Georgia Injury Law Blog
The United States Supreme Court heard oral argument in November in a case called Wyeth vs. Levine.The case comes out of a Vermont Supreme Court decision.Diane Levine was a musician who suffered from migraine headaches.A physician’s assistant administered the drug Phenergan during a “push-IV” injection.The PA accidentally injected the drug into Levine’s artery instead of a vein.This caused tissue necrosis, gangrene, and the eventual amputation of her hand and forearm.
The drug Phenergan, manufactured by Wyeth, had a warning label that warned of this risk if the drug was injected into an artery.The Federal Drug Administration (FDA) had approved the label.Levine warned that the label did not warn of the risks associated with hitting an artery during a push-IV. A Vermont jury awarded Levine $6.8 million against Wyeth.Wyeth argued that the approval by the FDA constituted pre-emption by federal law of state law tort claims.The Vermont appellate courts upheld the verdict, and Wyeth appealed at the federal level.
The United States Supreme Court is now considering whether federal law supersedes state law in drug labeling cases.Currently, state law could supercede federal requirements if new information became available about the drug or the FDA failed to disclose certain risks. In this case, however, Wyeth knew of the risk of harm and did in fact warn of the risk.The risk of harm caused by injecting into an artery is a 1 in 20 million chance of a gangrene adverse reaction. Levine argues the warning should have been stronger, specifically that the push-IV method increased the risk of hitting an artery.