Market share liability for pharmaceuticals. The distinction between DES and DPT.

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Market share liability for pharmaceuticals a

Frederick H. Fern R.N., J.D. & Leslie Steineker McHugh R.Ph., J.D.

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Partner, Lester Schwab Katz & Dwyer , 120 Broadway, New York, New York, 10279 b

Associate, Lester Schwab Katz & Dwyer , New York Published online: 23 Jul 2009.

To cite this article: Frederick H. Fern R.N., J.D. & Leslie Steineker McHugh R.Ph., J.D. (1990) Market share liability for pharmaceuticals, Journal of Legal Medicine, 11:4, 391-426, DOI: 10.1080/01947649009510836 To link to this article: http://dx.doi.org/10.1080/01947649009510836

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The Journal of Legal Medicine, 11:391-426 Copyright © 1990 by Hemisphere Publishing Corporation

MARKET SHARE LIABILITY FOR PHARMACEUTICALS

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THE DISTINCTION BETWEEN DES AND DPT Frederick H. Fern, R.Ph., J.D.* Leslie Steineker McHugh, R.N., J.D.†

INTRODUCTION Traditional tort law espouses basic concepts of justice and fairness, ensuring that liability is imposed upon a drug manufacturer only when a plaintiff's injury is caused by the manufacturer's negligence or by a defective product. Moreover, the plaintiff bears the burden of proving the identity of the party who caused the injury. During the past decade, courts have begun to recognize that, under certain extraordinary circumstances, the plaintiff's burden of proving the identity of the culpable party may be shifted to the defendant. This transfer is effected so that litigants injured through no fault of their own may be compensated by a defendant who is better able to absorb the loss, or spread the risk. Collective liability theories that shift the burden of identifying the tortfeasor have been presented to the courts as possible means of allowing recovery where the actual tortfeasor is unknown but all defendants are wrongdoers. These theories, including concerted action, enterprise liability, and alternate liability have been almost unanimously rejected in their pure forms in diethylstilbestrol (DES) cases.1 These cases are based on plaintiffs' alleged in utero exposure to DES during the 1940s, 1950s, and 1960s. * Partner, Lester Schwab Katz & Dwyer, New York. Mr. Fern is a registered pharmacist and President of the American Society for Pharmacy Law. Address correspondence to Mr. Fern at Lester Schwab Katz & Dwyer, 120 Broadway, New York, New York 10279. The authors gratefully acknowledge the assistance of Robyn Leibowitz, an associate at Lester Schwab Katz & Dwyer and Beverly Gordon, a litigation specialist at Lester Schwab Katz & Dwyer. † Associate, Lester Schwab Katz & Dwyer, New York and registered nurse. 1 Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 539 N.E.2d 1069, 541 N.Y.S.2d 941, cert. denied. 110 S. Ct. 350 (1989).

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DES is a synthetic hormone that was used during this period of time to prevent miscarriage. Plaintiffs allege that their exposure to DES caused a host of reproductive tract anomalies. Market share liability, the latest collective liability theory, was created as a response to the DES problem, where plaintiffs had an almost insurmountable burden of proof in identifying the manufacturer that allegedly caused their harm and assigning defendants percentages of damages proportionate to their participation in the DES market. The definition of the market and means of establishing proportionate shares varies from jurisdiction to jurisdiction. These new theories depart significantly from traditional tort law doctrine. The theories allowing plaintiffs to recover through the relaxation of traditional common-law proof requirements have been adopted in the DES context, and courts are now being asked to extend these theories to cases involving injury caused by vaccines, including DPT. The dual objectives of risk spreading and deterrence that underlie product liability law are not achieved by application of these novel collective liability theories. Rather, the underlying rationale of these theories is to compensate injured plaintiffs when they have been harmed through no fault of their own. This article examines the various legal theories that have been adopted to circumvent the identification problem in drug product liability litigation. Emphasis is placed on theories formulated by courts in various jurisdictions to assist DES plaintiffs in obtaining a remedy. Consideration is also given to the DPT vaccine situation, with a view toward comparing the manner in which courts have addressed the various problems that arise in these cases. As an aspect of this comparison, the authors highlight the decision of the New Jersey Supreme Court in Shackil v. Lederle? where the court declined to adopt a collective liability theory on the basis that it would frustrate overarching public policy and public health considerations and impair the prospect of the development of safer vaccines. I. COLLECTIVE LIABILITY THEORIES Essentially, collective liability theories allow for the apportionment of liability where the actual tortfeasor cannot be identified. The problem of identification arising in the context of cases involving the drug DES was the significant precipitating factor underlying judicial consideration of these liability theories. An examination of the unique problem of identification in DES cases merits consideration. DES is a synthetic estrogen invented by British researchers in 1937, but never patented. In 1941, 12 American manufacturers received approval 2

116 N.J. 155, 561 A.2d 511 (1989).



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from the Federal Food and Drug Administration (FDA) to market DES for various non-pregnancy related uses. In 1947, the FDA approved the marketing of DES for the prevention of human miscarriage. By 1951, the FDA had determined that DES was generally safe for use in pregnancy.3 In 1971, studies indicated a statistically significant association of adenosis and vaginal or cervical clear cell adenocarcinoma in the offspring of mothers who took DES.4 Soon thereafter, approval of DES for use in pregnancy was withdrawn by the FDA.5 Following extensive media coverage of these findings, a series of actions were brought by plaintiffs seeking recovery for injuries allegedly sustained as a result of their DES exposure. Through no fault of their own, the majority of DES plaintiffs cannot identify the exact manufacturer of the DES to which they were exposed in utero.6 In product liability actions, plaintiffs are traditionally bound to identify the defendant whose product caused the injury.7 The effects of DES are considered insidious and may cause injuries that do not manifest for many years. The identification of the tortfeasor is hampered by the passage of years over which "memories fade, records are lost or destroyed, and witnesses die."8 Furthermore, all DES manufactured was of identical generic chemical formulation and pharmacists customarily filled prescriptions with whatever brand was on the shelf.9 Difficulty in identification is further compounded by the fact that approximately 300 manufacturers produced DES, with companies entering and leaving the market continuously during the 24 years that DES was sold to prevent accidents of pregnancy.10 In response to this predicament, courts in a few states have created 3

Hymowitz, 539 N.E.2d at 1072; Murray, The DES Causation Conundrum: A Functional Analysis, 32 N.Y.L. Sch. L. REV. 939 (1987); Sheiner, DES and a Proposed Theory of Enterprise Liability, 46 FORDHAM L. REV. 963 (1978).

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Greenwald, Barlow, Nasca, & Burnett, Vaginal Cancer After Maternal Treatment with Synthetic Estrogens, 285 NEW ENG. J. MED. 390 (1971); Herbst, Ulfelder, & Poskanzer, Adenocarcinoma of the Vagina: Association of Maternal Stilbesterol Therapy with Tumor Appearance in Young Women, 284 NEW ENG. J. MED. 878 (1971). 36 Fed. Reg. 21, 537-38 (1971). Hymowitz, 539 N.E.2d at 1073. See also W. PROSSER & P. KEETON, THE LAW OF TORTS § 103, at

713 (5th ed. 1984); Restatement (Second) of Torts § 443B(1): American Law of Products Liability 3d § 1:6, 5:1-5:3 (1987); Mahl v. Dade Pipe & Plumbing Supply Co., 546 So. 2d 740 (1989); Mathers v. Midland-Ross Corp., 403 Mass. 688, 532 N.E.2d 46 (1989); McCreery v. Eli Lilly & Co., 87 Cal. App. 3d 77, 150 Cal. Rptr. 730 (1978). 7 Sheiner, supra note 3, at 972. 8 Hymowitz, 539 N.E.2d at 1072. 9 Sheiner, supra note 3, at 963-67; Fischer, Products Liability—An Analysis of Market Share Liability, 34 VAND. L. REV. 1623, 1625 (1981); Note, Market Share Liability: An Answer to the DES Causation Problem, 94 HARV. L. REV. 668, 670 (1981); Murray, supra note 3, at 942. 10 Schwartz & Mahshigian, Failure to Identify the Defendant in Tort Law: Towards a Legislative Solution, 73 CAL. L. REV. 941, 944-45 (1985); Murray, supra note 3, at 942; Fischer, supra note 9, at 1625.

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new theories of recovery to ease the plaintiffs almost insurmountable burden of proof, rationalizing that, "[p]roducts liability law cannot be expected to stand still where innocent victims face inordinately difficult problems of proof."" A. Theories Rejected by Courts


1. Alternative Liability Theory Plaintiffs have sought adoption of various theories to solve the identification problem associated with DES including the theory of alternative liability embodied in the case of Summers v. Tice.l2 This theory generally has not been adopted in DES cases.13 In Summers, both defendant hunters had negligently fired a shot in the plaintiffs direction, with only one of the defendants causing the plaintiffs eye injury. Although it was unknown which defendant was liable, the court chose not to allow both defendants to escape liability and fashioned a new theory to allow the plaintiff to recover. Under the theory adopted in Summers, "where two defendants breach a duty to the plaintiff, but where there is uncertainty regarding which one caused the injury, the burden is upon such actor to prove that he has not caused the harm."14 The underlying rationale was to force the defendants to exculpate themselves. Defendants who do not exculpate themselves are held jointly and severally liable.15 In Sindell v. Abbott Laboratories,*6 the court rejected the alternative liability theory because only five of the approximately 200 DES manufacturers were before the court, and thus, "there may be a substantial likelihood that none of the five defendants joined in the action made the DES which caused the injury, and that the offending producer not named would escape liability altogether."17 11

Bichler v. Eli Lilly & Co., 55 N.Y.2d 571, 936 N.E.2d 182, 450 N.Y.S.2d 776, 779 (1982) (quoting Caprara v. Chrysler Corp., 52 N.Y.2d 114, 123, 417 N.E.2d 545, 436 N.Y.S.2d 251 (1981)). See also Martin v. Abbott Labs., 102 Wash. 2d 581, 602-05, 689 P.2d 368, 381-82 (1984) (adopting market share alternative liability theory); Collins v. Eli Lilly & Co., 116 Wis. 2d 166, 191-94, 342 N.W.2d 37, 49-50, cert. denied, 469 U.S. 826 (1984) (enunciating a comparative liability standard); Abel v. Eli Lilly & Co., 418 Mich. 311, 337-40, 343 N.W.2d 164, 176-77 (1984) (articulating a modified alternative liability theory). 12 33 Cal. 2d 80, 199 P.2d 1 (1948). 13 See Fern, Evolving Tort Liabilities: Are They Taking the Pharmaceutical Industry into an Era of Absolute Liability?, 29 ST. LOUIS L.J. 763, 767 n.27 (1985). 14 Hymowitz, 539 N.E.2d at 1074 (quoting Restatement (Second) of Torts § 433B(3) (1965)). The reasoning for the rule rests on "the injustice of permitting proved wrongdoers, who among them have inflicted an injury upon the entirely innocent plaintiff, to escape liability merely because the nature of their conduct and the resulting harm has made it difficult or impossible to prove which of them has caused the harm." Restatement (Second) of Torts § 433B, comment f (1965). 15 Summers, 199 P.2d at 3. See also Restatement (Second) of Torts § 433B (1965). 16 26 Cal. 3d 588, 607 P.2d 624, 163 Cal. Rptr. 132 (1980). 17 Sindell, 607 P.2d at 631.


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The Supreme Court of Michigan, in Abel v. Eli Lilly & Co.18 also rejected alternative liability, observing, once again, that all possible defendants were not before the court. In the view of the court, there was a high likelihood that the actual tortfeasor would escape liability, and innocent defendants would bear the entire burden of liability. In DES cases, unlike the situation in Summers, the tortious behavior occurred over a period of many years and across a wide geographic area. Furthermore, in Summers, each defendant behaved negligently toward the plaintiff. Conversely, in DES cases, all defendants have not acted negligently toward every plaintiff, despite the fact that each may have been negligent toward at least one. 2. Concert of Action Theory The concert of action theory articulated in Bichler v. Eli Lilly & Co.,19 finds its paradigm in drag racing cases. Under this theory, joint and several liability is imposed on all defendants found to have had an express or tacit understanding to participate in a common plan or design to commit a tortious act.20 A defendant may be held liable for the conduct of another if the defendant acts tortiously with the other, knows the other's behavior is negligent, and substantially assists the other in obtaining an actionable result, while the defendant's conduct is also tortious. Courts generally have declined to apply the concert of action theory in DES cases, because plaintiffs have failed to prove that defendants had an agreement, tacit or otherwise, to behave in a tortious manner.21 In Hymowitz v. Eli Lilly & Company?2 the court rejected the theory of modified concerted action, which previously had been the law in New York. In dicta, 18 19 20

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4 1 8 Mich. 3 1 1 , 343 N.W.2d 164 (1984). 55 N.Y.2d 5 7 1 , 4 3 6 N.E.2d 182, 450 N.Y.S.2d 776 (1982). Restatement (Second) of Torts § 876 (1965) enumerates the principles of concert of action: For harm resulting to a third person from the tortious conduct of another, one is subject to liability if he (a) does a tortious act in concert with the other or pursuant to a common design with him, or (b) knows that the other's conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself, or (c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, separately considered, constitutes a breach of duty to the third person. Express agreement is not necessary, and all that is required is that there be a tacit understanding . . . . Hymowitz, 539 N.E.2d at 1074. See also Collins v. Eli Lilly & Co., 116 Wis. 2d 166, 342 N.W.2d 37, cert. denied, 469 U . S . 826 (1984); Martin v. Abbott Labs., 102 Wash. 2d 5 8 1 , 689 P.2d 368 (1984); Zafft v. Eli Lilly & C o . , 676 S.W.2d 241 ( M o . 1984). The Bichler theory has been expressly rejected in other DES cases in which it has been raised. See Morton v. Abbott Labs., 538 F. Supp. 593 (M.D. Fla. 1982); Ryan v. Eli Lilly & C o . , 514 F. Supp. 1004 (D.S.C. 1981); Payton v. Abbott Labs., 512 F. Supp. 1031 ( D . Mass. 1981); Mizell v. Eli Lilly & C o . , 526 F. Supp. 589 (D.S.C. 1981); Sindell v. Abbott Labs., 2 6 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, cert. denied, 449 U . S . 912 (1980); Namm v. Charles E. Frosst & C o . , 178 N . J . Super. 3 6 , 427 A.2d 1121 (1981). 73 N.Y.2d 487, 539 N.E.2d 1069, 541 N.Y.S.2d 9 4 1 , cert. denied, 110 S. Ct. 350 (1989).

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the Hymowitz court held that to infer an agreement from parallel activity alone improperly expands the concept of concerted action and potentially renders small manufacturers in DES cases and other industries jointly liable for all damages stemming from the defective products of an entire industry.


3. Enterprise Liability Theory DES plaintiffs also have advanced industry-wide or enterprise liability as a theory to allow recovery. This theory was first enunciated in the non-DES case of Hall v. E.I. DuPont De Nemours & Co.23 In Hall, 18 children injured by blasting caps in separate incidents were unable to identify the manufacturers of the products that injured them. Plaintiff then alleged that the industry, including six defendant blasting cap manufacturers, failed to take reasonable safety precautions and provide reasonable warnings.24 The enterprise liability theory shifts the burden of cause in fact to defendants when a plaintiff demonstrates that multiple defendants, who comprise virtually the entire industry, adhered to an industry-wide safety standard, had delegated safety design and investigation to their trade association, and had cooperated on an industry-wide basis in the design and manufacture of the product. These facts constitute proof that defendants contributed to the risk in a manner akin to concerted action.25 The enterprise liability theory also has been universally rejected in DES cases.26 The Hall court cautioned against application of the enterprise 23 24 25

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345 F. Supp. 353 (E.D.N.Y. 1972). Id. See Murray, Sindell v. Abbott Laboratories: A Market Share Approach to DES Causation, 69 C A L . L. REV. 1179, 1184 (1981). Sheiner, supra note 3 , at 995, suggested a variant of enterprise liability in DES cases if the following elements were present: 1. Plaintiff is not at fault for his inability to identify the causative agent and such liability is due to the nature of the defendants' conduct. 2 . A generically similar defective product was manufactured by all the defendants. 3 . Plaintiffs injury was caused by this product defect. 4 . The defendants owed a duty to the class of which plaintiff was a member. 5. There is clear and convincing evidence that plaintiffs injury was caused by the product of some one of the defendants. For example, the joined defendants accounted for a high percentage of such defective products on the market at the time of plaintiffs injury. 6. There existed an insufficient, industry-wide standard of safety as to the manufacture of this product. 7. All defendants were tortfeasors satisfying the requirements of whichever cause of action is proposed: negligence, warranty, or strict liability. See Fern, supra note 13, at 770 n.44. The enterprise liability theory has been rejected in all cases in which it has been raised. See Morton v. Abbott Labs., 538 F. Supp. 593 ( M . D . Fla. 1982); Ryan v. Eli Lilly & C o . , 514 F. Supp. 1004 (D.S.C. 1981); Sindell v. Abbott Labs., 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, cert. denied, 449 U . S . 912 (1980); Namm v. Charles E. Frosst & C o . , 178 N.J. Super. 36, 427 A.2d 1121 (1981); Martin v. Abbott Labs., 102 Wash. 2d 5 8 1 , 689 P.2d 368 (1984).


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theory to a decentralized industry such as the pharmaceutical industry composed of numerous producers. In DES cases, courts have found insufficient evidence of industry-wide delegation of responsibility for safety standards to a trade association. DES involved a fluid marketplace comprised of hundreds of drug companies, many of which had entered and left the market during the period in question.27


B. Theories Accepted by Courts Courts have been loath to apply concert of action, alternative liability, or enterprise liability theories to DES cases. Because of public policy pressure and the desire to compensate plaintiffs injured through no fault of their own, some courts have fashioned novel remedies to allow DES plaintiffs to recover when unable to identify the actual tortfeasor. 1. Market Share Liability (California) California was the first forum to articulate a market share theory for DES plaintiffs who were unable to meet their burden of identification. In Sindell v. Eli Lilly,2* Judith Sindell brought an action against 11 pharmaceutical manufacturers on behalf of herself and other women residents of California who were exposed to DES. The plaintiffs were unable to identify the manufacturers of the precise drugs ingested by their mothers.29 In an attempt to fashion a remedy for these plaintiffs, who admittedly could not identify the alleged tortfeasor, the court rejected concert of action, alternative liability, and enterprise liability theories. Based upon public policy, the court found that the plaintiffs "should" be allowed to prosecute their action against the manufacturers holding as follows: The most persuasive reason for finding plaintiff states a cause of action is that advanced in Summers: as 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. From a broader policy standpoint, defendants are better able to bear the cost of injury resulting from the manufacture of a defective product. As was said by Justice Traynor in Escola "[t]he cost of an injury and the loss of time or health may be an overwhelming misfortune to the person injured, and a needless one, for the risk of injury can be insured by the manufacturer and distributed among the public as a cost of doing business." The manufacturer is in the best position to

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Zafft, 676 S.W.2d at 2 4 1 ; Sindell, 607 P.2d at 924; Collins, 342 N.W.2d at 37; Martin, 689 P.2d at 368; Mulcahy, 386 N.W.2d at 67. 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, cert. denied, 449 U . S . 912 (1980). Sindell, 607 P.2d at 926.

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discover and guard against defects in its products, and to warn of harmful effects; thus holding it liable for defects and failure to warn of harmful effects will provide an incentive to produce safety. These considerations are particularly significant where medication is involved, for the consumer is virtually helpless to protect himself from serious, sometimes permanent, sometimes fatal injuries caused by deleterious drugs.30

The Sindell court found public policy reasons strong enough to obviate the traditional tort element of identification of the tortfeasor. The court held that it was reasonable to measure the likelihood that a defendant supplied the DES that allegedly injured the plaintiff on the basis of the ratio between the amount of DES sold by the defendant and the total quantity of the drug sold by all manufacturers for the purpose of preventing miscarriages. Sindell further required the plaintiffs to join a "substantial share" of manufacturers of the DES which the plaintiffs' mothers may have taken. What comprises a "substantial share" of the market has yet to be resolved.31 A defendant is liable for the proportion of a judgment represented by its share of the market unless it demonstrates that it could not have made the product that caused the plaintiff's injuries.32 Thus, defendant manufacturers in California are provided a means of exculpation, and injured plaintiffs have a chance of recovery. 2. Risk Contribution Theory (Wisconsin) In Collins v. Eli Lilly and Co. ,33 the Wisconsin Supreme Court found Sindell's market share theory attractive, but limited in its practical application because of the inherent difficulty in defining and proving market share.34 30 31

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Id. at 936 (citation omitted). The court was concerned that if plaintiff sued a small number of manufacturers, the culpable manufacturer would escape liability. With only a few defendants, the chances that one of them produced the offending substance is slim, therefore the court required plaintiffs proceeding on market share to sue a "substantial s h a r e " of DES manufacturers. Id. Id. 116 Wis. 2d 166, 342 N.W.2d 37, cert. denied, 469 U . S . 826 (1984). Collins, 342 N.W.2d at 4 8 . The Sindell theory frequently has been rejected. See, e.g., Ryan v. Eli Lilly & Co., 514 F. Supp. 1004 (D.S.C. 1981); Mizell v. Eli Lilly & C o . , 526 F. Supp. 589 (D.S.C. 1981); Namm v. Charles E. Frosst & C o . , 178 N . J . Super. 3 6 1 , 427 A.2d 1121 (1981). Sindell has been criticized as being no fairer than any of the common-law theories that it, and other DES courts, have rejected. Because all possible tortfeasors are not necessarily before the courts, the defendants comprising the requisite "substantial s h a r e " may be no more responsible than non-joined manufacturers. Also, not all defendants have acted negligently toward the plaintiff and therefore the shift in burden of proof is harsher than in the Summers paradigm. Furthermore, the Sindell court left unresolved certain questions: Is liability several or joint and several? What is meant by "substantial s h a r e " and "appropriate market"? Finally, are punitive damages available? See Schwartz & Mahshigian, supra note 10 (but note that in Brown v. Abbott Labs., 44 Cal. 3d 1049, 751 P.2d 470, 245 Cal. Rptr. 412 (Cal. 1988), the California Supreme Court held that liability was several, because joint liability would frustrate Sindell's goal of achieving a balance between the interests of DES plaintiffs and DES manufacturers).


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Once again, the plaintiff, who was exposed to DES in utero, sued several DES manufacturers, alleging that one of them, whom she could not identify, manufactured the DES that caused her reproductive tract injuries. After rejecting Sindell and traditional common-law theories, the court decided to forge a new remedy. The Collins court fashioned a "risk contribution" theory. The underlying policy reasons virtually mimic those cited in Sindell. The Collins court applied the Calabresi risk distribution approach35 and stated that: as between the injured plaintiff and the possibly responsible drug company, the drug company is in a better position to absorb the cost of the injury. The drug company can either insure itself against liability, absorb the damage award, or pass the cost along to the consuming public as a cost of doing business. We conclude that it is better to have drug companies or consumers share the cost of the injury than to place the burden solely on the innocent plaintiff.36

Upon proof of all necessary elements under the risk contribution theory, a plaintiff may recover all damages from one defendant. The court noted that, by suing more than one defendant, the plaintiff has a greater opportunity to establish liability and increase the chances of recovery in the event that a defendant is judgment proof.38 It is interesting that the Collins court found the Sindell market share theory impractical, in light of the 37

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See Calabresi, Some Thoughts on Risk Distribution and the Law of Torts, 70 YALE L.J. 4 4 9 , 517 (1961). Collins, 342 N.W.2d at 4 9 . The court found that each defendant contributed to the risk of injury because each sought to gain approval of DES for use in pregnancy o r in producing o r marketing DES in subsequent years. Therefore, each defendant shared a degree of culpability in producing a drug with possibly harmful side effects. See also Payton v. Abbott Labs., 3 8 6 Mass. 5 4 0 , 437 N . E . 2 d 171, 190 (1982) where Massachusetts rejected a market share theory, finding that public policy favors the development and marketing of new and more efficacious drugs and the imposition of such broad liability would seriously undermine that end. However, in McCormack v. Abbott Labs., 617 F. Supp. 1521 ( D . Mass. 1985), the district court found that the Payton court had not rejected market share theory outright. It found support in policy reasons identical to those enumerated in Collins to allow market share recovery for D E S plaintiffs. The elements of the risk contribution theory are as follows: That the plaintiff's mother took DES; that DES caused the plaintiffs subsequent injuries; that the defendant produced or marketed the type of DES taken by plaintiffs mother; and that defendant's conduct in producing or marketing the DES constituted a breach of a legally recognized duty to the plaintiff. In the situation where the plaintiff cannot allege and prove what type of D E S the mother took . . . the plaintiff need only allege and prove that the defendant drug company produced o r marketed the drug DES for use in preventing miscarriages during pregnancy. Collins, 342 N.W.2d at 50. Id. at 5 1 .

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cumbersome scheme it set up for apportioning liability among defendants unable to exculpate themselves.39


3. DES-Modified Alternative Liability (Michigan) The Michigan Supreme Court allowed DES plaintiffs to proceed by formulating a modified alternative liability theory, a forerunner of which was previously recognized under Michigan law. In Abel v. Eli Lilly & Co. ,40 the plaintiffs sued DES manufacturers for cancerous or precancerous conditions allegedly caused by their mothers' DES ingestion while in utero.41 The Abel court modified alternative liability to create a "DESunique" version, which required a plaintiff to satisfy three conditions:42 first, that all defendants have acted tortiously; second, that the plaintiffs have been harmed by the conduct of one of the defendants (plaintiffs therefore must bring before the court all manufacturers that may have caused the injury in fact); and third, that the plaintiffs, through no fault of their own, are unable to identify which manufacturer caused the injury.43 Once the plaintiffs satisfy these preliminary conditions of DESmodified alternative liability, they can avoid the traditional burden of proving causation in fact. The burden then shifts to each defendant to prove that it neither produced nor marketed the DES ingested by the plaintiffs' mothers. Defendants who are unable to exonerate themselves will be held jointly and severally liable.44 The Abel court also allowed the plaintiffs to proceed on a concert of action theory, because they had pled all the necessary elements. The plaintiffs alleged that all defendants acted together in negligently manufacturing and promoting DES that was ineffective and dangerous, inadequately tested, and distributed without sufficient warnings.45 In dicta, the Abel court commented that the fairness of applying the theory of alternative liability remained to be seen. Because there is no public policy cited as a basis for its opinion, the Michigan court clearly 39

Id. at 5 3 . In assigning a percentage of liability to each defendant, the jury may consider factors which include, but are not limited t o , the following: whether the drug company conducted tests on DES for safety and efficacy in use for pregnancies; to what degree the company took a role in gaining FDA approval of DES for use in pregnancies; whether the company had a small or large market share in the relevant area; whether the company took the lead or merely followed the lead of others in producing or marketing DES; whether the company issued warnings about the dangers of DES; whether the company produced or marketed DES after it knew or should have known of the possible hazards DES presented to the public; and whether the company took any affirmative steps to reduce the risk of injury to the public. Id.

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418 Mich. 3 1 1 , 343 N.W.2d 164, cert. denied, 469 U . S . 833 (1984). Id. at 167. Id. at 173. Id. Id. at 174. Id. at 176.

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was allowing plaintiffs to proceed on what it perceived were legal theories that already had been accepted under Michigan law.


4. Market Share Alternative Liability (Washington) The Washington Supreme Court in Martin v. Abbott Laboratories,*6 also adopted a new theory of recovery for DES plaintiffs. Plaintiff, Rita Martin, sued numerous DES manufacturers alleging that her DES exposure caused her vaginal clear cell adenocarcinoma. Neither her mother, her physician, nor her pharmacist could remember which company manufactured the DES Mrs. Martin ingested.47 In rejecting the concerted action, enterprise liability, alternative liability, and Sindell market share theories, the court outlined a new theory, which represented a hybrid of the alternative liability and the market share approaches.48 The Martin court found that each defendant contributed to the risk of injury to the public and, consequently, the risk of injury to individual plaintiffs. Therefore, each defendant must share, to a certain extent, the culpability in producing or marketing DES.49 Citing policy reasons, the Martin court shifted the cost of injury to the manufacturers from the innocent plaintiffs. Once again, the court found that, as between the injured plaintiff and the possibly responsible drug company, the latter is better situated than the plaintiff in terms of spreading the cost to society, because it can insure against liability, absorb the loss, or pass it on to its customers as a cost of doing business.50 In order to prevail, the plaintiff has the same requirements of proof that the Collins court established. The plaintiffs must sue only one defendant and prove the following: That the plaintiffs mother took DES, that DES caused the plaintiff's subsequent injuries; that the defendant produced or marketed the type of DES taken by plaintiffs mother; and that the defendant's conduct in producing or marketing the DES constituted a breach of a legally recognized duty to the plaintiff.51

Defendants unable to exculpate themselves52 are presumed to have equal shares of 100% of the market and are liable for only the percentage of the plaintiffs judgment that represents their presumptive share. Defendants 46 47 48 49 50 51 52

102 Wash. 2d 5 8 1 , 689 P.2d 368 (1984). Id. at 3 7 1 . Id. at 380-83. Id. at 382. Id. Id. Individual defendants are entitled to exculpate themselves from liability by establishing, by a preponderance of the evidence, that they did not: produce or market the particular type of DES taken by the plaintiffs mother; market the DES in the geographic market area where the plaintiffs mother obtained the drug; or distribute DES in the time period of the plaintiffs mother's ingestion of the drug. Id.

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can rebut the presumption, and reduce their potential liability by establishing their respective market share of DES in the plaintiffs particular geographic market. To the extent that other defendants fail to establish their actual market share, their presumed market share is adjusted so that 100% of the market is accounted for. When all named defendants prove that the total of their shares of the market is less than 100%, the plaintiff will not recover her entire judgment because the remaining percentage of the market share is the responsibility of unnamed defendants."


5. National Market Share Liability (New York) New York is the latest jurisdiction to adopt a market share theory of liability. In Hymowitz v. Eli Lilly & Co.,54 the New York Court of Appeals upheld the constitutionality of a statute reviving for one year actions for injuries caused by DES that were previously time-barred.55 Simultaneously, the court adopted a national market share theory as the appropriate method for determining liability and apportioning damages.56 Under the national market share theory, the defendants' shares of damages would be proportionate to the amount of DES each is found to have marketed nationally for pregnancy use or in a form suitable for use in pregnancy. The New York national market share method attempts to apportion liability to correspond to the overall culpability of each defendant, measured by the amount of risk of injury each defendant created for the public at large.57 A major distinction under the Hymowitz scheme, is that a defendant cannot exculpate itself, if it was a member of the market producing DES for pregnancy use, even upon submitting proof that it did not cause a particular plaintiffs injury. This concept is founded on the rationale that because liability is measured by risk created for the public at large, it would be a windfall for a defendant to escape liability solely because it manufactured a more identifiable pill or sold only to certain pharmacies.58 Concert of action and alternative liability theories were found to be inapplicable in DES actions,59 but at the same time the court recognized that the DES circumstances required a method of recovery for plaintiffs, "in order to achieve the ends of justice in a more modern context."60 The 53 54 55 56 57 58 59

60

Id. at 383. 73 N.Y.2d 487, 539 N.E.2d 1069, 541 N.Y.S.2d 9 4 1 , cert. denied, 110 S. Ct. 350 (1989). Id. at 1079. Id. at 1077. Id. at 1078. Id. Id. at 1074. Concerted action was disregarded because nothing in the record revealed anything to show tacit agreement to market DES for pregnancy use without taking proper steps to ensure the drug's safety. Alternative liability was rejected because DES defendants do not have better access to information, and the theory requires that all possible tortfeasors be before the court. Id. at 1075.



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policy underpinnings of Hymowitz are consistent with those noted in Collins, Sindell, and Martin—because so many manufacturers, each behind a curtain, contributed to the devastation, the cost of injury should be borne by the wrongdoers and not the innocent victims.61 The court sought a narrow basis on which to impose liability, seeking to bypass the problems inherent in the solutions designed in other states. The Hymowitz "national market" would be more workable than utilizing a smaller market.62 The Collins approach, although noted to be "the most refined approach by allowing a more thorough consideration of how each defendant's actions threatened the plaintiff," was rejected because of the probable injustices arising from delayed recoveries and the potential for inconsistent results.63 The final element of the Hymowitz national market share theory is that recovery is several only, and not joint and several. Thus, it is not inflated when all participants in the market are not before the court.64 The Hymowitz court accepted the possibility of less than 100% recovery as the tradeoff for refusing to allow defendants to exculpate themselves by showing they did not cause a particular injury. To hold otherwise would "unleash the same forces to increase a defendant's liability beyond its fair share of responsibility."65 Thus, the Hymowitz court attempted to balance the equities of aggrieved parties with an impossible burden to overcome with those of defendants who were faced with liability for injuries they did not cause. Although the Hymowitz court sought to learn from the perceived deficiencies of solutions proposed in other jurisdictions, the Hymowitz theory has yet to be tested and many questions remain unanswered. Patent from the decision is the court's failure to define clearly the language "DES marketed for pregnancy" and "DES in a form unsuitable for use during pregnancy."66 While these issues are being resolved, delays likely will be incurred during the initial stages of the market share proceedings. The market share issues currently being litigated will have to be resolved before a trial can commence on the liability and damages aspects of the case. As with most mass tort litigation, it is anticipated that the proceedings and trial in which market shares will be assigned will be both protracted and costly to all litigants. In his dissenting opinion, Judge Mollen considered the majority holding to be tantamount to the imposition of strict liability. In fact, the dissent argued that national market share liability amounts to concerted action without the requirement that plaintiffs prove that defendants tacitly agreed 61

id. Id. at 1077. 63 Id. 64 Id. 65 Id. 66 Id. 62


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to produce and market DES for pregnancy use without proper testing and adequate warnings. Judge Mollen characterized the majority holding as unfair and inequitable, as it does not allow exculpation for defendants who can prove that they did not cause the plaintiffs injury.67 The court's ruling actually does approach strict liability in view of the fact that defendants who may not be responsible are not able to present evidence to exculpate themselves. The Hymowitz court did not address the potential ramifications of this approach to the pharmaceutical industry. As has been pointed out, "notwithstanding the fact that the pharmaceutical industry is profit oriented, the products manufactured are essential to the health and welfare of the general population. This factor should outweigh the public policy of risk distribution."68 C. Jurisdictions Declining to Adopt a Collective Liability Theory Although several jurisdictions have found compelling policy reasons to create theories to allow recovery to DES plaintiffs who cannot identify the actual tortfeasor, the high courts of some states have found that such solutions are outside their judicial authority.

/. Missouri In Zajft v. Eli Lilly & Co.,69 once again, the plaintiffs alleged that their in utero DES exposure caused their cancerous or precancerous conditions. They sued 13 DES manufacturers alleging that they represented all or almost all of the known manufacturers, sellers, or distributors of Stilbene derivatives in Missouri at the relevant time. The plaintiffs were unable to identify the manufacturer of the specific DES to which they were exposed.70 The Supreme Court of Missouri distinguished alternative liability, concert of action, and enterprise liability theories and declined to apply them in the DES context. Furthermore, the court found the Sindell theory to be "unfair, unworkable, and contrary to Missouri law as well as unsound policy."71 The court was concerned about the risk that the actual wrongdoer is not among the named defendants, thus exposing those joined to liability greater than their responsibility.72 The Missouri high court refused to join other state courts which sculpted remedies for DES plaintiffs unable to meet the identification burden. It found "insufficient justification" in the DES circumstances to sub-

67 68 69 70 71 72

id. Fern, supra note 13, at 783. 676 S.W.2d 241 (Mo. 1984). Id. at 243. Id. at 246. Id. at 247.


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stantially alter the traditional rights and liabilities of the litigants. In acknowledging that its decision was based on public policy, the court stated: Competing with interests of appellants are legitimate concerns that liability will discourage desired pharmaceutical research and development while adding little incentive to production of safe products, for all companies face potential liability regardless of their efforts . . . and the consequences of imposing liability without identification extend to other areas of products liability law . . . (Salk anti-polio vaccine) . . . (asbestos).73


2. Iowa The Supreme Court of Iowa also rejected enterprise, alternative, and market share liability theories in the case of Mulcahy v. Eli Lilly & Co.14 The court distinguished the former two theories from the DES circumstances and rejected the latter for broad policy reasons. The court held that to award damages to an innocent party by means of a court-constructed theory that places liability on manufacturers who were not proved to have caused the injury involves social engineering more appropriately within the legislative domain.75 In refusing to devise a remedy for DES plaintiffs, the Iowa judiciary believed such a remedy was outside its realm of authority, and more appropriately left to the legislature. 3. Illinois Illinois is the latest jurisdiction to reject market share liability in the DES context. In Smith v. Eli Lilly & Co. ,76 the plaintiff alleged that her in utero exposure to DES caused her to develop vaginal clear cell adenocarcinoma. The plaintiff sued 138 drug companies, but was unable to identify the manufacturer of the DES her mother ingested. After reviewing the market share theories adopted in other states, the Illinois high court rejected any form of market share liability as an unsound theory that deviated too far from the existing Illinois tort principles.77 In rejecting the adoption of market share, the Illinois court found a host of flaws in the theory, a major one being that there is only a small amount of, and in some cases no reliable information available to establish 73

id. 386 N.W.2d 67 (Iowa 1986). 75 In Tidier v. Eli Lilly & C o . , 851 F.2d 418 (D.C. Cir. 1988), the court rejected all non-identification theories in a diversity action because they were not recognized by either Maryland or the District of Columbia. That court acknowledged that a common-law decision having such a marked effect on the known public policy of the jurisdictions concerned is outside the ambit of a federal court applying state law. In Mizell v. Eli Lilly & C o . , 526 F. Supp. 589 (D.S.C. 1981), the court determined that the Sindell market share theory would violate the public policy of South Carolina because that state required a plaintiff to prove that injury was caused by a particular defendant. 76 137 I11.2d 222, 560 N.E.2d 324 (1990). 77 Id. 74

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the defendants' percentage of the market. An attempt to establish percentages based on unreliable or insufficient data would create a tremendous cost, both monetarily and in workload, on both the courts and the litigants. Such percentages also would be arbitrary.78 The court highlighted the fact that it was inevitable that some wholly innocent defendants would shoulder some or all of the responsibility for the injury. Manufacturers' exposure would be broadened because they would need to insure against the losses arising from the products of others in the industry, as well as their own.79 The Smith court also added that any remedy should be within the province of the legislature.80 II. DPT LITIGATION Litigation surrounding the DPT (diphtheria, pertussis, and tetanus vaccine) controversy has created another opportunistic forum for the courts to fashion remedies to allow plaintiffs to recover from drug manufacturers whom they cannot identify when they are harmed through no fault of their own. To date, the highest courts of two states and at least three United States district courts have considered the issue and refused to apply collective liability in DPT cases. The reasons are manifold, but are most firmly based on public health and public policy considerations. This was clearly the basis for the New Jersey Supreme Court's decision in Shackil v. Lederle Laboratories,*1 which declined to adopt a collective liability theory in a DPT context. These policy considerations were sufficiently persuasive for the court to override the intrinsic proposition that courts should fashion remedies to meet the changing needs of our complex industrialized society82 and compensate plaintiffs who have been injured through no fault of their own. A. Background of DPT Vaccine DPT is a biological product83 that is classified by the FDA as a prescription drug.84 The product contains three components—diphtheria toxoid, tetanus toxoid, and pertussis vaccine, each of which stimulates the production of antibodies that protect the body against those diseases. 78 79 80 81

82 83

84

id. id. id. 116 N.J. 155, 561 A.2d 511 (1989).

Escola v. Coca Cola Bottling C o . , 24 Cal. 2d 4 5 3 , 150 P.2d 436 (1944). A biological product is defined as " a n y virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries of man." 21 C . R R . § 600.3(h) (1990). The manufacturer of DPT, a prescription biological, is subject to the regulation and oversight of the Office of Biologies Research and Review of the Food & Drug Administration and the provisions of



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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, which are chemically treated to stimulate immunity without causing disease symptoms. The diphtheria and tetanus portions of the DPT vaccine are therefore not the source of the alleged harmful side effects. The pertussis portion of the DPT vaccine is made from a whole cell type preparation and presumably harbors the alleged defect.85 There has been speculation regarding the cause of neurotoxic reactions attributed to pertussis vaccine. The vaccine is known to contain potentially reactogenic components, which have been temporally associated with major adverse events such as high fever, convulsions, hypotonic-hyporesponsive state (collapse, shock), encephalitis, and encephalopathy (including the onset of epilepsy with retardation, infantile spasms).86 The British National Childhood Encephalopathy Study (NCES) reported that one in 110,000 immunized children suffered post-vaccination neurological disorders, and permanent residual neurological deficits were found to have occurred in one in 310,000 doses.87 This large scale controlled epidemiological study still stands as the hallmark study in both scope and design, regarding pertussis vaccination and association to central nervous system effects.88 The above figures are cited by the Immunization Practices Advisory Committee (ACIP) in their current recommendations for DPT vaccination.89 In a further analysis, additional reports were added to the original NCES data, and concluded that the risk of acute encephalopathy was 1:140,000 immunizations and permanent residual deficits occurred in one in 330,000 doses.90 As it is the only large scale controlled epidemiological study, the

85

86 87

the Federal Food, Drug & Cosmetic Act, 21 U.S.C.A. § 301 et seq. (West 1988 & Supp. 1987), as well as the Public Health Service Act, 42 U . S . C . §§ 262-63. The pertussis portion of this vaccine is expressly governed by additional regulations. See 21 C.F.R. §§ 620.1-620.6 (1990). Each and every lot of D P T must be individually tested and approved by the Office of Biologies Research and Review prior to release. Id. §§ 620.1-620.6 & 620.14(c). Shackil, 561 A.2d at 5 2 1 ; David & Jalilian-Marian, DTP: Drug Manufacturers' Liability in Vaccine-Related Injuries, 7 J. LEGAL M E D . 187, 188 (1986). Report of the Task Force on Pertussis and Pertussis Immunization, 81 PEDIATRICS 959 (1988). Alderslade, Bellman, & Rawson, The National Childhood Encephalopathy Study, in WHOOPING C O U G H : REPORTS FROM THE COMMITTEE ON SAFETY O F MEDICINES AND THE JOINT COMMITTEE ON

88 89

90

VACCINATION AND IMMUNIZATION (London, Dept. of Health & Social Security, Her Majesty's Stationary Office 1981). Task Force Report, supra note 86, at 9 6 3 . ACIP, Diphtheria Tetanus and Pertussis: Guidelines for Vaccine Prophylaxis and other Preventive Measures, 34(27) M.M.W.R. 405, 405-14 & 419-26 (1985). Miller, Wadsworth, Diamond, & Ross, Pertussis Vaccine and Whooping Cough as Risk Factors in Acute Neurological Illness and Death in Young Children, 61 DEVELOP. BIOL. STAND. 389, 391 (1985).


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NCES data is presently utilized by the Centers for Disease Control (CDC) when informing parents about the potential risks of pertussis vaccine.91 The NCES estimates also are cited by the Committee on Infectious Diseases of the American Academy of Pediatrics, also known as the Red Book Committee in their recommendation regarding pertussis vaccine.92 Based upon 139 cases of severe neurological reactions reported to the CDC between 1978 and 1981, Cherry extrapolates that severe reaction occurs in one in 230,000 immunized children.93 From the Monitoring System for Adverse Events Following Immunization for adverse events temporally associated to the administration of a vaccine reported to the CDC between 1979 and 1982, the rate for febrile convulsions was 7.5 per million and the rate for encephalitis and/or encephalopathy was 0.2 per million occurring within 30 days after DPT immunization. The number of reported clinical illnesses per million doses administered should be interpreted as indexes for the true rates because of under reporting.94 Because of increasing concerns over apparent vaccine-related side effects, the federal government funded a study performed at UCLA and the Kaiser Medical Group.95 This study prospectively followed a group of children given 15,752 DPT immunizations and reported no encephalopathies or deaths, but indicated that both convulsions and hypotonic-hyporesponsive episodes occurred in one out of 1,750 immunizations.96 Critics chastised the authors for failing to report certain deaths and side effects in the final report.97 The study concluded that the rate of reactions following pertussis immunization was greater than previously believed.98 In two recent controlled studies looking at seizures and other acute neurological events following DPT immunization, no evidence was found of a causal relationship between pertussis vaccine and permanent neurological illness.99

91

92

93

94

95

96 97

98 99

Orenstein, Bernier, & Chin, Pertussis—A WEST. J. M E D . 339 (1989).

Disease and a Vaccine That Are Not Going Away, 150

COMMITTEE ON INFECTIOUS DISEASES, AMERICAN ACADEMY OF PEDIATRICS, REPORT OF THE COMMIT-

TEE ON INFECTIOUS DISEASES 321 (21st ed. 1988) (commonly known as the Red Book). Cherry, The Epidemiology of Pertussis and Pertussis Immunization in the United Kingdom and the United States, 14 CURR. PROB. PEDIATR. 153 (1984). Stetler, Mullen, Brennan, Orenstein, Bart, & Hinman, Adverse Events Following Immunization with DTP Vaccine, 61 DEVELOP. BIOL. STAND. 4 1 1 , 417 (1985). Cody, Baraff, Cherry, Marcy, & Manclark, Nature and Rates of Adverse Reactions Associated with DPT and DT Immunizations in Infants and Children, 68 PEDIATRICS 650, 654 (1981). Id. See Burke, DPT Vaccine Controversy—An Assessment of the Liabilities of Manufacturers and Administering Physicians Under Several Legal Theories, 17 SETON H A L L L. REV. 5 4 1 , 568 (1984). Cody, Baraff, Cherry, Marcy, & Manclark, supra note 9 5 . Walker, Jick, Perera, Knauss, & Thompson, Neurological Events Following Diphtheria-TetanusPertussis Immunization, 81 PEDIATRICS 345 (1988); Griffin, Ray, Mortimer, Fenichel, & Schaffner, Risk of Seizures and Encephalopathy After Immunization with the Diphtherial-Tetanus-Pertussis Vaccine, 236 J . A . M . A . 1641 (1990).



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The type of "whole cell" DPT vaccine that plaintiffs allege to be defective is now, and has been for many years, the only type of DPT vaccine licensed and authorized by the FDA for sale in the United States. Whole cell vaccines utilize whole, killed pertussis cells to stimulate the immune system to produce protective antibodies against the pertussis bacteria. Because it is not known what portion of the pertussis cells confer immunity, use of the whole pertussis cell ensures that the DPT vaccine will contain all the necessary immunity-conferring components. Because of the complex nature of the pertussis organism, the poisonous substances produced by the bacteria have been difficult to isolate. The whole cell vaccine is cruder than the toxoid preparation and allegedly has been accompanied by both local and systemic adverse reactions. All DPT vaccines manufactured and distributed in the United States are stringently regulated by the FDA pursuant to the authority delegated to it by congress under the Public Health Service Act.100 Each manufacturer wishing to produce and distribute a DPT vaccine must submit to the FDA a detailed application for a product license that must include, among other things, a full description of the vaccine, including the proposed manufacturing method and data demonstrating that the product meets prescribed standards of safety, purity, and potency.101 The FDA must review and approve the application and issue a product license before the manufacturer can begin to produce the DPT vaccine. After licensure, no proposed change in the manufacturing method or labeling accompanying the vaccine may be instituted without the prior review and approval of the FDA.102 The importance of DPT vaccine to the public health is evidenced by the fact that routine vaccination has been uniformly recommended by public health authorities for many years. Forty-one states, Puerto Rico, and the District of Columbia require pertussis vaccination prior to school entry.103 The United States government also has recognized the vital importance of DPT vaccine to the nation's health, and has repeatedly supported the continuing manufacture and distribution of DPT vaccines in this country. Various organizations, including the FDA, Centers for Disease Control, and the National Institute of Health, have promoted the continued vaccination of the population. Other organizations urging DPT inoculation are the Committee on Infectious Diseases of the American Academy of

100

101 102 103

4 2 U . S . C . A . § 2 6 2 (West 1982 & Supp. 1987); Federal Food, Drug and Cosmetic A c t , 21 U . S . C . A . § 301 et seq. (West 1972 & Supp. 1989). 21 C.F.R. §601.2 (1990). Id. § 601.12(b). C E N T E R S FOR DISEASE C O N T R O L , 1989-1990 STATE IMMUNIZATION REQUIREMENTS ( A u g . 1989). Only

Idaho, Missouri, N e w York, Oregon, Pennsylvania, Rhode Island, Texas, and Washington d o not require elementary students to be immunized with pertussis.

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Pediatrics (Red Book Committee) and the Advisory Committee on Immunization Practices of the United States Public Health Service. Prior to the licensure and use of the pertussis vaccine in this country, pertussis killed and crippled thousands of children annually. The dramatic decline in the incidence of whooping cough in this country is directly attributable to the effectiveness of the pertussis vaccine. As the vaccine usage became more prevalent during the middle part of this century the annual pertussis rate declined dramatically.m


B. Distinctions Between DES and DPT Diethylstilbestrol (DES) is a synthetic estrogen that was used pursuant to FDA approval for many indications, including the maintenance of pregnancy.105 It is a generic drug in the sense that it was manufactured according to a single chemical formula by different drug companies. It was never patented. The product literature accompanying DES contained no warnings concerning the risks of developing adenosis or cervical or vaginal clear cell adenocarcinoma in the female offspring of the mothers who ingested the product.106 In 1971, after receiving evidence of a statistical association between use of DES and the above disorders the FDA withdrew approval for DES use during pregnancy.107 The rare form of cancer and other gynecological abnormalities alleged to have been caused to daughters of mothers who ingested DES remained undetected for 15 to 20 years after ingestion. To ease the burden on plaintiffs who seek to recover for injuries caused through no fault of their own, courts adopted various collective liability theories as previously discussed. These theories were adopted in light of the peculiar characteristics of DES as well as other pertinent policy considerations, as highlighted below:108 1. The fungible nature of DES; 2. The absence of pertinent records to identify the manufacturer of the product ingested; 3. The long latency period of the condition allegedly caused by the DES; 104

105

106 107 108

Pittman, The Concept of Pertussis as a Toxin Mediated Disease, 3 PEDIATRIC INFECTIOUS DISEASES 467 (1984). Lester & Fudim, Pharmaceutical Law in the United States, in MONITORING FOR DRUG SAFETY 582 (W. Inman ed. 2d ed. 1986). Sindell, 6 0 7 P.2d at 926. See Sheiner, supra note 3 , at 9 6 5 . Brief for Defendant-Appellant Parke, Davis & Co., at 17, Shackil v. Eli Lilly & Co., 116 N.J. 155, 561 A.2d 511 (1989).


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4. The inability to identify the maker of the product through "no fault of the plaintiffs"; 5. The fact that the DES was used by someone other than the plaintiff; 6. The claim that DES was not efficacious for its intended purpose of preventing miscarriages;


7. The absence of any other remedy for the injured plaintiffs. Unlike DES, DPT vaccines are not generic or identical products. In fact, because DPT vaccines are biological, not chemical products, they differ from one manufacturer to the next. Each DPT vaccine manufacturer has its own proprietary methods for producing DPT vaccine, and the production processes of each are protected by patent or maintained as trade secrets. Moreover, manufacturers use different strains of pertussis organisms in different combinations and proportions to produce their vaccines. Accordingly, DPT vaccines differ from manufacturer to manufacturer. In addition, vaccines can contain individual variations from one lot to another. These variations occur even when the vaccine is produced by the same manufacturer, since vaccines are made from living organisms that are not uniform. Therefore, each batch of DPT vaccine will differ in characteristics such as opacity, unitage, potency, toxicity, and thus, the propensity, if 109

any, to cause injury. DPT vaccine has been shown to effectively immunize against diphtheria, pertussis, and tetanus. Unlike DES, where years, if not decades passed between ingestion and manifestation of the injury, the symptoms of DPT reactions usually occur within hours or days of inoculation. DPT vaccine is accompanied by warnings approved by the FDA advising of the potential risk of adverse reactions. Further, DPT vaccine is not clearly identified with a particular injury that is a "signature injury" as the Sindell court believed was the case with DES. The existence of a "signature injury" in DES cases,"0 in conjunction with the generic nature of the product, permits a court to assume not only that the causative link between the product and injury is established, but that all units of the product are uniformly defective and thus equally capable of causing injury. The neurological injuries allegedly associated with DPT vaccine present no scientific or pathological basis for identifying the claimed inju109

Supplemental Brief of Defendant-Appellant Lederle Laboratories, at 23, Shackil v. Eli Lilly & Co., 116 N.J. 155, 561 A.2d 511 (1989). See also Task Force Report, supra note 86, at 953. 110 The clear-cell adenocarcinoma affecting DES daughters is an example of an alleged "signature injury," a distinctive injury linked to a specific and determinable cause.

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ries with the vaccine. At best, there is a temporal relationship between inoculation and the central nervous system disorder. Mere temporal association is not proof of cause and effect between the inoculation and the child's neurological reaction. As DPT cannot be standardized, and lots cannot be made identical, it is scientifically impossible for each lot to have the same propensity to cause harm as the next. Each DPT manufacturer applied for and was granted an independent license to market DPT according to its own manufacturing formula. Also, each manufacturer prepared separate package inserts for its DPT product. Downloaded by [New York University] at 10:03 21 May 2015

C. Regulation of DPT Vaccine While all prescription drugs are extensively regulated by the federal government, the regulation of DPT vaccine is extraordinarily comprehensive and encompassing. Since biologicals are made from living organisms, which by their very nature are unique, the government carefully monitors the preparation and testing of each individual lot of vaccine. The government requires each manufacturer to submit test results for each lot of vaccine, as well as a sample of that lot, so that the government can perform the required tests." 1 Before any lot of DPT vaccine can be released for distribution, it must be approved as safe and effective by the government."2 All currently licensed DPT vaccines have been reviewed by a special review panel of experts assembled by the FDA, and have been found to be safe and efficacious."3 Based upon this regulatory experience and its independent scientific expertise, the FDA has determined that the whole cell DPT vaccine design is safe and effective."4 III. VACCINE CASES ADDRESSING COLLECTIVE LIABILITY THEORIES A. Overview of the Case Law There are a handful of cases addressing the question of whether collective liability theories, including market share liability, are applicable to vaccines. The case of greatest import is Shackil v. Lederle Laboratories."5 Discussion of this New Jersey Supreme Court decision will be set aside momentarily to review certain earlier cases to put the Shackil decision in context. 111 21 C.F.R. § 620.6(h) (1990). Required tests include those for toxicity and potency. 112 Id. § 610.1. 113 Id. § 601.25. 114 50 Fed. Reg. 51, 104 (1985); 50 Fed. Reg. 51, 055 (1985). 115 116 N.J. 155, 561 A.2d 511 (1989).


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In Senn v. Merrell Dow,1'6 the plaintiff received a DPT vaccination at age five months and later developed encephalopathy, which left her severely mentally and physically handicapped. A product liability lawsuit was initiated against the only two vaccine manufacturers that could have produced the vaccine given to the plaintiff. However, the plaintiff could not identify which of the two defendants actually was responsible. Before rendering a decision on the underlying facts, the Ninth Circuit Court of Appeals certified to the Oregon Supreme Court two questions, only the first of which is relevant to this discussion: Under Oregon law, if the plaintiff in a products liability action shows that two defendant drug manufacturers each produced a drug either defectively designed or defective because of failure to warn of risks inherent in the use of the drug but cannot show which manufacturer produced the drug plaintiff received, does the burden of proof shift from plaintiff to defendants to show that they did not cause plaintiffs injury?"7

In short, the Senn court addressed the issue of whether the alternative liability theory would apply in the DPT context. The evidence proffered from state purchasing records had narrowed the possible manufacturers to two. The trial court dismissed the other defendants on their motions for summary judgment. Oregon's highest court reviewed Sindell and the other DES cases in which courts had applied variations of the market share theory and rejected them all. The court concluded that the theory of alternative liability as set out in the Restatement (Second) of Torts, section 433B(3) was not available to the plaintiff in Oregon. In rejecting the alternative liability theory, the court noted: The larger difficulty with alternative liability theory arises from the violence it does to the causation-in-fact element of tort law. The effect of applying a rule of alternative liability to a case in which neither defendant is able to produce exculpatory evidence is to impose liability where the probability of causation is 50 percent or less ("as probable as not" or "less than probable") as opposed to the traditional 50+ percent ("more probable than not") preponderance of the evidence standard and to impose liability on all defendants when in fact only one of them could have caused plaintiffs harm." 8

The court emphasized the difficulty a plaintiff would have in proving liability, even where the number of defendants was narrowed to two. This difficulty stems from the impossibility of determining what quantum of 116

305 Ore. 256, 751 P.2d 215 (1988).

117

Id. at 216. Id. at 222.

118

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evidence is necessary to exculpate a defendant since it allowed a presumption of liability on a 50% or lower probability of causation. The Senn court concluded as follows:


[A]doption of any theory of alternative liability requires a profound change in fundamental tort principles of causation, and adjustment rife with public policy ramifications. The legislature may study and adopt one or another such theory, but we cannot pretend that any such theory is consistent with common law principles of tort liability."9

In Chapman v. American Cyanamid Co.,m the infant plaintiff died five days after being inoculated with DPT vaccine. The parents filed a product liability suit against two of three possible manufacturers. The trial court granted the defendants' motions for summary judgment and the parents appealed. The Eleventh Circuit Court of Appeals, applying Georgia law, refused to reverse established common-law precedent requiring product identification in order for plaintiffs to proceed under a theory of negligence or strict liability. The court stated that Georgia had not embraced the concept of alternative liability and declined to adopt the rule in this case, thus rejecting the application of a collective liability theory against a DPT manufacturer. The plaintiff, in Sheffield v. Eli Lilly and Co.,'21 brought suit against a number of drug companies for injuries allegedly arising from the Salk polio vaccine intended to immunize against poliomyelitis. The claim against the manufacturers was summarily dismissed because of the plaintiff's inability to identify the defendant who had supplied the injury causing vaccine. Like DPT vaccine, the Salk polio vaccine is a prescription biological. After the trial court entered summary judgment in favor of the defendant manufacturers, the plaintiff appealed, urging application of market share liability as enunciated in Sindell. The California Court of Appeals declined to extend the rationale of Sindell to the manufacturers of a product not intrinsically defective, holding: 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 the plaintiffs was itself not a unit of a total generic pharmaceutical product but a deviant defective vaccine. l22 119

Id. at 223. 861 F.2d 1515 (11th Cir. 1988). 121 144 Cal. App. 3d 583, 192 Cal. Rptr. 870 (1983). 122 Id. at 876. 120



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As such, the court refused to follow Sindell where the subject vaccines lacked identical defects. The court reasoned that it would be unfair to hold four innocent manufacturers responsible for the injury caused by the one tortfeasor who manufactured the defective dosage.123 Also, the Sheffield court refused to apply the Sindell market share theory to the polio vaccine because the delay in discovering the possible cause and effect was not related to the nature of the defective product, nor by any act or omission by an unknown tortfeasor.124 Finally, the Sheffield court rejected the market share theory because of the essential role played by vaccine manufacturers in the elimination of polio as a health threat. The inequity of imposing liability on all defendants for the allegedly defective product of only one manufacturer and the public policy of encouraging the production and marketing of products like the Salk vaccine carried the day. The Sheffield court specifically noted that, if market share liability had been prevalent in the mid-1950s during the development of polio vaccine, manufacturers would have been reluctant to proceed with dispatch in the distribution of the vaccine, and consequently thousands would not have been saved by the Salk vaccine program.125 In a fitting comment, which succinctly summarizes the dual tort law policy objectives of compensation and deterrence, the Sheffield court stated: The "deep pocket" theory may be socially desirable as a vehicle to insure that all victims of a defective product would be compensated from an industry-wide fund; but if applied indiscriminately to penalize a careful and careless producer alike it fails to act as a deterrent to the latter or provide an incentive to product safety industrywide, and may result in keeping beneficial, but potentially dangerous products off the market.126

In another California case, the court in Morris v. Parke Davis & Co.,127 permitted plaintiffs to proceed in discovery under a market share theory against DPT manufacturers, but collective liability never was actually imposed. The action was filed against five vaccine manufacturers seeking to recover for injuries allegedly suffered from DPT vaccine. The plaintiffs conceded their inability to identify the manufacturer of the particular vaccine administered to the infant. The defendant DPT manufacturers moved for summary judgment 123 124

Id..

T h e court also advanced a public policy rationale that was, in essence, adopted by the New Jersey Supreme Court in Shackil. 125 Sheffield, 192 Cal. Rptr. at 880. 126 Id. at 8 7 8 . 127 573 F. Supp. 1324 (C.D. Cal. 1983), modified on other grounds, 667 F. Supp. 1332 (C.D. Cal. 1987).

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arguing that Sindell market share liability did not apply to a case where injury was caused by a manufacturing defect.128 The court agreed with the defendants on the issue, but held that a manufacturing defect that is present in all of the products, nevertheless warrants Sindell treatment.129


B. The Shackil Decision Deanna Marrero, who was born in October of 1970, was given four DPT immunizations by her pediatrician, Dr. Leo Feld, during her first two years of life. According to the infant's mother, Mrs. Shackil, Deanna began screaming and crying within 24 hours after receiving her fourth shot. The plaintiffs alleged that the infant suffered neurological damage causing the rapid deterioration of her already acquired verbal, motor, and mental capacities as a result of the DPT vaccine. Deanna was diagnosed as having chronic encephalopathy and severe retardation requiring institutionalization and constant care. Although Mrs. Shackil suspected that the DPT injection may have been linked to her daughter's injury, she made no attempt to identify the vaccine manufacturer. She never spoke to the physician, the pharmacist, or a pharmaceutical company employee. In April of 1985, 13 years after the inoculation, the plaintiffs brought suit against Dr. Feld, the administering pediatrician, and Lederle Laboratories, one of the manufacturers of DPT vaccine during 1971 and 1972. The complaint asserted theories of negligence, breach of warranty, misrepresentation, and strict liability based upon design defects. An amended complaint was filed in November of 1985 that added Wyeth Laboratories, Parke Davis & Co., and Eli Lilly as defendants. A second amended complaint was filed in December of 1986 naming Pittman/Moore as a defendant. Each of the corporate defendants manufactured DPT vaccine during the years in which the infant plaintiff received her immunizations. Pursuant to court orders, discovery focused on the issue of product identification. Because of the extensive time that had elapsed between the inoculation and the law suit, the plaintiffs were unable to establish which manufacturer produced the vaccine that caused Deanna's injury. The pediatrician retained no records that revealed the brand and the pharmacist was deceased. Discovery of the various manufacturers failed to establish the identity of the responsible manufacturers. In fact, at the close of this initial phase of discovery, the plaintiffs conceded an inability to identify any of

128 The Sheffield decision had resolved this issue, finding that collective liability theories are inapplicable to vaccines that were defective because of manufacturing flaws. Sheffield, 192 Cal. Rptr. at 870. 129 Morris, 667 F. Supp. at 1342. Sindell allowed the plaintiff to proceed by simply joining a "substantial share" of the manufacturers while obviating the requirement for identification of the tortfeasor.



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the defendant manufacturers as the source of the DPT administered to Deanna. Defendants Parke Davis, Lederle, Eli Lilly, and Wyeth moved for summary judgment based on the plaintiffs' failure to identify the tortfeasor, an essential element under New Jersey tort law.130 The trial court granted the manufacturers' motions for summary judgment,131 however, the court's decision was reversed on appeal.132 The appellate court issued three opinions, two of which led to reversal and remand. Essentially, the court held that a "risk modified market share approach was most suited to the circumstances of the case."133 Under such an approach, the plaintiff need only name as defendants the manufacturers of a substantial share of the relevant market and then the burden is placed on the manufacturers to exculpate themselves by proving either nonparticipation, possession of a reduced market share, or that their product engendered a lower risk.134 In response to the defendants' petition, the New Jersey Supreme Court granted leave to appeal. On July 31, 1989,135 in a four to two decision, the court rejected a "risk modified market share" approach to liability for the vaccine-related injury. In the court's view, the modified market share liability theory created by the appellate division was essentially an extension of the alternative liability theory, which it did not find applicable.136 The court went on to review the cases that applied market share liability with modifications following the California Sindell decision.137 The court took note of the states that had rejected a market share theory in the DES context,138 as well as the three vaccine cases discussed previously which addressed the application of market share theory to vaccines.139 The Shackil opinion then focused on the threshold question of

130 131 132 133 134 135 136

137

138

139

Shackil, 561 A.2d at 513. Namm v. Charles E. Frosst & Co., 178 N.J. Super. 19, 427 A.2d 1121 (App. Div. 1981). Shackil v. Lederle Labs., 219 N.J. Super. 601, 530 A.2d 1287 (1987). Id. at 1287. Id. Shackil, 561 A.2d at 514. Id. at 5 1 5 . The Shackil court undertook a thorough review of the various exceptions to the causation in fact requirement that have been adopted b y other jurisdictions to allow plaintiffs to shift t o t h e defendant the burden of proof o n t h e cause in fact element. T h e exceptions reviewed included concert of action, enterprise liability, alternative liability, a n d market share liability. Sindell v. Abbott Labs., 607 P.2d 924 (Cal. 1980); Hymowitz v. Eli Lilly & Co., 539 N.E.2d 1069 (N.Y. 1989); Martin v. Abbott Labs., 689 P.2d 368 (Wash. 1984); Collins v. Eli Lilly & Co., 342 N.W.2d 37 (Wis. 1984). Mulcahy v . Eli Lilly & C o . , 386 N.W.2d 6 7 (Iowa 1986); Zafft v . Eli Lilly & C o . , 676 S.W.2d 241 (Mo. 1984). Senn v. Merrell-Law Pharmaceuticals, Inc., 305 Ore. 256, 751 P.2d 215 (1988); Sheffield v. Eli Lilly & Co., 144 Cal. App. 3d 583, 192 Cal. Rptr. 870 (1983); Morris v. Parke-Davis & Co., 667 F. Supp. 1332 (C.D. Cal. 1987).


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whether expansion of current principles of tort law was warranted to include a risk modified market share liability theory in the DPT context. The central consideration of the decision was whether sound public policy would allow modification of traditional tort theories to allow the plaintiffs' design defect claim to proceed.140 In examining this question, the court reviewed the underlying policies of the Sindell decision, as well as the specific policy considerations that would flow from an expansion of tort law in the vaccine arena.141 The threshold issue was whether DPT was a "a generic product which was uniformly harmful and therefore amenable to a market share analysis."142 Upon analyzing the background information concerning the various production processes of DPT, the individual patents by the manufacturers, the FDA requirements of testing each batch lot, and the inherent characteristics that distinguish DPT from DES, the court was unpersuaded by the differing patents and production processes. The court found "sufficient evidence that pediatricians used the whole-cell products interchangeably.'''43 Citing a scientific study that compared the vaccines produced by four manufacturers, the court concluded that there was no significant difference in the rates of more serious reactions by the vaccine manufacturers. Any differences that were observed for less serious reactions appeared to be related to differences in the various lots rather than the specific vaccines.144 Having been unpersuaded by the technical and scientific differences between DES and DPT, the court next moved to the public policy and public health considerations concomitant with the imposition of market share liability to vaccines. The New Jersey Supreme Court had previously accepted the basic working tenet that, "the torts process, like the law itself, is a human institution designed to accomplish certain social objectives."145 One of the primary social objectives is to ensure "that innocent victims have avenues of legal redress, absent a contrary, overriding public policy."146 The court then foreshadowed its ultimate conclusion by finding that the vaccine situation presented a "difficult circumstance in which societal goals, in encouraging the use and development of needed drugs, would be thwarted by the impo-

140 141 142 143 144

145

146

Shackil, 561 A.2d at 521. Id. Id. Id. at 522. Id. (citing Baraff, Cody, & Cherry, DPT-Associated Reactions: An Analysis by Injection Site, Manufacturer, Prior Reactions and Dose, 7 3 PEDIATRICS 31 (1984)). Id. (citing People Express Airlines, Inc. v. Consolidated Rail C o r p . , 100 N . J . 246, 2 5 4 , 4 9 5 A.2d 107 (1985)). Id.



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sition of unlimited liability on manufacturers in order to provide compensation to those injured by their products."147 The court opined that DPT vaccine was a product, "essential to the public welfare,"148 citing its long history of efficacy in reducing suffering and death caused by whooping cough. Recent developments, including product liability concerns, litigation costs, increasing prices for vaccines, and the difficulty in obtaining adequate insurance, were mentioned as threatening the supply of the DPT vaccine.149 Not only did the Shackil court consider the public health goal of assuring an adequate supply of current vaccines, but also the effort and significant expense required to develop a safer alternative vaccine. The court's vision even reached beyond DPT vaccine to the effect that market share liability would have on the development of other drugs including a vaccine against the spread of AIDS.150 The overriding public health policy of encouraging research and development of new and necessary drugs is not unfamiliar in product liability law. It is evident in the rationale behind comment k of the Restatement (Second) of Torts, section 402A, which exempts manufacturers of unavoidably unsafe products (including vaccines) from strict liability for unfortunate consequences attending their use, provided the drugs are accompanied by proper directions and warnings. This exemption is based on the fact 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."151 Notwithstanding these public policy concerns, the court was cognizant of the basic social policy of providing compensatory relief to those injured by vaccines through no fault of their own. The court found that the National Childhood Vaccine Injury Act of 1986 (Act)152 was a no-fault compensation scheme, under which awards can be made to vaccine-injured persons, quickly, easily, and with certainty and generosity. The court then outlined the procedural requirements to file under the Act and receive an award that was funded from an excise tax on vaccines. To assure adequate funding of the trust, congress made an initial appropriation. The Shackil court decided that the Act had sufficient funding to 147 148

Id.

Id. at 522-23. 149 Id. at 5 2 3 (citing Vaccine Injury Compensation: Hearing Before Subcommittee on Health and the Environment of the House Committee on Energy and Commerce, 98th Cong. 2d Sess. 2 9 5 (Sept. 10, 1984) (statement of Daniel Shaw, Jr., Vice President for Medical Affairs, Wyeth Laboratories). 150 Id. at 524. 151 Id. (citing White v. Wyeth Labs., 4 0 Ohio St. 3d 3 9 0 , 5 3 3 N . E . 2 d 7 4 8 (1988)). See Brown v. Superior Court, 4 4 Cal. 3d 1049, 1058, 751 P.2d 4 7 0 , 4 7 9 , 2 4 5 Cal. Rptr. 4 1 2 , 4 1 6 (1988). 152 42 U.S.C.A. §§ 300aa-l et seq. (West 1986). 153 H. REP. NO. 908, 99 Cong. 2d Sess., at 3 (1986).

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achieve congress' goal of affording a remedy for plaintiffs who would otherwise engage in protracted litigation against the vaccine manufacturer with the consequent risk of being denied recovery because of failure to


r

154

present a pnma racie case. The court was cognizant that Deanna Marrero, who was injured prior to 1988, had the option of withdrawing her state tort-law action and filing a claim for compensation under the Act at any time within two years following October 1988 or before final judgment. The court noted that the plaintiffs chose the "more hazardous and cumbersome route of attempting to reshape tort law theory to encompass their claim,"155 in lieu of accepting the certain compensation afforded under the Act. By rendering a final judgment against the plaintiffs, the court was not unaware that the plaintiffs would be precluded from filing a claim under the Act and would be left without a remedy.156 The court found the existence of the National Childhood Vaccine Injury Act to be critical under the circumstances for several reasons: (1) it illustrated the complex nature of the underlying problem, which cannot be resolved simply by expanding tort law theory; (2) it made available a means of compensatory relief for this injured victim, which, although potentially smaller than a jury award might have been, was nonetheless certain; and, (3) it satisfied the tort goal of encouraging the manufacture of safer products, inasmuch as the Act establishes a national program for the research and development of safer vaccines.157 In addition to the National Childhood Vaccine Injury Act, the court acknowledged that recent product liability statutes enacted by the New Jersey legislature,158 though not expressly concerned with the question of collective liability, evinced an intention to limit the expansion of product liability law by creating absolute defenses and rebuttable presumptions of nonliability.159 The court declined to analyze the market share liability theory within the context of vaccines. Rather, the justices focused on the public policy and public health issues and the "regressive effect that collective liability would have on the social policy of encouraging vaccine production and research."160 In conclusion, the Shackil court noted that its opinion was confined solely to the context of vaccines and that, 154 155 156 157 158 159 160

Shackil, 561 A.2d at 525-26. Id. at 5 2 6 . Id. at 527. See 4 2 U . S . C . A . § 300aa-11(a)(5)(A) & (B) (West 1986). Shackil, 561 A.2d at 527. N . J . STAT. A N N . § 2A:58C-1 to 7 (West 1988). Shackil, 561 A . 2 d at 525-26. See N . J . STAT. A N N . §§ 2A:58C-3(a)(1) et seq. (West 1988). Shackil, 561 A.2d at 522.


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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.161

Thus, the court was suggesting that market share liability may be available in the DES arena once an appropriate case reaches the high court for consideration. Justice Daniel O'Hern dissented. The dissent criticized the majority decision for depriving the plaintiffs of a remedy on the basis of theories never presented at trial and on the basis of a federal remedy (the Act) that did not exist when the case was filed and was not yet funded when the appeal was argued before the New Jersey Supreme Court. While the majority opinion did not disagree with the conceptual underpinnings of market share liability, the dissent contended that the public policy and the public health considerations that carried the day should not have left these plaintiffs without a remedy. The dissent further believed that the New Jersey court, which has liberal tendencies in the product liability field, now would be out of step with other liberal jurisdictions such as California and New York, where market share theories had been sculpted to meet the needs of their citizens.162 Albeit, this was within the DES context and not within the vaccine arena.

IV. ANALYSIS The market share liability theory, whether in its pure form as enunciated in Sindell or in a risk modified form as sculpted by Judge Dreier in the Shackil appellate division decision,163 possesses great superficial appeal. Innocent plaintiffs are allowed to recover, and, because each of the defendant's damages are apportioned according to the amount of harm attributable to it, each defendant is seemingly treated fairly.1 The Sindell decision was primarily a policy-based decision. The California Supreme Court's radical departure from accepted principles of tort law can only be viewed in light of the court's overriding concern for a well-defined class of innocent plaintiffs who had been grievously injured by what the court viewed as a clearly defective product and who were

161 162 163 164

Id. at 5 2 9 . Id. at 529-42. 219 N.J. Super. 601, 530 A.2d 1287 (1987). Fischer, supra note 9 , at 1626.


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unable to meet the traditional requirements of causation allowing them to recover.165 The particular policy concerns supporting the California Supreme Court's market share theory in DES cases are not applicable to DPT. DPT vaccines are not fungible products. Each vaccine product does not possess an identical propensity to cause injury, nor is it associated with a "signature" injury. The passage of time, which makes identification difficult, if not impossible, is not attributed to the actions or non-actions of the DPT manufacturers. Contrary to the DES scenario, there is no problem of latent injury related to the DPT vaccine.l66 In casting aside these arguments, the Shackil court was concerned, for the most part, with public policy ramifications. The imposition of market share liability is contrary to the societal goals of maintaining an adequate supply of vaccines and of developing safer alternatives to vaccines currently in use. The regressive effect that the imposition of market share liability would have on the social policies of encouraging vaccine research, development, and production was the linchpin upon which the court's ruling was based.167 The public health and public policy considerations upon which the Shackil court predicated its decision recognized the continuing public benefit of DPT in stark contrast to the now prohibited use of DES to prevent miscarriages.168 The Shackil court found it was of paramount importance that DPT vaccine is a "product regarded as essential to the public welfare."169 DES did not have the effect of promoting public health, nor of protecting the immunized population from the devastating effects of a severe and life threatening disease, as does DPT vaccine. Of significance is the fact that DPT vaccine, unlike DES, is a product with a 50-year history of safety and efficacy.170 The benefits of DPT vaccination dramatically exceed any concomitant risks, as evidenced by the fact that 41 states mandate pertussis vaccination before a child can enter public school.171 The Shackil court therefore refused to harness the development and use of necessary drugs and vaccines by imposing collective liability on pharmaceutical manufacturers. The continued freedom for manufacturers to concentrate their efforts, resources, and dollars on research and development of new and potentially safer and better drugs and vaccines was a prominent factor in 165 166 167 168 169 170 171

Supplemental Brief, supra note 109, at 3 3 . Id. Shackil, 561 A . 2 d at 522. Joint Brief of Defendants, at 16, Hussey v. Merrell D o w , N o . 86-570 (Sup. Ct. Maine 1989). Shackil, 561 A.2d at 522-23. Supplemental Brief, supra note 109, at 3 4 . See STATE IMMUNIZATION R E Q U I R E M E N T S , supra

note 103.



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the decision. This rationale had been utilized before in other drug product liability cases. For example, in Brown v. Superior Court,"2 the California Supreme Court held that, "because of the public interest in the development, availability, and reasonable price of drugs," the appropriate test for determining responsibility for adverse reactions is set forth in comment k.173 The public policy concern that the imposition of liability would inhibit drug research and development, and unreasonably raise the cost of health care, was a cardinal factor in the Sheffield court's rejection of market share liability in a polio vaccine case. The Shackil court expressed concern about the chilling effect that application of market share liability would have on the development of new drug products. The availability of no-fault compensation174 for injuries suffered following inoculation was a further reason to reject expansion of manufacturer liability. The establishment of market share liability is a drastic departure from basic tenets of tort law more within the sphere of the legislature than the courts. In Mulcahy v. Eli Lilly & Co.,"5 the court held that any change in the law to allow recovery in non-identification DES cases should come from the legislature.176 Congress has responded and enacted a remedy for those suffering from vaccine related injuries. This remedy, enacted for those suffering from vaccine related injuries, which eliminated the necessity of proving all elements of a tort cause of action, goes beyond even the most expansive judicial rulings in any vaccine case. The New York legislature evidenced its intention to allow innocent plaintiffs an opportunity to prosecute their claims by legislating the Revival Statute to revive previously time barred DES causes of action.177 In adopting its market share remedy, the New York Court of Appeals stressed in Hymowitz that the DES situation is a singular case with manufacturers acting in a parallel manner to produce an identical, generically marketed product, which causes injury many years later and which has evoked a legislative response reviving previously barred actions.'78 The circumstances stressed by New York's highest court in adopting a market share liability theory to address the DES problem simply are not present in the DPT situation. Accordingly, the New Jersey Supreme Court was unable to rationalize the adoption of a collective liability theory. Other courts, in analyzing a variety of product liability claims, have refused to 172

4 3 C a l . 3d 1049, 7 5 1 P.2d 4 7 0 , 4 7 7 (1988). Id. T h e court adopted the "unavoidably unsafe product" exemption to strict product liability law. 174 4 2 U . S . C . A . § 300aa-1 to 3 4 (West Supp. 1989). 175 3 8 6 N.W.2d 67 (Iowa 1986). 176 Id. at 75-76. 177 Hymowitz, 539 N . E . 2 d at 1079. 178 Id. at 1078-79. 173

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impose industry wide liability in the absence of a generic product and "signature injury."179 The facts, the science, the policy underpinnings, the legislative history, and the totality of the scenario all distinguish DES from DPT and show why imposing a collective liability theory in the context of vaccines is inappropriate. As the boundaries of product liability law have progressively expanded to a point where they already have a deleterious impact on the supply of essential Pharmaceuticals, the Shackil court's refusal to extend product liability law further is based on a solid and reasonable foundation. CONCLUSION The tort system has expanded and grown increasingly imaginative to allow recovery where none previously existed. Novel theories of recovery have been fashioned, relaxing, if not totally lifting, plaintiffs' burden of proving each element of a cause of action.180 The DES litigation presented courts with fertile ground to create novel theories, which for the most part modify, if not abolish, traditional tort theories. Public policy issues were dominant in each court's consideration in deciding whether to fashion a theory to ease plaintiffs' burdens on the product identification issue. The judicially devised theories fall into four broad categories181 with specific elements peculiar to each. Other jurisdictions have modified these four basic theories to create their own novel theories within the DES arena. Expansion of tort law by the judiciary has been based on the rationale that an innocent plaintiff should not suffer and that the manufacturer and others in the stream of commerce are better able to absorb and/or spread the cost of injury and actively invest in safety research. Plaintiffs

179

180

See, e.g., Cummins v. Firestone Tire & Rubber C o . , 4 9 5 A . 2 d 9 6 3 , 972 (Pa. Super. Ct. 1985) (multi-piece tire and rim assemblies produced by different manufacturers not sufficiently similar to be considered identical o r fungible); Bixler v. Avondale Mills, 4 0 5 N.W.2d 428 (Minn. A p p . 1987) (cotton flannelette not a fungible product); Dawson v. Bristol Labs., 6 5 8 F. Supp. 1036 (W.D. Ky. 1987) (tetracycline); Griffin v. Tenneco Resins, Inc., 6 4 8 F. Supp. 9 6 4 ( W . D . N . C . 1986) (benzidine congener dye); Coerper v. Dayton-Walther, N o . 85 C . 6887, slip op. ( N . D . Ill. Mar. 2 7 , 1986) (available on L E X I S , Genfed library, Dist. file) (wheel assembly); Mason v. Spiegel, Inc., 6 1 0 F. Supp. 401 ( D . Minn. 1985) (tennis dress); Bradley v. Firestone Tire and Rubber C o . , 5 9 0 F. Supp. 1177 ( D . S . D . 1984) (tire and wheel assembly); Cousineau v. Ford Motor C o . , 3 6 3 N.W.2d 7 2 1 (Mich.) (wheel assembly), cert. denied, 474 U . S . 9 7 1 (1985); Campagno v. Ipco C o r p . , 524 N.Y.S.2d 138 (Sup. Ct. Suffolk C o . 1987) (eyeglass lenses); Davis v. Yearwood, 612 S.W.2d 9 1 7 (Tenn. App. 1980) (padded cell furnishings). Fern, Recent Legislative Retraction of Court-Expanded Drug Products Liability Law, in DEFENDING D R U G AND M E D I C A L D E V I C E C A S E S ( D . Hirsch ed. 1989).

181

T h e four basic theories a r e : (1) concert of action; (2) alternative liability; (3) enterprise liability; and, (4) market share liability.



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have urged that collective liability theories be applied to vaccines, including DPT. Courts that have considered the issue believe that society, as a whole, would be ill-served by decreased commitment of resources for research and development of new and safer products, and the increased costs of biological products that would undoubtedly result if vaccine manufacturers were subject to market share liability. Biological products have eradicated or severely reduced a host of severe, debilitating, or fatal diseases, and are essential to the health and welfare of the general population. Imposition of collective liability would thwart the societal goal of encouraging development and use of necessary and helpful drugs. Although market share liability has been rejected by many courts, the theory is particularly inappropriate in cases involving DPT vaccine. When it has been applied by the courts, specific compelling reasons for departing from traditional common-law proof requirements have been present. The courts that have adopted collective non-identification liability theories have been faced with specific factual scenarios that include the following factors: (1) the products were identical; (2) the products all had the identical design defect; (3) the plaintiffs were unable to identify the manufacturer because of an insidious, latent injury; and, (4) unless a non-identification theory was adopted, injured plaintiffs would not have been able to obtain compensation. These factors are not present in DPT cases.182 Although New York became the most recent state to adopt a market share liability theory in DES cases where the manufacturer of a drug that injured a plaintiff was impossible to identify, the holding was explicitly limited to DES because of the factual and legislative scenario attendant to the DES situation.183 Within months after the New York decision, the New Jersey Supreme Court, with its usual liberal tendencies in the product liability field, emphatically rejected the imposition of market share liability on DPT manufacturers.184 Oregon's high court similarly refused to apply a collective liability theory to DPT vaccine.185 In fact, despite the opportunity to do so, not one court has imposed collective liability upon DPT manufacturers. The high societal costs of imposing such liability on DPT manufacturers, and the ever present public health policy, taken together with the nofault remedy that the federal government has provided to compensate those injured by vaccinations, have given the courts sufficient reason not to ap-

182

Brief, supra note 108, at 2 . Hymowitz, 539 N.E.2d at 1069. 184 Shackil, 561 A.2d at 511. 185 Senn v. Merrell Dow Pharmaceuticals, Inc., 305 Ore. 256, 751 P.2d 215 (1988). 183

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ply a market share liability theory to DPT, or vaccines in general. These reasons likely will continue to be applicable in the foreseeable future, and manufacturers of biological products should continue to be protected from industry-wide liability for injuries associated with the product when plaintiffs cannot identify the tortfeasor.

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Market share and veterinary practice management software.

Parallel trade of pharmaceuticals: The Danish market for statins.

Robotic surgery in urological oncology: patient care or market share?

Approaching the Distinction between Intuition and Insight.

Market exclusivity for top-selling pharmaceuticals: too long, too short, or just right?

Market share for flavour capsule cigarettes is quickly growing, especially in Latin America.

Letter: Distinction between formalin and formaldehyde.

Distinction between forensic evidence and dermatological findings.

Distinction between hydroxyl radical and ferryl species.

The myth of the distinction between classification and diagnostic criteria.

Neuroimaging distinction between neurological and psychiatric disorders.

Distinction between antinuclear antibody and P-ANCA.

Wavelength Division Multiplexers (WDM) Market Share, Size, Growth, Trends, Industry Analysis and Forecast 2025

On the distinction between psychological and physical stressors.

Fixed-Dose Combination Drug Approvals, Patents and Market Exclusivities Compared to Single Active Ingredient Pharmaceuticals.

The distinction between absence petit mal and psychomotor seizures.

Content consideration in the distinction between assertive and aggressive behavior.

On the Distinction between Analytical and Synthetical Judgments.

Neurobehavioral perspectives on the distinction between fear and anxiety.

Increases in Drug Utilization and Patent Expirations: A Recipe for Growth of Generics' Market Share, despite Stalling on Biosimilars.

Quantifying the relationship between financial news and the stock market.

Acoustic Radiation Force Impulse (ARFI) imaging for the distinction between benign and malignant thyroid nodules.