1990 DES Case: Smith v. Eli Lilly & Co.

Abstract

The plaintiff in this appeal alleges that she was injured by the drug diethylstilbestrol (DES), which her mother ingested during pregnancy. She seeks relief against defendant DES manufacturers. The issue is whether, in a negligence and strict liability cause of action, Illinois should substitute for the element of causation in fact a theory of market share liability when identification of the manufacturer of the drug that injured the plaintiff is not possible. The trial court granted defendants’ motion for summary judgment as to various counts of the complaint, including a negligence count, but denied the defendants’ motion as to the strict products liability count and adopted the market share liability theory developed in Sindell v. Abbott Laboratories (1980). The appellate court affirmed the trial court’s holding as to the products liability count, but reversed the trial court’s holding as to the negligence count, holding that the market share theory should apply to both the plaintiff’s negligence and strict liability counts. However, it rejected the Sindell rule which the trial court had adopted and instead adopted the market share liability theory as it was recognized in Martin v. Abbott Laboratories(1984). The appellate court affirmed the trial court’s entry of summary judgment for defendants on the other counts. We granted defendants’ petition for leave to appeal.

SMITH v. ELI LILLY & CO., Leagle, 1990359137Ill2d222_1353, Supreme Court of Illinois, July 3, 1990.

The plaintiff, Sandra Smith, was born on July 13, 1953, in Chicago, Illinois. In 1978, she was admitted to the Ravenswood Hospital in Chicago, where she underwent a dilation and curettage, cervical biopsy, and an excisional biopsy of the vaginal wall. The biopsy revealed that plaintiff had a form of cancer known as clear cell adenocarcinoma of the vagina. She was then transferred to the University of Illinois Hospital, where she underwent extensive surgery. Plaintiff alleges that the DES prescribed for her mother while plaintiff was in utero caused the cancer.

Elizabeth Smith, plaintiff’s mother, had a history of difficulty with pregnancy before she gave birth to Sandra. Therefore, in early 1953, when she learned of her pregnancy, she went to the Field Clinic in Chicago and consulted with Dr. Jack E. Davis regarding her condition. The doctor gave Mrs. Smith a prescription to be filled at the clinic pharmacy for “Tab 98.” The practice at the Field Clinic was to store and dispense drugs by number, rather than by name. The record establishes that Tab 98 designated 25 milligram tablets of DES. Mrs. Smith continued to take DES tablets daily up until the time she gave birth to Sandra. Dr. Davis attended Mrs. Smith throughout her pregnancy but at the time this suit was filed he was deceased.

The records recovered from the Field Clinic identify numerous companies which supplied drugs to the clinic, some of which were also suppliers of DES, but these are insufficient to match the company with the drug dispensed to the plaintiff’s mother. The person responsible for purchasing the pharmaceutical products stocked at the clinic’s pharmacy had also died by the time this suit was filed. Therefore, although the plaintiff knows the color, size and dosage of the drug her mother took, she is unable to identify the specific manufacturer of the product.

In 1980, plaintiff filed her initial complaint naming as defendants 138 drug companies. According to an affidavit of John Kraas, an employee of defendant Eli Lilly & Company, there were 81 companies which marketed DES in 25 milligram tablets between 1952 and 1953. This information was derived from medical and pharmaceutical industry references. Of the 81 potential manufacturers of the DES taken by plaintiff’s mother, 63 were not named in the complaint. Of the 138 companies named, 70 filed appearances. Motions were filed by a number of named defendants attacking jurisdiction, asserting changes in corporate structure or ownership that would bar successor liability, or charging error of identity. Twenty companies remained in the suit after these motions were resolved.

In November 1982, plaintiff filed a second amended complaint consisting of 11 counts. Counts I through VI sound in negligence, strict liability, breach of express warranty, fraud, breach of implied warranty, and violation of the Federal Food, Drug, and Cosmetic Act. Counts VII and VIII sound in conspiracy and pray for assessment of damages on various bases of concerted action, joint and several liability and joint enterprise liability. Counts IX and X allege theories of negligence and strict liability, respectively, and invoke market share as the means for apportioning damages. The thrust of these causes of action is that the drug companies failed to properly test DES and to adequately warn of its dangers. The last count is a tort action against the Field Clinic. There are apparently no motions pending on this count.

Following completion of discovery, 14 defendants filed a joint motion for summary judgment. Some of these defendants and a number of others filed individual motions for summary judgment on the ground that the plaintiff’s mother did not use their products. Twelve defendants were able to exculpate themselves on the basis that they could not have manufactured the DES that plaintiff’s mother took because their product either was not of the same dosage, color or type, or was not sold to the Field Clinic. The remaining eight defendant manufacturers included Abbott Laboratories, Eli Lilly & Company, Premo Pharmaceutical Laboratories, Inc., Carroll Dunham Smith Pharmacal Company, William H. Rorer,Inc., S.E. Massengill Company, Harvey Laboratories, Inc., and Boyle & Company.

The trial court granted the joint motion for summary judgment on counts I through IX of the second amended complaint. However, the court denied the motion with respect to count X, the strict liability action, and adopted market share liability, based on the theory that the California Supreme Court articulated in Sindell v. Abbott Laboratories (1980). The defendants appealed the denial of their motion for summary judgment as to count X and plaintiff cross-appealed the trial court’s grant of summary judgment as to counts I through IX. As noted above, the appellate court likewise adopted a theory of market share liability, although different from that applied by the trial court, and extended its application to the negligence count. The appellate court affirmed the dismissals of the other counts. The defendants filed a petition for leave to appeal to this court based on the denial of their motion for summary judgment on counts IX and X, and we granted leave to appeal. The plaintiff has not cross-appealed from the dismissal of the other counts. ” …

… continue reading SMITH v. ELI LILLY & CO., on Leagle.

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1990 DES Case: Singer v. Eli Lilly & Co.

Abstract

Plaintiffs, a husband and wife, brought this action against eight manufacturers of the prescription drug, diethylstilbestrol (DES), seeking the recovery of damages for injuries allegedly sustained as a result of the wife’s in utero exposure to the drug in 1949. Although expressly brought pursuant to New York’s “Toxic Tort Revival Statute” (L 1986, ch 682, § 4), and concededly commenced more than seven months after the expiration of the statute’s one-year window period, effective July 30, 1986, plaintiffs contend that the action is nonetheless timely by virtue of the commencement of two purported class actions within the one-year window period.

SINGER v. ELI LILLY & CO., Leagle, 1990363153AD2d210_1329, Appellate Division of the Supreme Court of the State of New York, First Department, January 4, 1990.

Defendant American Home Products Corp., pursuant to CPLR 3211 (a) (5), moved to dismiss on the ground that the action was time barred. Each of the other defendants thereafter moved on the same ground. In arguing that the pendency of two class actions filed within the window period on behalf of women similarly exposed to DES tolled the revival period, plaintiffs relied on American Pipe & Constr. Co. v Utah, which held that in certain circumstances the commencement of a class action tolls the running of the applicable Statute of Limitations as to all putative members of the class.

The motion court granted the motions, holding that commencement of the action within the one-year window period was a condition precedent to bringing a suit for personal injury arising out of DES exposure. Thus, the court reasoned, that period could not be affected by the tolling provisions applicable to Statutes of Limitation, even if New York courts were to adopt the Federal doctrine, as expressed byAmerican Pipe (supra), which permits tolling of a Statute of Limitations during the pendency of a class action. We affirm.

On July 30, 1986, Governor Cuomo signed into law a “tort reform” package, including the revival statute, which provided that any action seeking damages for personal injury, property damage or death caused by the latent effects of exposure to five substances, including DES, that was time barred or had been previously dismissed because the applicable period of limitations had expired, “is hereby revived and an action thereon may be commenced provided such action is commenced within one year from the effective date of this act” (L 1986, ch 682, § 4).

The revival provision was the second part of a two-pronged reform to remedy the inequity of New York’s former date-of-exposure rule for injuries caused by the latent effects of toxic substances. In that regard, the central focus of the reform package was the adoption of a discovery Statute of Limitations (L 1986, ch 682, § 2, adding CPLR 214-c). Henceforth, an injured party would be permitted to assert a cause of action within three years from the date of discovery of the injury, regardless of the time of exposure.

The revival statute was itself a product of compromise. “Legislative history indicates that the five named substances were distinguished from other toxic substances (§ 2) as a result of compromise between the Assembly (which had voted to permit revival for all toxic substances) and the Senate which wanted to limit revival. The Legislature ultimately limited revival based upon the existence of an identifiable group affected and the resulting ability to predict the future costs of such revival. The Legislature was apparently concerned that under a broader revival statute, the large number of unknown victims would create unpredictable risks and costs.” (Hymowitz v Lilly & Co.). Thus, the limitation of revival to a one-year period and the selection of only five substances reflected an intent to limit the effects of revival. ” …

… continue reading SINGER v. ELI LILLY & CO., on Leagle.

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1990 DES Case: Sorrells v. Eli Lilly & Company

Abstract

Plaintiff, Susan Sorrells, claims that she and her infant daughter Shanna were injured due to her mother’s ingestion of the drug diethylstilbestrol (“DES”) in 1951-1952 when she was pregnant with Susan..

Susan’s daughter, Shanna, was not exposed to DES in any way, but claims that her grandmother’s use of DES affected her mother’s ability to carry her to term, thus causing Shanna’s profound hearing loss and other injuries.

SORRELLS v. ELI LILLY AND COMPANY, Leagle, 19901415737FSupp678_11285, United States District Court, District of Columbia, May 24, 1990.

At bar is defendant’s motion to dismiss all of Shanna’s individual claims of negligence and strict liability on the grounds that Lilly owed no foreseeable duty to Shanna and plaintiff’s motion for certification of the issue to the Maryland Court of Appeals.. ” …

… continue reading SORRELLS v. ELI LILLY AND COMPANY on Leagle.

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1983 DES Case: Wetherill v. University of Chicago

Abstract

Both Rachel Wetherill (“Wetherill”) and Maureen Rogers (“Rogers”) claim injury by exposure in utero to diethylstilbestrol (“DES”), administered to their mothers as part of a study (the “Study”) conducted by Dr. William Dieckmann (“Dieckmann”) in the early 1950s at the University of Chicago (“University”) hospitals. Each Complaint contains the same three counts:

  1. Count I charges University committed a battery by subjecting plaintiff’s mother to the Study without her prior knowledge or consent.
  2. Count II sounds in malpractice, asserting various acts of negligence by University and its hospital employees.
  3. Count III seeks recovery on strict liability grounds.

WETHERILL v. UNIVERSITY OF CHICAGO, Nos. 77 C 1434, 77 C 2485, leagle, 19831694570FSupp1124_11546, 570 F.Supp. 1124 (1983).

Both actions have reached the final pretrial order stage and have been added to this Court’s list of cases ready for trial. Each plaintiff has now filed motions in limine:

  1. to declare the relevance of the testimony of Dr. Brian L. Strom (Dr. Strom) to Counts I and II,
  2. to exclude evidence concerning University’s asserted routine practice of obtaining the consent of participants in the Study under Fed.R.Evid. (Rules) 403, 406 and 802.

Dr. Strom‘s proposed testimony is described in the final pretrial order:

He will testify that at the time of plaintiff’s exposure to DES, the University of Chicago … knew, or by the application of reasonable, developed human skill and foresight should have had knowledge of the dangers of DES use. Dr. Strom will also testify that DES was inadequately tested prior to its marketing for treatment of accidents of pregnancy. ” …

… continue reading WETHERILL v. University of Chicago on Justicia US Law or on leagle.

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Medicine and the Law : First DES third-generation injury claim, 1991

On Feb 19, 1991, the New York Court of Appeals rejected the right to claim for a third-generation injury resulting from ingestion of diethylstilboestrol (DES) during pregnancy. The plaintiff was a 9-year-old girl with cerebral palsy. Her grandmother had taken DES during pregnancy in 1959, and her mother (born in 1960) had deformities in her reproductive system which, it was claimed, led to premature birth and neurological injuries in the third generation.

Medicine and the Law Diethylstilboestrol: third-generation injury claims, sciencedirect, Feb 19,1991.

DES was marketed for about 30 years in the belief that it reduced the risk of miscarriage. Over two hundred firms manufactured it, and it was widely prescribed in the Netherlands and USA. In 1971 it was “banned” by the US Food and Drug Administration (FDA) because of evidence of an abnormal incidence of vaginal and cervical cancer in the daughters of women who had taken DES during pregnancy. There were also adverse effects in male children.

… the daughters reached puberty at the earliest. Another problem has been to identify which manufacturer produced the brand of DES that each woman took. Furthermore, records have been destroyed or lost, manufacturers have closed down, prescribers have retired or died, and memories have faded. Early claims named the FDA as co-defendants but all claims against the Administration were dismissed.

One approach was the “concerted action petition”, which aimed to identify all distributors who participated in the “common purpose” of supplying DES to a particular area in which the plaintiffs mother had lived at the time of ingestion. This ploy was seldom successful, but in Michigan and New York courts ruled that the manufacturer’s marketing strategy showed evidence of conscious parallel strategies, and two cases did succeed. An attempt to shift the burden of proof on to a defendant, so that a manufacturer would have to establish his innocence, failed. The courts ruled that it would be unjust to find a firm guilty of dispensing an unsafe product when that individual manufacturer was merely one of a group whose identity was doubted. In California in 1980 plaintiffs were allowed to sue, on the basis of market share, all DES manufacturers who had supplied the drug to a particular area. This approach, though much criticised, has been the model for the later cases in which the plaintiff has been able to prove the manufacturer’s failure to test the safety of the drug or to warn the users of potential harm.

The claims for third-generation injuries by about 100 “DES granddaughters” marks a new stage in the battle for compensation. They allege that maternal uterine hypoplasia, cervical stenosis, and/or endometriosis caused by their mothers’ exposure to DES ingestion while in utero are responsible for their own congenital deformities. They also claim for large sums to compensate for anxiety over the increased risk of clear-cell adenocarcinomas. In most cases, thirty years or more have elapsed since the original DES ingestion, and such cases would normally be well outside time limits for bringing a suit. Even under the Consumer Protection Act 1987, which is not retrospective and which came into force in Britain on March 1, 1988, there is a maximum time limit of ten years in which claims may be brought. Beyond that, the plaintiff must pursue a claim in negligence in the normal way, if not time barred.

By a majority of 6 to 1, the New York Court of Appeals rejected in principle the right to pursue a third-generation DES injury claim.

Giving the judgment of the majority, Chief Judge Sol Wachtler said:

“For all we know, the rippling effects of DES exposure may extend for generations. It is our duty to confine liability within manageable limits. Limiting liability to those who ingested the drug or who were exposed to it in utero serves this purpose.”

Judge Stewart F. Hancock Jr, dissenting, argued that the girl

“should have the same right to sue the drug makers for her injuries as her mother… she is one of a class of thousands of persons who have allegedly suffered devastating abnormalities and injuries resulting from defendants’ marketing of DES … Is there any basis in the law or social policy or any principled reason in justice and fairness for holding that she-unlike other members of the class–should not be permitted to prove her case?”

The New York decision is likely to be persuasive in other states, though it is not binding outside New York, and with so much at stake the large numbers of would-be plaintiffs are unlikely to give up the struggle just yet.

Diana Brahams, 1991.

Click to download the full paper.

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Preconception tort liability: recognizing a strict liability cause of action for DES grandchildren

” DES cases are breaking new ground in tort litigation. In March 1990, J. David Roberts filed a $ 2,000,000 lawsuit in the United States District Court for the District of Columbia against drug manufacturer Eli Lilly and Company, alleging that his in utero exposure to DES caused his daughter’s cancer. Roberts sued under theories of strict liability, emotional distress, breach of warranty, negligence and misrepresentation. He also alleged that DES manufacturers conspired to produce the drug after they knew of its dangers. “

Abstract

Over the past decade more than 1,000 “DES daughters” have filed lawsuits against the manufacturers of DES, alleging that their in utero exposure to the drug caused various reproductive tract abnormalities, including cancer.

Plaintiffs now allege that their grandmothers’ use of DES during pregnancy caused genetic damage leading to cancer in third generations. This Note addresses the validity of preconception tort liability in the context of third-generation DES cases.

Plaintiffs in preconception tort liability cases have sought recovery under both negligence and strict liability causes of action. Courts should recognize the validity of preconception tort liability and allow a strict liability cause of action in third-generation cases.

Sources and More Information
  • Preconception tort liability: recognizing a strict liability cause of action for DES grandchildren, American journal of law & medicine, NCBI PubMed PMID: 1812769, 1991.
  • Preconception Tort Liability: Recognizing a Strict Liability Cause of Action for DES Grandchildren, Boston University School of Law, LexisNexis, 17 Am. J. L. and Med. 435, 1991.
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From Res Ipsa Loquitur to Diethylstilbestrol

Among the most troublesome cases for courts in California and elsewhere are those in which the plaintiff has suffered a major injury, wrongfully caused, but the plaintiff cannot identify the tortfeasor responsible. If the plaintiff can identify an injurer over the course of litigation all is well. If the plaintiff cannot significantly narrow the list of potential wrongdoers the tort system is unable to provide a remedy. Difficulty arises, however, when the plaintiff can identify a group of possible tortfeasors, but cannot identify any particular defendant as the one which actually caused his or her injury.

From Res Ipsa Loquitur to Diethylstilbestrol: The Unidentifiable Tortfeasor in California, Maurer School of Law: Indiana University, Indiana Law Journal: Volume 65 | Issue 3 Article 3, Summer 1990.

As a general principle of tort law, a plaintiff must establish a connection between his or her injury and an act or omission of the defendant. Inherent in this requirement is an identification of the defendant as the tortfeasor. The doctrine of res ipsa loquitur, in its ordinary sense, relieves a plaintiff of the burden of proving the precise cause of injury but not of the necessity of identifying the responsible tortfeasor. Thus, to permit recovery by plaintiffs victimized by unidentifiable tortfeasors, doctrinal expansion has been necessary. California courts have responded to the call.

In Part I of this article, I will discuss res ipsa loquitur as a rule of circumstantial evidence and will proceed to trace its doctrinal progression through a policy-driven version of the doctrine to the concerted action and alternative liability theories of liability. In Part II, I will focus on the setting in which the problem of unidentifiable tortfeasors has been most dramatically presented-women injured by the drug diethylstilbestrol (DES). Finally, in Part III, I will suggest considerations for courts fashioning new theories of liability for unidentifiable tortfeasor cases or applying existing tort theories to new factual situations.

I. THE DOCTRINAL PROGRESSION OF THE UNIDENTIFIABLE TORTFEASOR

A. Res Ipsa Loquitur and Inferences from Circumstantial Evidence

The doctrine of res ipsa loquitur, as it appears in its usual and most familiar form, is a rule of circumstantial evidence. More precisely, it allows (or compels) an inference of negligence from circumstantial evidence where the defendant is unable to present sufficient contrary evidence. The doctrine applies “where the accident is of such a nature that it can be said … that it probably was the result of negligence by someone and that the defendant is probably the person who is responsible.” It is worth noting that the “inference of negligence” permitted by the doctrine is not an inference that a particular act of the defendant was negligent, but is an inference that the defendant did some negligent act which proximately caused the harm in question although the specific cause of the plaintiff’s injury is unknown.

It may appear that the doctrine of res ipsa loquitur, as so stated, is no more than an embodiment of common sense. Surely judges and juries are capable of drawing conclusions from circumstantial evidence without the aid of a doctrine with a latin name. However, the doctrine, by focusing on the likelihood of the essential components of the plaintiff’s case, provides a logical framework for approaching circumstantial evidence. As such, it is a powerful antidote to an unfortunate judicial hesitancy to accept circumstantial evidence. This hesitancy, and the utility of res ipsa loquitur in combatting it, can be seen most clearly in a brief examination of the line of cases following Sargent v. Massachusetts Accident Co. and the commentary those cases have inspired.

Upham Sargent was a young adventurer who disappeared kayaking down the Nottaway River in Quebec. The Sargent case involved the effort of Sargent’s father (the beneficiary of Upham’s accident insurance policy), to collect a claim requiring that he prove by a preponderance of the evidence that the insured died from an accidental injury.”‘ Although the Massachusetts Supreme Court found this burden satisfied, it first made the following observations with respect to the preponderance of the evidence standard:

It has been held not enough that mathematically the chances somewhat favor a proposition to be proved; for example, the fact that colored automobiles made in the current year outnumber black ones would not warrant a finding that an undescribed automobile of the current year is colored and not black, nor would the fact that only a minority of men die of cancer warrant a finding that a particular man did not die of cancer…. The weight or ponderance of evidence is its power to convince the tribunal which has the determination of the fact, of the actual truth of the proposition to be proved. After the evidence has been weighed, that proposition is proved by a ponderance of the evidence if it is made to appear more likely or probable in the sense that actual belief in its truth, derived from the evidence, exists in the mind or minds of the tribunal notwithstanding any doubts that may still linger there.

This language was quoted approvingly in two subsequent Massachusetts Supreme Court decisions finding defendants not to have been sufficiently identified as the cause of the plaintiff’s injury. In Smith v. Rapid Transit, Inc., the plaintiff was forced off the street by a bus, but she offered no evidence other than that the defendant had the sole franchise for operating a bus line on that street. In Tartas’ Case, the plaintiff sued the Workmen’s compensation insurer of one employer, but the court found that the plaintiff’s decedent could have contracted his fatal illness while working for any of several employers.

The meaning of the Sargent court’s “actual belief” dictum has stirred considerable interest in academic circles. There are several possible explanations. A first possibility is that the “actual belief” required by Sargent exists only if the plaintiff shows that the likelihood of the proposition to be proved exceeds fifty percent by some significant margin. This would, of course, run counter to generally understood standards of proof in civil litigation. In addition, contrary to what the Sargent court may have thought, such a rule would in individual cases increase the likelihood of an erroneous decision. Moreover, none of the Sargent cases have discussed the proof requirement in numerical terms.

A more subtle interpretation is that Sargent requires a plaintiff to offer some individualized proof; general statistical evidence, except perhaps in rare instances, is not enough to satisfy the plaintiff’s burden? This position is defended either by asserting that particularistic evidence is necessary to provide a causal explanation, or by arguing that in most cases, taking into account the probative value of the nonproduction of particularistic evidence, the likelihood of the required showing is less than 50% even though the statistical evidence taken alone may suggest that the likelihood is greater. The counterargument is that, in terms of its value in deciding cases, particularistic evidence is not qualitatively different, much less better, than statistical evidence. Moreover, even taking into account the lack of particularistic evidence, the plaintiff’s statistical evidence may be strong enough to make the probability of the truth of his assertion greater than 50%. Although it is certainly relevant if a party that should be able to produce evidence does not produce it, the pursuit of certain kinds of evidence (i.e., nonstatistical evidence, or even noncircumstantial evidence) may interfere with proper factfinding.

A third explanation of the Sargent cases looks beyond the language of the courts to the factual records underlying the cases before them. Read narrowly, the Sargent cases stand for the simple proposition that a plaintiff may not recover if he or she offers no evidence on a crucial part of his or her case. Although cases are best decided by examining the whole of the evidence presented (taking into account, where appropriate, the nonproduction of other evidence), reconsidering the Sargent and Smith facts and concluding that the decisions were supportable does not solve the Sargent problem. The Sargent language, with its ambiguous implications, still creates confusion.

Res ipsa loquitur as a circumstantial evidence rule cuts through the uncertainties presented by the various analyses of Sargent. Application of the doctrine returns the factfinder’s focus where it belongs: to what the facts of the accident say about the likelihood of negligence and the defendant’s connection to it. If the facts of the accident are such that its cause was more likely than not the defendant’s negligence, the burden of proof shifts to the defendant. The degree of conviction in the factfinder’s mind and the type and quantity of evidence before the court are simply not in issue. Although this approach is proper for all negligence cases, it is most valuable where the complete story of the plaintiff’s injury is unavailable and the factfinder may be tempted to throw up its hands in confusion and to not weigh the evidence before it.

Notwithstanding the relatively simple concepts behind the res ipsa loquitur circumstantial evidence rule, California courts have experienced a great deal of difficulty in applying the rule. This difficulty has resulted from the problems inherent in reducing a rule to a formula and mechanically applying that formula without regard to its underlying purposes.  The starting point for the modern statement of the doctrine is the Wigmore formulation:

  1. the apparatus must be such that in the ordinary instance no injurious operation is to be expected unless from a careless construction, inspection, or user;
  2. both inspection and user must have been at the time of the injury in the control of the party charged;
  3. the injurious occurrence or condition must have happened irrespective of any voluntary action at the time by the party injured.

It may be added that the particular force and justice of the rule, regarded as a presumption throwing upon the party charged the duty of producing evidence, consists in the circumstance that the chief evidence of the true cause, whether culpable or innocent, is practically accessible to him but inaccessible to the injured person.

The California Supreme Court quoted Prosser’s restatement of Wigmore’s formula in Ybarra v. Spangard, and this language has been cited frequently.

In unidentifiable tortfeasor cases, the requirement of most concern is the second one-the requirement that the injury-causing instrument must have been under the “control” of the defendant. California courts have sometimes viewed this requirement as being simply a way of determining whether an injury was the result of the defendant’s negligence. More often, the control requirement has been treated as a special element to be shown. As a consequence, courts have in some cases applied res ipsa loquitur without sufficiently examining the possibility of negligence on the part of someone other than the defendant and, in other cases, courts have had to stretch the control “rule” so as to enable the plaintiff to proceed. Prosser’s remark that:

it would be far better, and much confusion would be avoided, if the idea of “control” were to be discarded altogether, and if we were to say merely that the apparent cause of the accident must be such that the defendant would be responsible for any negligence connected with it.

The problem presented by the unidentifiable tortfeasor cases, however, is fundamental and does not turn on whether the requirement is cast in terms of the defendant’s “control” of the injury-causing instrument or its connection with the alleged negligence. Where the facts disclose multiple defendants acting independently, no one of which more likely than not controlled the instrumentality or was connected with the negligence, no case-circumstantial or otherwise-has been proved by a preponderance of the evidence against any one of them. Courts sometimes fail to appreciate this issue, and occasionally consciously impose liability under these circumstances to promote separate policy goals.  The latter cases, the subject of the next section of this Part, in fact take the doctrine of res ipsa loquitur well beyond the confines of a rule of circumstantial evidence. They also highlight the fact that res ipsa loquitur, as a rule of circumstantial evidence, simply does not work for the case of the unidentifiable tortfeasor.

In completing this discussion of the circumstantial evidence rule formulation of res ipsa loquitur, it is worth noting the treatment of Wigmore’s statement concerning the rule’s relationship to the defendant’s accessibility to the chief evidence of the case. Although some California cases have considered the “superior knowledge” of the defendant,  this superior knowledge has been held not to be a prerequisite for the doctrine’s application. Prosser, moreover, considered the superior knowledge argument a makeweight which accomplishes nothing but to make the basis for decisions less clear. For res ipsa loquitur as a circumstantial evidence rule, this result is correct. Although nonproduction of important evidence which should have been available may affect the evaluation of the probabilities of the defendant’s negligence, this does not, for the simple purpose of deciding circumstantial evidence cases, require a formal burden-shifting doctrine. The defendant’s presumably superior access to relevant information, however, serves as the foundation for the policy-driven version of res ipsa loquitur.

B. Enhanced Res Ipsa Loquitur

Courts have, in a group of cases, relied upon the defendant’s presumably superior access to relevant information to shift the burden of producing evidence (if not the burden of proof) to the defendant. Although decided in the name of res ipsa loquitur, such cases in reality evidence a departure from the use of the doctrine as a measure of the inferences permissible from the evidence presented in pursuit of policy goals. I will refer to this policy-driven version of res ipsa loquitur as “enhanced res ipsa loquitur” to differentiate it from the circumstantial evidence rule. Enhanced res ipsa loquitur appears in two categories of cases. The first consists of cases in which a special relationship exists between the plaintiff and the defendant, and the courts have employed the doctrine to ensure that in the event of uncertainty the loss falls on the defendant. The second category consists of cases in which a special relationship may exist, but the doctrine is primarily used to sanction the defendant for the nonavailability of evidence.

Enhanced res ipsa loquitur first appeared in cases involving suits by passengers against common carriers. Housel v. Pacific Electric Railway Co., involved a collision on the streets of Los Angeles between a hay wagon and a street car bearing the plaintiff as a passenger. The California Supreme Court interpreted res ipsa loquitur, when applied to common carrier cases, as providing “that proof of the injury to the passenger while he was being carried as such creates a prima facie case or presumption of negligence on the part of the carrier, which the carrier is called upon to meet or rebut.” The court reasoned that in view of the high degree of care required of a carrier toward its passengers, “a collision would not happen in the ordinary course of events if the carrier exercised such care …. ” The court also noted that “the means of proving the specific facts as to the cause of the accident are peculiarly within the power of the carrier, and the explanation should come from it, rather than from the passenger, who very often is unable to ascertain and prove the real facts.” In Bourguignon v. Peninsular Railway Co., the “rule” was reduced to the following formula:

Where the accident is of such a character that it speaks for itself… and raises a presumption of negligence, the defendant will not be held blameless except upon a showing either

  1. of a satisfactory explanation of the accident, that is, an affirmative showing of a definite cause for the accident in which cause no element of negligence on the part of the defendant inheres,
  2. or of such care in all possible respects as necessarily to lead to the conclusion that the accident could not have happened from want of care, but must have been due to some unpreventable cause, although the exact cause is unknown.

The effect is to shift the burden of proof, and the loss if proof is unavailable, to the carrier.

The California Supreme Court later employed enhanced res ipsa loquitur as a products liability precursor in cases involving broken or exploded beverage bottles. In these pre-strict liability cases, to recover from bottlers plaintiffs were required to show either negligence in the bottling process or a defective bottle coupled with negligent inspection for defects by the bottler. The plaintiffs offered no specific evidence of either and the question presented was whether res ipsa loquitur could be used against the defendants. Much of the court’s opinion in each case is spent resolving the question of whether the defendant had sufficient “control” over the bottle in question at the time of the accident for the application of the doctrine, but more important for present purposes are the court’s discussions of the permissibility of inferring the defendant’s negligence from the fact that the bottles broke.

The issue was first debated in Honea v. City Dairy, a case concerning a young girl injured by a milk bottle which “just broke” while she was carrying it. The majority concluded that the court could not take judicial notice “that defects in glass bottles will not ordinarily occur unless the bottler is negligent,” and consequently disallowed application of the doctrine. The dissent argued:

  1. bottles do not ordinarily break unless they are defective;
  2. the bottler had a duty to inspect the bottle and discover any defects;
  3. and based upon evidence that “a defect would be discoverable by reasonable inspection,” failure to inspect or negligent inspection may be inferred from the fact that the defect was not discovered.

In Escola v. Coca Cola Bottling Co.,  a case involving a waitress injured by an exploding Coca Cola bottle, the court noted testimony concerning bottle testing practices and essentially followed the reasoning of the Honea dissent.

The cases use the language of res ipsa loquitur, but in fact much more is going on. A rule that, because practicable tests are available, any failure to detect a defect may be presumed negligent puts the bottler in a very disadvantageous position. There is no cost-benefit analysis of available tests, and even if a bottler performs complete testing, if in some instances the tests are not accurate the bottler would still be liable. As Justice Traynor noted in his Escola concurrence, the result is close to a rule of strict liability. The court used res ipsa loquitur to promote a policy of shifting defective product losses from consumer to producer.

The most prominent cases in which enhanced res ipsa loquitur has been used to sanction the defendants for the nonavailability of evidence are Dierman v. Providence Hospital and Haft v. Lone Palm Hotel. Mabel Dierman was injured during surgery when the electric needle being used to remove a wart from her nose ignited the gas used as an anesthetic.  The explosion could have been caused by the use of an improper gas, gas contaminated by an unclean anesthetizing apparatus, gas contaminated by the hospital or gas contaminated when purchased by the hospital from the manufacturer. The defendant doctor and nurse described the accident and procedures followed but did not offer proof either as to whether the gas was pure or whether they were responsible for its impurity. The jury was instructed on res ipsa loquitur and returned a verdict for the defendants, but the California Supreme Court reversed.

The Dierman case contains elements of a special relationship between defendant and plaintiff and the majority quotes the Bourguignon formula, but California courts in general have not imposed a duty upon physicians and hospitals above a simple negligence standard. The most noteworthy element of the majority opinion, however, is an extended criticism of the defendants’ failure to produce the tank of gas used, a chemical analysis of its contents, evidence of the condition of the tank or the circumstances under which it was stored. The court concluded:

In a res ipsa loquitur case where, in addition to the prima facie showing of negligence, it is admitted or appears beyond dispute that the defendant has it in his power to produce substantial evidence material to the issue but fails to do so, it must be presumed that such evidence, if produced, would have been adverse to defendant, and under such circumstances the evidence is insufficient to support a verdict for the defendant and plaintiff is entitled to a directed verdict.

Because, as Justice Traynor noted in dissent, the relevant time for testing the content of the gas container was the time of the accident and not the time of the trial, the majority’s approach attacks more than a failure to produce available evidence at trial; rather, the majority believed such evidence should have been available and sanctioned the defendants for its nonavailability.

Haft involved the drowning of Morris Haft and his five-year-old son in a motel pool in Palm Springs. In contravention of a state statute, the motel had neither provided a lifeguard nor posted a warning sign at the pool. The court resolved one issue in the case by concluding that the liability of a pool owner who has provided neither a lifeguard nor a warning sign should be measured with respect to the failure to provide a lifeguard. A second issue concerned the burden of proof as to cause-in-fact (i.e., whether the Hafts were responsible for their own drowning). This was also resolved in the plaintiff’s favor. Although the court alluded to the special duty of an innkeeper to his guests,  its principal rationale was that the lack of proof as to causation was a direct and foreseeable result of the defendants’ negligent failure to provide a lifeguard. The court noted that although the main purpose of a lifeguard is to aid those in danger, “an attentive guard does serve the subsidiary function of witnessing those accidents that do occur.”  Because the defendants were responsible for the nonavailability of evidence they were sanctioned with the imposition of the burden of proof. Haft has been followed in multiple collision cases to impose liability upon the defendant responsible for the later collision where that collision made unascertainable the extent of damage caused by the earlier collision.

The enhanced res ipsa loquitur cases, whether special relationship cases or sanction for nonavailability of evidence cases, ignore whether the defendant actually had relevant information that could have been produced at trial. Thus, more is involved than a failure to produce evidence affecting the probability that the defendant was negligent, and the relevance of these cases is not entirely eliminated by modern discovery rules. Rather, enhanced res ipsa loquitur, under the name of res ipsa loquitur and upon a foundation of “superior access to information,” represents a new rule of liability: If evidence is not available and either the defendant has a special relationship with the plaintiff or the defendant is responsible for the nonavailability of evidence, the defendant is liable.

Unlike res ipsa loquitur in the ordinary sense, enhanced res ipsa loquitur may be employed with substantial impact in unidentifiable tortfeasor cases. The leading example of this is Ybarra v. Spangard. The facts of Ybarra are sketchy but simple. Joseph Ybarra entered the hospital for surgery and subsequently developed paralysis and atrophy in his shoulder. Evidence was introduced to the effect that Ybarra’s condition resulted from pressure or strain applied between his shoulder and neck and could have occurred during surgery. The defendants included most of the doctors and nurses who attended Ybarra during his hospital stay and were related (as employees or independent contractors) in a variety of ways which would not normally make any one of them responsible for the conduct of all of the others.

The court’s opinion, although brief, is wide-ranging and speaks to the issues at hand in a variety of voices. The Ybarra decision can be attributed to the defendants’ superior access to relevant information and categorized either as a special duty case or as a sanction for nonavailability of evidence case. There is also a strong element of common enterprise or joint tortfeasor treatment. Finally, the case can be seen as a unique, resultoriented decision.

Ybarra is best viewed, however, as an early example of California courts’ willingness to stretch existing theories and to devise new tort doctrines to aid worthy plaintiffs in unidentifiable tortfeasor cases. Ybarra broke new ground. None of the strands discussed was enough by itself to support a decision for the plaintiff, but taken together they provided a basis to grant relief. The Ybarra “holding” has been followed to varying extents in subsequent cases involving operating room mishaps, but, of greater importance, the Ybarra result has been referred to appiovingly in doctrine expanding cases such as Haft,, Summers v. Tice and Sindell v. Abbott Laboratories. Enhanced res ipsa loquitur as used in Ybarra is a forerunner of express theories of liability designed to address the unidentifiable tortfeasor problem.

C. The Concerted Action and Alternative Liability Theories of Liability

Enhanced res ipsa loquitur is a new theory of liability under the guise of allocating burdens of proof. The next stage in the doctrinal progression was the development of two express theories of liability suitable for application in unidentifiable tortfeasor cases: the concerted action theory and the alternative liability theory. Concerted action and alternative liability are similar in that both involve defendants taking complementary actions and the doctrines are often called into play in comparable factual situations. Their theoretical underpinnings, however, are quite different.

Concerted action is a joint tortfeasor doctrine. As described by Prosser and Keeton, the doctrine provides that joint liability is imposed upon “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 the wrongdoer’s acts done for their benefit.” An express agreement among the defendants is not necessary and a tacit understanding will suffice, but it is “essential that each particular defendant who is to be charged with responsibility shall be proceeding tortiously, which is to say with the intent requisite to committing a tort, or with negligence.” The classic example of the concerted action theory is the case of an unlawful car race between A and B which results in a collision between B’s car and a car driven by C. Under the concerted action theory, A and B are engaged in a common tortious enterprise and C may maintain an action against A even though their cars did not touch.

The leading California concerted action case dealing with the unidentifiable tortfeasor problem is Orser v. George. Orser arose from an accidental shooting at a duck club outing. Vierra, Jacobson and James negligently fired a number of shots at a mudhen. Orser, who was working in a field and in the line of fire, was killed by a pistol bullet. Vierra (and possibly Jacobson) fired the fatal pistol and James fired a rifle. The court found that James must nevertheless be held as a defendant because:

the record of James firing alternately with Vierra at the same mudhen and in the same line of fire] permits a possibility James knew Vierra’s conduct constituted a breach of duty owed Orser and that James was giving Vierra substantial “assistance or encouragement”; also that this was substantial assistance to Vierra in a tortious result with James own conduct, “separately considered, constituting a breach of duty to” Orser.

Once concerted action is shown, particular causation is irrelevant and the problem of identifying the particular agent of causation is solved: All defendants participating in the common enterprise are responsible for the plaintiff’s harm. The challenge lies in determining whether the conduct by the defendants in a particular instance constitutes tortious “concerted action.” Express agreements with respect to tortious enterprises are not common and are in any event difficult to prove. Determining whether the course of conduct undertaken by the defendants evidences an implied understanding, on the other hand, requires difficult line drawing

These difficulties are illustrated by Hall v. E.I. DuPont de Nemours & Co., a federal district court case suggesting a variant on the concerted action theory sometimes referred to as “enterprise liability.” Hall involved a lawsuit against all six American manufacturers of dynamite blasting caps. The plaintiff children were injured while playing with blasting caps which, contained no warning label and could be easily detonated; individual manufacturers of specific caps could not be identified.” The court found sufficient allegations of joint control of risk on the part of the defendants through common adherence to industry safety standards and delegation of functions of safety investigation and design to a jointly sponsored trade association.” The result may very well have differed, however, depending upon factors such as the structure of the industry, the product, the alleged defect and the use made of the trade association. In industrial unidentifiable tortfeasor cases, the application of concerted action theory principles is far from simple.

The case establishing the alternative liability theory is Summers v. Tice. Summers, Tice and Simonson went quail hunting and, despite admonitions to “keep in line,” the hunters ended up being positioned at the points of a triangle.” Tice and Simonson each shot at a quail and one shot, from either Tice’s or Simonson’s gun, hit Summers in the eye. The trial court found that both Tice and Simonson were negligent in firing in Summers’ direction and that Summers was not contributorily negligent.

In considering the case, the California Supreme Court had before it two Mississippi precedents in which two persons had fired shots simultaneously but only one, who could not be identified, had hit another person. Oliver v. Miles, involving two hunters who negligently fired across a road and hit a passerby, and Moore v. Foster, involving two policemen who wrongfully fired at a fleeing suspect, had each been resolved on the theory that the defendants’ activity constituted concerted action. In Summers, however, the court did not rely on the concerted action theory, perhaps because the plaintiff had neglected to proceed on that theory at the trial court level. Instead, the court reasoned that because the defendants were both wrongdoers and created the situation where the negligence of one of them injured the plaintiff, the burden should rest with each defendant to absolve himself or be jointly liable for the whole damages.  Like enhanced res ipsa loquitur, Summers has been applied in multiple collision cases.  In general, however, incidents of contemporaneous negligence by two or more defendants resulting in an untraceable injury have apparently been rare and the Summers rule has not often been found controlling.

The concerted action theory, as a theoretical matter, fits neatly into the category of joint torts, the concerted action of the defendants constituting a central element of the tort. The alternative liability theory is quite different. Whether expressed in terms of a mere projection of proper behavioral norms or unfair liability for at least one defendant for an injury he did not cause, Summers represents the imposition of liability for negligent risk creation and represents a major departure from traditional principles of tort law. In allocating the burden of loss between an innocent plaintiff and negligent defendants, Summers comes very close to endorsing the concept of negligence in the air.

Notwithstanding their differences, the concerted action and alternative liability theories have each provided an express doctrine for dealing with unidentifiable tortfeasor cases. By admitting the formulation of independent theories of liability, each moves beyond the groping of Ybarra to a rulesystem by. which liability may be determined. These theories of liability provide the principal backdrop for the most challenging unidentifiable tortfeasor cases presented to date-those involving lawsuits by women injured in utero by DES.

II. THE UNIDENTIABLE TORTFEASOR AND THE DES CASES

A. The Market Share Answer to the DES Causation Problem

The unidentifiable tortfeasor issue has been brought to the fore in the last several years with the emergence of claims against the manufacturers of the drug diethylstilbestrol (DES) and the landmark California Supreme Court decision in Sindell v. Abbott Laboratories. DES is a synthetic estrogenic hormone first synthesized by a group of British medical researchers in the late 1930s. A number of drug companies thereafter filed New Drug Applications (NDAs) with the Federal Food and Drug Administration (FDA) requesting authorization to produce and market DES for several purposes, none related to problems in pregnancy. Following an FDA request for information pooling in late 1940, several drug companies formed a “small committee” to coordinate the joint submission of clinical data on DES in a “master file” to be used with respect to all DES NDAs. The FDA approved the marketing of DES for nonpregnancy uses in late 1941. Supplemental NDAs for the use of DES as a miscarriage preventative were filed in 1947. A few companies conducted experiments on the safety and efficacy of DES for this purpose, but most relied instead upon published studies done by independent researchers at several medical schools. The FDA approved the marketing of DES as a miscarriage preventative in July 1947. Following a study linking a form of cancer in young women with the use of DES by their mothers during pregnancy, the FDA contraindicated DES for use for the prevention of miscarriages in November 1971.

Although there were apparently a few principal producers, 34 as many as 200 to 300 companies manufactured and marketed DES between 1947 and 1971. As described by one court:

Some companies marketed the drug under a trade name; others marketed it generically. Several companies supplied DES to competitors. Because the DES compounds produced by the drug companies were chemically identical, pharmacists often filled prescriptions for DES with whatever company’s drug was in stock, a practice that the firms were aware of. None of the companies warned physicians about the possibility of carcinogenic or other risks to the offspring of women who took DES.

In fact, a number of the daughters of women who ingested DES during pregnancy have suffered clear cell adenocarcinoma, a fast-spreading vaginal and cervical cancer requiring radical surgery, and many more have suffered adenosis, a vaginal tract abnormality of uncertain import. Clear cell adenocarcinoma is extremely rare outside of the DES context and has a minimum latent period of ten to twelve years. Plaintiffs allege that drug companies did inadequate testing, knew or should have known that DES was unsafe and failed to give adequate warnings of its potential danger.

A significant difficulty facing DES plaintiffs has been an inability to identify any particular drug company as the producer of the DES ingested by their mothers. The DES problem is widespread with numerous actors (both drug companies and victims) and no unity of time or place, either with respect to the tortious acts performed or the injuries incurred. The difficulty in identifying particular tortfeasors results from both the time past and the indistinct marketing of DES. Memories have faded and records have been lost or destroyed and there were many manufacturers of a relatively fungible product. Although plaintiffs have asserted that the drug companies should bear the responsibility for the generic use of the drug and defendants have countered that the plaintiffs’ mothers had better access to their particular prescription information, plaintiffs’ inability to identify particular tortfeasors cannot be squarely blamed on either party. As one commentator has observed, the DES cases may be one of the rare instances “in which useful, nonquantitative evidence is all but impossible to obtain.”

The Sindell case was brought against eleven drug manufacturers by Judith Sindell, a DES daughter who suffered a malignant bladder tumor and adenosis. The suit was brought as a class action requesting compensatory and punitive damages for Sindell and equitable relief for the class. Sindell pleaded a number of theories of liability and alleged concerted action and a joint enterprise on the part of the defendants in an effort to make them jointly liable. Sindell acknowledged that she could not identify the manufacturer of the particular DES taken by her mother. The trial court dismissed the action on the basis of Sindell’s inability to identify a particular manufacturer, but the court of appeal reversed, holding that the plaintiff could proceed on both the concerted action and alternative liability theories of liability.

The California Supreme Court also reversed the trial court, but not for the reasons articulated by the court of appeal. The California Supreme Court rejected concerted action, alternative liability and other unidentifiable tortfeasor theories of liability  but instead fashioned a new theory of liability known as “market share liability.” The market share liability rule generally works as follows:

  1. If the plaintiff is innocent,
  2. the defendants are negligent (at least in general terms),
  3. the plaintiff’s injury was caused by a uniform product,
  4. the plaintiff, through no fault of her own, cannot identify the particular manufacturer responsible for her harm
  5. and the plaintiff has joined as defendants the manufacturers of a substantial share of the product that caused her injury,

then the burden shifts to each defendant to either demonstrate that it could not have made the particular product that caused the plaintiff’s injury or assume liability for the plaintiff’s loss in proportion to its market share.

The court elected to devise a remedy because, as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury. The court also reasoned that 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” and courts should fashion remedies to meet changing needs, just as courts created strict products liability to adapt to “an era of mass production and complex marketing methods.” In the DES context, the court found it reasonable to measure the likelihood that any of the defendants produced the actual injury-causing product “by the percentage which the DES sold by each of them for the purpose of preventing miscarriage bears to the entire production of the drug sold by all for that purpose.”

B. Sindell’s Unanswered Questions

In establishing market share liability in Sindell, the California Supreme Court left open a number of important questions relating to the doctrine’s application, only some of which have been addressed in subsequent DES cases. The first of these questions concerns the standard of care required of DES manufacturers and the related issue of which specific causes of action can be pursued on a market share theory when a particular responsible defendant is unidentifiable. In Sindell, the plaintiff pleaded a number of causes of action and requested punitive damages. Although the majority opinion in Sindell uses the language of negligence, the court did not address specifically the standard of care to be applied.

Most of the cause of action/market share questions were addressed directly in the California Supreme Court’s recent decision in Brown v. Superior Court of San Francisco. Brown involved at least sixty-nine individual DES cases that were consolidated for the purpose of deciding common legal questions. On appeal from pretrial rulings adverse to the plaintiffs, the court decided that drug manufacturers could not be held strictly liable for a defect in the design of a prescription drug. That determination was not based on the market share theory, but on “the public interest in the development, availability and reasonable price of drugs.”

The court also determined that neither a breach of express or implied warranty claim nor a fraud claim could be pursued on a market share theory, the former because recovery on a warranty theory would be inconsistent with the court’s resolution of the strict liability question, and the latter because an essential element of a fraud claim is the state of mind of a particular manufacturer, a showing too individualized to resolve on a market share basis. Although the punitive damages issue was not addressed in Brown, the court’s fraud analysis suggests that punitive damages cannot be recovered under a market share theory.

It is also worth noting that arguments more relevant to the standard of care question can easily enter the debate on the merits of the market share theory. This is the case in both the majority and dissenting opinions in Sindell, the majority characterizing the defendants as better cost spreaders and the dissent charging that market share liability will inevitably inhibit the dissemination of new drugs. The Brown decision will, one hopes, serve as a focal point for the standard of care debate and allow market share liability to be analyzed on its merits as an unidentifiable tortfeasor doctrine.

A second question left open by Sindell but resolved by Brown is whether, under a market share theory, the defendants before the court are jointly liable for all of the plaintiff’s losses (with the defendants’ market shares being used simply to apportion damages among the defendants) or whether the defendants are only severally liable for a percentage of the plaintiff’s losses equal to each defendant’s market share. Viewed another way, do the defendants (through higher payments) or the plaintiff (through a less than full recovery) absorb a loss for the market share of manufacturers who are out of business, bankrupt, not amenable to service of process or otherwise not joined as defendants in the action?

The majority opinion in Sindell can be read either way. The opinion refers to apportioning damages among the defendants, states that the defendants may cross-complain against other DES manufacturers and confesses that “a defendant may be held liable for a somewhat different percentage of the damage than its share of the appropriate market would justify.” On the other hand, the opinion asserts that each defendant will only be liable for the proportion of the judgment represented by its share of the market, manufacturers will not be held responsible for the products of another and “each manufacturer’s liability for an injury would be approximately equivalent to the damages caused by the DES it manufactured.” Most commentators have read Sindell as imposing only several liability, but others, including the Sindell dissent, have read Sindell to impose liability for 100% of the plaintiff’s damages. Of the three other state supreme courts adopting a market share type theory, one opted for a variant on joint liability,’ one opted for several liability and the third took an intermediate course.

In Brown, the California Supreme Court rejected the joint liability interpretation and concluded that, under a market share theory, each defendant should be liable only for the portion of a plaintiff’s damages that corresponds to the percentage of its share of the relevant market for DES. The court recognized that joint liability may subject a defendant to a portion of the judgment greatly in excess of its market share and that several liability would likely result in a less than full recovery for the plaintiff. The court’s choice of several liability was in large measure determined by “Sindell’s goal of achieving a balance between the interests of DES plaintiffs and manufacturers of the drug.

A rule of several liability, however, has more to commend it than simply being a good compromise between leaving plaintiffs remediless and subjecting defendants to damages in excess of their share. Several liability is more consistent with Sindell’s stated goal of reproducing what would occur if identification were possible in all cases. Also, if market share liability is to be championed as a doctrine imposing liability for risk creation, as opposed to merely dividing a loss between plaintiffs and defendants, the risk created by a particular drug company is not higher because not all manufacturers can be joined in an action. Also, economic efficiency considerations suggest that to force defendants to internalize losses properly attributable to the production (market share) of other drug manufacturers may result in overdeterrence of drug production. Finally, in breaking new legal ground to devise a remedy benefiting plaintiffs it is important institutionally for a court to at least appear to be treating defendants fairly.

Another limitation on plaintiffs’ ability to recover under a market share theory not fully articulated in Sindell is the requirement that the plaintiff join as defendants drug manufacturers whose market shares represent a “substantial share” of the DES market. The court noted that a law review note advocating a theory akin to market share liability suggested that 75- 80% of the DES market should be required but the court declined to establish a specific percentage as a threshold.

An opportunity to articulate the substantial share requirement more specifically was presented in Murphy v. E.R. Squibb & Sons. Murphy was brought by Christine Murphy, an individual DES daughter, against a single drug manufacturer, E.R. Squibb & Sons, Inc., on the theory that Squibb produced the particular DES taken by her mother. After the Sindell decision was announced, Murphy attempted to broaden her action against Squibb to include a market share theory and offered to prove that Squibb had a ten percent share of the national market for DES. The trial court only allowed Murphy to proceed on her original theory and the jury returned a special verdict finding that the DES purchased by Murphy’s mother was not manufactured by Squibb. The court of appeal affirmed on the theory that the special verdict established a market share theory defense by satisfying Squibb’s burden of proving that it did not manufacture the injury-causing DES. The California Supreme Court also affirmed the trial court,  but on a different ground, holding that ten percent of the DES market did not constitute a “substantial share.”

The court again left open, however, the percentage of the market it would consider a “substantial share.” Of more fundamental concern is whether the “substantial share” requirement is valuable at all. The California Supreme Court’s stated reason for the substantial share requirement was “to diminish the injustice of shifting the burden of proof to defendants to demonstrate that they could not have made the drug which caused the plaintiff’s injuries.” The court also appears to have been trying to minimize the extent to which market share liability departed from the alternative liability theory of Summers, which the court interpreted as requiring all possible tortfeasors to be before the court. If defendants were jointly liable under a market share theory for all of the plaintiff’s damages, a substantial share requirement would serve to reduce defendants’ exposure to overpayment.  With several liability, however, defendants are not exposed to overpayment. Moreover, the likelihood of any individual drug manufacturer being held liable for a portion of a judgment when it in fact did not cause the plaintiff’s injury is not affected by the presence of other defendants. This has led some to argue that the substantial share requirement is unnecessary.

The substantial share requirement is helpful, however, insofar as it serves as a forced joinder rule and an election of legal theory rule. Forcing a plaintiff to join a number of drug manufacturers in her market share suit can promote fairness in several ways. With more manufacturers participating in the action, better data on market shares is likely to be available. In addition, multiple defendants can spread legal costs, at least as to common issues. Plaintiffs also will not be able to force settlements on individual defendants with a small market share who face slight liability but for whom the cost of defending a suit would be burdensome, which also may decrease the number of suits filed.

The way the substantial share requirement acts as an election of legal theory rule is illustrated by the facts of Murphy. For Murphy to have proceeded on her traditional action against Squibb while at the same time joining a number of manufacturers and proceeding on a market share theory would have been awkward at best. By essentially forcing the plaintiff to choose between a traditional action against a single drug company and a market share suit, the substantial share requirement protects courts from having to handle two trials at once, and to the extent plaintiffs choose to proceed against a single manufacturer, the number of market share suits would decrease. Although the substantial share requirement denies plaintiffs like Murphy who try and fail to identify a particular manufacturer even a partial recovery, this disadvantage is outweighed by administrative advantages for the court.

An even more important issue with market share liability is the relevant definition of the market. The definition may (or may not) take into account a variety of factors, including time periods, geographic areas, product identifiability and marketing approaches. Manufacturers entered and left the DES market throughout the twenty-four year period during which DES was marketed as a miscarriage preventative, so DES market shares differed at different times. Also, national market shares differed from local market shares and information on both is sketchy. Neither national nor local market shares necessarily correspond to the amount of DES sold by a particular pharmacy. Although DES was manufactured using a standard scientific formula, pills differed, at least to some extent, in dosage, size, shape and color. Also, the marketing schemes employed by manufacturers differed, some using brand names, others selling generically, and with variations in price and perhaps record keeping and distribution schemes.

One approach is to define market share narrowly, focusing on the particular facts of the individual case at hand. Even if unable to identify a manufacturer, plaintiffs should at least be able to identify the time and place of pregnancy and may be able to provide some description of the injury-causing product. Market share could be determined with respect to the DES sold during a particular time period, in a particular pharmacy or city and/or with particular physical characteristics. The principal advantage of this approach is that if market share is sensitive to the facts before the court, it will most nearly approximate the probability that the defendant’s product caused the plaintiff’s injury. In addition, a tightly focused market share approach ties market share liability more closely to normal tort rules in the event the plaintiff has some information identifying the manufacturer.

An alternate approach is to define the market broadly without regard to the details of a given plaintiff’s situation. Defendants’ “market shares” would be constant from case to case notwithstanding the availability of particularized information affecting the probabilities of causation in a given instance. Even if DES suits are not pursued as class actions, mass-litigation techniques such as those employed in Brown allow parties and courts to benefit from economies of scale in fact-finding through the use of a single set of market share determinations in a number of cases. Over a large run of cases defendants’ liability in the aggregate should work out properly. Also, market share cases should have consistent outcomes.

With either approach “market share” can be refined to reflect not simply gross product sold, but the likelihood of the defendant having manufactured the injury-causing product in an unidentifiable tortfeaser case. Such refinement would attempt to account for variations in the identifiability or harmfulness of defendants’ products. Without such refinement, manufacturers with relatively identifiable products would face greater overall liability in that they would be solely responsible for damages in conventional suits in which they were identified without any reduction of their proportion of market share judgments. Making such adjustments to “market shares,” however, would likely present significant proof problems and would risk adding another level of complication and arbitrariness to already difficult adjudications.

In Sindell, the court defined the market broadly as the “entire production of the drug sold by all manufacturers for the purpose of preventing miscarriage,” but carved out an exclusion from liability for any defendant which can prove that it did not manufacture the injury-causing pills in a particular case. The wisdom of the Sindell approach depends upon the availability and quality of focused or direct evidence. The choice of market share definition inevitably involves a trade off of administrability and consistency versus precision in particular cases. If evidence to refine “market shares” is difficult to obtain or of questionable accuracy, the pursuit of precision may be little more than a costly exercise in arbitrariness. As a first venture into a new area with no way for the court to grasp the full evidentiary picture, Sindell’s broad approach is reasonable. The exclusion for defendants who could not have been responsible, although of little use to most manufacturers, at least minimizes the appearance of gross unfairness in particular cases.

A final issue presented by market share liability involves the cases in which the plaintiff has some information pointing to a particular manufacturer. In Rogers v. Rexall Drug Co., decided with Sindell, the plaintiff amended her complaint to allege that a particular defendant manufactured the DES which injured her. The court suggested that, should she fail to establish that fact, she could rely on a market share theory.

Alternatives are available. For example, suits in which plaintiffs pursue recovery against a particular manufacturer could be disallowed altogether. This would eliminate the costly pursuit of particular evidence and would avoid excess liability for defendants with identifiable products. On the other hand, this approach would deny plaintiffs a remedy under traditional tort theories and might force courts to unnecessarily incur the burdens of handling market share liability cases.

A less drastic alternative would be to deny plaintiffs the opportunity to pursue a market share recovery in cases where it does not seem necessary or appropriate. This would avoid the assertion that market share is a reasonable approximation of the likelihood that a particular manufacturer caused the plaintiff’s injury in the face of a significant amount of specific evidence, but might place plaintiffs with no specific evidence in a relatively better position, perhaps discouraging the production of evidence. As is the case in defining the relevant market, the best approach to these cases may only be determinable as courts gain experience.

The particulars of market share liability remaining unsettled after Brown are noteworthy but are perhaps inevitable with a new theory of liability. Their resolution is not necessary to evaluate the position of market share liability in the panoply of unidentifiable tortfeaser doctrines.

C. Market Share Liability in Perspective

An important aspect of market share liability which has received little attention from commentators is what the Sindell court could have done but did not do. Faced with the Sindell appeal and the set of facts pleaded, the California Supreme Court could have chosen any of three different courses of action:

  1. affirm the trial court and deny recovery to the plaintiff,
  2. conclude that the facts pleaded by the plaintiff stated a cause of action under recognized theories of liability for unidentifiable tortfeasor cases,
  3. or devise a new theory of liability (or make explicit modifications to an existing theory) to provide the plaintiff a remedy.

In addition to the general factors counseling restraint in the creation of new theories of liability,  in the DES context legislative or administrative solutions have considerable appeal. Yet administrative compensation systems are not without problems. Moreover, the legislative process to establish a compensatory scheme would by its nature be political, involving the political power of manufacturers as well as the sympathetic or moral appeal of victims. A premature closing of the courthouse doors would likely disadvantage the DES plaintiffs in that manufacturers would have little incentive to participate in a legislative solution if they no longer feared judicial liability. The DES unidentifiable tortfeasor problem is a tort law problem. Whether they endorse or deny a remedy, courts have an obligation to address the issue.

Unlike other courts,  the Sindell court held that the facts alleged by the plaintiff stated a cause of action. Before articulating its market share theory, however, the court rejected the application of enhanced res ipsa loquitur as embodied in Haft, the concerted action theory of liability and the enterprise liability variation thereof in Hall; and the alternative liability theory. The rejection of these unidentifiable tortfeasor doctrines on the pleaded facts was more than mere table-setting for market share liability. The endorsement of any one of these theories in the DES context would have expanded greatly its scope with significant consequence for future application in other situations.

Sindell argued that Haft was analogous because the “defendants’ failure to discover or warn of the dangers of DES and to label the drug as experimental caused her mother to fail to keep records or remember the brand name of the drug prescribed to her.  The court concluded, however, that the absence of evidence resulted “primarily from the passage of time rather than from the defendants’ acts of failing to provide adequate warnings” and was not “due to the fault of defendants.” The court also noted the “superior access to information” language in Ybarra and Summers but commented that in Sindell neither the plaintiff nor the defendants were in a better position to identify the manufacturer of DES ingested by the plaintiff’s mother.

Following the Haft reasoning to find DES manufacturers liable would have imposed significant record-keeping duties on drug manufacturers, especially given the time element and indirect relationship between manufacturer and user. To hold manufacturers liable for failing to provide labels that would have led to the availability of evidence is to overrun the unidentifiable tortfeasor issue. The failure to label is at the heart of the negligence issue, but does not provide a link between a particular manufacturer and a given plaintiff unless, under enhanced res ipsa loquitur notions, one makes a defendant’s negligence a sufficient reason to decide the identification issue against it as well. To hold negligent defendants automatically liable in an unidentifiable tortfeasor case without regard to their degree of cooperation, their relationship to the plaintiff or their present ability to produce evidence would isolate a single aspect of Ybarra as sufficient to impose liability. This would significantly expand enhanced res ipsa loquitur in the unidentifiable tortfeasor context.

Sindell’s concert of action claim was based upon allegations of

“planned and concerted action, express and implied agreements, collaboration in, reliance upon, acquiescence in and ratification, exploitation and adoption of each other’s testing, marketing methods, lack of warnings … and other acts or omissions.. .” and that “acting individually and in concert, [defendants] promoted, approved, authorized, acquiesced in, and reaped profits from sales” of DES.

These allegations, Sindell claimed, “state a ‘tacit understanding’ among defendants to commit a tortious act against her.”  The court of appeal concluded that Sindell’s allegations suggested that each defendant “gave substantial ‘assistance or encouragement’ to the tortious conduct of the others” and that a concert of action cause of action could be maintained.

The California Supreme Court, however, looked more deeply into the complaint and determined that ” the gravamen of the charge of concert was that defendants failed to adequately test the drug or to give sufficient warnings of its dangers and that they relied upon the tests performed by one another and took advantage of each others’ promotional and marketing techniques . . . which the court viewed as common parallel or imitative conduct. The court reviewed Orser v. George and other cases and characterized concert of action cases as involving a small number of defendants, a single plaintiff, actions occurring over a short span of time and direct participation by the defendant in the injury-causing act or encouragement or assistance of the person who directly caused the injury. The court also concluded that the genericness of the DES manufactured was understandable in the prescription drug context. Finally the court thought it “dubious whether liability on the concert of action theory can be predicated upon substantial assistance and encouragement given … pursuant to a tacit understanding to fail to perform an act.”

The Sindell court correctly perceived that the application of the concert of action theory to allow liability in that case would greatly extend the reach of that doctrine. By limiting the concert of action theory, the court prevented parallel conduct on the part of manufacturers from resulting in joint and several liability for each without regard to whether it produced, or demonstrably did not produce, the injury-causing product.

The Sindell court also rejected the “enterprise liability” variant on the concerted action theory of Hall v. E.I. DuPont de Nemours & Co. Sindell argued that DES manufacturers followed an industry-wide safety standard and pointed ‘to a law review comment detailing an “enterprise liability” approach to the DES causation problem.  The court, however, distinguished Hall because, unlike the blasting cap industry, there were a large number of DES manufacturers and no trade association had been delegated functions related to product safety. Also, FDA regulation resulted in product standards influenced to a considerable degree by the federal government. The court, in essence, took a narrow view of joint control of risk. Although following industry standards should not establish due care per se, neither should it establish liability without evidence of causation.

The most attractive of the existing unidentifiable tortfeasor doctrines before the Sindell court was the alternative liability theory of Summers v. Tice. Like Summers, Sindell can be characterized as a case involving an innocent plaintiff and negligent defendants in which evidence identifying the injury-causing defendant is unavailable through no fault of the plaintiff’s. The court of appeal, drawing on Ybarra and Haft, had found the alternative liability theory applicable.

The California Supreme Court, however, rejected alternative liability. In so doing, the court focused on the fact that, of as many as 200 DES manufacturers, only six were before the court. The court expressed concern that there was therefore a “substantial likelihood” that none of the defendants before the court had manufactured the DES which caused the plaintiff’s injuries. This, however, did not prevent the court from creating market share liability, although the “substantial share” requirement may be seen as an attempt to address the concern. The court’s concern with alternative liability, therefore, appears to have been primarily with imposing joint and several liability on all defendants without regard to the likelihood that a particular defendant produced the injury-causing product. Summers involved two defendants, both before the court, with each equally likely to have caused the plaintiff’s injury, so joint and several liability worked well. The absence of some manufacturers and the varying market shares of those present, however, would make dividing liability equally among those defendants before the court neither efficient nor fair.

In addition, Summers’ transfer of the burden of proof to the defendants to absolve themselves is most reasonable when all who may have caused the injury are before the court. Consider, for example, the facts of Eley v. Curzon. In Eley, a pedestrian on a highway in low visibility conditions was hit by a car or truck. Three drivers who may have hit the plaintiff were named as defendants. However, the plaintiff could have been struck by yet a fourth driver, and without the presence of a party to speak to this possible cause the defendants present would be left to absolve themselves through speculation.  By declining in Sindell to apply unmodified the alternative liability theory, the court contained the theory and prevented its expansion to cases far afield of the Summers scenario.

Market share liability is in some respects a radical theory. Like alternative liability, market share liability imposes liability for risk creation. Market share liability goes further, however, in at least one respect. In Summers the defendants each breached a duty toward a particular plaintiff before the court, but in Sindell defendants breached duties to indeterminate DES daughters whose mothers used their products. Market share liability deals with the identifiable tortfeasor issue in the aggregate, replacing individual responsibility with collective responsibility.

Viewed in perspective, however, market share liability is a narrow unidentifiable tortfeasor doctrine tailored to a particular set of circumstances. As presently articulated, the doctrine does not reach unidentifiable tortfeasor cases involving nonfungible products, cases in which the plaintiff’s injury may not have been wrongfully caused or cases in which not all defendants have acted tortiously. The nonfungibility problem has restricted the use of market share liability in the asbestos context. The non-wrongful cause limitation appears to limit the doctrine’s applicability in cases such as suits against polluters who increase risks of disease. Finally, the non-tortiouslyacting defendants limitation effectively precludes the use of market share liability in manufacturing defect (as opposed to design defect) product liability cases.

Perhaps Sindell’s most significant breakthrough is its demonstration of a court’s willingness to devise new tort doctrines to deal with specific unidentifiable tortfeasor situations. In the next Part of this Article I will suggest certain factors courts should take into account in devising new unidentifiable tortfeasor remedies. Measured by these criteria, market share liability appears to be a well-crafted approach to the DES causation problem.

III. UNIDENTIABLE TORTFEASOR DOCTRINAL CONSIDERATIONS

In Part I of this Article I examined the development of unidentifiable tortfeasor doctrines in a variety of contexts. In Part II, I examined the market share theory of liability and noted that, although market share liability marked a major breakthrough in the DES context, the theory was carefully crafted for the particular unidentifiable tortfeasor problem presented and is more limited than would have been the endorsement of the application of existing unidentifiable tortfeasor doctrines.

In this Part, I will discuss several interrelated categories of issues courts should consider in devising new unidentifiable tortfeasor doctrines or expanding existing doctrines. These categories can be loosely labeled evidence production considerations, effectiveness considerations, the moral imperative and institutional considerations. These will be considered in the light of two unidentifiable tortfeasor settings: the DES situation and the situation presented by the well-known “blue bus” hypothetical. The DES situation has been described earlier. The “blue bus” hypothetical can be stated as follows:

Mrs. Smith was driving on a public street and was forced off the road by a negligently driven bus. She is able to testify that the bus was blue, but is unable to describe the bus to any greater extent. Blue Bus Co. owns and operates 80% of the blue buses operating in the town. Mrs. Smith files a negligence action against Blue Bus Co. alleging the foregoing. Does she recover?

A. Evidence Production Considerations

The benefits for dispute resolution of having relatively full evidence before the court are plain. Fact-finding will be more accurate and judgments perceived to be based upon complete information will likely be accorded greater public acceptance. The evidence production question, therefore, is not whether additional evidence is beneficial but instead how far to pursue its production.

The question has two separate aspects. The first concerns incentives to produce available evidence in a given case. Evidence production can be encouraged by placing the burden on the party expected to be able to produce evidence to produce it or lose, even though evidence before the court suggests that that party should win.  Ybarra. reflects this concern in part.

The other aspect concerns incentives to obtain or preserve evidence in a particular category of cases. Assuming important evidence is not presently available, the responsible party can be held accountable, thereby providing incentives for labelling, record keeping and witnessing. This was the main thrust of the version of enhanced res ipsa loquitur propounded in Dierman and Haft.

In Sindell neither party could be expected to produce evidence as to specific causation and the lack of evidence could not fairly be attributed to the conduct of either the plaintiff or the defendants. In the blue bus case, however, evidence suppression is an important issue. Under most circumstances a driver run off the road by a bus would be able to make a more complete identification than simply that the bus was blue. Before providing Mrs. Smith a remedy, the court must be comfortable with her explanation of her inability to provide a better description. To award Mrs. Smith a recovery would otherwise create a disincentive for her to provide evidence. Evidence obtainment and preservation concerns are less salient but could be relevant if Mrs. Smith did not keep her spectacles prescription current or if Blue Bus Co.’s practices made its buses difficult to identify.

The pursuit of evidence can, of course, be taken too far28s and courts must be careful to avoid making, to quote Prosser, “sheer ignorance … the most powerful weapon in law.  Nevertheless, before fashioning or extending unidentifiable tortfeasor doctrines courts must be sensitive to the effects of such doctrines on incentives to produce, obtain and preserve relevant evidence.

B. Effectiveness Considerations

Effectiveness considerations involve the effectiveness of an unidentifiable tortfeasor doctrine in achieving the optimum distribution of loss between plaintiffs and defendants and among defendants. An effective remedy avoids overdeterrence and underdeterrence and leaves each party in a fair position. Effectiveness concerns are most significant with unidentifiable tortfeasor doctrines employing probabilistic or statistical evidence. One’ aspect of the problem concerns the efficiency of a remedy in a particular case or category of cases and another concerns the flexibility of the jurisdiction’s tort system.

Before devising or employing an unidentifiable tortfeasor doctrine based upon probabilistic or statistical evidence, courts must first consider the probative value of such evidence. If much specific evidence relating to the factual determinations to be made is before the court, probabilistic or statistical evidence may be of very little help. If specific evidence is not available, courts must, before employing probabilistic or statistical evidence, ascertain the closeness of the relationship between the measure employed and the determination sought. The value of background statistics can vary significantly.

In the DES context, although market shares are difficult to determine and the market share theory does not account for possible differences in the harmfulness of DES produced, the amount of DES produced by each drug manufacturer is a reasonable approximation of the amount of harm caused.

A close relationship between market shares and harm caused often does not exist, however, in many other cases which appear similar. Some products, like asbestos, appear in a variety of forms with varying toxicities. Some products, like cigarettes,  increase the risk of certain types of diseases without being the sole cause. Also, differences in marketing methods and the presence or absence of warnings and safety instructions may make equally dangerous products differ in their likelihood of causing injury. In such cases “market shares” alone are not sufficient, and reasonable causation probabilities can only be determined with difficulty and a fair degree of speculation.

In the blue bus case, it does not necessarily follow from the fact that Blue Bus Co. owns and operates 80% of the blue buses operating in the town that there is an 80% likelihood that Blue Bus Co. caused Mrs. Smith’s accident. Probabilities would differ if Blue Bus Co.’s drivers drove negligently more (or less) often than drivers of other companies294 and could change dramatically if the accident occurred on a regular route of Blue Bus Co. (or another bus company) or if the accident occurred near (or away from) Blue Bus Co.’s yard.

A more general consideration in devising probability-based unidentifiable tortfeasor doctrines is whether the jurisdiction’s tort rules are sufficiently flexible to apportion liability fairly. With market share liability, as amplified by Brown, DES manufacturers are liable only severally and in a proportion not in excess of their market shares. If the plaintiff cannot be limited to less than a full recovery or if the defendants’ liability must be joint and several, however, solvent defendants before the court may be subject to greater than “efficient” liability. In the blue bus case, for example, Blue Bus Co. may face liability for all accidents involving unidentified blue buses.

C. The Moral Imperative

The moral imperative supports applying an unidentifiable tortfeasor doctrine when it can be shown independently of the specific causation issue that the defendants each breached a duty of care owed to the plaintiff or similarly situated persons. In the DES situation presented in Sindell, all defendants were assumed to have been negligent and a cornerstone of the court’s decision was the rationale of Summers v. Tice that “as between an innocent plaintiff and negligent defendants, the latter should bear the cost of the injury.” Even if, as the Sindell dissent pointed out, it is more likely than not that a given defendant did not cause the injury of the particular plaintiff, each DES manufacturer did increase the risk of injury to the plaintiff and other DES daughters collectively and it is likely that each defendant’s wrongful conduct was responsible for harm to someone.

When, in an unidentifiable tortfeasor situation, causation and negligence are linked, however, uncertainty about identity is also uncertainty about negligence. In the blue bus case, for example, if Blue Bus Co. did not force Mrs. Smith’s car off the road, Blue Bus Co. did not act negligently toward anyone. If we believe there is an 80% chance Blue Bus Co. caused Mrs. Smith’s accident and Mrs. Smith is allowed to prevail, there is an 80% chance of having correctly held liable a tortfeasor. If, however, ten separate bus companies each operate 10% of the blue buses operating in the town, to award a remedy would impose liability on ten defendants each of which was substantially less likely than not negligent and nine of which were in fact innocent. The moral imperative for providing a remedy in such a case is at best weak and the message delivered by the court is more “don’t operate buses” than “don’t act wrongfully.

Unidentifiable tortfeasor cases involving manufacturing defects are similar. In Sheffield v. Eli Lilly & Co., for example, the plaintiff had been permanently disabled by an injection of defective Salk polio vaccine, the manufacturer of which could no longer be identified. A critical difference from Sindell was that all defendants in Sindell manufactured a defective generic product, while in Sheffield, although all defendants manufactured a generic product, only one manufactured a defective one and market share liability was rejected. Courts must be wary, therefore, of employing unidentifiable tortfeasor doctrines in cases involving isolated injuries or other situations in which an independent showing cannot be made on the standard of care issue.

D. Institutional Considerations

Before devising new unidentifiable tortfeasor doctrines or employing existing doctrines in new situations, courts must consider issues relating to the role and operations of the judicial system. A readily apparent issue concerns the role of the courts in addressing the existing harm. Legislative solutions are not always feasible and the denial or grant of a tort remedy may affect the legislative process. Nevertheless, many situations are better left in the legislative domain and/or are best addressed by providing administrative remedies.

A more subtle factor involves the public acceptance of judgments. A goal of the judicial process is to articulate statements about past events that can be accepted as true for purposes of entering a judgment and spelling out the rights of the parties thereafter. A problem for the acceptability of unidentifiable tortfeasor doctrines based primarily on statistical evidence is that uncertainty is acknowledged and the public is aware that the trier of fact cannot do better than make a probabilistic statement, a “bet.” Against this, of course, must be balanced public acceptance difficulties in withholding a remedy from deserving plaintiffs 0 and the value to the judicial system of being seen as attempting to reach probable results, thereby reducing the number of “errors.” There are a large number of DES cases and liability may be viewed as working out in the aggregate. Acceptability is a significant concern, however, in isolated incident cases.

A third institutional consideration is the wise allocation of judicial resources. Ideally, no proper remedy should be denied because of inadequate resources. Realistically, courts have limited resources which they should allocate in a manner maximizing the judicial system’s productivity. Even assuming accurate results are obtainable, overcoming formidable proof problems may be difficult and resource consuming. The DES situation involves a large number of cases and a great deal of harm. Providing a remedy for isolated incidents like the blue bus case, however, may not be worthwhile. To ensure that limited judicial resources are well spent, before devising or employing new unidentifiable tortfeasor doctrines courts must balance the magnitude of the problem presented, in terms of the number of like cases and the severity of harm caused, against administrative burdens and proof problems.

The practical realities of litigation also burden the parties so courts should evaluate the magnitude of the harm and the problem of proof from the litigants’ perspective. Granting a remedy while placing a virtually insurmountable burden of proof upon the plaintiff does not accomplish much. Conversely, placing heavy or impossible proof burdens on defendants may make suits difficult to defend from a practical standpoint and amount to an imposition of liability. A situation of particular concern would be one in which a plaintiff could maintain an action against a number of defendants with bare allegations or only a minimal factual showing. In such a case it may be cost-effective for a plaintiff to bring suit but not cost-effective to present even a meritorious defense, especially if a defendant’s share of the total liability is minor. Thus, the plaintiff may be able to readily obtain settlements without the need to have, or to establish, a case.

Finally, courts must consider the possibility that a new unidentifiable tortfeasor doctrine will be misapplied in subsequent cases. Unidentifiable tortfeasor doctrines are fact specific and the danger of error is great. Courts can misapprehend key factual elements of a case, apply liability theories without recognizing the absence of essential elements and misunderstand the purpose of doctrinal components. Also, with respect to unidentifiable tortfeasor remedies relying on probability determinations, courts must remember that mathematical “proofs” are often replete with inadequacies, both in terms of mathematical error and nonsubstantiation of data.

CONCLUSION

Unidentifiable tortfeasor cases present difficult problems of uncertainty. Courts must deal not only with uncertainty about the commission of a tort but uncertainty concerning the identity of the tortfeasor. While the doctrine of res ipsa loquitur provides a means to deal with uncertainty, overcoming the tendencies exhibited in the Sargent line of cases, it does not, as a circumstantial evidence rule, address the unidentifiable tortfeasor situation.

From res ipsa loquitur and the separate notion of certain defendants having “superior access to information,” California courts developed the doctrine I have referred to as enhanced res ipsa loquitur. Enhanced res ipsa loquitur deals with uncertainty by shifting the burden of proof (and loss, if proof is not available) to defendants standing in a special relationship to plaintiffs or who can be characterized as responsible for the uncertainty. As evidenced by Ybarra, when these factors are present, enhanced res ipsa loquitur can be used with major impact in unidentifiable tortfeasor cases.

The concert of action theory and alternative liability theory are express unidentifiable tortfeasor doctrines. Although these doctrines appear in similar factual situations involving complementary action by two or more defendants, their theoretical underpinnings are quite different. Both are limited, however, in that the concert of action theory requires an agreement and the alternative liability theory requires a limited number of potential tortfeasors, all of whom are before the court.

The DES situation presents the unindentifiable tortfeasor problem dramatically. The California Supreme Court responded in Sindell by fashioning a new unindentifiable tortfeasor doctrine-market share liability. Although properly hailed as a breakthrough, market share liability was actually less of a departure from current norms than would have been stretching existing unidentifiable tortfeasor doctrines to apply to the DES situation.

Although important aspects of the doctrine are still unsettled, market share liability appears to be generally well-suited to the DES situation: A large amount of harm needs to be redressed, there is, at least at the pleading stage, the moral imperative presented by innocent plaintiffs and negligent defendants, the use of market shares and several liability makes for an effective remedy and evidence production worries are relatively mild. With the hypothetical blue bus case the reasons for providing a remedy are less compelling. There are significant concerns about evidence suppression, effectiveness and the magnitude of institutional burdens relative to the amount of harm to be redressed.

Although courts have erred and misapplied doctrines, California courts have generally done a good job handling unidentifiable tortfeasor situations. Their and other courts’ ability to continue to do so in the future will hinge upon their sensitivity to issues presented by unidentifiable tortfeasor situations and their creativity and flexibility in formulating well-tailored responses.

Stephen A. Spitz, 1990.

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More DES DiEthylStilbestrol Resources

Resolving the Problem of Identifying DES Manufacturers

I. INTRODUCTION

In 1947, diethylstilbestrol (DES), a synthetic estrogen was approved by the Food and Drug Administration (FDA) for use as a miscarriage preventative to be marketed on an experimental basis. By 1952, when the need for FDA approval was dropped because DES was no longer considered a new drug, 123 drug companies had obtained FDA approval. The ultimate number of companies involved in the market, however, has been estimated to be as high as 300. The FDA banned the use of DES as a miscarriage preventative in 1971 following a finding that the daughters of women who used DES during pregnancy were more likely to contract vaginal or uterine cancer than the daughters of non-users.

Emerging Theories of Proof in Products Liability: Resolving the Problem of Identifying Des Manufacturers, Villanova University School of Law, Volume 26 | Issue 5 Article 2, 1981.

Numerous suits have been filed against DES manufacturers by these women with cancerous and pre-cancerous conditions. However, given the fact that the adverse effects of DES cannot be detected until after a latency period of ten to twelve years, victims are often unable to identify the manufacturer whose product was sold to their mothers. While this inability has caused the dismissal of many of the DES suits, two recent cases have permitted the plaintiff to proceed to trial using novel liability theories.

This comment will first review three rubrics which relieve negligence plaintiffs from identifying the specific tortfeasor – concert of action, alternative liability and enterprise liability. Next, the comment will examine three recent cases in which courts applied these rubrics to DES actions. Finally, the comment will analyze the relative merits of the approaches taken by the three courts.

II. THREE THEORIES USED TO ExcusE PLAINTIFF FROM IDENTIFYING THE SPECIFIC TORTFEASOR

In a cause of action for negligence, the plaintiff must prove that -the injury was caused by the defendant’s breach of duty. In a product-liability negligence action, this generally entails identifying an individual defendant as the manufacturer or seller of the injury-causing item. However, three theories have been recognized for excepting the plaintiff from this general rule: concert of action, alternative liability and enterprise liability.

A. Concert of Action

The concert of action doctrine developed to deter hazardous group conduct, and is based upon the premise that injury results from the dangerous situation created by the negligent conduct of all the defendants. Once concert has been established, each defendant is held jointly and :severally liable for the entire harm. Most commonly, the theory is applied to cases involving racing on public highways to hold all participants jointly and severally liable when a third party is struck by one of the racers. However, it has also been applied to cases involving pollution and shooting accidents.

The Restatement of Torts has defined concert as follows:

§ 876. Persons Acting in Concert For harm resulting to a third party from the tortious conduct of another, one is subject to liability if he

  • (a) does a tortious act in concert with the other or pursuant to a common design with him,
  • or (b) knows that the other’s conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself,
  • or (c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, separately considered, constitutes a breach of duty to the third person.

Mere knowledge of what another party is doing will not create concert since there is no affirmative duty to interfere with another per son’s activities. Furthermore, a defendant must be proceeding tortiously or negligently to be held liable under concert.

B. Alternative Liability

The alternative liability theory developed to relieve the plaintiff of the burden of establishing which of several defendants caused an injury. The basis for the theory was developed in Ybarra v. Spangard where the plaintiff awoke after an appendectomy partially paralyzed. Not knowing the person or the instrumentality which had caused his injury, the plaintiff sued six doctors and nurses, each of whom had been responsible for him at some point during his unconsciousness. Although the defendants claimed that res ipsa loquitur was inapplicable because of the number of defendants, the court applied the doctrine, stating: “Plaintiff was rendered unconscious for the purpose of undergoing surgical treatment by the defendants: it is manifestly unreasonable for them to insist that he identify any one of them as the person who did the alleged negligent act.”

The requirements of the alternative liability theory were set forth in Summers v. Tice. The plaintiff in Summers was injured when the two defendants independently fired in plaintiff’s direction while all three were hunting. Since the evidence adduced at trial was insufficient to determine which shot had actually caused the injury, the California Supreme Court held that, whereas the negligence of one of them had injured the plaintiff, “a requirement that the burden of proof on [causation] be shifted to defendants becomes manifest.”

Under the Summers approach, the plaintiff must establish an injury, a breach of duty (negligence) on the part of each defendant, and that one of the defendants caused the injury; which amounts to a primafacie case of negligence against the defendants as a group. Following this showing by the plaintiff, the burden of proof shifts to the defendants, all of whom are held liable if they cannot prove which one of them was responsible for causing the injury. Any particular defendant is released from liability upon a showing that it could not have been the cause of plaintiffs’ injury.

Many courts in other jurisdictions have adopted the Summers rationale; it has even been extended to situations where not all defendants were proved negligent. In a New Jersey case, Anderson v. Somberg, alternative liability was applied against a physician, a hospital, a medical supply distributor, and a manufacturer of surgical instruments, after the plaintiff was injured when an instrument broke in his spinal canal during an operation. The Anderson court, relying upon Summers, not only shifted the burden of proof on the causation issue to the defendants, but also stated that the jury must find at least one defendant liable.

C. Enterprise Liability

Enterprise liability provides a third theory of recovery for a plaintiff who is unable to identify the defendant responsible for her injuries. The purpose of the theory is to alleviate the necessity of proving which of many defendants was the cause of injury, and the effect is to hold all defendants jointly liable. The theory originated in Hall v. E.I. DuPont de Nemours & Co.,  where several children were injured by blasting caps in a series of separate accidents. In separateactions which were consolidated for trial, representatives of the injured children brought suit against six blasting cap manufacturers  who comprised virtually the entire blasting cap industry of the United States. The plaintiffs’ contended that the defendants had created an unreasonable risk of injury by failing to place warnings on the caps and by failing to take other safety precautions. The plaintiffs’ maintained that the industry practice of delegating safety functions to a trade association, which collected statistics on accidents and had considered and rejected the idea of labelling individual caps, demonstrated conscious agreement among the defendants sufficient to impose jointliability.

The Hall court, citing as precedent the principles inherent in work. men’s compensation statutes and the doctrine of respondeat superior, where employers are held vicariously liable because they are “the most strategically placed participants in a risk-creating process .. “… held that the entire blasting cap industry could be held jointly liable. Under this novel enterprise liability theory, plaintiffs would have to prove defendants’ joint awareness of the risks and their joint capacity to reduce or affect those risks, and the plaintiffs would then be relieved of the burden of identifying the manufacturer of each individual blasting cap. The entire industry would thus be held liable for harm caused by its operations.

III. THREE APPROACHES TO RESOLVING THE DES IDENTIFICATION DILEMMA

Recent cases have suggested three approaches to resolving the identification problem, drawn from the three theories previously discussed.

A. Sindell v. Abbott Laboratories

Plaintiff Judith Sindell brought a class action against ten drug manufacturers, alleging that the manufacturers were jointly liable for her injuries which resulted from her mother’s ingestion of DES. While Sindell was unable to identify the manufacturer of the drug taken by her mother and thus responsible for her injuries, she alleged that the defendants were jointly liable because of their express and implied agreements to collaborate in, rely upon, and adopt each other’s testing and marketing methods.

The trial court dismissed the action on the ground that no cause of action was stated since there was no identification of the defendant whose DES had harmed the plaintiff. The California Court of Appeals reinstated the action, finding that the complaint stated a cause of action under the concert of action and alternative liability theories. On review, the Supreme Court of California disagreed with the lower court’s determination regarding the applicability of the concert of action and alternative liability theories, and also concluded that the enterprise liability theory was inapplicable. Nevertheless, the court held that the plaintiff’s right of action was not precluded by her inability to identify the specific manufacturer of the DES which her mother had ingested. Rather, the court found that she had stated a cause of action under a new theory – market-share liability.

The Sindell court, in considering the alternative liability theory, accepted the defendants’ argument that, since only five of the two hundred companies which manufactured DES had been joined as defendants, there was no rational basis on which to infer that any named defendant had caused the plaintiff’s injuries. The court, noting that in Summers all responsible parties had been joined, concluded that the Summers rule of alternative liability was not applicable to a situation where there was a possibility that none of the joined defendants had caused the injury.

The California court next considered and rejected use of the concert of action theory, stating that the defendants’ alleged failure to test the drug adequately or to give sufficient warning of its dangers did not constitute concert of action. Moreover, the court rejected the plaintiff’s assertion that, since the defendants had engaged in parallel or imitative practices and had relied on each others’ promotional and marketing techniques, the defendants had acted in concert. Instead, the court described these actions as a common industry practice and stated that to apply the concert of action theory to the case at bar would so expand the doctrine as to “render virtually any manufacturer liable for the defective products of an entire industry.”

The Sindell court declined to apply the enterprise liability theory for three reasons. First, there were at least two hundred manufacturers of DES, and the Hall court had cautioned against use of the theory in a case involving a large number of producers. Second, the plaintiff could not show that the defendants had jointly controlled the risk. In Hall, joint control of the risk had been based upon the fact that responsibility for the formulation of safety standards had been delegated to a trade association; here, no such trade association of the DES manufacturers existed. Moreover, the plaintiff had failed to meet the standard for joint control of the risk under a concert of action theory. Finally, the court acknowledged the federal government’s role in setting standards for the testing and manufacture of drugs, and stated that it would be unfair to impose liability simply for following government-imposed standards.

Having discarded all of the extant theories which would have allowed the plaintiff to recover, but persuaded by strong policy arguments that the plaintiff ought to be compensated, the Sindell court developed the theory of market-share liability. The supreme court shifted the burden of proof of causation to the defendants, upon the plaintiff’s showing that those manufacturers whose sales of DES accounted for a “substantial share” of the market were joined as defendants. Failing to prove that its drug was not the one which had injured each individual plaintiff, each defendant manufacturer would be held liable for the proportion of the judgment represented by its share of the DES market. Anticipating that some discrepancy between market share and liability will occur under the new doctrine, the California court reasoned that the theory would treat each defendant fairly because “each manufacturer’s liability would approximate its responsibility for the injuries caused by its own products.” Thus, the court stated that the difficulty in apportioning damages and in defining the relevant market should not militate against adoption of the market-share liability theory.

In a dissenting opinion, Justice Richardson opined that the majority’s holding allowed the plaintiff to recover damages without proof that any defendant had either in fact caused or probably caused the plaintiff’s injuries. Moreover, Justice Richardson observed that market-share liability would fall disproportionately on those manufacturers amenable to suit in California, would treat DES-plaintiffs more favorably than other tort plaintiffs, and would be harmful from a social policy viewpoint.

B. Ferrigno v. Eli Lilly and Co.

In an action by eight daughters of DES users against twenty-two drug manufacturers, the New Jersey Superior Court stated that the identification problem posed two separate issues: first, the inability to identify the precise causative agent, and second, the possibility that the causative agent was not among the defendants before the. court. While it has been subsequently overruled, the Ferrigno, decision shows an interesting approach taken by one court to resolving the DES identification dilemma. The court viewed Anderson v. Somberg, as resolving the first issue. The court read that case as holding that, where a plaintiff, through no fault of her own, is unable to identify which of several defendants harmed her, it becomes the defendants’ burden for each to establish that it was not the cause of harm.

In addressing what it considered the more difficult second issue, the Ferrigno v. Eli Lilly and Co. court, again relying upon Anderson, decided that the burden of proof could be shifted to the defendants, even in the absence of joinder of all potential defendants. While the court interpreted the plurality opinion in the Anderson case as assuming that all potential defendants were before the court, the Ferrigno court concluded that even the dissenters in the Anderson case would uphold the shifting of the burden of proof.”

The Ferrigno court further concluded that the Anderson rationale of alternative liability should be extended beyond the particular facts of that case and applied to the case at bar. The court reasoned that, in both Ferrigno and Anderson, the plaintiffs had been innocent victims of an unforeseeable injury.” Also, in both cases, all of the defendants were potentially at fault and all of the defendants owed a special duty to the plaintiff.” The court considered the Ferrigno defendants to be more culpable than those in Anderson, however, in that they caused the identification problem by making a fungible good with long-delayed effects. And finally, since all of the defendants in Ferrigno were alleged tortfeasors, whereas it was presumed in Anderson that only one defendant was at fault, the shift in the burden of proof was thought to be more compelling.

Acknowledging the Sindell court’s rejection of the alternative liability theory, the Ferrigno court nevertheless was satisfied that, under New Jersey law, the theory could and should be applied. Having found the alternative liability theory a satisfactory method for providing recovery to the plaintiff, the New Jersey court declined to consider either the enterprise liability or the market-share liability theories and also rejected the concert of action theory on these facts. The court stated that any defendant could exculpate itself by identifying the actual manufacturer, by showing that it did not manufacture DES until after plaintiff was born, by showing that its drug could not have reached the location where the plaintiff-mother purchased it, or by showing that its drug was not the same shape, size, or color as that ingested by the mother.

However, the court decided that, for the purposes of allocating damages among the defendants, it would adopt the Sindell rationale and hold each defendant liable for the proportion of the judgment represented by its share of the market.

C. Abel v. Eli Lilly & Co.

Reviewing the grant of summary judgments in favor of defendants, the Michigan Court of Appeals, having noted that the concert of action theory was “well-established,”  found that the plaintiff had stated a cause of action under that theory  and held that the summary judgments which had been granted by the trial court were improper.

Moreover, in discussing the theory of alternative liability, the Abel v. Eli Lilly & Co. court noted that, although there were no Michigan cases directly on point, the burden of proof on causation had been shifted to the defendants in other contexts under Michigan law. In adopting the alternative liability theory, the Michigan court cautioned that each plaintiff must prove by a preponderance of the evidence that each defendant had breached its duty of care, and that the harm which she suffered had been caused by her mother’s ingestion of DES which had been manufactured by one of the named defendants. According to the Abel court, the defendants would then be required to apportion the damages among themselves.

IV. THE THREE APPROACHEs ANALYZED

The reasoning of the Abel court is well-supported by precedent. By slightly extending Michigan law with the adoption of the alternative liability theory, the Abel decision merely brings Michigan law into line with the law of many other jurisdictions. In contrast, the Ferrigno court based its decision to expand the scope of the alternative liability theory upon the New Jersey Supreme Court’s decision in Anderson. In particular, the Ferrigno court relied upon the Anderson court’s assumption that all of the defendants were before the court. However, where the Anderson court made this assumption because of the particular factual situation of the case, one in which the existence of other defendants was merely speculative, in DES cases it is more than likely that not all of the defendants can be joined. Moreover, it is doubtful whether the Anderson court in tended to allow a presumption of joinder of all defendants in any case where alternative liability is applied.

Unlike the New Jersey court, which molded the Anderson rationale to fit the facts of a DES case, the California Supreme Court in Sindell clearly acknowledged that it was taking a novel step beyond the Summers holding by extending alternative liability to a situation where not all of the defendants were joined, and in using market-share data to apportion damages.  This step was justified by strong public policy considerations which support the recovery of an innocent plaintiff over the protection of allegedly negligent defendants.

Although the alternative liability theory was the common device used by the Sindell court as well as the Abel 144 and Ferrigno courts to provide the plaintiff with a cause of action, the courts differed in their resolution of the problem caused by the inability to join all of the potential defendants. These contrasts among the courts can be seen, for example, in the language used by the Abel court indicating that it would require joinder of all of the potential defendants. The Sindell and Ferrigno courts recognized that this was a virtual impossibility. However, the Sindell court required that those manufacturers whose sales of DES accounted for a “substantial share” of the market be joined, while the Ferrigno court imposed no floor on the number of manufacturers who must be joined.

While the requirements regarding the joinder of defendants imposed by the Sindell and Ferrigno courts go far toward resolving the DES plaintiff’s dilemma of being unable to identify the manufacturer of the drug ingested by her mother, it is submitted that the Ferrigno result is inferior to the result reached in Sindell. This is because the joinder of only a small number of manufacturers would destroy the underlying presumption of the alternative liability theory, i.e., that with all manufacturers joined there is a high probability of causation collectively. In the interests of fairness to the defendants and the preservation of traditional tort principles, the courts should encourage joinder of the maximum number of defendants.

Addressing the issue of the apportionment of damages among defendants, the Abel court stated only that the defendants would be required to apportion damages among themselves, while the Sindell and Ferrigno courts stated that they would hold each defendant liable for damages in proportion to its market share. However, an unresolved issue in both Sindell and Ferrigno is whether the damages awarded by the jury will be paid in full by the defendants joined, or whether only that proportion of the damages will be paid which corresponds to those defendants’ percentage-share of the market. It is suggested that the latter result would better achieve the courts’ policy of balancing the interests of plaintiffs and defendants and achieving a result which is fair to each. This method of allocation would allow the Sindell court more flexibility in defining what constitutes a “substantial share” of the market, since the court would not have to be concerned that by setting too low a figure it would put an undue burden on the joined defendants. Moreover, this would protect the Ferrigno defendants against the imposition of an unfair burden which would result from the joinder of only a small number of manufacturers.

A question left unanswered in each of these three cases is whether a time-lag between the injury and its manifestation is necessary for the application of the doctrines developed by each court. It is submitted that the answer to this should be in the negative since, where the responsible manufacturer cannot be identified, the presence or absence of lapsed time in a case in no way changes the equities between the parties.

V. CONCLUSION

Unlike the Sindell and Ferrigno courts, the Abel court did not break new ground; and while the court in Abel did express concern for fairness to the plaintiffs, the decision provides little hope for future DES plaintiffs in light of the fact that the standards of proof set by the court are, it is submitted, simply too stringent for plaintiffs to meet.

In contrast, the Sindell and Ferrigno decisions provide great hope for recovery by DES plaintiffs. Moreover, the same policy considerations which led the California and New Jersey courts to their respective holdings should also extend the opportunity for recovery to plaintiffs injured in other circumstances, such as by pollution or industrial waste, where particular tortfeasors are seemingly untraceable. Finally, it is hoped that the Sindell and Ferrigno decisions will force manufacturers to show more concern for product safety, or, at the very least, provide drug manufacturers with an incentive to differentiate their products and, thus, eliminate the identification dilemma faced by DES plaintiffs.

Linda Mogul Madwayr, 1981.

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Products-Liability Class Suits for Injunctive Relief Under Federal Rule 23

INTRODUCTION

The abundance and variety of hazards associated with consumer products have led to a panoply of responses by the legal system. At the state level, standards of strict liability in tort were judicially developed in an attempt to meet society’s need to minimize the growing burdens of product-related injuries. Responding to the weaknesses of the individual claims system, Congress recently has enacted federal legislation designed to promote greater product safety and to supplement existing remedies. In addition, private plaintiffs seeking various forms of preventive injunctive relief4 have attempted to maintain products liability suits as class actions on behalf of all consumers of certain allegedly defective products. This Comment will examine the role of injunctive products liability class suits as an alternative means of implementing more fully the substantive policies underlying both state and federal products liability law.

Products-Liability Class Suits for Injunctive Relief Under Federal Rule 23, Fordham Law Review, Volume 47 | Issue 1 Article 4, 1978.

The ability to pursue products liability claims as class actions is an unsettled area of law. The drafters of rule 23 of the Federal Rules of Civil Procedure, which governs representative suits in the federal courts, cautioned that mass accidents ordinarily would not be appropriate for class treatment. Although products liability controversies, strictly speaking, do not arise out of mass accidents, this reasoning has been specifically relied upon by one court to deny class action status to one products liability action for damages. Moreover, several federal courts faced with claims for injunctive relief have refused to certify them as class actions on extremely narrow grounds, and two state courts have reached conflicting results on the same issue.

This Comment will argue that class action procedures can play a vital role in achieving the compensatory, deterrent and risk-spreading objectives of products liability law, and that injunctive products liability suits are particularly appropriate controversies for class treatment. The analysis wvill begin by examining the goals contemplated by the substantive theory of products liability law and the general role of class action procedures in attaining these goals. The function and propriety of injunctive relief in products liability class suits are then discussed. Finally, an analysis of the procedural prerequisites to class status for such controversies-and judicial reaction to such claims–is presented.

I. SUBSTANTIVE AND PROCEDURAL ARGUMENTS FOR CLASS CERTIFICATION OF INJUNCTIVE PRODUCTS LIABILITY SUITS

A. The Objectives of Strict Liability: Compensation, Risk Spreading, and Deterrence

The imposition of a standard of strict liability in tort upon sellers of defective products is designed initially to ensure that individual claimants are compensated for monetary losses resulting from product-related injuries. By marketing a product for use and consumption, a product seller is held to have assumed a special duty toward any consumer injured by his product. It is believed that the consumer of such products is entitled to the maximum … protection . . ., and the proper persons to afford it are those who market the products. The product seller is held to a standard of strict liability because it is believed that the costs of even unavoidable product-related injuries are better placed on the product seller than left on the injured consumer.

In addition to compensating injured consumers, damage awards and liability insurance also serve a risk-spreading function.  The seller is expected to pass on these added costs by increasing the prices of injury-causing products, thereby spreading the economic burdens of product-related injuries among all the consumers of those products.

Once the total cost to society of producing dangerous products is reflected accurately in the prices paid by consumers, it is reasonable to assume that they will generally decide to purchase safer and less expensive products. Many consumers who would purchase a relatively dangerous product at a price that did not reflect its accident costs may, instead, decide to purchase less expensive and safer products. In this manner, damage awards and the costs of liability insurance also act as a deterrent by creating market forces that promote greater product safety and consumer protection.

Unfortunately, in practice, the high cost of products liability litigation prevents many injured persons from prosecuting their claims and from recovering for their injuries. As a result, the total cost of producing dangerous products is not reflected in the prices paid by consumers. This failure to include accident costs in product prices results in the continued presence in the market place and continued consumer selection of more dangerous products than would be available if prices served their deterrent and risk-spreading functions. Indeed, a major federal role in the promotion of product safety was prompted by recognition of the “inadequacy of existing controls on product hazards.” Although congressional attention was concerned initially with the failure of the individual claims system to achieve compensatory goals, the legislative response ultimately focused on risk-spreading and deterrent aims and the broader consequences to all consumers that follow from the endemic failings of state common law.

Because the risk-spreading and deterrent objectives are dependent upon the success of the compensatory system, any limitations on the recovery of damages by deserving claimants will affect other consumers of similar products. The failure to compensate adequately perverts public policy by allowing product sellers to develop levels of product safety independent of consumer demands. 29 In addition, product sellers’ propensity to maximize profits may often lead to decisions that conflict with society’s interests in the prevention of avoidable product-related injuries. One car manufacturer reportedly decided not to make an $11-per-motor vehicle improvement-at a total model cost of $137 million-that would have prevented 180 burn deaths, 180 serious burn injuries, and 2,100 burned vehicles because it expected liability of only $49.5 million as a consequence of that product defect. Proper functioning of the compensatory system might well have led to greater exposure to liability and to voluntary preventive action by the manufacturer.

The individual claims system also suffers from the tendency to require duplication of judicial efforts and to impose added burdens on already congested court calendars. The prospect of repeated litigation is present throughout products liability law. Multiple suits concerning a single defect alleged to have injured large numbers of consumers frequently occur in defective drug litigation. Similarly, one car manufacturer’s decision to market a product allegedly known to be defective and to present a risk of physical injury was reportedly reached with the expectation of more than 2,000 claims based on a single defect affecting 12.5 million products. It is against this background of substantive goals and practical limitations that the propriety of products liability class suits seeking injunctive relief should be evaluated.

B. Products Liability Controversies as Class Actions

Rule 23 was designed primarily to promote judicial “economies of time, effort, and expense. Products liability controversies, which, as noted earlier, generate a staggering volume of litigation,  would seem to be ideal candidates for the furtherance of these judicial economies. Whether a particular product presents an unreasonable risk of injury to the ultimate users or consumers of that product posits the class question in all products liability class suits. The inquiry may focus upon the product’s inherent design, the manner in which it was manufactured, or the adequacy of any warnings concerning possible dangers associated with the product. Resolution of this threshold issue generally calls for difficult and complex factual findings that would be needlessly repeated in individual suits.

Products liability suits seeking damages, however, also present questions of law and fact affecting only individual class members, thereby reducing the extent of judicial economies afforded by class status. Issues concerning each class member’s postpurchase conduct, proximate cause, and damages, which must be resolved in all actions for damages, are not capable of uniform determination. Yet, these issues are not present in actions primarily seeking equitable relief such as an injunction. Rather, in equitable actions, the right of the class to the requested relief turns only upon the nature of the alleged defect, which remains constant as to each class member.  These products liability controversies are, therefore, often particularly appropriate for the furtherance of the judicial economies intended by the drafters of rule 23.

Rule 23 also was designed to promote greater fairness in the adjudication of claims brought by similarly situated claimants. To the extent that “the interests of absentees, who may be affected by the litigation regardless of its class nature, are given representation in the litigative process,” class action procedures promote judicial fairness. Indeed, the ability of products liability plaintiffs to pursue their claims individually is affected by the prosecution of other claims regarding the same alleged defect by the doctrine of stare decisis, since the holding in each decision will affect all controversies involving similar alleged defects. Class actions, on the other hand, would provide the court with an opportunity to reach a single adjudication concerning a claim of product defectiveness that is binding upon :all members of the consumer class. At the same time, the court’s supervision of the plaintiff’s legal representation ensures that the interests of each class member will be fairly and adequately protected.

Moreover, in any products liability claim the judiciary is called upon to do substantially more than adjust the legal relations between the protagonists. Decisions concerning liability and damage awards will have significant effects upon achieving the objectives of risk spreading and deterrence. Class actions will put before the courts the interests of absentees, thereby enabling the courts to see the “full implications” of their decisions, and to determine what results “would best serve the policies underlying” products liability law. The judiciary will, therefore, be better informed to make judgments that require it to weigh society’s interest in product safety against the expense and inconvenience that product recall or repair may impose upon the manufacturer.

Class actions also promote the realization of the substantive goals underlying products liability law by facilitating maximum claims prosecution. Class actions reduce per plaintiff legal costs since attorney fees are determined under judicial supervision on the basis of the benefits provided to all class members. By lowering the high cost of bringing a lawsuit, a major failing of the individual claims system, class actions would “open the courts to claims not ordinarily litigated,” therby allowing the judiciary “to enforce policies underlying causes of action in circumstances where those policies might not otherwise be effectuated.

Finally, class actions provide specific procedural advantages for those involved in products liability actions. With regard to injured consumers, in addition to reducing the per plaintiff legal costs and increasing the plaintiffs’ litigation posture by injecting the absentees’ interests into the controversy, the filing of the complaint tolls the statute of limitations for the benefit of the entire class, even when certification of the suit as a class action is subsequently denied. Moreover, the named representative satisfies the personal jurisdiction, venue, and service requirements on behalf of the entire class.

At the same time, defendants also benefit from class action procedures. The potential economies to be gained from avoiding multiple suits concerning a single alleged defect may be enormous. The defendant is given an opportunity to settle with the entire class after making a candid evaluation of exposure to liability. The defendant is thus able to obtain a unitary disposition of the controversy that is binding on all class members and, at the same time, is consistent with the substantive policies underlying both products liability law and class action procedures.

C. The Role of Injunctive Relief
1. Products Liability Class Actions Seeking Damages

Procedural obstacles to certification of products liability suits seeking damages require that class treatment be limited to injunctive actions. Certification of suits for damages as class actions under rule 23(b)(3) requires that the common questions of law or fact which must be present in all class suits “predominate over any questions affecting only individual members” of the class. Although common questions of law and fact do exist in all products liability class suits, the presence of significant issues concerning postpurchase conduct, proximate cause, and the extent of injury would appear to disqualify products liability damage suits as class action candidates. Indeed, these drawbacks have been dispositive in several class actions brought to recover damages arising out of various mass accidents, such as airplane crashes, in which the issues of postpurchase conduct and proximate cause do not vary from plaintiff to plaintiff.  This same reasoning has been relied upon to deny class action status in several products liability suits.  Related to the failure of such suits for damages to satisfy the “predomination” requirement is the likely finding that class status simply is not a “superior”  method for resolution of such controversies.

However, neither the “predomination” nor the “superiority” requirement applies to the certification of actions primarily seeking injunctive relief as class actions. Injunctive products liability claims may be certified as representative suits under entirely different class action categories, rules 23(b)(1) and (2), thereby obviating any need of satisfying the foregoing rule 23(b)(3) requirements. Consequently, a major stumbling block to class status is not present in equitable products liability actions.

Jurisdictional obstacles to the certification of damage suits as class actions in the federal system also act to limit class treatment to equitable products liability suits. In Snyder v. Harris, the Supreme Court held that the damages of individual class members cannot be aggregated in order to satisfy the amount in controversy requirement in diversity cases, at least when each claimant’s right to recover is separate and distinct from the rights of other class members. In Zahn v. International Paper Co., the Court later held that each individual class member must satisfy the amount in controversy prerequisite and that any plaintiff, named or unnamed, who failed to do so must be dismissed from the action and could not avoid the amount in controversy requirement under concepts of ancillary jurisdiction. Consequently, a federal forum is available only to those class action damage suits in which the members already have suffered relatively serious injuries.

Although the amount in controversy prerequisite must also be satisfied in injunctive products liability suits, it would appear that this requirement is more readily satisfied in such cases. The amount in controversy in injunctive actions generally is determined with respect to “the value of the right involved.” Thus, in products liability suits, the amount in controversy is the value of the right of each member of the class to protection against the risk of physical injury associated with the allegedly defective product. The cost of injuries already sustained is not, by itself, dispositive of the jurisdictional question. Consequently, in City of Chicago v. General Motors Corp. the court held that “plaintiff’s right not to be harmed by dangerous motor vehicle emissions and defendants’ converse right to unfettered manufacturing are both in excess of the jurisdictional amount.

In addition, it should be noted that the amount of damages suffered by those who one car manufacturer anticipated would be injured or killed by its product would satisfy the jurisdiction requirement. The manufacturer estimated that liability for each injury would be approximately $67,000, and liability for each death would be approximately $200,000. Therefore, it is reasonable to assume that injunctive products liability class suits will often meet the monetary requirement for diversity jurisdiction.

2. Injunctive Relief as a Substantive Remedy

The few products liability class suits seeking injunctive relief which have been brought were decided on narrow procedural grounds, and leave open the question of whether, as a matter of substantive law, equitable relief is ever appropriate in such tort cases. Although injunctive relief has historically been restricted to the protection of only property rights, it is now well established that equitable protection of personal rights by injunction is available upon the same conditions as those regarding the protection of property rights.  This recent expansion of the role of equitable relief has been attributed in large part “to the attractiveness of so flexible a remedy in a modern society with expanding regulation of complex economic and social affairs.  It is submitted that, notwithstanding the lack of any definitive precedent concerning the availability of injunctive relief to products liability claimants, regulation of the relationship between consumers and manufacturers of defective products is frequently an appropriate controversy for equity’s preventive intervention.

Perhaps the most useful analogy to products liability actions is the power of equity to enjoin a nuisance. The defendant is held to a standard of strict liability in tort in both types of action. Moreover, although the salient feature of a private nuisance is interference with the use and enjoyment of land, “many interferences with personal comfort. . . which at first glance would appear to be wrongs purely personal to the landowner… are treated as nuisances because they interfere with that right to the undisturbed enjoyment of the premises.” Consequently, the interests protected in nuisance and products liability actions often are quite similar. For example, an injunction issued over a century ago against the operation of a rifle range until it was made safe for use without endangering the lives of persons occupying the adjoining property acted ultimately to safeguard the plaintiffs’ personal and physical well-being. Indeed, the interests protected in that nuisance cause of action do not appear to be distinguishable in any meaningful sense from the gravamen of a products liability class suit brought to enjoin the sale of motor vehicles alleged to present a risk of injury from air pollution.

a. The Availability of Equitable Relief

There exists “no general formula”  governing the availability of equitable relief. Several principles limiting the issuance of preventive injunctions, however, are clearly recognizable and would thus establish the general parameters of equitable relief in products liability controversies. Initially, it must be shown that the mere recovery of damages at law will not be an adequate remedy and that the plaintiff will, therefore, suffer irreparable harm in the absence of the requested relief. Relevant factors in determining whether alternative remedies are inadequate include the potential need for a multiplicity of damage actions, the seriousness of the potential harm, the uniqueness of the interests protected, and the financial inability of the defendant to respond in damages.

With respect to products liability controversies, these factors would often appear to argue in favor of the propriety of equitable relief. The seriousness of the potential harm and the financial inability of the defendant to respond in damages, of course, present factual issues for case-by-case adjudication. Yet, an injunction directed against harmful conduct of a continuing nature, such as the risk of injury created by a product defect, obviates the need for the multiple damage actions often present in products liability situations, thereby conserving judicial resources and avoiding unnecessary burdens for the plaintiff.

The nuisance analogy noted above lends further support for the propriety of injunctions in products liability suits. The difficulty of ascertaining compensatory damages is frequently a factor favoring equitable relief against private nuisances. Similarly, the assessment of money damages for personal injuries resulting from defective products is highly speculative in nature.  Merely awarding compensatory damages manifestly fails to do justice whenever such personal injuries are likely to be substantial and are preventable.

Furthermore, injunctions are a common remedy in nuisance actions because every tract of land is regarded as “unique” and damages, therefore, are not considered adequate when the land’s usefulness is seriously impaired. Yet, human life and safety are no less important than property. Surely the interests protected by products liability law are, at the very least, as “unique” as those protected by nuisance actions.

Finally, it should also be noted that the issue of prematurity-whether the threat of harm is sufficiently ripe to make the grant of preventive relief appropriate-which often arises in nuisance actions is less problematic in products liability suits.  In nuisance actions, preventive relief will not be granted to a plaintiff who has suffered no actual damages unless he establishes that the threatened harm is imminent, substantial, and otherwise unavoidable. In products liability cases, on the other hand, typically the representative plaintiff or absentee class members have already suffered substantial personal injuries providing strong evidence that other consumers of the same defective product are likely to sustain similar injuries in the absence of preventive relief.

b. The Scope of Equitable Relief

Once it has been determined that equitable remedies are proper, the court can order any affirmative action it deems necessary to remove or render harmless the source of the threatened injury.  The scope of the appropriate relief in products liability cases, therefore, depends upon the risk of injury associated with the particular product defect.

Thus, injunctive products liability actions have been brought in federal courts for a variety of remedies. One injured consumer sought, on behalf of herself and other similarly situated plaintiffs, to enjoin the manufacture and sale of certain color television sets, dangerously prone to implosion and resulting fire, as well as certain mobile homes equipped wvith those defective televisions. Another plaintiff sued, as a private attorney general, 100 for the creation of a fund to be used on behalf of the class plaintiffs for

  1. conducting research into the causes, cures and prevention of the development of vaginal cancer and other conditions in the female children of mothers who, during the term of their pregnancies, took certain prescription drugs;
  2. alerting parents and their female offspring of the risks of developing vaginal cancer caused by those drugs;
  3. and paying the costs of routine preventive examinations of all identified female offspring among the class plaintiffs in order to detect the development of these injuries.

Moreover, the maintenance of class actions primarily seeking injunctive relief does not prevent courts from granting damages or other monetary relief to the class members in the same proceeding. As a result of the role played by compensation of individual claimants in furthering the objectives of risk spreading and deterrence, this relief acts to reinforce the efficacy of the preventive remedy, and is well within the equitable jurisdiction of the court. This power has been liberally exercised in favor of injured class members in injunctive class suits dealing with employment, welfare, securities and other controversies. One commentator has urged that “miass restitution recoveries by official agencies are … persuasive authority for the liberal allowance of ancillary relief for class members in class actions for primarily . . . injunctive relief instituted by ‘private attorneys general.’ ”

Finally, one may question why, even assuming the appropriateness of injunctive class products liability suits, an injured plaintiff would chose such an alternative to the traditional damage action. It is submitted that the enhanced litigation posture following from class action status, and the availability of ancillary monetary remedies in actions seeking injunctive relief would ensure an ample source of potential litigants. Although compensatory remedies are generally thought to be the primary focus of products liability litigation, oftentimes only equitable remedies can afford the most adequate relief. This is true not only in those cases in which the individual consumers thankfully have not yet suffered any actual physical injuries,  but also in those cases in which some of the absentee class members have suffered only relatively minor physical injuries not sufficient to justify the enormous litigation expenses required to adjudicate their claims for damages. The interests of these absentee class members may, therefore, be advanced by class representatives with substantial monetary claims, who in addition to furthering the interest of class members, may also recover for their own monetary claims.

II. FEDERAL RULES ANALYSIS

In order to maintain any suit as a class action under rule 23 a plaintiff must satisfy the four prerequisites contained in rule 23(a) and also must qualify the suit under one of the categories of class actions contained in rule 23(b). As noted above, products liability suits primarily seeking damages would appear to be unable to satisfy the “predomination” and “superiority” requirements for certification under rule 23(b)(3). Accordingly, the discussion that follows will be limited to an examination of the ability of injunctive products liability suits to satisfy the prerequisites of rule 23(a) and to qualify under the class action categories contained in rule 23(b)(1) and 23(b)(2).

A. Rule 23(a)-Prerequisites of All Class Actions
1. Numerosity and Joinder-Rule 23(a)(1)

The initial prerequisite to the maintenance of any suit as a federal class action is that the class be so numerous that joinder of all members is impracticable. Although numerosity of the prospective class is perhaps of primary importance, no inviolate criteria have been established, and other factors may be significant to this determination. Thus, the geographic diversity among class members is often considered to determine the practicability of joinder. Additionally, the financial inability of absentee class members to bring individual suits-one of the major stumbling blocks to recovery in products liability cases generally -is also highly relevant under rule 23(a)(1).

The numerosity prerequisite is easily satisfied in injunctive products liability class suits since, whenever it is alleged that the defendant’s defective product presents an unreasonable risk of injury and is distributed in the stream of trade, every ultimate user of that product is a potential class member. Thus, injunctive class actions have been brought on behalf of citywide, statewide, and nationwide consumer classes. The members of such large consumer classes will typically be geographically diverse and unable to bring individual suits either because of financial inability or ignorance of the risk of injury, thereby making joinder of those claims highly impracticable.

2. Common Questions of Law or Fact-Rule 23(a)(2)

Under rule 23(a)(2), a suit may be maintained as a class action only if “there are questions of law or fact common to the class.” Whether a particular product presents an unreasonable risk of injury to the ultimate users or consumers of that product posits the class question in all such suits. Thus, it is submitted, the commonality requirement is satisfied in all products liability class suits. Difficulties in determining issues such as causation, the extent of injuries and the adjudication of individual defenses, which typically are confronted in class suits seeking damages, are not present with respect to the issue of injunctive relief. The injunction question raises “no issues which focus on the activities or circumstances of individual class members. ‘ Although such individual questions would be present when the suit also seeks ancillary monetary relief for individual claimants, subdivision (a)(2) does not require that each question of law or fact be common to all class members. Finally, the nature and scope of the relief mandated by the risk of injury created by the specific product defect also presents a common question as to all class members.

3. Typicality of Claims or Defenses-Rule 23(a)(3)

Rule 23(a)(3) imposes a further requirement that “the claims or defenses of the representative parties be typical of the claims or defenses of the class”. This prerequisite also is satisfied in all injunctive products liability class suits since they are based upon a single alleged defect and seek identical relief as to each class member. Moreover, although individual claims for ancillary relief will include amounts for medical expenses, lost earnings, property damages, or wrongful death that will vary from claimant to claimant, subdivision (a)(3) is satisfied so long as all such claims stem from a single event or are based on the same legal or remedial theory.

4. Adequacy of Representation-Rule 23(a)(4)

Finally, rule 23(a)(4) imposes the obligation that the representative party “fairly and adequately protect the interests of the class.” Whenever class treatment fails to ensure adequately the protection of the interests of absentees1 who will be bound by the judgment, there is a failure of due process.)  Subdivision (a)(4), therefore, imposes a minimum obligation that the representative party have substantial claims, that all claims be vigorously prosecuted, and that the class representative have the financial wherewithal for protracted litigation.

Failure to satisfy subdivision (a)(4) has been the basis of several district court decisions denying class action status to injunctive products liability suits. In Weeks v. R.C.A. Corp., an action was brought by the survivor of a mobile home owner who was killed in the fire resulting from the implosion of an allegedly defective color television set manufactured and sold by one of the defendants. The plaintiff sought damages on her own behalf and on behalf of her deceased husband. Additionally, the plaintiff sought class action status for an order enjoining the defendant from continuing to manufacture or to sell other similarly defective products.  The court dismissed the class complaint reasoning that, because the named plaintiff no longer owned such a television set and was no longer directly exposed to the alleged risk of injury, she therefore lacked standing to seek injunctive relief on behalf of such an amorphous class.

The Weeks decision is in accord with other cases holding that a plaintiff may not represent a purported class of which that plaintiff is not a member. Among these cases is Rheingold v. E. R. Squibb & Sons, Inc., an action brought by a consumer of a certain prescription drug, diethylstilbestrol (DES), taken during pregnancy to prevent miscarriage. Plaintiff alleged that the female children born to all consumers of that drug were exposed to the risk of developing vaginal cancer. Plaintiff sued for injunctive relief on behalf of her own daughter and all other female children similarly situated against several defendants, each of which had manufactured and sold the drug. The named plaintiff thereby sought to represent the interests of female children born to consumers of drugs that had been manufactured by one or more of the multiple defendants. Because some members of the class might have been exposed to the risk of injury by a defendant different from the particular manufacturer of the DES consumed by the named plaintiff, the court denied class status for lack of proper standing.

It is submitted, however, that the Weeks and Rheingold decisions did not focus upon the question of the named party’s ability to represent the class members and turned on confused interpretations of rule 23. Both courts failed to distinguish between the issues of class membership and adequacy of representation. The Weeks decision appears to have overemphasized the significance of the representative’s failure to continue to own a defective television set. The representative plaintiff had suffered the loss of her spouse and her home allegedly as a result of the product defect complained of. She was still, albeit less directly, exposed to the risk of injury presented by the remaining defective television sets owned by other consumers. It would appear, therefore, that she was both capable and highly motivated to represent the proposed class.

The Rheingold decision suffers from the same error. By failing to appreciate the significance of the fact that all class members were exposed to the same risk of injury arising from the same defective product, the court manipulated the concept of class membership to deny class status, yet never reached the factors relevant to the separate inquiry prescribed by rule 23(a)(4).

Although express language of rule 23(a) requires that the named party be a member of the proposed class, the issue of class membership should not be dispositive of the named party’s ability to represent the class. The courts should employ a two-step process. They should first determine whether the named party is a member of the proposed class, and then examine his ability to represent absentee members. In attempting to resolve the second question, the courts should focus upon whether the named party has substantial claims, the financial wherewithal for a protracted litigation, and whether there exists any actual or potential conflict between the interests of the representative party and those of the class members. It is submitted that through this two-step process, adequacy of representation would be examined more thoroughly, and absentee members would receive greater protection.

The corresponding requirement in the California class action statute to that imposed by rule 23(a)(4) has been more clearly construed in the area of injunctive products liability suits. In Anthony v. General Motors Corp.,the plaintiffs were held to be adequate representatives of all owners of certain 1960-1965 models of the defendant’s trucks equipped with allegedly defective disc wheels, notwithstanding the named plaintiffs’ failure to own vehicles manufactured in each suspect model year. The court responded to the defendant’s argument that the plaintiffs were not members of the class they purported to represent by observing:

The gravamen of plaintiffs’ case is the contention that all wheels of the type involved contain an inherent defect which may cause them to fail …. It is patent from the record before us that that issue is one which will require an elaborate and probably a protracted trial. It is exactly the sort of common issue for which class actions are designed.

By thus focusing on the inherent risk of injury in such products distributed in the stream of trade, the Anthony court did not attach undue significance to the fact that the named plaintiffs each owned only one model of the defendant’s truck. Accordingly, plaintiffs were found to be members of the proposed class. Any question concerning the adequacy of the named plaintiffs’ representation of the interests of the absentee claimants required a separate examination of the factors noted above.

Ultimately, adequacy of representation will depend upon the facts of each individual suit. Yet, it is submitted that the central concern of such inquiries is properly upon adequacy of representation as it relates to the scope of and need for the requested relief, rather than on artificial conflicts created by misconceptions concerning membership in and definitions of the classes.

B. Actions Under Rule 23(b)(1)
1. Rule 23(b)(1)(A)

An action that satisfies the four prerequisites of rule 23(a) may be certified as a class suit under rule 23(b)(1)(A) when individual actions brought by or against potential class members “would create a risk of inconsistent or varying adjudications …which would establish incompatible standards of conduct for the party opposing the class.” The scope of rule 23(b)(1)(A) is the subject of some judicial controversy.

Several mass accident decisions have interpreted the rule broadly and granted certification under this subsection on the theory that, without class status, the respective defendants in those actions would be exposed to multiple individual suits and possible conflicting judgments as to liability.160 Other mass accident cases have, however, expressly repudiated such a reading of rule 23(b)(1)(A). Interpreting “incompatible standards of conduct” narrowly to refer only to “conduct required of the defendant in fulfilling judgments in separate actions,” these cases have held that mass accidents are not appropriate for certification under rule 23(b)(1)(A).

It would appear, however, that injunctive products liability suits stand on substantially different footing from other mass accident class actions and are well within the rule’s intendment. One example would be a series of actions seeking to prescribe various design modifications in order to reduce or to eliminate the risk of injury associated with a single product defect. Indeed, specific standards were proposed by the class representative in City of Chicago v. General Motors Corp., and it is not unreasonable to suppose that standards that might have been proposed in individual suits for the same relief could have varied greatly.

Moreover, the drafters suggested that this subdivision might be the appropriate class action category for suits brought to invalidate a bond issue, to abate a common nuisance, or to declare the rights and duties of riparian land owners. These actions, as well as injunctive products liability suits, all endeavor to impose various affirmative duties of conduct upon the respective defendants. The potential for incompatible standards of conduct stems from the differing obligations a court might impose upon a defendant. Thus, the fact that the defendant could be held liable for damages as to one plaintiff and not liable as to another, a situation which courts following the narrow reading of rule 23(b)(1)(A) have held not within the meaning of the rule, 168 is not relied upon for certification in these actions.

2. Rule 23(b)(1)(B)

Class status may be permitted under rule 23(b)(1)(B) when the prosecution of separate suits by individual class members “would as a practical matter be dispositive of the interests of the other members not parties to the adjudications” or when prosecution of separate suits would “substantially impair or impede the ability of the remaining claimants to protect their interests. The drafters suggested that the first part of this subdivision would be the appropriate category for an action by policyholders against a fraternal benefit organization to bar its financial reorganization or for an action by shareholders to declare a dividend, and that the latter clause would be appropriate for an action by creditors to set aside a fraudulent conveyance by a debtor.

In a strict financial sense, the refusal to certify an injunctive products liability suit as a class action acts only to leave absentee class members seeking the same relief with “the same complexity and expense as if no prior actions had been brought,” and does not alone qualify those actions for class status under either clause of rule 23(b)(1)(B). In addition, although one may argue that the prosecution of individual products liability suits may “substantially impair or impede” the ability of class members to bring their claims, it appears that certification would be improper under the latter clause of subdivision (b)(1)(B). However, the prosecution of separate suits for injunctive relief by products liability claimants would, as a practical matter, be dispositive of the interests of the remaining class members and thus argue for certification under the initial clause of rule 23(b)(1)(B).

First, by maintaining class actions, products liability plaintiffs would be entitled to have the court weigh the interests of the entire class as actual parties to the suit in determining the propriety of equitable relief. Conversely, any award of injunctive relief to an individual products liability plaintiff would necessarily affect other similarly situated consumers. Second, prosecution of individual products liability suits will also create stare decisis effects that extend to those controversies involving similar or related product defects. Finally, it should be noted that remedial consequences to other consumers of defective products are specifically contemplated by the riskspreading and deterrent objectives of products liability theory. Certification of such suits as class actions under the initial clause of rule 23(b)(1)(B) would, therefore, be entirely consistent with this substantive law theory.

C. Actions Under Rale 23(b)(2)

Products liability plaintiffs may also seek equitable relief on behalf of large classes of consumers under rule 23(b)(2). Class suits may be permitted under this subdivision when the prerequisites of rule 23(a) have been satisfied and “the party opposing the class has acted or refused to act on grounds generally applicable to the class, thereby making appropriate final injunctive relief or corresponding declaratory relief with respect to the class as a whole.” The drafters suggested that this subsection was well suited for civil rights and antitrust cases.

Although there is much overlap between the categories of class suits defined by subdivisions (b)(1) and (2), certification under the latter is limited to those class actions seeking primarily injunctive relief. Certification under subdivision (b)(2) is determined with respect to the appropriateness of injunctive relief based upon the defendant’s past conduct, as documented by the evidentiary record. Certification under subdivision (b)(1), on the other hand, depends upon the defendant’s future obligations or the prospective rights of other claimants, matters that are much less capable of demonstrative proof. Thus, whenever equitable relief is appropriate, rule 23(b)(2) would afford greater access to class treatment of injunctive products liability suits.

Rule 23(b)(2), however, does not permit certification of a class whose members have independent tort claims arising out of the same occurrence and whose representatives assert only liability for damages. Thus, although individual compensatory recoveries may be available in products liability suits certified as class actions, under this subdivision such monetary relief cannot be the predominant type of remedy sought. Thus far the representative plaintiffs in products liability class suits have sought highly specified injunctive relief. Other class representatives, however, may seek to avoid the insurmountable criteria for certification of damage actions under rule 23(b)(3) by conducting such suits under rule 23(b)(2) in the form of equitable actions. Whenever a complaint presents claims for both equitable relief and compensatory damages, close scrutiny will be required to determine the plaintiff’s true motivation.

On balance it would appear that rule 23(b)(2) offers the most promise for certification of products liability suits as class actions. The requirement that the party opposing the class must have failed to perform some legal duty with respect to the class as a whole will always be satisfied by the class question in all such actions–whether the defendant has breached a legal duty to the consumer class by distributing a defective and dangerous product in the stream of trade. Consequently, preventive injunctive relief for the benefit of that consumer class will often be the most “adequate” of all alternative remedies.

CONCLUSION

The imposition of a standard of strict liability is justified by the societal need to minimize product-related injuries and by the desire to distribute the economic burdens of unavoidable injuries more equitably among all consumers. Class treatment of products liability claims would appear to be entirely consistent with the realization of these social goals:

Class action procedures assist courts in giving full realization to substantive policies in two ways. First, to the extent that they open courts to claims not ordinarily litigated, class actions enable courts to enforce policies underlying causes of action in circumstances where those policies might not otherwise be effectuated. Second, to the extent that they enable courts to see the full implications of recognizing rights or remedies, class action procedures assist courts in judging precisely what outcomes of litigation would best serve the policies underlying causes of action …. Courts are more likely to see both the significance of the claims of a plaintiff and the consequences of imposing liability upon a defendant, and thus are more likely to arrive at a substantively just conclusion …. Moreover, the interests of absentees, who may be affected by the litigation regardless of its class nature, are given representation in the litigative process, and thus are more likely to be given their due.

This Comment has endeavored to explore the possible ways in which injunctive products liability suits are particularly appropriate controversies for class treatment. No categorical barriers appear to exist to certification of these suits as federal class actions. Such actions will generally satisfy the four prerequisites of rule 23(a) and, under the appropriate factual circumstances, appear to fit within either of the two categories of injunctive class actions contained in rule 23. Indeed, injunctive class suits can play a vital role in complementing the substantive theory of products liability law and, at the same time, ameliorate the principal defects in the individual claims system.

Joseph DeCarlo, Jr, 1978.

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The DESAD Project Experience

Abstract

In recent years, medical record review has been used to alert patients who have received drugs or treatments that have newly discovered side-effects. The experience of the national cooperative Diethylstilbestrol-Adenosis (DESAD) Project in identifying and notifying women exposed in utero to diethylstilbestrol (DES) shows this to be a difficult task. In order to identify 4,830 exposed women, 221,245 charts were reviewed. Detailed tracing data for one of the centers participating in the DESAD Project indicated that only 85 per cent of the 690 DES-exposed women identified at that center could be notified of exposure. The DESAD Project experience has led to recommendations for standardized prenatal records and drug lists, long-term storage of medical records, new legal guidelines, and improved recording of follow-up information, taking into account issues of privacy.

Introduction

Identifying and Tracing a Population at Risk : The DESAD Project Experience, American Public Health Association, NCBI PubMed PMC1650582 and amjph00638-0029, March 1983.

Medical chart review has long provided a major source of information for retrospective epidemiologic studies. In recent years chart review has also been used to identify and alert patients who received drugs or treatments that have newly discovered side effects. For example, attempts have been made to alert adults to their increased risk of thyroid cancer following head and neck irradiation in childhood and to alert women to their increased risk of clear cell adenocarcinoma of the lower genital tract following in utero exposure to diethystilbestrol (DES). In the case of DES, the National Cancer Institute in the 1978 Task Force Summary Report recommended that all women who received DES in pregnancy, as well as exposed daughters and sons, be informed of their exposure by a public information campaign, and notification of exposed individuals by their physicians. Although the cost of a public information campaign can be estimated from other such endeavors, limited information exists on the cost or problems involved in identifying a population from medical records and notifying these individuals of a hazardous exposure. The experience of the Diethylstilbestrol-Adenosis (DESAD) Project in obtaining access to records for review and in locating study participants gives insight into the difficulties of this task.

Methods

Synthetic estrogens including diethylstilbestrol (DES) were used in some pregnancies between the years 1940 and 1971. Exposure of the fetus to DES has now been associated with genital tract cancer in daughters and with benign genital tract anomalies in both daughters and sons. To date there is little evidence of risk for mothers who ingested the drug. The DESAD Project is an observational follow-up study of the daughters exposed in utero to DES. The study design has been reported previously. Participants enrolled at these institutions gained entry by referral from physicians, by self-referral, or through the process of prenatal record review carried out at each DESAD center for the purpose of identifying DES-exposed participants and unexposed controls. It is the prenatal record review group that is the focus of this paper.

Record Review

In most communities, obstetrical records are maintained by the private physician, with labor and delivery records in separate hospital files. Prior to the beginning of the DESAD Project, physicians in the Boston, Houston, and Los Angeles DESAD centers had been examining DESexposed daughters referred by private physicians. Through these contacts and through knowledge of their local medical communities, Project physicians were able to locate private physicians or clinics known to have administered DES to pregnant women and obtain permission to review office records. Some records had been in storage due to the physician’s retirement or death. In these private practices, because records of both obstetrical and gynecological patients were combined, all charts required review. At the Mayo and Gundersen Clinics, the prenatal and obstetrical records were combined in a unit record and were retrievable through a diagnostic index. Thus, all obstetrical records could be identified and reviewed without reading through the gynecological records.

Exposure was defined as any chart notation of DES or synthetic estrogens prescribed between conception and the week before delivery. Centers reviewed all available obstetrical records covering the years 1940, when the first DES-exposed birth could occur, through 1972, the year after the US Food and Drug Administration warned against DES for use in pregnancy.

Record abstractors were trained in obstetrical terminology; sex hormone identification was facilitated by the generic and drug trade name list prepared by the Coordinating Center and used during record review. Abstractors were reminded of the confidential nature of the chart contents and the importance of correctly ascertaining exposure status (that is, DES-exposed or unexposed) for each live birth.

The training period for a record abstractor varied from one day to one week, depending largely on the reviewer’s previous experience with medical records and ability to read the physician’s handwriting. The majority of record abstractors required no more than eight hours of training. The information abstracted from prenatal records by the centers is given in the Appendix.

Tracing

A variety of techniques similar to those described by Boice, Chung, and Edwards were used by centers to trace and locate those identified. Daughters had to be located by tracing their parents, since usually only sex and date of birth were recorded in the obstetrical chart. Because procedures were especially well documented at the Massachusetts General Hospital (MGH) center with regard to staff time and the number of contacts involved, the step-by-step tracing process as applied in Boston will be presented here.

At the MGH center, every name was first checked in the appropriate telephone directory. If not found, directories of surrounding cities were used to search the greater Boston area. If this failed or if multiple listings precluded positive identification, the name was checked through an occupational directory, alumni office, or out-of-state telephone directory when clues were available from the chart. Next, a search was made for the family’s name through the records of the Massachusetts Registry of Motor Vehicles (MRMV). Computer listings of licensed drivers within the Commonwealth of Massachusetts were reviewed at the Registry’s main office. The alphabetized listings provided name, date of birth, address, and city, as well as license identification number for all current license holders. DESAD personnel began by looking for the mother’s name and birth date, if available. Next, the father’s name was checked. His date of birth was seldom indicated in the mother’s record and this impeded the process of locating those persons with commonly occurring names. For those fathers with commonly occurring names, an attempt was made to match the mother’s name with the father’s name by looking for a common address. If these steps failed, the birth dates under the appropriate last name were scanned to locate a female with the daughter’s date of birth, which was then checked for an address match with the mother’s or father’s name.

When a family was located, a letter was sent to the parents explaining the DESAD Project, stating DES exposure status and inviting the daughter’s participation in the Project. Letters were sent from the delivering physician, if possible, or from the local DESAD center. If a letter was returned by the post office as “unable to forward” and all other methods of tracing were exhausted, the family was considered lost to follow-up.

Similar tracing procedures were used at the other centers. In addition, at the Mayo Clinic, babies were assigned clinic numbers at birth. These numbers are recorded in the mothers’ charts. Thus, it was possible to obtain daughters’ charts where the daughters’ names and occasionally current addresses were recorded. Because daughters’ names were available, birth certificates could be obtained if additional information such as father’s birthdate was needed for tracing.

Results

The three centers using private physicians’ records encountered many physicians who refused to allow their records to be reviewed. Concerns expressed by those physicians were: lack of adequate space in which to conduct the review; patient’s privacy and confidentiality; and possible lawsuits from DES-exposed individuals.

In Boston, Houston, and Los Angeles, a total of 73 physicians and hospitals initially allowed review of their records. Five of these physicians refused permission to contact individuals after the review was completed, while one physician terminated the review without explanation after one-third of the charts were examined. The records of one physician were largely illegible and too incomplete to pursue. Those of another physician were only partially reviewed before he became ill, after which his office was moved and records, including those not yet reviewed, were destroyed.

For all centers, available space in the physician’s offices limited the number of staff able to review records at any one time. In most offices, abstractors were allowed to work with the records only a few hours per week. Thus, the entire reviewing process in each office necessitated many visits.

Identifying and Tracing a Population at Risk: The DESAD Project Experience.

The time required to review and abstract each chart varied widely among centers (Table 1). The tedious nature of record reviewing cannot be overemphasized. Abstractors at all centers found that frequent rest periods were requiredat least 15 minutes every two hours-and that six hours of reviewing per day was the maximum possible.

DES-Exposed Females Identified

Records reviewed by all centers as of 1979 totaled 221,245 and represent the years 1940 through 1972. Table I presents the numbers of DES-exposed females identified by each center. The proportion of charts with DES-exposed mothers varies greatly among centers because of variations in the obstetrical-gynecological patient mix, and variations in the use of DES by physicians.

FIGURE 1 – Total DES-Exposed Live Born Females, by Year of Birth, Identified among Records of Physicians A-F.

Figure 1 presents a histogram showing the number of DES-exposed female live births by year identified among the charts of the six physicians (A-F) whose records were reviewed by MGH personnel. This is consistent with known patterns of DES exposure. 16 The MGH center also wished to estimate the proportion of pregnant women who were prescribed DES. Because of the cost, records of only two physicians were chosen for this special review. For these two physicians, a count was kept of all unexposed live born females between the years 1940 and 1966. Between the years 1946 (when the first DES-exposed female was identified in each practice) and 1966, DES was used by one physician in 8 per cent of female live births and by the other physician in 13 per cent of female live births. Since only live births are represented in these calculations, and since the two physicians administered DES primarily to women with vaginal bleeding, cramping, and threatened miscarriage, these are most likely low estimates of actual use.

During the 1945 to 1966 time period 2 per cent of all deliveries at the Gundersen Clinic were DES-exposed births; 9 per cent of deliveries were DES-exposed during the peak year of use in 1964. At the Mayo Clinic during the years 1943 to 1959, approximately 7 per cent of births were estrogenexposed. Peak usage at the Mayo Clinic reached 19 per cent in 1947.

Tracing Experiences
TABLE 2 - Methods for Locating 617 DES-Exposed Mothers Identified by the Massachusetts General Hospital Center
Identifying and Tracing a Population at Risk: The DESAD Project Experience.

Table 2 summarizes results of tracing methods used at MGH to locate mothers and daughters through the mothers. For 39 out of 167 families not found through the initial search of local telephone directories, an out-of-state move was indicated in the chart. Tracing through out-of-state telephone books doubled the search time per name. In addition, personnel time and travel expenses were incurred in order to use the out-of-state telephone directories at the New England Telephone Company. Eleven families were traced through other sources such as occupational or university alumni directories.

For the 147 mothers not located by previous methods, a search of MRMV records was instituted. Of these mothers, 31 per cent were classified as “correctly identified,” 19 per cent were classified as “possibly identified.” Overall, 84 per cent of mothers (85 per cent of the daughters) were located at MGH.

Identifying and Tracing a Population at Risk: The DESAD Project Experience.

Table 3 summarizes the time required for record review and tracking by MGH personnel. The tracking process could not be considered completed upon determination of vital status since, at a minimum, mothers had to be located and informed of their daughter’s exposure. If, in addition to notifying patients of exposure, the patients are to be enrolled in a study, time is also required to negotiate with cooperating physicians and explain the study and issues to prospective participants.

Costs in dollars are not given since these vary both geographically and temporally. Also, because the DESAD Project was designed to locate, enroll, examine and follow DES-exposed daughters, it was difficult to separate location and contact costs. Appropriate local salary and administrative costs can be applied to the time required for record review to give an estimate of the cost of identifying and contacting a similar group having a hazardous exposure.

Discussion

Tracing those identified is most successful and inexpensive when using telephone directories, but success depends largely on circumstances beyond one’s control such as geographic stability or availability of information in medical records on professional or other affiliations. The MGH study cohort showed exceptional geographic stability, which partially accounted for the success in tracing. Boice, in a retrospective study in Massachusetts, used lists of marriages as well as town lists, but for DES daughters the lists of marriages were not useful because the full names of daughters most often were not known until the mother was located. Also, town lists were not available to study personnel. When tracing by the most obvious method failed, subsequent tracing involved considerably greater costs, often with only marginally increased success. It was common to review a chart where the only tracing information consist ed of the first and last name of the mother and her husband, which virtually precluded locating their daughter by any means. Even well-organized file systems, such as those at the Gundersen Clinic or the Mayo Clinic, occasionally produced names of exposed patients who were impossible to trace. The use of a commercial credit investigation company was considered and rejected because offinancial constraints.

On a nationwide basis, implementing the DES Task Force recommendation that physicians identify and notify DES-exposed individuals from their practices is an undertaking of monumental difficulty. Even at the Mayo and Gundersen Clinics where prenatal and obstetrical records are combined, chart review is exceedingly time consuming. The process becomes even more difficult if the records are on microfilm. Edwards estimated that there were 500 DESexposed women born in the Bluebird Sanitarium, and that it would take one person working full-time two years to identify and locate these women from the microfilmed records.

Streamlining the process by reviewing records selectively-based on year of DES administration, geographical area, or indications for use-may also prove impractical. Heinonen reviewed data on 51,000 pregnancies between 1959 and 1965 in 12 hospitals to estimate nationwide exposure. He found exposure varied between a low of zero at Columbia-Presbyterian Hospital and John Hopkins Hospital and a high of 1.5 per cent of pregnancies at the Boston Lying-In Hospital. However, that study was based on hospital records from pregnancies in the late 1950s, well after the two reports in 1953 that indicated DES had no beneficial effect on pregnancy outcome.

Targeting particular years for review of records, as a less expensive alternative to reviewing all records, may also result in overlooking many exposed persons. Although temporal trends in popularity of DES are evident, even from the somewhat limited experience of the DESAD Project, Mayo Clinic’s greatest use occurred in the late 1940s, while use at Gundersen Clinic peaked in 1964. In Boston, use peaked in the early 1950s, although, two of the practices reviewed by MGH were heavy users of DES in the 1960s.

A review of only hospital records also would not identify the majority of DES-exposed persons. In the experience of three DESAD Project centers, DES was administered most often by private physicians and documented only in the office chart. Usually, hospital and delivery records of women with known DES therapy will not mention prenatal hormones. Thus, it is likely that in most communities, only private office records would contain information on drug exposure.

Finally, identifying women with problem pregnancies as likely recipients of DES may not be effective. DES was one of the first drugs approved by the FDA for marketing under the 1938 Food, Drug and Cosmetic Act. Available by prescription only, it was used in the treatment of menopause, senile vaginitis, juvenile gonorrheal vaginitis, and lactation suppression. As with other drugs, DES was used for non-approved purposes, including treatment of pregnant women, and for a wide variety of indications, including routine administration.

Since the Project’s inception in 1974, DESAD personnel have found access to private physicians’ office records increasingly limited. More charts are being destroyed by retiring physicians in accordance with statute of limitation regulations. This destruction of records may reflect the increased cost of storage or the physician’s wish to limit liability.

However, according to Fay Saber, writing in the Journal of Legal Medicine, physicians would not be held liable for administering DES prior to 1971 since they prescribed the drug in good faith following standard medical practice at that time. Instead, they could be held liable if they do not make some effort to inform women of their increased cancer risk due to the DES exposure. As of Spring 1982, the only widely publicized suit against physicians was Mink vs the University of Chicago. In this case, three women were suing on the grounds that they were used in a controlled clinical trial of DES during the 1950s without their knowledge or consent. Other authors such as Noller, Decker, et al, see notification of exposed women as a moral responsibility of physicians. These two positions do not seem to influence the current availability of records.

Some physicians denied access to their records out of concern for patients’ privacy. Since the purpose of the review was to notify women of a potentially harmful exposure, it is difficult to justify this position. In other situations, where the purpose of the review is to identify patients for a case control study, privacy concerns are more difficult to address. This problem of obtaining permission to review records is also compounded when large institutional review boards are involved. Herrmann, et al, described their experiences with 47 hospitals in the Philadelphia metropolitan area. These investigators wished to enroll patients in a colon cancer case-control study. Within six months of contact by the investigators, only 79 per cent of the hospitals had agreed to participate. Of the 214 eligible attending physicians within the consenting hospitals, 14 per cent refused to let their patients be contacted for the study. Rothman, in an editorial on the problems of obtaining cooperation for epidemiologic studies, noted similar difficulties in obtaining permission. Funch and Marshall contacted breast cancer patients after they had participated in an interview study to determine if these patients were upset by the questioning or thought their privacy had been violated. Only 2 per cent were sorry that their physicians had given permission for them to be contacted.

Implications

If the DESAD Project were to be initiated today, the investigators would make a few changes based on their experience. First, because cooperation of local physicians is essential, there would be more formalized presentations to local medical societies to introduce the study before its onset. Second, some physicians withdrew permission to contact patients after all the DES-exposed were identified. To limit this problem, tracing efforts would be initiated and letters sent to patients as they were identified rather than waiting for the full cohort to be identified. Where possible, written agreement from participating physicians would also be obtained.

The experience of the DESAD Project has demonstrated that tracing and notifying individuals of exposure is more difficult than carrying out a study that determines only vital status. The process is complicated by the lack of standardized information to facilitate locating an individual many years after an exposure and by the lack of systematically available information on actual drug exposures.

Each year new treatments and new medications are added to standard medical practice. Although many safety precautions are taken, not all hazardous effects can be foreseen and many years may pass before such an effect can be noted. The DES-adenocarcinoma link was not discovered until more than 30 years after the drug was introduced. Thus, it is apparent that standardized record keeping is essential, particularly as it pertains to medications, treatments, diagnoses, and locator information. Record keeping should be instituted with long-term storage and retrieval capabilities in mind. For example, physicians who are now using computers for business and billing purposes should perhaps consider adding key items of medical information to their data files.

Since obstetricians are becoming accustomed to standardized prenatal records, a standardized drug list could be introduced more easily in the private practice of obstetrics than in other fields. Much progress has been made in recent years with the use of commercially available combined prenatal and delivery record systems. Many hospitals now require pre-delivery registration, which includes the accumulation of prenatal history forms from the obstetrician. Also, the Joint Commission on Accreditation of Hospitals, in their 1980 manual, has recognized the need for complete information on patient medications. The Commission states that institutions must provide for a medication record or drug profile to be kept on each patient and must have written drug recall protocols that can be readily implemented. Thus, the resulting quality, quantity, and consistency of this medical information is becoming more uniform. Further improvement can be made by using standardized diagnostic nomenclature nationwide in both ambulatory and hospital settings.

Some physicians and institutions are starting to use a patient’s social security number for purposes of identification and billing. This would aid location of patients and record linkage. However, health care consumers, professionals, and legislators must also come to some consensus on the issue of privacy versus accessibility so that patient locator information from sources such as third-party payers, Social Security, health maintenance organizations, and commercial credit companies can be used to facilitate notifying individuals of hazardous exposures. Without such cooperation, those people who move frequently, who use hyphenated last names, or who change their last names will inadvertently prejudice their opportunity to be made aware of their exposure.

Given that better records are maintained, the DESAD experience and that of others indicate a continuing need to improve access to these records by increasing physicians’ awareness of the principles and importance of epidemiologic research. Herrmann’s data showing that younger physicians appear more likely to give consent for their patients to participate in studies substantiates this conclusion since younger physicians are also more likely to have had an introduction to epidemiology. To ensure access to records, a legal mechanism should be developed to limit a physician’s liability in situations similar to that of DES where a physician prescribed a drug or treatment based on the best available information at that time.

In conclusion, there is a continued use of drugs both for approved and unapproved indications. New technology spawns new treatments and diagnostic procedures. It is likely that despite current safeguards it will again be necessary to contact patients regarding newly discovered hazards from medical exposures. The experience of the DESAD Project should give full warning that improved follow-up procedures and new legal guidelines are necessary. Standardized and well-indexed medical records that include a medical exposure list and locator information must become widely used and accessible if those individuals exposed to hazards are to be found.

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