A study recently published in the New England Journal of Medicine has expanded on the links between diethylstilbestrol (DES) and many forms of cancer. Researchers looked at 6,500 women, 4,600 of whom received exposure to DES while in the womb. They found substantially higher risk of cancer, including breast cancer and adenocarcinoma. They also found a higher risk of infertility and neonatal death. The study serves as a reminder of the risks posed during widespread use of DES decades ago, which led to a landmark court decision regarding liability for drugs that cause medical complications.
DES is a synthetic form of estrogen first developed in 1938 and used to treat breast and prostate cancers, among other uses. The U.S. Food and Drug Administration approved it in 1941 to treat menopausal symptoms, vaginitis, and to suppress lactation after childbirth. It was used from the 1940’s to the 1980’s in estrogen-replacement therapy. It was a standard treatment for prostate cancer for 40 years, until more effective treatments were approved in the 1980’s. DES was also a common treatment for breast cancer from 1960 to 1977.
For a period of about 30 years, doctors gave DES to pregnant women believing it could reduce the risk of complications or losses in pregnancy in women with a history of miscarriage. The FDA approved DES for this use in 1947, but withdrew it from use with pregnant women in 1971 after studies linked it to certain tumors in girls and women exposed to the drug in utero. Further study showed medical complications in people exposed after birth. Women exposed to DES in the womb have been encouraged by the National Cancer Institute to seek regular specialized medical examinations to look for complications due to the drug.
Women who took DES while pregnant have shown a slightly higher rate of breast cancer. Women exposed in the womb, known as “DES daughters,” have shown a wide array of health complications, including multiple types of cancer. In addition to its carcinogenic properties, DES is considered a teratogen, meaning it can cause malformations in children exposed in utero. Men exposed to DES in utero have shown elevated rates of testosterone deficiency and neurological issues.
Once negative publicity developed around DES, multiple lawsuits were filed against the drug’s manufacturers across the United States in the 1970’s. This led to the California Supreme Court’s 1980 decision in Sindell v. Abbott Laboratories, which demonstrated the legal doctrine of market share liability. The plaintiff had developed cancer because of her mother’s use of DES. Due to the number of years that had passed from the time the mother took the drug to the time the daughter learned of her injuries, she could not identify the specific manufacturer of the pills her mother took. The doctrine put forth by the California court made all manufacturers of the drug liable in proportion to their share of the drug’s market at the time of use. Since then, courts have only applied the market share doctrine to cases involving pharmaceutical products.
DES has not been used in human medical treatment since the 1970’s, so it no longer poses a risk. Women using the drug in the 1940’s through the 1970’s had little ability to research drugs, unlike today. The history of DES illustrates the importance of remaining educated about one’s medications and aware of prescriptions and dosages.
The Maryland pharmacy error attorneys at Lebowitz & Mzhen can assist you if you have been injured by drugs administered in error during pregnancy. Contact an experienced lawyer today to see if you may recover damages.
DES Update: Consumers, Center for Disease Control
Diethylstilbestrol (DES) and Cancer, National Cancer Institute
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