Consumers can still use certain state laws to sue pharmaceutical companies for personal injuries resulting from use of medications approved by the Food and Drug Administration (FDA)—at least for now, as the U.S. Supreme Court handed down a split decision in the Warner-Lambert v. Kent case in early March.
The lawsuit was brought by 27 Michigan residents who alleged that they suffered liver damage from the antidiabetic drug troglitazone, which was withdrawn from the market in 2000 because of liver toxicity. A Michigan law allows consumers to sue manufacturers on claims of fraud, namely, that the company defrauded the FDA and attained the agency's approval with deception.
The Supreme Court justices voted 4-4 on whether federal rules that regulate the pharmaceutical industry preempt Michigan's law, which allows consumers to bring such a suit. Chief Justice John Roberts recused himself from the case because he owns between $15,001 and $50,000 in Pfizer stock, the Associated Press reported in February. Pfizer acquired Warner-Lambert in 2000. The tie in effect upholds a previous decision by a federal appeals court, which ruled that the Michigan law was not preempted by federal regulations and that the suit could proceed.
This decision does not completely resolve the broader issue of whether consumers can sue pharmaceutical companies over FDA-approved indications of drugs and safety warnings. The Supreme Court faces another preemption case, Wyeth v. Levine, which may shed more legal light on the question of whether the FDA's approval of drug labeling precludes injury suits filed by consumers. In this case, Wyeth is challenging a multimillion-dollar judgment against it awarded to a vermont plaintiff whose arm was amputated after she had a severe reaction to an injection of the company's drug promethazine. Wyeth argues that the FDA-approved labeling information, which warns of the possible adverse effect, preempts the state liability laws and shields the company from the suit. No hearing date for the case has been scheduled, but according to the New York Times, the Supreme Court is likely to hear it in October.
In February, the Supreme Court handed down a decision in favor of medical-device manufacturers on similar preemption arguments. In Riegel v. Medtronic, the justices voted 8-1 that federal approval and regulation of medical devices preempt claims for personal injury based on state law.▪
