In the case of Wyeth v. Diana Levine, the U.S. Supreme Court ruled in favor of Levine in 2008. The case revolved around a musician from Vermont named Diana Levine who lost her arm due to gangrene after being administered an anti-nausea drug called Phenergan by IV push method, which was manufactured by pharmaceutical company Wyeth (now part of Pfizer). She sued the company on state law grounds for failure to adequately warn about risks associated with this administration method and won damages at trial level. On appeal, Wyeth argued that federal law preempted state law claims because it had complied with FDA labeling regulations; however, the court rejected this argument stating that compliance with federal laws did not shield companies from liability under state laws if their product is found defective or unreasonably dangerous.

In the dissenting opinion for Wyeth v. Levine, Justice Alito, joined by Chief Justice Roberts and Justice Scalia, argued that federal law preempted state law in this case. They contended that the FDA's approval of a drug label after careful consideration should supersede any state-level judgments about its safety or efficacy. The dissenters believed that allowing juries to make determinations about drug warnings undermines the expert judgment of health professionals at the FDA who are better equipped to evaluate complex scientific data. Furthermore, they expressed concern over potential negative impacts on public health if pharmaceutical companies were deterred from developing new drugs due to fear of unpredictable liability exposure under varying state laws.