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State Claim Not Preempted By Federal Drug Labeling Law

By Tony Mauro
March 31, 2009

The decisive March 4 U.S. Supreme Court ruling against Wyeth in a landmark pharmaceutical product liability case may also close off a major front in a hard-fought battle by businesses and the Bush administration to insulate national corporations from state tort litigation. By a 6-3 margin in Wyeth v. Levine, the Court ruled that the federal drug labeling law did not preempt the state court claim of Vermont musician Diana Levine, who sued when she lost her forearm in 2000 to gangrene because of improper administration of Phenergan. The labeling on the Wyeth-produced anti-nausea drug, she claimed, had failed to adequately warn medical personnel that the method used to give her the drug, an “IV-push,” was dangerous and could lead to gangrene.

“Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling,” Justice John Paul Stevens wrote for the majority. He also noted that until recent years, the Food and Drug Administration viewed state litigation as complementary to its regulations.

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