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Shackil v. Lederle Laboratories

Decided: July 31, 1989.

CLARA MORGAN SHACKIL, ALBERT SHACKIL, AND DEANNA MARRERO, P/P/A HER MOTHER AND NEXT FRIEND, CLARA MORGAN SHACKIL, PLAINTIFFS-RESPONDENTS,
v.
LEDERLE LABORATORIES, A DIVISION OF AMERICAN CYANAMID CO.; AND PARKE-DAVIS, A DIVISION OF WARNER-LAMBERT CO., AND ELI LILLY AND COMPANY, DEFENDANTS-APPELLANTS, AND WYETH LABORATORIES, A DIVISION OF AMERICAN HOME PRODUCTS CORPORATION; WYETH LABORATORIES, INC.; PITTMAN-MOORE AND ITS SUCCESSOR, THE DOW CHEMICAL COMPANY AND LEO FELD, M.D., DEFENDANTS



On appeal from the Superior Court, Appellate Division, whose opinion is reported at 219 N.J. Super. 601 (1988).

For reversal -- Justices Clifford, Pollock, Garibaldi and Stein. For affirmance -- Justices Handler and O'Hern. The opinion of the Court was delivered by Clifford, J. O'Hern, J., dissenting.

Clifford

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 Pitman-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 Biologics 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 marketshare 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 utero. 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 plaintiff's 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 plaintiff's 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, plaintiff's 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 poliovaccine 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 plaintiff's 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.

III

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, ...


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