The US Supreme Court recently held that federal approval of drug labelling does not prevent state law claims against the drug’s manufacturer for alleged failure to warn of the risks of the product.  

In Wyeth v Levine 555 US ___ (2009), the Supreme Court held by a majority of six to three that labelling approval by the US Food and Drug Administration (FDA) does not automatically pre-empt state law and so protect pharmaceutical companies from product liability claims. In so doing, it departed from an earlier ruling that shielded manufacturers of medical devices from liability in similar circumstances. A day after the decision, Democratic lawmakers in the House of Representatives and the Senate proposed new legislation that would make it easier to bring claims against manufacturers of medical devices.  

A jury awarded $6.8m in standard damages to Mrs L evine, a professional musician from Vermont whose arm had to be amputated following an incorrect injection of the anti-nausea drug Phenergan manufactured by Wyeth. The jury found that the drug’s labelling had not adequately warned about the risks of the technique that was used to inject it.  

Wyeth contended that the claim was pre-empted by federal law because the Phenergan label had been reviewed and approved by the FDA. The company argued that FDA regulations prohibited it from strengthening the warning without the agency’s approval and that any attempt to do so would run contrary to the legislator’s intention to entrust the FDA alone with complex scientific labelling questions.  

The Supreme Court was not persuaded. It agreed with Wyeth that a drug manufacturer may generally change a drug label only once the FDA had approved the change. However, the court said the FDA regulations allowed certain pre-approval labelling changes to add or strengthen a warning, in particular through the so-called ‘changes being effected’ provision. It was therefore not impossible for Wyeth, said the court, to comply with its state law duties on which the claim was based and the federal labelling duties under the FDA regulations.  

The Supreme Court agreed with Wyeth that federal laws and regulations can in some cases pre-empt conflicting state law requirements and therefore product liability claims based on state law. However, the history of the Food, Drug and Cosmetic Act showed, according to the court, that the legislator did not intend to pre-empt product liability claims against drug manufacturers.