Product liability lawsuit preemption by federal regulation is scheduled for oral argument before the U.S. Supreme Court on November 3, 2008. In 2000 a state court jury in Vermont awarded Diana Levine $6.5 million in a product liability lawsuit against Wyeth Pharmaceuticals. The outcome of Levine's case will have major ramifications for drug makers and consumers. The U.S. Supreme Court is expected to decide whether people can sue under state law or are pre-empted from doing so- for harm caused by a drug approved by the federal Food and Drug Administration.
In 2000 Diana Levine was prescribed an "IV push" of Phenergan to combat nausea brought upon by migraine headaches and pain killers she was taking. Unfortunately the "IV push" of Phenergan punctured an artery, causing her right arm to become gangrenous. After several weeks her right arm was amputated.
Levine sued Wyeth contending that the label of Phenergan should have more clearly warned about the danger of giving the "IV push." Combating an upset stomach with a method that can end up causing limb loss is an "unfathomable benefit-risk ratio" according to Diana Levine.
Wyeth maintains that when a drug like Phenergan has a federally approved label its manufacturer is immune from lawsuits in state court. Levine's position is that federaal regulation should represent the floor, not the ceiling, of a drug company's responsibility.
The Supreme Court of Vermont which affirmed the jury's verdict held that negligence and failure to warn claims on the labelling of an anti-nausea drug, "did not conflict with the FDA's labelling requirements...because Wyeth could have warned against the danger without prior FDA approval and because federal labelling regulations create a floor not a ceiling for state regulation." Levine v.Wyeth, 944 A. 2d 179 (Vt. 2006), cert. granted 128 S. Ct. 1118.
It is ironic that the Bush administration which has successfully pursued an agenda against federal regulatory oversight, will have its judicial appointees leading the way to eliminate pharmaceutical company liability utilizing federal regulations.