Supreme Court's Wyeth Ruling Deals a Blow to Preemption Defense

The U.S. Supreme Court ruled 6-3 in a case against pharmaceutical company Wyeth, concluding that the federal drug labeling law did not pre-empt the state court claim. The decision, however, is limited to this category of implied preemption in failure-to-warn claims.

Wyeth argued it was immune from liability because it had met the U.S. Food and Drug Administration’s requirements. In essence, Wyeth, and other industry players argued that federal regulations provide a ceiling on safety, not a floor. The Supreme Court disagreed, ruling that state laws do not interfere with FDA rules but are meant to enhance them. The Court acknowledged that the FDA, with its limited resources, cannot adequately monitor the safety of 11,000 drugs on the market and ensure that makers are properly warning of the risks.

The ruling involved Vermont musician Diana Levine, who lost her arm to gangrene after a common anti-nausea drug Phenergan was injected and hit an artery. The drug label's warnings had been approved by the FDA, but a Vermont jury found that Wyeth could have — and should have — made those warnings stronger.

Manufacturers have long lobbied Washington for low safety standards and then shielded itself from liability by claiming that those federal regulations are the final word on product safety, regardless of how old, how outdated or how weak they are. Known as “federal preemption,” many industries have spent millions on lobbying and campaign contributions to achieve this. The Bush Administration and Republicans in general, who typically champion "states' rights," have allowed federal preemption. During the Bush administration, agencies passed rules shaped by the companies they were supposed to regulate, then quietly inserted language to shield them from lawsuits. With the Supreme Court’s ruling, it is now clear, at least in the pharmaceutical drug context, that such efforts to preempt State laws will not be recognized.