bailment chain, plaintiff was unable to establish which defendant was handling the machine when it was damaged. The absence of “identification” evidence resulted in dismissal of plaintiff’s case at trial. That ruling was affirmed by a divided Appellate Division panel. This Court reversed, holding that plaintiff could make out a prima facie case by proving “the nature of the damage, the identity of the respective defendants who handled [the machine], and the general capacities in which they did so.” Id. at 284. Because the defendants separately owed plaintiff a duty of care and had superior knowledge of the occurrence, this Court concluded that it was appropriate to impose on the defendants the burden of going forward with evidence demonstrating their “particular part in the overall transaction in explanation or exoneration of [their] conduct with relation to the damage.” Ibid. Plaintiff retained the ultimate burden of persuasion in respect of each defendant.

A situation somewhat analogous to NOPCO was presented in Anderson v. Somberg, supra, 67 N.J. 291, in which plaintiff, during the course of his surgery, was injured by a defective medical instrument but was unable to establish, as among the hospital, the doctor, and the instrument’s manufacturer or distributor, exactly where culpability should lie. A plurality of this Court devised a sharply limited exception to the traditional rule that plaintiff carry the entire burden of proof in establishing liability. The exception provided that

where an unconscious or helpless patient suffers an admitted mishap not reasonably foreseeable and unrelated to the scope of the surgery (such as cases where foreign objects are left in the body of the patient), those who had custody of the patient, and who owed him a duty of care as to medical treatment, or not to furnish a defective instrument for use in such treatment can be called to account for their default. They must prove their nonculpability, or else risk liability for the injuries suffered. [Id. at 298.]

Unlike the approach taken in NOPCO, the plurality shifted to defendants not merely the burden of going forward with explanatory evidence but also the burden of persuasion on the liability question, ruling that the Appellate Division had correctly determined that “since at least one of the defendants could not sustain his burden of proof, at least one of them would be liable.” Ibid. That approach, which could conceivably be characterized as one of “alternative liability,” has not been duplicated in any New Jersey case since Anderson. It is limited to one factual context.

Although the plurality opinion in Anderson relaxed the burden of persuasion in respect of the element of causation, it did not eliminate the requirement that some “reasonable connection” be established between the defendant and the ultimate harm. Prosser & Keeton, supra, § 41 at 263; see, e.g., Thompson v. Johns-Manville Corp., supra, 714 F.2d at 583. Significantly, plaintiff in Anderson sued all who might have been liable for his injury, as defined by all those who participated in the chain of events leading up to the injury. 67 N.J. at 304; see NOPCO, supra, 59 N.J. 274. Indeed, one of the justifications for shifting the burden of persuasion was that the defendants had engaged in conduct that “activated legal obligations by each of them to plaintiff.” Anderson, supra, 67 N.J. at 298 (emphasis added). In sum, the decision in Anderson, even were it construed to apply outside of its factual context, does not support the adoption of market-share liability, which would eliminate the requirement of proof of any connection between defendant and the actual injury.. Hence, there is no trend in this jurisdiction toward wholesale adoption of market-share liability.

Ill

With the foregoing in mind, we proceed to the question of whether New Jersey should expand current principles of tort law to adopt risk-modified market-share liability in the DPT context. Preliminarily, we must address the issue of whether DPT is a “generic product” that is uniformly harmful and therefore amenable to a market-share analysis. However, the central consideration on which our decision is essentially premised is whether as a matter of sound public policy this Court should modify traditional tort theory to allow plaintiffs’ design-defect claims to proceed. In examining this second question, we look to the general policies that formed the basis of the Sindell decision as well as the specific policy considerations that would accompany an expansion of tort law in the context of vaccines.

A determination of whether DPT is “uniformly harmful” must rest on a full understanding of the product involved in this appeal. DPT is a biological product made from three separate components: diphtheria toxoid, tetanus toxoid, and pertussis vaccine, each of which stimulates the production of antibodies that protect the body against those childhood diseases. Two major kinds of preparations used to produce immunity are the toxoid type (diphtheria and tetanus), and the whole-cell type (pertussis). Toxoid preparations contain small amounts of the toxins produced by certain bacteria, chemically treated to stimulate immunity without causing disease symptoms. The diphtheria and tetanus portions of the DPT vaccine are therefore not the source of any harmful side-effects. Instead, it is the pertussis portion of the DPT vaccine, made from a whole-cell type of preparation, that harbors the alleged defect.

Apparently because of the complex nature of the pertussis organism, the poisonous substances produced by the bacteria have been difficult to isolate. Consequently, the vaccine that was developed, still in use today, is made from a whole-cell type of vaccine preparation in which whole cells have simply been isolated and inactivated. This type of vaccine preparation is cruder than the toxoid-type preparation, and has been accompanied by adverse reactions varying from local to systemic. The injury alleged in this case — acute encephalopathy — represents a severe injury that is estimated to occur once in every 110,000 doses of the vaccine. Staff of the House Subcomm. on Health and the Environment of the House Comm, on Energy and Commerce, 99th Cong., 2d Sess., Report on Childhood Immunizations 25 (Comm. Print 1986) (hereinafter Comm. Print).

Two other methods of vaccinating against pertussis should be mentioned. The first alternative method, which was on the market under the trade name Tri-Solgen at the time of Deanna’s inoculation, is a “split-cell” or “soluble” vaccine, in which cells of the pertussis have been split or fragmented by a chemical process. It is unclear whether that method removed the poisonous substances from the organism, or what portions of the pertussis cell remained in the vaccine. However, according to one of the clinicians who conducted early tests on the product, Tri-Solgen produced a “high degree of antibody response and markedly lower incidence of systemic and local reactions.” Weihl, “Extracted Pertussis Antigen,” 106 American Journal of Diseases of Children 210-15 (1963).

According to plaintiffs, however, Tri-Solgen too was defectively designed inasmuch as the vaccine did not completely eradicate the dangerous toxins inherent in pertussis. Plaintiffs refer us to another method of pertussis vaccination, developed by the Japanese, in which all of the toxins have allegedly been eliminated. This “acellular” method of pertussis vaccination has been in widespread use in Japan since 1981 but is not licensed in the United States. Its overall safety and clinical efficacy have not been formally reported.

At the time of Deanna’s inoculation, five DPT manufacturers were producing a whole-cell pertussis vaccine, whereas one, Eli Lilly, was producing a split-cell vaccine. The products were clearly not identical because Eli Lilly’s Tri-Solgen engendered a lower risk of harm. Nevertheless, the Appellate Division lead opinion swept all producers into one market share, placing the burden on Eli Lilly to prove that its product was less dangerous. Although we reserve decision on the general appropriateness of including products with differing degrees of risk in a market-share analysis, we are wary of the inclusion, in the lead opinion below, of Tri-Solgen inasmuch as the product may have represented the “state of the art” in vaccine design at the time of the inoculation. See, e.g., N.J.S.A. 2A:58C-3(a)(l) (providing that “state of the art” is an absolute defense in products-liability actions).

We are not persuaded, however, that the remaining whole-cell vaccines were also inappropriate for market-share analysis solely because they were made from a biological, as opposed to a chemical, formula. Although the vaccines were separately patented or carried separate trade names, there is sufficient evidence that pediatricians used the whole-cell products interchangeably. One notable study, conducted on vaccines produced by Wyeth, Connaught, Lederle, and Parke-Davis, concluded that there was no significant difference in the rates of more serious reactions by vaccine manufacturers. Baraff, Cody, Cherry, “DPT-Associated Reactions: An Analysis by Injection Site, Manufacturers, Prior Reactions and Dose,” 73 Pediatrics 31 (Jan. 1984). Indeed, any differences that were observed were for less-serious reactions and appeared to be related to differences in vaccine lots rather than in the specific vaccines. Ibid.

We turn, then, from the arguments that have been premised on technical distinctions between DES and DPT to the thrust of this appeal: the public-policy and public-health considerations that would accompany the imposition of market-share liability in this context.

IV

This Court has adopted the basic tenet that “[t]he torts process, like the law itself, is a human institution designed to accomplish certain social objectives.” People Express Airlines, Inc. v. Consolidated Rail Corp., 100 N.J. 246, 254 (1985). One of the primary objectives is to ensure “that innocent victims have avenues of legal redress, absent a contrary, overriding public policy.” Id. at 254-55. Thus, implicit in any decision to broaden liability in order to provide compensation is a judgment that the goals of public policy will likewise be served. See, e.g., Kelly v. Gwinnell, 96 N.J. 538, 545 (1984) (imposition of social-host liability is consistent with overall social goal of reducing drunken driving); Henningsen v. Bloomfield Motors, Inc., 32 N.J. 358 (1960) (“society’s interests can only be protected by eliminating the requirement of privity between the maker and his dealers and the reasonably expected ultimate consumer”). In this case, however, we are presented with a difficult circumstance in which societal goals, in encouraging the use and development of needed drugs, would be thwarted by the imposition of unlimited liability on manufacturers in order to provide compensation to those injured by their products.

We deem it a matter of paramount importance that this case involves a vaccine — a product regarded as essential to the public welfare. Before the vaccine’s appearance, the disease pertussis claimed the lives of thousands of children in the United States each year and left many others with severe injuries, including spastic paralysis, mental retardation, and other neurological disorders. Comm. Print, supra, at 9. In one epidemic alone, pertussis was responsible for as many as 7,518 deaths, afflicting a total of 265,269 children. Id. at 10. As a result of national immunization efforts sponsored by the federal government and begun in the early 1950s after the development of the vaccine, the country showed a ninety-nine percent reduction in the number of reported cases per 100,000 population during the years 1943 to 1976, and an even more dramatic reduction in the number of. deaths. Hinman and Koplan, “Pertussis and Pertussis Vaccine: Reanalysis of Benefits, Risks and Costs,” 251 J.A.M.A. 3109-13 (1984). Indeed, Congress has noted that the

[v]accination of children against deadly disabling, but preventable]]] infectious diseases has been one of the most spectacularly effective public health initiatives this country has ever undertaken. [H.R.Rep. No. 908, 99th Cong., 2d Sess, 4, reprinted in 1986 U.S.Code Cong. & Admin.News 6344, 6345.]

Those efforts notwithstanding, pertussis, not having been entirely eradicated, continues to pose a threat to the health of this country’s children. Cherry, “The Epidemiology of Pertussis and Pertussis Immunization in the United Kingdom and the United States: A Comparative Study,” 14:2 Current Problems in Pediatrics 67 (February 1984). Where there has been a reduced level of pertussis immunization, such as in Great Britain and Japan, major epidemics of the disease have recurred. Id. at 69. Hence, the federal government continues actively to finance and monitor immunization efforts through the National Institutes of Health, the Food and Drug Administration, and the Center for Disease Control. New Jersey has assisted in this effort, as have the majority of states, by mandating that all school children be immunized before beginning their elementary-school education. N.J.A.C. 8:57-4:10. Nevertheless, a recent study from the Children’s Defense Fund indicates that DPT immunization rates have fallen sharply since 1980, particularly among non-white infants. CDF, The Health of America’s Children xi, 62-64 (1989).

Recent trends in the production and distribution of DPT have threatened the supply of the vaccine, with a predictable effect on the nation’s immunization efforts.

These trends include rapidly increasing prices for vaccines, a decline in the number of organizations involved in the production and distribution of vaccines which in turn may lead to interruptions in the supply of vaccines, and an increasing number of product liability lawsuits against vaccine manufacturers which allege injuries due to vaccines. [Comm. Print, supra, at 59.]

There are now only two commercial entities willing to produce the DPT vaccine, id. at 68, as contrasted with five in 1984. The overwhelming reason for the decrease in the number of manufacturers is the “extreme liability exposure, [the] cost of litigation and the difficulty of continuing to obtain adequate insurance.” Vaccine Injury Compensation: Hearing Before Subcomm. on Health and the Environment of the House Comm. on Energy and Commerce, 98th Cong., 2d Sess. 295 (Sept. 10 1984) (Statement of Daniel Shaw, Jr., Vice-President for Medical Affairs, Wyeth Laboratories). As a consequence of this withdrawal phenomenon, the remaining firms must concentrate their efforts on expanding production to meet the nation’s supply needs as opposed to focusing on research and development. Comm. Print, supra, at 67-70. The market’s fragility has been reflected in the exorbitant increase in price of the DPT vaccine from eleven cents a dose in 1984 to $11.40 a dose in 1986 (eight dollars of which goes to insurance costs). Brown v. Superior Court, supra, 44 Cal.3d at 1064-65, 245 Cal.Rptr. at 421, 751 P.2d at 479.

In addition to the policy of ensuring the continued use of this essential drug is the more immediate need to develop a safer alternative vaccine. The creation of an alternative-vaccine design is a slow and complex process that demands the consolidated efforts of scientists, researchers, government agencies, and manufacturers. More importantly, it involves significant expense, shouldered almost entirely by vaccine manufacturers. Comm. Print, supra, at 89. Although research is already underway on an acellular vaccine, similar to that developed in Japan, id. at 38, it is estimated that research will be costly; a dose of the vaccine will cost approximately ten times more than the vaccine currently produced by the whole-cell method. Ibid; Anderson, “The Problems Associated With a Development in Clinical Testing of an Improved Pertussis Vaccine,” 20 Adv. App. Microbio. 43, 52 (1976), cited in Burke, “DPT Vaccine Controversy: An Assessment of the Liabilities of Manufacturers and Administering Physicians Under Several Legal Theories,” 17 Seton Hall L. Rev. 541, 548 (1987).

It is against this backdrop that we are asked to expand the scope of liability to which vaccine manufacturers may be held, irrespective of whether they actually produced the injury-causing product. We are told that this expansion represents the “trend” in modern tort law — an assertion that fails to take into account that “[i]t is not, however, the trend, but the social policy underlying it, that should guide the development of the common law.” Frame v. Kothari, 115 N.J. 638, 653, 560 A.2d 675, 683 (1989) (Wilentz, C.J., and Garibaldi, J., concurring) (citing B. Cardozo, The Paradoxes of Legal Science (1928), reprinted in Selected Writings of Benjamin Nathan Cardozo 251, 284 (M. Hall ed. 1947). It is apparent that DPT manufacturers would have difficulty sustaining the increased cost attendant on the imposition of market-share liability while simultaneously covering ascending research costs in order to halt the unfortunate sequence of events that spawned this appeal, as well as continuing to meet current production needs. So much is clear from the extensive Congressional research on this subject, see Hearings, supra, at 1-350 (Sept. 19, 1984, & Dec. 19, 1984); Comm. Print., supra, at 1-103, which has spawned the development of a new system of vaccine-injury compensation, National Childhood Vaccine Injury Act of 1986, 42 U.S.C.A. §§ 300aa-1 to -34 (West Supp.1988) (the Act). Of broader concern is the effect of market-share liability on the development of other experimental drugs, such as a vaccine against the spread of acquired-immune-deficiency syndrome (AIDS). See McKenna, “The Impact of Product Liability Law on the Development of a Vaccine Against the AIDS Virus,” 55 U. Chi. L. Rev. 943 n. 4 (1988).

The overriding public policy of encouraging the development of necessary drugs is not unfamiliar to products-liability law. It is encompassed within comment k of the Restatement (.Second) of Torts 402A, which provides that the producers of unavoidably unsafe products (products, including vaccines, that in the current state of human knowledge are incapable of being made safe for their intended and ordinary use) are not strictly liable for the unfortunate consequences attending their use. To merit that protection the product must be properly prepared and accompanied by proper directions and warnings. The exemption is premised on the ground that it would be “against the public interest” to apply strict liability to unavoidably dangerous products because of “the very serious tendency to stifle medical research and testing.” White v. Wyeth Laboratories, 40 Ohio St.3d 390, 533 N.E.2d 748 (1988); see Brown v. Superior Court, supra, 44 Cal.3d at 1058, 245 Cal.Rptr. at 416, 751 P.2d at 479. The policies underlying the exemption are supportive of today’s decision. See Payton v. Abbott Laboratories, 386 Mass. 540, 562-563, 437 N.E.2d 171, 184 (1982) (rejecting application of “market share” theory inasmuch as “[pjublic policy favors the development and marketing of new and more efficacious drugs.”).

Mindful of the desirability of providing compensatory relief to vaccine-injured persons, we look to the recent comprehensive efforts of Congress. After extensive research and hearings on the subject of the unique problems presented by childhood vaccine injuries, see, e.g., Hearings, supra; Comm. Print supra, Congress devised a no-fault compensation scheme, entitled the National Childhood Vaccine Injury Act of 1986, 42 U.S.C.A. §§ 300aa-1 to -34, “under which awards can be made to vaccine-injured persons quickly, easily, and with certainty and generosity.” H. Rep. No. 908, 99th Cong., 2d Sess., at 3 (1986), reprinted in “1986 U.S.Code Cong. & Admin.News” 6344 [hereinafter House Report]. See generally 38 L. Frumer & M. Freedman, Products Liability § 51.02 (1988) (providing extensive analysis of the Act); Schwartz & Mahshigian, “National Childhood Vaccine Injury Act of 1986: An Ad Hoc Remedy or a Window for the Future?” 48 Ohio St.L.J. 367 (1987) (examining vaccine-liability crisis and the Act’s remedies); Note, “The National Childhood Vaccine Injury Act of 1986: A Solution to the Vaccine Liability Crisis?” 63 Wash. L. Rev. 149 (1988) (addressing the “role of the tort system in the vaccine liability crisis” and the probable success of the Act in resolving that crisis).

The Act provides that a person who has suffered illness, injury, or death need only submit a petition to the United States Claims Court alleging that the injury is vaccine-related. A presumption of vaccine-relatedness arises when the injury suffered is listed in the Vaccine Injury Table, contained in 42 U.S.C.A. § 300aa-14, and when the first symptoms of the injury occurred within the time period set forth in the Table. A special master then reviews the claim and the evidence, and prepares findings of fact and conclusions of law on whether compensation is appropriate, and, if so, the amount of the award. 42 U.S.C.A. § 300aa-12(c).

For those injured by a vaccine administered before October 1, 1988, the award is to represent “actual unreimbursable expenses” incurred from the date of the judgment awarding such expenses, and “reasonable projected unreimbursable expenses” including rehabilitation costs and costs incurred for custodial care. 42 U.S.C.A. § 300aa-15(a)(1)(A) & (c). The only significant limitation is that the amount for pain and suffering, lost earnings, and attorneys fees may not exceed $30,000. 42 U.S.C.A. § 300aa-15(b). If the petitioner filed a civil action before the effective date of the compensation program and chose to withdraw from the action in order to file a petition, however, the Court of Claims may award costs and expenses incurred in the civil action, including the reasonable value of the attorney’s time if suit was filed under a contingent-fee arrangement. 42 U.S.C.A. § 300aa-15(e)(2).

The Act is funded by a “Manufacturers Excise Tax on Childhood Vaccines.” House Report at 34, reprinted in “1986 U.S.Code Cong. & Admin. News” 6375. The tax is “set to generate sufficient annual income for the [National Vaccine Injury Compensation Trust] Fund to cover all costs of compensation * * Ibid. To assure funding during the nascent stages of the Act, Congress has authorized and appropriated advances to the Fund. “Departments of Labor, Health and Human Services, and Education and Related Agencies Appropriations Act,” 1989, Pub.L. No. 100-436, 102 Stat. 1680 (1988). Specifically, for payments of claims associated with post-Act administrations of vaccines, Congress has appropriated, for fiscal year 1989 alone, “such sums as may be necessary”; for those claims associated with pre-Act administrations, Congress has appropriated “such sums as may be necessary, not to exceed eighty million dollars.” Ibid. Therefore, as we understand it, Congress has appropriated, for pre-Act vaccine injuries, up to eighty million dollars for fiscal year 1989 as an advance or “front” money to the Fund, so that there will be funds on hand immediately for the payment of claims. Those dollars came from general revenues. The scheme contemplates that once the excise tax gets up to speed and generates enough money to keep the Act funded, the Fund will pay back, with interest, the amount it “borrowed” from the general revenues. We are therefore satisfied that the Act currently enjoys sufficient funding; moreover, it is clear that Congress has exercised the foresight to maintain that status in the future.

The goal of Congress was to afford a remedy for plaintiffs who would otherwise engage in protracted litigation against a vaccine manufacturer with the consequent risk of being denied recovery because of failure to prove the prima facie elements of a tort-law cause of action. The compensation scheme contained in the Act therefore does away with the traditional tort-law requirements of proof with respect to causation, injury, negligence, and defect. House Report, supra, at 12, reprinted in “1986 U.S.Code Cong. & Admin.News” at 6353. As the legislative history to the Act notes,

[c]urrently, vaccine-injured persons can seek recovery for their damages only through the civil tort system or through a settlement arrangement with the vaccine manufacturer. Over time, neither approach has proven satisfactory. Lawsuits and settlement negotiations can take months and even years to complete. Transaction costs — including attorneys' fees and court payments— are high. And in the end, no recovery may be available. Yet futures have been destroyed and mounting expenses must be met. [House Report, supra, at 6, reprinted in “1986 U.S.Code Cong. & Admin.News” at 6347.]

Thus, by eliminating traditional elements of proof that often prove fatal to a tort-law claim, the compensation scheme contained in the Act went “beyond even the most [expansive] ruling issued by a court in a vaccine case.” Id. at 26, reprinted in “1986 U.S.Code Cong. & Admin.News” at 6367. It could even be argued that in one sense the Act embodies a theory of collective liability, inasmuch as it does not require identification of a manufacturer; moreover, it allocates the cost of vaccine-related accidents among all manufacturers by imposing a tax on each dose of vaccine produced.

In addition to serving the goal of compensation, the Act was also intended to protect the unstable vaccine market by maintaining an adequate number of vaccine manufacturers. The legislative history observes that

[t]he loss of any of the existing manufacturers of childhood vaccines at this time could create a genuine public health hazard in this country. Currently there [are] only * * * two manufacturers of the DPT vaccine * * *. [T]he withdrawal of even a single manufacturer would present the very real possibility of vaccine shortages, and, in turn, increasing numbers of unimmunized children, and perhaps, a resurgence of preventable diseases. [Id. at 7, reprinted in "1986 U.S.Code Cong. & Admin.News” at 6348.]

Consequently, the compensation scheme embodied in the Act is structured so that all victims who are injured after 1988 must first prosecute a claim under the Act before pursuing a separate cause of action under tort law. 42 U.S.C.A. § 300aa-11. Although victims injured before 1988 have the option of filing a claim under the Act, all victims regardless of the date of injury are precluded from receiving a subsequent award in a civil trial if they have agreed to accept a compensation award under the Act. In that way the compensation scheme is “intended to lessen the number of lawsuits against manufacturers.” Id. at 12, reprinted in “1986 U.S.Code Cong. & Admin.News” at 6353.

In this case plaintiffs had the option of withdrawing their state tort-law claim without prejudice and filing a claim for compensation under the Act. The relevant section is 42 U.S.C.A. § 300aa-11(a)(5)(A), which provides:

A plaintiff who on the effective date of this subpart has pending a civil action for damages for a vaccine-related injury or death may, at any time within 2 years after the effective date of this subpart or before judgment, whichever occurs first, elect to withdraw such action without prejudice and file a petition under subsection (b) of this section for such injury and death.

See, e.g., Foyle by McMillan v. Lederle Laboratories, 674 F.Supp. 530, 533 (E.D.N.C.1987) (noting “withdrawal” provision of the Act). Given the expedient procedures for filing a claim under the Act and the near certainty of an award, as contrasted with the arduous process of convincing a state appeals court to dispense with the requirement of causation-in-fact, the first option would appear to have been plaintiffs’ more prudent course of action. Indeed, under the Act, attorneys consulted about a vaccine-related injury are required to inform their clients of the availability of compensation under the Act. 42 U.S.C.A. § 300aa-10(b).

Instead of pursuing that remedy under the Act, however, plaintiffs have chosen the more hazardous and cumbersome route of attempting to reshape tort-law theory to encompass their claim. They remind us that if we affirm the order of summary judgment, and thereby disallow collective liability in this instance, they will then be precluded from filing a claim under the Act. See 42 U.S.C.A. § 300aa-11(a)(5)(A) & (B). But that predicament, admittedly harsh, was a risk of which they were well aware and one that they willingly encountered. It therefore cannot form the basis of a determination by this Court to allow market-share liability or any modification thereof. The aim of the Act has always been to make vaccine liability more predictable by attracting claimants like these plaintiffs, whose legal position is tenuous, before they received a final determination by a court of law. No statutory purpose would be served if all potential claimants were permitted to cast the die first in a lawsuit and then turn to the Act in the event they were denied relief.

In sum, the existence of the Act is critical in this case for several reasons. First, it illustrates the complex nature of the problem underlying this appeal, which cannot be resolved simply by expanding tort-law theory. Second, it made available a means of compensatory relief for this plaintiff, which, although potentially smaller than a jury award might have been, was nonetheless certain. Finally, it satisfies the tort goal of encouraging safer products, inasmuch as the Act establishes a national program for the research and development of safer vaccines.

Not to be confused with this analysis is the separate question of whether the Act preempts state tort-law claims for design defect. See Hurley v. Lederle Laboratories, 851 F.2d 1536 (5th Cir.1988); Abbot v. American Cyanamid, 844 F.2d 1108 (4th Cir.1988); Foyle by McMillan v. Lederle Laboratories, supra, 674 F.Supp. at 533 (E.D.N.C.1987); Martinkovic v. Wyeth Laboratories, 669 F.Supp. 212 (N.D.Ill.1987); Graham v. Wyeth Laboratories, 666 F.Supp. 1483 (D.Kan.1987); Patten v. Lederle Laboratories, 655 F.Supp. 745 (D.Utah 1987); Note, “DPT Vaccine-Related Injury Actions: Federal Preemption Reconsidered,” 41 Rutgers L. Rev. 373 (1988). The preemption issue appears to be well settled: the National Childhood Vaccine Injury Act does not expressly or impliedly preempt traditional state tort-law claims. Hurley, supra, 851 F.2d at 1539-40; Abbot, supra, 844 F.2d at 1112-13. (The Act does, however, limit state tort claims based on an injury arising after the effective date of compensation program to the extent that it codifies comment k of the Restatement (Second) of Torts, 42 U.S.C.A. § 300aa-22(b)(1), and creates a presumption that a vaccine’s warning was valid if it complied with FDA requirements. 42 U.S.C.A. § 300aa-22(b)(2).) The fact that there is no preemption does not dissuade us from our result, because the issue in this case is not whether to allow a currently-viable claim to proceed, but whether to expand existing precedent in the face of a federal statute whose main goals — the development of an alternative approach to compensation and the protection of an unstable vaccine market — are in conflict with such an expansion.

In addition to the National Childhood Vaccine Injury Act, another piece of remedial legislation must be briefly acknowledged. The legislature recently passed a series of statutes, N.J.S.A. 2A:58C-1 to -7, in an effort to “establish clear rules” in respect of various product-liability issues, as well as clarify “specific matters as to which the decisions of the courts in New Jersey have created uncertainty.” Senate Judiciary Committee Statement, No. 2805, A. 1987, c. 197. Although there is no provision in those enactments governing the question of collective liability, they evince an intent to limit the expansion of products-liability law by creating absolute defenses and rebut-table presumptions of nonliability. See N.J.S.A. 2A:58C-3(a)(l) (adopting “state of the art” as complete defense in design defect claims); N.J.S.A. 2A:58C-3(a)(2) (providing that a product is not defectively designed if inherent characteristics of the product are known to ordinary person who uses it or consumes it with knowledge common to class of persons for whom product was intended); N.J.S.A. 2A:58C-3(a)(3) (adopting comment k of the Restatement (Second) of Torts, which provides that a manufacturer or seller is not liable for a design defect if harm results from unavoidably unsafe aspect and product is accompanied by proper warning); N.J.S.A. 2A:58C-4 (establishing presumption of adequate warning if warning approved or prescribed by FDA). In this manner, the legislature sought to “balance[ ] the interests of the public and the individual with a view towards economic reality.” Shackil, supra, 219 N.J.Super. at 543. We perceive our decision today as consistent with that goal.

Rather than approach our decision from the perspective of an analytical criticism of the market-share approach, we have chosen to posit today’s ruling on the regressive effect that collective liability would have on the social policy of encouraging vaccine production and research. Our dissenting colleagues argue (1) that our analysis is not compatible with the procedural posture of this appeal, post at 213, (2) that our result is based on public-policy considerations more relevant to the issue of “duty” than of “causation,” post at 192, 203, and (3) that our analysis has mistakenly applied considerations of the “unavoidably unsafe” nature of the product to the more general market-share question, post at 192. We address these points separately.

Plaintiffs’ brief accompanying their motion for leave to appeal from the trial court’s summary dismissal of their action alleges two errors: first, that there was a genuine issue of material fact regarding identification of a culpable defendant; second, “that defendants’ motion for summary judgment should not have been granted because a concert of action, alternative liability, or enterprise theory of liability [was] applicable on the facts of the case.” On appeal the lead opinion in the Appellate Division went right past the first issue — understandably, given that opinion’s approach — and found that in respect of the second issue a “risk-modified market share” theory was applicable, thereby shifting proof of causation-in-fact to defendants. The applicability of market-share theory was subsequently briefed and argued by all parties and amici in defendants’ interlocutory appeal to this Court. There was no motion by plaintiffs seeking to have us address any other issue. It is therefore puzzling that the dissent should contend that “[i]t is terribly unfair to deprive this tragically disabled child of any remedy whatsoever for her catastrophic injuries on the basis of theories of law never presented to the Law Division * * Post at 213. In fact the court below treated the precise issue that plaintiffs raised — the applicability of collective liability to the circumstances of this case — and this Court has sought to give comprehensive treatment to the issues — all of the issues— raised here.

A separate procedural infraction perceived by the dissent is the premising of our decision on an insufficient factual record. Post 213-14. The dissent would have us remand this case to the trial court to permit plaintiffs to demonstrate “that the nature of this product and industry is such that market-share liability is an appropriate principle of causation to apply to the breaches of duty asserted.” Id. at 213. Stated another way, our colleagues would allow a jury to determine the issue of an “unavoidably dangerous” design defect before the action could be dismissed on the basis of absence of proof of causation.

The difficulty with that approach is that it would place a fundamental public-policy decision, one to the analysis of which this Court is peculiarly well-suited, in a jury’s hands to consider under the guise of an “unavoidably dangerous” design-defect analysis, which the dissent assumes embodies the same considerations as those that address the question of dispensing with the element of causation-in-fact. It clearly does not. The only commonality that exists between the current analysis and the “unavoidably dangerous” exception contained in comment k of the Restatement (Second) of Torts § 402A is that they are premised on the similar policy of encouraging the production of safe and efficacious drugs. Neither the language of comment k nor its underlying spirit would support the dissent's maneuver of placing the cart before the horse by calling for a decision on the issue of defect before the issue of causation.

In addition, the dissent argues that our result is based on public-policy considerations “more relevant to the question of ‘duty’ than to the ‘causation’ question before us today.” Post at 192. The contention is that “[wjhile causation questions are primarily concerned with the difficulty of proving, discovering, or even conceptualizing physical causal relationships, the tortious conduct question concerns even more profound notions of duty and moral responsibility.” Post at 203. One need look no further than the early decisions in Summers and Sindell, which expanded principles of causation, to counter that assertion. In both cases, the underlying rationale was that as a matter of general policy, it was fairer to place the cost of injury on the negligent defendants than on an innocent plaintiff. Sindell, supra 26 Cal.3d at 610-11, 163 Cal.Rptr. at 144, 607 P.2d at 936; Summers, supra, 33 Cal.2d at 88, 199 P.2d at 3-4. An additional policy consideration was that the imposition of liability would provide an incentive to produce safer products. Sindell, supra, 26 Cal.3d at 610-11, 163 Cal.Rptr. at 144, 607 P.2d at 936. None of those justifications was based more on “causation,” as opposed to “duty,” principles; instead, the courts’ focus was in furthering the general goals of tort law: morality, justice, fairness, and compensation to victims. An attempt to compartmentalize those goals into “causation” and “duty” issues is inventive but unconvincing.

Although we agree with the dissent's observation that New Jersey’s approach to tort law “has been flexible to adapt traditional limitations on causation and recovery to the evolving needs of a complex society,” post at 201, a more significant countervailing consideration informs today’s decision: the imposition of market-share liability in this case would cut against the societal goals of maintaining an adequate supply of life-saving vaccines and of developing safer alternatives to current methods of vaccinations. Our aim is not to insulate vaccine manufacturers from liability, but to acknowledge a painful reality — that the excessive exposure to liability that imposition of this novel theory would produce would inevitably discourage highly useful activity.

V

The foregoing discussion should make clear that our opinion is confined solely to the context of vaccines. It should not be read as forecasting an inhospitable response to the theory of market-share liability in an appropriate context, perhaps one in which its application would be consistent with public policy and where no other remedy would be available. This case, the Court’s first exposure to market-share liability, may therefore come to represent the exception rather than the rule.

Reversed. The judgment for defendant manufacturers is reinstated. No costs.