1984 DES Case: Zafft v. Eli Lilly & Co.

” This pharmaceutical product liability action arises from the use of diethylstilbestrol (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 utero exposure to DES absent proof which identifies the particular manufacturer of the DES taken by their mothers. Affirmed.

ZAFFT v. ELI LILLY & CO., Leagle, 1984917676SW2d241_1876, September 11, 1984.

DES is a synthetic estrogenic hormone which, along with similar chemical derivatives of stilbene, was first manufactured as a miscarriage preventative in 1947. DES duplicates the activity of estrogen, a female sex hormone linked to problem pregnancies in the 1930’s. As opposed to the natural estrogen formerly used in the treatment of problem pregnancies, DES was inexpensive and easy to administer, Ferrigno v. Eli Lilly & Co. (1980). From the time the United States Food and Drug Administration approved the drug to 1971, more than 200 drug companies participated in the market, Ryan v. Eli Lilly & Co. (1981). DES continues in use today for non-pregnancy related disorders, Lyons v. Premo Pharmaceutical Laboratories, Inc. (1979). In 1971, researchers reported a statistical link between fetal exposure to DES during pregnancy and the subsequent development of cancer of the reproductive organs in the female offspring. Late that year, the FDA halted use of the drug to prevent miscarriage.

The instant action is one of a number of similar lawsuits filed across the country. Note, Market Share Liability: An Answer to the DES Causation Problem, 94 Harv.L. Rev. 668 (1981). Plaintiffs here filed two separate actions for actual and punitive damages against thirteen manufacturers and distributors of DES for use in the prevention of miscarriage. Plaintiffs allege that these defendants represent all or substantially all of the known manufacturers, sellers, or distributors of stilbene derivatives in Missouri at the relevant time. Plaintiffs further allege that their mothers, while pregnant with plaintiffs, ingested DES manufactured, sold or distributed by one of the named defendants. Plaintiffs claim that the cancerous or pre-cancerous conditions from which they suffer are a direct result of their exposure in utero to DES. Plaintiffs charge that defendants represented the drug as safe while they knew or should have known of its potential carcinogenic effects, and engaged in common marketing practices of generic distribution of DES without adequate warning or testing.

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. …

… GUNN, Judge, 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 (1948), referred to in the majority opinion. The conduct of the two hunters who tortiously exposed plaintiff to injury also made it impossible for plaintiff to identify the particular hunter whose conduct had injured him. Nor was it likely that either hunter could have proven that he did not cause the plaintiff’s injury. Nevertheless, the burden to disprove causation was placed upon defendant hunters who, if the burden was not met, remained jointly and severally liable for the whole of plaintiff’s damages.

In the present case, as in Sindell, plaintiffs allege that manufacturers of DES tortiously 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 applicable to the DES milieu, although not without some alteration. Plaintiffs were permitted to shift the burden of proof only upon a showing tht the particular defendants joined in the action together accounted for a substantial portion of all the products which could have actually caused the injury. Defendants who could not prove that their product did not cause the damage would nevertheless be responsible only for that portion of plaintiff’s damages corresponding to the relative likelihood that plaintiff’s mother purchased their product as opposed to a product manufactured by any one of the other defendants. By adapting the Summers v. Tice approach to suit the particular context, the Sindell court produced a cogent and fair setting in which DES litigation could proceed.

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. In either sense of the term, the “relevant market” is defined by the DES mother herself, the only real distinction being the means of proof used to describe that market.

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 in terms of probability) provides the justification for the presumption embodied in the shifting burden of proof. ” …

… read the full paper ZAFFT v. ELI LILLY & CO. on Leagle.

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