“An unconscionable delay”: warnings about DES ignored

Addressing a public health issue from a legal perspective, 2015

In April 1970, Dr Arthur Herbst and his colleagues published six case studies of gynaecological cancers (specifically, clear-cell adenocarcinoma) in young girls aged 15 to 22 in a prestigious American medical journal. The following year, the same doctors published a second article proving that these cancers had been caused by in utero exposure to diethylstilbestrol (DES) during the mother’s pregnancy. Introduced in 1941, the drug was then administered to millions of American women to prevent miscarriages. DES continued to be prescribed even after clinical trials in 1953 revealed its ineffectiveness. Thanks to the work of Dr Herbst and his colleagues, for the first time a clear and direct link was shown between taking a medicine during pregnancy and its subsequent morbid effect on offspring after a considerable timeframe had elapsed. Since then, the list of actual and potential side effects of in utero exposure to DES has grown steadily to include infertility, significant prematurity, urogenital malformations, cancers, psychiatric disorders, eating disorders, etc. Moreover, the populations affected have grown to include “DES daughters”, “DES sons” and even “DES grandchildren”.

The history of DES in America can be summarised as a total lack of precaution and unheeded warnings, followed by the drug’s prohibition in 1971. The drug’s trajectory in France repeated and exacerbated those tragic mistakes. DES was initially prescribed to pregnant women during the 1950s; it was recommended until 1976, although marginal use is documented until 1982. American research on the topic went largely unnoticed in France. When Dr Herbst spoke at a conference in Paris in 1972 in front of the French medical elite, most obstetrician-gynaecologists still refused to believe in the harmful effects of DES on their female patients.

In 1981, alarmed by her patients’ problems with infertility and uterine malformation, Dr Anne Cabau launched an appeal to DES daughters in the magazine published by the health insurance provider MGEN. The results of her study were reprinted by Le Monde in February 1983 under the headline: “DES Children: A Monumental Mistake”. The article received widespread media coverage. Public institutions and the medical profession then took a highly reassuring stance with regard to the problems caused by DES in France, sometimes going so far as to accuse Dr Cabau of hidden advertising. A group of researchers commissioned by Inserm (the French Institute of Health and Medical Research) conducted a study and found that 200,000 women had been treated with DES in France, and 160,000 babies had been exposed to the drug in utero. The group issued a series of recommendations outlining how to inform and support patients. But these recommendations largely remained unheeded.

In 1988, hired by the first patients’ association dedicated to DES issues, a group of clinicians and researchers developed a brochure about the dangers of DES under the auspices of the Ministry of Health. The vast majority of these experts opposed distributing the brochure to patients; its dissemination was consequently limited to healthcare professionals. The brochure’s effect was so limited that a second campaign was launched in 1992. In 2003 and 2010, worried by the persistent low levels of knowledge about DES among gynaecologists the Agence nationale de sécurité du médicament et des produits de santé (ANSM – French Agency for the Safety of Health Products) sent medical professionals a new information bulletin that contained a number of recommendations. Even today, however, some gynaecologists maintain that they have “never met a DES daughter”. Information on the drug and its long-term effects has often trickled down through non-specialised media outlets, rather than medical professionals. DES daughters have thus often suffered from lengthy periods of diagnostic error and inappropriate forms of potentially iatrogenic care, despite the fact that they displayed “typical” anomalies and clinical trajectories.

A similar lag compared to the US characterised DES victim associations in France. At the end of the 1970s, DES victims began to receive attention in the American legal arena which coincided with innovations within tort law.
Faced with the almost insurmountable difficulty of designating a responsible party in the American market, where many different pharmaceutical companies had sold DES, California’s Supreme Court invented the concept of market share liability. This new mechanism forced all the different companies to compensate the victims pro rata in accordance with their market share. Market share liability has subsequently been the subject of heated debates and numerous legislative proposals over the course of the past three decades. This ruling, which marked a radical departure from traditional liability law, had a two-fold impact. On one hand, it could apply not only to DES victims as a whole, but also to the victims of other chemical or pharmaceutical products – a potentially vast population. On the other, the ruling marked the transition between a fault-based liability regime and a risk-based liability regime. The French dispute started much later: the first complaint was filed in 1991, but it only reached a court of first instance in 2002, displaying a remarkable lack of speed for a civil case. This legal mobilisation was inseparable from the work of support and advocacy organisations. In 1994, Réseau DES (DES Network) was created, and its founder (whose daughter had been diagnosed with clear-cell adenocarcinoma) instigated the first civil court case. Two other associations have since been created, both active in the legal arena as well. Hhorages (Halte aux hormones artificielles dans le cadre de la grossesse – Stop the use of artificial hormones during pregnancy), founded in 2002, focuses on adverse psychological effects and the third-generation impact of taking artificial hormones during pregnancy. Since 2003, Les Filles DES (DES Daughters) has worked on fertility problems among women who were exposed to DES in the womb.

As in the United States, the DES legal dispute in France has illustrated significant progress in the development of a DES cause. First of all, jurisprudence has forced defective goods liability to evolve, marking an undeniable shift in favour of victims’ rights. Moreover, this success has led to the unprecedented media coverage of DES as a public health issue, equivalent to the watershed moment in the case of asbestos. Like many victims of occupational illnesses, DES daughters were long invisible, epidemiologically, medically and socially speaking, a situation that only began to change with the first courtroom victories.

References

  • Abstract from “From Individual Redress to the Development of a Collective Cause: The Legal Mobilisation of Victims of DES”, Revue française de science politique (English Edition), Pages 583 – 607, 2015/4.
  • Image credit Mauricio Artieda.
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