U.S. Supreme Court Rejects Federal Preemption Claims in Prescription Drug Labeling, ‘Light’ Cigarette Fraud Cases
The U.S. Supreme Court recently issued two resoundingly pro-consumer decisions rejecting federal preemption of state-law claims involving injured consumers.
In a March 4 ruling, the Court held 6-to-3 that federal law does not preempt lawsuits against prescription drug manufacturers for failing to warn of their drug’s dangers. Public Justice had filed amici briefs in both cases urging the Court to rule as it did.
Not long before that, in another case critical to consumers, the Court held 5-to-4 that federal law does not preempt – or. wipeout – lawsuits against tobacco companies for defrauding the public by advertising that their “light” cigarettes deliver less tar and nicotine than “regular” cigarettes.
Wyeth v. Levine
Wyeth was filed on behalf of a professional guitarist, Diana Levine, who lost an arm after an injection of the nausea drug Phenergan. She claimed that Wyeth failed to adequately warn of the drug’s risk and won a judgment of $6.8 million in a Vermont trial. The Vermont Supreme Court upheld the verdict, saying that the FDA’s approval of the drug’s label should not affect her ability to sue for her terrible injuries, which could have easily been prevented by a proper warning label. In the U.S. Supreme Court, both Wyeth and the United States took the position that the plaintiff’s claims were preempted by federal law because the drug’s label had been approved by the United States Food and Drug Administration (FDA).
The Court’s decision, authored by Justice Stevens, rejected this contention outright, holding that the mere fact of agency approval of the drug’s label does not absolve the manufacturer of its responsibility to warn the public of new risks that emerge over time. In so ruling, the Court first reaffirmed the strong presumption against preemption in cases involving “the historic police powers of the States.”
In light of that presumption, the majority went on to hold that the federal Food, Drug, and Cosmetic Act (FDCA) neither expressly nor impliedly preempts Ms. Levine’s claims. It also rejected the U.S. Food and Drug Administration’s new pro-preemption position under President Bush, holding that it “does not merit deference.”
Justice Stevens rebuffed the drug companies’ implied-preemption arguments in plain terms, stating “Wyeth contends that the FDCA establishes both a floor and a ceiling for drug regulation …The most glaring problem with this argument is that all evidence of Congress’ purposes is to the contrary.” The Court went on to emphasize, as our amici brief did, the important role damage suits play in protecting the public. It says, “The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information about their drugs, especially in the post-marketing phase as new risks emerge.
State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They also serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.”
Finding no pre-emption, the Court concluded, “Congress has repeatedly declined to preempt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight.”
Read the U.S. Supreme Court Decision in Wyeth v. Levine.
Altria v. Good
The Altria plaintiffs alleges that cigarette manufacturers, by touting Marlboro and Cambridge Lights as “light” and having “lowered tar and nicotine,” violated Maine’s prohibitions on fraudulent misrepresentation. They sought damages for having been tricked into purchasing cigarettes that are not, in reality, any “lighter” than regular cigarettes. The cigarette companies sought total immunity on the ground that federal law expressly and impliedly preempted the plaintiff’s claims. The Supreme Court rejected the defendants’ arguments on all counts.
As in Wyeth, the decision starts by reaffirming the presumption against preemption of state law, stating that “when the text of a pre-emption clause is susceptible of more than one plausible reading, courts ordinarily ‘accept the reading that disfavors preemption.’”
Against that backdrop, the Court held that the Act does not expressly immunize tobacco companies for making allegedly fraudulent statements, finding that the plaintiffs’ attempt to hold the tobacco companies liable for fraudulently advertising their cigarettes as “light” did not constitute a “requirement or prohibition” within the meaning of the Act’s express preemption clause.
Regarding implied preemption, the tobacco companies argued that the plaintiffs’ claims should be held preempted because they conflict with the FTC’s allegedly “long-standing policy” of “promoting the development and consumption of low tar cigarettes…” The Supreme Court rejected this argument without difficulty, noting that “[t]he Government itself disavows any policy authorizing the use of ‘light’ and ‘low tar’ descriptors.” Given the United States’ position that it “has no long-standing policy authorizing” the advertising of cigarettes as “light,” the Court rejected the tobacco companies’ implied preemption argument as meritless.
Public Justice’s amici brief in Wyeth was authored by Gerson H. Smoger, the President of the Public Justice Foundation, with assistance from Public Justice Staff Attorney Leslie Brueckner and Executive Director Arthur Bryant.
Public Justice’s amici brief in Altria was authored by Georgetown Law Professor David C. Vladeck. David Frederick of Kellogg, Huber, Hansen, Todd & Evans, PLLC, in Washington, DC, represented the plaintiffs before the US Supreme Court in both cases.
Read the U.S. Supreme Court Decision in Altria v. Good.