Supreme Court rejects limits on drug lawsuits

Edited from article by Mark Sherman, Associated Press Writer

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. Levine, 63, struggled with her emotions when told of the ruling in a phone call from an Associated Press reporter Wednesday: “Oh, my God. I’m so, so happy. I can’t believe this phone call,” she said.

“I’ve been waiting for so long, and I had no idea of what the chances were. I’m just ecstatic. I’m going to have to sit down,” said Levine, once a professional guitar and piano player. She now plays with one hand, and sings.

Levine’s lawsuit said she wasn’t sufficiently warned of the risks of using Phenergan. But Bert Rein, a Washington lawyer who represents Wyeth, said the company’s label complied with federal law.”The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product’s label,” Rein said in a statement.

Wyeth is in the process of being bought by rival Pfizer, Inc., in a $68 billion deal that is expected to close later this year.

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

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. Stevens said there could be circumstances where consumer lawsuits would not be allowed, including if the FDA had considered and rejected a stronger warning label.  But that was not the case with Phenergan, he said. “As we have discussed, the FDA did not consider and reject a stronger warning against IV-push injection of Phenergan,” Stevens said.

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