Pfizer Inc., the world’s largest drugmaker, has settled almost half of the lawsuits over its menopause drugs and increased the funds set aside to resolve the cases, the company said in a regulatory filing.
Pfizer and its Wyeth and Pharmacia & Upjohn units have resolved about 46 percent of suits that claimed the companies’ hormone-replacement medicines, including Prempro and Premarin, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases.
“We have recorded a charge of $260 million in the first nine months of 2011 that provides for the minimum expected costs to resolve all the remaining hormone-replacement actions,” Pfizer officials said in the Nov. 10 filing.
More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, exceeded $2 billion before the release of the Women’s Health Initiative study sponsored by the National Institutes of Health.
Until 1995, many menopausal women combined Wyeth’s Premarin, an estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill. Pfizer, based in New York, acquired Wyeth in 2009.
At the height of the litigation, Pfizer faced more than 10,000 claims that its menopause drugs caused breast cancer, according to lawyers for former users. Those lawsuits included more than 8,000 cases consolidated in federal court in Arkansas and suits in state courts in Pennsylvania, Nevada and Minnesota.
Pfizer in May disclosed the $772 million reserve and said it had resolved a third of the cases, or about 3,300. The November filing indicates Pfizer officials have now settled almost 5,000 of the suits.
“Pfizer continues to have a strong record of success in defending these cases,” Chris Loder, a company spokesman, said in an e-mailed statement. “While we will continue to look for opportunities to enter into favorable settlements where appropriate, we will also continue to vigorously defend these medicines in litigation.”
Wyeth and Upjohn have now lost 10 of the 18 Prempro cases decided by juries since 2006. Pfizer got some of those verdicts thrown out or had the awards reduced. It resolved some of the verdicts through settlements, while other decisions are on appeal. Pfizer also has had cases thrown out before trial.
Earlier this month, a Philadelphia jury ordered the Pfizer units to pay $72.6 million in compensatory damages to three women who blamed the drugs for their breast cancers. Pfizer agreed to settle the case before jurors were asked to decide whether the company should face punitive damages. Terms of the settlements weren’t released.
The $260 million Pfizer has reserved for the remaining Prempro cases is only “an estimate” and “additional charges may be required,” the company said in the Nov. 10 filing.
Zoe Littlepage, a lawyer representing women suing Pfizer over the menopause drugs, said that reserve doesn’t provide enough compensation to spur settlements of outstanding claims.
“Based upon the size of the jury verdicts to date, and the fact that multiple appellate courts have now affirmed some of those verdicts, this new amount of money set aside by Pfizer seems grossly insufficient to resolve the remaining claims,” Littlepage said in an e-mailed statement.
The consolidated case in Arkansas is In Re Prempro Products, 03-CV-015070-WRW, U.S. District Court, Eastern District of Arkansas (Little Rock).