Lead Opinion
This pharmaceutical product liability action arises from the use of diethylstilbes-trol (DES). The trial court determined that under Missouri law the admitted inability of plaintiffs to identify which, if any, of the defendants made the product that allegedly caused their injuries was fatal to their claims and granted summary judgment for defendant drug manufacturers. The judge filed a memorandum opinion analyzing DES litigation theories to date and suggesting a theory of his own. The Court of Appeals, Eastern District, agreed with the summary judgment and, citing the trial judge’s memorandum, transferred the case to this Court as one of general interest and importance calling for a policy decision and prompting reexamination of existing law. The issue, one of first impression in this state, is whether plaintiffs may recover for injuries allegedly caused by in útero exposure to DES absent proof which identifies the particular manufacturer of the DES taken by their mothers. Affirmed.
DES is a synthetic estrogenic hormone which, along with similar chemical derivatives of stilbene, was first manufactured as a miscarriage preventative in 1947. Comment, Overcoming the Identification Bur
The instant action is one of a number of similar lawsuits filed across the country. Annot.,
Most important to review of this litigation, is plaintiffs’ inability to identify which of the defendants manufactured, sold or distributed the particular products ingested by their mothers. DES was marketed generically by as many as 300 drug companies. The problems linked to its use surface many years following exposure, and neither memories nor records provide assistance in matching a specific dosage with an individual manufacturer. Collins, supra. In their appeal of the summary judgments for defendants, appellants contend, however, that “justice requires” that Missouri law recognize some form of “enterprise” liability against DES manufacturers despite the inability of a plaintiff to identify the manufacturer of the particular drug which caused the individual injury.
Respondents raise various procedural objections to review, asserting that appellants failed to state wherein and why the ruling of the trial court is erroneous. R. 84.04(d). The purpose of the rule is to ensure that opposing counsel and the court receive notice of the issues raised. Thummel v. King,
The affidavits and accompanying materials filed by respondents in support of their motions, not denied by appellants, stand admitted. Cherry v. Hayti Heights,
Appellants sought recovery on theories of breach of implied warranty; negligence per se in failing to comply with the federal drug laws; common law negligence in failing to test, or inadequately testing the product, and in failing to warn of its potential harm; and strict liability in tort, all of which are recognized in Missouri. In addition, the trial court analyzed four theories recognized in DES cases in other jurisdictions but not yet considered by the courts of this state. All were denied by the entry of summary judgment.
Actionable negligence requires a causal connection between the conduct of the defendant and the resulting injury to the plaintiff. Warner v. St. Louis and M.R.R. Co.,
The four theories considered by the trial court, recognized in other jurisdictions and presented by appellants for consideration either relax or dispense with the element of causation.
One, alternative liability, applies when two or more defendants act tortiously toward plaintiff who, through no fault of his own, cannot identify which one of the joined defendants caused the injury. The burden of proof shifts to each defendant to prove his innocence. Restatement (Second) of Torts § 433 B(3) (1965); Summers v. Tice,
The concert of action theory imposes liability upon “all those who, in pursuance of a common plan or design to commit a tor-tious act, actively take part in it, or further it by cooperation or request, or who lend aid or encouragement to the wrongdoer, or ratify and adopt his acts done for their benefit....” Prosser, Law of Torts § 46, at 292 (4th ed. 1971). Restatement (Second) of Torts § 876 (1977). A frequent illustration of the theory is the automobile drag race. The element of agreement or cooperation necessary to application of this theory is lacking in this case. The history of the development and marketing of DES reveals independent, albeit similar, conduct on the part of the drug companies. Ryan, supra, at 1008-1011. The only activity that resembles “concerted action” occurred in 1941 when the FDA required companies interested in manufacturing DES for non-pregnancy related purposes to pool their clinical data in a master file for the agency’s consideration. One of the two courts adopting the concert of action theory in a DES case acknowledged that these activities are distinct from the 1947 application process which preceded FDA approval of the drug to treat accidents of pregnancy. Bichler v. Eli Lilly & Co.,
A third theory proposed as a basis for recovery against defendants here is industry-wide liability. Appellants cite Hall v. E.I. Du Pont de Nemours & Co., Inc.,
The case most often cited in reported opinions on the liability of unidentifiable manufacturers is Sindell, supra. The Sin-dell majority, after considering and rejecting each of the three theories discussed above, adopted an extended version of alternative liability, since denominated “market share liability.” This theory requires that plaintiffs join as defendants a number of DES manufacturers sufficient to constitute a substantial share of the market. The burden then shifts to each defendant to exonerate itself or to join, by third party petition, other drug producers not named by plaintiff. Damages would then be apportioned among the remaining defendants on the basis of the share of the market each held. Comment, DES and a Proposed Theory of Enterprise Liability, 46 Fordham L.Rev. 963 (1978). The prediction of the dissenters in Sindell that few courts
Respondents argue that market share liability is unfair, unworkable, and contrary to Missouri law, as well as unsound public policy. This Court agrees. The California court did not define the relevant market, nor did it specify what constitutes a “substantial” share of the market. Sindell, supra,
The trial judge’s own theory provokes respondents to argue that the theory is not properly the subject of review because not raised by appellants below. The trial court raised the theory sua sponte. It incorporates principles raised in the petitions. Compare Huter v. Birk,
Under the theory suggested by the trial judge, plaintiffs must prove, in addition to the traditional elements of a products liability action, that defendants knew that the product would be sold and used in a manner such that identification with a particular manufacturer would be impossible. If plaintiffs further allege that they are unable, through no fault of their own, to identify the manufacturer, their claims will withstand dismissal. The record before this Court does not support the assumption apparently underlying this theory, that defendant drug manufacturers unwisely accelerated the marketing of their products in generic form so as to render identification impossible.
This Court acknowledges and respects the compelling reasons motivating the trial court and courts of other states to resolve the dilemma presented in these cases by straining existing law or adopting novel theories. Plaintiffs are innocent and claim serious injuries alleged to result from their mothers’ use of DES. Yet simply to state, as have courts ruling in favor of plaintiffs, that as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury, Collins, supra,
Missouri law does not guarantee relief to every deserving plaintiff. O’Neill v. Claypool,
If the injury may have resulted from one of two causes, for one of which, and not the other, the defendant is liable, the plaintiff must show with reasonable certainty that the cause for which the defendant is liable produced the result; and, if the evidence leaves it to conjecture, the plaintiff must fail in his action.
Warner, supra,
Because the theory appellants urge has no support in precedent, the case presents a public policy choice, one with which legislatures, as well as courts, have struggled. Sindell, supra (opinion of Richardson, J., dissenting). Competing with the interests of appellants are legitimate concerns that liability will discourage desired pharmaceutical research and development while add-] ing little incentive to production of safe! products, for all companies face potential] liability regardless of their efforts./ McCreery v. Eli Lilly & Co.,
This Court concludes that the theories advanced by plaintiffs do not persuade the Court to abandon the Missouri tort law which requires that they establish a causal relationship between the defendants and the injury-producing agent as a precondition to maintenance of their causes of action. Strict liability in tort continues to provide a remedy to those plaintiffs who satisfy the identification requirement. Ferrigno, supra (manufacturers identified in three cases); Lyons, supra (manufacturer identified).
Accordingly, the summary judgment for defendants is affirmed.
Dissenting Opinion
dissenting.
I dissent for the reason that I would apply the rule developed in Sindell v. Abbott Laboratories,
The propriety of shifting the burden of proof to defendants on the issue of causation-in-fact is amply demonstrated in Summers v. Tice,
In the present case, as in Sindell, plaintiffs allege that manufacturers of DES tor-tiously exposed the offspring of consumers to serious medical harm. Yet, the nature of the risk combined with the fungible form in which the drug was produced make it impossible to identify the particular manufacturer whose product caused a given injury. It is possible to prove, however, what quantities of the drug were produced and distributed by specific manufacturers in a specific time frame.
The Sindell court concluded that the basic approach taken in Summers v. Tice was
The majority opinion notes the danger that if less than all of the manufacturers whose products may have been purchased by a plaintiff’s mother are named as defendants, the responsible manufacturer may not be held liable and those who are named may pay more than their fair share. Nevertheless, the ability of manufacturers to interplead other manufacturers whose product accounted for a significant portion of the market reduces this risk, although certainly does not eliminate it. The “substantial share of the appropriate market” threshold in Sindell does no more than shift to defendants the hazard that certain manufacturers may be defunct or otherwise not amenable to suit.
Furthermore, it is not clear whether the Sindell court intended to apportion plaintiff’s damages based on a defendant’s share of the market relative to the other named defendants or a defendant’s share of the market relative to all other manufacturers of DES. See Robinson, G., Multiple Causation in Tort Law: Reflections on the DES Cases, 68 Va.L.Rev. 713, 726 (1982). This latter approach would be more consistent with probability and more consistent with a theory of “apportionment of causation” as opposed to apportionment of fault. Id. Such a scaling of liability in accordance with probability would vitiate the danger of proceeding against less than all of the manufacturers who may have manufactured the product which caused the harm and would render the “substantial share” threshold unnecessary.
The majority expresses concern that the Sindell court did not define the “relevant market” concept. It would seem that there are actually two different concepts of “relevant market” applicable to this situation. The first is a component of the threshold requirement that the named defendants together account for a substantial share of the relevant market; i.e., a substantial likelihood that their products were actually purchased and consumed by the DES mother. Since this threshold need not be a stringent one to meet, this likelihood could be demonstrated by fairly general proof regarding defendants’ shares of the total amount of DES marketed. No great degree of specificity should be required of plaintiffs prior to discovery.
The second “relevant market” concept comes into being once plaintiff has survived a motion to dismiss. At that point the precise issue becomes the relative likelihood that the plaintiff’s mother actually purchased the product manufactured by the individual defendant. The relevant market is the area of her residence, her drugstore, her pharmacist. While proof of this issue may be fraught with difficulty, it is a difficulty which is more appropriately born by the manufacturers than by the plaintiffs — a legitimate concept in products liability. Katz v. Slade,
The Sindell approach, applied in the context of modern apportionment of fault and third-party practice, affords a high degree of correlation between the individual manufacturer’s share of the risk and its liability for damages. Quite apart from the evident policy concerns, this correlation (expressed
For the reasons expressed, I would reverse the trial court’s judgment and remand for trial.
