Seeking tort resistance

The immediate impact of last week's U.S. Supreme Court decision on preemption in Wyeth v. Levine will likely be to cause companies to revisit their drug labels to determine if new safety information should be added in an attempt to make them tort-proof - or at least more tort-resistant. In the long-term, this could pile more work onto an already over-taxed FDA and result in labels with many more warnings, no matter how tenuous the link between the drug and potential side effects.

The case began in 2000, when Diana Levine received Phenergan via IV push at her local health clinic for nausea associated with migraine. Shortly thereafter, she developed gangrene and her forearm was amputated. Levine sued her doctor and the clinic, who settled out of court for an undisclosed amount. She also sued Wyeth under state tort law for failing to properly warn of the dangers of IV push delivery of Phenergan. The Vermont courts awarded her $6.8 million...