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preemption

A Texas appeals court has ruled that Wyeth must face a lawsuit by a woman who claims her breast cancer was caused by the hormone replacement drug Prempro, according to a Bloomberg article.  The appeals court cited the U.S. Supreme Court’s recent decision in Wyeth v. Levine rejecting Big Pharma’s argument that FDA approval barred lawsuits by people injured by prescription drugs.

Wyeth is defending about 5,000 lawsuits over its menopause drugs Prempro and Premarin. As many as 6 million women took the hormone-replacement therapies to ease menopause symptoms, such as hot flashes and mood swings, before a 2002 study showed a link to cancer.

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The U.S. Supreme Court has ruled 6-3 that FDA approval of a prescription drug label does not preempt state tort claims by persons injured by the drug, according to Bloomberg and other sources. “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,” Justice John Paul Stevens wrote for the court. The ruling affirmed a $7 million award to a musician who lost her arm after being injected with Wyeth’s Phenergan nausea treatment.

This settles an issue which has hung over consumers and the plaintiffs’ bar for several years. The Bush administration had agressively pushed for FDA preemption, as well as preemption in a number of other areas.

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