Victimes de médicaments : repenser le droit des victimes

Intervention d’Irène Frachon, Pneumologue, Lanceuse d’alerte, Mars 2015

Allocution de clôture du colloque “Faut-il repenser le droit des victimes d’effets indésirables de médicaments ?“, (Mars 2015).

  • (Re)Voir toutes les interventions du colloque, prescrire, 13 mars 2015.

La voie (d’action pour les victimes) contentieuse : longue, coûteuse et éprouvante

Intervention de Maître Martine Verdier, Avocate à la Cour d’Orléans

Vidéo (et texte) du colloque “Faut-il repenser le droit des victimes d’effets indésirables de médicaments ?“, (Mars 2015).

Le Distilbène DES, en savoir plus

Victimes de médicaments : sortir du déni sociétal

Intervention de Gérard Bapt, Député, Mars 2015

Allocution d’ouverture du colloque “Faut-il repenser le droit des victimes d’effets indésirables de médicaments ?“, (Mars 2015).

Le Distilbène DES, en savoir plus

Victimes d’effets indésirables graves du Distilbene DES : d’épreuves en épreuves

Intervention d’Emmanuelle Brun, Vice-présidente de Réseau DES France, Mars 2015

Vidéo (et texte) du colloque “Faut-il repenser le droit des victimes d’effets indésirables de médicaments ?“, (Mars 2015).

Le Distilbène DES, en savoir plus

Le Procès de Julien, Petit-Fils Distilbène

L’hormone qui frappe la 3ème génération : Julien, le fils de Sylvie LE COSSEC

rallumer-les-étoiles

Communiqué de presse

Il est grand temps de rallumer les étoiles, celles de l’espérance et de la confiance en l’avenir. Bientôt en mars 2016, le procès du Distilbène devant la justice, l’hormone qui a frappé la 3ème génération de la famille Le Cossec: Julien, leur fils aîné polyhandicapé.

Le 10 mars 2016 aura lieu le second procès de Sylvie Le Cossec contre le laboratoire UCB Pharma, à l’origine du scandale du Distilbène.
Ce procès devra considérer si l’exposition au Distilbène de Sylvie LE COSSEC est responsable de l’accouchement prématuré, qui lui-même explique de façon directe le handicap majeur dont souffre son fils Julien.

En mars 2014, le premier procès avait permis d’établir le lien de causalité entre la mère, qui avait pris ce médicament, et sa fille, Sylvie Le Cossec.
Elle était enfin reconnue comme victime.
Un complément d’expertise avait été ordonné par le tribunal pour valider le lien de causalité entre Sylvie Le Cossec, fille DES comme on les appelle, et son fils Julien, né prématurément et lourdement handicapé.

Ce premier procès fut aussi celui des responsables du laboratoire pharmaceutique UCB Pharma qui commercialisa, dès 1953, cette molécule malgré sa haute toxicité. En dépit des mises en garde, le laboratoire continua de commercialiser ce médicament pendant 25 ans.

Ce procès fut celui des détenteurs de l’autorité morale et opérationnelle qui n’ont pas respecté leur devoir élémentaire de protection de la santé des personnes.

Ainsi, dans cette optique, nous avons pleinement confiance en notre justice.

Le TGI de Nanterre aura à se prononcer sur la responsabilité d’UCB Pharma sur ce dossier touchant maintenant la 3ème génération de la famille LE COSSEC.

Pour rappel, Le Distilbène est une hormone de synthèse prescrite aux femmes entre 1950 et 1977 pour prévenir les fausses couches.

Le fabricant, UCB Pharma, a décidé de rendre publique sa contre indication en 1977, soit 6 ans après son interdiction aux Etats-Unis.

Handicap : le Distilbène devant la justice. L’hormone qui frappe la 3ème génération : Julien, le fils de Sylvie LE COSSEC.

Sylvie LE COSSEC, la mère de Julien accuse le Distilbène d’être à l’origine du handicap de son fils Julien. Le médicament a provoqué une malformation utérine chez Sylvie LE COSSEC. Cette exposition au Distilbène in utero est responsable de son accouchement prématuré à la suite de la rupture prématurée de la poche des eaux à 31 semaines.

Aujourd’hui, Julien souffre d’un handicap à 80%.

  • Il présente une paralysie cérébrale très sévère.
  • Il n’a pas d’autonomie pour les actes de la vie courante, il a besoin d’une assistance en permanence.
  • Il présente une pathologie orthopédique secondaire évolutive.
  • Julien a des capacités d’expression limitée, il ne fait pas de phrase et se limite à répéter des idées.
  • C’est un enfant de 2 ans dans le corps d’un adolescent de 17 ans.

2 grossesses pathologiques, un cancer de l’utérus, une vie de femme et de famille irréversiblement bouleversée. Sylvie le Cosseccontact média souhaite ardemment la reconnaissance du handicap de son fils Julien.

Elle pourra alors entamer un processus de reconstruction et gagner une certaine forme de liberté et de sérénité pour elle et sa famille.

Sources
Le Distilbène DES, en savoir plus

Settlement effected for damages for victims of diethylstilbestrol (DES)

The collective settlement of diethylstilbestrol claims in the Netherlands is unique and highly beneficial for Dutch DES victims

collective settlement resource image
In 2007 the Dutch DES Fonds started payment to Diethylstilbestrol DES victims in a collective settlement.

Abstract

Nederlands tijdschrift voor geneeskunde, NCBI PubMed PMID: 17557761, 2007 May 26.

In 2007 the Dutch DES Fonds (DES Fund) starts payment to victims of exposure to diethylstilbestrol in a collective settlement.

This is unique in the world because the arrangement covers the entire range of DES-related disorders and individual persons do not have to start an expensive and emotionally taxing legal procedure with uncertain outcome, which would last several years. Individuals can now be compensated based on medical evidence of DES exposure and the presence of a DES-related disorder covered by the settlement.

In close collaboration with the DES Centre (an association of DES victims) a careful procedure was followed before this settlement was realised. The Dutch Expert Committee on DES-related Health Effects first reviewed the literature for evidence and established a list of disorders with a causal association with DES. For each DES-related disorder covered by the settlement, the appropriate compensation was determined by the attributive risk and the severity of the disease. The Dutch collective settlement is the result of close collaboration between all parties involved.

More DES DiEthylStilbestrol Resources

Market Share Liability in DES Cases: The Unwarranted Erosion of Causation in Fact

In the final analysis, the legislature, and not the court, is the appropriate forum for determining whether to adopt or reject market share liability

image of Hand-of-Justice
The Article concludes that market share liability is an unsound concept, that it represents too wide a leap in our tort principles, and that the abrogation of such a fundamental tort requirement is unwarranted. Hand of Justice.

Introduction

DePaul Law Review,
David M. Schultz,
Volume 40, Article 5,
Issue 3 Spring 1991.

As our society progresses in complexity, theories of tort law have evolved in order to provide redress for the harms caused in a changing world. Tort law evolution has resulted in the creation of new remedies and, in many instances, the erosion of certain preconditions for recovery in tort. Nevertheless, with limited exceptions, there has not been significant erosion of the requirement that a plaintiff must first be able to identify the person or entity that caused her injury before she can recover in tort. In the past decade, however, a small number of courts have abrogated this principle, which is referred to as “causation in fact.” In the place of causation of fact, these courts have adopted the concept of “market share liability.

The market share liability theory has developed mainly through lawsuits filed by women who claim to suffer injuries resulting from their mothers ingestion of the drug Diethylstilbestrol (DES) while pregnant. These plaintiffs are commonly referred to as the “DES daughters.” The time that passes between the maternal ingestion of DES and the diagnosis of the injuries is generally twenty or more years because the injuries do not manifest themselves until sometime after the daughter has reached puberty. A DES daughter is often unable to identify the specific manufacturer of the drug her mother took for two key reasons: the long passage of time and the fungible nature of DES. Faced with the possibility of leaving these plaintiffs without a remedy as a result of their inability to identify the manufacturer, some courts have instead abolished the traditional requirement of establishing causation in fact. In place of causation in fact, these courts have adopted a theory that imposes liability upon any defendant who participated in the manufacturing or marketing of DES in the relevant market. Under this “market share liability” theory, each defendant is liable for the proportion of the judgment that its share of the market represented during the relevant time period.

Market share liability is a flawed concept that likely will apply only to a narrow class of plaintiffs and defendants.

Market share liability has been controversial since its inception. The concept has been adopted with varying modifications by a handful of courts and promoted by a larger number of legal commentators. At the same time, other courts have denounced the theory of market share liability when faced with the opportunity to adopt the proposition in either DES cases or cases involving other products. Currently, only nine state supreme courts have addressed the market share liability issue in a DES case. Most likely, however, other jurisdictions will eventually be forced to face this issue, especially in light of the fact that DES was used nationwide, some plaintiffs have achieved success with the theory, and there is the potential for large recoveries.

Most legal commentary on the issue of market share liability has supported the adoption of the theory. Commentators and courts that support the market share liability theory correctly argue that there is a need to adapt our existing tort law in the face of progress. They also argue that there is strong emotional appeal to insure a remedy for all plaintiffs, especially plaintiffs who are innocent of any wrongdoing. However, this Article contends that courts should not develop a market share liability concept.

  1. This Article begins with a brief history of the development of the drug DES.
  2. In the next section, this Article reviews the tort requirement of causation in fact.
  3. The third section outlines the DES cases in which state supreme courts have adopted market share liability,
  4. and the fourth section addresses cases where courts have rejected the theory in the DES context and in other actions.

Some DES plaintiffs have been able to establish the identity of the specific manufacturer, while others will be able to establish enough evidence to proceed to trial on the issues of causation in fact or negligence.

The Article concludes that market share liability is an unsound concept, that it represents too wide a leap in our tort principles, and that the abrogation of such a fundamental tort requirement is unwarranted. Two ideas are presented to support this conclusion.

  1. First, there is insufficient data to accurately develop the required market shares for each of the hundreds of pharmaceutical companies that produced DES. This lack of data precludes the fair allocation of liability for DES related injuries among all DES manufacturers.
  2. Second, upon close scrutiny, the underlying policies offered to justify adoption of the market share liability theory are either not achieved by the theory, and even if they can be achieved, they do not provide sufficient reasons to adopt it.

This Article proposes that the judicial development of market share liability involves making public policy determinations that more appropriately should be left for state legislatures. A legislative response, similar to the federal legislation established to compensate persons injured by childhood vaccines such as the diphtheria, pertussis, and tetanus (“DPT”) vaccine is a proper method of compensation, and one that will not require a radical change in a state’s tort law.

More DES DiEthylStilbestrol Resources

HIV, Women and Access to Clinical Trials: Tort Liability and Lessons from DES

Are we destined to repeat the DES experience with AZT use by pregnant women?

image of pregnant-woman-1950s
In the early 1950s, large controlled clinical trials of DES were conducted on pregnant women.

SELECTED Abstracts

The purpose of this Article is to examine the tort liability experience with DES, compare it to the recent and ongoing trials of AZT in pregnant women, and extract lessons that can be used to mitigate against the likelihood of tort liability and to encourage the inclusion of women of childbearing age in clinical trials.

… “Although many factors may have contributed to the underrepresentation of women in clinical studies, the potential exposure of drug trial sponsors to tort liability frequently is cited as one of the primary reasons for excluding women from trials. The true source of legal anxiety in the recruitment of female research subjects arises, however, not from a concern for women’s safety, but from the fear of potential injuries to their offspring. Observations and reports of birth defects in children of women who had been treated with thalidomide or bendectin brought liability concerns to the forefront.  When the courts held manufacturers liable for injuries caused to the offspring of women exposed to Diethylstilbestrol (DES), it became yet another reason for excluding pregnant women and women of childbearing age from clinical trials. “…

…”In the early 1950s, large controlled clinical trials of DES were conducted on pregnant women at the University of Chicago, which led to the cases of alleged research-related injury. Both cases were brought after the discovery of the carcinogenic potential of DES in offspring of women who had been given DES. In Mink v. University of Chicago,  three women, on behalf of themselves and approximately one thousand women who had participated in the trials, alleged injury, as well as increased risk of injury, to their daughters. In Wetherill v. University of Chicago, the plaintiffs were two daughters who had contracted cancer that they attributed to the DES that was administered to their mothers while they were pregnant. In both Mink and Wetherill the plaintiffs claimed that the women taking DES never knew that they were participating in an experiment or that they were even taking DES.

Read the Full Paper,
DUKE JOURNAL OF GENDER LAW & POLICY,
Volume 5:167, 1998.

In the hearing in Mink on whether the case brought by the mothers against the manufacturer and the institution conducting the research should be dismissed, the court held that the manufacturers had a duty to notify the women about the risks posed by DES at the time when the company became aware of them or should have become aware of them.63 The court permitted the battery allegations against the University of Chicago to stand, stating that nonemergency treatment performed without consent or knowledge raises a claim of battery. The case was settled with financial compensation to the plaintiffs and an agreement by the University of Chicago to provide medical services to women in the trials and to their offspring. In Wetherill, the court permitted the daughters to bring an action against the manufacturer and the University of Chicago. This case also settled, although the terms of the settlement were undisclosed.”…

More DES DiEthylStilbestrol Resources

The DES Manufacturer Identification Problem: A Florida Public Policy Approach

University of Miami Law, School Institutional Repository, 1986

The court must take some action that will encourage manufacturers to assure that their products are traceable back to themselves. To do otherwise will leave open a loophole through which manufacturers can escape liability for injuries sustained by their consumers. This result would be inconsistent with the court’s declared policy that “the law will step in to protect people against risks which they cannot adequately guard against themselves.”‘

3-1-1986 – Introduction

Terri Lynn Conley suffered from cervical adenosis.  She underwent surgery for removal of most of her cervix, as well as removal of other precancerous and cancerous tumors. Conley’s mother ingested the drug diethylstilbestrol (DES) twenty years before while Conley was present in utero. Doctors commonly prescribed DES as a miscarriage preventative around the time period that Conley’s mother was pregnant but subsequent research linked in utero exposure to DES to the kind of cancer that Conley developed.

Conley brought an action against eleven manufacturers who had produced DES both before and during her mother’s pregnancy. She alleged that the DES her mother ingested during pregnancy caused her own medical complications. She was unable to identify the specific manufacturer of the DES that her mother ingested but she suggested four alternative theories of recovery in lieu of the traditional tort requirement that the plaintiff identify specific tortfeasors.

The trial court granted motions to dismiss and judgments on the pleadings for the defendants because of Conley’s inability to identify the specific manufacturer. On appeal, the Fourth District Court of Appeal affirmed, held: failure to allege legal causation by identifying the specific tortfeasors precludes recovery. The district court recognized, however, the compelling argument in favor of relaxing the identification requirement in DES-like situations, and considered various theories fashioned by courts of other jurisdictions. The court proposed its own theory of liability for adoption in Florida, and urged its serious consideration by the supreme court. The court concluded, however, that it lacked authority to approve a new theory of liability before the Supreme Court of Florida had done so. It certified the following question to the supreme court as an issue of great public concern: “Does Florida recognize a cause of action against a defendant for marketing defective DES when the plaintiff admittedly cannot establish that a particular defendant was responsible for the injury?”

Conclusion

Confrontation with any traditional legal doctrine requires a thorough examination of the public policy considerations which are the substance of the law. The court must recognize the changes that have occurred in society, and if the scope of those changes is great enough, it must rework tort doctrine so that tort law can continue to serve its original purpose-that of making the public policies of society a reality in the everyday lives of individuals. This exercise is one of the essential roles courts play in the society they serve.

The Conley v. Boyle Drug Co. case will be a difficult decision for the Supreme Court of Florida. Only if the court relaxes the defendant identification requirement will Terri Lynn Conley have a remedy. Relaxation of the defendant identification requirement is consistent with the court’s policy of compensating injured plaintiffs for injuries caused by wrongs committed by others. It is also consistent with the policy of preferring innocent plaintiffs over possibly culpable defendants. Because the Conley case is a products liability action, the relaxation of the defendant identification requirement promotes the court’s policy of giving manufacturers the incentive to produce safe products. It is also consistent with the court’s recognition that manufacturers are better able than consumers to spread the risk of loss caused by defects in their products. The court must also recognize that the expanding use of generic drugs will inevitably cause the problem to occur again. The court must take some action that will encourage manufacturers to assure that their products are traceable back to themselves. To do otherwise will leave open a loophole through which manufacturers can escape liability for injuries sustained by their consumers. This result would be inconsistent with the court’s declared policy that “the law will step in to protect people against risks which they cannot adequately guard against themselves.“‘ By recognizing that Terri Lynn Conley is entitled to a remedy at law, the court will protect Florida citizens from similar incidents in the future.

Sources
More DES DiEthylStilbestrol Resources

DES and the identification problem

DES plaintiffs face many problems, both legal and practical

Proposals to “further strengthen product liability laws as a substitute for direct government intervention“‘ were studied in this 1983 study.

AKRON LAW REVIEW, Vol. 16:3, by BARRY S. ROBERTS and CHARLES F. RoYSTER. full PDF Winter, 1983.

Diethylstilbestrol (DES), a synthetic estrogen, was developed in 19371 and was widely prescribed in the 1940’s, 1950’s and 1960’s for pregnant women to prevent miscarriages.

The drug has caused a number of maladies to daughters who were exposed in utero to the drug, the most serious of which is clear cell adenocarcinoma, a rare form of vaginal cancer.

The Food and Drug Administration (FDA) withdrew its approval of DES as a miscarriage preventative in 1971, and since then the focus has shifted to products liability actions filed against the drug manufacturers. The plaintiffs have been largely unsuccessful in these actions, although some innovative judicial theories have recently been advanced in allowing recovery.

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

More DES DiEthylStilbestrol Resources