Wyeth asserts that because the FDA approved Phenergan and its warning label, patients such as Levine are preempted by federal law from bringing personal injury claims against it in state court. According to the doctrine of preemption, federal regulation takes precedence over state laws, which can vary significantly across the country.
Levine certainly makes a sympathetic plaintiff, and several justices have expressed dismay that a drug used to treat a relatively minor ailment (nausea) would be administered when it could lead to such devastating consequences. Furthermore, it seems the FDA had adequate warning of Phenargan’s dangers, given at least 20 people previously developed gangrene after receiving it, and drug giant Pfizer had already stopped administering anti-nausea drugs by intravenous injection after two amputations resulted.
It should be noted, however, that Levine already sued – and received a substantial settlement – from the clinic which faultily administered the drug to her. The case before the Supreme Court is not about compensating Levine; rather, it’s about federal preemption. Some say that preemption in necessary, at the very least for public policy’s sake, and I agree. It would be dangerous to allow juries, who generally lack the requisite medical background, to set safety standards for new drugs coming to market.
Ultimately, permitting juries to determine each medication’s safety profile will bog down the medical system in wasteful litigation and may even dissuade drug manufacturers from making their medications available on the market. Moreover, a lack of uniform regulations may lead drug manufacturers to incorporate under the laws of those states with the least stringent guidelines, allowing them to in effect bypass safety measures that would have been in place if federal regulations still governed nationwide. Finally, if erratic drug safety laws aren’t scary enough, the outcome of this case could set precedent in many industries, for example affecting automobile safety standards.
Instead of allowing juries to determine individual state safety standards, wouldn’t it be wiser to force federal regulators to improve their review procedures and tighten their standards?