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Editor: Katharine Van Tassel
Akron Univ. School of Law

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Wednesday, March 4, 2009

Wyeth v. Levine: No Preemption

In Wyeth v. Levine, the Supreme Court in a 6-3 vote held today that a drug manufacturer's compliance with federal (Food and Drug Administration) regulations did not preempt the ability of an injured plaintiff to sue that manufacturer in state court.   According to the Washington Post,

The Supreme Court on Wednesday upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea for limiting lawsuits against drug makers.  In a 6-3 decision, the court rejected Wyeth Pharmaceuticals' claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont. . . .   The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.

A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein, a method called IV push. Gangrene is likely if the injection accidentally hits an artery _ precisely what happened to Levine.  The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the Food and Drug Administration, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.

Justice John Paul Stevens, writing the majority opinion, said Wyeth could "unilaterally strengthen its warning."  Stevens said he was persuaded that until a recent change by the FDA, the agency "traditionally regarded state law as a complementary form of drug regulation" because it monitors 11,000 drugs.  Justice Clarence Thomas agreed with the outcome of the case, but did not join Stevens' opinion.  Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia. . . . 

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