Wyeth Ordered to Face Lawsuit Over Menopause Drug Linked to Breast Cancer
Drug giant Wyeth must face a personal injury lawsuit filed by a woman who accuses the company of failing to warn her and millions of other users that the popular menopause drug, Prempro, might cause breast cancer, a Texas appeals court has ruled.
Susan Brockert sued Wyeth claiming the company did not adequately warn her and others about the risks associated with Prempro, a hormone-replacement drug. Wyeth also markets another hormone-replacement therapy drug called Premarin. As many as six million women took the drugs to treat hot flashes, mood swings, and other symptoms of menopause before 2002, when a study linked them to an increased risk of cancer. The drugs now carry warnings about the risk of cancer of the uterus.
Wyeth is now being acquired by another large drug company, Pfizer Inc., in a blockbuster deal valued at about $64 billion.
Federal Preemption Argument Defeated
A Texas appeals court recently ruled that Brockert’s claim is not preempted, or blocked, by federal laws regarding drug labeling. In doing so, the court overturned a February 2007 court ruling which had barred her claim.
As many as 5,000 of similar lawsuits alleging injuries from Prempro and Premarin have been in legal limbo for more than a year while the U.S. Supreme Court ruled on the issue of federal preemption as it applies to the labeling of drugs that have earned Food and Drug Administration approvals.
Drug companies, including Wyeth, have argued that they should not be held responsible for injuries blamed on insufficient product labeling once the drug’s labeling has been FDA-approved, but that legal argument has now been dealt blows by courts siding with injured patients.
The Supreme Court recently ruled against Wyeth in a landmark case regarding a different drug and held that injured patients may seek financial damages in their state courts for injuries caused by insufficient safety warnings on the products’ labeling.
That ruling is expected to set off a landslide of personal injury suits filed in state and federal courts alleging injuries caused by insufficient safety warnings on FDA-approved drugs.
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