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March 4, 2009

Supreme Court Finds No Preemption in Wyeth v. Levine

In a much-anticipated decision released today, the U.S. Supreme Court ruled that state common law product liability claims against prescription drug manufacturers are not preempted by the federal Food & Drug Administration's approval for marketing of the drug and its label.  Diana Levine was injured when she was injected with Wyeth's anti-nausea drug, Phenergan.  The drug was adminstered by the "IV-push" method in which the drug is injected directly into the patient's vein.  But the drug entered an artery instead.  Levine developed gangrene as a result, a risk known to Wyeth, and had to have her arm partially amputated.  A Vermont jury found that Wyeth failed to warn adequately about the risks of administering the drug by this method.  The trial court rejected Wyeth's argument that this claim was preempted because the drug's label had been approved by the FDA and the state's supreme court upheld that ruling.

Writing for a 6 - 3 majority, Justice Stevens said that there was no direct conflict between federal and state law that would make it impossible for Wyeth to both comply with the FDA's labeling requirements and to make the Phenergan warnings stronger.  The FDA had not specifically considered and rejected a stronger warning and, under the agency's regulations, Wyeth could have unilaterally strenghthened the warnings regarding the risks of IV-push administration.  Nor, said Stevens, would compliance with state law create an obstacle to achieving an important federal purpose.  No weight should be given to the FDA's 2006 "preemption preamble" asserting that state law represents such an obstacle.  That agency interpretation of the law is inherently suspect in light of the FDA's failure to offer interested parties notice or opportunity for comment on the preemption question; it is at odds with the available evidence of Congress' purposes; and it reverses the FDA's own longstanding position that state law is a complementary form of drug regulation without providing a reasoned explanation, said the court.



March 4, 2009 | Permalink


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