1983 DES Case: Yustick v. Eli Lilly & Co.

” This is a products liability diversity action for injuries allegedly sustained as a result of the ingestion of diethylstilbestrol (DES) by plaintiff’s mother while she was pregnant with plaintiff in 1952. In January 1973, plaintiff became aware of her alleged injuries and that the generic drug DES was involved. Despite diligent efforts, she did not discover until August 1979 which of the several DES manufacturers selling the drug had actually manufactured and sold the drug her mother consumed. The instant lawsuit was filed on February 8, 1980..

YUSTICK v. LILLY & CO., Leagle, 19832131573FSupp1558_11875, November 9, 1983.

The issue is when plaintiff’s cause of action accrued, and the case is before the Court on defendant’s motion to dismiss because of the running of the statute of limitations. The Court finds that the statute of limitations did not accrue until plaintiff had the opportunity, after making reasonably diligent efforts, to identify the manufacturer of the drug in question, since the identity of the alleged tort-feasor is a “critical fact” or essential element in this cause of action. The motion to dismiss will therefore be denied.

While pregnant in 1952, plaintiff’s mother took DES supplied by Dr. John Comstock.

On December 14, 1972, plaintiff was examined as an outpatient of the University of Michigan Hospital. In January 1973, she was admitted to the University Hospital and underwent a vaginal biopsy. Vaginal adenosis, related to her mother’s ingestion of DES during her pregnancy with plaintiff, was discovered. At this time, plaintiff knew of her alleged injuries and their relationship to her mother’s ingestion of DES while pregnant.

In September 1976, plaintiff retained counsel and on September 16, 1976 plaintiff’s counsel wrote to the University of Michigan Hospital requesting plaintiff’s medical records for January 1973, and, on November 2, 1976, the hospital provided counsel with a complete copy of plaintiff’s medical records, including her January 1973 records. Plaintiff’s mother’s medical records from Dr. Comstock were also obtained in November of 1976.

On December 2, 1976, a physician at the University of Michigan Hospital wrote to plaintiff’s counsel, describing plaintiff’s injuries as diagnosed, and her mother’s ingestion of DES.

In 1977, plaintiff filed suit in Oakland County Circuit Court against Dr. Comstock, which was later settled. After filing that suit, and before its settlement, plaintiff’s counsel had conversations with representatives of the insurance company insuring Dr. Comstock and requested them to identify the manufacturer of the drug that Dr. Comstock distributed from his office in 1952. In late 1977 and early 1978, plaintiff’s counsel was informed that neither Dr. Comstock nor his office knew the identity of the manufacturer of the DES.

At the same time, plaintiff’s counsel was in communication with plaintiff’s parents and requested them to attempt to identify the manufacturer. These inquiries produced no helpful information prior to the summer of 1979.

In the summer of 1979, plaintiff’s father, while cleaning the attic of his house, found a bottle containing pills prescribed for plaintiff’s mother. These pills were presented to plaintiff’s counsel on August 1, 1979, and plaintiff’s counsel stated that he confirmed that the manufacturer of the pills was defendant Eli Lilly & Company. The instant action was commenced on February 8, 1980. ” …

… continue reading the full paper YUSTICK v. LILLY & CO. on Leagle.

More DES DiEthylStilbestrol Resources

DES and The Identification Problem

DIETHYLSTILBESTROL (DES), a synthetic estrogen, was developed in 1937 and was widely prescribed in the 1940’s, 1950’s and 1960’s for pregnant women to prevent miscarriages. The drug has caused a number of maladies to daughters who were exposed in utero to the drug, the most serious of which is clear cell adenocarcinoma, a rare form of vaginal cancer. The Food and Drug Administration (FDA) withdrew its approval of DES as a miscarriage preventative in 1971, and since then the focus has shifted to products liability actions filed against the drug manufacturers. The plaintiffs have been largely unsuccessful in these actions, although some innovative judicial theories have recently been advanced in allowing recovery.

DES and The Identification Problem, AKRON LAW REVIEW, Vol. 16:3, Winter 1983.

This article will examine the history of this drug, how it was used and regulated as well as the subsequent legal turmoil and the proffered resolutions to the quandary. The impact of these theories and of proposals to “further strengthen product liability laws as a substitute for direct government intervention” will also be studied.


Diethylstilbestrol was first synthesized in 1937 by Dr. E. C. Dodds at Oxford and Middlesex Hospital in England. The abbreviation “DES” is used to designate diethylstilbestrol (which is also known as stilbestrol) and sometimes for the related synthetic estrogen, dienestrol, also discovered by Dr. Dodds.

Diethlystilbestrol represented a tremendous improvement over the use of natural estrogens. Natural estrogens were very expensive due to the extensive hormone isolation process and had to be injected into the buttocks with the frequent side effect of abscesses. DES was much less expensive and it could be administered orally.

Dr. Dodds was not connected with any drug manufacture but rather was working under a grant from the Medical Research Council of Great Britain. Most significantly, Dr. Dodds never patented DES which led to the manufacture of DES by many drug companies and to the tendency for doctors to prescribe the drug by its generic name (diethylstilbestrol).


Drug regulation began in the United States in 1890 with limitations on the importation of adulterated or unwholesome food, drugs, or liquors. This was followed by the Food and Drug Act of 1906 (“Wiley Act”) which provided the first direct regulation of drug manufacturers. However, the FDA was not created until passage of the first comprehensive statute in this area, the Federal Food, Drug, and Cosmetic Act of 1938, which remains the basis of United States drug law.

The next major change in United States drug laws was passage of the Kefauver-Harris Amendment of 1962. This, most importantly, amended Section 505 of the 1938 Act to require drugs be effective as well as safe. DES was originally approved and marketed under the 1938 Act.

Obviously, fulfilling the requirements of the FDA is a major concern of drug manufacturers. Compliance does not, however, fully end their legal responsibilities. The products liability laws of the various states become applicable when anyone is harmed by a drug. Evidence of compliance with FDA requirements may be presented to the jury to show proper care and adequate testing, but such compliance is not conclusive on this issue.

The law has made great strides to allow consumers legal redress against sellers and manufacturers. The law of products liability can be traced to the English case of Winterbottom v. Wright. This case led the way for the elimination of the privity requirement in tort actions. In 1963, in Greenman v. Yuba Power Products, Inc., a manufacturer was held strictly liable in tort for injuries sustained due to a defective product.  This case led the way toward the adoption of strict liability in tort.

The exposure of drug manufacturers can best be understood by analyzing Section 402A of the Restatement (Second) of Torts:

402A Special Liability of Seller of Product for Physical Harm to User or Consumer.

  1. One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate use or consumer, or to his property, if
    • the seller is engaged in the business of selling such a product,
    • and it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.
  2. The rule stated in Subsection (1) applies although
    • the seller has exercised all possible care in the preparation and sale of his product, and
    • the user or consumer has not bought the product from or entered into any contractual relation with the seller.

The Restatement, moreover, is accompanied by a number of comments and guidelines. Most important for purposes of this article is Comment K entitled “Unavoidably Unsafe Products,” which provides in pertinent part:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended or ordinary use. These are especially common in the field of drugs … Such a product, properly prepared, and accompanied by proper directions and warnings is not defective … It is … 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 of 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 situations call 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, attendant with a known but apparently unreasonable risk.

This exception recognizes the fact that drugs (and especially prescription drugs) cannot be made completely safe. This is in essence a decision that frequently the benefit and utility of the drug outweighs its risk, at least if proper warnings are given. Therefore, drug manufacturers are held to the duties of adequately testing their products and of adequately warning of known dangers. Some courts nevertheless have ruled that Comment K’s insulation is lost and strict liability applies

  1. where the drug could not reasonably have appeared to be useful and desirable at the time of manufacture
  2. or where, despite some apparent efficacy, the medically recognizable risk feasibly outweighed its utility.

Regardless of the result of a Comment K analysis, three essential requirements remain under traditional products liability doctrine in order for the plaintiff to recover. In order to recover, a plaintiff must show a product is defective, that the defective product is attributable to the party to be held responsible, and that the defect in the product caused the plaintiff’s injury. The second requirement has been articulated as the identification requirement. This is where the DES plaintiffs have the most problem. Due to the long time lapse since ingestion by their mothers, and poor recordkeeping by pharmacies and doctors, most plaintiffs “cannot identify the manufacturer of the drug ingested by their mothers.”  The identification requirement has clearly been a crucial element. It is a fundamental principle of products liability law that a plaintiff must prove, as an essential element of his case, that a defendant manufacturer actually made the particular product which caused injury.

DES plaintiffs face many problems, both legal and practical. Among the legal problems are: class action certification; the possible running of the statute of limitations; and denial of a cause of action because the injury was prior to birth or viability. The biggest obstacle, however, as already indicated, is the identification requirement. This is the area in which courts have created new doctrine and is the principle focus of this article.


As previously noted, DES was developed in 1937 by Dr. Dodds. Since it was not patented, many drug companies were interested in marketing it in the United States. In order to do so, a drug company had to file a New Drug Application (NDA) pursuant to § 505 of the Federal Food, Drug, and Cosmetic Act. The NDA had to state proposed uses (indications), clinical data and studies establishing the safety of the drug, chemical composition, manufacturing method, and proposed labeling.

The first NDA for DES was filed in 1939. Ten firms had made separate NDA filings by the end of 1940. These NDA’s were for the following indications: “the treatment of post-menopausal symptoms, senile vaginitis, gonorrheal vaginitis, and suppression of lactation.”

The FDA then decided to ask the drug companies to pool their clinical data. According to Dr. Theodore Klumpp, the Chief of the Drug Division of the FDA at that time:

It was feared that to consider each NDA separately would present “an overwhelming problem” and so it was decided, “in the public interest,” to request that the drug companies pool all their clinical materials and present them together. The companies apparently received this suggestion with little enthusiasm, but accepted it when it was pointed out that consideration of individually submitted data would mean delay in approving the applications. As a result, a committee, whose members represented the drug companies, was formed which put together and summarized all clinical data supplied by the individual pharmaceutical companies eventually presenting this data to the FDA.

The drug companies complied with this request and the “small committee” was formed in early 1941.

The FDA, nevertheless, made further requests of uniformity. The companies were required to use the same United States Pharmacopeia standard so that the active ingredients of all DES products were the same. The FDA also requested that uniform labeling (warnings and dosages) be used. Finally, the FDA requested that the companies include a “permissions clause” in their NDA’s. This clause allowed any company to refer to the “master file” of clinical studies in their NDA’s. In 1941, the FDA began approving the NDA’s for the four indications previously noted.

Meanwhile, research was begun in the 1940’s into the use of DES in the treatment of problems of pregnancy. Apparently, all research was originally done by independent medical researchers, although the drug companies later cooperated by supplying DES to the researchers.

In 1947, several drug companies submitted supplemental NDA’s in order to market DES as a miscarriage preventative. These applications referred to the independent research done, particularly that of Drs. 0. Smith and George Smith of Boston. The companies did not, however, conduct laboratory tests on pregnant laboratory animals. This later became a claim of inadequate testing in several DES cases.

The FDA began approving these NDA’s in 1947 based upon all available information. Eventually approximately 300 companies marketed DES in various dosages and for various indications.

In 1952 the FDA declared that DES was no longer a “New Drug” but was instead “generally recognized as safe” under § 201(p) of the 1938 Act. 4 This meant that a drug company could now enter the DES market without submitting an NDA, thus prompting a great number of manufactures to enter the market. The new companies had only to meet the manufacturing standards and to market the drug for the previously approved indications. During the period 1947-1971 DES was widely prescribed as a miscarriage preventative. It was estimated that between 500,000 and 2,000,000 pregnant women used the drug. High dosages were needed when DES was used as a miscarriage preventative. The most popular tablet for this indication was the 25 mg. size. Multiple tablets of lower dosages, primarily 5 mg. and 10 mg., were also probably prescribed.

In 1967, the National Academy of Sciences-National Research Council (NAS-NRC) completed its review, required by the 1962 Drug Amendments, 9 of the efficacy of DES. The NAS-NRC rated DES as “possibly effective” as a miscarriage preventative. The FDA, however, delayed further action until 1971.

By 1971, the link between DES used in pregnancy and the development of vaginal cancer in DES exposed daughters was well demonstrated. This form of cancer, adenocarcinoma, is rare, and in fact the incidence rate in DES exposed daughters is still fairly low. There have been approximately 250 reported cases of adenocarcinoma in DES exposed daughters. Further, although the disease is serious, its treatment is extremely effective if it is detected in its early stages.

DES daughters, nevertheless, suffer from other health problems as well. The most common is adenosis, which is the abnormal presence of glandular tissue in the vagina. Current research indicates that adenosis is not a precancerous condition and that it may tend to disappear over time. Apparently, daughters exposed earlier in pregnancy have a higher incidence of adenosis. DES daughters have also developed structural abnormalities other than adenosis. Furthermore, there is a slightly increased risk of an unfavorable pregnancy (for DES exposed daughters) according to the National Cooperative Diethylstilbestrol Adenosis Project (DESAD Project). There does not, however, appear to be any carryover to the children of DES daughters as of yet, although research is continuing. There have been some reports of noncancerous abnormalities of DES exposed sons, but, it does not appear that there is any cancer risk.

In 1971, the FDA issued a warning which required a labeling change which contraindicted the use of DES during pregnancy.  By contraindicting the use of DES as a miscarriage preventative, the FDA removed its approval of the drug for that use.

Thus, after 1971 DES was no longer used as a miscarriage preventative. It is very hard not to sympathize with the DES plaintiffs, especially those who have developed adenocarcinoma. Yet, DES should not be viewed as a total mistake. It is still an approved drug for many indications, and several companies still produce it, although in lower dosages.


The number of pending DES suits is tremendous. There are over 1,000 suits pending today. As one writer observed, given the magnitude of the potential liabilities, these DES cases in the aggregate appear to this writer very much like a tidal wave, still miles out to sea, but sweeping inexorably toward shore.

Further, these products liability actions appear to be an inefficient method of compensating the plaintiffs. In a general drug products liability suit, one observer estimated that the plaintiff receives only thirty cents out of a dollar after attorney fees and costs are deducted. As we have seen, DES cases are even more complicated than the average drug case. The defendant drug manufacturers obviously do not fare well either. The minimum defense costs of a “simple” DES case has been estimated at $50,000. The national total in claims alone could reach $40 billion.

Defendants have prevailed in the vast majority of DES cases decided to date; the usual reason being the plaintiffs’ failiure to identify the manufacturer. The plaintiffs have attempted to overcome this obstacle by asserting two traditional theories, alternative liability and concert of action, as well as proffering two novel theories. The first of these novel theories was initially presented in a 1978 law review comment entitled “DES and a Proposed Theory of Enterprise Liability.” This excellent and often-cited article began the trend toward enterprise or market share liability. The second development was the California case of Sindell v. Abbott Laboratories .  Sindell proposed a market share approach to the DES identification problem. Sindell will first be discussed since it contains a discussion of all of the proposed theories.


In Sindell the Supreme Court of California held four-to-three that the plaintiff’s action should not have been dismissed solely because the plaintiff could not identify the manufacturer of the DES they had been exposed to in utero. Instead of requiring specific identification, the Court said that upon a showing that the manufacturers joined as defendants produced a substantial percentage of the drug in question each manufacturer would be held liable for his share of the market.

In dissent, Judge Richardson noted practical and theoretical deficiencies in the majority’s reasoning. The dissent felt that such a drastic change in products liability law should have a legislative rather than judicial source. By obviating the required proof of cause-in-fact, the dissent observed that Sindell was indeed “a new high watermark in tort law.”

Plaintiff Judith Sindell brought suit against eleven drug companies and 100 “Does.” She sued on behalf of herself and on behalf of all similarly situated women of California. She developed a malignant bladder tumor which was surgically removed, and suffers from adenosis. Sindell stated that she was unable to identify the manufacturer, and her case was therefore dismissed at trial.

The Sindell opinion recognizes the plight of the plaintiff who cannot meet the identification requirement. It must be remembered that the identification problem in DES cases is due to the long latency period before the adverse reactions develop, the delay before the cancer relationship was established, and the fact that DES tended to have been marketed generically.

Sindell then analyzed the case under several theories. It rejected the following: alternative liability; concert of action; and enterprise liability. Each of these theories will be examined in later sections of this article.

After finding existing theories inapplicable, Sindell fashioned a new theory, market share liability. The Court, nevertheless, stated that the theory is merely a modification of the alternative liability theory of Summers v. Tice. The Sindell majority boldly based its market share theory on the policy grounds that “as between an innocent plaintiff and negligent defendants, the latter should bear the cost of injury.” Justice Mosk observed:

In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer. The response of the courts can be either to adhere rigidly to prior doctrine, denying recovery to those injured by such products, or to fashion remedies to meet these changing needs.

Fashion a remedy they did. Under the market share liability theory, plaintiffs are required to join a “substantial share”  of DES manufacturers and prove that each was negligent. Each defendant is then allowed to show that his product could not have caused the plaintiff’s harm. If not absolved, each defendant will be liable “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 by all for that purpose.

The dissent too felt sorry for the plaintiffs, but felt that the majority’s solution was too large a break from prior doctrine. Justice Richardson stated:

The majority adopts a wholly new theory which contains these ingredients: The plaintiffs were not alive at the time of the commission of the tortious acts. They sue a generation later. They are permitted to receive substantial damages from multiple defendants without any proof that any defendant caused or even probably caused plaintiffs’ injuries.

The dissent would abide by prior case law which required identification unless the case fell within one of the exceptions that California recognizes, which even the majority dismissed as inapplicable.

Since the plaintiff joined only five drug manufacturers, the dissent observed that it was far from certain that the manufacturer who actually caused the injuries was joined. The majority countered this by their “substantial percentage” requirement and by noting that the plaintiff claimed that Eli Lilly and five or six other producers accounted for 90 percent of the DES market. The dissent further argued that by having only 5 of 200 manufacturers, the alternative liability theory or its derivatives should be inapplicable.

The dissent would adhere to the requirement that causation in fact be proven. Justice Richardson felt courts should resist the “deep pocket theory of liability” and further observed that plaintiffs who could not make a specific identification would be rewarded by “being offered both a wider selection of potential defendants and a greater opportunity for recovery.” In addition, Justice Richardson continued his assault by asserting:

The “market share” thesis may be paraphrased. Plaintiffs have been hurt by someone who made DES. Because of the lapse of time no one can prove who made it. Perhaps it was not the named defendants who made it, but they did make some. Although DES was apparently safe at the time it was used, it was subsequently proven unsafe as to some daughters of some users. Plaintiffs have suffered injury and defendants are wealthy. There should be a remedy. Strict products liability is unavailable because the element of causation is lacking. Strike that requirement and label what remains “alternative” liability; “industry-wide” liability, or “market share” liability, proving thereby that if you hit the square peg hard and often enough the round holes will really become square, although you may splinter the board in the process.

The dissent concluded by observing the “omnious ramifications” of the majority’s theory. It questioned whether the pharmaceutical industry should be made an insurer for any and all injuries attributable to drugs. Justice Richardson suggested that a legislative approach would be preferable, in particular a system “which would establish and appropriate funds for the education, identification, and screening of persons exposed to DES, and would prohibit health care and hospital service plans from excluding or limiting coverage to person exposed to DES.

Alternative Liability

The case of Summers v. Tice created the theory of alternative liability, or double fault and alternative liability. In Summers, two hunters simultaneously and negligently fired their guns in the same direction. One bullet hit their companion, the plaintiff Summers. Clearly only one of the defendants actually caused the injury, but identification was not possible. The Court therefore shifted the burden of proof or cause-in-fact to the defendants. If they could not absolve themselves, joint and several liability results.

The “DES Comment” argued that alternative liability could be used to solve the DES identification problem. The author, however, admits that the reasoning must be strained a bit, but concludes that the theory is viable on policy grounds since the plaintiffs are innocent and the defendants were all tortfeasors.

Other commentators have rejected the alternative liability theory for DES cases. The chief reason why Summers should not apply is that in Summers all the potentially responsible parties were joined, this is clearly not true in the DES cases. Indeed, it is quite possible that the actual defendant would not be before the court.  Other distinctions include that in Summers, the negligence caused the identification problem, yet in the DES cases the problem was largely caused by the lapse of time, and in Summers, the defendants arguably had better access to the information than the plaintiff, although this is more ques- tionable in the DES cases.

The Sindell majority rejected the alternative liability theory for many of these same reasons. The key reason was that not all possible responsible parties were joined. The Court also considered, but did not rest its decision on, the fact that the defendants had no greater access to information which might facilitate identification. It must be remembered that this is the Court that decided the key precedents for the alternative liability theory, Ybarra v. Spangard and Summers v. Tice, and it found the theory inapplicable to DES cases.

It seems clear that alternative liability cannot be the solution to the DES identification problem. The one authority which justified it, the “DES Comment,” did so only as an alternative to its main proposed theory. As one author stated:

Applying the theory of alternative liability to DES litigation, wherein an entire industry may be held liable for an unforeseeable reaction to a product arguably produced in the public interest, goes far beyond the circumstances of a nonrecurring hunting accident. In the context of DES litigation, the benefit of alternative liability to the plaintiff’s ultimate recovery may strain the very notion of “fairness” upon which the Summers decision was based.

Nevertheless, some courts, including the lower court in Sindell, have employed the alternative liability theory in DES cases. One case, Abel v. Eli Lilly & Co., held that the theory stated a sufficient cause of action, and another, Ferrigno v. Eli Lilly, used alternative liability in fashioning a market share approach. It must be noted that Ferrigno was severly criticized in a subsequent case also before the New Jersey Superior Court, Namm v. Frosst and Co. Namm flatly rejected the theory of alternative liability.

Concert of Action

The concert of action theory is based upon the requirement of a “common plan or design to commit a tortious act. Actual agreement is not necessary, but the court must find a tacit understanding and tortious acts pursuant to the common plan. As with alternative liability, the defendants under a concert of action theory are held jointly and severally liable.

The classic fact situation for concert of action to be applied is the illegal drag race. The agreement or tacit understanding can be inferred from the parallel conduct of the participants.

This theory was argued in Sindell, and the “DES Comment” also argues it as a viable theory for DES cases. The “DES Comment” argued that the case of Hall v. E. L DuPont De Nemours & Co., supports this position. In Hall, thirteen children were injured by the explosion of dynamite blasting caps. The specific manufacturer could not be identified since all markings on the caps were destroyed in the explosion. The plaintiffs, therefore, sued the six American manufacturers of blasting caps and their trade association under the concert of action theory. The court held for the plaintiffs upon finding that the manufacturers had known of the dangerous nature of their product but had agreed among themselves not to place warnings on the caps. The effect of this holding was to shift the burden of proof on identification to the defendants. The “DES Comment” author contends that, in the DES situation there is enough conscious parallel behavior involved in the pooling of clinical data and other cooperative activity by the drug manufacturers in 1941 to find concerted action.

The Sindell Court nevertheless refused to apply the concert of action theory because they could not find a tacit understanding or a common plan among the drug manufacturers. Most of the activity alleged to be parallel was indeed required by law. Justice Mosk admitted:

Application of the concert of action to this situation would expand the doctrine far beyond its intended scope and would render virtually any manufacturer liable for the defective products of an entire industry, even if it could be demonstrated that the product, which caused the injury was not made by the defendant.

A good reason not to apply the concert of action theory is the pervasive regulation by the FDA. The testing, manufacturing, and marketing of drugs is all highly regulated. Further, Hall is clearly distinguishable from the DES situation. In Hall, the entire industry was joined as it consisted of small number of firms, and the identification problem in Hall was caused by the explosion itself.

Although most courts have rejected the concert of action theory in DES cases, the theory has, nevertheless, found some support. The lower court in Sindell applied this theory as well as alternative liability. In Bichler v. Eli Lilly & Co., a case involving a DES action against only that named manufacturer, the New York appellate court ruled there was sufficient evidence to support the jury’s finding of concerted action. The reasoning of this case has been criticized, in particular because of the reliance placed by the court upon parallel activity by the drug companies prior to their efforts to seek approval of DES as a miscarriage preventative. Another DES case, Abel v. Eli Lilly & Co., approved the concert of action theory as having stated a cause of action which should go to the jury.

Enterprise Liability

Enterprise liability is the term used for the theory developed by the author of the “DES Comment.” According to the author, it is available whenever the plaintiff cannot identify the cause-in-fact of the injury. The elements of enterprise liability as stated are:

  1. Plaintiff is not at fault for his inability to identify the causative agent and such liability [sic] is due to the nature of the defendant’s conduct.
  2. A generically defective product was manufacturered by all the defendents.
  3. Plaintiff’s injury was caused by this product defect.
  4. The defendants owed a duty to the class of which plaintiff was a member.
  5. There is a clear and convincing evidence that plaintiff’s injury was caused by the product of some one of the defendants. For example, the joined defendants accounted for a high percentage of such defective products on the market at the time of plaintiff’s injury.
  6. There existed an insufficient, industry-wide standard of safety as to the manufacture of this product.
  7. All defendants were tortfeasors satisfying the requirements of whatever cause of action is proposed: negligence, warranty, or strict liability.

Enterprise liability was developed specifically for the identification problem of the DES cases. After proving these elements the burden of proof or causation is shifted to the defendants. Any defendant can then absolve himself by showing that his product could not have caused the injury. In order to meet the clear and convincing evidence standard of element number five, a plaintiff must join manufacturers of “a high percentage of the defective products on the market, approximately 75% to 80%.

This theory was designed to correct some of the logical inconsistencies found when trying to fit DES cases into concert-of-action or alternative liability theories. The author justifies the theory upon a basic policy argument that the United States drug industry, as a whole, caused this problem and that it, therefore, should be liable. Further, the author stated that by the use of selfinsurance and captive insurers, the drug industry can better afford to pay the cost. Other policy arguments include: that enterprise liability would provide incentives for the drug companies to improve their testing and adverse reaction reporting systems; that the drug industry is financially sound and can easily afford these losses; that drug companies presently do not spend sufficient amount of funds on research and development; and that any losses could be easily passed along to the consumer through higher prices.

The Sindell court rejected enterprise liability by first distinguishing Hall, upon which the theory relies. Justice Mosk felt that the differences between a six-member blasting cap industry and the DES industry of over 200 firms were simply too great. Most importantly, however, the Sindell majority felt that it was unfair to condemn the industry for standards which were so highly compelled by the federal government. Justice Mosk stated:

But since the government plays such a pervasive role in formulating the criteria for the testing and marketing of drugs, it would be unfair to impose upon a manufacturer liability for injuries resulting from the use of a drug which it did not supply simply because it followed the standards of the industry.

There are also several policy considerations which argue against the theory of enterprise liability. It remains questionable whether a drug manufacturer should be held liable for a product which only “could” have caused the injury. As already noted, plaintiffs who cannot identify the manufacturer will be favored over those who can by having a larger pool of defendants. Further, expansion of manufacturers’ liability will further increase the cost of products liability insurance, if it is indeed available at all. It is highly questionable whether liability here will serve any deterence function since the injuries were arguably not foreseeable to begin with. Apparently, no court has adopted the enterprise liability theory as proposed in the “DES Comment.

Market Share Liability

As previously discussed, Sindell created the theory of market share liability. Justice Richardson, in dissent, aptly recognized that although the majority rejected enterprise or industry-wide liability, the difference between it and the majority’s market share liability was a difference of form rather than substance.

The theories are not, however, identical. As already noted, enterprise liability requires a 75-80% joinder while Sindell requires only a “substantial share.” The theoretical differences of each theory have been observed by many commentators. One writer observed that allocatoin under enterprise liability is based on a national market, the Sindell approach is presumably based on the California market. Similarly, each defendant under enterprise liability faces joint and several liability, while under Sindell he arguably only faces liability for his proportional share of the market. This can lead to profound differences to defendants and to plaintiffs.


The extensive efforts made by courts and commentators to expand traditional products liability and tort doctrines to solve the identification problem faced by DES plaintiffs are understandable. As one writer observed, “Sindell is a classic example of the admonition that hard cases make bad law. While pursuing a noble motive – the compensation of innocent victims of adverse drug reactions – the Sindell court gravely overstepped the boundaries of judicial lawmaking. The same, of course, can be said for the enterprise liability theory and the alternative liability and concert of action theories which are logically inapplicable anyway.

The most basic reason to resist these theories is the tremendous break they make from prior law. The causation issue is such a fundamental requirement of products liability law that it should not be eliminated. As Dean Prosser noted: the plaintiff must introduce evidence which affords a reasonable basis for the conclusion that it is more likely than not that the conduct of the defendant was a substantial factor in bringing about the result. A mere possibility of such causation is not enough ….  These theories similarly have extended potential liability so far that a particular defendant may be held proportionately liable even though mathematically it is much more likely than not that it played no role whatever in causing plaintiffs’ injuries.

Extension of liability here would severely strain the drug companies’ ability to obtain adequate insurance coverage. Products liability insurance rates for United States drug companies already reflect the tremendous liability exposures. In fact, many United States drug companies have already been forced to self-insure because insurance companies are unwilling to underwrite these risks. The risks are large enough that at least one company is now viewed as a poor investment risk.

Despite protestations to the contrary, United States drug manufacturers do put forth great amounts of effort and resources into research and development. Public policy obviously favors the development of new drugs, but as each new product faces huge and seemingly unlimited liability, the incentive to continue research is reduced. One writer analyzed the harm done society as strict liability is imposed:

There are two risks involved in the development of new drugs:

  1. the risk that unforeseen, perhaps catastrophic, injuries will result because a new drug is used in man too soon;
  2. and the risk that needless human suffering and death will occur because a beneficial drug is withheld from mankind too long. Absolute liability for the adverse effects of new drugs would enlarge the latter risk to unacceptable proportions, while giving a remedy to those injured by the former risk.

Thus, society as a whole is better off by not further expanding our products liability laws in this setting.

Further doctrinal expansion will serve only a compensation function and not a deterrence function. If we are to hold drug companies liable for latent defects in their products, then we should at least leave the causation burden with the plaintiff. In this way the defendant who caused the harm would be the one deterred.

As already noted, defense costs in DES cases are high, and the actual amount received by plaintiffs low. This points up the tremendous costs of using the legal system to solve this problem. The DES cases are very complicated, legally and medically. The costs mount up with each new case, a new jury, a new judge, and often new attorneys must be taught the unique facts of a DES case.

The market share and enterprise liability theories were developed for the DES cases, but their impact could extend much further. It was observed that Sindell is potentially applicable in any case where identification of the manufacturer is impossible or where a generically similar defective product is produced by multiple manufacturers. An especially likely area of exportation would be the over 6,000 already pending cases involving asbestos.


FDA Regulation

While it cannot compensate the victims, the FDA should be allowed to continue to regulate the drug industry. The suggestions to let products liability actions take the place of federal regulation seem ludicrous in the DES context.

Were DES introduced today for the use of preventing miscarriages it would surely not be approved by the FDA. While the benefit of hindsight is difficult to ignore, the FDA’s testing procedures have been vastly improved since the 1940’s. The tests done in the 1940’s did not generally include possible effects on a fetus, although today the FDA would certainly require such studies, especially for a drug meant to be given to pregnant women. DES would not be approved today for use as a miscarriage preventative for the additional reason that the drug has been proven not effective for that use. Since the KefauverHarris Amendments of 1962, drugs must be safe and effective to receive FDA approval.

Legislative Solutions

Many observers have suggested a no-fault insurance system for product injuries. Even the “DES Comment” recommended this, but recognized it was within the province of the legislature.

Most of these proposals would apply to all industries. One especially notable proposal appears in a 1979 law review comment. The author proposes a “latent technological injury compensation” system where an injured party could go to an administrative body for relief if his injury was not discoverable within a certain specified period after initial purchase. After this “statute of limitations” ran, the plaintiff would lose his tort or products liability actions. The plaintiff would be compensated by the administrative body upon: showing that she was injured; tracing her injury to a type of product; and showing her injury was not discoverable during the statutory period. Compensation would be for bodily injuries including medical expenses and lost earnings but not for pain and suffering. This system would be funded by a uniform tax on all manufacturers.

While this system has much to commend it, the authors would prefer a system limited to the DES situation. Other industries and products, such as asbestos, could be added later as the legislature saw fit. Such a system would be similar to the one suggested by Justice Richardson in Sindell. It is believed, however, that a national system would be preferable to a state-by-state approach.

This proposed national system should be funded by a tax upon the manufacturers who produced DES for use as a miscarriage preventative. The tax should be equitably imposed upon them, most probably based upon total national market share. While it is true, that this will involve some of the same difficulties presented by the Sindell approach, figures for such a national market are already available. As with the “latent technological injury compensation system” discussed earlier, recovery should be limited to medical expenses and lost earnings and it would, of course, displace other remedies. Hopefully, the cooperation of the drug companies could be obtained since they have much to gain by the system, most importantly avoiding needless defense costs and possible awards for pain and suffering.

In conclusion, Sindell and the enterprise liability proposal were indeed noble efforts to compensate the innocent victims of DES exposure. It is hard to imagine plaintiffs more innocent than those who were exposed to the drug before their birth. The judicial theories, however, wreak too much havoc upon our legal doctrines. The solution must be of legislative origin, not judicial. The DES identification problem must be answered finally by a policy decision. The difficulties and adverse effects of a judicial solution make the legislative one preferable.

Barry S. Roberts and Charles F. Royster, Winter 1983.

Click to download the full study.

More DES DiEthylStilbestrol Resources

Proving Causation in Toxic Torts Litigation


During the past thirty to forty years, the production and use of chemicals have become a major part of American industries , Such industries generate hazardous waste as a by-product of manufacturing goods such as medicines, textiles, petroleum products, leather, and paints. The Environmental Protection Agency has estimated that more than 54 million metric tons of hazardous waste are generated each year in the United States. Approximately ninety percent of this waste is handled improperly from the time it is generated with the result that many toxic substances have negatively affected the lives and health of unknowing victims. In fact, the problem of hazardous waste disposal has been described as “a public health nightmare of extraordinary dimensions.”

Proving Causation in Toxic Torts Litigation, Hofstra Law Review, Volume 11, Issue 4, Article 7, 1983.

Millions of Americans are unaware that they are encountering potentially serious health risks everyday. Most victims never consciously choose to face the risks of exposure to hazardous waste. They select their living environment unaware of the danger that may lurk underground. Because many hazardous waste disposal sites still have not been discovered, there is a “chemical time bomb ticking beneath the earth” which could explode at any time causing devastation to innocent people.

The notorious incident at Love Canal brought the disastrous effects of improper toxic waste disposal to the forefront of public attention. The residents of the Love Canal homesites became innocent victims of the hazardous waste buried beneath their homes. They developed afflictions such as cancer, leukemia, liver tumors, and nervous system disorders, resulting in serious debilitation or death. Many pregnant women suffered miscarriages or bore children with birth defects.

Victims of toxic torts are usually unaware of their exposure to toxic substances. The substances often are invisible, tasteless, and odorless; they are transported through the air or by percolating surface or ground waters. The latency period between exposure and discovery of the injury is usually long. Detection and causation problems are complicated because manifestations of toxic substance contamination may vary with each victim and many illnesses or injuries, including cancers or miscarriages, have other possible causes. Furthermore, the harm-causing substance may be a combination of benign substances that were discharged by a number of industries.

The characteristics of toxic substances create a number of obstacles that a toxic tort victim must surmount to obtain a judicial remedy. Among these are the statute of limitations, the expense and difficulties involved in accumulating data, and proof of causation. The causation problem is two-fold: First, the victim must determine the substance that caused the injury and second, the party responsible for discharging that substance must be identified. This note addresses the latter aspect of the causation issue relating to identification of the responsible party and examines how courts have dealt with this issue in toxic tort cases.

The burden of identifying the responsible party can be an impossible one to meet. The Love Canal situation is atypical because it was known that Hooker Electro Chemical Company generated and transported the hazardous waste to the canal. Furthermore, the canal was owned and operated as a disposal site by Hooker. Therefore, the management of the site and the bulk of the wastes buried there can be attributed to one party.

The typical hazardous waste disposal site involves many participants, who have been categorized as generators, transporters, and disposal site operators. To complicate the identification issue further, the substances disposed of in a site may have come from several different generators and the site may have had more than one owner. Generators often use the services of more than one transporter, and transporters typically carry the wastes of several generators to any number of disposal sites. Records by generators, transporters and site owners are rarely kept. Consequently, the plaintiffs, through no fault of their own, may not be able “to isolate a culpable party in the waste disposal chain.”

Similarly, without proof of the precise cause of the injury, the plaintiff may not be able to meet the two traditional tests of causation: the “but for” and the “substantial factor” tests. ” Under the but for” test, the defendant’s conduct is not deemed to be the cause of the plaintiff’s injury if the injury would have occurred in the absence of such action.  A person exposed to a toxic substance that escaped from a hazardous waste landfill will encounter difficulties proving that his injury would not have occurred “but for” the defendant’s conduct, particularly where the injury sustained has more than one possible medical cause.

The “substantial factor” test of causation would require the plaintiff to prove that the defendant’s conduct was a “substantial factor” in bringing about the plaintiff’s harm. In general, the characteristics of toxic substances are such that victims often face considerable difficulty in proving that a particular defendant’s conduct was a substantial factor in causing their harm. Thus, although this test may be less burdensome than the “but for” test, as a practical matter, it is also generally inappropriate3  if the plaintiff is to be given any opportunity to recover.

Courts have alleviated the victims’ burden of proving this aspect of causation in other toxic tort areas, such as asbestos-related diseases  and DES injuries. This note examines the approaches taken by the courts in these areas and analyzes the applicability of these judicial approaches to hazardous waste victims.



Although the mineral asbestos has been known and utilized for centuries, its use did not become commonplace until the end of the nineteenth century. During World War II, the use of asbestos became extremely widespread. Nearly thirty-two million tons of asbestos had been used in the United States by 1978, with the bulk of it used after 1940. During that period, a number of diseases became linked with the inhalation of asbestos dust. The first asbestosrelated disease to be discovered was asbestosis, defined as pulmonary fibrosis, which produces fibrotic changes … in the lung substance itself and in the pleura, the lining of the chest cavity that also surrounds the lung tissue. It is an incurable disease whose characteristics include scarring of the lung tissue, chronic coughing and shortness of breath. As the disease progresses, the victim may have difficulty breathing during exertion or even at rest. Asbestosis is the cumulative result of long-term exposure to asbestos.

In the early 1970’s, mesothelioma also became associated with asbestos inhalation. Mesothelioma produces a malignant tumor in the lining of the chest, thorax, or abdomen. Unlike asbestosis, the development of mesothelioma is not cumulative; one exposure to asbestos dust could result in the growth of the tumor. The disease usually does not manifest itself until thirty to thirty-five years after exposure.

Victims of asbestos-related diseases who seek judicial remedies must prove legal causation (that the asbestos that caused the disease originated with the defendant), and medical causation (that the affliction, in fact, was caused by asbestos). The burden of proving legal causation is a heavy one since it is difficult, if not impossible, to ascertain who exposed the plaintiff to the particular asbestos that caused his disease. Courts faced with asbestos litigation have taken various approaches towards this causation issue in an effort to lessen the plaintiffs’ burden of proof. Medical causation is easily proved in cases of asbestosis and mesothelioma since the inhalation of asbestos dust is the only cause of these ailments. This is not the case, however, for a victim of lung cancer. While lung cancer can be contracted from breathing asbestos dust, studies have shown that cigarette smoking and asbestos dust have a synergistic effect. An asbestos worker who smokes has a much greater chance of contracting lung cancer than would a non-smoker, or a smoker who is not exposed to the mineral. An asbestos worker who smokes cigarettes, therefore, would find it more difficult to prove that his lung cancer is medically caused by asbestos than would a non-smoking victim of asbestosis or mesothelioma.

In cases where factors in addition to asbestos exposure affected the victim’s health, some courts have held the asbestos to be a cause of the disability if the absestos contributed to or accelerated the disability. In Self v. Starr-Davis Co., the decedent had been employed by the defendant for twenty-two years, during which time he was continually exposed to asbestos dust. Upon learning that he had contracted asbestosis, the decedent immediately left his job with the defendant; subsequently, he died of a brain tumor. The decedent’s wife filed a claim for workers’ compensation death benefits and was ultimately awarded compensation. The hearing commissioner found that, although the primary cause of death was a brain tumor, which was not causally related to the asbestosis, the asbestosis had accelerated and contributed to the decedent’s death.

The state court of appeals affirmed the finding of the commissioner, stating that, although it was true that “asbestosis did not aggravate the tumor and had no relation whatsoever to the tumor,” the asbestosis accelerated and contributed to the death of the decedent.

In Crump v. Hartford Accident & Indemnity Co., the Supreme Court of Louisiana also determined that the claimant was entitled to workers’ compensation benefits. Crump, who contracted asbestosis, had worked for the National Gypsum Company for twentyeight years. He sued for benefits, naming National Gypsum and its compensation insurer as defendants. At trial, conflicting medical evidence was presented as to the cause of the plaintiff’s disability. The three physicians who examined Crump agreed that he was totally disabled, but only one concluded that asbestosis was the sole cause. The others testified that Crump’s age and excessive weight were the primary causes of his disability. The trial court applied the “substantial factor” test of causation and determined that while the claimant’s age and weight contributed to his inability to work, the asbestosis was “a substantial contributory cause” to his disability. Based upon the foregoing analysis, the Supreme Court of Louisiana upheld the trial court’s judgment that the defendants were liable.

The more difficult questions of proof lie in the area of legal causation. Under traditional theories of legal causation, a person who has been exposed to asbestos in more than one place would have difficulty proving which of the exposures caused his disease. In Yocom v. Gentry, however, the Supreme Court of Kentucky alleviated the plaintiff’s evidentiary burden of proving which exposure caused his injury. Gentry had worked with asbestos and fiberglass at Ebonite Company for three and one half years. After he developed asbestosis and became disabled, Gentry filed a claim against Ebonite for workers’ compensation benefits. Ebonite contended that since “there is slight exposure to asbestos particles by the general public,” the asbestos that caused Gentry’s disease may not have come from Ebonite. The court rejected this argument and held Ebonite liable because Gentry’s “only significant exposure . . . to the hazards of the disease was with Ebonite. The Yocom court had to determine, therefore, whether Gentry’s disease was incident to his employment at Ebonite or the result of general exposure to asbestos.

The dilemma faced by the Yocun court is complicated greatly in situations where the victim was exposed to asbestos dust at more than one work place. In such cases, there is virtually no way to determine where the victim inhaled the asbestos that caused his harm. Fortunately, not all asbestos victims are left remediless simply because they cannot prove whose product caused their disease. A number of approaches have been used by the courts to lessen the victims’ causation burden and to impose liability on the defendants. Courts have applied the “substantial factor” test, the market share liability theory, the last injurious exposure rule, and the duration and intensity approach.

Substantial Factor” Test

The “substantial factor” test was applied by the court in Borel v. Fibreboard Paper Products Corp. Borel was the first asbestosis claim to be tried to a final verdict. Clarence Borel was employed as an industrial insulation worker from 1936 until 1969 when he became disabled from asbestosis. Because he was unable to determine which asbestos exposure had caused his disease, he brought suit against eleven manufacturers of asbestos insulation materials whose products he had been in contact with throughout his career.

Since each exposure to asbestos contributes to the harm and causes more tissue damage, the victim’s condition is the result of past and recent exposures. Additionally, although the latency period usually varies from ten to twenty-five years, the disease has been known to manifest itself less than ten or more than twenty-five years after the initial exposure. The combination of these factors made it practically impossible to ascertain which exposure or exposures actually caused the plaintiff’s injury.

Recognizing that legal causation could not be proved to an absolute certainty, the Borel court applied the “substantial factor” test of causation: A defendant’s conduct is the cause of the event if it was a substantial factor in bringing it about. Since Borel contracted asbestosis from inhaling asbestos dust to which he was exposed by each of the defendants on numerous occasions, and because the cumulative effect of exposure was undisputed, the court found enough circumstantial evidence to hold each defendant liable as a substantial factor in bringing about Borel’s harm.

Market Share Liability

The Borel decision brought to the courts a barrage of asbestosrelated cases. Fifty-seven of these cases were consolidated for determination of pretrial motions and were captioned Hardy v. JohnsManville Sales Corp. Faced with the task of ruling on the consolidated discovery motion seeking information relating to the defendants’ share of the asbestos market, a federal court in Texas had to determine whether the market share liability theory was applicable to asbestos-related litigation. The market share liability concept allows plaintiffs to recover damages notwithstanding the fact that they cannot identify a particular defendant whose product caused the harm. The plaintiff initially must come forward with proof of exposure to the product and proof of medical causation, i.e., that the product caused the injury. If the plaintiff satisfies this requirement, the burden then shifts to the defendants to demonstrate that their product(s) could not have caused the plaintiff’s harm. The defendants who cannot meet this burden are held individually liable for a portion of the judgment equal to their proportionate share of the market.

Because the cumulative nature of asbestosis and the long, indefinite latency period for asbestosis and mesothelioma may hamper a victim’s ability to pinpoint the exact causative agent of the disease, the market share theory of liability appeared to the Hardy court to be a logical way of dealing with the causation issue. Furthermore, the Hardy court noted that the California court, which had created the market share theory, relied upon the alternative and concurrent liability theory set forth in Summers v. Tice, and that Summers had a precedential equivalent in Texas. For these reasons, the federal court in Hardy felt safe in assuming that a Texas state court faced with an asbestos-related claim would apply the market share liability theory and, thereby, relieve the plaintiff of the burden of proving causation. As a result, the court granted the discovery motion related to this theory. Although the market share liability approach appears to be an equitable solution in the context of asbestos injury litigation, its acceptance has been limited as exemplified by its codification in the workers’ compensation law of only one state.

Last Injurious Exposure

The “last injurious exposure” rule is followed by the majority of jurisdictions faced with occupational disease cases, in workers’ compensation contexts, where the exact cause of the disease is uncertain. In Mathis v. State Accident Insurance Fund, Mathis had worked with asbestos for several employers for more than thirty years. He left his last position with Metalclad Insulation only four months after learning that he had contracted asbestosis. His claim against Metalclad and its insurance company for workers’ compensation was denied because he failed to establish a causal link between his last employer and his disability. On appeal, the Oregon Court of Appeals adopted the “last injurious exposure” rule. This rule imposes full liability on a defendant/employer where the plaintiff was last exposed to the hazardous material during his employment with that defendant and the hazardous condition bears a causal relation to the disability. Legal causation need not be proved-the last employer will be liable as long as there is “sufficient evidence to support the general rule requirement that the conditions of the last employment were such that they could cause asbestosis over some indefinite period of time.” To illustrate: Suppose V was first employed by A for thirty years and then by B for twenty-five days. At both places V worked in an asbestos-filled environment. He discontinued his employment with B when he discovered that he had contracted asbestosis. According to the “last injurious expqsure” rule, only B will be liable for V’s harm if the conditions where V was employed by B could have caused asbestosis over that period of time.

Mathis demonstrates that the general rule may present inequities to short-term employers. The Oregon Legislature, however, has given employers a means to protect themselves by allowing employers to require potential employees to submit to a medical examination. In this way, employers can avoid hiring workers who are suffering from advanced occupational diseases.

Other state legislatures have modified the “last injurious exposure” rule in a different manner to guard against the aforementioned problem. These states have set forth minimum periods of employment before the employer can be held liable. To recover, the plaintiff only must identify the last employer who exposed him to asbestos for more than the statutory period of time. In addition, the plaintiff must prove that he inhaled asbestos dust at that place of employment, that asbestos dust is the cause of his disease, and that he is disabled. This statutory scheme effectively removes the plaintiff’s burden of proving legal causation.

The Missouri Court of Appeals, in Ringeisen v. Insulation Services, Inc.,  has analogized the “last injurious exposure” rule to a “rule of convenience.” The adoption of this rule in Missouri was precipitated by the finding that “any search for positive proof of causation among several employers in cases of occupational diseases was a futile search. In this jurisdiction the victim’s last employer will be liable as long as the victim was exposed to the hazardous substance at that last place of employment.” The last employer cannot be held liable, however, if the victim worked there for less than ninety days.

While Mathis pointed out how inequitable the “last injurious exposure” rule can be to a short-term employer, Ringeisen expressed its discontentment with the potential effects of the ninety day time constraint on injured workers who have not worked in any one place for that length of time. It was undisputed that the plaintiff in Ringeisen had contracted asbestosis and that he had been exposed to asbestos dust both at Owens Corning Fiber Glass Corporation and at Insulation Services, Inc. Since he was not employed at either place for more than ninety days, however, the court could not compensate him because of the “clear meaning of the statute“. The court suggested that the legislature should give this dilemma further consideration.

Duration and Intensity

Another approach to the causation problem was applied in Caudie-Hyatt, Inc. v. Mixon, by the Virginia Supreme Court. The suit originated as a workers’ compensation claim by Henry Mixon, and was pursued by his wife after he died of mesothelioma Mrs. Mixon was awarded death benefits and Caudle-Hyatt appealed to the Virginia Supreme Court.  One of the issues raised on appeal was the claimant’s failure to prove causation. The defendants contended that although Mixon had been exposed to asbestos during his employment at Caudle-Hyatt, the exposure did not “cause, augment, or aggravate the disease. For a Virginia employer to be liable, the Virginia workers’ compensation statute requires that the employee have had “an exposure to the causative hazard of such disease which is reasonably calculated to bring on the disease in question. The Caudle-Hyatt court, holding in favor of Mixon, stated that actual causation need not be proved; the plaintiff need only show that the “aggravation of the disease or . . . the exposure was of such duration and intensity that it generally causes the disease in question, even though actual causation or aggravation cannot be established in the claimant’s case.

The Caudle-Hyatt case demonstrates that a plaintiff afflicted with an asbestos-related ailment need not be denied relief simply because proof of actual causation is difficult or impossible to obtain. The plaintiff need only prove that his exposure was of a certain duration and intensity.  In this case, a medical expert testified that exposure to asbestos for one month could produce mesothelioma. In addition, Mixon’s co-workers testified that Mixon worked for at least one month in an environment where asbestos dust and insulation remnants existed . The court held that the evidence supported the conclusion that Mixon was “‘injuriously exposed‘to asbestos in that it was “‘reasonably calculated to bring on the disease in question. ”

These cases demonstrate that although people afflicted with asbestos-related diseases cannot prove with certainty which exposure to asbestos caused their disease, they are not always left without a remedy. The approaches to this problem vary in these jurisdictions, but the end result is the same: liability may be found even though legal causation is never proved.


Victims of hazardous waste injuries often face comparable difficulties in proving the cause of their afflictions. First, the hazardous waste victim cannot always isolate the harm-causing substance. Second, once the substance is identified, it is often problematic for the victim to trace it to its specific source.

The first difficulty is analogous to that of the asbestos worker who contracted asbestosis but died from a brain tumor, or the asbestos worker whose age and excessive weight contributed to his disability. The courts allowed these plaintiffs to recover where asbestos accelerated or contributed to the victim’s death or disability. Similarly, the judiciary could reach a comparable result by applying these modified causation theories (derived from asbestos litigation) to those hazardous waste cases where the victim cannot isolate the injurious substance.

The lenient approach of the Caudle-Hyatt court, where the plaintiff only had to prove that the duration and intensity of his exposure generally caused the injury he sustained, is an easier burden for a victim of an asbestos-related disease to meet than for a hazardous waste victim. Asbestos has been widely used since the end of the nineteenth century and its properties are well-known. It was first linked to various diseases in the middle part of this century and an abundance of information has accumulated regarding the nature and characteristics of the diseases. In contrast, toxic torts from leaching hazardous waste were first brought to the forefront of public attention in the 1970’s with the incident at Love Canal. Little is known about the injuries that may result from the chemicals that have been disposed of in landfills. Therefore, due to this relative disparity in knowledge, hazardous waste victims would have a greater burden to prove duration and intensity of exposure than the asbestos-related victims. If the hazardous waste victim can identify the substance that caused the harm, proving duration and intensity of exposure to that substance would be less burdensome. The victim would still have the difficult task of proving who disposed of the specific harm-producing chemical.

Lessening the plaintiff’s burden may appear to be unjust to the defendant since the producer of a toxic substance may then be held liable for injuries suffered by the plaintiff despite the lack of direct proof that the defendant caused the harm. Moreover, the defendant may not be in a better position than the plaintiff to prove that the plaintiff’s harm originated from another source. While this may seem to push the tort system past its limits,  the plaintiff should not be denied compensation merely because other factors contributed to his injury as long as it still can be proved that the hazardous substance disposed of by the defendant may have contributed to or accelerated the harm. The defendant who exposes the plaintiff to the risk of harm by discharging the toxic substance should not escape liability simply because other factors also contributed to the plaintiff’s injuries.

In the second situation where the victim can identify the substance that caused the injury and can trace it to a number of possible sources, the courts could apply the theories used in the asbestos cases so that innocent victims can be compensated without proof of the precise causal source. This would be analogous to the asbestos worker in Borel who was exposed to the asbestos products of a number of manufacturers and could not determine which exposure was the actual cause. That court applied the “substantial factor” test of causation and allowed the plaintiff to recover without proving specifically which manufacturer’s asbestos caused his disease. The cumulative nature of asbestosis made the substantial factor test applicable since each asbestos product could conceivably have contributed to his injury. The reasoning of the Borel court could be applied to a hazardous waste case if the plaintiff can establish that his injury resulted from the cumulative exposure to the defendant’s toxicant. To do so, however, the plaintiff must ascertain information as to the nature and characteristics of that substance. Since toxic torts resulting from hazardous waste disposal are relatively new in comparison with asbestos-related diseases, such information would probably not be available to the plaintiff. Therefore, the “substantial factor” test of causation, as applied in Borel, may not be useful to hazardous waste victims.

The court could apply the “last injurious exposure” rule when the plaintiff can identify the last defendant to discharge the hazardous substance causally related to the victim’s injury. Although the inequities of this rule were observed in the asbestos cases, it nevertheless was adopted in a number of jurisdictions. This rule would allow the hazardous waste victim to recover without proving causation if he can identify the harm-causing substance and the last source of his exposure. Unless accurate records were kept by the defendants as to the quantity and time of discharges, the plaintiff would face the impossible task of proving who was the last to discharge the substance. Furthermore, where the “last injurious exposure” rule was applied to asbestos cases, the different exposures to asbestos were distinct events. This is generally not the case in the hazardous waste area, since the plaintiff is not moving from one place of exposure to another. In situations where multiple defendants disposed of hazardous substances in the same landfill, the issue of whoever dumped last would be irrelevant if the substances leached out several years after the last discharge occurred. The victim would be exposed to each defendant’s toxicant at the same time. Therefore, the “last injurious exposure” rule, if used at all in the hazardous waste area, would have very limited applications.

While the solutions to the causation problem in the asbestos cases could have an impact on hazardous waste cases, it is apparent that some modifications would be necessary to accomodate the special needs of hazardous waste plaintiffs. The approaches some courts have taken in the DES area may be of assistance to these victims.



DES refers to a group of synthetic estrogens which were prescribed to pregnant women from the late 1940’s until 1971 for a variety of reasons, including the prevention of miscarriages. The drug, which was developed in England in 1938, was not patented by its inventor and, therefore, anyone could market it. In 1947, when the Food and Drug Administration (FDA) approved the use of DES for the prevention of certain complications during pregnancy, hundreds of pharmaceutical companies in the United States became involved in marketing the drug in subsequent years.

In 1971, the FDA indicated that DES was both ineffective and dangerous for use by pregnant women. Studies revealed a link between the use of DES during pregnancies and a form of gynecological cancer in daughters born from those pregnancies. By the time the FDA “banned” the use of DES during pregnancies, millions of women had consumed the drug while pregnant and many of their female offspring had been confronted with the possibility of developing vaginal and cervical cancer.

Approximately one thousand lawsuits have been commenced against DES manufacturers based on a products liability cause of action. One commentator noted that plaintiffs are able to prove that DES caused their injuries, that the defendant drug companies manufactured DES for the prevention of miscarriages, that the defendants knew or should have known that DES was carcinogenic, and that the defendants failed to warn the plaintiffs’ mothers of the hazards of the drug. The plaintiffs, however, still have the burden of identifying which drug company manufactured the DES that their mothers ingested. Establishing this causal link is extremely difficult, and perhaps, impossible, since the various brands of the unpatented and fungible DES pills were essentially interchangeable.  As a result, physicians often prescribed it without specifying a particular brand aid pharmacists often dispensed it with whatever brand they happened to have had in stock at the time. Records of which brand filled a particular prescription are usually unavailable.

A number of plaintiffs have been precluded from recovering damages for their injuries because they failed to identify the specific drug company that manufactured the DES that caused their injury. Other courts, cognizant of the difficulties in applying traditional causation theories to DES cases, have allowed plaintiffs to recover notwithstanding their inability to prove a causal connection between their injury and a particular manufacturer.

Market Share Liability

In Sindell v. Abbott Laboratories, the daughters of women who had ingested DES while pregnant brought a class action suit against eleven pharmaceutical companies that produced DES. The plaintiffs claimed that their cancerous or precancerous conditions resuited from in utero exposure to DES. They identified the drug that caused their injuries and alleged negligence on the part of the defendants for inadequately testing the drug and failing to warn users of its potential dangers. The trial court dismissed the complaint, however, for failure to identify the precise manufacturer of the actual pill that caused their harm.

On appeal, the Supreme Court of California found that it could not apply any existing exception to the traditional causation theories to allow the plaintiffs to recover;  it did not, however, leave the victims without a remedy. Instead, the court fashioned a theory of market share liability, based on the reasoning in Summers v. Tice, that “as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury.”‘ The Sindell court noted:

In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer. The response of the courts can be either to adhere rigidly to prior doctrine, denying recovery to those injured by such products, or to fashion remedies to meet these changing needs.

In addition, according to the court, not only were the defendants in a better position than the innocent plaintiffs to bear the financial burden that resulted from their defective products, but the imposition of liability would encourage the defendants to manufacture safer products.

The market share theory requires that the plaintiffs join a “substantial percentage” of the manufacturers which may have produced the defective product. The burden of proving causation then shifts to the defendants, who must demonstrate that they could not have manufactured the product that caused the plaintiff’s harm. Each defendant that cannot exculpate itself is “liable for the proportion of the judgment represented by its share of the market ….

A number of problems in implementing the market share approach were left unanswered by Sindell. The court did not specify what would constitute a “substantial percentage” of the market, opining that while 75 to 80 percent of the market is suggested as the requirement we hold only that a substantial percentage is required. Additionally, the court determined that any difficulties that the plaintiffs may encounter in specifying the relevant market and in ascertaining the defendants’ share of that market, would be left for the trial court to consider as matters of proof. As a result, it is unclear what a future plaintiff would have to prove with respect to the defendants’ market shares to satisfy her burden.

Alternative Liability

Other jurisdictions have allowed DES victims to recover without adopting the market share approach enunciated in Sindell. A New Jersey court, faced with a DES causation dilemma, held for the plaintiffs in Ferrigno v. Eli Lilly & Co. on the theory of alternative liability. In that case, eight women brought suit against twentytwo manufacturers and distributors of DES. The court relied on Anderson v. Somberg for the proposition that where plaintiffs, through no fault of their own, cannot pinpoint which of a group of negligent defendants caused their harm, the burden shifts to the defendants to exculpate themselves. Those who cannot disprove their liability remain jointly and severally liable.

The question on appeal was whether the defendants could be held jointly and severally liable even though it was uncertain that the specific causative agent was one of the defendants before the court. The Sindell court, concerned with this precise issue, chose to modify the alternative liability rule by requiring that the plaintiff need only join a substantial percentage of all potential defendantmanufacturers. The Ferrigno court, however, relying upon Anderson, held that all possible defendants need not be before the court for the alternative liability rule to apply in an unmodified form. In Anderson, the court could neither discern who was responsible for the plaintiff’s harm, nor guarantee that the wrongdoer was among the defendants. The court nevertheless imposed joint and several liability upon the defendants.

Although Ferrigno recognized that Anderson intended to limit its holding to similar cases, Ferrigno found a number of parallels between the plaintiffs in the two cases and, therefore, applied the principles of Anderson to the DES case. The Ferrigno court found:

  1. the defendants were members of a group where all members could be at fault;
  2. the defendants owed a special responsibility to the plaintiffs as manufacturers of a potentially dangerous drug;
  3. the plaintiffs were totally innocent;
  4. the harm to the plaintiffs was not reasonably foreseeable to them and was not related to the purpose for which their mothers ingested DES;
  5. and the plaintiffs’ inability to identify the exact cause was the fault of the defendants for marketing a fungible drug.

Furthermore, the latency period compounded the plaintiffs’ inability to identify the cause, since any records their mothers may have kept would reasonably have been discarded by the time their daughters’ injuries surfaced. Based on the principles of Anderson and the strong policy in New Jersey favoring recovery by innocent plaintiffs-as opposed to the exoneration of culpable defendants-where the plaintiffs cannot identify the cause of their injuries, the court will hold for the plaintiffs.

In Abel v. Eli Lilly & Co., the plaintiffs were similarly situated to the Sindell and Ferrigno plaintiffs. The Michigan Court of Appeals recognized two existing theories under which the plaintiffs stated a cause of action without proof of the precise causative agent  and, therefore, found no need to adopt the market share theory. Like the Ferrigno court, the Michigan Court of Appeals recognized that the alternative liability rule that Sindell modified to create the market share theory could be applied in its original form to Abel. Alternative liability is applicable where

independent acts by two or more tortfeasors exist, all of whom have acted wrongfully, but only one of whom has injured the plaintiff. Joint and several liability is imposed, not because all are responsible for the damage, but because it is impossible to tell which one is responsible. Rather than deny the innocent plaintiff his recovery because he cannot prove which of two or more wrongdoers injured him, the courts impose joint liability on all wrongdoers.

Under this theory, the plaintiffs “must establish . . . that each defendant breached its duty of care in producing the product, that the harm to each plaintiff was the result of ingestion of DES by her mother, and that one or more of the named defendants manufactured the DES so ingested.” The burden then shifts to each of the defendants to prove that it did not produce the pill that injured the plaintiff.

Unlike the court in Sindell, the Michigan court did not believe that an injustice would be served by holding the defendants jointly and severally liable instead of apportioning damages according to the defendants’ proportionate share of the market. The court refused to increase the plaintiffs’ burden by requiring production of evidence concerning the defendants’ percentages of the DES market. It is possible that this refusal stemmed from the fact that in Abel, unlike Sindell, every DES manufacturer that distributed the drug in the state during the relevant time period was named as a defendant, so that the chance that the causative agent would escape liability was minimal. As a result, the Abel court held that the plaintiffs need not apportion damages among the defendants in order to state a claim for recovery based on an alternative liability theory.

Concerted Action

The second theory discussed by the Abel court upon which relief could be granted is the concerted action theory under which

all those who, in pursuance of a common plan or design to commit a tortious act, actively take part in it, or further it by cooperation or request, or who lend aid or encouragement to the wrongdoer, or ratify and adopt his acts done for their benefit, are equally liable with him. Express agreement is not necessary, and all that is required is that there be a tacit understanding ….

In short, if the plaintiffs can establish that the defendants engaged in concerted activity, all of the defendants are liable even though only one directly caused the harm. As in the alternative liability situation, the burden of proving causation shifts to the defendants to disprove their liability. The court concluded that the plaintiffs’ allegations that the defendants acted in concert by wrongfully producing and marketing a dangerous drug without adequate testing or warnings were sufficient to state a cause of action without identifying the precise cause of their harm.

In Bichler v. Eli Lilly & Co., a New York court modified the concerted action theory to allow the plaintiff to recover notwithstanding her inability to identify with certainty the causative agent of her harm. The plaintiff, seeking recovery under the concerted action theory, brought suit against only one manufacturer of DES. The defendant, Eli Lilly and Company, was a major producer of DES at the time the plaintiff’s mother ingested the drug. Since Lilly, acting in concert with other makers of DES, wrongfully tested and marketed the drug without warning consumers of its hazards, the plaintiff alleged that Lilly should be held jointly and severally liable for the resulting injuries.

The Bichler court agreed with the Abel decision that “the law, especially in the products liability area, was not so rigid as to preclude an injured party, with an otherwise valid claim, from a remedy” solely because she could not discern the cause of her harm. For this reason, Bichler upheld the trial court’s modified definition of concerted action, under which the defendants are deemed to have acted in concert even though they acted independently of each other in committing the same wrongful act, if their acts had the effect of substantially encouraging or assisting the wrongful conduct of the other, which, in this case, was the alleged failure to adequately test. The court concluded that “it does not strain one’s sense of fairness to allow a limited expansion of the doctrine of concerted action to cover the type of circumstances faced in a DES case where the traditional evidentiary requirements of tort law may be insurmountable.” As a result, the plaintiff was able to recover without proving causation.


Victims of hazardous waste face problems in proving causation similar to those encountered by DES victims. Since their injuries are caused by fungible goods, they confront the initial problem of identifying the cause of their injuries. Assuming that hazardous waste victims can pinpoint the substance that caused their harm, they are left with the burden of proving who allowed the particular injury causing substance to leach out into the environment.

The theories applied by the courts in the DES cases to shift the burden of proving causation to the defendants may be useful to courts faced with hazardous waste injury cases. Like DES victims, hazardous waste victims are usually not certain of who caused their exposure to the toxic substance at the root of their injuries. To determine which theory of causation should be applied, the circumstances surrounding the injury must be examined. Where a person is contaminated by an identifiable substance emanating from a dumpsite, he may be able to trace it to a number of defendants. The victim could then bring an action against all those that allowed the toxic substance to escape.

If the market share theory is applied, numerous difficulties would be encountered. First, if all those responsible for the leaching of the harm-causing substance constitute the “market,” the victim would have to join a “substantial percentage” of those producers to maintain a suit under the market share theory. Since “substantial percentage” was inadequately explained in Sindell, it is not known if the plaintiff must join a substantial percentage of the site owners, generators, or transporters of the substance, or, alternatively, a substantial percentage of all three combined. If the defendants include all three categories of actors, determining their proportionate market share would be nearly impossible since they are parts of different markets. The fact that accurate records were rarely kept by generators, transporters and site owners compounds the problems of finding all possible defendants and ascertaining what constitutes their percentage of the market. Furthermore, a manufacturer’s percentage of dumping may not be equal to its percentage of the market. For example, one paint producer may generate more of a substance than its competitor; or one manufacturer may recycle more of its waste than another. It is likely that not all those responsible for discharging the substance will be known to the victim; this, however, would not deter a court from applying the market share theory since the named defendants would only be liable in proportion to their percentage of the market. As a result of these complications, the market share theory as set forth in Sindel may not be the best available doctrine upon which hazardous waste victims should seek recovery.

A concerted action theory of liability might be better suited where the plaintiff cannot identify which defendant caused his injury. If the plaintiff alleges that the defendants acted in concert by wrongfully discharging hazardous chemicals into a common dumpsite without adequately providing for their containment, the court, following Abel v. Eli Lilly & Co., could find that a cause of action exists notwithstanding the lack of identification of the precise cause. Alternatively, the modification of concerted action in Bichler v. Eli Lilly & Co., might aid the toxic tort plaintiff to recover. The plaintiff could argue that, although the defendants acted independently, their acts of dumping the substance encouraged or assisted the wrongful behaviors of the other defendants. The named defendants would be jointly and severally liable unless they could exonerate themselves. The possibility that every wrongdoer is not before the court should not preclude the plaintiff from recovering damages. The defendants could either join as third party defendants other culpable parties not named by the plaintiff, or commence a separate action against such parties for contribution.

The expanded theory of concerted action, if applied to the hazardous waste situation, might allow the victims to be compensated without proving the specific cause of their injuries. Although this may appear inequitable to the defendants, they engaged in a hazardous activity that exposed the plaintiffs to serious risks. The equities, therefore, weigh in the victims’ favor, and the courts should adopt this theory for such cases.

Application of the alternative liability approach may vary with the jurisdiction, depending upon which view is followed with respect to whether all possible defendants must be joined. Sindell stated that alternative liability cannot be utilized unless every potential wrongdoer is before the court. Ferrigno, however, disagreed with Sindell. In Ferrigno, recovery was permitted under the alternative liability theory even though the court was not positive that the precise wrongdoer was before it. Following Ferrigno, if the plaintiff establishes that the defendants breached their duty of care in disposing of the toxicant, that the plaintiff’s harm resulted from the substance, and that the defendant produced that type of toxic substance, then the burden of proving causation shifts to the defendants. Those defendants who cannot meet this burden will be held jointly and severally liable. A hazardous waste victim who can bring suit under an alternative liability theory would have a chance to recover even where it is not possible to name all potential wrongdoers.

Shifting the burden of proving causation onto the defendants may seem unfair since the defendants may not be in a better position than the plaintiffs to prove whose substance caused the plaintiffs’ harm. The defendants, however, contributed to the identification problem by inadequately disposing toxic substances at the same landfill. Futhermore, while it may be true that the adoption of an alternative liability theory for hazardous waste torts may cause traditional concepts and basic principles of tort law to be distorted or abandoned, the hazardous waste tort is not a “traditional” injury. Rather, it is the result of our industrialized society. Therefore, our traditional legal notions must evolve to keep up with our progressing society.


Courts have been willing to dispense with traditional causation tests to allow victims of asbestos and DES-related injuries to recover without having to prove who manufactured the product that caused the injury. The approaches these courts have utilized vary with respect to what the plaintiffs must prove in order to recover, but they all share a common denominator-the burden of proving causation shifts to the defendants. Although none of the tests set forth in the asbestos or DES cases could be applied to hazardous waste cases without some modifications, the courts could alleviate these victims’ difficulties by shifting the burden of proof to the defendants. The plaintiffs would be required to prove

  1. that they have sustained an injury,
  2. that the injury was caused by exposure to toxic substances,
  3. that the defendants produced and disposed of such substances,
  4. and that they were exposed to the substance.

The burden of proof would then shift to the defendants to exonerate themselves by either disproving the plaintiffs’ offer of proof or by establishing that the particular substance they produced could not have injured the plaintiff.

Although the plaintiff would still have some obstacles to overcome, his burden of proof would no longer be impossible to meet. The victim may still bear the financial burden of having tests and studies conducted, but even this burden may be lessened in time. As in asbestos litigation, the first few plaintiffs had to present medical and scientific evidence regarding the effects of asbestos inhalation. Subsequent plaintiffs, however, had this data available to them. As more is learned about the characteristics of specific toxic substances, plaintiffs’ expenditures to collect data for proof will decrease. In time, collateral estoppel may even eliminate the need for such proof.

At the same time, this proposal is not unfair to the defendants who, by producing and inadequately disposing of a fungible item, have created the situation where innocent plaintiffs are harmed and are unable to trace the injury-causing substance back to its source. Furthermore, the defendants are given the chance to exculpate themselves; lessening the victims’ burden of proof, therefore, is justified.

Traditional notions of causation were developed before the existence of toxic torts was acknowledged. Applying these tests to toxic tort cases is analogous to placing a square peg into a round hole-it just will not fit. The courts have realized this dilemma in the asbestos and DES cases and have modified causation theories accordingly. The same should be done for hazardous waste cases. By shifting the burden of proof of causation to the defendants, the courts would be placing the burden into the hands of those responsible for creating the problem in the first place.

Myra Paiewonsky Mulcahy, Summer 1983.

Click to download the full study.

More DES DiEthylStilbestrol Resources

Market Share Liability: an Answer to the DES Causation Problem

market-share-liability book cover imagePublished by: The Harvard Law Review Association

DOI: 10.2307/1340682

Stable URL: http://www.jstor.org/stable/1340682

Page Count: 13

Harvard Law Review
Vol. 94, No. 3 (Jan., 1981), pp. 668-680.

More information: see our posts tagged Market Share liability.

More DES DiEthylStilbestrol Resources

Overcoming the Identification Burden in DES Litigation: The Market Share Liability Theory


The English case of Winterbottom v. Wright is generally viewed as marking the beginning of product liability law. When Winterbottom was decided in 1842, the industrial sector of society was in its infancy and the courts, in order to encourage industrial development, sought to restrict the tort liability of industrial concerns. In the 140 years since Winterbottom, as the industrial sector has become more powerful, the courts have expanded the liability of manufacturers and generally made it easier for a plaintiff to recover for a product-related injury. This expansion has occurred in response to drastic changes in the market place since pre-industrial times. The direct relationship between manufacturer and consumer has disappeared as more sophisticated methods of manufacture and distribution lengthen the chain of commerce. Also, products have become more complex, reducing the ability of the consumer to evaluate his purchases intelligently. These changes have forced a shift in the judiciary’s view of which parties should be afforded greater protection as a matter of public policy.

Overcoming the Identification Burden in DES Litigation: The Market Share Liability Theorys, Marquette Law Review, Volume 65, Issue 4, Article 4, Summer 1982.

Despite the historical trend toward liberalization of the requirements for recovery in product liability actions, plaintiffs must still establish three elements:

  1. that the product that injured them was defective;
  2. that the defect caused the plaintiff’s injury;
  3. and that the defect was attributable to the party to be held responsible.

The last element – called the identification requirement – requires the plaintiff to specify the particular manufacturer of the product that injured him. Unless the plaintiff can do so, an essential element of his case will be lacking and recovery will be precluded. Traditionally, the rule has been strictly applied even where two or more manufacturers produce an identical product: unless the plaintiff can exclude all but the specific manufacturer of the particular product that injured him, recovery will not lie, even if all manufacturers were clearly negligent

Recently the courts have been faced with a series of cases wherein the wisdom of the identification requirement, when applied to a certain factual context, has been seriously questioned. Most of these cases have been brought by the daughters of women who ingested the drug diethylstilbestrol (DES), prescribed to prevent miscarriage. These daughters allege that their in utero exposure to DES has caused them to develop a variety of serious genital tract disorders. The plaintiffs in these cases have faced numerous roadblocks to recovery, the most serious being their inability to identify the specific manufacturer of the DES their mothers ingested. In earlier DES cases where the identification requirement was strictly applied, plaintiffs were barred from recovery. More recently, however, two courts have shown a willingness to apply a market share theory of liability under which plaintiffs can circumvent the identification requirement in DES cases, thus increasing their chances of recovery.

This comment will assess the unique nature of the DES cases, and analyze and critique the various theories that have been proposed in an effort to assist plaintiffs in overcoming the identification requirement. Particular emphasis will be placed on the market share liability theory and how it can best be adapted to achieve an equitable result in DES litigation.


Diethylstilbestrol (DES) is a synthetic estrogen. In 1947, the Food and Drug Administration (FDA) authorized the marketing of DES for use as a miscarriage preventative, but only on an experimental basis, with the requirement that the drug contain a warning label regarding its experimental status. Between 1947 and 1971, hundreds of pharmaceutical companies marketed DES, and it was prescribed for millions of pregnant women. In 1971, statistically significant relationships between the use of DES and the subsequent development of genital tract cancer in the users’ daughters were reported in the medical literature. In that same year, the FDA banned the marketing and promotion of the drug for use as a miscarriage preventative is on the basis of its apparent danger and ineffectiveness.

Estimates of the number of “DES daughters” – women whose mothers took DES during pregnancy – range from five hundred thousand to three million. In lawsuits against DES manufacturers, plaintiffs have alleged that DES causes a variety of gynecological disturbances including structural deformities, adenosis and clear-cell adenocarcinoma, the form of cancer linked to DES in earlier studies. Estimates of the actual number of suits filed range up to one thousand, and many of the major drug companies have been brought in as defendants.

The plaintiffs in these cases have been able to present a strong case that the drug manufacturers were negligent in the marketing and testing of DES. Justice Mosk in Sindell v. Abbott Laboratories stated that:

During the period defendants marketed DES, they knew or should have known that it was a carcinogenic substance, that there was a grave danger after varying periods of latency it would cause cancerous and precancerous growths in the daughters of the mothers who took it, and that it was ineffective to prevent miscarriage. Nevertheless, defendants continued to advertise and market the drug as a miscarriage preventative. They failed to test DES for efficacy and safety; the tests performed by others, upon which they relied, indicated that it was not safe or effective. In violation of the authorization of the Food and Drug Administration, defendants marketed DES on an unlimited basis rather than as an experimental drug, and they failed to warn of its potential danger.

Plaintiffs have faced a raft of difficulties in the DES suits, however. These include problems in meeting the requirements for class action certification, the possible inability to establish a cause of action for fetal injury prior to viability, and the running of the statute of limitations in jurisdictions where the cause of action is deemed to accrue at the time of actual injury, rather than at the time the injury is discovered. Clearly, however, the plaintiffs’ most serious problem has been their inability to identify the specific manufacturer of the DES that caused them harm. Several factors have given rise to this problem. First, the sheer number of DES manufacturers (between approximately one hundred and three hundred firms) makes identification difficult. Second, the genital tract cancer associated with DES (adenocarcinoma) has a ten to twenty year latency period. With the passage of time, prescription or purchase records which might identify the source of the DES to which the plaintiff was exposed – whether those records were possessed by the plaintiff’s mother, the mother’s doctor, or the mother’s pharmacist – are likely to have disappeared. Third, even if prescription records were still available, it could not be said with certainty that the drug brand specified on the prescription blank was the actual brand sold to the plaintiff’s mother. DES is a fungible drug produced by many firms, and it was once a common practice of pharmacists to fill prescriptions for DES with whatever brand they had on hand, whether or not that brand was the one specified on the prescription blank.

For the above reasons, plaintiffs argue that strict adherence to the identification requirement in DES cases is unfair. Plaintiffs have proposed three alternate theories of liability – a “concert of action” theory, an “enterprise liability” theory, and an “alternative liability” theory – under which they might recover notwithstanding the difficulties posed by the identification requirement. These three theories, and the courts’ responses to them, are discussed below.


Section 876 of the Restatement (Second) of Torts recognizes three factual patterns in which a concerted action theory might be applied to hold multiple defendants jointly and severally liable. In the first, all defendants act tortiously toward the plaintiff according to a common plan or design. Thus, for example, if A, B, C and D went together to E’s house with the common intent to commit a robbery, and A broke down E’s door, B tied E up, C beat him and D converted his property, A, B, C and D would be jointly and severally liable for the total damages caused by their own and each other’s torts. In the second fact pattern, one or more defendants give substantial assistance or encouragement to another defendant, knowing that the latter’s behavior is tortious. Thus, for example, where A urges B to throw a rock at C, and B does so, injuring C, both A and B are jointly and severally liable for C’s damages, even though A’s behavior, separately considered, was not tortious. In the third fact pattern, two or more defendants participate in a joint activity, and any one defendant is jointly and severally liable for the results of the united effort if his act, considered separately, is tortious, irrespective of his knowledge that his act or the acts of the others is tortious. For example, each of a number of trespassers who are jointly excavating a ditch is liable for the entire harm caused thereby, although none believes that he is trespassing. Prosser summarizes the concerted action doctrine as follows:

Those who, in pursuance of a common plan or design to commit a tortious act, actively take part in it, or further it by cooperation or request, or who lend aid or encouragement to the wrongdoer, or ratify and adopt his acts done for their benefit, are equally liable with him. Express agreement is not necessary, and all that is required is that there be a tacit understanding ….

The gravamen of the plaintiffs’ charge of concert in the DES cases is that the defendants relied upon each other’s inadequate tests and took advantage of each other’s promotional and marketing techniques. For example, plaintiffs note that in 1941, twelve drug companies submitted a joint clinical file pursuant to their request for FDA approval of DES.

The Sindell court went on to state that there is no allegation here that each defendant knew the other defendant’s conduct was tortious toward the plaintiff, and that they assisted and encouraged one another to inadequately test DES and to provide inadequate warnings…. There was no concert of action among defendants within the meaning of that doctrine.

Historically, the concerted action theory developed to discourage tortious group behavior by expanding the scope of liability for a tortiously caused injury: it was not created specifically to aid plaintiffs in overcoming the identification requirement. The concerted action theory typically is applied in situations in which, unlike in the DES cases, a particular defendant is already identified as the factual cause of the plaintiff’s harm, and the plaintiff merely wishes to extend liability to those acting in league with that defendant. For example, the theory has been applied in illegal drag race cases to hold all participants jointly and severally liable even though only one participant actually struck the plaintiff. In cases such as these where the concert of action theory has been applied, identification of the defendants has rarely been an issue.

For the above reasons, plaintiffs have rarely been successful’in suing on a concert of action theory in DES litigation. Outside the DES area, the concerted action theory has never been successfully applied to avoid the identification requirement in product liability cases.


A second theory under which plaintiffs have attempted to avoid the identification requirement in DES cases has been termed “enterprise liability.” Numerous different theories have appeared under this general rubric. This comment adopts the theory of enterprise liability first suggested in Hall v. E.L DuPont de Nemours & Co. That case involved twelve separate accidents in which thirteen children were injured by dynamite blasting caps. Evidence identifying the manufacturer of the caps was destroyed in the explosions. The defendants were the six major domestic manufacturers of blasting caps and their trade association, which comprised virtually the entire blasting cap industry in the United States. Several Canadian manufacturers, however, could have supplied the caps. The plaintiffs alleged that the failure of the blasting cap industry as a whole to place a warning on individual blasting caps created an unreasonable risk of harm which resulted in the plaintiffs’ injuries.

Despite the plaintiffs’ inability to identify the specific manufacturer of the blasting caps that caused their injuries, the Hall court held that the defendants were not entitled to a dismissal for plaintiffs’ failure to state a claim. The court noted that there was evidence that the individual defendants had adhered to industry-wide safety standards and had in effect delegated duties of safety investigation and design, such as labeling, to a trade association. The court reasoned that this evidence could support a conclusion that all the defendants jointly controlled the risk, and if such control were shown, the issue of who caused the injury would become secondary to the fact that the enterprise or industry as a whole engaged in joint, hazardous conduct. Under these circumstances, if plaintiffs could show by a preponderance of the evidence that the caps were manufactured by one of the joined defendants, the burden of proof as to causation would shift to the defendants, allowing a specific manufacturer to exculpate itself only if it could show that it did not manufacture the caps that injured the plaintiffs..

The theory of enterprise liability suggested in Hall is predicated largely upon the existence of industry-wide standards or practices adhered to by a group of defendants. When the standards can be shown to be deficient, identification of a specific defendant decreases in importance, since the standards themselves can be conceptualized as the primary causative agent. Each industry member contributes to the plantiff’s injury by adhering to, and therefore perpetuating, the standard, which results in the manufacture of the defective product.

The enterprise liability theory is distinguishable from the concerted action theory in that, under the latter theory, defendants cannot exculpate themselves by showing that they did not manufacture the injury-producing product. Indeed, the very purpose of the concerted action theory is to extend liability beyond manufacturers to those who render substantial encouragement or assistance to them. Also, under the enterprise liability theory, proof of an express agreement or “tacit understanding” is not required, as it is in the concert cases: the joint, parallel activities of the industry members in adhering to the safety standard substitutes for this requirement. Finally, unlike the concerted action theory, the enterprise liability theory was specifically formulated to aid plaintiffs in overcoming the difficulties posed by the identification requirement. This purpose becomes clear from an examination of the procedural history of the Hall case. When the plaintiffs in Hall amended their complaint to name a particular manufacturer alleged to have caused their injuries, the court held that “the amended complaint .. .does not preserve the joint [enterprise] liability aspects of the case.

The existence of industry-wide standards for drug manufacturing would seem to render the DES cases ripe for the application of the enterprise liability theory. For several reasons, however, this theory has generally not been successfully applied in the DES litigation to date . First, the promulgation of standards for drug manufacturing is largely uncontrolled by the drug manufacturers themselves. The Federal Food and Drug Administration regulates many phases in the testing, manufacturing and marketing of drugs, including the contents of warning labels. While adherence to FDA standards cannot insulate a manufacturer from liability, to the extent that compliance with these standards is compelled by the federal government it would be unfair to impose liability on a drug manufacturer simply for following the standards, when the plaintiffs are unable to identify that manufacturer’s product as the cause of their injuries.

A second factor militating against enterprise liability in DES litigation is the large number of defendants involved (between one hundred and three hundred). The Hall case involved only six manufacturers, representing the entire blasting cap industry. The court cautioned against applying the enterprise liability theory in cases involving large numbers of defendants, stating that what would be fair and feasible with regard to an industry of five or ten producers might be manifestly unreasonable if applied to a decentralized industry composed of thousands of small producers. As the number of manufacturers increases, joint control and awareness of the risks at issue, and joint capacity to reduce those risks, becomes more difficult to imply as a predicate to liability.

Finally, it should be emphasized that the enterprise liability theory, as explicated in Hall, does not allow a plaintiff to avoid the identification requirement in toto. The plaintiff is still required to show that at least one of the joined defendants manufactured the injury-producing product, which most plaintiffs in the DES cases simply cannot do.


The most promising theory advanced by DES plaintiffs in an effort to avoid the identification requirement has been termed “alternative liability.” This theory is based on the celebrated California case of Summers v. Tice. In Summers, two hunters negligently and simultaneously shot in the plaintiff’s direction, injuring his eye. Neither the plaintiff nor the defendants could determine which hunter had injured the plaintiff, and only one could have done so. The California Supreme Court held that when two negligent tortfeasors independently harm a plaintiff, and the plaintiff, through no personal fault, cannot prove which tortfeasor caused the harm, the burden of proof as to causation shifts to the defendants, who will be held jointly and severally liable unless able to prove that one defendant did not cause the plaintiff’s injury. This holding represented a policy determination that an innocent plaintiff should not go remediless simply because the plaintiff is faultlessly unable to determine which of two negligent tortfeasors caused the injury. The holding was also based on the presumption that under the circumstances in Summers, the defendants are often in a “far better position” to offer evidence on the causation issue. Section 433B(3) of the Restatement (Second) of Torts has codified the Summers rule.

As a means of avoiding the identification requirement in DES litigation, the alternative liability theory, as explicated in Summers, is ostensibly superior to the concert of action and enterprise liability theories. Unlike the concerted action theory, alternative liability was specifically formulated to aid the plaintiff in overcoming the identification requirement where its imposition would be unfair. Also, to prove concerted action, the plaintiff must show an express agreement or “tacit understanding” among the defendants: no such requirement exists under the alternative liability theory, which can impose joint and several liability on defendants who act independently. In addition, unlike the enterprise liability theory, alternative liability requires no showing that the defendants adhered to an inadequate industry-wide safety standard for which the industry itself bore primary responsibility.

The facts in Summers are superficially similar to the facts in the DES cases. As one commentator has noted:

Many of the elements of the Summers fact pattern are present in the DES cases. Defendants’ manufacturer of dangerous pills for the unwary public can be compared to the hunters shooting in the direction of their companion. In each situation, all defendants are tortfeasors owing a duty of care to the injured plaintiff. In both the DES cases and Summers, the tortious nature of each of the defendants’ conduct was identical and created the same type of risk. Neither the plaintiff in Summers hit by a bullet nor the DES daughter who developed cancer is at fault for being unable to identify the one who caused his injury.

Arguably, then, the Summers rule should operate in the DES cases to shift the burden of identification to the defendant manufacturers and to impose upon them joint and several liability if they fail to discharge that burden. As with the other theories plaintiffs have presented, however, numerous factors militate against the application of the alternative liability theory to DES litigation, particularly as that theory was developed in Summers.

In civil cases, a plaintiff must generally prove liability by a “preponderance of the evidence, interpreted as a mathematical probability of greater than fifty percent. Where the alternative liability theory is applied to a situation involving only two defendants, as in Summers, the probability of causation for each defendant is still only fifty percent, which is less than the civil standard. This is tolerated under the theory in light of the policy determination that, under certain circumstances, the requirement that a plaintiff show at least a fifty one percent likelihood that a particular defendant harmed him will be relaxed when the plaintiff can establish a one hundred percent probability (i.e., a certainty) that at least one of a group of tortfeasors harmed him.

The fairness of this policy is contingent upon two factors. First, the group of tortfeasors to whom the identification burden, and potential joint and several liability, is shifted must be small enough so that the probability that any one tortfeasor in fact injured the plaintiff does not become inequitably low. In Summers, only two tortfeasors were involved, with a fifty percent possibility of causation. Consider an analogous situation, however, involving ten tortfeasors. There, the probability that any one defendant injured the plaintiff diminishes to ten percent, considerably less than the civil standard. The precise point at which such probabilities diminish to where the inference of causation, and the imposition of joint and several liability, becomes inequitable is of course a debatable issue. In the DES litigation, however, the most conservative estimates of the number of tortious DES manufacturers hover around one hundred, which would establish a mere one percent probability of causation for each individual defendant. Clearly, this level of probability provides neither a rational nor an equitable basis upon which to infer causation or impose joint and several liability. In this circumstance, a defendant who had only a one percent probability of being the causal tortfeasor could potentially be held liable for the plaintiff’s entire damage assessment – a patently unfair application of the alternative liability theory.

The fairness of the policy underlying alternative liability is also contingent upon complete joinder of all tortious defendants. Complete joinder, which would ensure that the negligence of at least one of the tortfeasors was causal, constitutes the quid pro quo for relaxing the civil standard of proof of causation as applied to each single defendant. It also guarantees that the actual causal party will not escape liability.

In the DES cases, however, complete joinder is a practical impossibility; hence the application of alternative liability is again contraindicated. Even if all DES manufacturers could be joined, the presumption, implied by the alternate liability theory, that all defendants would possess an equal probability of being the causal party is dubious at best. Some manufacturers held a greater share of the DES market than others, and thus were more likely to have supplied the drug to a particular plaintiff. Under the alternative liability theory, however, market share would have no bearing upon the assessment of probabilities related to the identification issue. Neither would it bear upon the issue of damage assessment: in those states that provide for equal contribution among negligent defendants, each DES manufacturer would be equally liable for the plaintiff’s damages despite its share of the relevant market.

Finally, it should be noted that in the Summers case, from which the alternative liability theory was derived, the events took place simultaneously in a single location with the defendants in each other’s presence. This allowed them a reasonable opportunity to identify the causal party, which was doubtless a factor in the court’s decision to shift the identification burden. By contrast, the defendants’ conduct in the DES cases occurred over the entire United States over a period of years. This fact, in conjunction with the lack of documentary evidence of identification, virtually eliminates any way for DES defendants to exculpate themselves by inculpating other defendants. Given the basic wisdom of the policy underlying alternative liability, the defendants’ evidentiary problems should not prevent the shift of the identification burden to them, especially where innocent plaintiffs are faced with essentially the same problems. However, the Summers practice of both shifting the evidentiary burden and imposing joint and several liability raises the potential, in the DES cases, for damage apportionments grossly disproportionate to the defendant’s probability of causation. Primarily for this reason, the alternative liability theory, as explicated in Summers, has not been successfully applied in the DES litigation to date.


If the plaintiffs in the DES cases were confined to the above theories of liability, recovery would doubtless be precluded. Nonetheless, sound policy reasons exist for not denying recovery in DES litigation. Foremost among these is that advanced in Summers: as between innocent plaintiffs and negligent tortfeasors, the latter should bear the cost of injury. This policy factor is particularly applicable when, as in the DES cases, the plaintiffs are not at fault for their inability to obtain recovery under traditional tort doctrines.

Various economic criteria also support shifting the tort losses to the DES defendants. The DES manufacturers are best able to absorb these losses by distributing them among the public as a cost of doing business. The losses would be appropriately allocated, via increased prices, to that segment of the public that benefits most by the drug industry’s activities, that is, drug consumers. The drug industry is apparently in good financial health, and individual manufacturers are able to insure against drug-related losses.

The drug manufacturers are also in the best position to discover, warn against and prevent defects in their products. Drug consumers are virtually helpless to protect themselves from drug-related injuries and must rely almost wholly upon the manufacturers’ representations of safety. Shifting the losses to the DES defendants would also provide incentive for safer manufacturing practices.

The contradiction in the DES cases between the above policy factors supporting recovery, and the inadequacy of traditional tort doctrines in providing recovery, forces a “crisis” in the tort recovery system. The response of courts could be either to stick to traditional doctrines and deny recovery or to fashion new remedies that are more equitable given changed social, technological and economic conditions. In taking the latter course, Justice Traynor, in Escola v. Coca-Cola Bottling Co., urged the adoption of strict liability over traditional standards of negligence in product liability actions. The changed relationships between manufacturer and consumer which gave rise to his opinion are even more evident in the modern era. Referring specifically to the DES litigation, one commentator has noted that:

Technological advances and current market conditions now allow an entire industry to manufacture a complex fungible product; modern scientific research can link contact with this product to harmful effects after a significant lapse of time. Since these advances now make identification of the injury-producing product inaccessible to the consumer, themanufacturer’s obligation to the consumer can only be met by some new form of liability.

The California Supreme Court, in Sindell v. Abbott Laboratories, fashioned just such a “new form of liability,” termed market-share liability, as a means of avoiding the identification requirement in DES litigation. Under the market share liability theory, if a plaintiff who is unable to identify the manufacturer of the DES which injured her is able to join as defendants manufacturers that together account for a “substantial” market share of the DES her mother might have taken, the burden of proof as to which manufacturer actually supplied the injury-producing DES would be shifted to the defendants. A particular defendant could exculpate itself by showing that it could not have produced the DES to which the plaintiff was exposed. Each defendant that failed to do this would be held liable for a proportion of the plaintiff’s judgment corresponding to its percentage share of the market.

The Advantages of the Market Share Approach

Two practical advantages of the market share theory to DES plaintiffs, in addition to the elimination of the identification burden, are evident. First, the plaintiff need prove neither concerted action nor adherence to a defective industry-wide safety standard. Second, complete joinder, a necessity under the alternative liability theory, is not required under the market share approach.

Numerous theoretical advantages also accrue under the market share theory. This approach provides a much more accurate measure of the probability that a particular defendant caused the harm than the Summers alternative liability theory provides. Under the Summers theory, causation probability is treated purely as a mathematical function of the number of defendants joined; thus, where two defendants are present, the causation probability is fifty percent; with four defendants, twenty-five percent. The problem with this approach is that there is simply no rational connection between the number of defendants joined and the probability that any one defendant caused the plaintiff’s injury. There is clearly a rational connection, however, between market share and causation probability, at least in the context of the DES cases. Obviously, the more prevalent a particular manufacturer’s DES was in the marketplace, the more likely that a particular plaintiff ingested that manufacturer’s drug.

The market share approach also provides a more rational means of apportioning damages than the joint and several liability imposed by the other theories. Since each defendant is liable only for that proportion of the plaintiff’s damages corresponding to its percentage share of the DES market, each defendant’s damage assessment is more closely related to the probability that it caused the plaintiff’s harm. Curiously, under the market share approach, a particular defendant’s aggregate liability in the total number of DES cases is arguably the same as it would be if identification in all cases could be made. As one commentator explains:

If X Manufacturer sold one-fifth of all the DES prescribed for pregnancy and identification could be made in all cases, X would be the sole defendant in approximately one-fifth of all cases and liable for all the damages in those cases. Under [market share] liability, X would be joined in all cases in which identification could not be made, but liable for only one-fifth of the total damages in these cases. X would pay the same amount either way. Although the correlation is not, in practice, perfect, it is close enough so that defendants’ objections on the ground of fairness lose their value.

Delimiting the defendant’s liability via market share also provides a quid pro quo for holding the defendant liable where its probability of causation is less than the civil standard of proof, here defined as a mathematical probability of greater than fifty percent. Thus, for example, it becomes tolerable to hold a defendant liable where its probability of causation (that is, market share) is only ten percent – much lower than the civil standard – since its damage assessment will be correspondingly limited.

Problems with the Market Share Approach

Market share liability represents a novel and creative solution to the plaintiff’s identification problems in DES litigation. The theory, however, is subject to numerous criticisms, on both operational and public policy grounds.

Although under the market share approach joint and several liability is eliminated, the plaintiff is still able to recover one hundred percent of the damages. Since the plaintiff need join only defendants which together represent a substantial, rather than a complete, share of the DES market, each defendant may be held liable for a portion of the plaintiff’s damages that substantially exceeds the defendant’s market share. For example, assume that the plaintiff joined two defendants, each with thirty-five percent of the DES market. Assume further that their combined market share, seventy percent, is deemed “substantial” by the court, which results in the shift of the identification burden to the defendants. Since the plaintiff is entitled to full recovery, if the defendants cannot satisfy the identification burden, each will be liable for fifty percent of the plaintiff’s damages, rather than the thirty-five percent that represents their respective market share.

The discrepancy between the market share and damage apportionment percentages will vary according to the actual combined market shares present in individual cases: the discrepancy decreases as the aggregate share approaches one hundred percent and disappears at that point. Of course, the combined market shares present in individual cases will depend greatly upon how individual courts define a “substantial” share of the market since, presumably, a plaintiff will be motivated to join defendants only up to the point where a substantial market share is represented in her case. The Sindell court did not define the point at which combined market share percentages become “substantial,” a question with which trial courts will have to grapple in future DES litigation.

Difficulties also arise under the market share theory in the definition of the relevant DES market. Market share data may simply be unavailable, particularly for the time periods when plaintiffs’ mothers first ingested DES. Also, DES was used for various purposes other than to prevent miscarriage, and it may be difficult to determine what percentage of DES was sold for use by pregnant women. In addition, a troublesome question arises concerning the geographic scope of the relevant DES market: should it be restricted to a particular state, city or even pharmacy, where the plaintiff’s mother purchased, or might have purchased, DES? While recognizing these problems, the Sindell court did not indicate how they might be resolved or which party would have the burden of defining the relevant market.

Ironically, the market share approach may operate to treat plaintiffs who cannot identify the causal manufacturer more favorably than those who can. In the ordinary tort case where a single causal defendant is identified, the plaintiff’s damages will be recoverable solely from that defendant, who may or may not be solvent. This would presumably be the case where a particular DES defendant was identified as the causal party: the plaintiff’s damage recovery would be restricted to that defendant alone, and the plaintiff assumes the risk that the defendant can respond financially. Where the plaintiff cannot identify the causal manufacturer, however, the market share theory literally imposes industry-wide liability, substantially reducing the risk that the plaintiff will be without a solvent defendant. The theory therefore operates to “punish” those plaintiffs who are able to satisfy traditional tort doctrines by identifying the causal manufacturer. The theory also operates to expose defendants to double liability, once to plaintiffs who can identify them as the causal party, and once again to plaintiffs who cannot.

The dissent in the Sindell case felt that the market share theory represented an unwarranted and unprecedented extension of liability. As Justice Richardson stated, under the market share theory,

recovery is permitted from a handful of defendants each of whom individually may account for a comparatively small share of the relevant market, so long as the aggregate business of those who have been sued is deemed “substantial.” In other words, a particular defendant may be held proportionately liable even though mathematically it is much more likely than not that it played no role whatever in causing plaintiff’s injuries …. The majority rejects over 100 years of tort law which required that before tort liability was imposed a “matching” of defendant’s conduct and plaintiff’s injury was absolutely essential.

The dissent additionally claimed that

market share” liability… represents a new high water mark in tort law. The ramifications seem almost limitless, a fact which prompted one recent commentator, in criticizing a substantially identical theory, to conclude that “elimination of the burden of proof as to identification [of the manufacturer whose drug injured plaintiff would impose a liability which would exceed absolute liability“.

Courts have expressed concern that changes in the tort law might overly enlarge a manufacturer’s duties and extend liability too far. The Defense Research Institute has suggested that product liability law can continue to function effectively only if present theories of recovery are not extended further. The Institute notes that unmitigated extensions of liability for defective products may have an effect opposite to that intended: instead of improving consumer protection and making damage reparations more certain, recovery will be diminished because of lack of money. Extending the liability of drug manufacturers may have the additional undesirable effect of “chilling” research and development efforts channeled toward the development of new or experimental drugs. The recent enactments of product liability statutes restricting the scope of a manufacturer’s liability 16 may be a response to the fear that product liability has been, or will be, extended too far.


The criticisms leveled at the market share theory have merit and deserve attention. They are insufficient, however, to impeach the basic soundness of this approach, at least as applied to the DES line of cases.

Uncertainties in the determination of market share, and discrepancies between market share and liability, are indeed inevitable under this theory; however, lack of complete precision in the determination of liability is a problem that is ubiquitous in the law of torts and hardly restricted to the market share theory. For example, juries cannot be expected to precisely correlate fault and liability in applying the doctrine of comparative negligence or partial indemnity. As the court stated in Summers, where a perfect division of liability among tortfeasors cannot be made, the trier of fact may make it the best it can.

Fears that the market share theory will generally lead to counterproductive extensions of product liability ignore the unique factual circumstances out of which the theory arose and to which it was narrowly adapted. In the DES cases, all the defendants were shown to have been negligent; market share data was used solely to apportion liability, not to prove negligence. Further, the plaintiffs’ injuries were uniquely traceable to a single product, rendering market share a reasonably good estimate of the harm done by individual manufacturers. More importantly, plaintiffs were injured by a product which masked its harmful effects for many years, making identification of the causal tortfeasor impossible. Courts can and should use great caution in extending the application of market share liability to cases where these distinguishing factual circumstances are absent.

Minor modifications in the market share theory could go far toward ameliorating the remaining inequities that exist in its application. One possible modification would be to limit a defendant’s liability to its exact percentage share of the market, which would eliminate the discrepancies between market share and damage apportionment percentages that result under the “pure” form of the theory. The defendant’s damage liability would thus be maximally correlated with its probability of causation. Of course, plaintiffs would no longer be guaranteed recovery of one hundred percent of their damages, since recovery would be restricted to that percentage of plaintiff’s damages that corresponded to the aggregate market share of all defendants joined. Clearly, however, this would motivate plaintiffs to join as many defendants as possible, which would help assure that the plaintiff’s damages would be more equitably distributed among all tortious defendants. Another possible modification in the market share theory would be to broaden its applicability to plaintiffs who can identify the causal DES manufacturer. …

Randy S. Parlee, Summer 1982 .

Click to download the full study.

More DES DiEthylStilbestrol Resources

Applying Concerted Action to the DES Cases


In Bichler v. Eli Lilly & Co., a unanimous New York Court of Appeals affirmed a lower-court ruling which held that a plaintiff may bring an action for damages against a drug manufacturer without being able to identify such manufacturer as the actual maker of the drug which caused her injury. The Court of Appeals decision, which accepted an expanded concerted action theory as the basis of liability, removes a major obstacle faced by many of the DES daughters, the victims of the synthetic estrogen ingested by their mothers when pregnant. Due to the generic nature of the drug and the length of time between ingestion by the mother and manifestation of injury in the daughter, most victims have been unable to identify the maker of the drug which injured them. Without such identification, they fail to prove a crucial element of the traditional tort requirement of showing cause in fact, and therefore have been precluded from seeking a remedy for an otherwise justiciable claim. Although the narrowness of its ruling throws some doubt on the precedential value of the case, the Court of Appeals’ decision, allowing plaintiffs to circumvent the identification requirement, marks a significant development in products liability law.

Bichler v. Lilly: Applying Concerted Action to the DES Cases, School of Law, Pace Law Review, Volume 3, Issue 1, Article 5, Fall 1982.

The plaintiff in Bichler brought an action against Eli Lilly, a DES manufacturer, for damages sustained by her as a result of her mother’s ingestion of DES when pregnant with plaintiff. Diagnosed as having vaginal and cervical cancer at age seventeen, plaintiff underwent a radical hysterectomy, which rendered her sterile and impaired her sexual functioning. Although she could not prove the identity of the maker of the particular drug taken by her mother, she claimed that the defendant should nevertheless be found liable. She based her claim on an expanded theory of concert of action, alleging that the defendant was jointly and severally liable as one of the group of DES manufacturers who had wrongfully tested and marketed the drug for use in pregnancy. She asserted that the wrongful conduct of each company evidenced either the tacit agreement with or substantial encouragement of the others’ conduct necessary to supply the requisite showing of concerted action. The jury found that even though plaintiff had failed to establish that the defendant was the manufacturer of the DES taken by her mother, the defendant had engaged in concerted action with other manufactuers and could therefore be held liable for her damages. The appellate court upheld the verdict, finding ample evidence from which a jury could determine that defendant had engaged in concerted action. The Court of Appeals affirmed, holding that the trial court’s instructions on concerted action liability were not erroneous and that the evidence before the jury was legally sufficient to support a verdict based on concerted action.

In allowing plaintiff to bring her claim against the specifically unidentified manufacturer, New York became one of the few jurisdictions to sustain such actions when the cause in fact requirement has not been met. Each of these jurisdictions, however, has relied on a different basis on which to predicate liability. This note examines the theory adopted in Bichler and compares it with those used in other jurisdictions. It concludes that the use of the concert of action theory as expanded in Bichler operates to impose a species of enterprise or industrywide liability on the DES manufacturers.


The Development of DES

DES, or diethylstilbestrol, is a synthetic estrogen first developed in England in 1938. Because its makers did not patent the drug, it could be made and sold by any number of manufacturers under its generic name. In 1939, several American manufacturers sought Food and Drug Administration (FDA) approval to market DES, proposing its use for a variety of estrogen disorders in women. The first applications were rejected by the FDA because they were based solely on foreign studies. At the FDA’s suggestion, the companies joined together to pool their clinical data on the drug in order to expedite the approval process by a joint filing. They also agreed to follow a uniform chemical formula and to use uniform labeling and product literature. Initial FDA approval in 1941 did not include the use of DES to prevent miscarriage. Supplemental applications for that use, first filed in 1947, were based primarily on two studies which were soon shown to be suspect for inadequate controls and unsubstantiated claims. Nevertheless, FDA approval was granted. Serious questions regarding the efficacy and potential carcinogenic effect of DES existed before FDA approval and multiplied afterward, but at no time did the companies perform tests on laboratory animals to determine the possible effects of the drug on the human fetus. After medical studies later revealed a link between maternal use of DES and subsequent development of vaginal cancer in daughters, the FDA in 1971 contraindicated the use of DES in pregnancy.

Between 1947, when the FDA first approved the use of DES for preventing miscarriage, and 1971, when such use was discontinued, several hundred companies were involved in the manufacture and marketing of the drug. During that period, possibly two million women took DES in the larger doses prescribed for prevention of miscarriage. Years later, their daughters, exposed in utero, were discovered to have developed precancerous and cancerous vaginal tract abnormalities related to the use of the drug. Discovery of the link led to an estimated one thousand suits being filed by DES victims, with most suits still pending at the pre-trial stages.

The Identification Problem in DES

Litigation DES plaintiffs face considerable problems of proof, but the most significant problem thus far has been how to overcome the threshold requirement of identifying the defendant as the manufacturer of the product which is the cause in fact of their injury. Proof of cause in fact is a fundamental requirement of an action in tort, and implicit in the requirement is the necessity of identifying the defendant as the actual tortfeasor. Most DES plaintiffs are unable to determine the identity of the maker of the product used by their mothers, because of two factors beyond their control. First, the generic nature of the drug makes its manufacturer extremely difficult to trace, and second, in most cases considerable time has passed since ingestion, so that crucial medical and pharmaceutical records have long since been lost or destroyed. The lack of proof of identification leaves the plaintiff open to motions to dismiss for failure to state a claim or motions for summary judgment. Until very recently, this identification requirement acted as an effective bar to recovery in most DES cases.

To defeat this identification problem, plaintiffs have sought to impose joint and several liability on every DES manufacturer. In the few cases where plaintiffs have been successful, two theories have emerged as means by which the identification barrier may be circumvented: concerted action, and alternative liability.

The ancient doctrine of concerted action is employed when two or more parties are alleged to have acted in pursuance of a common plan to commit a tortious act. Each participant can be held liable for the damage done by his co-participants, even though his own acts have not caused the injury. Express agreement to pursue the plan is not necessary; a tacit understanding is enough. The classic illustration of this doctrine is the case where two or more cars participate in a spontaneous drag race, and one car injures a bystander. Each driver will be considered jointly and severally liable for that injury, although only one car actually struck the plaintiff. The element of tacit agreement necessary to prove such liability may be inferred from the parallel conduct of the participants.

The theory of alternative liability applies in situations where each defendant, acting independently, has behaved tortiously, but only one unidentifiable defendant actually caused the injury. The theory originated in the case of Summers v. Tice. There, plaintiff’s two hunting companions fired their guns carelessly in his direction. Although only one bullet injured plaintiff, it was impossible to determine from whose gun it was fired . The court considered the application of the concert of action theory, but refused to strain the concept since an inference of tacit agreement to pursue a common plan would be an obvious fiction in this case. Instead, the court allowed the burden of proof of causation to be shifted to the defendants on the grounds of fairness to the injured party. Since both defendants were wrongdoers, and since it was their conduct that had placed plaintiff in the unfair position of having to prove the cause of his injury, the court determined that shifting the burden was justified. Rather than leave plaintiff remediless, policy reasons compelled the court to hold each defendant jointly and severally liable if he could not exculpate himself. This theory has traditionally been available only when plaintiff has joined all possible tortfeasors.

Both theories were successfully asserted in a Michigan DES case, Abel v. Eli Lilly & Co., where plaintiff joined as defendants all manufacturers who had distributed DES in the area during the time the drug had been prescribed to her mother. The Michigan Court of Appeals, in refusing to grant defendants’ motion for summary judgment, held that plaintiff’s allegations that defendants had acted in concert to produce and market ineffective and dangerous products, without adequate testing or warning, were sufficient to state a cause of action. The court also permitted a reliance on the alternative liability theory, noting that in special circumstances “policy and fairness” dictate a shifting of the burden to the wrongdoer.

The unmodified use of the alternative liability theory was rejected by the California Supreme Court, in Sindell v. Abbott Laboratories, where plaintiff had not joined every possible manufacturer. The Court stated that unless all were joined, there would be no basis for inferring that the product of any one defendant was the cause in fact. The Sindell court also rejected the concerted action theory because the requisite element of implied agreement was not, in that court’s opinion, supplied by a showing of conscious parallel conduct by the manufacturers. The court reasoned that stretching the doctrine to encompass a common industry practice would not only go far beyond the intended scope of the doctrine, but would hold virtually any manufacturer liable for the defective products of an entire industry, even if the defendant could prove that his product was not the cause in fact of the injury. Although it rejected the traditional doctrines, the Sindell court felt compelled by reasons of policy and fairness to find a basis for allowing the claim. Recalling Justice Traynor’s famous concurrence in Escola v. Coca Cola Bottling Co., the court reaffirmed its rejection of a rigid adherence to traditional tort law in the fact of the complex problems created by modern technology. When fungible goods which harm consumers cannot be traced to any specific producer, the Sindell court noted, “some adaptation of the rules of causation and liability may be appropriate . . . .,, The court chose to modify the Summers theory of alternative liability by permitting an action when a substantial number of the manufacturers were joined as defendants. Each manufacturer, however, would be liable only for its proportionate “market share” of the judgment. Further, each defendant would also have the opportunity to fully exculpate itself by proving that it did not manufacture the product which actually caused the injury.

Bichler v. Lilly: The Lower Court Decision

The issue presented in the Bichler case was whether an injured plaintiff who cannot identify the actual manufacturer of the drug which caused her injury, and thus cannot satisfy the traditional tort requirement of showing cause in fact, may impose joint and several liability on a single DES manufacturers.

A unanimous New York appellate division court, adopting an expanded concert of action theory, held that, in the “special circumstances” of the DES cases, joint and several liability could be imposed without proof of identity as an element of cause in fact. The court cited several factors in support of its holding. First, the court found sufficient evidence to justify the jury finding that the defendant and the other manufacturers of DES had wrongfully tested and marketed the drug. Reservations about the efficacy of DES for treatment of complications of pregnancy, doubts about the adequacy of the two studies relied on, and concerns about the potential carcinogenic effect of the drug on mother and fetus were shown to have all been raised prior to 1953, when plaintiff’s mother used DES. Yet none of the companies producing or marketing DES responded to these issues by performing any tests on either humans or animals. The court also found that the evidence of “conscious parallel activity” by the drug companies amply supported an inference of a tacit understanding among the companies to wrongfully market the drug for use in preventing miscarriage without first performing laboratory tests upon pregnant mice. The original cooperation and pooling of data by the first twelve applicants set the pattern for later manufacturers, who used the same basic chemical formula and literature. When FDA approval was later sought for the use of DES in pregnancy, the companies relied on the same research studies and prescribed the same dosages. On these facts, the court found “ample evidence” of concerted action.

The court admitted that it was doing what the Sindel court had found unacceptable: it was stretching concert of action to encompass the common practice of an entire industry by allowing “conscious parallelism” to evidence the required element of tacit agreement. The Bichler court, however, characterized this as only a “limited -expansion” of the doctrine, justified by both legal precedent and equitable considerations.

As legal precedent, the court pointed to a previous tailoring of the doctrine in Hall v. E.I. Du Pont De Nemours & Co. In Hall, plaintiffs were children injured in separate blasting cap explosions. Unable to identify the manufacturers of the product which caused their injuries, they joined six manufacturers, who comprised virtually the entire domestic industry. The court, in Bichler, noted that Hall had fashioned a theory which combined elements of concerted action and alternative liability. Concerted action was shown both by express agreement among the defendant blasting-cap manufacturers not to warn of their product’s danger, and by the companies’ reliance on industry-wide safety standards. The alternative liability doctrine was invoked to allow a shifting of the burden of proof of causation to the defendants, permitting them to exculpate themselves if they could show that their product did not cause the injury. As further support for its theory the court pointed to the fact that “conscious parallel behavior” without express agreement had long been accepted by the Supreme Court as a basis for finding conspiracy in antitrust cases.

In addition to the legal justifications cited, the court also emphasized the policy considerations which mandated expansion of traditional doctrines “to adapt to the exigencies of trying a case in the rapidly developing area of the law of strict products liability.” The complexity of modern products, the court noted, often means that the manufacturer is the only party who can know if the product is safe. The court refused to allow such a manufacturer to escape liability by hiding behind the “shroud of anonymity” created by the generic nature of his product and the parallel practices of his industry. Citing Abel and Sindell as examples of the responses by other courts to the “special circumstances” facing the DES plaintiffs, the New York Appellate Division joined the Michigan and California courts in refusing to bar an otherwise valid claim when the traditional requirement of causation was impossible to prove.

The court found no unfairness in imposing liability on the sole defendant. Plaintiff had the option of going against any joint tortfeasor; as a participant in concerted tortious action, defendant was jointly and severally liable. Furthermore, defendant could proceed against the other manufacturers for contribution under the theory of Dole v. Dow Chemical Co., which allows allocation of the judgment according to equitable share.

The Court of Appeals Decision

The Decision

The New York Court of Appeals unanimously affirmed the lower-court ruling. The opinion was so narrowly drawn, however, as to leave undefined the scope of the expanded concerted action theory. Limiting itself only to those issues preserved for its review, the court held that the trial court’s instructions on the concerted action theory were “not erroneous as a matter of law,” and that the jury’s verdict in light of those instructions was not without sufficient evidentiary support.

The court refused to address Lilly’s claim on appeal that it was “jurisprudentially unsound” to permit recovery against it on a concerted action theory. Noting that Lilly had not raised this claim at any prior stage of the proceedings, the court held that the theory of concerted action therefore became the “controlling law” of the case. Having made this determination, it only remained for the court to decide whether, to the extent the issue was preserved, the trial court’s instructions on concerted action were erroneous, and if not, whether the evidence was sufficient to support the verdict.

The court first considered the trial court’s instructions to the jury on concerted action. The instructions specified two theories of concerted action upon which defendant’s liability could be premised: first, concerted action by agreement, in which an express or implied understanding is manifested by “consciously parallel conduct” on the part of the drug companies in failing to test DES on pregnant mice; and, second, concerted action by substantial assistance, in which the companies acted independently of each other in failing to test but with the result that such independent actions had the effect of substantially encouraging the failure to test by the others. Although the court enumerated Lilly’s challenges to these instructions, it refused to explore the merits of Lilly’s claims, holding that such exploration was precluded by the fact that none of the challenges had been preserved for review by appropriate request of exception. The sole exception to the concerted action charge which Lilly had made concerned the issue of intent, an issue which the court stated did not “even arguably relate” to any of the claimed errors urged on appeal. Without proper objection having been taken, the trial court’s charge on concerted action therefore became the law of the case.

The court then addressed the issue of whether the evidence was legally sufficient to support the jury’s finding of concerted action, either by agreement or by substantial assistance. With regard to concerted action by agreement, the court held that the jury could infer, solely from evidence of “consciously parallel behavior,” an implied agreement by the drug companies not to test DES on pregnant mice. Similarly, the court found that the charge on concerted action by substantial agreement allowed the jury to infer from Lilly’s failure to test that other manufacturers were substantially encouraged to do the same. Confining its review of the evidence to events beginning in 1947, the court held that the conduct of Lilly and the other companies in filing new drug applications for use of DES for treatment of problems of pregnancy “was sufficient to support jury findings of both conscious parallelism and substantial assistance or encouragement under the jury instructions to which no exception was taken.

Analysis of the Court of Appeals Decision

The Court of Appeals decision, characterized by a deliberate emphasis on the procedural aspects of the appeal and a corresponding narrowness in the scope of its review, provides little guidance as to the acceptability of the concerted action theory. After stating positively that products liability law cannot be expected to stand still where innocent victims face inordinately difficult problems of proof, the court avoided every opportunity to set forth a clear rule on concerted action. Further, the court refused to consider, even in passing, the other theories of liability proposed for application in the DES cases; instead, the court stated that it was expressly leaving for another day consideration of whether other theories of liability may in the DES context establish a cause of action. Announcing that it would address only the basis of liability pleaded, concerted action, the court further narrowed its review of that basis only to the extent that the issue was preserved for our review.

Throughout the decision, the court repeatedly emphasized the limited nature of its scrutiny. First, although it allowed concerted action to form the basis of a full recovery against Lilly, it did so almost grudgingly, giving as its only reason the fact that Lilly had allowed the case to proceed on that basis. Furthermore, it considered the trial court’s instructions with regard to concerted action only in light of whether proper exception had been taken; by this test, it found them to be “not erroneous as a matter of law,” hardly an enthusiastic endorsement. Finally, in its review of the sufficiency of the evidence, the court found the evidence to be sufficient, but emphasized that it had only measured the sufficiency under the “jury instructions to which no exception was taken.

The penurious nature of the court’s endorsement of the concerted action theory may have a purely procedural explanation. Section 5501 of New York’s Civil Practice Law and Rules provides that an appeal brings up for review “any charge to the jury, or failure or refusal to charge as requested by the appellant, to which he objected. Section 4017 further provides that “failure to. . . make known objections. . . may restrict review upon appeal.” The court of appeals, struggling with a huge caseload, cannot be expected to knowingly expand its scope of review to embrace issues not properly raised on appeal.

Although the precedential value of the court of appeals decision in Bichler remains open to question, there are oblique indications in the opinion which suggest that New York will remain a sympathetic forum for a DES plaintiff who relies on the concerted action theory. First, the court’s express declaration that products liability law cannot be expected to stand still where innocent victims face inordinately difficult problems of proof indicates the court’s willingness to entertain new theories or, as in Bichler, new applications of old theories. Furthermore, the court found that there was sufficient evidence of conscious parallelism among the first group of companies who sought approval of the use of DES for problems of pregnancy in 1947 and 1948, basing its finding on the facts that the companies filed their applications within a short span of time, relied on the same studies, and requested approval for the same dosages. Moreover, the court found that Lilly’s participation in this first wave of filings could fairly be found by the jury to substantially encourage the other companies who subsequently manufactured and marketed DES for the same purpose in 1953, the year the drug was ingested by plaintiff’s mother.

Analysis of Ramifications of Bichler

The precedential value of the use of the concerted action theory in DES cases must remain unclear. Until the court of appeals deals with a case in which the issues have been fully preserved for its examination, its endorsement of the theory is questionable. Nevertheless, its decision represents a significant development in products liability law.

The most obvious result of this decision is that a New York plaintiff, unlike her counterparts in California and Michigan, need not join all or even most DES manufacturers; one defendant is enough. This frees the New York plaintiff from the necessity of serving out-of-state defendants or trying to assert jurisdiction over them, and from the expensive, time-consuming business of determining which of the hundreds of DES manufacturers might have supplied the relevant geographical area at the time of ingestion. The defendant may be held liable for the entire judgment even if it can prove that it did not manufacture the particular product ingested. Further, a manufacturer who made only one pill will be held fully liable.

At first glance, the Sindell court’s shifting of the burden and limiting the extent of liability to market share seem to lead to a fairer result. The inequities which seem to result in Bichler are not really meaningful, however, in light of the nature of concerted action liability. Unlike alternative liability, which holds only one actor as truly culpable, under concerted action all the participants in a wrongful activity are considered as culpable as the actual producer of the product which inflicted the injury. In a sense, the wrongful activity becomes the cause in fact, so that any participant in the activity is also a participant in the causation of the injury. On the practical level, the Sindell shifting of the burden will likely prove a hollow victory for defendants, since they face as insurmountable a problem in disproving cause in fact as plaintiffs face in proving it.

Aside from the arguably unfair placement of liability on one manufacturer, the Bichler doctrine’s most vulnerable element is the nature of the showing required to prove tacit agreement. The conscious parallel activity of the drug companies is largely a function of standard industry practice, and probably the inevitable result of producing generically identical products. By holding the entire industry liable on the basis of this parallel conduct, the Bichler court is really endorsing a species of enterprise, or industry-wide, liability. The court clearly feels that such extended liability is appropriate in certain circumstances, for much the same reasons that justify imposing strict liability. Since the manufacturer is often the only one who can know if a product is safe for its intended use, it is fair to hold it strictly liable, without proof of fault or privity. By the same reasoning, if all the manufacturers in an industry negligently produce identical, and identically defective, products, it is fair to extend liability across the whole industry. In adapting concerted action to the DES situation, the Bichler court furthers the original twofold goals of the doctrine: to assure a deserving plaintiff of a remedy, and to deter dangerous group behavior. By accepting plaintiff’s bold adoption of a little-used theory,  the Bichler court lifts the “shroud of anonymity” which had protected the manufacturers of DES.


In Bichler, the New York courts responded to the identification problem faced by the DES plaintiffs by allowing the concert of action theory to establish joint and several liability on an industry-wide basis. The Bichler courts accepted a showing of parallel conduct in the drug manufacturers’ testing and marketing procedures as sufficient evidence of the tacit agreement element of concerted action. A drug manufacturer who produces a generic product may thus be found liable even if his own product did not cause the injury. To the extent that the lower court’s opinion was affirmed by the court of appeals, the decision represents a significant development in products liability law.

Andrea Riger Potash, September 1982 .

Click to download the full study.

More DES DiEthylStilbestrol Resources

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

In an action for damages brought by a plaintiff who claims that she was prenatally exposed to diethystilbestrol (DES) and developed vaginal cancer, we are confronted with the question whether a hospital which is alleged to have treated her improperly may seek contribution from the pharmaceutical manufacturer which produced, marketed and sold the alleged cancer-causing agent. We hold that under the facts in this case as framed by the pleadings the hospital may seek contribution.

HELMRICH v. LILLY & CO., Leagle, 198253089AD2d441_1457, November 9, 1982.

DES is the generic name for a medication which duplicates the effects of natural estrogens in the human body. It has been used, and is still being used, to treat a variety of medical conditions. In 1971, however, the Federal Food and Drug Administration “banned” the use of DES for the treatment of problems of pregnancy because of mounting evidence that it was ineffective in preventing miscarriage and dangerous to the unborn children as well. Since then, “the link between prenatal DES exposure and the later development in female offspring of clear cell cervical or vaginal adenocarcinoma, a hitherto rare disease involving cancerous growth in glandular tissue, has been unquestionably confirmed” (Bichler v Lilly & Co.).

Plaintiff was born in 1955 to a mother who ingested DES during pregnancy. In 1969 she began to experience a variety of gynecological disorders which persisted after she enrolled as a student at Syracuse University in 1973. Between 1973 and 1977 she was treated at the university’s Student Health Center as her gynecological symptoms worsened. On July 20, 1977 a private gynecologist consulted by plaintiff diagnosed her condition as clear cell vaginal adenocarcinoma. Radical female pelvic surgery was performed upon her shortly thereafter and all of her internal reproductive organs were removed.

In September, 1979 plaintiff commenced this action against Eli Lilly & Co. (Lilly), a manufacturer of DES, and Syracuse University in which she seeks damages for injuries sustained as a result of her prenatal exposure to DES and the malpractice of the university in treating her. Causes of action were alleged against Lilly in negligence, strict products liability, breach of warranty, misrepresentation and fraud in connection with its production, marketing and sale of DES.

Plaintiff claims in each cause of action against Lilly that she has “sustained serious and permanent injuries”. She also claims that as a result of the university’s conduct in treating her improperly she “has suffered a hysterectomy and other and serious and permanent injuries and damages, incurred economic expense and loss, suffered unnecessary pain, suffering [sic] and mental anguish and has been deprived thereby of the ability to bear children and other injuries and damages. In response to a demand by the university to specify every injury plaintiff claims she sustained because of the acts of defendant [Lilly], or the University, or both”, plaintiff alleged in a verified bill of particulars that “as a result of the negligence of Lilly and the University, plaintiff underwent radical female pelvic surgery and has lost all of her reproductive organs; there is danger of further metastasis and fear of further spread of cancer.”

Plaintiff’s suit against Lilly has been dismissed as barred by the Statute of Limitations. The university, however, asserts in its answer a cross claim against Lilly for contribution. Special Term granted summary judgment to Lilly and dismissed the cross claim on the ground that the university, as a successive independent tort-feasor, can only be liable for the aggravation of plaintiff’s condition and, as such, is not entitled to contribution from the prior tort-feasor, Lilly. We disagree. ” …

… continue reading the full paper HELMRICH v. LILLY & CO. on Leagle.

More DES DiEthylStilbestrol Resources

Product Liability of the 1980s: Repose Is Not the Destiny of Manufacturers

In response to the growing number of product liability suits and dramatic rises in insurance premiums, many state legislatures were persuaded to enact statutes of repose. Adopted under the pressure exerted by the lobbies of special interest groups, the statutes of repose stand as a form of special legislation that in effect denies the existence of a duty between a defendant and potential plaintiff after a specified number of years. In the context of the delayed manifestation injury, Professor Dworkin argues that the time bar set by the statutes of repose may be successfully avoided by several means: distinguishing between old-product injury and delayed manifestation cases, tolling the statute of limitations period, and challenging the constitutional validity of the repose statutes on equal protection and due process grounds. Although comprehensive legislative action addressing the special problems of delayed manifestation injury would be preferred, the courts are likely to counteract the harsh effects of the statutes of repose by emphasizing the rights of plaintiffs injured by technologically defective products.

Product Liability of the 1980s: Repose Is Not the Destiny of Manufacturers, Carolina Law Scholarship Repository, Volume 61 | Number 1 Article 7, 10-1-1982.

Certainty generally is an illusion, and repose is not the destiny of man.” Neither does repose appear to be the destiny of manufacturers. Despite recent legislation designed to give manufacturers repose from product liability, many factors indicate that these statutes will not afford the certainty sought.

Repose statutes were a response to the upheaval in product liability law of the 1970s. As consumerism swelled, injured parties gained greater awareness of their rights, and courts facilitated suits by wider adoption of theories such as strict liability and expansion of traditional tort theories. This development in turn led to an escalation in the number of suits brought against manufacturers, and in the number and amounts of awards. Insurers, reacting in part to this situation and to open-ended liability, raised premiums for product liability insurance by hundreds and sometimes thousands of percent. A feeling of crisis permeated the business and insurance world, and in the latter half of the decade these groups exerted their considerable influence to effect legislative changes to counteract these trends. As a result, product liability reform statutes have been passed by a majority of states, and passage of a federal bill may be forthcoming. These acts feature statutes of repose as the primary vehicle for alleviating the problem of extended liability. Concurrent with this legislative trend has been the continuing, countervailing common-law trend to increase manufacturers’ liability. A key factor in this increase has been the expansion of liability for widespread, time-delayed product injuries. Time-delayed injury suits may well come to dominate tort litigation of the 1980s, and for some manufacturers such liability will far exceed that which was threatened in the Seventies. Since the injury in this type of suit usually manifests itself after the repose period statutorily established by the new statutes, an increasingly important question is whether these statutes will be interpreted to time-bar such suits.

This article will examine the pro consumer trends such as market share liability and corporate successor liability, recent developments regarding statutes of limitations and statutes of repose, and the likely results when these conflicting common-law and legislative trends meet in the context of time delayed product injuries. Public policy issues, as reflected in decisions based on constitutionality, duty, estoppel, and tolling or suspension of the running of the limitations period, indicate that many courts will not find the statutes to be a bar.


The recognition and protection of a repose interest is not new. It has long been conceded that some time limitation on the ability to bring suit is necessary if practicality as well as justice are to be served.1 Defendants at some point should be able to institute financial plans with certainty, free from the threat of stale claims; plaintiffs, if truly aggrieved, should pursue remedies within a reasonable period of time; and defendants and courts should not have to deal with cases in which the passage of time seriously hampers the search for truth. For the traditional statute of limitations, the legislature balances the interests of the parties in light of these considerations, and determines that at some point the right to be free from stale claims must prevail over the right to prosecute them This determination is usually made to cover a wide class of actions, such as torts, or to encompass similarly situated parties.

The conflict between a plaintiffs interest in bringing suit and a defendant’s repose interest has been most sharply highlighted by cases in which the plaintiff has been injured but does not discover the injury, or does not discover the connection between the injury and the action causing it, until after the period set by the legislature has run. Interpretation of the statutes of limitations to bar such suits has not been consistent, but in the first half of the twentieth century courts generally put greater emphasis on the repose interest and strictly construed the statutes by starting the limitations period at the time of the incident causing the injury. Thus, the plaintiffs suit was denied if discovery of the injury took place after the statutorily defined period. This strict interpretation has gradually given way to a rule that focuses upon the actual time of discovery of injury. Such a rule now exists in some form in most jurisdictions when personal injuries are involved. Under this interpretation, the statutory period begins to run when the injury is or should reasonably have been discovered, not when the alleged tort is committed.

This “discovery rule” was first widely adopted in medical malpractice cases in which a foreign object was left in the patient’s body. In these cases the limitations period is short (generally one or two years), the nature of the injury often prevents the plaintiff from quickly discovering what is wrong, and he or she often is forced to rely on the defendant’s statements. The courts determined that under these circumstances plaintiffs should not be denied their right to sue. The discovery rule has now been adopted in many other tort areas, the courts having concluded that the equities involved in non medical cases are essentially the same as those present in the medical malpractice situation.

Increasingly, the trend toward favoring a plaintiffs right to bring suit for personal injury has been furthered by adoption of a causal-connection-accrual rule. Under this rule, counting for the limitations period does not begin until the plaintiff discovers both the injury and that defendant has caused it, and in some instances, not until the plaintiff also discovers he or she has a cause of action.

In a strictly commercial setting, in which damages are economic, courts have been more reluctant to adopt a discovery rule, and repose interests are emphasized. Stability and predictability are considered crucial in the business context if commerce is to thrive. This repose preference is reflected in the limitations period generally adopted by the states from the Uniform Commercial Code, which bars suits brought more than four years after the sale of the product in question. Here too, however, when personal injury results from a commercial transaction, courts have tended to deemphasize repose and opt for a plaintiffs right to bring suit. When personal injury is caused by a product, most courts have construed the suit to be a tort action rather than a warranty action under the U.C.C., and have allowed the tort accrual-from-discovery rule to prevail.

This preference for a plaintiffs right to sue was carried over into the construction of limitations statutes for strict liability. Since strict liability theory draws from both tort and warranty law, the use of either the four-year statute of repose of the U.C.C. or the tort discovery limitations period would have been supportable. Most jurisdictions, however, have favored the plaintiffs interests over repose interests and have applied the tort time-of-discovery limitation. Thus, discovery accrual has often been used in delayed manifestation suits, which are increasingly based on strict liability.

A recent case that demonstrates the degree to which courts are willing to stretch the discovery rule to accommodate a plaintiffs delayed manifestation product liability suit is Ferrer v. Richardson-Merrell, decided in 1980 by the California Court of Appeal. Plaintiff, a doctor, self-prescribed MER/29 in March 1960. A few months later he was unable to read, suffered severe dermatitis, was unable to work for four to six weeks, and suffered some permanent eye damage. Plaintiff knew that these reactions were “likely” related to the MER/29 and discontinued its use. In 1976 he developed cataracts, and at that time filed suit against the drug manufacturer. The California limitations period is one year. Citing “straws in the wind,” such as special limitations rules in nuisance and progressive occupational disease cases and currently developing merger exceptions of res judicata, the court found that plaintiff should be able to split his cause of action and sue for the cataract damage, especially since he did not claim that the 1960 troubles were MER/29 related. Accrual would begin not when plaintiff first suffered serious damage and knew the cause, but sixteen years later when he suffered further damage. “The simple fact is that rules developed against the relatively unsophisticated backdrops of barroom brawls, intersection collisions and slips and falls lose some of their relevance in these days of miracle drugs with their wondrous, unintended, unanticipated and frequently long-delayed side effects.

The equitable reasoning behind these changes clearly expresses this and other courts’ greater concern for a plaintiffs right to bring suit than for a defendant’s repose interests. If a plaintiff has been blameless in failing to discover the injury, then justice requires that the suit be allowed. The statute of limitations is construed to require only that the plaintiff act within a reasonable time after discovering that his or her rights have been invaded. In opting for a tort discovery approach, courts have emphasized the rights of innocent plaintiffs and safety considerations, as compared to the interests of defendants who were responsible for their products, limited expectations of defendants concerning repose, and stale evidence. Many of the same considerations have prompted the courts to expand or adapt traditional tort theories to facilitate delayed manifestation suits when the delay has caused non statute of limitations problems in bringing suit.


An example of this facilitation to overcome time-related problems can be seen in recent DES decisions. DES, or diethylstilbestrol, is a drug that was generically prescribed between 1941 and 1971 for the prevention of miscarriages. The medication causes cancer and precancerous growths in daughters of the ingesters a minimum of ten to twelve years after ingestion. Because of the delayed manifestation of injury and the generic nature of the drug, which permitted pharmacists to fill doctors’ prescriptions and refills with whatever was on hand, plaintiffs were unable to identify which of the over 200 DES manufacturers produced the drug that injured them. Recently, courts have started allowing these suits despite the inability to identify the specific manufacturer, rather than nonsuiting on the causation question as they previously had done.

The California Supreme Court made the most important and controversial change in Sindell v. Abbott Laboratories, Inc. In Sindell the court expanded the earlier ground-breaking precedent of Summers v. Tice by adopting the theory of market share liability. Under this theory, if a plaintiff joins enough defendants so that together defendants had a “substantial share” of the relevant market, the burden of proof is shifted to the defendants to show that they, individually, did not produce the drug that injured the plaintiff. Since defendants have no better information than plaintiffs, they generally are unable to meet this burden. The court held that this shift was fair, however, because defendants who were responsible for marketing the drug have to pay only a percentage of the judgement proportionate to their share of the market. Other courts recently have reached similar results, although not necessarily by the same theory.

Another time-related change in products liability law designed to facilitate plaintiffs’ suits is the recent liberalization of corporate successor liability in some jurisdictions. Traditionally a successor corporation did not assume the debts or liabilities, including tort-related liabilities, of the corporation it purchased if all assets were transferred free of fraud and no provision was made for the successor corporation to do so. In 1977 California broke with tradition by adopting the “product line” approach, allowing the successor corporation to be sued in strict liability for a product it did not produce if that product was in the same product line as the one the successor corporation was now manufacturing. A primary reason cited by the court for changing the law was that plaintiffs otherwise would be remedyless because their recourse against the predecessor was virtually extinguished by the acquisition. In addition, the successor had the ability to assume the risk-spreading role and purchased the risk along with the good will of the predecessor.

New Jersey recently followed California’s lead and adopted this theory in Ramirez v. Amsted Industries The New Jersey Supreme Court used the product line concept to allow suit by a plaintiff injured by a power press manufactured in 1948 or 1949. In another case decided the same day the court expanded the concept by allowing suit against an intermediate successor corporation who was no longer producing the line, but was still in business Pennsylvania adopted the Ramirez product in formulation because it implemented “the social policies underlying strict product liability.

In explaining the reasons for facilitating plaintiffs’ suits in these circumstances courts again have emphasized the innocence of plaintiffs, who would otherwise be left remedyless, as compared to the responsibility of defendants for marketing the product, spreading costs, and promoting safety, as well as the relative unimportance of stale evidence. These are essentially the same considerations that initially prompted many courts to adopt strict product liability, and the facilitation of claims represents a continuation of that pro-plaintiff/consumer trend. The new statutes of repose fly in the face of this trend


Modem statutes of repose differ from the conventional statutes of limitations because they heavily emphasize the repose interest in order to protect a special class of potential litigants. They set a definite accrual time unrelated to discovery of injury, and in essence deny that the defendant owes a duty to the plaintiff after a specific number of years. In product liability repose statutes, for example, it is the age of the product, not the timeliness of the plaintiffs actions, that is the focus of the statute, and suit often is barred before injury occurs. Rather than following the balance struck by the courts between a plaintiffs right to sue and a defendant’s repose interests, the legislatures, at the request of and under pressure from special interest groups, have chosen to protect defendants in order to solve a perceived crisis in various segments of the economy. Such statutes have been passed to protect architects and builders, and health care providers, as well as sellers of products.

Architects’ and builders’ repose statutes were the first passed and were generally upheld. This success offered support for the passage of similar medical malpractice legislation, but increasingly the statutes protecting health care providers, as well as those protecting architects and builders, have failed to withstand challenge. The product liability statutes of repose, the latest legislative time control effort, are even more likely to meet with failure in the courts, especially when challenged in the context of delayed manifestation suits, despite the assumptions of most commentators.

Several indications support this assumption. The strong pro-plaintiff/consumer bias, which has led to the wide adoption of strict liability, the expansion of theories to facilitate delayed manifestation suits, and the application of discovery-of-harm accrual for statutes of limitations, has already been discussed. These trends and biases will not easily be set aside by the courts, especially when it is not clear that the legislators had delayed manifestation cases in mind when the repose statutes were enacted, when there is less of a crisis than originally feared, and when the statutes, which are special legislation, change substantive rights but may not alleviate the problem. In addition, although statutes of repose affect a relatively static number of people injured by architects, builders, and health care providers, many new types of product-caused delayed manifestation injuries are discovered yearly. The non-suiting of hundreds of thousands of injured plaintiffs cannot fail to influence judicial decisions.


Courts faced with plaintiffs whose injuries do not manifest themselves until after the repose period has elapsed can pursue several options to allow plaintiffs’ suits. A few courts have already used some of these options, which include distinguishing between delayed manifestation and delayed injury (oldproduct) suits, tolling, and declaring the repose statute unconstitutional. The advantage of the first two options is that delayed manifestation suits may be prosecuted without directly upsetting legislative judgment in an area in which wide discretion has traditionally been allowed. While no court has yet distinguished delayed manifestation from delayed injury in avoiding the time bar, good reasons exist for doing so.

A. Delayed Manifestation and Delayed Injury

As the liability of manufacturers increased and insurance rates soared, both manufacturers and insurers tended to focus on the “long-tail” problem as the primary cause of their ills. Manufacturers viewed the extended potential liability for old products as making them insurers of their products, and insurers cited that phenomenon as one of the main factors in their inability to predict liability and hold down premiums. “Horror stories” were cited to prove the point -liability for a 17-year-old bus, a 24-year-old tractor, a 30- year-old pickling machine. When insurers and business groups went to the legislators to lobby for change, similar examples of old products causing injury were used. Little attention was paid to injuries that were old by the time they manifested themselves. Thus, there is little indication that legislators meant to include delayed manifestation cases within the repose statute’s bar.

While the equities involved in old-product injuries and delayed manifestation injuries are similar–“innocent plaintiffs” are barred from suit before they discover their injury-there are aspects that might have led legislatures to differentiate. Most old-product injuries involve capital goods in a workplace situation. Thus, while plaintiffs may be barred from suit against the manufacturer, they will still receive payment under workers’ compensation plans. The same is not true for a large proportion of persons injured by products causing delayed manifestations, such as drugs, radiation, and hazardous waste. Barring suit against the manufacturer in these cases will bar recovery altogether.

A similar distinction may also be made based on the type of product involved. Capital and other long-lived goods very often are sold with an express warranty that extends beyond the repose period. Since almost all the statutes of repose except express warranties from the repose period, these kinds of suits would not be barred, and plaintiffs injured by warranted capital goods still will have an alternative recourse in the courts. Delayed manifestation claimants will not.

A final distinction concerns the number of plaintiffs barred from remedy. The number of plaintiffs injured by old products who are barred from suit is relatively quite small. A study by the Insurance Services Office indicates that cases based on products over six years old which caused injury are less than hree percent of litigated claims. The number of delayed manifestation cases is approaching 100,000 annually and growing yearly as new hazards of “advances in science and technology” are discovered.

Whether these differences would have prompted different legislation is problematic. There are indications that when delayed manifestation problems were brought to the drafters’ attention, some allowance was made. Some legislatures exempted specific delayed manifestation injuries such as asbestiosis and ionizing radiation injuries from their statute’s coverage, and the drafters of the Model Uniform Product Liability Act, who made the most comprehensive study of the situation, exempted delayed manifestation cases altogether.

The drafters of the Model Uniform Product Liability Act, after balancing plaintiffs’ and defendants’ interests, favored plaintiffs by refusing to adopt a statute of repose because it “may deprive a person. . . of the right to bring a claim based on a defective product before the injury has actually occurred.” Instead, they substituted a rebuttable presumption that after ten years a product is beyond its useful safe life, and increased the burden of proof necessary to overcome this presumption. Nevertheless, even after rejecting a statute of repose the drafters felt delayed manifestation plaintiffs needed further protection, and exempted them from the coverage of the ten-year presumption. Thus, under the Model Act delayed manifestation cases would be governed by the usual time-of-discovery statute of limitations. A few states have also adopted the rebuttable presumption approach.

Legislative history is seldom an infallible indication of intent, and speculation about reactions to different kinds and strengths of information is risky at best. Courts, however, may take cognizance of these differences and, following the lead of the Model Act, find that the statutes should not apply to delayed manifestation cases. Statutes in derogation of the common law are to be construed narrowly, and such a construction would be consistent with this tradition. In addition, courts deluged with thousands of plaintiffs who are denied compensation through no fault of their own are more likely to be influenced by the volume and to make allowances. Once some courts do so, others will likely follow, especially those that see deference to the legislature as “out of vogue” and believe that the idea “that changes should come from the legislature is not in good repute.”

B. Tolling

Another approach the courts could take that would both generally uphold the repose legislation and allow delayed manifestation suits is the application of tolling. Tolling of a statutory limitations period has traditionally occurred to give an injured party a reasonable chance to pursue his or her claim. Limitations periods traditionally have been tolled in cases involving fraudulent concealment, absence of the defendant from the jurisdiction, minor or incompetent plaintiffs, wrongful death, and contribution and indemnity claims. In addition, courts have used time extensions in product liability cases to avoid nondiscovery statutory time bars by finding continuing duties to correct or wam, by starting accrual for cumulative injuries from multiple uses at time of last exposure, and by recognizing express warranties.

While a few states have specifically included an individual tolling provision in their product liability reform statutes, most statutes are silent as to the applicability of these traditional tolling exceptions to their repose periods. Tolling is clearly inconsistent with a firm repose period and would not allow the actuarial certainty for which the statutes were passed. Yet the notion of equitable tolling is long established. The application of tolling exceptions for infants and other incompetents, as well as for absence from the jurisdiction seems likely in the delayed manifestation context. These traditional exceptions will affect few cases and will not unduly upset repose interests.

The United States Supreme Court recently upheld the application of tolling in a product liability suit involving a birth control drug but no delayed manifestation injury. In G.D. Searle & Co. v. Cohn, plaintiff brought suit eleven years after suffering a stroke allegedly caused by defendant’s contraceptive. Defendant, an out-of-state corporation, was served without problem under New Jersey’s long-arm rule. When defendant moved for summary judgment based on New Jersey’s two-year statute of limitations, plaintiff alleged the statute should be tolled because defendant was “not represented” in New Jersey “by any person or officer upon whom summons or other original process may be served.” The Court upheld a New Jersey Supreme Court finding” that being amenable to service through a long-arm statute is not the equivalent of inpersonam service and rejected the district court’s reasoning that since the long-arm statute, which made foreign corporations amenable to service in New Jersey, was passed after the tolling provision, the tolling provision no longer served a logical purpose and therefore discriminated against unrepresented foreign corporations. The Court remanded the case for a determination whether requiring a foreign corporation to register to do business in New Jersey to avoid tolling, and thereby subjecting the corporation to all duties and liabilities imposed on domestic corporations, is a violation of the commerce clause.

It is not clear that this statute as interpreted by the New Jersey Supreme Court can survive a commerce clause challenge. But if it does, and if other states adopt similar interpretations, courts can avoid statute of limitations bars in most cases. Thus, the remanded case will play a very important role in resolving the balance between plaintiffs’ right to bring suit and defendants’ repose interests. In any event, the minimal requirements for tolling adopted by the Court1 are likely to encourage other courts to recognize more readily tolling exceptions in the delayed manifestation context with greater flexibility.

Tennessee’s ten-year product liability statute of repose was tolled before the Cohn decision in a case involving a minor with a delayed manifestation injury. In Tate v. Eli Lilly & Co. the District Court for the Middle District of Tennessee found that the statute, which runs from six years from date of injury or ten years from the date on which the product was first purchased for use, except for minors who must bring suit within one year of reaching majority if that occurs sooner, did not bar plaintiff’s DES claim. The court found that Tennessee had a long-standing policy of protecting the accrued rights of minors until they reach majority and, therefore, the phrase “whichever occurs sooner” for minors should have no effect. The majority believed that simple inadvertence was responsible for the legislature’s failure to delete the phrase during the deliberative process. A different Tennessee district court, however, refused to allow an adult’s DES suit only a month later, finding the ten year statutory bar “harsh” but constitutional.

An Illinois appellate court, in deciding a constitutional challenge to the ten-year statute of repose brought by an eight-year-old boy injured by a product purchased ten years and eleven days before his injury, did not apply tolling. Using an approach similar to a rational basis test, the court found the statute denied neither due process nor the state’s guarantee of a remedy for every wrong. Denial of tolling in such a situation has been interpreted as a denial of due process by some courts and commentators, and will be discussed in the next section. This suit involved a typical delayed injury which was clearly within the contemplation of the legislature when the statute was passed. It is not clear whether the court would decide the same way if a delayed manifestation injury were involved.

Tolling exceptions involving fraudulent concealment and continuing duties would have a much greater impact on plaintiffs’ ability to bring suit, especially in delayed manifestation cases. Delayed manifestation situations are particularly amenable to charges of defendant’s fraudulent concealment or failure to warn. Because of the nature of the injury, delayed manifestation product-related injuries generally involve a time lag between the discovery of the cause and effect relationship and the general public knowledge of that relationship. Product manufacturers are in the best position to collect data on their products’ effects and usually have information regarding injuries or the possibility of injuries before others gain such knowledge. Many of the delayed manifestation suits, such as those involving DES and asbestos, are based in part on allegations that defendants knew or should have known that the product was dangerous, but kept that information from the public and continued to advertise and market the product or expose people to it. Thus, the seeds of-an estoppel argument are planted in most delayed manifestation cases.

Courts have consistently applied tolling in fraudulent concealment cases as an equitable bar to estop a defendant from benefiting from his own wrongdoing. The Supreme Court, recognizing the equitable necessity for such a bar in a recent discovery-rule case said:

That plaintiff has been injured in fact may be unknown or unknowable until the injury manifests itself; and the facts about causation may be in the control of the putative defendant, unavailable to the plaintiff or at least very difficult to obtain. The prospect is not so bleak for a plaintiff in possession of the critical facts that he has been hurt and who has inflicted the injury. He is no longer at the mercy of the latter.

In the former case, the Court would begin accrual at the time of discovery, but not in the latter, when plaintiff is aware of his injury but not of his legal rights. Other courts have recently expressed similar concerns, and have ruled accordingly.

The same equities are involved in cases alleging continuing duties to warn, which are increasingly providing a basis for recovery. The Indiana Supreme Court refused to toll the state’s ten-year statute of repose in a challenge based in part on such an argument. The case, however, did not involve a delayed manifestation injury. Other Indiana courts have indicated that a delayed manifestation case might lead to different results.

In light of today’s proconsumer atmosphere and the willingness of courts to construe limitations statutes to facilitate suits, it is most unlikely that courts will not apply tolling to estop a defendant from benefitting from its alleged wrongdoing in delayed manifestation cases. Use of tolling exceptions will enable courts to allow delayed manifestation suits while maintaining the statute’s constitutionality and bar to old-product suits. Nonetheless, the greater the number of exceptions to the bar that are allowed, the more arbitrary the statute will appear, and its use as a predictor of potential liability will be minimal. Thus, use of estoppel may prove to be only a temporary measure on the way to invalidation of product liability statutes of repose.

C Constitutionality

Constitutional challenges are the most common and comprehensive way of eliminating strict repose periods. Statutes of repose are increasingly being overturned on constitutional grounds as courts more closely examine the actual equities involved. At least eleven states have found architects’ and builders’ repose statutes unconstitutional. A similar number of courts have found part or all of the medical malpractice reform statutes constitutionally infirm, and many of these contain repose periods. While a few courts have based their decisions on equal protection or due process grounds, most have based them on state constitutional provisions granting access to the courts for redress of injury or on provisions barring special legislation. These provisions protect interests similar to those protected by due process and equal protection clauses, and courts usually discuss them as if they were interchangeable. Product liability statutes of repose are subject to challenge on the same grounds.

1. Equal Protection and Special Legislation

In an equal protection challenge, the classifications made by the legislature must be shown to be reasonably related to the state’s objective in order to be upheld. The reasonableness of the relationship is subject to different levels of scrutiny-rational basis, intermediate, and strict scrutiny. The closer the scrutiny, the less likely the legislation is to be upheld. It is clear that a strict scrutiny test is not appropriate for statutes of repose because they involve neither suspect classifications nor fundamental rights. Thus, courts must choose between rationality and the intermediate (close and substantial relationship) standards when reviewing repose statutes on equal protection grounds. Courts have invalidated repose statutes under each of these standards in non-product liability cases.

Most courts have used the less demanding rationality standard to test the architects’ and builders’ repose statutes, and although most have found the classifications rationally related to the goal of controlling liability in the construction industry and thereby alleviating the “crisis,” an increasing number are not so finding. Like statutes of repose for manufacturers and sellers of products, architects’ and builders’ statutes of repose were passed to solve a perceived crisis in the industry caused by changing laws and expanded liability. Although coverage of the architects’ and builders’ statutes is not uniform, most apply only to contractors, builders, architects, and similar groups involved in the construction process, but not to groups such as owners and material suppliers who also face significant liability. It is this limited coverage that has proved fatal under special legislation and equal protection challenges. Following the lead of the “seminal” decision of Skinner v Andersen, courts, in overturning the statutes, have found no rational reason why only certain groups should be singled out for protection from all those who are potentially liable.

A similar challenge may be made to the product liability statutes of repose: they protect only some of the persons or groups potentially liable in a product liability suit. Owners of products or premises where injuries occur are not specifically granted the immunity given to manufacturers and sellers. Nevertheless, this denial of equal protection argument is less persuasive for the product liability statutes because these statutes protect a greater number and wider class of potential defendants, or simply bar most actions based on product injury no matter who the defendant may be. Because of this wider coverage and inclusion of groups most likely to be defendants and most involved in the crisis, courts are more likely to find the legislation rationally related to the goal of reducing insurance rates by limiting liability. At least one court has so held in an old-product injury suit. An argument based on denial of equal protection to manufacturers of short-lived as opposed to long lived products is also unlikely to be successful when examined on a rational relationship basis.

An equal protection argument potentially more appealing to today’s courts in the product liability setting is based on the denial of equal protection to plaintiffs. Persons whose injuries do not manifest themselves until after the running of the statutory period are denied the protection accorded to plaintiffs whose injuries are readily apparent soon after the product is used. Similarly, persons injured by older products do not receive the same protection as those injured by newer ones. Even though these classifications may not be seen as irrational, they are likely to be overturned if an intermediate standard is used.

While no one disputes the legislature’s right to make distinctions, the classifications must not be arbitrary. Under a mere rationality standard there is evidence that a repose period which cuts off a plaintiff’s right to sue for oldproduct injuries after ten years is not arbitrary. The legislature has chosen a time period during which almost all evident product injuries occur. The assumption behind choosing a fairly long period is that if a product functions safely for a number of years, it may be assumed to be nondefective, and if it causes injury after that time, the injury probably occurred for some reason unrelated to defect, such as product misuse, alteration, or use beyond the product’s reasonable safe life. Thus, while a more rational distinction could have been made-for example, setting different periods for short-lived and long-lived capital goods-no reasonable period would have been perfect, and some repose was considered necessary to stabilize insurance rates and therefore to help ease the crisis. If some cutoff period is acceptable, one that allows a fairly long time for a product to manifest defects and allows for inclusion of almost all old-product suits is likely to meet the minimum rationality test.

Delayed manifestation equal protection challenges might be more successful because a much larger number of these cases are excluded by the statutes, and the courts and legislatures traditionally have seen greater inequities in not allowing suit for someone who is injured and does not know it. In addition, precedent exists under the medical malpractice statutes of repose for disallowing such distinctions. Delayed manifestation injury cases are similar to delayed discovery of foreign object cases in medical malpractice. The latter were generally exempted from inclusion in the statutes of repose passed to protect health care providers, and a discovery statute of limitations was maintained for them. There is little rational reason to deny suit to delayed manifestation plaintiffs, whose injuries are often deadly or life-threatening and debilitating, while allowing suit to plaintiffs injured by doctors and other health care providers who have left foreign objects in their bodies. Both the medical malpractice and product liability statutes were passed to solve an economic crisis, and that solution will not be helped by allowing suit in one case but not the other.

The New Hampshire Supreme Court, which recently overturned a medical malpractice statute of repose in Carson v. Maurer, used a middle standard of review to find that distinctions made on the basis of delayed discovery due to hidden injuries were unconstitutional. One provision of New Hampshire’s medical malpractice act reduced the statute of limitations from six to two years, and started it running from the commission of the act, not discovery, unless suit was based on the discovery of a foreign object in the body. In the latter instance, suit had to be commenced within two years of the time of discovery. The act also abolished the tolling of the statute for infants and incompetents.

The court found the legislature could not abolish the discovery rule for just one class of medical malpractice plaintiffs, nor could it penalize infants and incompetents in relation to their kind under nonmalpractice circumstances. Other courts have indicated a willingness to adopt similar holdings. The court in Carson used an intermediate standard of review in examining the constitutionality of the statute. In so doing it followed several other courts that have used this stricter standard to find the medical malpractice acts unconstitutional. The use of this middle tier approach would be equally appropriate in examining product liability statutes of repose.

It is fitting to use a heightened review for this type of legislation for several reasons. Unlike traditional statutes of limitations which set procedural duties, statutes of repose extinguish substantive rights by denying a duty of care from manufacturers to consumers. This removal of substantive rights, which affects thousands of plaintiffs injured by widely used products, requires more careful scrutiny than that accorded procedural changes. Moreover, in these instances the heightened review becomes even more compelling because of the aura of special legislation. The repose statutes were brought to the legislators and supported by a lobby of the very groups they were intended to protect. These are groups that wield considerable power, money, and influence and can therefore exert considerable pressure on the lawmakers. Those injured by the special legislation had no such power or influence to act as a counterbalance, and no unified voice to represent them. The legislation was presented in a “crisis” atmosphere in which quick solutions rather than careful examination of actual facts and figures were the order of the day. It is precisely in this type of situation, in which it is clear that both sides were not adequately represented and that the substantive rights of the under-represented group were harmed, that the middle review is appropriate.

Use of such a standard comports with the views of modem constitutional writers who predicted and called for greater use of a stricter standard in a wider variety of cases over a decade ago. Professor Gunther foresaw the increased use of closer scrutiny in a wider range of cases in which interests were not adequately represented. More recently, Professors Nowak and Ely have urged more careful review of issues involving equal protection. Ely, whose book Democracy and Distust has sparked considerable discussion and debate, divides provisions of the Constitution into two groups: (1) mandates from the Framers requiring certain actions, and (2) provisions that are open-ended statements of ideals whose substance is to be filled in subsequently by courts. The equal protection clause belongs to the latter group. In setting the parameters of equal protection and in reviewing legislation in light of them, courts are to be guided by the notion that broad participation in the processes and distributions of a representative democracy, rather than individual notions of fairness and due process, is the crucial goal. The issues involved in these statutes of repose do not rise to the blockage of participation in democracy as does the denial of voting privileges, nor do they involve a discrete and insular minority requiring substantial constitutional protection. They do, however, call for greater scrutiny than mere rationality because of the lack of participation and power of the harmed group and the importance of the right denied.

Courts have used this middle standard when reviewing statutes denying compensation for bodily injury in non-product liability contexts. In Hunter v. North Mason School District for example, the Washington Supreme Court found that a statute which limited plaintiff’s right to bring suit against the government by requiring formal notice of the claim within 120 days placed a “substantial burden” on a “substantial property right . . . in many cases fundamental to the injured person’s physical well-being and ability to live a decent life.” Since most tort victims did not know of the notice requirement, suit against the government in most instances was barred, while tort victims of nongovernmental defendants were allowed three years within which to bring suit. Such a distinction, when tested by a middle standard of review because of the “substantial” importance of the right, denied equal protection. The same reasoning has been applied in the medical malpractice context. The court in Carson v. Maurer, in fact, cited Hunter as primary support for its holding that barriers put in the way of a medical malpractice victim’s ability to bring suit affected an important substantive right and therefore should be judged by the use of the middle standard. Courts in other contexts have similarly used a more than mere rationality test when barriers to the right to bring suit were involved. The same reasoning is applicable to denial of compensation for bodily injury caused by products.

Once a stricter, middle standard is used, it is appropriate for courts to examine whether a crisis actually exists and, if so, whether the legislation will alleviate that crisis. It is appropriate to question both the existence of the crisis and the extent to which increases in awards contributed to that crisis, because without a crisis the classification would neither serve an important governmental end nor could its alleviation be substantially achieved. In the delayed manifestation situation, the answer to both these questions appears to be no. As in the medical malpractice area, writers and courts are beginning to discover that the crisis may have been more perceived than real.

Over five years ago, after extensive study of the problem, the Interagency Task Force on Product Liability concluded that the crisis may be more imagined than real, that the open-ended problem was not very significant, and that insurance rates were not necessarily responsive to actual liabilities. As stated in the Analysis to the proposed Model Uniform Product Liability Act, “The limited available data show that insurers’ apprehensions about older products may be exaggerated.” Over ninety-seven percent of product-related accidents occurred within six years of product purchase, and the problem caused by the few old-product cases that were successfully prosecuted was never adequately documented. There was little evidence to support the claim that businesses were being forced to close because of the jump in rates. Recent evidence indicates that plaintiffs are not particularly more successful in prosecuting claims than they were several years ago. Old-product claims are especially difficult for plaintiffs because the older the product, the heavier the burden on the plaintiff to overcome the natural assumption that a product in use without incident for a long period of time was not defective. As one commentator put it, a “few horror stories” drove rates up because rates are based on subjective factors.

In the great majority of cases insurance companies did not rely on actual product liability data when increasing premiums. Because product liability coverage was part of a comprehensive general liability package, the claim payout ratio for product liability injuries could not be determined, and the subjective loss estimates that form the basis of premium settings were even more subjective in the product liability area. States recently have taken this subjective factor into account when considering product liability reform. The pattern of the subjective nature of rate setting and the artificial creation of a crisis atmosphere, which has been well documented in the medical malpractice field, is emerging in the products liability area as a key cause of the highly increased premiums.

In addition, even if there were a crisis, it is far from clear that the repose statutes would alleviate it. Since most product manufacturers and product liability insurers operate on a multistate basis, anything short of a nationwide repose period would do little to alleviate the problem of open-ended liability because premiums are calculated on the experience in all relevant states. If, as has been suggested, the rates are more the result of economic fluctuations and unsuccessful investment practices than realistic liability predictions, requirements that premiums be well documented and based on actual state insurance claims would be far more useful and equitable.

As in the medical malpractice challenges, use of a middle standard of review is likely to result in overturning the product liability statutes of repose on equal protection and special legislation grounds.

2. Due Process and Guaranteed Access to the Courts

Courts have also begun to take a closer look at repose statutes when evaluating their validity on grounds of due process and guaranteed access to the courts. Product liability statutes of repose that have been declared unconstitutional were overturned primarily on this latter ground. The Florida Supreme Court, in a 4-3 decision in Battilla v. Allis Chalmers Manufacturing Co. , declared the Florida product liability statute of repose to be in violation of the state constitution. The basis for this finding was an earlier decision, Overland Construction Company v. Simmons, which invalidated the Florida repose statute for architects and builders because it was in violation of the Florida constitutional provision granting access to the courts for redress of injury. The Overland court interpreted this provision to mean that a common-law right cannot be taken away unless the legislature “has shown an overpowering public necessity for this prohibitory provision, and an absence of less onerous alternatives. ” The court found that the legislature had not expressed such a necessity, and the court could not find one in the changed circumstances which led to increased liability. In addition, the problems of reliable evidence and changes in technology were no different than those faced by all litigants, and there was not sufficient reason to protect the construction industry at the expense of the injured plaintiff. The court did not discuss less onerous alternatives, but in a product liability setting, measures such as different repose periods for different kinds of goods, rebuttable presumptions of nondefectiveness, and closer monitoring of the setting of premiums are well recognized.

In a subsequent decision the Florida court, with only one dissent, affirmed its finding of unconstitutionality of the product liability statute of repose in a delayed manifestation case. Plaintiff in Diamond v. E.A Squibb & Sons, Inc. suffered injury from DES, but the injury did not manifest itself until twenty years after her mother’s ingestion of the drug. The differences between delayed manifestation and old-product injury cases persuaded two of the judges who dissented in Battilla to change their opinions.

States that have held architect and builder repose statutes unconstitutional may also overturn their product liability statute of repose. In Bolick v. American Barmag Corp. , the North Carolina Court of Appeals recently used its state constitutional provision guaranteeing legal remedy for injury done to declare that state’s six-year product liability statute of repose unconstitutional. While recognizing that legislatures have the power to set limitation periods, the court found that this statute was not one of limitation because it cut off claims before they could accrue. This bar to the seeking of redress before the right arose violated the constitutional guarantee of remedy. The court cited the Florida and Kentucky decisions as well as other states’ decisions overturning architects’ and builders’ statutes. Unlike Florida and Kentucky, however, North Carolina had not previously overturned a repose statute.

In Thorton v. Mono Manufacturing Co. Illinois also recognized that the state’s ten-year limitation statute was not a true statute of limitations but a law extinguishing a right of action. Nevertheless, the Illinois Appellate Court did not find the statute to be in violation either of due process or the state constitution’s guarantee of a judicial remedy for every wrong. The court distinguished its constitutional provision from Florida’s by stating that in Illinois the access principle was merely a philosophy, whereas the Florida court had interpreted the provision as granting vested rights in certain remedies which could be abrogated only by showing overpowering public necessity and absence of less onerous alternatives. The Illinois statute, however, applies only to strict liability actions. Thus, plaintiff is not foreclosed from suit but merely from one theory. Indiana has also upheld its statute against attack based in part on the state constitutional provision granting legal remedy for injury.

It is not clear at this point whether many other courts are likely to adopt this due process/access-to-courts reasoning. Most of the challenges to the architects’ and builders’ repose statutes, both successful and unsuccessful, were based on equal protection clauses. More recently, however, in the medical malpractice area, several courts have overturned reform statutes on the ground that they limit access to the courts. Although these decisions have focused on the statutes’ requirement of use of medical malpractice panels, they indicate a greater willingness to review closely legislation on court access/due process grounds. Again, it is the judicial willingness to engage in close review that will be the key.

It is well recognized that constitutional provisions requiring remedy by due course of law are not blanket guarantees. Not every injury is remedied. And even for those that have been remedied in the past, legislatures may modify the law to reflect changing realities. Most states have found that rights which are not fundamental and have not vested can be rationally created or abrogated at the legislatures’ will. Changing the time period in which suit can be brought (a time period that comports with earlier statutes of limitations interpretations) to solve a perceived economic crisis while allowing the majority of suits has been found to comport with this legislative right. But the denial of rights to thousands of plaintiffs in delayed manifestation suits may cause the courts to require either an “overpowering public necessity” or a showing of less onerous alternatives.

A further distinction based on delayed manifestation injuries is possible. Due process challenges to statutes of repose primarily have been based on the argument that the legislature cannot take away a right without providing a reasonable alternative. In tort, however, there is no cause of action and therefore no vested property right upon which to base a due process challenge, until injury occurs. Therefore, an injury occurring after the running of the statutory period, such as an injury from old products, is not entitled to due process protection. Delayed manifestation suits, however, present a slightly different problem. In these cases injury often occurs within the statutory period; plaintiff is just unaware of its existence. Thus, in these cases a challenge to the statutes may rest upon a theoretical basis entirely distinct from the more traditional challenges. These cases are similar to those that involve denial of tolling of the statute for children and incompetents. Traditionally, statutes of limitations were tolled for these groups until they reached majority or regained competency in order to allow them full cognizance of their injuries and adequate time to pursue legal remedies. Denying tolling of the period until awareness of injury occurs is arguably a denial of due process because it denies reasonable access to the courts without providing adequate alternatives. The same may be said of repose statutes in delayed manifestation cases.

Two other potential due process problems exist for some statutes that do not provide for a grace period at the end of the statutory period or between the former law and the new repose period. Since the legislature may modify a vested right only if it provides a reasonable alternative, the new statutes must allow a grace period during which suits that would not be barred under the former law can be brought before being barred by the new period. Likewise, if no provision is made for persons who are injured near the end of the repose period, such as incorporating the usual two-year statute of limitations so a reasonable time is provided during which to bring suit, the statute may be violative of due process. These due process problems, while individually important, are easily remedied without changing the definite cutoff date for the vast majority of plaintiffs, and will therefore probably have little impact.


Product liability statutes of repose were passed in a “crisis” atmosphere to help swing the pendulum away from what manufacturers and insurers saw as an extremely proplaintiff position. Generally, the language of the statutes is unequivocal and would seem to indicate a legislative intent to cut off liability after a specific number of years. The legislative preference for repose in order to maintain a healthy business atmosphere is clear. If strictly interpreted, the statutes will bar thousands of suits in which injured plaintiffs, through no fault of their own, do not discover their injuries until after the statutory period has run. To be sure, barring such suits would be consistent with repose interests and a legislative desire to limit liability and thereby promote a probusiness climate. Nonetheless, such an interpretation would be inconsistent with the loss-spreading and safety-promoting policies currently fostered by courts in a wide variety of decisions. An absolute time bar provides little incentive to produce safe, long-lasting products, and may lead to practices such as dumping potentially dangerous products in states that have repose statutes and establishing long shelf lives before sale.

Courts are being asked to review these statutes, and except for those courts that give extreme deference to legislative judgment, they are not likely to find the statutes as unequivocal as had been assumed, especially when statutes are challenged in delayed manifestation cases. The climate of crisis has passed. Courts reviewing the legislation in this calmer atmosphere will probably. see less reason to protect insurance companies and businesses at the expense of plaintiffs’ substantive rights, particularly in light of the evidence indicating these groups were at least in part responsible for the “crisis” and possessed the influence to have legislation passed to protect themselves. Precedents set in cases construing repose statutes that protect health practitioners and architects and builders will likely be used by many courts to invalidate the product liability statutes on constitutional grounds. Two state courts have already done so. Other jurisdictions may take a less sweeping approach by applying time extensions such as tolling or by upholding the repose statutes but finding that they apply only to old-product injury cases.

In our litigious society, courts are increasingly asked to provide antidotes to modem social problems. Delayed manifestation injuries caused by technological innovation are prime examples of such problems. Little has been done so far by legislatures to deal comprehensively with these technological effects. Until such responsible action is taken, courts are likely to review legislation closely. Many preferable legislative responses could have been made: closer regulation of rate setting, rebuttable presumptions of non defectiveness, different periods of repose for different types of goods, and so on. Since legislatures did not choose one of these less restrictive alternatives, many courts are likely to ameliorate the statutes’ harsh effects by opting to protect the rights of the delayed manifestation plaintiffs.

Terry Morehead Dworkin, 1982.

Click to download the full study.

More DES DiEthylStilbestrol Resources

1981 DES Case: Tate v. Eli Lilly & Co.

This is a diversity case in which plaintiff seeks to recover damages for personal injuries allegedly resulting from her in utero exposure to the drug diethylstilbestrol, commonly known as DES. Defendant Merck & Co., Inc., has filed a Rule 12 motion to dismiss the complaint. It maintains that the ten-year “cap” on products liability cases contained in section 3 of the Tennessee Products Liability Act of 1978 [the Act], codified at T.C.A. § 29-28-103 (1980), bars plaintiff’s right of action.

TATE v. ELI LILLY & CO., Leagle, 19811570522FSupp1048_11436, September 18, 1981.

Plaintiff argues that the ten-year cap is inapplicable because her complaint alleges an injury that she sustained as a minor, and thus, in the words of the statute, she had “a period of one (1) year after attaining the age of majority” to bring the action, a condition that she satisfied. Plaintiff filed this lawsuit on December 24, 1980, six days before her nineteenth birthday on December 30, 1980. The Court holds that the statute creates an exception for causes of action based upon injuries to minors, and these may be brought within a period of one year after attaining majority, without regard to the generally applicable limitations contained in subsection of T.C.A. § 29-28-103. Accordingly, defendant’s motion is denied.

The statute, in relevant part, provides as follows:

29-28-103. Limitation of actions — Exception.
Any action against a manufacturer or seller of a product for injury to person or property caused by its defective or unreasonably dangerous condition must be brought within the period fixed by §§ 28-3-104, 28-3-105, 28-3-202 and 47-2-725, but notwithstanding any exceptions to these provisions, it must be brought within six (6) years of the date of injury, in any event, the action must be brought within ten (10) years from the date on which the product was first purchased for use or consumption, or within one (1) year after the expiration of the anticipated life of the product, whichever is the shorter, except in the case of injury to minors whose action must be brought within a period of one (1) year after attaining the age of majority, whichever occurs sooner.

The crux of defendant’s argument is that the last clause, “whichever occurs sooner,” manifests a legislative intent to preserve the cause of action of a minor only if it accrues within ten years from the purchase of the product at issue. Under defendant’s interpretation (as presented in its March 18, 1981, brief), a minor would have until his nineteenth birthday to bring a products liability action even if the ten years had run, so long as his injury was discovered within ten years of the date of purchase.

Plaintiff maintains, in essence, that the exception carved out for minors is absolute, so that any person with a right of action accruing at any time during infancy could recover so long as suit was filed before his or her nineteenth birthday, without regard to the accrual date. …

… In summary, the Court holds that T.C.A. § 29-28-103 subsection preserves accrued products liability rights of action of minors until they reach majority, after which time they have one year to bring an action. This holding follows from the Court’s conclusion that the last three words of subsection are a nullity. “

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

More DES DiEthylStilbestrol Resources