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Sep. 9--Thousands of American women, including hundreds in Ohio, are filing lawsuits against Wyeth Pharmaceuticals, alleging that its hormone-replacement medications caused breast cancer, blood clots and other serious health problems.
Two local women -- one from Stark County, the other from Wayne County -- are the latest to file suit.
Columbus lawyer Gerald Leeseberg filed the suits recently in U.S. District Court in Cleveland on behalf of Jennifer Brubaker of Doylestown and Rose Ann Mastroine of Waynesburg. Both women contend that their use of Wyeth-produced hormone-replacement therapy led to their breast cancers.
The lawsuits allege that Premarin, Provera and Prempro are "dangerous and defective drugs."
Wyeth spokesman Doug Petkus declined to comment on the cases brought by Brubaker and Mastroine because he was not aware that they'd been filed. Wyeth faces between 3,600 and 5,500 lawsuits by women who say they were harmed by hormone therapy.
As for the safety of Wyeth's hormone-replacement medications, Petkus said, "The products are approved by the FDA, still on the market, and millions of women are still using them."
A key basis of the lawsuit is the Women's Health Initiative study of estrogen-progestin therapy released in July 2002. The trial of 16,000 women was stopped abruptly by the National Heart, Lung, and Blood Institute (part of the National Institutes of Health) when it was discovered that women taking estrogen-progestin had a 26 percent increased risk of breast cancer, a 41 percent increased risk of strokes, a 29 percent increased risk of heart attacks, a 100 percent increased risk of blood clots, and a 22 percent increased risk of cardiovascular disease.
In the case of breast cancer, Leeseberg said, the belief is that estrogen can fuel certain cancer cells to spread, when without the added estrogen they would not have proliferated. He said specific biological markers in patients can identify whether their type of cancer was fueled by estrogen.
The lawsuits accuse Wyeth of failing to conduct adequate research before the drugs went on the market, failing to undertake adequate surveillance after the drugs were approved by the FDA, and failing to provide proper warnings of the health risks.
The cases are not part of a class action, Leeseberg said. However, the cases will be combined under an Arkansas federal judge during the discovery phase, after which the cases will be returned to the jurisdictions where they were filed to be heard individually.
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