Sindell v. Abbott Labs: a Market Share Approach to DES Causation

In Sindell v. Abbott Laboratories, the California Supreme Court allowed a cause of action against a group of manufacturers of the drug diethylstilbestrol (DES) even though the plaintiff was unable to identify which manufacturer had supplied the drugs that plaintiff’s mother had taken to prevent a miscarriage. The decision is an attempt by the court to provide victims of latent product defects a means of recovery where they would otherwise be unable to establish causation because of prolonged delay in injury manifestation. In doing so, Sindell departs from traditional common law recovery requirements and raises numerous problems in its application.

Part I of this Note briefly describes the case. Part II discusses existing tort theories which the Sindell court could have adopted to allow a cause of action for DES induced injuries and explains why these theories were not suitable. Part III analyzes the market share cause of action created by the court, examining problems in defining the essential requirements of the theory and potentially faulty factual assumptions upon which the action is based. Part IV examines the market share action from a broader perspective and considers its impact on conflicting social policies that the court failed to expressly consider. It concludes that Sindell’s market share approach to liability may produce significant undesirable social costs.


Sindell v. Abbott Laboratories: A Market Share Approach to DES Causation, California Law Review, Volume 69 | Issue 4 Article 12, July 1981.

Plaintiff Judith Sindell brought a class action suit against eleven drug manufacturers for personal injuries sustained as a result of prenatal exposure to DES marketed by the defendants. The complaint alleged that the manufacturers had negligently manufactured, marketed, and promoted DES as a safe drug without adequate testing or monitoring and that they had collaborated in marketing DES, relied upon each other’s tests, and adhered to an industrywide safety standard. Additionally, the complaint predicated liability on theories of strict liability, violation of express and implied warranties, fraud, misbranding, conspiracy, and lack of consent. The trial court sustained the defendants’ demurrers and dismissed the action on the basis that the plaintiff could not identify which DES manufacturer had produced the drug to which she had been exposed.

The supreme court reversed the trial court’s dismissal of plaintiff’s action. Justice Mosk, writing for the majority, announced a new cause of action which dispensed with any requirement that plaintiff identify the particular manufacturer that supplied DES to plaintiff’s mother. Rather, each defendant would be liable for the portion of plaintiff’s damages equal to that defendant’s percentage share of the DES market. The court reasoned that when the producers of a substantial share of the market are joined as defendants in all such cases, each defendant’s total liability will be roughly equal to what would be the case if perfect identification were possible in all cases.

In reaching the conclusion that a new approach was necessary, the court examined three other possible theories of liability: “alternative liability” based on Summers v. Tice, “concert of action” liability, and “enterprise liability” based on Hall v. E.Z Du Pont de Nemours & Co. Although the court drew inspiration in part from all three theories, which shared an underlying policy goal of protecting plaintiffs in the face of unidentifiable tortfeasors, and described the market share approach as a modification of the rule of Summers, it concluded that none of them alone was adequate for a fair judicial treatment of the DES problem.


One of the basic rules of American tort law is that a plaintiff cannot recover absent a showing that injury resulted from some act or omission of the defendant. 6 Over the years,, however, courts have recognized the potential inequity in leaving a plaintiff uncompensated simply because fortuitous circumstances render identification of the tortfeasor impossible. As a result, a number of exceptions have emerged.

Alternative Liability

In the landmark case of Summers v. Tice, the California Supreme Court established the principle of alternative liability. Summers was injured when two hunters negligently shot in his direction. Although it was impossible to determine whose shot actually caused the injury, the court held both defendants jointly and severally liable for all the damages. The court observed that if Summers were required to establish identity, both defendants would likely escape liability since it was equally probable that either one was responsible. In order to put the loss on the culpable shooters rather than on the innocent plaintiff, the court shifted the burden of proof of identifying the wrongdoer to the defendants, “each to absolve himself if he can.

The Sindell court held, however, that liability could not properly be imposed in the DES context solely on the basis of Summers. Unlike Summers, the Sindell defendants come from a large ill-defined class of as many as two hundred companies which produced DES for a variety of uses under at least seventy different trade names. If the probability that any one of the defendants supplied the injury-causing drug is measured by taking the reciprocal of the number of possible tortfeasors, then the possibility that the actual supplier of DES to Sindell’s mother was before the court is quite small. The court concluded that it would be unfair to require each defendant to exonerate itself when there was a substantial likelihood that none of the defendants joined in the action actually made the DES that caused the injury. The court asserted that there was “no rational basis on which to infer” that any of the manufacturer-defendants supplied the drug to plaintiff’s mother. Yet if the plaintiff actually joined producers of more than ninety percent of the DES market as she alleged, then there was a ninety percent chance that one of the defendants was the actual supplier. In this instance, the court’s rejection of alternative liability based on the great number of DES manufacturers is not convincing.

There is, however, another reason for avoiding a blind acceptance of alternative liability for DES litigation. Summers imposed joint and several liability, holding each of the hunters liable for the full amount of damages, since the two were equally likely to have caused the injury. In a DES case there are often many defendants who supplied widely varying amounts of the drug. To treat large and small producers as equal contributors to the harm suffered by plaintiff seems manifestly unfair.

Concert of Action

A second theory advanced by Sindell and by other DES plaintiffs is known as concert of action. The classic concert of action case is the illegal drag race in which a bystander is injured by one of the participants. The person may sue any or all of the participants and they are jointly and severally liable for her injuries. All the plaintiff need allege is that each defendant acted pursuant to a common design or gave substantial assistance or encouragement to an actor whose conduct caused the harm. An express agreement is not necessary; a tacit understanding will suffice, and this may be shown by the parallel actions of the defendants.

Although concert of action is not expressly designed to eliminate the identification problem, it can apply to situations in which the immediate injury-causing agent is unknown. If the tortious event is the group activity itself, then any participant will be liable regardless of whether plaintiff can point to the immediate wrongdoer. For example, if plaintiff is not sure which driver in the illegal drag race caused the injury, she may still proceed to sue some or all of the participants. The action, however, is limited by the requirement of showing some sort of understanding by which all the defendants are implicated in the tortious act.

The Sindell court rejected the use of a concert of action theory to impose liability. While the court recognized considerable parallel acts among industry members, it held that application of concerted action to the DES context would represent too great an expansion in the doctrine. Some of the parallel acts among industry members were dictated by Food and Drug Administration (FDA) regulations. The court refused to imply a tacit understanding from the defendants’ compliance with federal regulations controlling the manufacture of DES or from conformity to industry marketing practices. Moreover, there was no basis for finding that each defendant knew other defendants were acting tortiously toward the plaintiff, nor that they assisted or encouraged one another to inadequately test DES.

Enterprise Liability

The federal district court case of Hall v. E.1 du Pont de Nemours & Co. is the basis of a third theory called enterprise liability. Thirteen children injured by exploding blasting caps in separate accidents brought suit against six blasting cap manufacturers and their trade association. The evidence showed that the defendants, constituting virtually the entire industry, had adhered to an industrywide safety standard, had delegated safety design and investigation to the association, and had cooperated on an industrywide basis in the design and manufacture of blasting caps. These facts showed that the defendants contributed to the risks in a manner akin to concerted action. Therefore, if the plaintiffs could establish that the caps were produced by any of the defendants, then the burden of proof to identify which defendant caused the injury would shift to the defendants.

The supreme court rejected the enterprise liability theory suggested by Hall. That case had specifically recognized that its holding should be limited to an industry comprising only a small number of units, all or most of which were joined in the suit. In Sindell, the court was faced with approximately two hundred manufacturers of DES, of whom only eleven were joined, in contrast with the six blasting cap defendants who made up nearly the entire industry in Hall. Moreover, the defendants in Hall had delegated safety standards to their trade association whereas the DES manufacturers had not. The Sindell court also observed that the federal government plays a pervasive role in formulating criteria for the testing and marketing of new drugs, and that it would be unfair to impose liability on a manufacturer who did not supply the drug to plaintiff simply because it had followed FDA standards. But while this unfairness was sufficient to prevent the application of enterprise liability theory, the court noted that adherence to those FDA standards would not absolve a manufacturer of any liability to which it would otherwise be subject.


The Theory

Having concluded that existing tort mechanisms were not suited to providing recovery in the DES context, the Sindell court fashioned a new theory to allow DES daughters a cause of action for their injuries. Stressing the gravity of the injury and the ability of the common law to adapt to the changing structure of society, the court pointed to several broad policy arguments favoring imposition of liability. Assuming for purposes of appeal that all DES defendants were negligent, the court adopted the Summers rationale that as between culpable defendants and an innocent plaintiff, defendants should bear the loss caused by their own conduct. Furthermore, defendant manufacturers were better able to guard against defects, to warn the public of side effects, and to insure against losses resulting from introducing defective products into the stream of commerce. The court believed that this was particularly true with respect to drugs since the consumer is virtually incapable of recognizing and protecting against any defects. Additionally, although less clearly articulated, the court felt that the mere fortuity that a defect does not manifest itself for a prolonged period, thus making it difficult or impossible for plaintiffs to identify the supplier, was not a principled reason for shielding the defendant from liability.

Under the new theory each manufacturer is liable for a percentage of plaintiff’s damages based on its market share of the DES production used for prevention of miscarriages. To take advantage of this new approach to causation, plaintiff must join the producers of a substantial share of the DES market. If the defective drug caused plaintiffs injuries and if all defendants produced the drug from an identical formula, then plaintiffs suit will not be barred for failure to identify the particular manufacturer of DES in her case. A manufacturer can escape liability, however, by demonstrating that it could not have made the product that caused plaintiffs injuries.

The court argued that market share liability would produce the same result as would occur if every DES plaintiff could identify a particular manufacturer. In a world of perfect identification, a producer of twenty percent of DES sold would be a sole defendant in approximately twenty percent of all cases. Under the market share approach, the same supplier would now be a defendant in all DES cases but would be liable only for twenty percent of the damages. The process of matching percentages serves as a fairness justification for the decision because liability is limited to what would hypothetically occur if identification were possible. Total costs, including all administrative costs, under Sindell could potentially be much greater than costs in identification suits, because each manufacturer will be a party to more suits under the market share approach than in a perfect identification world. The court, however, focused only on matching liabilities, rather than total costs, and concluded that although in practice the correlation would not be perfect because market shares were probably impossible to determine exactly, any variation was within the limits commonly tolerated by the law.

Although the Sindell approach has superficial appeal, it leaves many unresolved questions. The court ignored the extreme practical difficulties in actually defining market shares empirically by dismissing them as “largely matters of proof.” In making joinder of a substantial share of the market a condition of bringing suit, the court provided little guidance for determining when the requirement would be met. The extent of liability under the market share theory is equally unclear: the joined defendants may be liable for one hundred percent of plaintiff s damages or merely for the aggregate amount of their respective market shares.

How is a Market Share Defined?

In order to calculate market shares, the scope of the market itself must be defined in terms of the time period, the geographical area covered, and the range of identifiable product forms included. The only market factor mentioned by the court was time-if a manufacturer could prove that it did not sell DES during the period of time that plaintiff’s mother purchased the drug, then that manufacturer could be dismissed from the suit. The reason for considering this factor is that market share is used as a theoretical proxy for the likelihood that a defendant supplied the product which allegedly injured plaintiff.

A similar analysis can be made with respect to geographical area. Theoretically, each DES plaintiff should sue only those producers who supplied the drug to an area in which plaintiff’s mother lived when plaintiff was in utero. Whether the appropriate area is local, state, regional, or national in scope depends on the structure of the DES market and the methods of distribution of DES. For producers who supplied only limited areas, a decision as to relevant market size will determine who is a proper defendant in many cases. For example, a supplier only to Detroit would not be liable to any plaintiffs exposed outside of the Detroit area. However, such a producer would have large liability for suits brought by plaintiffs exposed to DES in Detroit.

Use of a nationwide market has several advantages over other market sizes. First, calculation of market shares will be less complicated for a national market than for a state or local market because geographical data is very scarce . Second, national shares will be less likely to generate inconsistent case by case determinations of the relevant market size and the associated percentage breakdown of damages. Third, the DES market is dominated by a few very large producers who sold DES throughout the country-it has been suggested that five or six suppliers made ninety percent of the total DES production. Thus, percentage market shares for the industry leaders may not vary greatly with respect to market size.

However, when small local producers are included, the national market approach may result in unfair distributions of damages. Suppose defendant D is a small local producer of DES who supplied sixty percent of the Detroit market and that the national giants furnished the remaining forty percent. If plaintiff uses national shares, the D’s maximum liability will be very small because the sixty percent share of the Detroit market will be a very small share of the national market. At the same time, the large companies will pay the bulk of the damages even though the odds are low that plaintiff’s mother used their products in Detroit. The goal of having market share liability mimic what would occur in the hypothetical world of perfect identification suggests that the Detroit case be resolved on a Detroit area market.

A California resident who was exposed to DES in Detroit, however, may not be able to obtain jurisdiction over the Detroit-only supplier. By failing to join a sixty percent supplier in her California suit, plaintiff will not meet the requirement that she sue makers of a substantial share of the relevant market. Even if she could proceed, she would only get forty percent of her damages if each company is only liable for its relevant market share percentage of the award. If the joined defendants are forced to pay all of the damages, however, they will not be able to compel contribution by supplier D in Detroit unless Michigan also recognizes the market share theory of liability; having failed to get contribution from defendant D, the suppliers of forty percent of the Detroit market would pay much more than their share of liability.

There is nothing in Sindell, however, that requires courts to follow any specific definition of market size. Each court can define the scope of the market to fit the needs of a particular case. A court could start with a national market and put the burden on each defendant to show that it could not have made the DES which injured the plaintiff. A local supplier would be dismissed from cases if it could show that none of its product reached outlets in the area in which the plaintiff’s mother lived.6 The hypothetical plaintiff from Detroit may recover much less than her entire damages under this approach if she cannot obtain jurisdiction over the local supplier, but this will occur only if the large companies can succeed in proving the domination by a local producer. This is hightly unlikely because of the strong market position held by the leading drug companies.

Another potential market factor is the identifiable physical characteristics of the product. Plaintiffs mother may be able to remember taking a pill of a certain size, shape, or color. Where this is true the relevant submarket could be defined to include only those manufacturers who produced pills with that particular physical characteristic. Use of such submarkets, however, will cause defendant manufacturers of pills with unique and memorable physical characteristics to be sued more often than other producers. They will be liable for one hundred percent of plaintiffs damages in all cases where the feature is remembered, and also for their market share in cases where no identifying features are recalled. Thus, the goal of matching actual liability with the results expected in a world of perfect identification will not be met if suits based on special submarkets are permitted.

The same possibility of double exposure exists when some plaintiffs can identify the manufacturer of DES that supplied the drug to their mothers. If identification results from one supplier having more detailed records or having used a more direct distribution system to pharmacies, then that supplier will be a defendant more often, assuming that both market share and traditional theories of liability coexist. Only if identification suits are randomly distributed over all manufacturers will the distortion not occur. Because it is likely that identification will be predicated on market behavior unique to specific producers, the existence of both market share suits and traditional suits poses the threat of double liability for some defendants.

There are two ways to avoid this double liability. The first is by adjusting damages among producers after all suits have reached final resolution-a complicated and unlikely event since no court would have authority to make post hoe readjustments of liability. The other solution is to use market share apportionment exclusively and therefore preclude DES suits tied to identification of product characteristics. Even plaintiffs who could identify a particular manufacturer as sole defendant would be forced to rely on the market share approach otherwise a few easily identifiable producers will pay more than their share. Precluding suits based on traditional theories, however, creates several problems. Plaintiffs who fail to obtain jurisdiction over a substantial share of the relevant market may go remediless even though they can identify and obtain jurisdiction over the specific DES producer that supplied the drug. Any other reason for a court’s dismissal of a market share based action will result in the same unfairness to all plaintiffs who could have proceeded on traditional theories of liability.

The Sindell decision does not hold, however, that market share liability is the exclusive remedy for DES plaintiffs. It allows the new approach where defendants “produced a drug from an identical formula and the manufacturer of the DES which caused plaintiff’s injuries cannot be identified.” Where identification is possible the plaintiff may proceed against the identified producer. The tone of the decision suggests that the court would be more willing to tolerate the possibility of imposing excess liability on some suppliers than to deny plaintiffs a cause of action. Furthermore, in breaking new ground in tort causes of action the court should be reluctant to preclude old approaches without more information about whether there will be any significant overlap of market share suits and identification suits.

The Measure of Damages

The court did not clearly specify how each defendant manufacturer’s damages would be measured. One possible approach would make each defendant jointly and severally liable for all of plaintiffs damages. Thus a plaintiff would be compensated for all her injuries regardless of how many manufacturers are joined as defendants because plaintiff could collect her entire judgment from any defendant. A second approach would impose liability solely on the basis of each defendant’s share of the DES market. This pro rata distribution of liability has two consequences:

  1. a plaintiff will recover only that percentage of her total damages which is equal to the sum of the market shares of the defendants joined in her suit,
  2. and a plaintiff will bear the risk of a defendant’s insolvency because other defendants will not be forced to pay more than their respective market share percentages of damages.

For example, if a plaintiff joined eighty percent of the market and one defendant with a ten percent market share was insolvent, plaintiff’s recovery would be seventy percent of her total damages. In contrast, the joint and several approach would yield a recovery of one hundred percent of the damages, which could be collected from any of the remaining solvent defendants. Although there is language in the Sindell opinion supporting both approaches to liability, this Note concludes that pro rata liability is more consistent with the logic underlying the market share cause of action than is joint and several liability.

There are several indications in the opinion that the court would impose joint and several liability on DES suppliers.

  1. First, the Sindell pleadings allege that defendants are jointly and severally liable under each of the several theories offered in the complaint. Since the majority does not unambiguously delete this feature from its new theory, one might infer that joint and several liability is required by the decision.
  2. Second, the dissent draws that inference; presumably the majority would have forthrightly dispelled this implication if it were not true.
  3. Third, the Sindell decision is based on an expansion of Summers v. Tice, which imposed joint and several liability on the defendant hunters.

The court’s reference to the availability of third party impleader also implies that joint and several liability was intended. If each defendant can be held liable for plaintiff’s total damages, or some variable portion thereof, then defendants will have a strong incentive to join other producers to share the liability. On the other hand, if each defendant is liable only to the extent of its market share percentage of the damages, then it will have little incentive to join other producers since its dollar amount of liability will be the same regardless of the number of defendants.

Moreover, joint and several liability is consistent with the substantial share joinder requirement. The rule that plaintiff must sue producers of a substantial share of the DES market avoids the possibility that a lone defendant might shoulder an entire judgment for lack of success in obtaining contribution from other producers. Both third party impleader and the joinder requirement serve to spread liability among as many defendants as are solvent and amenable to jurisdiction in California.

In describing the market share cause of action, however, the court several times said that damages were to be apportioned in relation to their market share. In answer to the Sindell defendants’ arguments contesting the fairness of the decision to impose liability, Justice Mosk stated:

Most of their arguments, .. are based upon the assumption that one manufacturer would be held responsible for the products of another or for those of all other manufacturers if plaintiff ultimately prevails. But under the rule we adopt, each manufacturer’s liability for an injury would be approximately equivalent to the damages caused by the DES it manufactured.

Since the measure of each defendant’s liability would be its percentage market share of plaintiffs damages and since no defendant is to be responsible for another producer’s product, the Sindell decision requires that market share function as an absolute limit to each defendant’s liability. In contrast, joint and several liability could result in some defendants paying a greater percentage than their market share would dictate. Therefore, the most direct language in the decision concerning liability points to the pro rata market share approach as the appropriate measure of each defendant’s share of the successful plaintiff’s damage recovery.

Moreover, pro rata market share liability is more consistent with the goal of the Sindell decision to reproduce what would occur if identification were possible in all cases. The producer of twenty percent of the market held liable for twenty percent of the damages in all DES suits should pay the same amount as would be paid if twenty percent of plaintiffs could identify that same supplier and recover one hundred percent of their damages. To hold that same supplier jointly and severally liable for one hundred percent of the damages in one hundred percent of all DES suits could increase liability above the total amount that would be imposed in the hypothetical world of perfect identification. Although joint and several liability could generate a result similar to pro rata market share liability when all defendants are solvent and before the court, the court should have held that each supplier’s maximum liability is fixed by its market share in order to ensure that no producers incur excess liability.

The rejection of joint and several liability requires that the court’s remarks about third party crossclaims be re-evaluated. If each defendant is liable only for its market share percentage, then defendants will have little incentive to join other producers except in the rare case in which a defendant will be able to prove that another producer in fact supplied a plaintiffs mother with DES. Thus, third party complaints seeking indemnification are not essential for the Sindell theory. However, since the court very much wanted to ensure that as many DES suppliers as possible would be defendants, its mention of crosscomplaints against additional producers probably reflected the goal of holding the entire industry liable for DES injuries. That goal is more directly served by the substantial share joinder requirement.

The Substantial Share Requirement

Under Sindell, plaintiffs must sue manufacturers of a substantial share of the DES market in order to state a cause of action. The court declined to give a numerical definition to “substantial,” despite the dissent’s criticism that lack of a precise definition left the issue openended. Perhaps the court simply wished to avoid making the new approach too inflexible by specifying a fixed percentage. A more critical issue is why the court imposed the requirement at all.

The court mentioned several reasons for the substantial joinder requirement. First, it noted that joining producers of a large aggregate market share would reduce the likelihood that “the offending producer would escape liability.” This argument reflects the court’s desire to keep the Sindell theory similar to older, well-established notions about tort liability. In Summers v. Tice, for example, the court knew that one of the two hunters fired the shot that hurt the plaintiffs and hence the actual offender would not escape liability.

The court’s second reason for the joinder requirement is that it diminishes the “injustice of shifting the burden of proof to defendants.” Having the major producers in court will facilitate the determination of the dimensions of the relevant market. The greater availability of market information in court will presumably yield a more thorough and accurate picture of DES distribution. The composition of the relevant market may thus indicate which defendants were less likely to have caused the plaintiffs injuries. If a supplier can prove that it did not sell any DES within the relevant market, then it will not be held liable. Furthermore, if a supplier can prove that another defendant in fact made the DES which injured the plaintiff, it will again be relieved of any liability. Thus, the presence of many manufacturers in court will give each one a better opportunity to show that it did not supply the drug to the plaintiff’s mother.

Third, the court argued that the presence of a substantial share of the market “provides a ready means to apportion damages among the defendants.” Although the court again did not elaborate on its underlying reasoning on this point, the argument suggests that having the main suppliers together will simplify the calculation of the market shares that form the basis for each defendant’s liability and will avoid inconsistent determinations which could result from separate actions. Furthermore, dividing the damages in one action will involve lower costs for the parties and the courts than would occur if each producer were sued in a separate case.

The substantial joinder requirement serves other functions which the court did not discuss. It will prevent plaintiffs from forcing settlements against companies with high name recognition, yet small DES production. Because such a company produces very little DES, its market share and hence its ultimate liability would be small, but its litigation expenses as the sole defendant would be substantial. Plaintiffs might be able to force settlements on these defendants if there were no joinder requirement. The potential for forced settlements is much less when there are many defendants because small market share producers can expect the major suppliers to handle much of the defense.

The requirement also serves as a substitute for the element of causation which the plaintiff must show in traditional tort actions. The court has excused DES plaintiffs from identifying the particular supplier whose drug caused her injury, and in effect has apportioned responsibility for all DES injuries to all suppliers. Thus the joinder rule ensures that most of the causal elements are accounted for in court.

Analogizing substantial share joinder to causation raises the issue of how much the plaintiff must prove to satisfy her burden of proof. In order to show that she has joined a substantial share of the market, plaintiff will have to produce some evidence concerning DES production at the time her mother took the drug. If the showing of substantial market share requires plaintiffs to identify approximate market shares for each defendant, Sindell actions may be extremely difficult to maintain. At this time the data is extremely scarce and defendants are likely to be the only ones possessing production and sales figures. Plaintiffs therefore will have to conduct extensive and costly discovery, and if market share data is wholly nonexistent, plaintiffs’ causes of action would be precluded.

The court did not explore how accurate the market share apportionment must be for plaintiffs to recover under this theory. It did say that “the difficulty of apportioning damages among the defendant producers in exact relation to their market share does not seriously militate against the rule we adopt.” Further, it noted that where the data is scarce the jury is to divide the liability “the best it can.” Although these statements indicate that the court will not insist on precise accuracy in determining market shares, the plaintiff must still provide some reasonably good figures on DES production and its ultimate uses in order for the trier of fact to make an estimate. Furthermore, because the logic of the decision depends on market share liability reproducing what would occur in a world of perfect identification, a minimum standard of accuracy is necessary for this goal to be achieved. Otherwise, liability will be arbitrarily divided among defendants and there will be no correlation with what would happen if producers could be identified.


The thrust of the analysis in Part III has focused on the court’s failure to define the central elements of market share, substantial share, and the nature of liability and has noted the dependence of the approach on the existence of adequate market data and of the availability of sufficient insurance coverage. This Note has suggested solutions to some of these issues with respect to the DES problem. If the decision is subsequently applied to defective products in other industries in which, unlike the drug industry, market control is not centralized in a few large firms subject to nationwide jurisdiction, precise definition of market share and substantial share will become crucial to the decision’s fairness. Whether market share liability should be applied in other contexts, therefore, cannot be answered solely on the basis of whether the theory operates fairly in the DES context. Before applying Sindell to other industries, this Note cautions that the market structure of those industries must be evaluated to determine if special obstacles to fairness might exist.

Sindell’s potentially enormous reach may both inspire positive developments in the product safety area and pose significant social policy problems that the court might not have considered carefully. On the one hand, the decision promotes several broad policies underlying all of tort law. It will result in loss spreading by imposing liability on companies that can insure against such losses and that can pass along losses to those who use the product by increasing prices. In addition, the decision will encourage investment by manufacturers in product safety. Finally, the decision marks a commendable attempt at prohibiting fortuitous circumstances from shielding a negligent defendant from liability which in fairness it should bear.

On the other hand, however, Sindell’s impact on the drug industry and specifically on consumers of pharmaceutical products may not be consistent with other competing social policies. Sindell may have two types of impact on the drug industry and consumers. First, and most importantly, imposing liability for DES injuries nearly a decade after the FDA banned use of DES as a miscarriage preventive will require drug companies to spread their losses over other product lines. This means that drug prices in general will rise, including those for safe, beneficial drugs. Moreover, since part of this increase will result from increased insurance costs, and since insurance rates are set on a nation-wide basis, drug prices will be adversely affected throughout the country. Sindell therefore will conflict with the social policy of minimizing increases in health care costs, especially if market share liability results in higher administrative costs than would traditional forms of recovery in a world of perfect identification.

Not only might drug prices in general rise, but actual consumption may be curtailed as consumers respond to price increases by purchasing less. This price response of consumers is one of the justifications for imposing liability on producers because use of dangerous products is discouraged. Price increases, however, cannot be confined to DES because it is no longer used as a miscarriage preventive. To the extent manufacturers spread DES liability costs to other drugs, consumption in general may be discouraged. Sindell therefore may have a socially undesirable effect on consumption of safe, beneficial pharmaceuticals which by definition are socially useful.

The second adverse impact Sindell may have is to deter the rapid development and marketing of new drugs. The decision will encourage longer periods of testing than was customary when DES was first marketed because manufacturers will have more economic incentives to eliminate unsafe drugs. Longer testing, however, is not beneficial in and of itself. The cost from delay in marketing due to extra testing, in terms of continued suffering and lives lost, must be weighed against the likelihood that adverse side effects of the drug will be discovered through longer testing. A negligence standard theoretically forces manufacturers to strike the proper balance. Sindell, therefore, to the extent it simply avoids the identification problem and imposes liability for negligent behavior should encourage striking the proper balance. The problem that Sindell poses, however, is that manufacturers may tend to overvalue liability risks and engage in excessive testing if market share liability results in greater liability than what liability would be if perfect identification were possible. As the Sindell court itself recognized, long run matching will not be perfect. How imperfect it will be depends upon a number of factors, including whether joint and several liability is imposed and how the industry market is actually found to be structured within an area. Under the best possible scenario long run matching may be quite good. However, one may also envision scenarios in which lower court interpretations of the ambiguities left by Sindell, in combination with real world facts different from those assumed by the Sindell court, create major distortions in matching.

This problem of overtesting may be avoided by the incentive Sindell supplies for manufacturers to keep better records and thus avoid market share liability altogether. Whether this actually happens, however, will depend on whether it costs more to test than it does to keep records. Large producers may have to keep extremely detailed records if they are to escape market share liability. This is because small producers may have an incentive to not keep any records or differentiate their product in any way from those of large producers, in the hope that in market share actions they would not even be sued since their small market share would not make joining them worthwhile. Keeping detailed records, however, may be both complicated and exceedingly costly given the present structure of the drug distribution system with its thousands of physicians, pharmacies, and middlemen. This could be especially true with respect to nonprescription drugs since there is presently no control over who purchases them. However, since nonprescription drugs tend to have less medical value, marketing delay due to prolonged testing may not be particularly socially detrimental. With respect to prescription drugs, though, Sindell may result in an undesirable deterrent to marketing and development.


The Sindell case constitutes a major development in tort law. To the extent its market share approach to liability results in manufacturers bearing the cost of their negligent conduct, the decision should be applauded. At present, however, it is difficult to determine what the outcome will be. Unless market shares are properly defined and reliable market share data found to exist, the decision could result in wholly arbitrary assignment of liability. Moreover, there appears to be a basic conflict, which is not likely to be resolved, between liability based on market share, and traditional identification liability. Furthermore, unless damages are measured on the basis of pro rata liability rather than joint and several, serious distortions in long run matching between market share liability and what liability would be in a world of perfect identifiation may result. Since the existence of long run matching goes to the very heart of the decision’s fairness, proper resolution of the measure of damages issue is extremely important.

Depending on how these questions are resolved, Sindell may prove to have serious negative effects both on consumption of safe, beneficial pharmaceuticals and on the lag time between such medications’ development and ultimate marketing. The Sindell decision, therefore, while potentially a vital and commendable step forward in the protection of consumer interests, could conceivably prove under a “worst case” scenario to be a nightmare for both consumers and the pharmaceutical industry. At the very least, the California Supreme Court should hasten to explicate the difficult issues surrounding practical application of market share liability.

Richard P. Murray, 1981

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More DES DiEthylStilbestrol Resources

DES and Emotional Distress: Payton v. Abbott Labs

In Payton v. Abbott Labs, the Massachusetts Supreme Judicial Court held that no cause of action exists for negligently inflicted emotional distress absent physical harm. The author analyzes Payton in relation to the historical development of mental and emotional distress in the law of torts. The author argues that the physical harm requirement is arbitrary and unreasonable and that it often precludes the litigation of serious claims.

If the plaintiff is to recover every time that her feelings are hurt, we should all be in court twice a week.”


DES and Emotional Distress: Payton v. Abbott Labs, University of Miami Law Review, 11-1-1982.

Diethylstilbestrol (DES) first appeared on the market as a miscarriage preventative in 1947, and until 1971, physicians commonly prescribed the drug for millions of pregnant women. In 1971, medical studies identified DES as a possible cause of clearcell adenocarcinoma, a fast spreading and often fatal form of cancer. This disease has attacked the reproductive organs of many women whose mothers ingested DES. Research also linked DES to adenosis, abnormal vaginal and cervical growths commonly found in DES daughters.

Many women exposed to DES before birth have filed suits against the drug companies that produced the synthetic hormone. Those plaintiffs sought recovery for abnormalities of their reproductive organs or clear-cell adenocarcinoma – physical conditions which the plaintiffs alleged were the result of their mothers’ ingestion of DES. Brenda Payton, representing a class of approximately 4,000 women, claimed no physical harm as a result of her exposure to DES but alleged that she is “anxious and emotionally upset” over the possibility of developing clear-cell adenocarcinoma in the future. She brought suit in federal district court in Massachusetts against Abbott Labs and five other DES manufacturers. The district court, finding no controlling precedent, certified four questions of law to the Massachusetts Supreme Judicial Court. The first question posed’ was whether Massachusetts recognized a right of action for negligently inflicted emotional distress absent any evidence of physical harm. The supreme judicial court responded in the negative, holding that even when emotional distress results from an increased statistical likelihood of contracting serious disease in the future, no cause of action in negligence exists absent any evidence of physical harm.

Payton dealt with an issue that has troubled the judiciary for many years: how to deal with claims for damages for emotional distress. The courts have recognized that mental or emotional distress can be both real and serious in some instances, while trivial, evanescent, feigned, or imagined in others. The various methods of treating these claims represent judicial attempts to separate genuine claims from those that are fictitious.


The impact rule was the first attempt at making the desired distinction. Under this rule, there could be no recovery for negligently inflicted emotional distress unless a qualifying physical injury or physical impact accompanied the distress.

The leading cases on the impact rule demonstrate its mechanical nature. For example, in Spade v. Lynn & Boston Railroad Co. a train conductor threatened to throw a drunken passenger off a crowded commuter car. Even though the plaintiff, after watching the fight, suffered serious bodily harm as a result of her nervous shock, the court refused to grant recovery without a contemporaneously inflicted “injury to the person from without.” An equally harsh result was reached in Mitchell v. Rochester Railway. There, the plaintiff was waiting to board the defendant’s horsedrawn trolley. As the trolley approached, the driver negligently turned so close to the plaintiff that she was trapped between the horses’ heads when the team stopped. Although she was not touched, the plaintiff was so frightened that she fainted and suffered a miscarriage. The court denied relief.

To overcome the harsh results of cases such as Spade and Mitchell, the courts were sometimes willing to stretch the boundaries of the term “impact” to include even the most trivial forms of contact. In Zelinski v. Chimics the plaintiff was involved in a minor automobile accident. Although there was no bodily harm, the court held that the “jostling” of the plaintiff in the automobile was a “physical impact” and allowed recovery for the emotional distress. Similarly, in Kenney v. Wong Len the plaintiff, a customer at defendant’s restaurant, ate some roast chicken dressing that contained a dead mouse. Discovery of the mouse made the plaintiff ill and a nervous shock resulted. The court granted recovery; a mouse hair had touched the roof of the plaintiff’s mouth.

Decisions under the impact rule were arbitrary and produced harsh and often anomalous results. While courts sometimes granted an overly generous award based on the most trivial contact, serious emotional distress and the resulting physical harm frequently went uncompensated because the negligent act that caused the emotional distress failed to produce any impact. For example, in Bosley v. Andrews2′ the plaintiff became physically incapacitated after her neighbor’s 1500-pound Hereford bull chased her around her yard. Fortunately, she was saved from a leadenfooted toreador’s end when her dog diverted the bull. Nevertheless, the plaintiff was terrified and collapsed, suffering a heart attack. The court refused to grant relief since there was no physical contact. Similarly, in Sullivan v. H.P. Hood & Sons, Inc. the court denied recovery for severe emotional shock suffered after drinking milk from a container in which the plaintiff discovered a dead mouse. The court reasoned that the plaintiff was not harmed physically by ingesting the milk containing the “fecal matter of the mouse;” she was harmed solely as a result of her mental disturbance at seeing the mouse in her milk. Although the plaintiff’s mental distress was arguably real and serious, this court, unlike the court in Kenney v. Wong Len, did not strain to find impact.

Inconsistent results such as Sullivan and Kenney led to general dissatisfaction with the impact rule. Even courts that had staunchly supported the impact rule eventually abandoned it. Today, only Florida maintains a tenuous hold on this outdated doctrine. In place of the impact rule, courts have adopted more liberal theories of recovery. Some courts embraced the “zone of danger” test; others applied general negligence concepts, requiring only that the foreseeable plaintiff suffer physical harm as a result of the negligently inflicted emotional distress.


The zone of danger test is now the majority viewpoint. This rule disregards the requirement of physical impact and instead demands that the plaintiff be within the physical zone of danger created by the defendant’s negligent act. A plaintiff who has been subjected to the risk of bodily injury and who, as a direct result, suffers emotional distress has a cause of action.

Two cases illustrate the parameters of this rule. In Whetham v. Bismarck Hospitals the plaintiff sought recovery for severe emotional distress after witnessing a hospital employee negligently drop her newborn baby. The court denied relief, holding that the plaintiff was never physically threatened by the defendant’s negligent act. The court reasoned that the defendant owed no duty to those outside the range of physical peril. A contrary result was reached in Niederman v. Brodsky. In that case, the plaintiff suffered a heart attack after narrowly escaping the destructive path cut by the defendant’s negligently driven car. Because he alleged that he was within the zone of danger and feared for his own safety, the court held that the plaintiff had stated a prima facie cause of action for the nervous shock and resulting harm he suffered. Courts following the zone of danger rule explain that it produces reasonable results while still providing an additional element of proof that the claim for mental distress is real. The imposition of liability is regarded as justifiable because the defendant created a foreseeable risk of bodily injury to those within the zone of danger. That the plaintiff’s bodily harm results from mental distress, and not from impact, does not preclude liability. Some courts, however, view the rule as inadequate because a strict application of the doctrine would prevent recovery in cases when recovery should not be denied. These courts would extend the rule to allow recovery regardless of whether the plaintiff was in the zone of danger.


The first American court to allow another basis for recovery was the Texas Supreme Court in Hill v. Kimball. There, the court repudiated the requirement of impact and regarded the physical consequences of the mental distress as a sufficient guarantee that the claim was real. In Hill the plaintiff alleged that she sustained emotional distress leading to a miscarriage after she witnessed her landlord violently assault two men in her yard. The court stated: “It may be [very] difficult to prove the connection between the alleged cause and the injury, but if it be proved, and the injury be the proximate result of the cause, we cannot say that a recovery should not be had.”

This approach treats the claim of negligent infliction of mental distress from an ordinary negligence standpoint without the zone of danger limitation. It recognizes a duty to avoid a foreseeable, unreasonable risk of emotional harm to another. If breach of this duty proximately causes bodily harm, the defendant is liable. Courts adhering to this rule do not require a plaintiff to prove direct physical impact, nor do they require that the plaintiff be within the physical zone of danger. Instead, these courts hold that a plaintiff states a cause of action when he alleges that the negligently inflicted mental distress was foreseeable and that it resulted in bodily harm.

Massachusetts was one of the first jurisdictions to reject the zone of danger rule in favor of this more liberal approach. In Dziokonski v. Babineau the plaintiff suffered severe emotional distress after she witnessed her daughter lying injured on a street.’5 The Massachusetts Supreme Judicial Court overruled the impact doctrine and held that the plaintiff stated a compensable claim for the negligent infliction of emotional distress even though she was not within the zone of danger. The court stated that although the zone of danger rule produces more reasonable results than does the impact rule, it is nonetheless inadequate because it does not recognize the reasonable foreseeability of an injury to those outside the physical zone of danger. Reasonable foreseeability, explained the court, is the proper starting point in deciding whether a negligent act leads to liability. Thus, Dziokonski expanded the notion of duty beyond the zone of danger of direct harm to the zone of foreseeable risk of harm. Unlike the zone of danger rule, which limits liability to an absolute physical area, the zone of risk rule is based on the traditional negligence concept of foreseeability. A growing minority of courts view this approach as the better one.

The courts have been inconsistent in attempting to resolve the public policy problems inherent in mental distress cases. The impact rule has been universally condemned as unfair and illogical. The zone of danger rule, while still the majority viewpoint, is the subject of much criticism. The emergence of the zone of foreseeable risk test indicates that some courts are now willing to abandon the earlier, more restrictive tests in determining liability. The Dziokonski approach abrogated one of the arbitrary limitations on recovery, but retained another – the bodily harm requirement. Fear of fraudulent claims and a desire to limit the scope of liability may have produced this compromise. Regardless of the reasons for the requirement, the Dziokonski court distinguished emotional distress manifested by physical injury and emotional distress absent physical manifestations. This distinction prevented recovery in Payton v. Abbott Labs.


Payton held that no cause of action exists for the negligent infliction of emotional distress absent any evidence of physical harm. The majority’s opinion focused on three public policy concepts which courts have traditionally weighed against recovery in mental distress cases:

  1. fear of a flood of litigation;
  2. fear of fictitious claims;
  3. and reluctance to subject a defendant to liability for mental distress when he was merely negligent.

The fear of a flood of litigation is based on an expected increase in actions of a trivial nature coupled with an increase in fraudulent claims. The court explained: “It is in recognition of the tricks that the human mind can play upon itself, as much as of the deception that people are capable of perpetrating. . . that we continue to rely upon traditional indicia of harm to provide objective evidence that a plaintiff actually has suffered emotional distress. ”

Previously, the fear that a flood of litigation would ensue had been advanced in support of the impact requirement. This argument has two weaknesses. First, those courts that have relaxed the impact rule have not experienced any substantial increase in litigation. Second, courts should not refuse to adjudicate a particular type of case simply because their docket may increase. A court’s duty is to remedy legal wrongs “even at the expense of a ‘flood of litigation;’ and it is a pitiful confession of incompetence on the part of any court of justice to deny relief upon the ground that it will give the court too much work to do.

The second public policy concept – fear of fraudulent claims – also should not limit recovery. This fear has always troubled the judiciary but now, because of the recent advances in psychiatric and psychological knowledge, there is no longer any justification for denying recovery for purely emotional injuries. Therefore, courts can no longer legitimately deny recovery on the strength of precedent that points to the difficulty of distinguishing between serious and fraudulent mental distress.

In fact, the argument that a jury may be unable to distinguish between a legitimate claim and a fictitious claim is a spurious one which can be advanced in any situation. The Massachusetts Supreme Judicial Court recognized this, and seven years before Payton the court dismissed the notion that tort liability in particular classes of cases should be denied because of the threat of fraud. In Sorenson v. Sorenson6 the court stated that it would be a sad expression of incompetence if we were to admit that the judicial processes are so ineffective that we must deny relief to a person otherwise entitled because in some future case a litigant may be guilty of fraud or collusion. Once that concept were accepted then all causes of action should be abolished.

In Agis v. Howard Johnson Co., a 1976 case mentioned only briefly in Payton, the court rejected this same argument:

That some claims may be spurious should not compel those who administer justice to shut their eyes to serious wrongs and let them go without being brought to account. It is the function of courts and juries to determine whether claims are valid or false. This responsibility should not be shunned merely because the task may be difficult to perform.

For reasons not specified, the Payton court ignored its own reasoning in Agis and Sorenson and resurrected the “fear of fictitious claims” argument.

The third public policy concept the court discussed is that where the defendant’s conduct is negligent, not intentional, he should not be held liable for a purely mental disturbance. This concept is rooted in the misguided belief that the reckless or intentional nature of a defendant’s conduct permits a jury to infer that the plaintiff suffered genuine emotional distress. But the degree of the defendant’s fault bears no relation to the genuineness of a claim for damages for emotional distress. In a well-reasoned dissent, Judge Wilkins pointed out that the defendant’s extreme behavior should be the basis for recovery rather than the basis for inferring genuine emotional distress.

Yet, it was for these three rather unpersuasive policy reasons that the court in Payton upheld the Dziokonski distinction between emotional distress manifested by physical injury and emotional distress absent physical manifestations. This distinction suffers from two serious flaws. First, it assumes that emotional distress without physical manifestations is likely to be trivial. This assumption is incorrect. Because of the subjective nature of anxiety reactions, precise levels of suffering and disability cannot be objectively determined. Relatively mild emotional distress may result in bodily harm to one person, while extremely severe mental trauma may not produce any physical manifestations in another. There is no legal justification based on medical knowledge for prohibiting all plaintiffs from attempting to prove that their injuries are real.

The second drawback to the Dziokonski distinction is that it actually clouds the real issue. The essential question in any mental distress case is one of proof: whether on the facts presented, the plaintiff has suffered a serious and compensable injury. This is a question of fact for the jury. Jurors, by referring to their own experiences, are best able to determine whether the defendant’s conduct has resulted in emotional distress and whether the plaintiff is entitled to compensation. When the judge reads the complaint to determine whether there was a resulting physical injury, he is invading the province of the jury.

The physical harm requirement is simultaneously overinclusive and underinclusive. It is overinclusive because it permits recovery for mental distress when the physical harm is trivial. It is underinclusive because it prevents the litigation of valid claims. In addition to these faults, the physical harm requirement fails to serve its intended purpose – it does not prevent the litigation of fraudulent claims. This shortcoming is illustrated by the simple suggestion that those capable of perjuring evidence in the first instance will not hesitate to fabricate a slight injury to insure recovery.

In short, the physical harm requirement is arbitrary and unreliable. Courts have long feared that compensating the loss of mental tranquility would too often result in undeserved liability. The Payton court hoped to lessen this fear by distinguishing between serious and trivial mental distress based upon the presence or absence of physical harm. However, the majority was so anxious to uphold its convenient distinction that they did not bother to examine what effect their decision would have on the 4,000 plaintiffs. It is questionable whether Judge Lynch, writing for the court, ever studied the factual circumstances that led to the certified question. The court summarily dismissed an entire class of claims as trivial when the claims could have easily been viewed as legitimate. Surely, the facts warranted a jury determination of the reasonableness of the plaintiffs’ claims for emotional distress. A rule that would dismiss as trivial emotional distress without resulting physical injury before there is a jury determination is not a fair one.

In dissent, Judge Wilkins argued that emotional distress is not always trivial. He remarked that emotional distress may result from any number of circumstances.

It may be the product of a reasonable concern about one’s increased prospect of contracting a fatal disease, which may be treatable only by radical surgery or radiation. It may be the result of concern over the expenses, reasonably to be incurred, in submitting to medical examinations. While, on the facts given to us, I cannot declare with certainty that each plaintiff considered in question one may recover for the consequences of her emotional distress, it appears that at least some of the plaintiffs may be able to demonstrate emotional distress of more than a trivial nature.

The fact that most jurisdictions would not have granted relief absent physical harm does not condone adherence to an illogical and oftentimes unjust rule of law. As Judge Wilkins noted. The inertia which results from reliance on a ‘majority view‘ guarantees a glacial development of the law. Even earlier, Judge Musmanno stated, “A precedent can not, and should not, control, if its strength depends alone on the fact that it is old, but may crumble at the slightest probing touch of instinctive reason and natural justice.”

The arguments in support of the physical injury requirement are old and have crumbled in other jurisdictions. Yet the Payton court upheld its former rule of law. The dissent, however, had the better argument; in this case the plaintiffs’ claims should have been submitted to a jury, although there was no allegation of physical harm. Because the plaintiffs were exposed to DES, good medical practice requires interference with their normal lives. The dissent recognized that the time devoted to medical tests affects the plaintiffs’ earning power, and the expense of the testing affects their pocketbooks. The plaintiffs’ concerns are not trivial, evanescent, or feigned. It is apparent from the factual circumstances that the alleged emotional harm is genuine and serious. These circumstances present, in the words of the majority, although they do not perceive it, an ‘objective corroboration of the emotional distress alleged.’

Admittedly, the court was very concerned with “objective corroboration” and the traditional fears of granting recovery for emotional distress. It would seem, however, that the real reason for denying relief rested on some other ground, not articulated by the court. This ground was probably the fear that, once the rigid lines drawn by the artificial restrictions are erased, a defendant might be susceptible to unlimited liability. This fear is one of the motivating forces behind the various limiting doctrines in other jurisdictions.


The possibility of unlimited liability is a legitimate concern, but even this possibility must be balanced against the interest of the injured plaintiff. The law should not seek to provide a remedy every time a plaintiffs feelings are hurt. Conversely, the honest plaintiff should not be denied relief for a foreseeable injury that was negligently caused by another.

The evolution in the area of negligently inflicted mental distress indicates a growing willingness to abandon unnecessarily restrictive tests in assessing liability. Courts that have abandoned these arbitrary rules have found that traditional principles of duty, foreseeability, and proximate cause are sufficient to resolve the judicial fears inherent in mental distress cases. Although there are difficult problems of proof involved, these are neither insurmountable nor unique to mental distress cases and should not prevent a plaintiff from presenting her case in court.

It therefore seems likely that the liberal trend will continue and that even Massachusetts will one day abandon the physical harm requirement. But until that day, it is unfortunate that the courts continue to deny women like Brenda Payton the opportunity to litigate their claims.

Gary S. Glickman, 1982

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1982 DES Case: Morton v. Abbott Laboratories


” This is a product liability action brought against eight drug manufacturers, four of whom have been served. Plaintiff Mary Morton1 alleges that she contracted vaginal adenosis as a result of her mother’s use of the drug diethylstibestrol (DES) while plaintiff was in utero. Plaintiff does not allege which drug company manufactured the pills taken by her mother. Rather, she alleges that the defendant drug companies manufactured a substantial share of the DES pills produced during the period in question, and argues various theories to support liability without the necessity of proving which company manufactured the pills in question. Defendants do not deny that they manufactured the drug DES during the period in question. Instead, they state, by motions for summary judgment, that at least 149 drug companies manufactured DES during that period, any one of which might have produced the pills taken by plaintiff’s mother. Plaintiffs have responded to the motions for summary judgment, and have documented their response by filing a certified transcript of portions of the deposition testimony of Dr. Don Carlos Hines, taken in Bichler v. Eli Lilly and Co.

MORTON v. ABBOTT LABORATORIES, Leagle, decision/19821131538FSupp593_11043, March 25, 1982.

The motions for summary judgment were heard by the Court. At hearing, which was attended by plaintiffs Mary T. and David M. Morton, counsel for plaintiffs filed a motion to continue the hearing and a motion to withdraw.  …

… Plaintiff relies on several legal theories in support of her argument that recovery is available without proof of which drug company actually manufactured the pills in question. The first two theories concern joint torts: plaintiff would establish the liability of several companies jointly under the “concert of action” or “enterprise liability” theories, thereby entitling her to recover from those joined as defendants. The requirement of causation remains intact under these theories. The last two, however, are novel theories of causation rather than of joint liability: plaintiff argues that the Court should overlook the flaws in traditional causation under either the theory of “alternative liability” or that of “market share.” Each of these four theories will be discussed below.

Concert of Action

Relying on the concert of action theory of joint tort liability, plaintiffs would hold these several defendants liable for having acted in concert with each other and other drug manufacturers in causing her injury. Specifically, plaintiffs allege that the drug companies acted in concert “in the testing, manufacturing, distribution, promoting, marketing and sale of DES and the dissemination of literature regarding DES to practicing physicians.” . Further, plaintiffs allege that defendants are liable for manufacturing and selling DES “with identical chemical constituency by a mutually agreed-upon formula,” thereby enabling the marketing of DES as a generic drug and preventing consumers from identifying the manufacturer. …

Enterprise Liability

Like concert of action, plaintiff’s second theory — enterprise liability — would impose liability on each DES manufacturer on the basis of their group conduct. The concept of enterprise, or industry-wide, liability derives from Judge Weinstein’s opinion in Hall v. Du Pont De Nemours & Co. …

Alternative Liability

The remaining two theories relate not to the joint conduct — and therefore joint liability — of defendants, but to the element of causation. The first of these causation theories, that of alternative liability, is based on several decisions, most notably Summers v. Tice, and Ybarra v. Spangard. It has been nicely distilled:

Where the conduct of two or more actors is tortious, and is proved that harm has been caused to the plaintiff by only one of them, but there is uncertainty as to which one of them has caused it, the burden is upon each such actor to prove that he has not caused the harm.

Market Share

The final theory urged by plaintiffs, termed that of market share, was formulated by the Supreme Court of California as an extension of its alternative liability doctrine. In Sindell v. Abbott Laboratories, supra, a DES plaintiff asserted several theories in support of recovery despite her inability to prove which company caused her injury. After rejecting each of the three theories discussed above, the court adopted a novel — perhaps radical — means of allowing plaintiff to circumvent the element of causation.

The Sindell court held that plaintiff need only show that her condition was caused by the drug DES and that those companies joined as defendants produced a substantial share of the DES pills on the market when plaintiff’s mother took the drug. Upon such a showing, each defendant would be held liable according to its share of the market unless it could prove that it did not manufacture the pills in question. Thus, the California court shifted the burden just as it had inSummers v. Tice, supra, despite the possibility that no defendant caused the injury. The court based its holding on the “rough justice” of the result: the adjudication of many DES cases under this theory would assertedly lead to each manufacturer being responsible for that share of the total DES liability that is proportional to its share of the DES produced.

The market share theory unquestionably represents a radical departure from the traditional concept of causation. Plaintiffs argue at length that the development of product liability law in Florida suggest a loosening of the causation requirement, and therefore that Florida would adoptSindell. Plaintiffs’ position is not advanced by their argument that Florida has adopted strict liability, see West, supra, and rejected the defense of contributory negligence in favor of the comparative negligence doctrine. …

… read the full paper MORTON v. ABBOTT LABORATORIES on Leagle.

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1982 DES Case: Miles Laboratories, Inc v. Superior Court


Plaintiff (Susan Fisher) brought an action against a number of pharmaceutical companies, including Miles Laboratories, Inc. (Miles) for personal injuries allegedly sustained by reason of her mother’s ingestion during pregnancy of the drug diethylstilbestrol (DES), a synthetic compound of the female hormone estrogen. Defendant Miles moved for summary judgment on the ground it manufactured and marketed DES for use only as a palliative treatment of prostate cancer in males, not for female use as a miscarriage preventative. The trial court denied the motion without prejudice. Miles thereafter filed the instant petition seeking a peremptory writ of mandate from this court to compel the trial court to vacate its order denying the motion for summary judgment and to grant the same. We issued an alternative writ and order to show cause.

MILES LABORATORIES, INC. v. SUPERIOR COURT, Leagle, 1982720133CalApp3d587_1676, July 6, 1982.

… Defendants, individually and in concert, promoted the sale of DES from 1941 to 1971 for use by pregnant women for the prevention of miscarriages. Defendants knew or should have known that DES was neither safe nor effective for that purpose. In 1947 the FDA authorized production of the drug for use by pregnant women to avoid miscarriage but solely on an experimental basis and only with an express warning to that effect on labels. Despite the limited FDA authorization, defendants marketed and promoted the sale of DES on an “unlimited and wide-open basis” as a miscarriage preventative without any warning as to the experimental nature of the drug or of its potential carcinogenic effect.

In 1971 the FDA ordered defendants to cease marketing and promoting DES as a miscarriage preventative and to warn physicians and the general public that the drug should not be used by pregnant women because of the carcinogenic dangers to their children. The FDA action was based on hospital reports concerning the carcinogenic effect on daughters of women who used the drug. The form of cancer suffered by the daughters is known as adeno-carcinoma, a fast-spreading, deadly growth with minimum treatment calling for radical surgery. The disease manifests itself after a minimum latent period of 10 or 12 years.

Plaintiff was born in October 1961 and was exposed to DES through her mother who ingested the drug as prescribed during her pregnancy. Though there were other safe and effective drugs for the prevention of miscarriage, physicians were persuaded to prescribe DES by defendants’ promotional advertising concerning its safety and effectiveness. As a result of her exposure to DES, plaintiff was required to undergo surgical removal of her female reproductive organs.

Defendants acted in concert, on the basis of express and implied agreement and by the ratification, exploitation, and adoption of each other’s testing and marketing methods. Defendants were jointly liable regardless of the particular brand of DES ingested by plaintiff’s mother because defendants collaborated in testing, marketing and promoting the drug as fungible and interchangeable regardless of the brand name and because it was the practice of physicians to prescribe DES by its generic rather than brand name and of pharmacists to fill such prescriptions from whatever brand of DES they happened to have on hand and that “[d]efendants planned for, exploited and reaped the profits from this marketing and promotional scheme. 

In the recent landmark decision of Sindell v. Abbott Laboratories, our Supreme Court addressed the problem faced by plaintiffs, such as Susan Fisher herein, who are unable to identify the manufacturer of the DES which was ingested by their mothers. The court adapted the principle enunciated in Summers v. Tice (1948) to the circumstances of the DES cases. The court reasoned that in the context of the DES cases it would be reasonable “to measure the likelihood that any of the defendants supplied the product which allegedly injured plaintiff by the percentage which the DES sold by each of them for the purpose of preventing miscarriage bears to the entire production of the drug sold by all for that purpose.” (Sindell v. Abbott Laboratories) Accordingly, the court stated that “if plaintiff joins in the action the manufacturers of a substantial share of the DES which her mother might have taken, the injustice of shifting the burden of proof to defendants to demonstrate that they could not have made the substance which injured plaintiff is significantly diminished.” The court declined to require a specific percentage of the market to be joined, holding that it was only requiring “a substantial percentage.”

The Sindell court held that when a substantial share of the market has been joined, each defendant “will be held liable for the proportion of the judgment represented by its share of that market unless it demonstrates that it could not have made the product which caused plaintiff’s injuries.” (Sindell v. Abbott Laboratories, supra.) The court noted that one DES manufacturer in Sindell was dismissed from the action upon proof by declaration that it had not manufactured DES until after plaintiff was born. ” …

… continue reading MILES LABORATORIES, INC. v. SUPERIOR COURT on Leagle.

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1981 DES Case: Payton v. Abbott Labs


In May 1941, the small committee submitted the “master file” of clinical data to the FDA. The FDA approved the marketing of DES for uses unrelated to problems of pregnancy in late 1941. Thereafter, the small committee was disbanded, never again to reconvene. The ADMA continued to file NDAs up through 1943 on behalf of other companies seeking to market DES for the uses previously sanctioned.

Experimental use of DES as a miscarriage preventative began in the early 1940’s. Several drug companies supplied DES to independent researchers for such experimentation. The drug companies also sent representatives to medical conferences on this topic.

The first supplemental NDAs for the use of DES as a miscarriage preventative were filed in 1947. Only a few companies conducted their own experiments to establish the safety and efficacy of DES for this purpose. Among these, none tested DES on pregnant laboratory animals. The applicants relied instead upon published studies done by independent researchers to support their applications, in particular, the work of Dr. Karl John Karnaky of Houston and Drs. O. Watkins Smith and George Van S. Smith of Boston. The supplemental NDAs did not refer to the “master file” of clinical data that had been submitted with the 1941 NDAs. The FDA’s policy in reviewing supplemental NDAs, however, was to take into consideration all of the material that it had in support of the original NDAs.

The FDA began approving the supplemental NDAs in July 1947. Soon thereafter, DES was marketed as a miscarriage preventative. Some companies marketed the drug under a trade name; others marketed it generically. Several companies supplied DES to competitors. Because the DES compounds produced by the drug companies were chemically identical, pharmacists often filled prescriptions for DES with whatever company’s drug was in stock, a practice that the firms were aware of. None of the companies warned physicians about the possibility of carcinogenic or other risks to the offspring of women who took DES. Several, however, had warned against the use of DES in women having a history of cancer.

The number of firms marketing DES has fluctuated considerably over the years. In 1941, ten firms filed NDAs for DES. By 1947, 71 companies were producing or distributing the drug. In 1957, this had increased to 151 firms. And by 1967, the number of firms marketing DES had dropped back to 91. Additionally, companies have entered and left the DES market at different times.

In 1952, the FDA decided that DES was no longer a “new drug” within the meaning of § 505 of the Food, Drug, and Cosmetic Act. This meant that companies wishing to market DES for the first time would not have to file NDAs.

In 1971, Dr. Arthur Herbst and several other physicians published a study linking the outbreak in young women of clear cell adenocarcinoma, a form of cancer, with the ingestion of DES by their mothers during pregnancy. In November of that same year, the FDA required the drug companies to include a statement on all labels that “DES is contraindicated for use in the prevention of miscarriages.” Today, the FDA continues to permit the use of DES in treatments unrelated to problems of pregnancy. …

PAYTON v. ABBOTT LABS, Leagle, 19811543512FSupp1031_11381, April 23, 1981.

In order to survive defendants’ motion for partial summary judgment, plaintiffs must establish the existence of a genuine and material issue of fact under any of these theories. …

Concert of Action

Plaintiffs argue that the drug companies that marketed DES tortiously agreed not to test the drug properly to determine its safety and efficacy as a miscarriage preventative and not to warn of the carcinogenic danger which DES posed to the fetus. For purposes of this motion, it will be assumed that the individual drug companies acted tortiously.5 The only issue, then, is whether plaintiffs have met the burden of presenting evidence creating a genuine issue of fact as to whether such an agreement between the defendants existed.  …

Aiding and Abetting

Plaintiffs argue that the drug companies gave substantial assistance and encouragement to each other in marketing DES for use as a miscarriage preventative and, therefore, that they are collectively liable for any injuries resulting from such use. In plaintiffs view, the following undisputed facts raise a genuine issue as to whether the defendants substantially assisted and encouraged one another:

  1. the DES marketed by all drug companies was chemically identical;
  2. physicians frequently prescribed DES generically;
  3. and pharmacists often filled such prescriptions with whatever drug company’s DES they happened to have in stock. …
Joint Venture

Plaintiffs argue that the marketing of DES had all the characteristics of a joint venture. They reason that the generic aspects of the DES market created a community of pecuniary interest among the companies, to which all contributed and from which all received benefit. This, in addition to the firms’ cooperative efforts in 1941, raises an issue of fact as to the existence of a joint venture, in their view. ” …

… read the full paper PAYTON v. ABBOTT LABS on Leagle.

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1982 DES Case: Pipon v. Burroughs-Wellcome Co.


In Lyons v. Premo Pharmaceutical Labs, Inc., the mother identified the prescribing physician who in turn identified the medication and said he did not specify a brand. The pharmacist established that the prescription was filled with tablets made by Premo. It was then found that the bulk medication was supplied to Premo by its manufacturer, Specific Pharmaceutical Labs, Inc., through a broker who never had physical control of the product.

PIPON v. BURROUGHS-WELLCOME CO., Leagle, decision/19821169532FSupp637_11046, June 30, 1982.

Suit was against more than a dozen defendants, among them being Premo, its supplier and the broker, but not Burroughs-Wellcome, the defendant here. All other defendants were granted summary judgment since they were not within the chain of distribution. The case was then settled with Premo and its supplier, but continued against the broker on the theory of strict liability in tort. The opinion does not indicate whether any claim was made against the physician or the pharmacist. …

… The Appellate Division affirmed the summary judgments in favor of manufacturers other than Premo and its supplier after considering theories of “concert of action”, “joint action”, “alternative liability” and the “enterprise theory of liability.” …

… Another case is Namm v. Charles E. Frosst and Company, In that case, 44 defendants were served including Burroughs-Wellcome. The mother identified the physician and the pharmacist. She identified that the medication came as tablets (not capsules) of various sizes, which were white or light in color and none smaller than five milligrams. The pharmacist could only say that he obtained his DES supplies from various sources but could not say whose product was used to fill the prescriptions. …

Plaintiffs here argue that the motion should not be granted but that the case should be placed on a “reserve calendar” until some case involving DES reaches the Supreme Court of New Jersey and is decided. Plaintiffs are confident that the highest court will reverse the requirement that the actual manufacturer be identified. They do not say that a case is now pending there but predict that one will be “in the foreseeable future.

… Putting aside questions that would need to be faced if the case were allowed to stand, such as whether it can be proven that DES caused the injury claimed, or whether DES was taken at all (and the Court notes that the 1965 PDR identifies medications other than DES to prevent miscarriages and there have long been therapies for the purpose that do not involve medication), or whether, if DES was taken and did cause the injury, whether there would have been a miscarriage rather than a birth and so on, it is plain that plaintiffs cannot prove a case against this defendant under the applicable New Jersey law as laid down by its highest court. …

… read the full paper PIPON v. BURROUGHS-WELLCOME CO. on Leagle.

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1982 DES Case: Renfroe v. Eli Lilly & Co.


The complaint in this action was filed August 17, 1978. The complaint alleges that plaintiff Renfroe developed adenocarcinoma of the cervix, and that plaintiff Smith developed squamous cell carcinoma of the cervix, as a result of their in utero exposure to certain drugs (hereinafter collectively referred to as DES) manufactured by the defendants. Plaintiffs have allegedly undergone surgery to remove the cancer. The complaint states claims against the defendants for negligence per se, negligence, breach of express and implied warranty, fraud and deceit, strict liability, and conspiracy to defraud and deceive. Plaintiffs each seek recovery for pain, for medical expenses, lost wages, and the loss of ability to bear children, as well as punitive damages. …

RENFROE v. ELI LILLY & CO., Leagle, decision/19821346541FSupp805_11230, June 30, 1982.

… Hence, it is evident that plaintiffs’ claims did not originate or arise at least until plaintiffs’ physical injuries reasonably could have been discovered. (This requirement in itself forecloses the plaintiffs’ theory of the time of accrual of their claims, because, as the facts discussed below make clear, the fact that plaintiffs would develop cancer as a result of their exposure to DES was not reasonably discoverable until long after their births.)

However, in a case such as this, it could be most unfair to hold that a claim accrues as soon as physical injury manifests itself, because the likely cause of the injury might be totally unknown at that time. Plaintiffs have alleged in their complaint that “in approximately 1972, medical science discovered that teenage girls whose mothers had taken defendants’ drugs, were developing [cancer] and that this condition was a direct result of their mothers having taken defendants’ drugs.” Complaint, Thus, women with in utero exposure to DES who developed cancer prior to “approximately 1972” would have had no reason at that time to believe that their injury had a legally actionable cause. The defendants apparently concede that accrual of a cause of action bears some relation to discovery of the cause of injury, because they concede that plaintiff Renfroe’s claims may have accrued as late as 1976, when plaintiff Renfroe formed the opinion that the cancer for which she had undergone surgery in 1971 had been caused by her exposure to DES.

The Court’s research has not disclosed any Missouri case directly discussing this point. However, it may be inferred from Krug v. Sterling Drug, supra, that Missouri courts would not bar a cause of action for slowly developing injuries caused by a drug because the plaintiff learned too late the cause of her injuries, especially where plaintiff learned of that cause as soon as her doctor did. Moreover, in the analogous context of occupational disease cases brought under the Workmen’s Compensation Act, it has been held that the statute of limitations did not begin to run until the plaintiff was aware that he had a compensable disability in the sense of a disability caused by an occupational disease which resulted from his ordinary work activities. Myers v. Rival Manufacturing Co. …

… In accordance with all of the foregoing authorities, especially, of course, the Missouri cases, the Court believes that Missouri courts would hold that the present plaintiffs’ claims did not arise or accrue until

  1. the plaintiffs suffered reasonably discoverable injuries
  2. and the plaintiffs knewor, in the exercise of reasonable diligence should have known, whichever first occurred, that their injuries were caused by DES exposure.

Hence, their claims originated when (and where) the later of those two factors developed. ” …

… continue reading RENFROE v. ELI LILLY & CO. on Leagle.

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DES Cases and Identification of Parties


One of the most interesting legal issues in connection with identifying the potential parties to a toxic substances occurs when a plaintiff is aware of the particular agent that caused harm, but cannot establish a causal connection between that agent and a specific defendant In Ryan v. Eli Lilly & Co., the plaintiff alleged that she suffered a pre-cancerous condition caused by prenatal exposure to diethylstilbestrol taken by her mother during pregnancy. She could not however, identify the specific drug company that manufactured and sold the drug ingested by her mother. She sought to maintain suit against various manufacturers of DES under theories of alternative liability and market share liability. Although the court granted the defendants’ motion for summary judgment based upon her failure to identify the manufacturer of the drug taken by her mother, each of these theories may have potential application in other toxic substances cases where a plaintiff has similar problems in identifying a defendant.

Toxic Substances Litigation in the Fourth Circuit, University of Richmond, Law Review Volume 16, Winter 1982.

There are any number of techniques for establishing join torts and several liability including; vicarious liability, common duty; concurrent causation of a single, indivisible result which neither cause would have accomplished alone; concurrent causation of a single, indivisible result which either would have caused alone; damage of the same kind which is difficult to apportion; and acts innocent in themselves that together cause damage. Alternative liability is a common approach. The typical application of this theory occurs in the context of two or more tortfeasors who combine to bring about harm to a plaintiff such as two hunters who fire rifles at the same time, one of whom shoots at plaintiff. The alternative liability doctrine allows the plaintiff to shift the burden of proof to the defendants to establish which one caused the alleged harm. If the burden is not met both defendants will be jointly liable. The application of this theory to DES cases has generally been limited because of the following arguments: there are a large number of potential defendants and not all of them are brought into the lawsuit; the defendants do not have any greater access to information concerning who sold the drug and are dealing with the same level of uncertainty as the plaintiff; there is no specific information that any one of the name defendants sold the drug that allegedly caused the harm; and the activities of the defendants are different in time and place.

Concert of action is another theory that may be used t solve a plaintiff’s identification problem. Under this approach a group of defendants may be liable if they act in concert pursuant to a common design, knowingly give substantial assistance to others engaged in breaching a duty to give substantial assistance while breaching a separate duty to a plaintiff. The typically cited example of concert of action involves a suit brought by an innocent person who is injured as a result of a drag race. The specific facts connected with defendants’ actions are usually controlling and courts have been inconsistent in applying this theory in DES cases. Reasons cited for not applying this theory have included lack of evidence of anti-social behavior, passage of time between conduct complained of and subsequent activities, lack of tacit understanding or a common plan, joinder of fewer than all potential defendants, large numbers of defendants and evidence only of mere manufacturing activities with similar economic results. On the other hand, one jury has found that there was sufficient evidence of concerted action to hold the defendant manufacturers liable for failing to make sufficient tests and for marketing DES without adequate warnings.

Closely related to concert of action is a theory of civil conspiracy also considered in Ryan v. Eli Lilly & Co. Plaintiffs alleged that the named manufacturers of DES conspired to fraudulently misrepresent the benefits of DES or acquiesed in such misrepresentation. On motion for summary judgment the court found that there was no evidence of an agreement by the named defendants to commit a criminal act or intentional tort pursuant to a common scheme.

Other plaintiffs have suggested that there is a concept of “enterprise liability” that should be appropriate for assisting plaintiffs to identify defendants in these kinds of cases. This type of enterprise liability should be distinguished from the larger social theory that enterprises should bear the risk of loss for all harm caused by that enterprise. This theory proposes that various overwhelming social policies would be better served by shifting the risk of loss to an offending industry as a whole rather than maintaining the risk of loss on injured consumers. In the DES cases there has been no support for this approach for a number of reasons including the large number of defendants, the presence of pervasive governmental regulation, and a dearth of legal precedent.

The most recent suggestion by plaintiffs to surmount the difficulties of identifying defendants has been for “market share liability”. According to this theory, if a plaintiff suffered harm caused by a toxic substance but cannot identify the manufacturer of that substance, then the plaintiff may sue a substantial portion of the entire industry producing the substance and recover damages to be paid by each manufacturer in proportion to respective shares of the market for that substance. This doctrine is based upon the express social policies of providing the most appropriate incentives for product safety and of placing liability on the parties most capable of bearing compensation costs. Objections to this theory have included the lack of precedent, unfairness to some defendants and plaintiffs, and that it is counter to such social policies as the encouragement of medical research.

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1981 DES Case: Needham v. White Laboratories, Inc.


In 1946 the Food and Drug Administration (“FDA”) authorized defendant-appellant White Laboratories, Inc. (“White”), to market dienestrol, a synthetic estrogen, for the treatment of menopausal symptoms and suppression of lactation In 1950 the FDA authorized White to market dienestrol for treatment of threatened and habitual miscarriages.

Mary Needham, plaintiff-appellee Anne Needham’s mother, took dienestrol in 1952 during her pregnancy with plaintiff. In early 1974 Dr. Jerome Warren informed Anne Needham that she had clear cell adenocarcinoma, a rare form of vaginal cancer. Needham claims that the dienestrol her mother took in 1952 is the proximate cause of her cancer.

NEEDHAM v. WHITE LABORATORIES, INC., Leagle, decision/19811033639F2d394_1963, April 27, 1981.

The trial of this cause was trifurcated. A jury was impaneled to determine whether the Illinois statute of limitations barred this suit. The jury found that the Illinois two-year statute of limitations did not bar plaintiff’s cause of action. A new jury was impaneled to decide the liability and damages issues. That jury returned a verdict for plaintiff and, after the subsequent damages trial, awarded the plaintiff $800,000. White appeals. We reverse and remand.  …  …

The limitations period does not commence when the plaintiff learns of his injury, but only after the plaintiff knows or has reason to know that he or she has a physical problem and also that someone is or may be responsible for it.

White claims that the jury finding that Needham did not know of the connection between her injury and the dienestrol her mother took before March 22, 1974, is not supported by the record. We disagree.

Needham testified that she first learned of the possible connection between her injury and the dienestrol in May 1974. Her mother testified that neither she nor plaintiff knew of the relationship between the cancer and the dienestrol before May 1974. The only evidence tending to prove that Needham knew or should have known of the connection between her injury and dienestrol before March 22, 1974, was the testimony of her father and her gynecologist, Dr. Jerome Warren. Needham’s father testified that he knew of the connection between Needham’s injury and the dienestrol on March 1, 1974, but that he did not discuss the possible connection with his daughter before March 22, 1974. Dr. Warren testified that he discussed the connection between the cancer and dienestrol with plaintiff and her mother at a meeting on March 2, 1974. Plaintiff and her mother, however, testified that no meeting occurred on March 2, 1974, and Dennis Rauen testified that he was with Needham all day March 2, 1974.

The jury’s function is to resolve the conflicts in the testimony and weigh the credibility of the witnesses. Legally sufficient evidence in the record supports the jury’s resolution of the conflicts in favor of the plaintiff, and we affirm its finding that this suit is not time-barred.

White claims that the district court erred in permitting Needham to introduce evidence that dienestrol was not effective in preventing miscarriages. We agree with defendant and reverse and remand. In ruling that inefficacy evidence was admissible, the district court erroneously interpreted Illinois case law and the comments to section 402A of the Restatement (Second) of Torts. …

…  Second, the manufacturer will be strictly liable if it fails to warn of a known risk inherent in the product. Comment j of section 402A explains that a product may be unreasonably dangerous if the manufacturer fails to warn of an inherent danger.

The seller is required to warn [of a danger], if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of … the danger. Likewise in the case of poisonous drugs, or those unduly dangerous for other reasons, warning as to use may be required.

… Third, a court will impose strict product liability even if a warning is given if the product remains unsafe when the warning is followed and the risk of danger outweighs any apparent usefulness of the product.

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warnings, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. ” … …

… continue reading NEEDHAM v. WHITE LABORATORIES, INC. on Leagle.

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Daughters at Risk : a Personal DES History

image of daughters-at-risk book
Anne Needham, who as a young DES Daughter had a hysterectomy for cancer, sued White Laboratories, makers of a DES drug. Lawrence S. Charfoos – an attorney in the litigation – and Stephen Fenichell detail the case and provide a history of DES development, research linking it early to cancer, the FDA’s approval, the pharmaceutical company promotion, and the medical community’s involvement.

This is the legal story of one of the first DES cases to go to trial, as told by the plaintiff’s lawyer and a journalist covering the case; and it conveys neither the victim’s feelings nor the drama of the experience.

Anne Needham was 20 when operations for the rare vaginal cancer now appearing in DES daughters left her unable to bear children, partially incontinent, and emotionally in turmoil. Six years later an Illinois court awarded her $80,000 in damages ; a decision that was reversed on appeal and remanded for trial; and there the story ends.

The authors competently recount the development of DES in England; its popularization by the Smiths of Harvard as a drug to ward off miscarriage; how the first cases of vaginal cancer were connected to DES; and the role of the FDA.

It seems however that “the particulars of Anne Needham’s personal ordeal and of the trial are vague and incomplete” and that “at the trial, the importance of the legal maneuvering is never quite established“.

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