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Lawsuit Alleges Pregnancy Drug Caused Breast Cancer



Four women are suing Eli Lilly and Co., the former maker of DES (or diethylstilbestrol), in a case set to unfold in federal court on Friday when it will become one of the first of scores of such claims around the U.S. to go to trial. The Melnick sisters are seeking unspecified damages.

The numerous pharmaceutical companies that made or marketed the drug argue that no firm link has been established between breast cancer and DES, a synthetic estrogen that was prescribed to millions of women from the late 1930s to the early 1970s to prevent miscarriage, premature births and other problems.

The Centers for Disease Control and Prevention estimates between 5 and 10 million pregnant women and children were exposed to the DES.

It was eventually pulled from the market after being linked to a rare vaginal cancer in women whose mothers used DES. And studies showed the drug did not prevent miscarriages after all: The idea behind the drug before its 1938 launch was that miscarriages and premature births occurred because women did not produce enough estrogen naturally.

The CDC says potential side effects seen in so-called “DES Daughters” include the rare vaginal and cervical cancer clear cell adenocarcinoma, reproductive tract abnormalities like a T-shaped uterus, infertility and pregnancy complications such as ectopic pregnancy and early delivery.

Indianapolis-based Eli Lilly and Co. dominated the market for DES. The company argues in court documents that there is no evidence that the women’s mother, Frances Melnick, even took DES. She and her doctor are dead, and the drug company says there are no medical records documenting her treatment.

The CDC says potential side effects seen in so-called “DES Daughters” include the rare vaginal and cervical cancer clear cell adenocarcinoma, reproductive tract abnormalities like a T-shaped uterus, infertility and pregnancy complications such as ectopic pregnancy and early delivery.

Indianapolis-based Eli Lilly and Co. dominated the market for DES. The company argues in court documents that there is no evidence that the women’s mother, Frances Melnick, even took DES. She and her doctor are dead, and the drug company says there are no medical records documenting her treatment.

The Melnick sisters are among 51 women who have DES lawsuits pending in Boston against more than a dozen drug companies. Mediation ordered by a federal judge failed to produce settlements. Jury selection in the Melnick case is set to begin Friday.

The Food and Drug Administration told doctors to stop prescribing DES to pregnant women in 1971 after a study found that the drug appeared to increase the risk of their daughters developing a rare vaginal cancer. Thousands of lawsuits have been filed since then alleging links between DES and vaginal and cervical cancer, as well as fertility problems. Many of those cases were settled.

Lawyers for the Melnick sisters cite a study published in the New England Journal of Medicine in 2011 that suggests the risk of breast cancer is nearly double in DES daughters over 40. The study, led by Dr. Robert Hoover, a researcher at the National Cancer Institute, found that the chances that a DES daughter will develop breast cancer by age 55 are about 1 in 25. For the average woman, it is about 1 in 50.

 

 

 

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