1993 DES Case: Ashley v. Boehringer Ingelheim Pharmaceuticals

Abstract

“This appeal primarily concerns the ability of a party that prevails on the merits to obtain appellate review of adverse interlocutory rulings. The issue arises on the appeal of defendant Boehringer Ingelheim Pharmaceuticals (“Boehringer”) from the September 14, 1992, judgment of the District Court for the Eastern District of New York (Jack B. Weinstein, Judge) dismissing with prejudice the complaint of Debra and Andrew Ashley. Boehringer, the successor to a California manufacturer of diethylstilbestrol (“DES”), hopes by this appeal to challenge the District Court’s April 13, 1992, interlocutory order that (a) upheld personal jurisdiction over Boehringer in New York and (b) applied to Boehringer New York substantive law on DES liability. In re DES Cases (E.D.N.Y.1992). Boehringer contends that these rulings are unconstitutional or constitute erroneous interpretations of New York law. We conclude that the general rule prohibiting a prevailing party from appealing applies to this case, and dismiss the appeal.”…

IN RE DES LITIGATION, Leagle, 1993277F3d20_123, July 2, 1993.

… “On September 30, 1991, a group of plaintiffs, comprising women allegedly injured by DES, along with their husbands, filed the instant suit in the Eastern District of New York against 33 manufacturers, or successors to manufacturers, of DES. The plaintiffs, who are New York or foreign residents, asserted jurisdiction on the basis of diversity of citizenship. The sole appellant, Boehringer, is a Delaware corporation authorized to do business in New York. Boehringer never sold or manufactured DES, but it is the successor to Stayner Corporation, which manufactured limited amounts of DES in Berkeley, California, between 1949 and 1971. Stayner sold products in California, Washington, Oregon, and Montana. It never marketed any products in New York, was not licensed to do business in New York, and had no significant contacts with New York. Stayner’s sales of DES were very small; the only years for which figures are available suggest that annual revenue from DES was about $5,000. In 1973, Stayner was acquired by Pharma-Investments, Ltd., a Canadian Corporation, and in 1979, Stayner was merged into Boehringer.”  …

… continue reading the full paper IN RE DES LITIGATION, on Leagle.

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1993 DES Case: Bilello v. Abbott Laboratories

Abstract

“These two DES cases were recently consolidated for trial. … …

Plaintiff Suzanne Bilello, a resident of New York State, alleges that as a result of her prenatal exposure to DES in 1955-1956 she has developed abnormalities of the reproductive tract and infertility.

Plaintiff Marie Theoret, a Canadian citizen, claims that she developed a form of vaginal cancer as a result of her exposure to the drug in 1956-1957. There has been extensive motion practice and discovery in these cases. They are ready for trial.

BILELLO v. ABBOTT LABORATORIES, Leagle, 19931300825FSupp475_11211, July 2, 1993.

At one time more than five hundred DES cases were pending against scores of defendants in New York State alone in federal and state courts. Since it was estimated that individual trials of these cases would have required more than fifty judge-years and thousands of jurors, a Special Master was jointly appointed for the state and federal cases to assist the parties in settling the cases. In re New York County DES Litigation, 142 F.R.D. 58 (E.D.N.Y.1992). Settlement of the state cases involving this defendant was made more difficult because orders to consolidate state cases for trial were appealed and have remained undecided for some time.

There has been extraordinary cooperation between the state and federal courts and among the parties to the litigation in connection with settlement negotiations. Through the efforts of the Special Master, Kenneth R. Feinberg, Esq., about half of the cases have been settled. Many defendants have entered into global settlements with all plaintiffs. Other cases are currently in negotiations.

In May and June of 1992, this court, in its settlement role, met in chambers on four occasions, on the record, with plaintiffs’ counsel in the instant case, a number of DES daughters and one DES son as well as a number of family members. These were representative plaintiffs, engaged in settlement negotiations, who desired to share their DES experiences with the court, to express their views about the litigation and to hear from the court how the cases might be resolved without trial. At the time of these meetings no DES cases were pending before the federal court because those that had been pending had been tried or settled. This court, in cooperation with New York State Supreme Court Justice Ira Gammerman, was continuing to assist in settling all state cases.

The women recounted tragic stories of how DES had affected their lives. Helene G., a DES mother, lost her eighteen year old daughter to cancer. Thirty-eight year old Charlotte L. told of countless surgeries in twenty-four years and more than eight years of infertility treatments with medical costs exceeding $113,000. Deena H. described her fear at learning that she had a recurrence of clear cell cancer, six years after she was told she was cured. She described the pain and humiliation of the invasive procedures to which she has been subjected in attempting a permanent cure. Margaret B. recounted how at barely nineteen she discovered she had vaginal cancer. Nine years later she developed lymphedema which caused her body to swell to such gross proportions that she was unable to sit or stand. She described her humiliation at being deposed about her sexuality. Susan H. described the gynecological problems she has been experiencing since the age of fourteen. As a result of developing vaginal cancer at age twenty-one, she had a radical hysterectomy and vaginectomy. Because her vagina was reconstructed with her colon, she had to catheterize herself daily. Her bout with vaginal cancer has resulted in three surgeries and ten hospitalizations. She was dropped by one health insurer. The insurance she currently maintains at extremely high premiums gives little protection. She is infertile and lives in constant fear of a recurrence of cancer.

These were but a sample of the stories that the court heard during those sessions. In addition, the court received letters from several DES victims, some of which were read into the record. Each letter was acknowledged by the court. Each was filed and docketed.

The court explained to the participants some of the problems associated with DES litigation such as those associated with causation. The court also outlined the law of New York respecting market share (see Hymowitz v. Eli Lilly & Co., and the extension of the statute of limitations). The women were informed of the difficulty in bringing cases to trial because of lack of judicial resources and of the courts’ efforts to settle the cases. The court expressed regret that the law was not in a position to help establish a fund to benefit those who suffer from DES exposure, as requested by some of those present, similar to the funds established for victims of asbestos, Agent Orange and the Dalkon Shield intra-uterine device.

The court maintained its neutrality at all times. It noted the importance of giving due process to both plaintiffs and defendant drug companies. Above all, the court emphasized the desirability that these cases be settled so that plaintiffs could put the matter behind them and get on with their lives.

At the close of the May 27 meeting, a woman whose name is recorded in the transcript as “Susan Bill” recounted her experiences as a DES daughter, including her ever-present fear of developing clear cell cancer and her inability to have biological children. The woman referred to as Susan Bill is, it is stipulated, the plaintiff, Suzanne Bilello, in the instant case. She had also submitted two letters to the court.

The May 27 meeting was reported on Newsday. The article described how the court listened intently and sympathetically to “wrenching stories of cancer and infertility.” The reporter characterized the session as providing an opportunity for the women to “put their tragic experiences on the record finally after years of waiting for their day in court.” 

The court, together with the Special Master and his staff, has been working with the parties in the case in an attempt to reach a settlement for these and over one hundred other pending cases. The parties disagree about a fair settlement figure. At the court’s suggestion, the Special Master utilized a settlement formula to guide the parties and the court. The relatively high historical settlements achieved by attorney for plaintiffs were analyzed case-by-case and were averaged. The same calculation was made for the historical settlements of defendant. Recent settlement figures were isolated to determine what, if any, trends there have been in settlement values for the last year. In the course of these settlement discussions, the court became fully aware of the contentions of all parties. The detailed contentions of defendants as to the instant cases were presented forcefully.

Defendant moves to disqualify the court based on the court’s ex parte communication with Ms. Bilello at the May 27 meeting. Defendant urges that disqualification is now required because the court has personal knowledge of disputed evidentiary facts and the situation is one that has the appearance of partiality. Moreover, defendant argues that the court’s contact with plaintiff was extrajudicial because it did not center around any pending case. Defendant also contends that the court’s sympathetic attitude toward these DES plaintiffs requires disqualification.”  …

… continue reading the full paper BILELLO v. ABBOTT LABORATORIES, on Leagle.

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1993 DES Case: Wind v. Eli Lilly & Co.

Abstract

“Plaintiff Janice Wind, a New York domiciliary, sued defendant pharmaceutical companies in New York state court in 1986. She claimed injuries resulting from her mother’s ingestion of the drug diethylstilbestrol (“DES”) during pregnancy. Justice William D. Friedmann, Supreme Court of New York, Queens County, has presided over motions and discovery. Defendants Eli Lilly & Company (“Lilly”) and The Upjohn Company (“Upjohn”) claim that on January 29, 1993, shortly before jury selection was to begin, plaintiff reached a settlement with defendant E.R. Squibb & Sons, Inc. (“Squibb”). Although there is no written record available, Lilly and Upjohn point to Squibb’s absence from subsequent court proceedings as evidence confirming Squibb’s advice that it had settled.

WIND v. ELI LILLY & CO., Leagle, 19931119814FSupp305_11047, February 23, 1993.

On February 4, 1993 defendants Lilly and Upjohn removed the case to federal court pursuant to 28 U.S.C. § 1441. Their grounds were that with Squibb, the only New York defendant, no longer in the case, complete diversity exists between the plaintiff and the remaining defendants. Defendants believe that removal would be advantageous because the federal court offers them greater latitude in conducting discovery. Based on information allegedly recently uncovered, they contend that if they are permitted to depose the doctor of plaintiff’s mother and obtain the mother’s medical history, they could obtain proof that plaintiff was never exposed to DES in utero. Such discovery in state court is limited. See in the Matter of New York County DES Litigation.

Plaintiff moves to remand the case to state court. She characterizes defendants’ attempt to remove the case on the eve of trial as “frivolous” and a “misuse of the judicial process.”.

First, plaintiff denies that any settlement was reached by her with Squibb because she did not consent to it. She states in an affidavit:

  • That I was advised that due to a confidentiality agreement entered into between the Squibb attorneys and my attorneys, the total sum could not be communicated to me.
  • That I was advised that the sums that would be allocated to each of the plaintiffs represented by the Finz office would depend upon many factors such as the strength and weakness of each individual case.
  • That this procedure of a global sum was consistent and in keeping with the manner in which cases that fell into the category of mass tort litigation was handled historically by the Courts and the Special Master in the past.
  • That I advised my attorneys that I would not settle with Squibb without settling with all of the named defendants in my case.
  • That I did not consent to a piecemeal settlement with any single defendant and that I would give consent only to a settlement with all defendants at the same time.

Defendants argue that plaintiff’s purported refusal to accept the Squibb settlement is in bad faith and is motivated solely by plaintiff’s desire to avoid removal to federal court. It was only upon the filing of the removal document, defendants claim, that there was any dispute as to the existence of a settlement between plaintiff and Squibb. They urge the court to hold a hearing on the circumstances surrounding the settlement. For reasons indicated below, the court need not consider the serious factual, ethical and privilege problems raised in this affidavit proffered by plaintiff’s attorney.

Second, plaintiff claims that even if complete diversity now exists, as a result of Squibb’s absence from the case, removal would still be precluded by 28 U.S.C. § 1446(b) which places a limitation of one year from the commencement of an action for a defendant to remove the action to federal court based on diversity of citizenship. She argues that the statute, which was amended in 1988 to include this one-year limitation, should be applied to cases initiated prior to the amendment. Defendants submit that the one year limitation in the present statute should not be applied to cases brought prior to the 1988 amendment.

Finally, plaintiff claims that even if the court finds that the removal statute should not be applied retroactively, defendants are precluded from removing the case under the pre-1988 version of the statute because the case was removable from its inception in 1986. According to plaintiff, defendants’ receipt of pleadings in numerous other DES cases involving Squibb put them on notice that Squibb is not a New York domiciliary. Defendant Squibb’s absence from the litigation, therefore, would have no effect on the diversity issue. If defendants wanted to petition for removal they should, plaintiff contends, have done so in 1986, thirty days after defendants received the initial pleadings.

Also at issue is whether defendants possess the “order or other paper” required by 28 U.S.C. § 1446(b) which would serve as notice that diversity of citizenship now exists. Although defendants concede that they have no tangible document to evidence the settlement with Squibb, they argue that the settlement discussion coupled with the subsequent absence of Squibb from the proceedings constitute a good faith basis for the removal petition.

In the interim, while the remand motion is being decided, the court has before it defendants’ discovery request. Plaintiff objects to any action by the court that affects the substance of the litigation. She insists that the court has only limited power to consider the issue currently before it — whether the case may be removed to federal court.”

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

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In Re DES Cases (1971 to 1991)

Abstract

This diversity case presents a classic illustration of why traditional limits on personal jurisdiction must be modified for mass torts. The torts alleged here involve numerous claims of injury from exposure in utero to diethylstilbestrol (DES). DES was developed and tested in laboratories throughout the country and the world. Permission to use it was sought and obtained from the federal Food and Drug Administration by pharmaceutical companies scattered across the nation. Some companies conducted national advertising and a national corps of salespersons hawked the drug in doctors’ offices in every part of the country. Discussions among medical specialists and word-of-mouth information traded among doctors and patients led to national acceptance of the drug as useful for the prevention of miscarriages. Even companies producing exclusively for local markets relied on the nationally developed understanding and consensus about DES and used knowledge and chemicals from all parts of the United States and the world. Thousands of persons in hamlets and cities across the country are now claiming to have been adversely affected by exposure to the drug. In short, the technology, marketing, sociology, and possible ill effects of DES knew no state boundaries. The national nature of the resulting toxic tort litigation must be reflected in the law’s treatment of jurisdictional issues.

IN RE DES CASES, United States District Court, E.D. New York,
Leagle, 19921341789FSupp552_11225, April 13, 1992.

Motions to dismiss for lack of jurisdiction raise the following questions:

  • Do the complaints against the moving defendants state a claim under New York’s substantive laws?
  • Are those laws constitutional?
  • Are New York’s substantive laws applicable under New York’s choice-of-law rules?
  • Are those choice-of-law rules constitutional?
  • Do New York’s jurisdictional statutes provide for jurisdiction over a successor corporation licensed to do business in New York for causes of action relating to the activities of its predecessor corporation, which never sold DES in New York and was never present in New York?
  • Does New York’s long arm statute provide for jurisdiction over a manufacturing corporation which never sold DES in the New York market and was never present in New York?
  • Are New York’s jurisdictional statutes constitutional?
  • In light of the specific characteristics and history of the moving defendants, and of all the parties and the suit, would requiring the defendants to litigate in New York be fair so that jurisdiction is not barred by the Constitution and should not be declined under a prudential theory akin to forum non conveniens?

All must be answered “yes”.

TABLE OF CONTENTS

I. INTRODUCTION
II. FACTS
A. Background
B. Present Actions
C. Motions
III. NEW YORK SUBSTANTIVE LAW AND RULES AFFECTING SUBSTANTIVE RIGHTS
A. History of New York Products Liability Law and Mass Tort Law Generally
B. New York DES Law
C. Constitutionality of New York DES Law
IV. CHOICE OF LAW
A. Erie Doctrine
B. New York Choice-of-Law Rules in Mass DES Torts
C. Constitutionality of New York Choice-of-Law Rules in Mass DES Torts
V. PERSONAL JURISDICTION
A. New York Jurisdictional Statutes
1. C.P.L.R. § 301
2. C.P.L.R. § 302
B. Constitutionality of New York Statutes
1. Current Due Process Doctrine and Problems Raised by Its Application to Mass Torts
2. Case Law in Non-Mass Torts
a. Pennoyer and Its Problems
b. Pennoyer to International Shoe: The Emergency of Fairness Inquiry
c. International Shoe: Sovereignty, Fairness and Nexus Requirements
3. Sovereignty and Fairness in Mass Torts
4. Due Process Standard for Mass DES Torts
VI. APPLICATION OF LAW TO FACTS
A. Boehringer
1. Failure to State a Claim
2. Personal Jurisdiction
B. Boyle
1. C.P.L.R. § 302(a)(3)(ii)
2. Due Process
VII. CONCLUSION

…continue reading the full paper IN RE DES CASES, on Leagle.

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Ethical and Legal Issues of Including Women in Clinical Studies

Abstract

HISTORY OF DEVELOPMENT AND TESTING OF DES
image of Women-and-Health-Research book cover
Ethical and Legal Issues of Including Women in Clinical Studies

Diethylstilbestrol (DES) is a synthetic estrogen. It was first produced in London in 1938 and was prescribed from 1945 to 1971 to prevent spontaneous abortions. The earliest studies of DES in pregnant women in the United States were conducted at Harvard University in the late 1940s. Although the studies were criticized because they were conducted without the use of controls, the physicians directing the studies concluded that DES was effective against a variety of pregnancy complications and resulted in a healthier maternal environment. In 1947 the FDA approved new drug applications (NDAs) to market DES for the purpose of preventing miscarriages.

Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1, Chapter: Appendix C: DES Case Study, (1994).

In the 1950s, however, controlled studies of DES in pregnant women yielded different results. At Tulane University, researchers found that more of the DES-treated women had miscarriages and premature births, while the controls had bigger, healthier babies. At the University of Chicago, every pregnant woman at the University’s Lying-In Hospital became part of a clinical trial: one-half were randomized to receive DES and the other half received placebos. None of the women were told they were part of a study, nor were they told what drug they were taking. The study found that twice as many of the DES-treated mothers had miscarriages and small babies. Despite growing evidence that DES was ineffective, for the next 20 years the drug was administered to pregnant women to prevent miscarriage. In 1951 the FDA concluded that DES was safe for use during pregnancy and stopped requiring manufacturers to complete NDAs prior to marketing the drug as a preventive against miscarriage.

DES-RELATED INJURIES

In 1971 an article in the New England Journal of Medicine reported that between 1966 and 1971 seven cases of clear-cell adenocarcinoma (CCA) had been found in teenage girls. CCA is an extremely rare cancer, particularly in young women. The common element to these seven cases was that their mothers had taken DES during their pregnancies. In that same year, the FDA contraindicated the use of DES as a miscarriage preventive; but by that time, an estimated 1.5 million babies had been exposed to DES. Thirty thousand were exposed in 1971 alone.

Research has found that DES interferes with the formation of normal genital tissue during fetal development. Many studies have found possible associations between DES exposure and abnormalities in daughters of women who took DES while pregnant. These studies, including one looking at DES daughters whose mothers were involved in the University of Chicago experiments, have found possible associations between DES exposure and vaginal and cervical dysplasia (a type of abnormal tissue that either reverts with time or progresses slowly to cancer); adenosis (glandular proliferation); cervical ridges and cervical erosion; uterine structural abnormalities, such as a T-shape of the endometrial cavity and/or an unusually small uterus; uterine hypoplasia (underdeveloped cells); infertility; menstrual irregularities; ectopic pregnancies; fetal death and premature birth; and breast and reproductive-tract cancers. The pathologic changes were more common in women exposed to high DES doses and those exposed early in gestation. It is estimated that there are almost two million ”DES daughters” now of childbearing age (NIH, 1992).

Injury to male babies, or DES sons, has also been reported. No malignant tumors have been reported, but certain genital and semen abnormalities are more common in men exposed to DES in utero than in men not exposed to DES. These abnormalities include penile bleeding, testicular masses, epididymal cysts, hypoplastic testes, and cryptorchidism (undescended testicle) (NIH, 1992). One article reported that one in three DES sons is sterile. Other authors call for more studies to determine whether the observed abnormalities are correlated with an increased risk of infertility (NIH, 1992).

There have also been allegations of injury to third generations. Two legal actions were initiated on behalf of DES granddaughters who claim that their disabilities were caused by their premature birth, which resulted from damage to their mothers’ reproductive organs from in utero DES exposure (see Enright v. Eli Lilly & Co. and Sorrels v. Eli Lilly & Co.). In addition, one DES son filed a legal action alleging that his teenage daughter’s fatal case of clear-cell adenocarcinoma was caused by his exposure to DES in utero.

In addition to reproductive abnormalities, research in animals has shown that DES may induce certain autoimmune disorders. Two small studies done on humans have shown altered T-cell and natural killer cell function in women exposed in utero to DES, and data from one cohort of “DES daughters” shows an increase in reported incidence of autoimmune diseases. Whether DES exposure is associated with an increased risk of developing an autoimmune disorder is an active area of research (NIH, 1992). Concern over the effects of DES on persons exposed in utero continues to prompt further study. The National Cancer Institute (NCI) recently issued a request for applications (RFA) inviting cooperative agreement applications from investigators to assist NCI in studies of women with DES-associated clear-cell adenocarcinoma of the cervix or vagina (The Blue Sheet, 1993). Another RFA from NCI and the National Institute of Child Health and Human Development (NICHD) invites cooperative agreement applications to develop a national program to inform health professionals and the public on the adverse effects of DES (NIH, 1993). Initial awards for both RFAs were expected to be made in September 1993. In addition, an added $2.9 million in federal funds was recently allocated to fund further studies of health problems in DES sons, as well as in daughters and their mothers.

LIABILITY

There have been numerous legal actions initiated by daughters whose mothers were exposed to DES during pregnancy; more than a thousand were pending nationwide as of February 1991. Because over 300 companies manufactured DES according to the same formula and pharmacists often filled prescriptions at random, the chief barrier to recovery for most DES plaintiffs is identifying the manufacturer who supplied the drug that a particular mother ingested. Many of the successful cases have relied on theories of joint and several liability.

There have been two reported cases coming out of the University of Chicago experiments in the 1950s.

  1. In Mink v. University of Chicago, three women filed an action against Eli Lilly, a pharmaceutical company manufacturing DES, and the University of Chicago to recover for their daughters’ development of abnormal cervical cellular formations and for their daughters’ increased risk of vaginal and cervical cancer. They also alleged that they themselves and their sons had suffered reproductive and other abnormalities and an increased cancer risk. In addition, the plaintiffs asked the court to allow them to represent the other women in the experiment who were given DES by certifying their case as a class action. The court declined to certify the case as a class action, but issued an opinion on whether the plaintiffs’ claims of injury to themselves and their daughters had merit.

    The plaintiffs claimed they were not told that they were part of an experiment, nor were they informed that they were taking DES. They also claimed that since the DES-cancer link was known by 1971, the manufacturer should be liable for making no effort to warn them until late 1975-1976. The plaintiffs maintained that the University had committed a battery by performing a medical experiment on them without their knowledge. They also asserted that the University had breached a duty to notify them that they had taken DES and that their children should be regularly examined. The plaintiffs claimed that Eli Lilly was strictly liable for the manufacture of a defective and unreasonably dangerous drug.

    In a hearing on whether the case should be dismissed, the court held that Eli Lilly had a duty to notify the plaintiffs about the DES risks when the company became aware of them or should have become aware of them. Under Illinois tort law, however, in order for the plaintiffs to recover under theories of breach of duty to warn and in strict liability, they must allege physical injury to themselves. Because the plaintiffs in their complaint cited risk of injury or physical injuries to others (their children) under their claims of breach of duty to warn and strict liability, the court dismissed these complaints.

    The court did not dismiss the battery allegations. The court held that performing nonemergency treatment without consent or knowledge is an unauthorized contact with another person, or a battery. The court stated that the resolution of the case would not turn on the issue of informed consent or whether there was incomplete disclosure of risks before consent was obtained; because there was a complete absence of consent, the issue to be resolved was whether the University had committed battery against these women.

    The case was settled before trial, and the plaintiffs together received a monetary settlement of $225,000 from the University of Chicago for the battery claim. Although the court declined to certify the case as a class action, attorneys for the plaintiffs were able to get the University to agree to provide some services to the other women and their offspring as part of the settlement agreement. The University agreed to treat, free-of-charge, the daughters of any women involved in the 1950 experiments who develop DES-associated vaginal or cervical cancer. They also agreed to provide free annual or biannual medical exams for all offspring exposed to DES in utero during these experiments (Schultz, 1982).

  2. In the second reported case of DES injury from the University of Chicago experiments, two DES daughters initiated legal action against the University of Chicago and Eli Lilly, alleging their injuries resulted from their mother’s participation in the experiments while they were in utero. The plaintiffs also based their legal claims on theories of battery, strict liability, and breach of duty to warn/lack of informed consent. The case was settled out of court for an undisclosed amount (Wetherill v. University of Chicago).

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1993 DES Case: Moll v. Abbott Laboratories

AbstractS

“In these pharmaceutical products liability actions, we are asked to determine when a cause of action for latent toxic injuries accrues for statute of limitations purposes. We hold that the discovery rule controls the determination of when a cause of action accrues in a pharmaceutical products liability action. Thus, the statute of limitations begins to run when the plaintiff discovers or, through the exercise of reasonable diligence, should have discovered a possible cause of action. Furthermore, we hold that in the absence of disputed facts, the question whether a plaintiff’s action is barred by the statute of limitations is a question of law, to be determined by the trial judge.”…

Moll

MOLL v. ABBOTT LABORATORIES, Leagle, 1993445444Mich1_1445, September 21, 1993.

Jean Moll has an “incompetent cervix,” and for that reason is unable to carry a pregnancy to term. Because her cervix appeared irregular, her gynecologist, in 1975, asked her if she had had an abortion. She had not, and the gynecologist said that she had nothing to worry about regarding her cervix. Another gynecologist, in 1977, told her that she had a “hood over her cervix,” asked her if her mother had taken DES while she was pregnant with Moll, and asked that she obtain her mother’s medical records. That physician also told her that her cervix “didn’t look good,” that the condition might be related to exposure to DES, and that her difficulty conceiving might be related to DES. The physician added that DES exposure could lead to some forms of cancer. The physician also advised her to have a fertility test. Moll did not have the test at that time because she was “too chicken” and preferred to continue attempting to conceive.

By 1985, Moll, not having become pregnant, had the fertility test. After the test, her physician identified the hooded cervix as the probable cause of her inability to conceive.

This action was commenced on December 30, 1986, seeking damages for injuries from in utero exposure to DES. Abbott Laboratories filed a motion for summary disposition, asserting that Moll’s mother had not ingested DES. The motion was granted, but entry of the order was stayed until Moll could complete her search for her mother’s medical records.

In October, 1988, Moll obtained medical records establishing that her mother had taken DES. Abbott Laboratories then moved for summary disposition, asserting that Moll’s claim was barred because more than three years had elapsed since she knew or should have known that her injuries may have been caused by in utero exposure to DES.

The circuit judge denied the motion. The Court of Appeals affirmed, but remanded for a finding when a reasonable person in Moll’s circumstances would have concluded that her mother’s ingestion of DES was a likely cause of her hooded cervix.

The issue is whether Moll exercised reasonable diligence in discovering that DES exposure had caused her cervical condition and inability to conceive I agree with my dissenting colleague that in assessing the reasonableness of Moll’s delay in commencing this action, one should consider a number of factors including whether Moll sought to learn whether her mother had ingested DES, had informed herself through medical advice or lay literature of the potential connection between DES and reproductive problems, or sought to verify that DES, rather than another element, was a cause of her inability to conceive.

In the DES context, the concept of reasonable diligence should take into account that when a reasonable woman learns that she may be afflicted with a serious reproductive disorder, she may initially take steps to address her medical problem in light of the available medical information and the course of treatment prescribed by her physician. Such a reasonable woman may reasonably continue to focus on the healing or diagnostic process until she has reasonable confidence that her condition has been correctly diagnosed or is under control. Reasonable diligence should include as a factor that a woman anxious to have children may, although advised that she may be a victim of defective drugs, be more concerned about her health and achieving conception than abandoning those efforts in favor of recourse to the courts.

The record on appeal is sparse. We are therefore not in a good position to evaluate comprehensively the reasonableness of Moll’s behavior in delaying the commencement of this action We do not have the full depositions either of Moll or her mother. The small bit of evidence that the parties have chosen to include in the record is sufficient, however, to lead me to conclude that the issue of Moll’s diligence should not have been decided summarily.

Moll’s testimony shows a woman confused about her condition, unable to obtain her mother’s medical records, and fearful of a fertility test. Moll was receiving mixed signals from her physicians, who appear to have sought to alert her to the possibility of DES exposure without unduly frightening her. For instance, as the majority notes, in 1978 Moll was informed that the results of her colposcopy “were … fine” and also that “there was no cause for real concern at that time,” but also that her cervical condition could indicate DES exposure which could lead to cancer.

After receiving these mixed signals about her health and the warnings about possible DES exposure, Moll did make an attempt to locate her mother’s medical records in 1979. Her mother’s records had been stored at the Highland Park General Hospital, which had since closed because of fire, and Moll was unable to obtain the records. Moll’s physician then made an unsuccessful attempt to locate the missing records. That, too, failed. Moll decided to focus her energies on conceiving a child to determine if the DES exposure had truly left her unable to bear children. She did not pursue the medical records again until after this action was commenced. Even then, Moll was able to find and obtain the records only pursuant to a court order. The records finally confirmed that Moll’s mother had been treated with DES during Moll’s gestation.

The majority concludes, as a matter of law, that Moll did not exercise due diligence in attempting to discover the cause of her medical problems. However, before 1985, Moll’s physicians were only able to speculate about a possible link between her health problems and her mother’s ingestion of DES. No doctor told her with a fair degree of certainty that her condition was caused by DES.

The consultations with her physicians concerning her possible DES exposure came while Moll was undergoing examination and treatment for ailments such as excess vaginal discharge and infertility. The trier of fact could reasonably conclude that during this period Moll was reasonably justified in focusing on solving her medical problems rather than immediately searching to discover whether DES was a cause of those problems.

In all events she made a good-faith attempt to discover whether DES was a cause, without success. Moll and her physician each made attempts to find her records in the late 1970’s, but failed to do so. A reasonable trier of fact could conclude that due diligence required no more.

In holding that the statute of limitations begins to run as soon as a woman, situated as was Moll, discovers a “possible cause of action,” the majority places all such women in an untenable dilemma. If Moll had commenced an action when she was able to allege only a “possible” link between DES exposure and her injury, she very well may have suffered summary disposition. The majority’s approach thus effectively may deprive women like Moll of a meaningful opportunity to commence an action and recover for their injuries.

The Ohio Supreme Court recently struck down a DES-specific statute of limitations — which mirrored the Court’s approach in this case — because the statute did not afford DES-exposed women a reasonable opportunity to bring a claim for their injuries. The statute at issue in Burgess provided that a cause of action for DES-related injuries accrues “upon the date on which the plaintiff learns from a licensed physician that he has an injury which may be related to such exposure, or upon the date on which by the exercise of reasonable diligence he should have become aware that he has an injury which may be related to such exposure….” In the Ohio court’s words, the statute of limitations “is triggered when the plaintiff learns that she possibly has a DES-related injury.”

In a well-reasoned opinion, the court explained why the statute was unreasonable:

If a plaintiff were to file a complaint stating that she suffered a bodily injury which might be related to DES, the complaint would be dismissed for failure to state a claim…. Because the statute of limitations begins running when there is the slightest evidence that DES may be a possible cause of plaintiff’s symptoms, an attorney may be forced to file a complaint long before he can believe that there is good ground to support it. The alternative is to file no complaint. A plaintiff encounters further difficulties at the summary judgment level. A claim … must be filed based upon the possibility of an injury. A plaintiff faces the likely prospect that her claim will be unable to survive a motion for summary judgment. 

The “possible” claim approach was seen as unreasonable by the Ohio Supreme Court because it deprived plaintiffs of “an opportunity for remedy at a meaningful time or in a meaningful manner.” The majority’s approach deprives women of remedies for DES-related harms in much the same way as the Ohio statute in Burgess.

Harrington

Judith Harrington was exposed to DES in utero. She became aware of her DES exposure in January, 1975, and, between 1975 and 1983, saw several physicians who informed her that she exhibited certain abnormalities associated with DES exposure, including having a mosaic on her cervix. In 1983, because she was having difficulty becoming pregnant, she had an HSG test — an x-ray of the uterus and fallopian tubes. On December 27, 1983, her physician informed her of the results of the test — that she had a bicornuate uterus, and that it might also be abnormally T-shaped, whichcould cause difficulty in conceiving or carrying a pregnancy to term — and he scheduled additional tests, including a D and C.

During that office visit the physician told Harrington, however, that while some DES exposed daughters have difficulty conceiving and carrying a pregnancy to term, he was optimistic it would not be the case with her.

The circuit judge granted Abbott Laboratories’ motion for summary disposition on the basis that, pursuant to the discovery rule set forth in Larson v Johns-Manville Sales Corp, the three year statute of limitations began to run on December 27, 1983 — when Harrington learned of the result of the HSG test and knew that she had suffered “some damage” in the form of a misshapen uterus. The Court of Appeals affirmed.

The issue is when Harrington “knew” or “should have known” that she was “injured.” I would hold that considering the unique nature of DES-related harms, a reasonable trier of fact could conclude that Harrington should not have known that she was injured before she learned of her infertility.

Exposure to DES can have multiple effects — some of which will develop into compensable injuries — including cancer, uterine abnormalities, and difficulty with conception and then carrying a pregnancy to term. Not all the effects caused by DES exposure are in fact “harms” or “injuries” at the instant that the DES effect is discovered.

Harrington’s physician told her that DES exposure might have caused the development of her abnormal uterine condition. He also told her that this condition could cause difficulty in conceiving and carrying a child to term, but he was optimistic that would not be the case with her. At the same time, her physician advised her that many DES-exposed daughters do not have difficulty bearing children. The trier of fact could reasonably conclude that when Harrington first learned of her uterine condition it was not causing her any harm, and that she was reasonably justified in not considering it to be a present injury.

The Court errs in defining Harrington’s initial uterine condition as her injury and in defining the infertility as mere “additional consequences” of her “physical abnormality.” Harrington’s physical abnormality was not, in itself, clearly an injury that would cause her any sort of distress. Only after Harrington discovered that the physical abnormality would indeed prevent her from conceiving and carrying a child to term did she know that she had been truly harmed.

The majority’s approach places plaintiffs like Harrington in an untenable position in much the same way as the majority placed plaintiffs like Moll in an untenable position. The majority would have had Harrington file her action before she learned whether the uterine condition would truly be a problem. If she would have filed an action when she first learned of her uterine condition, before she knew whether the condition would cause infertility or other health problems, her action would probably have been dismissed on a motion for summary disposition. At that juncture, Harrington would not have been able to show how she had been harmed by DES. Her own physicians were telling her that they were optimistic that she could have children even with the uterine condition. Harrington would not have been able to identify any harm she was then suffering from the DES exposure, nor could she have carried the burden of showing that it was reasonably certain that her DES-related condition would eventually develop into a compensable injury. A reasonable trier of fact could conclude that Harrington acted with reasonable diligence in waiting until 1986 to conclude that she had suffered an injury.”  …

… continue reading the full paper MOLL v. ABBOTT LABORATORIES, on Leagle.

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1992 DES Case: Grover v. Eli Lilly & Co.

INTRODUCTION

The basic purpose of the law of torts is to afford compensation for injuries sustained by one person as the result of the conduct of another. In Grover v. Eli Lilly & Co. , the Ohio Supreme Court acted to curtail this purpose. The Court held that the grandson of a woman who ingested the defective prescription drug, diethylstilbestrol, could not recover for injuries which were proximately caused by his mother’s in utero exposure to the drug. Although the Court did not accept an absolute rule precluding future actions based on preconception torts, the Court’s failure to allow such an action in the Grover case displayed a lack of foresight as to the evolving function of tort law.

GROVER V. ELI LILLY & CO., DES EXPOSURE: THE RIPPLING EFFECTS STOP HERE, AKRON LAW REVIEW, Vol. 26:2, 1992.

This Note first discusses the nature of DES, prenatal torts, and preconception torts. The Note then reviews product liability law in Ohio. The remainder of the Note analyzes the Grover decision and discusses its impact on public policy.

BACKGROUND

The Unique Nature of DES

DES is a synthetic estrogenic substance capable of producing the same effects as natural estrogens. It was first developed in England in 1938. DES was less expensive than natural estrogen and less painful to administer. Consequently, it became the preferred source of hormone therapy. In 1941, the FDA first approved the use of DES in the United States for a variety of medical problems but limited to uses unrelated to pregnancy. By 1947, the use of DES expanded to include the prevention of miscarriages. Between 1947 and 1971, DES was manufactured by several hundred companies and ingested by several million pregnant women.

The FDA contraindivated the drug’s use by pregnant women in 1971 after mounting evidence revealed that DES was ineffective at preventing miscarriages and increased the risk of vaginal and cervical cancer to females exposed to the drug in utero. Because this cancer may not develop in those women exposed in utero until well after they reach their late teens and early twenties, the victim may not realize the harm until decades after exposure. Due to the insidious  nature of DES and the latent manifestation of the injuries caused by exposure to the drug, legal debate abounds concerning liability.

Legal Liability Beyond the Traditional Tort

Prior to 1946, if a pregnant woman was injured, causing her child to be born in an injured or deformed state, the child was precluded from bringing any cause of action against the tortfeasor. Courts determined that a defendant had no legal duty to an individual who did not exist at the time of his tortious act, – and furthermore that allowing such causes of action would launch the law into “a boundless sea of speculation.”

As early as 1900, the judiciary realized that tort law needed to keep pace with medical science. This realization did not culminate into a legal cause of action for a child harmed in utero until 1946 when the United States District Court for the District of Columbia decided Bonbrest v. Kotz. However, the Bonbrest Court allowed recovery to a child only if there was a direct injury, the child survived the birth, and the child was viable at the time the injury took place.

The viability standard, however, remains a difficult one to distinguish and maintain. Hence, the modem trend of courts is to disregard the issue of viability and allow recovery for a child regardless of when the injury occurred provided that the child is subsequently born alive. Consequently, “once courts began to recognize a duty of care to a fetus before viability, no great intellectual leap was necessary to justify the imposition of liability for harm that occurred prior to conception.

The first case to allow a cause of action for a preconception tort was Jorgensen v. Meade Johnson Labs., Inc. The Jorgensen case was based on products liability law. The court, in allowing a cause of action based on wrongful conduct prior to the plaintiffs conception, focused upon causation, rather than upon traditional concepts of legal duty.

The first case to recognize a cause of action for a preconception tort based on a negligence theory was Renslow v. Mennonite Hosp. The Renslow Court directed its focus on the concept of legal duty and held that “there is a right to be born free from prenatal injuries foreseeably caused by a breach of duty to the child’s mother.”

To date, only a handful of courts has addressed the issue of legal liability to a child harmed by a preconception tort. Although only a small number of courts have confronted the issue of preconception torts, an abundance of authority on the topic exists.

Product Liability Law in Ohio

“In Ohio the law in the field of products liability has had a slow, orderly and evolutionary development.” In 1958, Ohio established an action in tort for the recovery of personal injuries based upon a manufacturer’s breach of an express warranty. The doctrine of strict liability in tort was adopted in Ohio in 1966. In order for a party to recover based upon a theory of strict liability in tort, it must be proven that:

  1. the product manufactured and sold by the defendant contained a defect;
  2. the defect existed when it left the hands of the defendant;
  3. and the defect was a direct and proximate cause of the plaintiff s injury.

In 1977, Ohio’s law of strict liability was expanded by the adoption of Section 402A of the Restatement (Second) of Torts which now governs strict liability for defective products in Ohio. In determining liability under a section 402A analysis, the focus should be on the product and the nature of the defect rather than the conduct of the manufacturer.

The theory of strict liability has been used as a basis for recovery for injury suffered as a result of a manufacturer’s failure to warn adequately of dangers associated with the use of the product. The claimant in such a case must prove that the manufacturer knew, or should have known, in the exercise of ordinary care, of the risk about which it failed to warn. Additionally, no liability will be found unless it can be shown that the manufacturer failed to take the same precautions as that of a reasonable person who was presenting a product to the public. Therefore, the standard imposed upon the defendant in a strict liability claim based upon an inadequate warning is the same as that imposed in a negligence claim based upon an inadequate warning. Due to the similarities, courts have encountered difficulty in distinguishing negligence claims from those founded on strict liability where the defect for section 402A purposes is asserted to be a lack of adequate warning.

STATEMENT OF THE CASE

Charles Grover was prematurely born on November 22, 1981. Charles suffers from cerebral palsy and other serious injuries. Plaintiffs allege that these injuries were the result of Charles’ premature birth and that such birth was proximately caused by Charles’ grandmother‘s ingestion of DES.

In 1952 and 1953, June Rose, grandmother of Charles Grover, was prescribed and ingested DES. During this time, June became pregnant and gave birth to Candace Grover, mother of Charles Grover. While in utero, Candace was exposed to the DES ingested by her mother, June Rose.

At the age of 22, Candace Grover discovered that she suffered from cervical abnormalities which were caused by her in utero exposure to DES. Six years later, Candace became pregnant and gave birth to her second son, Charles. Candace’s pregnancy with Charles remained uncomplicated until September, 1981 when a Shirodkar procedure was performed in an attempt to prevent a premature birth due to an incomplete cervix. Charles Grover was subsequently born 11 weeks premature.

On behalf of themselves and their two minor sons, Candace and Brent Grove filed suit against Cooper Laboratories, Inc. and Eli Lilly & Co.  in Federal District Court alleging strict liability, negligence and breach of warranty. The pharmaceutical companies filed several Motions for Summary Judgment, one of which stated that Charles Grover’s tort claims must be dismissed as Ohio does not recognize a cause of action on behalf of a child who was not concieved at the time of the alleged tort. The District Court certified a question of law to the Ohio Supreme Court, as this issue was one of first impression.

Certified Question of Law

The certified question presented to the Ohio Supreme Court stated: “Does Ohio recognize a cause of action on behalf of a child born prematurely, and with severe birth defects, if it can be established that such injuries were proximately caused by defects in the child’s mother’s reproductive system, those defects in turn being proximately caused by the child’s grandmother ingesting a defective drug (DES) during her pregnancy with the child’s mother?

The Supreme Court’s Answer to the Certified Question of Law

The Supreme Court of Ohio answered the certified question in the negative. Although the Court declined to adopt an “absolute no duty rule” as to a cause of action for preconception torts, the Court held that because of the remoteness in both time and causation, “a pharmaceutical company’s liability for the distribution or manufacture of a defective prescription drug does not extend to persons who were never exposed to the drug, either directly or in utero.” The Court noted that the pivotal question in ascertaining liability was “whether the drug companies should have known, at the time that it was prescribed, that DES could cause a birth defect that would result in the delivery of a premature child twenty or thirty years later.” Based upon the Court’s evaluation of that pivotal question, the Court determined as a matter of law that such a birth defect was not foreseeable.

In a strong dissent, Justice Resnick stated that “there can be no question that pharmaceutical companies should have known the dangers of [DES]. Justice Resnick, noting the “insidious nature” of DES,  stated that the majority, in its decision, failed to consider the uniqueness of the drug. “To hold under these circumstances that Charles Grover’s injuries were not foreseeable is to ignore an entire body of scientific information which was available or could have easily become available with a measure of care concerning the effects of DES on subsequent generations.”

ANALYSIS

For the purpose of evaluating the certified question before it, the Ohio Supreme Court assumed that Charles Grover was able to prove that his injuries were proximately caused by his mother’s in utero exposure to DES. In Therefore, although a direct causal link between the defective product and Charles’ injuries was deemed established, the Court concluded that “because of the remoteness of time and causation, . . . Charles Grover does not have an independent cause of action.” Due to this conflicting language regarding causation, the basis for the majority’s denial of a cause of action to Charles Grover remains unclear. Furthermore, because the Court addressed tort causes of action in general and interchanged language peculiar to negligence and strict liability, the specific impact of this decision is precarious at best.

Assessing the Manufacturers’ Knowledge

To find liability in a strict liability for failure to warn case, Ohio law requires that a plaintiff prove that the manufacturer “knew or should have known, in the exercise of ordinary care, of the risk or hazard about which it failed to warn.” The majority, in discussing the impact of such knowledge, found that “even if knowledge of DES’ dangerous propensities is sufficient to create liability to the women exposed to the drug in utero, this same knowledge does not automatically justify the extension of liability to those women’s children.” The Court precluded Charles Grover from pursuing his cause of action without analyzing the most crucial issue in this case: Whether knowledge of DES’ dangerous propensities extended to include harm to the offspring of females exposed to DES in utero.

The Court appears to be selecting an arbitrary cut-off point as to where foreseeability and causation will no longer allow a cause of action in tort. However, the Court gives little indication as to how it arrived at such a point. If DES manufacturers “knew or should have known” that females exposed to the drug in utero would be born with defective reproductive systems, then does it not follow that those same manufacturers “knew or should have known” that some of those females would choose to employ those reproductive systems in the future?

Where these women would not reach childbearing age until at least 16 years after their birth, could or should the manufacturers have known that DES could cause a birth defect in those women exposed in utero that would result in the delivery of an injured child twenty or thirty years later? The majority, with little justification for its position, decided that the answer to such a valid and pertinent question was no.

In reaching this decision, the majority engaged in a narrow analysis of what the manufacturer knew or should have known. Evidence exists indicating that in the 1930s and 1940s, the manufacturers of DES had available information which indicated that the drug caused reproductive tract abnormalities and cancer in exposed animal offspring. The duty of a drug manufacturer to warn of dangers associated with the drug extends beyond any actual knowledge the manufacturer gains from research it performs to include knowledge available to an expert through scientific literature. Where such knowledge is vital to establishing liability, the court’s indication that “this generalized knowledge” is not sufficient to impose liability for injuries to a third party that occur 28 years later is far too superficial of an analysis of what the manufacturer knew or should have known.

Determining Foreseeabiliy, or Lack Thereof

The Court, in analyzing the issue of foreseeability, did not adequately account for the unique nature of DES and the threat it poses to future generations. This nature was, however, addressed by the Ohio legislature. In an effort to deal with the latent hazards of DES, and to preserve a right to pursue a remedy, the legislature sought to protect those injured by allowing a suit to be advanced within two years of when the plaintiff reasonably discovered the existence of the injury incurred.

In discussing foreseeability, the Court notes that if an actor’s conduct creates a risk of harm to a certain class of plaintiffs, and such risk of harm actually injures a person of a different class to whom the actor could not reasonably have anticipated injury, then the actor is not liable to the party injured. However, this statement erroneously assumes that Charles Grover’s “class” could not be foreseeable.

Injuries to the reproductive organs of Charles Grover’s mother were deemed foreseeable. The harm to Charles was inextricably linked to those same foreseeable injuries in his mother’s reproductive organs. Therefore, although Charles may be in a different “class” than his mother, that “class” is not automatically unforeseeable merely because it may have been ignored or overlooked by the manufacturer.

Plaintiffs aver that scientific information regarding the risks of DES to reproductive organs of those exposed in utero was available to manufacturers as early as 1930. In light of this scientific information and the Ohio legislature’s special accommodation for actions brought pursuant to injury caused by DES, to hold that Charles was not foreseeable would be to ignore the “very fact of the insidious nature of DES.

A more thorough inquiry into what the manufacturer knew or should have known would have led the Court to a sound determination of foreseeability. Unfortunately, the Court chose a more cursory route on its way to precluding a cause of action for Charles as well as others in his “class.”

Public Policy and the Implications of the Grover Decision

The Court relied upon Enright v. Eli Lilly & Co., as persuasive authority. 101 As in Enright, the Ohio Supreme Court predicated its decision to preclude liability for Charles Grover’s claim on the basis of such a claim’s impact on public policy. The Court appears to be concerned that the “imposition of liability would invoke ‘staggering implications’ and ‘rippling effects,” upon the legal system.” However, as noted in an earlier decision by the Ohio Supreme Court, an increased possibility of litigation is not a valid reason for denying a judicial forum.

The same Court that denied a cause of action to Charles Grover once stated that it is the business of the law to remedy wrongs that deserve it, even at the expense of a ‘flood of litigation’; and it is a pitiful confession of incompetence on the part of any court of justice to deny relief upon the ground that it will give courts too much work to do. Furthermore, the general improbability of preconception torts’ resulting in actionable injuries as well as the practical problems associated with proof and causation will no doubt keep courts protected from the possibilities of a “floodgate of litigation.”

Although harmed irreparably by the tortious conduct of another, Charles Grover and others like him will have to go through life uncompensated. However, the cost of such tortious conduct will not go unpaid.

“Recognizing a cause of action for preconception torts serves a twofold purpose.” First, a deterrent force is added to tort law by requiring those responsible for inflicting debilitating physical injuries upon children to pay for the additional costs needed to enable the child to adapt to a society that is geared toward those without such injuries. 10 Such a requirement would prevent a windfall for the tortfeasor as well as help to alleviate from both society and the child’s family the enormous costs associated with raising a handicapped child. Second, it would keep with the traditional notion of compensation via the body of tort law. Therefore, the result of recognizing a cause of action for preconception torts would help to promote an accurate economic distribution of costs and permit an effective allocation of society’s resources. The Grover decision burdens the citizens of the State of Ohio by requiring them to pay for the tortious conduct of large drug manufacturers. By not allowing Charles Grover his day in court and his chance to prove his cause of action for the tort committed upon him, the burden will seem that much heavier.

CONCLUSION

“Any legal system, to remain viable over a span of time, must have the flexibility to admit change.” After the Grover decision, the viability of tort law in Ohio remains questionable. While the Court was required to assume that Charles could prove a direct causal link between the tortious conduct of the pharmaceutical companies and his injuries, the Court determined that too much time had passed to allow Charles a chance to advance his cause of action.

“To find solutions for a succession of differing problems in a continuously changing context the legal system must be creative.” By relying on traditional and stagnant concepts of duty and foreseeability, the Ohio Supreme Court has shown no creativity.

Although the Court did not accept a “blanket no-duty rule” regarding causes of action for preconception torts, their failure to provide guidelines as to when such causes of action may be advanced leaves potential litigants guessing, and the rest of us paying the bill.

LISA A. NAPOLI, 1992.

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1992 DES Case: Bowe v. Abbott Laboratories, Inc.

Abstract

“Plaintiffs, William Bowe and Catherine Bowe, individually and as parents and next friends of Andrew Bowe, a minor, appeal the circuit court orders which dismissed their complaint with prejudice, denied their motion to file a first amended complaint, and denied their motion to reconsider these orders.

For the reasons which follow, we find that the trial court abused its discretion in denying plaintiffs an opportunity to amend their complaint.

BOWE v. ABBOTT LABORATORIES, INC., Leagle, 1992831608NE2d223_1797, December 16, 1992.

Plaintiffs seek relief for injuries allegedly sustained as a result of exposure to diethylstilbestrol (“DES”). They filed their complaint against numerous (151) DES manufacturers and distributors, and set forth their claim as a negligence action under the theory of market share liability.

After the Illinois Supreme Court rejected market share liability as a proper basis for identifying the tortfeasor in Smith v. Eli Lilly & Co. (1990), plaintiffs attempted to file an amended complaint under the theory of alternative liability.

A fundamental element in a negligence or strict liability action is the burden placed upon the plaintiff to identify the defendant who caused the alleged harm or injury. The identification element of causation serves to assign blame to culpable parties and to limit the scope of potential liability.

The reoccurring problem in DES cases has been the inability of the plaintiffs to identify the particular DES manufacturer which produced the drug which caused their injuries to establish the causation-in-fact requirement in tort. The identification problem is exacerbated by the extended passage of time since the ingestion of the injury-producing DES, the unavailability of pertinent records, and the disappearance of DES producing companies due to mergers, acquisitions, dissolution, and all the other reasons for going out of business. Consequently, courts throughout the country created certain exceptions to allow a plaintiff to shift to a defendant or a group of defendants the burden of proof or the burden of persuasion on this issue. The theories of market share liability and alternative liability are two exceptions advanced to overcome the difficulty, if not impossibility, of tracing and identifying the specific manufacturer of the injury-producing DES.

In essence, the theory of market share imposes liability on manufacturers which may have produced or marketed DES and apportions damages in some manner consistent with the manufacturer’s share of the market. The four States which have adopted some version of the market share liability theory (California, New York, Washington, and Wisconsin) do not agree on its application or the remedy.

The theory of alternative liability applies where two or more defendants act tortiously toward a plaintiff who, through no fault of her own, cannot identify which one of the joined defendants caused the injury. The burden of proof shifts to each defendant to prove his innocence.” …

… continue reading the full paper BOWE v. ABBOTT LABORATORIES, INC., on Leagle.

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1992 DES Case: Hibbs v. Abbott Laboratories

Abstract

Joan Hibbs was born on November 7, 1950. Prior to her birth, Joan’s mother, Bernadine Raymond, was prescribed diethylstilbestrol (DES), a synthetic estrogen, by Dr. Robert N. Rutherford to prevent miscarriage during her pregnancy with Joan.

Joan Hibbs has been diagnosed as having anatomical changes of the genital tract and reproductive system, including a “T” shaped uterus, and a cervical ridge. She is unable to successfully carry a child to term. In July 1987, Hibbs underwent surgery for an ectopic pregnancy which resulted in the partial removal of her right fallopian tube. Currently, she must follow a rigorous schedule of frequent vaginal and colposcopic examinations.

HIBBS v. ABBOTT LABORATORIES, Leagle, 199151362WnApp451_1461, January 15, 1992.

On April 20, 1988, the Hibbses sued Eli Lilly & Company, the G.W. Carnrick Company, and other manufacturers of DES claiming that Joan Hibbs’ injuries were caused by her in utero exposure to the drug.1 In their complaint, the Hibbses alleged, inter alia, that the manufacturers were liable for marketing an unsafe product and for failing to provide adequate warnings.

In April 1989, Lilly brought a third party action against Kirkman Laboratories, Inc. Lilly alleged that Kirkman manufactured and distributed DES in Washington prior to Joan Hibbs’ birth and thus should be included in determining the defendant manufacturers’ market share liability, citing Martin v. Abbott Laboratories. On July 27, 1989, the Hibbses amended their complaint to include Kirkman as a defendant.

On April 4, 1990, Lilly moved for summary judgment and dismissal, contending that the Hibbses could not demonstrate that Lilly’s alleged failure to issue adequate warnings was the proximate cause of Joan Hibbs’ injuries.

In support of the motion, Lilly submitted excerpts from the deposition of Dr. Rutherford, Bernadine Raymond’s obstetrician. Dr. Rutherford testified that he first learned about the use of DES in treating pregnancy complications in 1939 while a resident at the Free Hospital for Women in Brookline, Massachusetts. It was there that he worked closely with Drs. Olive and George Smith, two respected pioneers in the study of using DES to prevent miscarriages. Dr. Rutherford agreed with the Smiths’ conclusion that DES was a safe and efficacious drug for use as a miscarriage preventative. He also testified that his decision to prescribe DES was based on his own observation of its beneficial effects on patients and his ongoing review of scholarly literature, not on drug company promotional literature.

In response to the motion for summary judgment, the Hibbses submitted the affidavits of two experts: Henry T. Lynch, M.D., and Robert J. Stillman, M.D.

Dr. Lynch testified that he was familiar with the state of scientific knowledge regarding DES in 1950. He related that drug companies selling DES for use during pregnancy did no research into whether the drug was safe for use during pregnancy .This failure to independently test DES occurred despite the existence of animal studies in the 1940’s showing that DES caused abnormalities in the reproductive organs of rodent offspring exposed in utero. Dr. Lynch added that valid studies in the 1950’s conclusively demonstrated that DES did not reduce the risk of spontaneous abortion. In summary, Dr. Lynch opined that DES should not have been marketed for use during pregnancy in 1950 because there was valid evidence available to DES manufacturers disproving the safety and efficacy of the drug.

Dr. Stillman testified that scientifically valid studies in the 1950’s showed that women who used DES during pregnancy had no greater rate of pregnancy-salvaged births than control groups. The studies demonstrated that DES did not reduce the risk of spontaneous abortion. In Dr. Stillman’s opinion, had drug companies conducted such studies before they began selling DES for use during pregnancy, they would have arrived at the same results which could have been conveyed to the medical community.

On April 10, 1990, Kirkman and Carnrick joined in Lilly’s motion for summary judgment. Kirkman submitted excerpts from the depositions of its founders, Lyle Wellman and William Graham, taken in another case. According to Wellman and Graham, Kirkman’s involvement with DES consisted of purchasing the drug from other pharmaceutical companies, tabletizing it, and then reselling the drug generically.

Prior to oral argument on the motion for summary judgment, Lilly settled with the Hibbses and was dismissed from the case. On May 10, 1990, the trial court granted summary judgment in favor of Kirkman and Carnrick. Given Dr. Rutherford’s testimony about his reasons for prescribing DES, the trial court determined that the Hibbses could not, as a matter of law, establish proximate cause. Carnrick has since been dismissed, leaving Kirkman as the only remaining respondent on appeal.”

… continue reading the full paper HIBBS v. ABBOTT LABORATORIES, on Leagle.

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Matter of DES Market Share Litigation

Abstract

“In Hymowitz v Lilly & Co., this Court, recognizing that “extant common-law doctrines, unmodified, provide no relief for the DES plaintiff unable to identify the manufacturer of the drug that injured her,

” adopted a market share theory to create a “realistic avenue of relief for plaintiffs injured by DES.”

Since our decision in that case three years ago, Supreme Court, Erie County, has issued an order severing the market share issue from every DES case pending in New York and consolidating these actions so that the market share issue can be resolved in a single proceeding. The question now before us is whether the DES plaintiffs are entitled to a jury trial on the issue of market share.”…

MATTER OF DES MKT. SHARE LITIG., Leagle, 199237879NY2d299_1352, March 31, 1992.

… “In our effort to address this critical problem of proof unique to DES cases, we examined the common-law doctrines of alternative liability and concerted action and concluded that these doctrines, unaltered, would not afford relief to DES plaintiffs. Next, we looked for guidance to other State courts that had already considered the identification dilemma faced by DES plaintiffs. Based on our survey of the various approaches taken by other State courts and our appreciation for the realities of mass tort litigation in this State, we concluded that a market share theory, based on a national market, was the best solution to the identification problem unique to DES cases. Under that theory, each defendant who marketed DES for pregnancy use was to be held liable according to that manufacturer’s market share.

In choosing to adopt a national market share theory as a matter of New York law, we stated that

“use of a national market is a fair method * * * of apportioning defendants’ liabilities according to their total culpability in marketing DES for use during pregnancy. Under the circumstances, this is an equitable way to provide plaintiffs with the relief they deserve, while also rationally distributing the responsibility for plaintiffs’ injuries among defendants”.

Only those defendants who did not participate in the marketing of DES for pregnancy use would not be held liable for a particular plaintiff’s injury.

“Because liability * * * is based on the over-all risk produced, and not causation in a single case, there should be no exculpation of a defendant who, although a member of the market producing DES for pregnancy use, appears not to have caused a particular plaintiff’s injury”. “…

… read the full paper MATTER OF DES MKT. SHARE LITIG., on Leagle.

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