Ellington

Yesterday, the U.S. Supreme Court ruled in favor of consumers and against drug makers, upholding a $6.7 million award to a musician who had her arm amputated following an injection.

Consumer groups such as Public Citizen are calling it a victory for all consumers.

Vermont defendant Diana Levine was a professional musician who played the guitar and piano. She received an injection of Phenergan from a medical technician for relief of migraine symptoms. The anti-nausea drug, made by Wyeth Pharmaceuticals, hit an artery, causing gangrene.

The complication is rare, and Wyeth mentioned its possibility in the drug's FDA warning label. The Supreme Court, however, said juries can award damages for harm as the result of unsafe drugs even if manufacturers satisfy federal regulations, according to The New York Times.

The ruling could have significant implications beyond drug manufacturing. Many companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.
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The Supreme Court has been sympathetic in recent years to arguments that federal law should pre-empt state injury suits. Last year, in Riegel v. Medtronic, an eight-justice majority of the court ruled that many state suits concerning injuries caused by medical devices were barred by the express language in a federal law. Wednesday's decision addressed implied pre-emption, a different legal standard.
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Justice John Paul Stevens, writing for the majority in Wednesday's decision, Wyeth v. Levine, No. 06-1249, said Congress could have required pre-emption in the case but had not. "Evidently," he said, "it determined that widely available state rights of action provided appropriate relief for injured consumers."

Justice Stevens noted that Congress did adopt just such an express pre-emption provision for medical devices in the law at issue in the Riegel case.

Until a recent change in policy under the Bush administration, Justice Stevens wrote, the drug agency had welcomed state injury suits as a useful complement to federal regulation. But in "a dramatic change in position" in 2006, Justice Stevens said, the agency reversed that longstanding policy not withstanding its "limited resources to monitor the 11,000 drugs on the market."

The agency's new position, Justice Stevens wrote, "is entitled to no weight." He was similarly dismissive of a brief supporting Wyeth filed by the Justice Department under former President George W. Bush, saying it was "undeserving of deference."

U.S. News and World Report said the decision is "likely to unleash a torrent of similar lawsuits around the country."

"Some trial lawyers who had been hesitant to bring claims against pharmaceutical companies are now going to be more willing to do so," Benjamin C. Zipursky, professor of law at Fordham Law School in New York City told U.S. News. "A number of cases that were stayed in state and federal court pending this decision will now go forward and go forward with a more plaintiff-oriented posture. This is going to change the balance of incentives for lawyers who are thinking about suing pharmaceutical companies to make them more willing to sue and make trial judges and appellate courts less willing to throw out weak cases."

In a separate editorial, The New York Times wrote: "The decision to permit state damage suits will give consumers another avenue of redress for injuries and should force the manufacturers to exercise greater care in production and labeling. We hope this decision will put the brakes on efforts to stifle damage suits in other areas as well."

As for Levine, she told a Bloomberg News reporter that she "collapsed into tears for quite a while and that turned into jumping up and down."

"It's not my arm, but it's just going to help so much in terms of my economic stress level," she said.