A Texas appeals court has ruled Wyeth must face a personal injury lawsuit filed by a woman who claims Prempro, a hormone-replacement drug, caused her breast cancer.
The court found, Susan Brokert’s “failure-to-warn” claims are not preempted - the legal notion that FDA approval of a drug supersedes state law claims challenging safety, efficacy, or labeling - by federal drug-labeling regulations.
In doing so, the court overturned a February 2007 ruling which had barred her claim.
The appeals panel cited the U.S. Supreme Court decision to uphold a $7 million award to Diana Levine, a musician that lost the lower half of her right arm when the nausea medication, Phenergan, was inadvertently injected into an artery which led to gangrene.
She successfully argued that, even though the labeling on the drug complied with FDA requirements, the labeling was inadequate for this particular method of administering the drug.
The higher court ruled that patients can sue drug-makers for failing to provide adequate safety warnings, even when a treatment and its packaging have been granted FDA approval.
Wyeth is the target of nearly 5,000 lawsuits over its drugs Premarin and Prempro, both hormone-replacement therapies (HRT). As many as 6 million women took these drugs to ease the symptoms of menopause before a 2002 study found HRT increased the risk of adverse events including blood clots, heart attack and breast cancer in hormone users.
Wyeth is being acquired by the Pfizer, Inc. in a blockbuster deal valued at $68 billion. #