On November 3, the Supreme Court will review the case Wyeth v. Levine regarding whether FDA approval of prescription-drug label precludes any state lawsuit based on a claim that a better label was needed to make a drug safer. The plaintiff, Diana Levine, lost her hand and forearm to gangrene after she improperly received an injection of the nausea medication Phenergan into an artery during a push IV injection. Even though the FDA approved the Phenergan label, Levine sued the drug maker, Wyeth, in Vermont state court, alleging the company failed to provide adequate warnings on the label about the risks of push IV injections. The jury awarded Levine $6.8 million .
In its appeal to the Supreme Court, Wyeth argues that FDA approval of medication labels precludes lawsuits in state courts filed over alleged problems with the labels. It contends federal rules — not varying state standards — should control drug safety. To read the full story, click here.