Pfizer has reportedly settled a third of all pending Prempro lawsuits, and has set aside at least $772 million to resolve all claims filed by women who allege that the hormone replacement therapy caused them to develop breast cancer.
According to a regulatory filing (pdf) with the U.S. Securities and Exchange Commission, Pfizer took a charge of $172 million in the first quarter to settle Prempro lawsuits and pay verdicts in cases it has already lost at trial. The company also set aside $300 million as the minimum cost expected to resolve the remaining cases.
These funds are in addition to another $300 million in charges that were noted in prior quarters, bringing the total amount that the New York-based drug maker is currently prepared to pay to resolve the Prempro litigation to $772 million. However, the company has indicated that additional charges may be necessary if their estimated values are inaccurate.
Prempro contains a combination of the drugs Provera and Premarin, to artificially boost hormone levels in women undergoing menopause due to surgery or in postmenopausal women. Known as hormone replacement therapy, or HRT, the drugs are designed to provide relief from symptoms such as hot flashes, irregular menstruation or weight gain.
About 10,000 lawsuits over Prempro have been filed against Pfizer’s wholly-owned subsidiary Wyeth. All of the claims involve similar allegations that Wyeth failed to adequately research the side effects of Prempro or warn that the medication may increase the risk of breast cancer.
Most of the complaints were filed after a 2002 study by the National Institutes of Health found that women receiving hormone replacement therapy (HRT) were at a higher risk of breast cancer, strokes and heart attacks. By that time, Prempro and other HRT drugs had been used by more than 6 million women.
A number of Prempro trials have resulted in multi-million dollar compensatory awards against the drug maker and even larger punitive damage awards after juries determined that Wyeth intentionally hid the risk of breast cancer from Prempro.
Pfizer announced in its filing that it reached Prempro settlements on March 31 with roughly one-third of the plaintiffs who have brought a claim. Another 3,000 of the cases were successfully dismissed. However, that still leaves company with thousands of Prempro breast cancer lawsuits to settle or otherwise resolve.