http://bmj.com/cgi/content/full/324/7350/1354/d
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 Collections under
which this article appears: Cancer:
gynecological Medicine
and the law (incl forensic medicine) Adverse
drug reactions |
Alexander Dorozynski Paris
Two women who developed cancer after their mothers took the drug diethylstilbestrol have won their case against the pharmaceutical company UCB Pharma.
The company continued to market the drug until 1977, six years after it was found to be associated with an increase in vaginal cancer in girls and young women whose mothers had taken it, and six years after it was taken off the market in the United States. This is the first successful suit involving the drug in France.
The court ordered the company to pay each of the women €15 244 (£9634; $13 994) as an interim payment, until full damages are assessed.
It is estimated that about 160 000 men and women in France were exposed to the drug while in the womb. Girls are at risk of uterine malformations and extrauterine pregnancy, cancer of the uterus and vagina, and malformations of the Fallopian tubes that render pregnancy problematic. Boys are at increased risk of genital anomalies.
The first lawsuits were begun in 1991 by 10 women suffering from cancer of the vagina or uterus. The lengthy legal procedure was slowed down while many scientific documents were translated into French and a four year expert study was carried out into the drug. The delays discouraged most of the plaintiffs, and only two of them persisted: Nathalie Bobet, now 33 years old, and Ingrid Criou, 28.
But now that the two women have won their case, other cases may be revived and new complaints registered. Martine Verdier, the plaintiffs’ lawyer, said that she had about 30 cases waiting on her desk
An association, called Réseau DES France, has been set up for women who have developed problems as a result of exposure to diethylstilbestrol and it has started receiving telephone calls from women who want to lodge a complaint.
Some lawsuits may also be filed against another laboratory, Novartis, which marketed the drug under the name Stilboestrol. In the Netherlands lawsuits against several laboratories producing the drug have led to the creation of a compensation fund of €35m.
Many doctors in France are still wondering why it took so long to take action to stop the widespread use of the drug, which was prescribed to prevent miscarriage. Dictionnaire Vidal, the French directory of pharmaceutical products, warned against its use in 1977, but the Ministry of Health published a warning brochure for doctors only in 1989.
Dr Michel Tournaire, head of the department of obstetrics and gynaecology at the Saint Vincent de Paul Hospital, Paris, told Le Monde (25 May 2002) that there are still French doctors today who claim that "it wasn’t serious or who think the affair is over."
Because use of the drug peaked in France between 1965 and 1975, its consequences are expected to be felt until about 2015.
Dr Sylvie Epelboin, head of the reproductive medicine unit at the St Vincent
de Paul Hospital, said patients needed to be properly informed about the drug.
Exposure to diethylstilbestrol did not mean a woman could never have a child,
she said. If they persevered, 85% of them could, but some might need
intrauterine insemination or in vitro fertilisation, she added.
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Collections under
which this article appears:Cancer:
gynecological Medicine
and the law (incl forensic medicine) Adverse
drug reactions |
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