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Prempro, Provera Makers Must Pay $27.1 Million in Punitive Damages for Arkansas Woman's Breast Cancer

Mar 7, 2008 | Parker Waichman Alonso LLP

A woman injured by Prempro and Provera hormone replacement therapy (HRT) drugs was awarded more than $27 million  in punitive damages  by an Arkansas jury.  The jury had found that Wyeth, the maker of Prempro, and Pfizer Inc/, the maker of Provera, were responsible for her breast cancer.  This is the second time that Wyeth has been ordered to pay out punitive damages in  lawsuits filed over Prempro and its other HRT drug, Premarin.

Prempro is a hormone replacement therapy (HRT) that consists of a combination of estrogen and progestin.  Prempro was introduced by Wyeth Pharmaceuticals in 1996, and it is used to treat hot flashes and other symptoms of menopause.  In 2002, a major HRT study conducted by the National Institutes of Health (NIH) determined that Prempro and similar drugs resulted in a 26 percent higher chance of developing breast cancer. The study results were so alarming that the NIH canceled the study, citing risk to the study's participants. The authors of the study suggested that many of the women who used Prempro and other estrogen and progestin combinations should quit and talk to their doctors about alternatives.

Earlier this week the NIH issued a follow-up to the 2002 study that found that women who had ended combination HRT therapy still faced an increased risk of breast cancer.  Women who took estrogen and progestin during the study but stopped in 2002 were still about 27 percent more likely to develop breast cancer than the women who did not take the hormones at all. Researchers also noted a 24 percent increased risk in developing any form of cancer, chiefly lung cancer, among women who had been in the hormone group. Overall, there were 63 more diagnoses of cancer during the follow-up study, or three per 1,000 participants per year, according to the NIH.

Wyeth and Pfizer Inc. were ordered to pay the Arkansas women $27.1 million in punitive damages.  The jury had found that Wyeth's Prempro and Pfizer's Provera had caused her to develop breast cancer, and further determined that the companies had shown ``reckless disregard'' for the health risks posed by their HRT drugs and should be punished.  Wyeth's share of the punitive damages came to $19.3 million, while Pfizer's amounted to $7.7 million.

This is not the first time Wyeth has been ordered to pay punitive damages because of its HRT drugs.  In October 2007, a Nevada Jury awarded $99 million in such damages to three women after finding that the treatments caused their breast cancers. A judge slashed the award to $58 million last month.  In all, Wyeth faces 5,300 lawsuits over its HRT drugs, and has lost four cases since 2006.