1980 DES Case: Ferrigno v. Eli Lilly & Co.

ABSTRACT

These are actions by eight female offspring for personal injuries they allegedly sustained because each of their mothers took a drug during pregnancy to prevent miscarriage. In the popular press, they have been denominated “the DES cases.”

The first legal complication arises because plaintiffs-mothers and daughters alike-are unable to link the pills used about a quarter of a century ago to a particular drug company. Plaintiff daughters were in utero when their mothers ingested the drug; a generation has passed, and because the need to identify was not and could not have been anticipated, no records have been maintained.

FERRIGNO v. ELI LILLY AND CO., Leagle, decision/1980726175NJSuper551_1669, July 2, 1980.

Although these are complex multi-party cases with forecasts of protracted trials involving novel legal issues of major import, the parties declined the court’s invitation to address some of the issues in advance of trial.

What I view as two of the most important issues shall be dealt with:

  1. the question of nonidentification
  2. and the legal principles that are to govern the trials.
Procedural History

Plaintiff Linda Ferrigno and her mother Marilyn instituted the first of the two actions involved here in June 1976. The complaint sought relief on their behalf and on behalf of a proposed class.

The would-be class was generally described as

… all those females born to mothers who consumed DES manufactured by the defendants, and were either born in this state or reside now in this state, and either:

  • developed cancer of their genital organs;
  • or developed structural changes of their genital organs not amounting to cancer;
  • or who have been exposed, but are yet to manifest any change or disease.

The Ferrigno complaint alleged that Marilyn took the drugs in 1952 and 1953 during the gestation period of Linda who was born on July 1, 1953. As a consequence, plaintiffs contended Linda developed cancer in or about 1970.

In November 1976 the Ferrignos filed a motion, in what was then the only pending action, to file an amended complaint. The amendment sought to add 19 additional plaintiffs and several additional defendants.

A month later, before a ruling had been rendered on the motion to amend, the same plaintiffs named in the proposed amendment commenced a second suit against the same defendants named in the proposed amendment. Further, plaintiffs for the first time sought to name a defendant class consisting of all manufacturers, processors, packagers and distributors in the United States dealing in DES, prescribed by physicians to New Jersey women “to prevent so-called accidents of pregnancy.”

In May 1977 an order was entered permitting plaintiffs to file the amended complaint in the first action and consolidating it with the second for purposes of discovery. At the same time, another order was entered staying without date the assertion of crossclaims and third-party claims.

Plaintiff class certification was denied in March 1979 and defendant class certification was likewise denied in April 1980.

Because of their scope, the actions were assigned to one trial judge who handled all phases of the litigation until March 1980, when they were reassigned to me.

In the interim, the individual claims of Linda and Marilyn Ferrigno were settled for an undisclosed amount and a dismissal was filed in March 1980. All other claims remain.

The Pleadings

Eight of the plaintiffs, including Linda Ferrigno, named in the amended complaint in the first action and in the complaint in the second suit (hereafter “the complaint”), are daughters whose mothers when pregnant with each took a synthetic estrogen prescribed by their doctors to prevent miscarriage. The remaining plaintiffs are either parents or spouses of those daughters.

The complaint alleges that as a direct consequence of the mothers taking the drugs their daughters developed a variety of serious ailments, including cancer of the vagina and cervix, adenosis and certain structural changes.

From 1946 to 1972, the complaint says, the 22 defendants manufactured, distributed and sold large quantities of the kind of prescription drugs ingested by the mothers. Collectively denominated as DES by plaintiffs, the drugs are alleged to have been diethylstilbestrol, stilbestrol and dienestrol.

According to the complaint, 12 of the defendants, at an unspecified time, joined together to form an organization known as the American Drug Manufacturers Association and also formed a “Small Committee for Stilbestrol” to develop DES. These 12 companies, acting together, were responsible for getting the drug on the market.

The complaint sounds in strict liability, negligence, misrepresentation and breach of warranties.

Negligence is charged in the design, testing, investigation, experimenting with, manufacturing, packaging, marketing, distributing, inspecting, promoting and labeling of the drugs. As to misrepresentation, the complaint asserts that defendants misstated to plaintiffs and to the medical profession that the said products were adequately and fully tested, that they were safe for use as directed and that they would cause no serious or deadly long-range side effects, which was untrue, and that defendants marketed the drugs after knowing they were ineffective.

Plaintiffs also allege that defendants knew, or in the exercise of reasonable care should have known, that the drugs were capable of causing cancerous and precancerous growths and were nevertheless promoted by the defendants for prescription by doctors to pregnant women to prevent loss of the fetus by spontaneous abortion.

Plaintiffs further maintain that defendants prospered from the many sales of the DES before 1972 when the Federal Food and Drug Administration (hereafter the FDA) “banned” its further sale and use for the prevention of miscarriages.

Plaintiffs acknowledge in the complaint that they are unable to determine in any of the cases, except for the Ferrignos, which of the defendants manufactured, distributed and sold the DES involved.1 However, they allege that where the particular manufacturer of DES cannot be established, liability should be borne by members of the industry in proportion to the amount of DES each sold during the periods of time the product was marketed as an anti-miscarriage drug.

The answers of defendants generally deny the significant allegations of the complaint; they assert plaintiffs were negligent and invoke the statute of limitations as an affirmative defense. “

… continue reading FERRIGNO v. ELI LILLY AND CO. on Leagle.

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1980 DES Case: Sindell v. Abbott Laboratories

ABSTRACT

This case involves a complex problem both timely and significant: may a plaintiff, injured as the result of a drug administered to her mother during pregnancy, who knows the type of drug involved but cannot identify the manufacturer of the precise product, hold liable for her injuries a maker of a drug produced from an identical formula?

Plaintiff Judith Sindell brought an action against eleven drug companies and Does 1 through 100, on behalf of herself and other women similarly situated. The complaint alleges as follows:

SINDELL v. ABBOTT LABORATORIES, Leagle, decision/198061426Cal3d588_1587, March 20, 1980.

Between 1941 and 1971, defendants were engaged in the business of manufacturing, promoting, and marketing diethylstilbesterol (DES), a drug which is a synthetic compound of the female hormone estrogen. The drug was administered to plaintiff’s mother and the mothers of the class she represents, for the purpose of preventing miscarriage. In 1947, the Food and Drug Administration authorized the marketing of DES as a miscarriage preventative, but only on an experimental basis, with a requirement that the drug contain a warning label to that effect.

DES may cause cancerous vaginal and cervical growths in the daughters exposed to it before birth, because their mothers took the drug during pregnancy. The form of cancer from which these daughters suffer is known as adenocarcinoma, and it manifests itself after a minimum latent period of 10 or 12 years. It is a fast-spreading and deadly disease, and radical surgery is required to prevent it from spreading. DES also causes adenosis, precancerous vaginal and cervical growths which may spread to other areas of the body. The treatment for adenosis is cauterization, surgery, or cryosurgery. Women who suffer from this condition must be monitored by biopsy or colposcopic examination twice a year, a painful and expensive procedure. Thousands of women whose mothers received DES during pregnancy are unaware of the effects of the drug.

In 1971, the Food and Drug Administration ordered defendants to cease marketing and promoting DES for the purpose of preventing miscarriages, and to warn physicians and the public that the drug should not be used by pregnant women because of the danger to their unborn children.

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

Because of defendants’ advertised assurances that DES was safe and effective to prevent miscarriage, plaintiff was exposed to the drug prior to her birth. She became aware of the danger from such exposure within one year of the time she filed her complaint. As a result of the DES ingested by her mother, plaintiff developed a malignant bladder tumor which was removed by surgery. She suffers from adenosis and must constantly be monitored by biopsy or colposcopy to insure early warning of further malignancy.

The first cause of action alleges that defendants were jointly and individually negligent in that they manufactured, marketed and promoted DES as a safe and efficacious drug to prevent miscarriage, without adequate testing or warning, and without monitoring or reporting its effects.

A separate cause of action alleges that defendants are jointly liable regardless of which particular brand of DES was ingested by plaintiff’s mother because defendants collaborated in marketing, promoting and testing the drug, relied upon each other’s tests, and adhered to an industry-wide safety standard. DES was produced from a common and mutually agreed upon formula as a fungible drug interchangeable with other brands of the same product; defendants knew or should have known that it was customary for doctors to prescribe the drug by its generic rather than its brand name and that pharmacists filled prescriptions from whatever brand of the drug happened to be in stock.

Other causes of action are based upon theories of strict liability, violation of express and implied warranties, false and fraudulent representations, misbranding of drugs in violation of federal law, conspiracy and “lack of consent.”

Each cause of action alleges that defendants are jointly liable because they acted in concert, on the basis of express and implied agreements, and in reliance upon and ratification and exploitation of each other’s testing and marketing methods.

Plaintiff seeks compensatory damages of $1 million and punitive damages of $10 million for herself. For the members of her class, she prays for equitable relief in the form of an order that defendants warn physicians and others of the danger of DES and the necessity of performing certain tests to determine the presence of disease caused by the drug, and that they establish free clinics in California to perform such tests. “

… continue reading SINDELL v. ABBOTT LABORATORIES on Leagle.

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1979 DES Case: Abel v. Eli Lilly & Company

Abstract

Plaintiffs appeal as of right from an order of the Wayne County Circuit Court granting partial summary judgment in favor of defendants. This is a multiple-plaintiff, multiple-defendant products liability action involving a widely-distributed prescription drug. The trial judge ruled that each plaintiff, in order to state a cause of action sufficient to withstand a motion for summary judgment, must identify in the complaint which of the defendants allegedly manufactured the specific product which caused his or her harm. Those plaintiffs who could not name the particular defendant whose product harmed them had summary judgment of no cause of action entered against them. Those plaintiffs who named a particular defendant had their claims against all defendants other than the named defendant dismissed.

This action was commenced on September 17, 1974, when plaintiffs filed a complaint alleging that defendants are jointly and severally liable for damages on the theories of negligence, breach of express and implied warranties, fraud and conspiracy. The complaint was amended 14 times. Specifically, the complaint alleged that defendants were negligent in failing to perform adequate tests on the synthetic estrogens known as dienestrol, diethylstilbestrol or diethylstilbestrol diproprionate (hereinafter DES),1 in distributing DES and promoting it for the prevention of miscarriages in pregnant women when they knew, or in exercise of due care would have discovered, that it presented a danger to the child in utero, and in failing to warn consumers of the dangers inherent in use of DES to prevent miscarriages. The complaint further alleged that DES was defective in that it was not effective in the prevention of miscarriage, in that it caused the development of cancerous or precancerous lesions in the vaginas of females whose mothers consumed DES while pregnant, and in that the product carried inadequate warnings of the danger presented to unborn children whose mothers consumed DES while pregnant. The female plaintiffs alleged that they developed cancerous or precancerous conditions as a result of the consumption of DES by their mothers while plaintiffs were in utero. The male plaintiffs are husbands of the female plaintiffs.

Plaintiffs’ complaint also alleged that the defendants named therein constituted all of the known manufacturers of DES whose products were distributed in Michigan during the relevant time period, that one or more of the named defendants caused the harm to each of the plaintiffs, but that some plaintiffs were unable to discover which particular defendant caused their harm because of the destruction of medical and pharmacy records. Plaintiffs further alleged that the inability to name the individual defendant should not bar recovery, in that defendants were jointly and severally liable for the harm to plaintiffs because all defendants acted wrongfully and only the drug companies named in the suit could have caused plaintiffs’ harm. The complaint further alleged that defendants were collectively liable for plaintiffs’ harm.

ABEL v. ELI LILLY & COMPANY, Leagle, decision/197915394MichApp59_1141, December 5, 1979.

Discovery and other proceedings, for the most part irrelevant to this appeal, consumed more than two years and produced a voluminous record. On February 1, 1977, defendants filed a motion for partial summary judgment alleging:

  1. that they were entitled under GCR 1963, 117.2 to summary judgment of no cause of action against all plaintiffs who were unable to name the manufacturer of the particular product which caused their injury;
  2. that plaintiffs’ allegations of collective, industry-wide liability did not state a cause of action cognizable under the laws of the State of Michigan, thus requiring summary judgment as to that claim under GCR 1963, 117.2 ;
  3. and that there existed no genuine issue as to any material fact regarding the conspiracy or concert of action count and that defendants were entitled to summary judgment as a matter of law under GCR 1963, 117.2 .

Defendants’ motion was supported by affidavits which stated that more than 300 manufacturers were listed in standard reference works as offering DES for sale during the relevant time period. In opposition to the motion, plaintiffs produced affidavits to the effect that the list of defendants was “inclusive of” manufacturers whose products were being distributed in Michigan during the relevant time period.

On May 16, 1977, the trial court issued its opinion granting summary judgment of no cause of action:

  1. for all defendants against those plaintiffs unable to allege specifically the defendant whose product harmed them;
  2. for all defendants, other than the defendant named, against those plaintiffs who alleged that a particular defendant caused their harm;
  3. and for all defendants against all plaintiffs on the claim of collective liability. All judgments were granted pursuant to GCR 1963, 117.2.

On August 25, 1977, plaintiffs filed their 14th amended complaint, in which 70 plaintiffs alleged that a particular defendant caused their harm. On the same date, the trial court entered a final order granting partial summary judgment for defendants in accordance with its opinion of May 16, 1977. On September 7, 1977, claim of appeal was filed in this Court on behalf of 182 plaintiffs. “

… continue reading ABEL v. ELI LILLY & COMPANY on Leagle.

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1978 DES Case: McCreery v. Eli Lilly & Co.

Abstract

Plaintiff, Nancy J. McCreery, appeals from a summary judgment granted defendant, Eli Lilly and Company, in a product liability action. Plaintiff suffers from a benign cell disorder of the cervix described as vaginal adenosis. She alleges her condition is attributable to her mother’s use of diethylstilbestrol (DES) to prevent miscarriage during pregnancy in 1953, and inferentially, she fears that her cell disorder may become malignant.

Plaintiff now asserts liability against defendant, Eli Lilly and Company, notwithstanding her inability to identify the specific manufacturer of the pharmaceutical compound (diethylstilbestrol) taken by her mother, on the theory that defendant was one of at least 142 manufacturers of DES at the time of her conception and as such, was a jointly and severally liable tortfeasor.

By her complaint, plaintiff asserted four causes of action;

  1. the first alleged that defendants, Eli Lilly and Company (Lilly) and 30 Does, were the manufacturers and suppliers of the drug known as diethylstilbestrol, and negligently tested, manufactured, and marketed the drug;
  2. the second alleges that Lilly and 30 Does “designed, manufactured, distributed and sold a defective product, to wit, DES;”
  3. the third alleges that Lilly and the Does falsely labeled and misrepresented to plaintiff and her mother’s physician material facts about the drug. The second and third causes of action seek to impose strict product liability.
  4. The fourth cause of action is for the physician’s alleged malpractice in prescribing the drug.

McCREERY v. ELI LILLY & CO., Leagle, decision/197816487CalApp3d77_1158, December 6, 1978.

Discovery revealed that plaintiff did not know and could not ascertain the specific pharmaceutical compound taken by her mother or the identity of the manufacturer; that her mother was unable to remember the name, color, dosage, or dosage frequency of the medication taken; that her mother had not relied upon any advertising by Lilly and did not suffer any side effects after taking the drug; that her mother’s doctor could not recall the drug prescribed or whether he had preferred one manufacturer’s drug over that of another; that the pharmacy that had filled the prescription had been sold upon the owner’s retirement and that the records pertaining to the prescription had been destroyed; and that the only record relating to the prescription kept by the doctor during the period of pregnancy stated only that “`Des stilbesterol 25 mgs., b.i.d. beginning the first day of her period.’ … `continued to take stilbesterol.’ … `patient was nausiated [sic] by two stilbesterols a day….'”

Moreover, counsel for plaintiff concedes that he named Lilly as a defendant only after consulting a 1970 copy of a Physician’s Desk Reference Book and finding Lilly listed as the only manufacturer of diethylstilbestrol, but now acknowledges that the identity of the manufacturer of the specific drug taken cannot, under any circumstances, be identified.

Upon these facts, defendant moved for and was granted summary judgment. “

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

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

Abstract

” Plaintiff Joyce Bichler brought this product liability action against defendant Eli Lilly and Company (Lilly) and two other defendants for damages sustained by her as a result of the use of the prescription drug diethylstilbestrol (DES), a synthetic estrogen, which her mother ingested in 1953 while pregnant with plaintiff.

At the age of 17, plaintiff was diagnosed as having carcinoma of the cervix and vagina. In 1972, she underwent a radical hysterectomy which removed her ovaries, both fallopian tubes and two thirds of her vagina. As a result of that operation, she cannot bear children and, as she has testified, her sexual relations with her husband are also impaired.

In 1974, she and her father brought this action against Lilly as the alleged manufacturer of the DES pills plaintiff’s mother ingested, and against two other defendants who are no longer parties to the action. The claims of Mr. Bichler, the father, were barred due to the running of the Statute of Limitations.

BICHLER v. ELI LILLY & CO., Leagle, decision/198139679AD2d317_1351, February 24, 1981.

A bifurcated trial was ordered by the trial court at Lilly’s request. The first, a trial on the issue of manufacturer identification, commenced in May, 1979. At this identification trial, the jury found that plaintiff had not established by a fair preponderance of the credible evidence that defendant Lilly was the manufacturer of the DES pills her mother had taken. DES, as a generic drug, was, and still is, manufactured by a number of drug companies. Lilly dominated the market at the time DES was approved by the Food and Drug Administration (FDA) and at the time plaintiff’s mother used it.1 As a major producer of the drug, Lilly also sold DES in bulk to other drug companies for use under their own names, a common practice in the drug industry. The pills Mrs. Bichler ingested were not identifiable by any markings. The dispensing pharmacist testified at this trial that he had stocked DES from four or five manufacturers, including Lilly, but was not able to recall, nor did he have the records to establish, which pills he chose to fill the prescription for plaintiff’s mother. Plaintiff appeals from this verdict as against the weight of the evidence and claiming other errors committed by the trial court.

First, although the trial court did conduct most of the voir dire itself, objection to that practice is rendered meaningless where, as here, the record is clear that counsel for both parties had ample opportunity to scrutinize prospective jurors. Secondly, no prejudice to either party is shown by the fact that the court, after a thorough questioning by himself and both counsel, permitted a pharmacist’s wife to become a juror. We find it significant that in this instance plaintiff did not challenge the juror for cause. We also find plaintiff’s other claims of error to be without merit and further hold that upon review of the record, the jury’s finding that Lilly was not proven to be the manufacturer of the DES pills ingested by Mrs. Bichler is not against the weight of the evidence.

Plaintiff, in her amended complaint, had claimed in the alternative that Lilly could be found liable even if it had not manufactured the DES Mrs. Bichler ingested. At the second trial, on this issue, the jury answered seven interrogatories, found Lilly liable and awarded damages in the sum of $500,000, plus costs, disbursements and interest. The verdict was reduced by the amount of a settlement with defendant doctor who prescribed the drug. In this second phase of the action, plaintiff proceeded against Lilly alone, as a tort-feasor jointly and severally liable. Plaintiff did so on an expanded theory of concerted action claiming Lilly and other manufacturers of DES did wrongfully test and market this drug for treatment of accidents of pregnancy. Lilly appeals from that part of the judgment based on the second verdict. ” …

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

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1977 DES Case: Bichler v. Willing

Abstract

This appeal, from an order denying defendant Willing’s motion for summary judgment or for dismissal of the complaint with prejudice, concerns itself with a pharmacist’s liability, as a retailer, for injuries allegedly occasioned because of the use of a prescription drug, sold by the pharmacist.

It is alleged that in 1953, while Dorothy Bichler was pregnant with the plaintiff, Joyce Bichler, she ingested diethylstilbestrol (DES) a drug manufactured by defendant, Eli Lilly & Co., prescribed by defendant Fleischer, a physician, and dispensed by the appellant, a pharmacist. Some time later Joyce Bichler allegedly suffered severe and permanent personal injuries because of this drug. Thereafter several personal injury actions were commenced, including this action against the pharmacist, in which the theories of recovery asserted are negligence, breach of warranty and strict products liability.

BICHLER v. WILLING, Leagle, decision/197738958AD2d331_1332, July 14, 1977.

The record does not reveal any actual negligence on the appellant’s part. Indeed it appears he filled the prescription precisely as he was directed. There being no allegation that he did any compounding, added to or took from the product as it had been prepared by the manufacturer, or that he did anything to change the prescription furnished him or that he adopted and represented the product as his own, appellant, as a matter of law, cannot be said to have been negligent in any of these respects. Nor can plaintiffs recover in negligence on the hypothesis that appellant dispensed the drug without first inspecting or testing it for the purpose of discovering its latent dangers. And, in view of the absence of any showing of a difference between the DES chosen by the druggist and other available brands, his choice of the particular name brand of DES cannot be classified as negligence. Accordingly the negligence cause of action must be dismissed. ” …

… continue reading BICHLER v. WILLING on Leagle.

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Lilly, DES and the Law

Abstract

The appellate court’s decision requiring Eli Lilly and Company to pay $500,000 to the now 28-year-old daughter of a woman who took diethylstilbestrol (DES), a Food and Drug Administration approved drug, while pregnant with the plaintiff must be regarded as a low point in the history of jurisprudence.

The court awarded the money to the plaintiff despite the fact that it was in full possession of the following facts:

  1. plaintiff failed to prove that Lilly manufactured the DES ingested by the plaintiff’s mother (in 1953),
  2. the physician had prescribed a regimen that was unlike Lilly’s as well as unlike that recommended by any known DES manufacturer,
  3. and the plaintiff, who learned in 1971 that she had an adenocarcinoma, filed suit against Lilly with full awareness of the fact that she would find it difficult to prove that Lilly manufactured the DES ingested by her mother and presumed awareness of her late father’s heavy history of adenocarcinoma.

Lilly, DES and the law, American Family Physician. 1981 Jul; 23(7):89-90, popline.org/node/386081, 1981.

What was most astounding was the court’s decision to render a $500,000 verdict, against Lilly, when there “was no proof of any connection between the plaintiff’s mother and Eli Lilly.” The court justified its verdict by claiming that Lilly had acted in concert with “the other drug companies“. No evidence was introduced to show that any 2 of the firms which manufactured DES ever acted together with respect to the manufacture and distribution of DES for treatment of certain accidents of pregnancy. What happened was that the jury felt sorry for the plaintiff and, unable to blame any individual or manufacturing firm, levied a $500,000 verdict against Lilly and Company. It’s not possible to review this case without concluding that Lilly did no harm to the plaintiff and that the court reached well beyond the realm of reason in finding Lilly guilty and awarding the plaintiff $500,000.

Too bad this opinion paper is not signed…

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DES Daughter: The Joyce Bichler Story

Joyce-Bichler-DES-Daughter book cover image
Joyce Bichler was the first DES daughter to sue and the first to win her law suit.

The book DES Daughter: The Joyce Bichler Story – paperback: 192 pages,  publisher: Avon, 1981 – is a gripping memoir by a DES daughter that interweaves her experiences of having treatment for vaginal cancer with the experiences of suing a drug company for exposing her to DES.

Joyce Bichler was the first DES daughter to sue and the first to win her law suit. She tells of her testimony, of the court case and of the jury’s verdict.

“… in the much publicized New York case of Bichler v. Eli Lilly & Co., a jury awarded $500,000 to a twenty five year old woman who developed vaginal and cervical cancer as a result of her mother’s ingestion of DES. There the plaintiff alleged joint enterprise liability. This approach, if successful on appeal, is sure to have a major impact on the more than 400 DES suits still pending.”

Taken from: The DES Cases and the Problem of Proving Causation, Liability in Mass Immunization Programs, BYU Law Review, 1980.

Joyce-Bichler-DES-Daughter book cover image
A True Story of Tragedy and Triumph.

“The first case against a manufacturer was brought in 1971, and there are now more than 500 lawyers concerned in DES suits. One typical case is that of Joyce Bichler. In 1953 Dorothy Bichler, Joyce’s mother, was given a prescription for DES for vaginal bleeding while pregnant. Nobody knows who made the drug she was prescribed. The doctor prescribed the drug because he had read about it in a medical journal and knew “gynaecologists all over the world” were using it.

Joyce Bichler was born normal and healthy in January 1954, but in 1971 she had cancer diagnosed and underwent hysterectomy and vaginectomy. In October 1974 she and her father brought an action against Eli Lilly and Company, the Bronx Lebanon Hospital Centre, and the doctor. In March 1975 they also sued the chemist who had sold Dorothy Bichler the drug, but this suit was dismissed in May 1978. The case against the hospital was dismissed in April 1977.

In 1979 the court set a date for the remaining trials, ordered that there should be a separate trial on whether Lilly made the drug that Dorothy Bichler took, and also allowed that the plaintiff could maintain her case against Lilly even if she could not prove that the company had made the drug. The doctor settled out of court for $30 000, and the trials started in May 1979. The first jury decided that Lilly did not make the drug. In a second trial the jury found Lilly liable and awarded $500 000 damages. The trial ended on 16 July 1979, and Lilly are now appealing.”

Taken from: Compensation for Drug Injury, Product liability all dressed up American style, BMJ, 1981.

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Market Share Liability Method of Recovery for DES Litigants

In recent years, courts have encountered serious problems in applying products liability law to fungible defective products. While some plaintiffs injured by fungible products have identified the culpable manufacturers and successfully litigated their claims, other injured parties have faced serious threshold identification difficulties. The nature of fungible products is such that litigants may be unable to identify the manufacturer who supplied the injury-causing product. Unless this problem of identification is overcome, the injured plaintiff is barred from presenting a valid cause of action. Consequently, traditional products liability law theories have offered an inadequate basis for compensation to many plaintiffs injured by defective fungible products.

Market Share Liability: A New Method of Recovery for D.E.S. Litigants, Catholic University Law Review, Volume 30 Issue 3 Spring 1981 Article 8, 1981.

Litigation involving diethystilbestrol (DES) illustrates the current problems in applying traditional products liability law to fungible defective products. Originally distributed in 1947 to prevent complications during pregnancy, DES was later recognized as a cause of vaginal abnormalities in the daughters of women who took the drug. Many of these daughters are now seeking to recover damages from drug manufacturers for injuries sustained as a result of the maternal ingestion of DES during pregnancy. These plaintiffs claim that the pharmaceutical companies negligently manufactured and marketed DES without adequate testing; however, most have been unable to identify the specific manufacturer of the DES ingested by their mothers. As a result, plaintiffs have been forced to proceed under one or more of three existing theories of liability applied when the identity of the injury-causing defendant is uncertain: alternative liability; concert of action; or industry-wide liability.

Courts, however, have generally been unwilling to apply these theories to DES cases. Among the reasons given for finding these theories inapplicable to DES cases are the number of defendants involved in the suits, the failure of all potential guilty parties to be joined as defendants, and the unique characteristics of the pharmaceutical industry. As a result, most plaintiffs have been left with no means of recovery under current products liability theories.

The California Supreme Court has recently proposed a solution to this dilemma in Sindell v. Abbott Laboratories. In this case, the plaintiffs brought a class action against eleven pharmaceutical companies, seeking damages for injuries sustained as a result of their mothers’ consumption of DES during pregnancy. Although the plaintiffs failed to identify the specific manufacturers of the DES actually taken by their mothers, they suggested that liability could be based on one of the three traditional theories of liability. The court refused to apply any of these theories, but it enunciated a new basis for liability upon which the action could be tried. Basing its decision on a modification of the alternative liability theory, the court held that the plaintiffs would be allowed to recover upon a showing that the manufacturers, in the aggregate, produced a substantial percentage of the drug causing the plaintiffs’ injuries. Under the ruling, each manufacturer would be liable for damages proportionate to its share of the market unless the manufacturer could demonstrate that it did not produce the drug which induced the plaintiffs’ injuries. The court concluded that under this approach, each manufacturer’s liability would approximate the damages caused by its product.

The controversial theory of liability espoused in Sindell represents a dramatic breakthrough for DES victims. Moreover, this theory of market share liability could extend to cases which involve other fungible products and an unidentifiable manufacturer. Under this theory, plaintiffs need prove only that the defendants were manufacturers of the same defective product which caused their injury and that the joined defendants represent a substantial portion of the market for the product in question. Plaintiffs need not prove which individual defendant manufactured the specific injury-causing product, nor must they rely on an expanded judicial interpretation of the traditional theories of liability to support a valid cause of action. Essentially, the Sindell court made a policy decision to forgo rigid adherence to prior doctrines and instead to design a remedy which could meet the needs of modern plaintiffs injured by fungible products like DES.

This Note will examine the various theories upon which DES plaintiffs have advanced their claims prior to Sindell and will explain why these theories have not provided plaintiffs with a recognized cause of action. It will then examine the theory of market share liability enunciated in Sindell and assess it in conjunction with the policy considerations underlying products liability law. Finally, this Note will conclude that the theory of market share liability is a novel yet well-founded approach to litigation involving fungible defective products, consistent with the prior doctrine of products liability law, and represents a necessary expansion of tort liability in today’s complex industrial society.

HISTORY OF DES

In 1947, the Food and Drug Administration (FDA) approved the distribution of DES on an experimental basis for use in the prevention and treatment of complications during pregnancy. This approval was based on two studies attesting to the safety and effectiveness of DES in preventing pregnancy problems. Between 1947 and 1952, approximately eighty five companies manufactured DES. In 1952, the FDA declared that DES was no longer a new drug and was considered safe for general use. This declaration meant that any manufacturer could market the drug without submitting additional data to the FDA concerning its safety and effectiveness. By the end of that year, no fewer than 191 companies were manufacturing and distributing DES.

In 1971, two medical studies associated an increase in a rare form of vaginal cancer called adenocarcinoma with the maternal ingestion of DES during pregnancy. Pursuant to these findings, the FDA required that pregnancy be listed by the manufacturers of DES as a contraindication to the use of the drug and that all other estrogens include a warning on their labels concerning the association between DES and vaginal cancer. Additional studies have since confirmed this association. Although DES is no longer used during pregnancy, it is still prescribed for treatment of unusual menopausal symptoms and of certain kinds of cancer of the breast and prostate.

It is estimated that between one-half million and three million women were exposed to DES between 1947 and 1971. A large number of these women remain unaware of that exposure and of the potential complications. Although only a small percentage of DES daughters have contracted adenocarcinoma, the vast majority of the DES women suffer from adenosis and must be constantly monitored by a physician.

THEORIES OF LIABILITY PRIOR TO SINDELL

It is estimated that more than one thousand DES cases are presently pending nationwide, with most of the major pharmaceutical companies joined as defendants. Prior to the Sindell decision, few DES plaintiffs had succeeded in presenting a valid cause of action against the drug companies for injuries sustained from the maternal ingestion of the drug. Various procedural barriers such as the statute of limitations, failure to obtain class action certification, in personam jurisdiction, and the nonapplicability of the successor-liability doctrine, resulted in early dismissal of many cases. Some plaintiffs, including Ms. Sindell, have had difficulty asserting a valid cause of action under one of the traditional theories of liability because causation is difficult to establish when no specific manufacturer of the injury-causing product can be identified. A review of the theories of alternative liability, concert of action, and industry-wide liability provides a foundation to determine whether the market share liability theory presented in Sindell is a consistent development in products liability law.

Alternative Liability

The alternative liability theory is one which provides a plaintiff with a means to hold more than one defendant liable when the specific source of the injury is uncertain. Under this theory, a plaintiff who cannot identify which one of multiple defendants caused an injury may shift the burden of proof to the defendants to show that they were not responsible for the plaintiff’s injuries. The theory is applied to cases in which the plaintiff proves that each defendant acted tortiously and that the harm suffered by the plaintiff resulted from the conduct of one of the defendants. Alternative liability is premised upon the rationale that proven wrongdoers should not escape liability merely because a plaintiff is unable to identify which defendant actually caused the injury. When the burden of proof is shifted, each defendant has the opportunity to exonerate himself by submitting proof that he could not have caused the plaintiffs injury. Shifting the burden of proof in such situations is justified by the presumption that a defendant would normally be in a far better position than the plaintiff to offer evidence establishing that another defendant caused the injury. Traditionally, this theory has been limited to cases where all of the potential tortfeasors have been joined as defendants and where the conduct occurred simultaneously and created substantially the same risk. These requirements preclude the possibility that one who actually caused the harm to the plaintiff might escape liability by not being joined as a defendant in the action.

The classic illustration of the alternative liability theory is embodied in Summers v. Tice. In that case, each of the defendants had simultaneously and negligently shot in the direction of the plaintiff during a hunting expedition, and each was forced to bear the burden of proving that the shot which injured the plaintiff was not fired by him. In holding both defendants jointly and severally liable, the California Supreme Court made a policy determination that a plaintiff should not go without a remedy merely because the defendants’ tortious acts made it impossible for the plaintiff to identify the specific party responsible for causing the harm.

The alternative liability theory has also justified shifting the burden of proving causation in other situations. In Ybarra v. Spangard, another California case, the plaintiff suffered paralysis of his shoulder while undergoing an appendectomy. The court determined that it would be an unfair burden to require the plaintiff, since he was unconscious on an operating table when the injury was sustained, to identify the particular defendant who inflicted his injury. The plaintiff was allowed to join as defendants all those medical personnel responsible for his safety during the operation, and to infer negligence under the doctrine of res ipsa loquitur. The court then shifted the burden of proving causation and disproving negligence to the individual defendants. Once again, the court’s justification for this shifting of the burden of proof was its determination that the plaintiff should not go remediless merely because he could not identify the specific cause of his injury under the circumstances created by the defendants’ conduct.

Furthermore, alternative liability may be used in situations where the plaintiff has suffered indivisible injury through defendants’ independent tortious actions. Multiple automobile collisions are a common example of this situation, as illustrated by Eramdjian v. Interstate Bakery. There the plaintiff was involved in a motorcycle accident, and as he was lying unconscious on the street was subsequently run over and crushed by a truck. The California Court of Appeals held that each defendant must bear the burden of establishing that his acts did not cause the plaintiffs injuries. The court concluded that the wrongdoer should bear the burden of explaining circumstances where he would otherwise escape liability. As these cases illustrate, the alternative liability theory provides a plaintiff with the means to present a valid cause of action when the defendants’ negligence is clear but when there is doubt as to the issue of causation.

Concert of Action

The second theory under which causation may be proved in situations where the identity of the injury-causing defendant is uncertain is concert of action. This theory is applied where a plaintiff seeks to recover damages for injuries caused by a defendant who, by express or tacit agreement, encouraged, cooperated, or actively participated in a common plan or design to commit a tortious act. The plaintiff may elect to sue one, all, or any combination of participants, each being jointly and severably liable for plaintiffs injuries. Imposition of joint liability is justified by the court’s determination that the causative tortious event was the concerted action in which each of the defendants participated, rather than the actual infliction of injury to the plaintiff.

The most common illustration of concerted action is an illegal drag race where each participant is held liable for any injuries sustained by an innocent bystander, whether or not the particular defendant in fact injured the plaintiff. In Bierczynski v. Rogers, for example, two drivers were participating in such a race when one of their automobiles struck an oncoming automobile driven by the plaintiff. The court held that regardless of which defendant’s automobile actually collided with the plaintiffs, participation in an illegal drag race proved negligence and therefore both participants were liable for injuries sustained by an innocent third person. Similarly, in Sprinkle v. Lemley, the concert of action theory was applied to hold two physicians liable, each for the negligence of the other. The two physicians were held liable for plaintiffs ischemic contracture which resulted from the treatment of a fractured leg. The court noted that the concert of action theory was applied correctly because the acts of one physician were not independent of the other when both physicians treated the patient in concert.

To establish concert of action, the conduct of the defendants must be shown to constitute an agreement to participate in the commission of a tortious act; mere knowledge by one defendant of another defendant’s actions is insufficient. Moreover, each defendant must intend to act in furtherance of the tortious act. Thus, in Duke v. Feldman, the fact that a wife watched her husband assault a third person and subsequently drove him away from the scene was insufficient to impose liability on the wife in an action for civil assault. Absent evidence that she assisted her husband or encouraged the assault, the wife could not be considered a participant in a design to perpetuate the tortious action.

The rationale underlying the concert of action theory is probably more the deterrence of hazardous group behavior than the solution of the problem of identifying the actual injury-producing party. Nevertheless, the theory effectively obviates the need to identify the actual defendant who caused a plaintiff’s injury by holding each defendant liable for substantial encouragement of a tortious act.

The Theory of Industry-Wide Liability

The theory of industry-wide liability is the most recent exception to the general requirement that a plaintiff must identify the actual party causing his injury in order to present a valid cause of action. This theory was suggested in Hall v. El Du Pont De Nemours & Co. , where the court held that there are certain circumstances in which an entire industry may be liable for harm caused by its operations.

The Hall case, commonly known as the “blasting cap case,” arose when the parents of children injured by exploding dynamite blasting caps sought to recover from the manufacturers. The individual blasting caps were neither labeled nor marked with any warning of the potential danger, and the plaintiffs alleged that the defendants, six manufacturers and their trade association, consciously agreed to establish an industry-wide practice of omitting such warnings. This practice, together with the failure of the defendants to take other safety precautions, allegedly created an unreasonable risk of harm which resulted in injuries to their children. The United States District Court for the Eastern District of New York reasoned that under such limited circumstances, industry-wide liability may be imposed. The court stressed that the evidence established that the defendants had jointly controlled the risk through their adherence to an industry-wide standard of safety, and that some functions of safety, including labeling, had been delegated to their trade association. Furthermore, although all the defendant-manufacturers had participated in joint creation of the risk, the specific defendant manufacturing the injury-causing blasting cap could not be identified because the evidence was destroyed in the explosion. In such circumstances, the court reasoned, a shifting of the burden of proof of causation could be justified.

The theory of industry-wide liability combines elements of classic concerted action and alternative liability for use in situations where neither theory would be applicable by itself. The concept of “joint control of the risk” by the defendants in industry-wide liability evolves from the required “agreement” between the defendants in concert of action cases. Under both theories, each defendant’s participation in the tortious event may be regarded as the cause-in-fact of the plaintiffs injury. Liability is imposed on each defendant to deter hazardous group behavior in the future. Joint control of the risk, however, may be proved by evidence of an independent adherence to an industry-wide standard or custom, although such adherence is insufficient to constitute a tacit agreement under the concert of action. This evidence is sufficient to shift the burden of proving causation to the defendants, so that, as in alternative liability, a guilty rather than an innocent party would bear the loss from the failure to meet the burden of proof.

The theory of industry-wide liability is consistent with the general policy considerations of products liability law: namely, to compensate for injuries caused by the use of a defective product and to discourage manufacturers from producing unsafe products. Furthermore, industry-wide liability promotes the theory that losses to society caused by such activity should be internalized by the responsible party to further the social policies of conservation of resources and fair distribution of the cost of accidents among society’s members.

SINDELL v ABBOTT INDUSTRIES: THE NEED FOR A NEW THEORY OF LIABILITY

In 1976, Judith Sindell initiated a class action in a California trial court for personal injuries resulting from her mother’s ingestion of DES during pregnancy. The plaintiff filed her complaint against eleven drug manufacturing companies, and sought to recoVer general damages in the amount of $1,000,000 and punitive damages in the amount of $10,000,000. She also sought equitable relief in the form of an order compelling defendants to inform the public of the risks inherent in DES exposure and to establish appropriate clinics for treatment of DES daughters.

The plaintiff proceeded under eight causes of action, each alleging that the manufacturers were jointly liable because they had acted in concert and in reliance upon each other’s testing and marketing methods to exploit the drug. Since the plaintiff could not identify the manufacturer of the injury-causing drug, the complaint suggested that liability be based on alternative liability, concert of action, or industry-wide liability.

In a well-reasoned and thorough opinion, the California Supreme Court did not apply these theories to the facts of the Sindell case. The court, however, declined to bar the plaintiff from recovery and proceeded to enunciate a novel theory under which Ms. Sindell could proceed with her cause of action. This theory, based upon each manufacturer’s market share of the defective product, will be referred to as “market share liability.”

In Sindell, the plaintiff first claimed to have a valid cause of action under the doctrine of alternative liability. Essentially, the plaintiff averred that the manufacturers had acted tortiously in marketing, manufacturing, and promoting DES, and that this conduct had resulted in injury to the daughters of women who had ingested the drug. Additionally, she argued that had the manufacturers provided adequate warnings to those who ingested the drug, documentation would have existed which, in the case of potential injury resulting from the use of the drug, would have eliminated the uncertainty in identifying the specific manufacturer. Under these circumstances, the plaintiff maintained that the burden of proof should shift from the innocent plaintiff to the negligent defendants. This shift would require the defendants to exonerate themselves by presenting evidence establishing that they could not have manufactured the specific drug ingested by the plaintiffs mother.

The plaintiff sought to analogize her case to Summers v. Tice. In both cases, the defendants committed negligent acts, the plaintiffs were innocent, and the fungible nature of the injury-causing substance made it impossible for the plaintiff to identify which of the negligent defendants had caused the actual damage. Since the plaintiff argued that the manufacturers’ negligence in failing to provide warnings on the drug’s label directly created the identification problem, she contended that application of the theory of alternative liability was even more appropriate here than in the Summers case, where the identity problem was due to the defendants’ simultaneous shooting, not itself tortious conduct.

The plaintiff also compared her case to Haft v. Lone Palm Hotel, where the plaintiff was uncertain as to the cause of the drowning of his son in the defendant’s hotel pool. The Haft court ruled that the lack of evidence of causation was due to defendant’s failure to provide a lifeguard as required by law. The court then shifted to the defendant the burden of proving causation-that its action was not the cause of the boy’s death. In so doing, the court stated that the absence of definite evidence on the issue of causation was a direct and foreseeable result of the defendants’ negligence, and that, under the circumstances, the defendant should bear the burden of proof.

Ms. Sindell asserted that her case presented a similar situation since the defendants’ negligence in not properly labeling the drug as experimental, and in failing to discover or warn of the dangers of DES, had resulted in the plaintiffs mother’s failure to keep adequate records or to remember the identity of the manufacturer which had supplied the DES. Ms. Sindell also addressed economic considerations, contending that the defendants realized cost savings and increased sales through their improper labeling and manufacturing of DES. Accordingly, the plaintiff argued that, as a matter of policy, all customers of the drug companies rather than one particular user of DES should bear the burden of loss resulting from these economies. In presenting this argument, the plaintiff again relied on Haft, in which the court had stated that the burden of the loss should be borne by the entire group benefiting from the cost savings realized by not employing a lifeguard rather than by one particular guest.

After arguing initially that an appropriate situation existed for application of alternative liability, the plaintiff confronted the substantive problems associated with the theory’s use. First, she asserted that the burden of proof should shift to the defendants regardless of their lack of knowledge on the subject of causation. According to the plaintiff, the issue was not whether the defendants had knowledge of the cause of the injury but whether the plaintiffs inability to identify the defendant responsible for her injury was due to the defendant’s conduct in marketing the drug. Second, the plaintiff contended that the alternative liability theory did not require all potential defendants to be before the court, for if a defendant could exonerate himself as a causative factor, he could do so regardless of the number of defendants joined in the action. Moreover, the plaintiff asserted that liability under the theory was joint and several and that the plaintiff could select the party or parties against whom to execute the judgment. Accordingly, an individual defendant’s potential liability would be arguably the same regardless of the number of codefendants in the action.

Finally, the plaintiff argued that even if Summers required all potential defendants to be before the court, the modification of the equitable idemnity rule by the California Supreme Court in American Motorcycle Association v. Superior Court of Los Angeles County rendered this prerequisite unnecessary. After American Motorcycle, the defendants named in the suit could join all other appropriate defendants, thereby gaining the opportunity to recover from their codefendants, according to their percentage of negligence. Consequently, she argued that defendants’ ability to seek indemnity from other jointly liable defendants strengthened her contention that she should not have to bear the undue burden of naming more than a small number of defendants.

The California Supreme Court declined to accept the alternative liability theory presented by the plaintiff. The court first addressed the defendants’ contention that the theory could not be applied because the manufacturers were not in a better position to offer evidence to determine which one caused the injury. However, the court correctly pointed out that the factual circumstances of the Summers case itself precluded an explanation of the cause of the plaintiffs injury.  Thus, although defendants are ordinarily in a better position to offer evidence of causation, application of the alternative liability theory is not foreclosed when they cannot offer such evidence.

The court did find, however, that the alternative liability theory as previously applied could not be the basis for liability in this case. According to Judge Mosk, in applying the traditional theory of causation, the possibility that one of the five defendants joined in the action was actually the supplier of the DES given to the plaintiffs mother was too remote. In support of this conclusion, the court noted that the theory had previously been limited to situations in which all potentially guilty parties were before the court. Without this limitation, the offending party might not be named and therefore could escape liability altogether. Thus, the court concluded that in the Sindell case, where any one of 200 companies could have produced the particular drug ingested by the plaintiffs mother, only five of whom were before the court, application of the alternative liability theory was precluded.

The plaintiff next contended that she could recover under the concert of action theory, alleging that her injury was caused by a tacit understanding among the defendants to act in concert to market, manufacture, and promote DES as a miscarriage preventative. The plaintiff relied on Orser v. George in asserting that under the concert of action theory, her claim was valid even though the possibility existed that none of the named defendants had manufactured the DES actually ingested by her mother. In Orser, a wrongful death action, decedent was killed by a pistol fired by one of defendant’s two companions. The court reversed a summary judgment and held that the rifle-carrying defendant could be found liable for the decedent’s injuries on a concert of action theory. There was evidence in the record that defendant possibly knew that his companions’ conduct breached a duty of care owed to the decedent, and that the defendant substantially assisted or encouraged such tortious conduct.

The Sindell plaintiff argued that as in Orser, no one defendant could be shown to have been the actual cause of the plaintiffs injury; nevertheless, each could be found to have substantially encouraged the tortious conduct of the others. Emphasizing that there existed a common and mutually agreed upon formula for DES, that the drug was marketed by each defendant as a safe and effective product, and that each defendant knew of its generic nature, the plaintiff contended that these facts were sufficient to satisfy the requirements of Orser to proceed under the concert of action theory.

The court found the facts before it inappropriate for application of the concert of action theory. It rejected plaintiff’s argument that the conduct of the defendants, collaborating in and relying upon each other’s inadequate testing and marketing methods and failing to give warnings concerning the hazards of DES, constituted a tacit understanding among the defendants to commit a tortious act against the plaintiff. The court noted that DES was produced from a common and mutually agreed upon formula in compliance with the requirements set forth in the United States Pharmacopoeia and not as a concerted tortious action. The court found further that parallel testing and marketing techniques were characteristic of the drug industry and that a decision rendering such conduct concerted action would be an unjust expansion of the theory. The court distinguished the cases cited by the plaintiff by noting that they involved situations where only one plaintiff was injured; the tortious conduct was by a small number of individuals over a short span of time; and each defendant either directly participated in or encouraged and assisted in the act causing the injury. In Sindell, however, millions of women were allegedly injured; the tortious conduct occurred over a quarter of a century and involved approximately 200 individual drug manufacturers; and there was no evidence that each defendant directly participated in or encouraged and assisted a concerted tortious act.

The plaintiffs final argument alleged that a valid claim existed under the industry-wide theory of joint liability. The plaintiff asserted that there was a considerable risk involved in manufacturing and marketing DES, and that this risk was jointly controlled by the drug manufacturers. Specifically, the plaintiff stated that all DES manufacturers knew of the risk involved in distributing an experimental drug and that the manufacturers tacitly agreed to omit the required FDA warning labels on DES packages. She also asserted that the entire drug industry adhered to an inadequate standard for testing the drug. Furthermore, she contended that the DES manufacturers’ method of promotion encouraged pregnant women, physicians, and pharmacists to rely on the generic nature of the drug and to prescribe it interchangeably. The plaintiff concluded that each manufacturer had benefited from exploitation of the drug by all other manufacturers and that sales of DES had been boosted throughout the industry. In presenting this final argument, the plaintiff relied on Hall v. El Du Pont De Nemours & Co. Essentially, the plaintiff claimed that the facts evidenced parallel behavior among the drug manufacturers and an inference of tacit cooperation as well as independent adherence to a tortious industry-wide standard of behavior. The plaintiff concluded that this joint control of the risk should shift the burden of proving causation to the defendant manufacturers.

The theory of industry-wide liability, termed by the court a “novel approach to the problem, was similarly rejected for a variety of reasons. As interpreted by the court, this theory of liability would be applied when each manufacturer in a particular industry adheres to a standard found to be negligent by a court and also found to be the cause of the plaintiffs injuries. The Sindell court emphasized that the number of producers in the industry and the degree of joint control of the risk are important factors in deciding whether to apply this theory. Thus, in Sindell, where no allegations existed that safety functions had been delegated to a trade association and where the industry was decentralized, the application of the industry-wide theory of liability would be unreasonable. Furthermore, the drug industry itself is regulated by the FDA and the industry standards are defined by the FDA standards to a considerable degree. The court concluded that it would be unfair to impose liability on a manufacturer who did not supply the injury-producing drug because it followed the accepted drug industry standards.

THE SINDELL SOLUTION: THE THEORY OF MARKET SHARE LIABILITY

Having rejected the three prongs of Ms. Sindell’s argument, the California Supreme Court nevertheless stated that it would be unfair to allow her to go without a remedy. It began its formulation of a theory on which the plaintiff could proceed by noting that the policy considerations argued by the plaintiff, together with the court’s view that legal theories should adapt to changes in society, justified the court’s formulation of a novel approach.

The court first recognized that, in contemporary industrial society, there is an ever increasing number of fungible goods available to the consumer. Use of these fungible goods, which often cannot be traced to a specific manufacturer, can leave an injured consumer remediless because identification is impossible and current tort theories cannot be applied. As the court noted, the response by the judicial system to this gap in tort liability can be either to deny recovery or to respond to the changing circumstances by fashioning new theories of recovery through the adaptation of the rules of causation and liability. The court chose the latter alternative and proceeded to modify the alternative liability theory to encompass the situation where the fungible nature of the injury-producing product rendered identification of the manufacturer impossible.

Initially, the court needed to develop a method to decrease the likelihood that the manufacturer actually responsible for the injury would escape liability. It noted that the great probability of the responsible party escaping liability, when only five of a possible 200 defendants were joined in the action, rendered shifting the burden of proof according to the alternative liability doctrine as previously applied impossible. The court determined, however, that rather than approaching the issue of causation in the traditional manner of measuring the possibility of a particular defendant causing the injury by the number of possible defendants, it would measure the likelihood that one specific defendant supplied the injury-producing drug according to the market share of the particular manufacturer. Thus, by the plaintiffs joining the manufacturers with the largest percentage of the market, the probability that the guilty manufacturer would escape liability was significantly decreased. The problem of proving causation was satisfied by becoming a probability rather than a remote possibility. The court noted that this theory could be applied where the plaintiff had joined manufacturers that, in the aggregate, represented a substantial share of the market.

The court then used the market share concept to formulate the extent of liability for which each manufacturer would be responsible. In holding that each defendant would be liable for the proportion of the judgment represented by its share of the market, the court stated that this approach, although not immune from minor discrepancies in the correlation between market share and liability, would render each manufacturer’s liability an approximation of its responsibility for the injuries caused by its own production of the drug.

The market share liability theory developed by the Sindell court was founded upon the policy determination that “as between an innocent plaintiff and negligent defendants, the latter should bear the cost of injury.” The court found that, under the circumstances of the case, neither the plaintiff nor the defendants could be attributed with the failure of providing evidence as to which DES manufacturer actually caused the plaintiffs injuries. The court stated, however, that the conduct of the drug manufacturers in marketing DES “played a significant role in creating the unavailability of proof.” Furthermore, the court asserted that the pharmaceutical industry, through insurance and risk distribution, was better able to absorb the cost of injuries suffered by the plaintiff. The imposition of liability on manufacturers in this case would encourage vigilance in detecting and publicizing the harmful effects of a product. It would also provide compensation for injuries suffered by an unaware and “virtually helpless” consumer. The court concluded that these factors, along with the important policy considerations of products liability law, were determinative in their decision to create a new theory of liability upon which the plaintiff could present a valid cause of action.

CRITICAL ANALYSIS OF THE MARKET SHARE LIABILITY THEORY

On October 14, 1980, the Supreme Court of the United States denied a petition for a writ of certiorari to review the California Supreme Court’s decision in Sindell v. Abbott Laboratories. In filing this petition, the pharmaceutical companies termed the imposition of market share liability as “wholly arbitrary and irrational” and contended that destructive liability and anticompetitive consequences would result from the imposition of this theory. Another critic referred to the decision in Sindell as being “one step further towards the dawn of the age of ‘absolute’ products liability. The criticisms of the Sindell decision, as well as the practical effect of the imposition of market share liability, warrant examination in order to determine the viability of market share liability as a means of closing the gap in products liability law where the identification of the manufacturer of the injury-causing product is virtually impossible.

The first contention raised by the pharmaceutical companies in their petition was that the Sindell decision created unworkable and irrational procedural devices which, in effect, eliminate proof of causation in violation of due process and equal protection. Proof of causation is an essential element in every products liability case, and it serves to prevent the imposition of liability based on pure speculation or conjecture. Accordingly, the pharmaceutical companies maintained that “to establish causation by the joinder of a substantial share of a given market where identification of the responsible party is not now possible” is unreasonable and, in actuality, is a violation of due process. In support of this argument, the companies asserted several arguments as to why the decision is unreasonable. To illustrate this assertion, the manufacturers pose the following hypothetical:

Defendants before the court might consist of Manufacturer A with 40% of the market, Manufacturer B with 4% of the market, and Manufacturer C with 0.4% of the market. Since even plaintiffs would not dispute that the statistical correlation between DES exposure and clear cell adenocarcinoma does not exceed 1.4 per 1,000, there is no way to determine whether sales by the 4% or 0.4% market share defendants might have resulted in any injuries whatsoever. A’s presence does not in any way increase the likelihood that either B or C was the responsible manufacturer.

The manufacturers assert that a particular defendant’s liability will almost always exceed its market share because, although only 44.4% of the market is joined in the hypothetical, the defendants are jointly and severally liable for 100% of the injuries sustained by the plaintiffs. However, the manufacturers failed to point out that they are afforded the opportunity to join the other pharmaceutical companies, not joined in the action, which may have supplied the DES actually ingested by the plaintiff’s mother. Accordingly, if a particular defendant does not wish to absorb the market shares of nonparty DES manufacturers, it may proceed against such manufacturers by way of third party complaint for contribution in accordance with their respective market share. Thus, although Manufacturers A, B, and C may be held liable for more than twice their market shares, they need not bear this total amount unless they forgo the procedural devices available to them.

Second, the manufacturers contended that once a defendant exculpates itself from liability or a plaintiff succeeds in identifying the manufacturer responsible for her injuries, the defendants would bear disproportionate measures of liability. The manufacturers stated that a particular defendant may be found responsible for the entire amount of one plaintiffs injuries upon proof of causation and other elements of the case, and may still be liable for a percentage of another plaintiffs claim. The manufacturers contended that these two cases together would expose a defendant to liability greater than that of its market share.

Each plaintiffs claim, however, is a separate cause of action and each defendant’s liability is determined independently. The fact that a manufacturer is found to be the sole cause of a plaintiffs injury in one cause of action should have no effect on another plaintiffs claim under the market share liability theory. Furthermore, the manufacturers’ contention that this theory would discourage a plaintiff from offering evidence of one manufacturer’s liability is unjustified because even if such evidence did exist, it would most likely be discoverable by the manufacturer and used to exculpate itself from any liability.

The manufacturers next argued that the definitions of the product market and the geographical market would be construed arbitrarily by the courts because the drug was dispensed in such a wide variety of quantities throughout the United States. Leaving factual determination of a defined market to the courts may present a problem in the application of the market share liability theory to particular cases, but definitional problems exist in all areas of law. For example, in the area of antitrust enforcement, courts are called upon to define the relevant market in a particular fact situation. The definition of the relevant market by the court may well determine whether a corporation has violated antitrust regulations. As in the application of antitrust laws, the determination of the “product market” and the “geographical market” in DES cases will be a matter for the court to adjudge according to the particular fact situation and evidence presented. A judicial analysis of the factors to be considered in defining the relevant market for application of the market share liability theory will most likely develop on a case-by-case basis.

The manufacturers also argued that the Sindell court failed to consider adequately the fact that its decision may render the pharmaceutical companies uninsurable and that many firms in the industry, especially the smaller ones, would not be able to absorb the costs of litigation and “random liability” associated with the market share liability theory. These economic considerations have been of major concern to the business and legal communities where courts have contemplated any expansion of products liability law. Although the manufacturers may have overstated the severity of the problem in their petition, it is clear that many pharmaceutical companies may suffer serious financial loss because of the Sindell decision.

One of the manufacturers’ most persuasive arguments against the market share liability theory is that the pharmaceutical industry will be unable to obtain liability insurance for its products. This problem of products liability insurance has increased in recent years, especially within the pharmaceutical industry. The major factor contributing to the increase in cost of liability insurance is the corresponding increase in the number and size of successfully litigated claims by products liability plaintiffs. The drug manufacturers asserted that the market share liability theory would render the insurer unable to determine the scope of exposure for a particular manufacturer if that manufacturer could be compelled to litigate and compensate a plaintiff for injuries sustained by an industry product not directly attributed to the insured manufacturer.

Several solutions have been proposed for dealing with the problems of products liability insurance. First, consumers may be able to absorb the increase in the cost of liability insurance of the manufacturer through an increase in the price of the product. As for those firms that cannot increase their prices because of the competitive market, there exists the option of organizing a collective insurance company to insure against products liability claims asserted against the founding firms. Small firms may also choose to become self-insured by establishing a reserve fund to protect against the risks of its product. Another alternative is for companies, especially those who manufacture products like DES which have the potential for causing injury years after consumption, to purchase claims-made policies rather than the standard occurrence policies for its products. Still another alternative exists in the form of legislative action which may limit the amount of a particular liability claim; make direct governmental insurance available to those industries producing high-risk or fungible products; or allow a periodic payment system for compensation to a successful products liability claimant.

These economic considerations were also noted in the dissenting opinion in Sindell. Justice Richardson stated that the application of the “deep pocket” theory of liability under these circumstances would result in two separate rules of law which would be determined by the wealth of the defendant. Moreover, the dissent stressed that Sindell has the effect of making the pharmaceutical industry “an insurer of all injuries attributable to defective drugs of uncertain or unprovable origin” and this effect could spread to other industries. Recent commentators have expanded on the criticisms expressed in the dissenting opinion, contending that the Sindell decision has created a system of ‘no-fault’ products liability that will result in costly, complicated litigation in many types of products liability suits.

Essentially, such economic considerations are justified and should be given careful study by judges and legislators. The capacity of defendants to bear the loss is one factor traditionally taken into consideration, as are effects on the development of the industry and insurance consequences. However, other factors are given consideration when determining the relative ability of the parties to absorb the injury caused by a defective product, and economic considerations alone should not be the determinative factor when deciding whether a plaintiff may proceed with a cause of action in a products liability case.

The second prong of the manufacturers’ argument in their petition for writ of certiorari was that the court’s decision in Sindell was invalid as contrary to federal drug policies encouraging the development and growth of the pharmaceutical industry, and that imposition of liability under this theory would create an undue burden on interstate commerce. The manufacturers asserted that the immediate effect from the imposition of this “random, destructive liability would be to discourage the development and distribution of new drugs and result in anticompetitive trends. They argued that smaller firms would be unable to continue manufacturing generic drugs under the increased burdens of insurance and litigation costs, and that these increased costs would erect barriers for new firms considering entering the pharmaceutical industry. Essentially, the manufacturers stated that such discouragement of the development of new drugs and discrimination against interstate commerce renders the Sindell decision invalid on a constitutional basis.

There is presently no concrete evidence to determine whether the market share liability theory will result in any of the consequences asserted by the manufacturers. An argument can be made that the drugs which are not produced, or which are delayed in being marketed because of the expansion of liability, may be those which a manufacturer suspects may be harmful to a consumer. Furthermore, those companies that cannot compensate for injuries caused by their product should not be allowed to manufacture and market their products. It can also be argued that there is an important state interest in providing adequate compensation to those citizens injured by defective products. The Sindell decision will likely survive the constitutional challenge that it imposes an undue burden on interstate commerce because the sole objective of the decision is to preserve the health and welfare of citizens and not to protect the economies of the situation.

Another criticism of the Sindell decision is that it represents a radical departure from prior tort liability theories. Justice Richardson, in his dissent, asserted that the majority now expressly abandons the foregoing traditional requirement of some causal connection between the defendants’ act and the plaintiffs’ injury in the creation of its new modified industry-wide tort. Justice Richardson reached this conclusion after analyzing the established principles of causation, stressing that there was no proof in the instant case that the drug manufacturers were responsible for the plaintiffs’ injuries. Furthermore, he alleges that the market share theory will result in the imposition of liability on pure conjecture, that plaintiffs will be able to select the defendants against whom they wish to proceed, and that the majority’s decision will result in “broad and ominous ramifications . . . equally threatening . . . to many other areas of business and commercial activities.

A careful analysis of the historical development of products liability law, especially in California, will show that the Sindell decision is a logical expansion of liability based on the policy determination that “as between an innocent plaintiff and negligent defendants, the latter should bear the loss. In the landmark case of Summers v. Tice, the practical effect of the California court’s decision to shift the burden of proof to the defendants was to impose liability on each defendant. Since both defendants shot simultaneously in the direction of the plaintiff, there was no reason to believe that either defendant could have known which bullet caused the injury to the plaintiff. Similarly, the defendant hotel owners in Haft v. Lone Palm Hotel were no more capable of proving the circumstances of the child’s death than was the plaintiff. These cases are but two illustrations of the broad judicial interpretation given to the requirement that the plaintiff prove a reasonable connection between the negligent act of the defendant and the injury sustained. There is no overriding policy reason why such a broad interpretation of causation should not be applied to areas where a product, rather than the acts of a person, has caused the injury to the plaintiff.

Moreover, the extent of Sindell’s applicability to other industries must be examined. It is feasible that any industry now manufacturing fungible goods may be subject to liability under the market share liability theory. Such industries would most likely include those producing chemical and other pharmaceutical products, agricultural goods, cigarettes, and asbestos. The devastating effects some commentators have predicted would be significantly lessened, however, if judicial application of the theory were to be prudent and appropriate to the fact situation.

The market share liability theory should be applied primarily in cases where the passage of time or some other unusual circumstance renders impossible the identification of the manufacturer of the injury-causing product. Since the overwhelming majority of products liability cases are reported within two years after the date of the occurrence of the injury, this limitation would allow the theory to be applied in only a small number of cases. Moreover, it should be imperative that plaintiffs have no feasible method of ascertaining the identity of the manufacturer, and that this situation is in no part due to the plaintiffs calculated oversight. Sufficient evidence is usually available to the vast majority of products liability claimants to discover the identity of the manufacturer of the injury-causing product. For example, the purchasing records of a chemical substance alleged to have caused injury may divulge the identity of one or more manufacturers who may have supplied the area in which the plaintiff resided at the time of the injury. In cases where there is some degree of loyalty to a particular brand of product, as with cigarettes, a plaintiff should not be allowed to forgo inquiry by the defendants as to the brand of cigarettes the plaintiff normally consumed. Furthermore, if a reasonable person should have known the identity of the product consumed, the plaintiff should not be allowed to plead ignorance and proceed under the market share liability theory.

In addition, the plaintiff should be required to prove that every manufacturer joined in the action under this theory is at fault for marketing a defective product. Injury alone, regardless of the severity, cannot impose liability. Courts should not apply the market share liability theory unless the plaintiff proves that the joined defendants breached their duty to market a safe product or to provide sufficient warnings as to the harmful effects of the product.

Finally, it must also be noted that the market share liability theory as applied in Sindell would allow the joined defendants to join other drug manufacturers who may have produced the injury-causing drug. Without this procedure, plaintiffs would be able to target and litigate against specific manufacturers, thereby allowing other potential defendants to avoid liability. Moreover, these targeted manufacturers may subsequently be liable for all damages awarded to plaintiffs under this theory. It is apparent that unless a similar procedural device exists in the jurisdiction, courts should forgo the application of the market share liability theory or risk a disproportionate number of manufacturers absorbing all litigation and liability costs.

CONCLUSION

The market share liability theory as espoused in Sindell v. Abbott Laboratories is a dramatic breakthrough in products liability law. As in prior situations in which courts have expanded liability, the case presented a unique fact situation in which traditional doctrines could not be readily applied. The California Supreme Court responded to this situation, as it has done in the past, by formulating a new theory of liability rather than leaving the injured plaintiff without a remedy. The policy determination that, as between an innocent plaintiff and negligent defendant, the latter should bear the loss, has once again given rise to an expansion of liability in products liability law. The feasibility of implementing the market share liability theory remains to be seen. Only through a case-by-case determination of the application of the theory can its consequences be realized. Moreover, any adverse effects produced by the application of the theory may well be offset by the fact that many plaintiffs, once barred from recovering for injuries sustained from defective fungible products, are now able to present valid causes of action to proceed against manufacturers of fungible goods.

Patricia A. Meagher, 1981.

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Market Share Liability for DES Diethylstilbestrol Injury

INTRODUCTION

Dynamic changes in products liability have occurred during the past several decades. The courts, focusing on consumer protection, have expanded producers’ liability by moving away from the privity doctrine and toward strict liability for manufacturers. A current effort to protect consumers through products liability law involved a series of DES cases, in which the plaintiffs proposed “intra-industry joint liability.” This theory of products liability allows plaintiffs to hold entire industries liable for injuries caused by defective products of unknown origin. The number of plaintiffs involved in these cases and the likelihood that other plaintiffs will adapt the theory to different types of cases give the implications of intra-industry liability a continuing interest.

Market Share Liability for DES (Diethylstilbestrol) Injury: A New High Water Mark in Tort Law: Sindell v. Abbott Laboratories, 26 Cal. 3d 588, 607 P.2d 924, 163 Cal. Rptr. 132, cert. denied, 101 S. Ct. 285 (1980), Nebraska Law Review, Volume 60 | Issue 2 Article 9, 1981.

There are four possible bases for intra-industry liability: concerted action, alternative liability, industry-wide liability, and market share liability. Each would allow a plaintiff to collect substantial damages from multiple defendants without proof that any particular defendant caused the plaintiff’s injuries. Eliminating the plaintiff’s burden of proving which manufacturer’s product injured the plaintiff virtually guarantees that plaintiffs will prevail on the causation issue.

In Sindell v. Abbott Laboratories, the California Supreme Court discussed intra-industry liability for adverse effects of drugs and adopted the market share liability theory for DES injuries. Although the majority purported to shift only the burden of proving causation from the plaintiff to the defendants, the effect of its adopting the intra-industry joint liability concept (or, more specifically, the market share doctrine) is to guarantee that the plaintiff will prevail on the causation issue. By departing from traditional tort doctrine and effectively eliminating causation as an issue, market share liability thus represents a new high water mark in tort law. This Note will analyze Sindell and the various approaches taken to overcome the obstacle of product identification in DES cases. In addition, it will examine the legal, social and economic ramifications of intra-industry joint liability.

FACTS

The plaintiff in Sindell brought a class action suit which sought to hold several major drug companies jointly and severally liable for injuries she had sustained as a result of her mother’s use of DES as a miscarriage preventative while she was pregnant with the plaintiff. The complaint alleged that DES had caused her to develop precancerous and cancerous tumors and lesions, but it did not identify the specific manufacturer of the DES ingested by her mother. The trial judge sustained the defendants’ demurrers on the ground that the plaintiff failed to identify which defendant had manufactured the drug responsible for her injuries.

The California Court of Appeals reversed the trial court’s decision, concluding that the plaintiff had alleged facts sufficient to state a claim against the defendants. These included allegations that the defendant drug companies had collaborated in testing, marketing, and promoting DES and that they had agreed to a common formula for the drug in order to permit filling prescriptions with a brand other than that prescribed. Pointing to these allegations, the court concluded that the theories of concerted action and alternative liability were available to the plaintiff.

FOUR THEORIES OF INTRA-TNDUSTRY LIABILITY

The appellate court in Sindell identified two theories which would support joint and several liability of the defendants. Under the first theory, concerted action, a person would be liable for harm resulting from the tortious conduct of others if he assists or encourages that conduct, and either has breached a duty owed the plaintiff or has knowledge that the others’ conduct constitutes a breach of duty.

Under the second theory, alternative liability, all negligent defendants would be liable for the plaintiff’s injuries if it is possible to ascertain which defendant actually caused the injuries and if it is fairly certain that the injuries were caused by one of them. The appellate court relied on a well-known California case, Summers v. Tice, in which two negligent hunters were held jointly and severally liable for the plaintiffs injuries, where it was fairly certain that the shot came from one of them, but it was impossible to tell which hunter had fired the particular shot. The burden of proving causation was shifted to each defendant to exculpate himself if possible. The Summers court concluded that it would be unfair to leave the plaintiff remediless in the face of the defendants’ concurrent negligence.

Although not relied upon by the appellate court in Sindell, two other theories of liability have been proposed as bases for intraindustry liability: industry-wide and market share liability. The industry-wide liability theory was suggested first in Hall v. E.I. Du Pont De Nemours & Co., Inc. , which involved children who were injured by the explosion of dynamite blasting caps. The manufacturer of the blasting caps could not be identified because their markings had been destroyed in the explosion. The plaintiffs sued six American manufacturers of blasting caps and the industry trade association, alleging concerted action. The court decided that a cause of action existed under the concerted action allegation because all of the manufacturers had agreed to not place warnings on the blasting caps although they knew that the caps were dangerous. The court also determined that the defendants jointly controlled the risk because they had delegated some safety functions to a trade association. The court concluded that imposing industry-wide liability upon the manufacturers joined in the action was justified because they were aware of the risk and jointly controlled it. The Hall theory of industry-wide liability grounds each manufacturer’s liability for all injuries caused by its product upon industry-wide adherence to a specified standard of safety. The industry standard itself becomes the cause-in-fact of the plaintiff’s injury. Each industry member contributes to the plaintiff’s injury by adhering to the standard, thereby perpetuating the resulting manufacture of an unidentifiable injury-producing product.

The market share liability theory is an extension of the Summers doctrine. Using an undiluted Summers rationale, it is inappropriate to shift the burden of proving causation to the defendants where there is a possibility that none of them made the product which injured the plaintiff. However, the market share theory alters this doctrine by shifting the burden of proof to the defendants if the plaintiff joins the manufacturers of a “substantial share” of the type of product which caused the plaintiff’s injury. Under the market share theory, each manufacturer’s liability is equivalent to its percentage of total sales by all manufacturers of the product. Thus, a manufacturer’s liability should correspond to its responsibility for the injuries caused by its own products.

THE DECISION

Although the California Supreme Court rejected the appellate court’s reasoning, it affirmed the outcome of the case on a different basis: market share liability. The supreme court concluded that the concerted action and alternative liability doctrines, as interpreted by the appellate court, could not be applied to hold the Sindell defendants liable. The court reasoned that the defendants’ parallel or imitative conduct in relying on each others’ testing and promotion methods described a common practice in the industry, not a concerted action. The formula for DES is a scientific constant which a manufacturer producing the drug must follow by law. For these reasons, and because application of the concerted action theory to Sindell would expand the doctrine beyond its intended scope, the court found no concert of action among the defendants.

The supreme court also rejected the alternative liability theory.  While in Summers v. Tice there was a fifty percent chance that one of the two defendants was responsible for the plaintiffs injuries, the court noted in Sindell that any one of two hundred companies which manufactured DES might have made the product which injured the plaintiff. Therefore, there was no “rational basis upon which to infer that any defendant in the action caused plaintiff’s injuries, nor even a reasonable possibility that they were responsible. The court found the chance that any one of the five defendants supplied the DES to plaintiff’s mother was “so remote that it would be unfair to require each defendant to exonerate itself.” The court, therefore, did not use the alternative liability doctrine to relieve the plaintiff’s burden of proving which drug manufacturer caused her injuries.

The supreme court also discussed two other bases of liability: industry-wide and market share liability. It declined to apply the former theory, but concluded that adoption of the latter doctrine was warranted.

The court rejected industry-wide liability because the large number of producers of DES would create practical problems of management. In addition, it would be unfair to impose liability upon a manufacturer for injuries resulting from the use of a drug manufactured within standards suggested or mandated by the government.

The supreme court did adopt the market share doctrine as the basis for the defendants’ liability. Although it perceived that some discrepancy in the correlation between the market share and liability is inevitable, the court concluded that policy reasons nevertheless warranted application of the market share theory. The policy reasons presented by the court were:

  1. A change in the rules of causation and liability is necessary to fashion remedies that meet the changing needs arising from our complex, industrialized society;
  2. between an innocent plaintiff and negligent defendants, the latter should bear the cost of injury;
  3. defendants are better able to bear the cost of injuries resulting from the manufacture of a defective product;
  4. and holding drug manufacturers liable for defects provides an incentive for product safety.

The majority did not define what constitutes a “substantial share” of the DES market, but it did reject a suggested requirement of seventy-five to eighty percent. Therefore, from the majority’s viewpoint, it appears that a “substantial share” is something less than seventy-five percent.

ANALYSIS

Is Market Share Liability an Extension of, or a Break from, Traditional Tort Law?

According to the Sindell majority, the DES cases are merely a factual variant upon the theme composed in Summers v. Tice; hence, the shift in the burden of proof inherent in market share liability does not completely lack precedent.

However, according to the dissenting justices, the Summers case differs so fundamentally from the DES cases that its precedential value is suspect. In Summers the entire class of responsible parties was before the court; however, only some of the potential defendants were joined in Sindell. “Furthermore, the negligence of the defendants in Summers caused the plaintiff’s inability to identify the tortfeasor.” Conversely, in Sindell the plaintiff’s inability to satisfy the identification requirement resulted from the passage of time. Thus, the dissenters’ suspicions of an unprecedented extension of liabilty seem well-founded. The majority in Sindell argued that the plaintiffs cause of action was based on a reason similar to that advanced in Summers: as between an innocent plaintiff and negligent defendants, the latter should (Summers), or are better able to (Sindell), bear the cost of the injury. This “deep pocket” theory of liability, however, should not play a role in the legal analysis of the case because a defendant’s wealth is an unreliable indicator of fault. In addition, a system priding itself on ‘equal justice under law’ does not flower when the liability… aspect of a tort action is determined by a defendant’s wealth.

Policy Considerations

Adoption of the market share doctrine seems unfair if one considers that the theory imposes liability upon manufacturers who may have had nothing to do with causing the injury. Such an inference of fault approaches the imposition of liability on the basis of injury alone. Allowing courts to infer fault in this manner transforms manufacturers into insurers of societal safety. Also, such a broad extension of liability may diminish the money available for recovery.

In addition to the problems involved in imposing liability under the market share theory, allocation of liability is similarly perplexing. Assuming that no state other than California will adopt the market share doctrine because of its radical departure from traditional tort principles, California courts will allocate liability only to those manufacturers who are amenable to suit in California. Accordingly, as an eventual result of Sindell, California producers of DES may be held liable for 100 percent of a plaintiff’s injuries despite the fact that their aggregate share of the market may be considerably less. Similarly, DES victims would recover unevenly under the market share theory. California plaintiffs are in a better position than are out-of-state plaintiffs to recover fully for their injuries because California plaintiffs can pick and choose their defendants. For example, if the producer which actually caused the injury is now insolvent, a California plaintiff may recover by joining in the action other manufacturers of the same product. Conversely, in other states which still require identification a plaintiff may have a judgment which is valid but unenforceable because of insolvency.

Practical Implications of the Market Share Approach

In view of the legal, social, and economic consequences of the market share theory, it is essential to consider its practical implications. Market share liability would pervasively affect product safety and research and development of new products, and it also could have a detrimental impact on free competition.

Theoretically, market share liability would promote product safety because manufacturers of similar products would find it advantageous to join in establishing higher industry safety standards. However, it is also possible that the market share doctrine would decrease product safety because manufacturers would feel that despite whatever extra precautions are taken during production, they still could be held responsible for injuries resulting from the careless manufacturing practices of others. In addition, if manufacturers are liable regardless of fault, products liability judgments may become a mere business expense. If it is less costly to pay tort claims than to improve safety, producers may not bother to correct an injury-causing product. Market share liability, therefore, loses sight of one of the principal goals of the tort system: to reduce the number of injuries.

Adoption of the market share doctrine may prove to be similarly shortsighted as a matter of social policy concerning the promotion of research and development of new products. Although one commentator maintained that current drug research is duplicative and wasteful, public policy favors the research and development of new pharmaceuticals. The market share theory could hamper this research and development because each new discovery would be a potential source of liability. If policymakers want to encourage the development and marketing of new pharmaceuticals, they must absolve manufacturers of liability arising from dangers hidden prior to the marketing of the new drug. Furthermore, if the drug industry is required to anticipate side effects or medical complications which might surface a generation after ingestion, pharmaceutical research laboratories would be burdened with the duty to predict the future.

Free competition is one of the most important underpinnings of the American standard of living. However, it also could suffer from the Sindell decision. The market share theory suggests the socialistic concept of centralized authority for redistributing private resources. If all producers were held liable for similar products manufactured by the various members of the industry, the larger producers would have an incentive to organize the industry and to attempt to set quality-control standards. Dissenting marginal producers could be driven out of the market, leaving the largest manufacturers in control. If so, the market share liability doctrine would affect the economic structure of American industry extensively.

A NEW APPROACH TO THE INTRA-INDUSTRY LIABILITY PROBLEM

The Sindell majority referred to Justice Traynor’s opinion in Escola v. Coca Cola Bottling Co.,11o which recognized the need to adapt tort principles to changing and complex methods of mass production and marketing. One cannot quarrel with the need for some alteration in the present system of compensating plaintiffs injured by defective products. The theory of intra-industry joint liability, which eliminates proof of causation, is an attempt by the courts to keep pace with society. While market share liability is a worthy effort at balancing the rights of producers and consumers, the problems inherent in the market share theory warrant a search for an alternative solution.

Many commentators have proposed no-fault schemes of products liability to replace our current system. Others have suggested a limited no-fault version to be administered by an administrative tribunal. However, the problems that would arise from these systems make such changes undesirable. There are, undoubtedly, more satisfactory alternatives for apportioning losses from DES injuries than no-fault or market share liability. Yet, such an apportionment exceeds judicial competence. It is the province of the legislature, not the judiciary, to weigh the various economic, social, and political factors involved in such a complex policy determination.

Several minor legislative changes might result in better apportionment of DES losses. Partial governmental liability has been suggested, relying upon the belief that government approval of DES should carry with it some financial responsibility. Another suggestion is to limit the amount of damages a plaintiff could recover; this would decrease a manufacturer’s exposure in individual cases in order to offset its overall expanded liability. A legislature also might boost funding for the agencies responsible for regulating manufacturing. Banning sales of products which violate statutory quality and safety standards would spur manufacturers to develop safer products. Agency scrutiny, if properly funded, would deter irresponsibility in the research and development of new products without substantially inhibiting such undertakings.

While minor changes in the system will aid plaintiffs today, major alterations are needed to cope with the increasing number of plaintiffs who cannot locate or even identify the manufacturers of injury-causing products. Perhaps the most satisfactory solution would be congressional action to establish a framework for uniform loss apportionment. This would eliminate the market share doctrine’s problems of uneven distribution of recovery and unfair allocation of liability.

For example, a scheme similar to the Federal Deposit Insurance Corporation (FDIC) could be instituted, whereby each manufacturer deposits into a federal fund a percentage of its gross sales. Such a plan could be called Manufacturer’s Deposit Insurance Corporation (MDIC) and would function as follows: Each manufacturer of a designated product would pay into the fund a percentage of its gross income from sales of that product according to a flexible rate assigned to the product. Federal administrators could increase the rate for a manufacturer found negligent in its manufacturing practices or could revoke its manufacturing license. Plaintiffs could collect from the fund for injuries and losses attributable to defective products without proving that the defect was foreseeable or that the manufacturers had “joint control of the risk.” The only producer identificaton required would be that the product is American-made.

MDIC would balance the positions of both manufacturers and consumers. If products became defective, or if unforeseeable flaws were discovered, the fund could buy back the products, or pay the resulting injury claims, or both. Hence, a manufacturer would not face bankruptcy because of an unexpected imperfection in its product. Research and development of new products would flourish under MDIC because the introduction of a new product would not be inhibited by the threat of liability. Because contributions to the fund would be proportional to each producer’s gross sales, marginal producers could still compete with large manufacturers, and free competition would remain as the mainstay of the American economy. MDIC would allocate liability more equitably than would the market share doctrine because manufacturers of all states (rather than just California) would contribute to the payment of claims. The fund’s cost would become a business expense imposed concurrently with the manufacture of a product; consequently all producers would bear responsibility for injuries caused by their products, even those occurring after bankruptcy.

MDIC offers advantages to consumers as well as to producers. Under this plan, recovery for injuries or losses would be allocated among plaintiffs in all fifty states. In addition, a plaintiff could collect compensation for her injuries regardless of whether the producer at fault is currently solvent. The absence of a manufacturer identification requirement would allow recovery for plaintiffs who previously were unjustly denied compensation for their injuries or losses because of their inability to match the injury-causing product with a producer. Under MDIC, product safety and quality standards would be policed by federal administrators. Such supervision and the threat of lost sales or a rate increase would deter negligent production practices.

MDIC would include all manufacturers and would not discriminate against certain industries. It would allocate liability fairly and distribute recovery evenly. The MDIC system for compensation would not sacrifice deterrence as a control on product safety.

CONCLUSION

The market share doctrine is an attempt to resolve equitably the question of intra-industry joint liability. Although market share liability is not the appropriate solution, the California Supreme Court’s decision in Sindell is instructive. Several unsettling questions raised by the appellate court in Sindell were answered by the supreme court. First, it reaffirmed the Hall “joint control of risk” requirement for industry-wide liability. Second, it held that alternative liability could not be asserted in DES cases. Some queries, such as the due process ramifications of market share liability, remain unresolved and may require consideration by the United States Supreme Court.

Sindell will affect manufacturers throughout the country. Any producer dealing in interstate commerce can reasonably expect that, at some point, its product will reach California. It is difficult to predict fully the effect on products liability law; however, Sindell certainly is a landmark in the struggle to solve the producer identification problem.

Legislatures should aid the courts in adapting traditional tort doctrines to modern technology. Minor changes in the present system will aid plaintiffs and judges today, but major alterations are imperative for the future. In this regard, MDIC may be a viable alternative solution to the problem of intra-industry joint liability. Legislative changes in the future will not assist the courts in making today’s decisions concerning the producer identification problem in products liability cases. However, Sindell may encourage the search for more equitable solutions to the problem of intra-industry joint liability.

Barbara J. Koperski, 1981

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