Prempro Lawsuits
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Prempro Lawsuits Info
In 1995 the FDA approved the use of Wyeth Pharmaceutical's Prempro for the treatment of menopausal symptoms. In July 2002, The National Institute of Health (NIH) stopped a 16,608-woman study on the benefits of hormone replacement therapy three years early, concluding that hormones such as estrogen and progestin place women who still have their uterus at risk of developing invasive breast cancer.
The medication most directly affected by this news was Prempro, one of the early drugs for hormone replacement therapy that used this combination of hormones in its formula. At the time, the NIH decision was thought to threaten the future of hormone therapy in general.
Prempro Gets a Black Box Warning
In 2003 the FDA insisted on a black box warning for Prempro packaging, warning that, "The estrogen plus progestin sub-study of the Women's Health Initiative (WHI) reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens…combined with medroxyprogesterone acetate..."
What this warning suggests and the data shows is that Wyeth's dual drug treatment for menopausal symptoms has hazards beyond the usual threats of blood clotting in the veins that is associated with hormonal therapy.
The Lawsuits Begin to Stack Up
By 2006, four thousand women had suggested via liability lawsuits that Wyeth's Prempro had caused the development of breast cancer. From a CNN story in 2006: "The overwhelming majority of women in these cases suffer from breast cancer as a result of their use of Prempro," said lawyer Tobias Millrood, whose firm Schiffrin & Barroway is representing plaintiffs in about 1,000 Prempro cases. "Wyeth aggressively over-promoted these drugs for conditions that [weren't approved by] the FDA. [Prempro] was truly a panacea. This drug was promoted as the fountain of youth."
Granted, this story makes it clear that at least one law firm was engaged in some aggressive aggregating of clients for a class action. But the fact that there were 4,000 viable candidates to make this accusation suggests that the drug company may have a problem. Veteran FDA researchers will tell you that the Agency believes information for about 10% of the relevant complaints on issues like this actually reach their offices.
Today Prempro is Still on the Market and Still in Court
By 2008, continuing reports had convinced the FDA that there was more than strong suggestion in the data coming in about Prempro: "July 31, 2008 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of the increased risk for breast cancer in patients receiving estrogen plus progestin therapy..."
As of November 5th 2009 Pfizer's Wyeth unit has lost five of eight trials, including the last three in a row, over the drugs since cases began reaching juries in 2006. Thirty-three additional Prempro cases have been set for trial so far, and 19 have been thrown out by judges or withdrawn by plaintiffs. The loss on November 5th occurred in Chicago, where a breast cancer victim who took Prempro was awarded $75 million.
As of November 2009 our lawyers are investigating new Prempro related claims. If you or someone you know has suffered due to Prempro please fill out the Free Case Evaluation form. Someone will be in touch with you shortly.
