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.
The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the Food and Drug Administration, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.
Justice John Paul Stevens"™ opinion speaking for five Justices, and Justice Clarence Thomas"™ separate opinion joining in the result, provided in combination a reinforcement of these ideas: thatdrug companies are primarily responsible for keeping their warning labels up to date and complete (and may pay for it if they don"™t), and that the FDA not only needs to police the industry more closely "” even if itlacks resources "“but that it alsohad better have the clearest mandate from Congress before it tries to scuttlepatients"™ lawsuits in state courts.
Supreme Court Shoots Down Drug Company
