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withdrawn from the market in 2000 because of liver toxicity.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
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.▪