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. â€œCongress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness,â€ 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 Wyethâ€™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.