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Pfizer Says Prempro Settelements will Cost it at Least $772 Million

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Pfizer Inc. has set aside $772 million for settlements on pending cases over Prempro its menopause drug linked to causing breast cancer. The company has settled a third of cases alleging the drug caused breast cancer. Pfizer has not reported how many cases would be settled, but the company reported to the U.S. Securities and Exchange Commission that the reserve amount provides “the minimum expected costs to resolve all of the other outstanding” lawsuits.

Prempro is a hormone replacement therapy (HRT) drug used to treat hot flashes and other symptoms related to menopause. In 2002, the Women’s Health Initiative, a major study conducted by the National Institutes of Health, reported that Prempro and

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other similar drugs increased the risk of breast cancer, blood clots, and stroke. The study included more than 16,600 women: 8,506 participants in the estrogen plus progestin study group and 8,102 in the placebo group.

The study ended three years ahead of schedule because researchers found the hormones were causing only a slight but significant risk of breast cancer, blood clots, and stroke. The New York Times reported that with longer follow-up the effect of HRT drugs will appear larger. Dr. Peter Bach, a New York physician at the Memorial Sloan-Kettering Cancer Center, said, “Although the increase in cancer in the study seemed small, it becomes larger when multiplied out over the population.”

Sales of Prempro significantly decreased following the study. Prior to the 2002 study, sales of the drug exceeded $2 million, but according to Reuters, sales have fallen almost 50 percent since the results were released. The Times wrote that despite the abrupt ending, American women were impacted by the 2002 study. The number of women taking HRT drugs has decreased from six to three million. The study indicated that if 10,000 women take HRT drugs for a year, they are eight times more likely to develop breast cancer than those who are not taking the drugs. An additional seven will suffer a heart attack says the Times, eight will have a stroke, and 18 will have blood clots.

To date, Pfizer has settled 3,300 cases related to Prempro causing breast cancer. Bloomberg.com reported that in February the company agreed to pay approximately $330 million to resolve 2,200 similar cases with the average payout being $150,000 per woman.

Pfizer has lost eight of the 15 jury trials, says Bloomberg, since trials began in 2006. A plaintiff in Puerto Rico who developed breast cancer was awarded $1.5 million in damages.

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