Pfizer Prempro lawsuits are being settled, according to a U.S. Securities and Exchange Commission (SEC) filing. At one time, Pfizer faced around 10,000 lawsuits involving its hormone medications, Prempro and Premarin.
Pfizer acknowledged paying $896 million for some 60% of cases against it that allege Prempro, its hormone replacement therapy (HRT) drug, caused breast cancer. To date, Pfizer has settled about 6,000 lawsuits claiming Prempro and other HRTs caused breast cancer, said Bloomberg.com. Pfizer set another $440 million for resolution of the remaining 4,000 lawsuits, according to the SEC filing. That reserve translates to over $1.2 billion to resolve claims that Pfizer’s Wyeth and Pharmacia & Upjohn units over allegations it never appropriately warned women about Prempro’s health risks. Pfizer is expected to pay about $150,000 per case, according to the filing, said Bloomberg.com.
Prior to release of study results in 2002 of the Women’s Health Initiative (WHI), over 6 million women took Prempro and other HRT medications to treat the symptoms of menopause, including hot flashes and mood swings, noted Bloomberg.com. The major study was conducted by the National Institutes of Health (NIH) and determined that some HRT medications significantly increased risks of stroke, blood clots, heart attacks, and breast cancer. The results were so alarming that the NIH canceled the study, citing risk to the study’s participants. WHI study researchers also suggested that many of the women who used the medications should quit and talk to their doctors about alternatives. Wyeth continues to sell the drugs.
Until 1995, many women going through menopause took a combination of Wyeth’s Premarin, an estrogen-based medication, with Upjohn’s progestin-based Provera. Wyeth combined estrogen and progestin in its Prempro pill, explained Bloomberg.com.
Current figures indicate that Pfizer and its units have lost 11 of the 21 cases it has faced over HRT drugs since 2006. Some verdicts were tossed after trial or saw reduced awards, some verdicts were resolved through settlements, and other decisions are on appeal, said Bloomberg.com. “After nine years of litigation involving this medicine, we are confident in our medicine, our track record of success in court where we have won eight of the last 10 final verdicts at trial, and in our ability to resolve these cases on appropriate terms,” Chris Loder, a Pfizer spokesman, said in statement emailed to Bloomberg.com.
This April, a federal jury in New Haven, Connecticut, ordered Pfizer to pay about $4 million in damages to one woman who was diagnosed with breast cancer; the panel also ordered the drug maker to pay out punitive damages for the way in which it handled Prempro. The judge is still deciding the punitive damage assessment, said Bloomberg.com. We also recently wrote that three breast cancer victims were awarded $72 million in damages following allegations they developed breast cancer after taking Prempro.
Meanwhile, we just wrote that analysis conducted by a federal task force has found that HRT risks outweigh its benefits, specifically in certain women and for certain reasons. The recommendation was recently published in the Annals of Internal Medicine and is largely based on a revised review of the massive WHI.