The Supreme Court's already substantial investment in defining the boundary between federal regulation and state tort law grew even bigger on Friday. The justices added two new cases to their docket on drug and cigarette labeling requirements.
In each case, as in four others the court has already agreed to decide in the current term, the question is one of federal pre-emption. The cases offer variations of a common question: if a product meets federal standards, can the manufacturer be liable for damages under state law for injuries suffered by consumers?
In the cigarette case, Altria Group Inc. v. Good, No. 07-562, the issue is whether state consumer-fraud laws can be used to sue cigarette makers for advertising a brand as containing low tar and nicotine.
Altria, the parent company of Philip Morris USA, argues that any finding of liability is pre-empted by the Federal Cigarette Labeling and Advertising Act as well as by the fact that the low-tar and low-nicotine descriptions are based on the results of a test required by the Federal Trade Commission.
The United States Court of Appeals for the First Circuit, in Boston, in a case brought under Maine's law prohibiting deceptive trade practices, rejected Altria's claim and reinstated a lawsuit brought by smokers who claimed that the packaging for Marlboro Lights and Cambridge Lights was deceptive. The plaintiffs argue that because smokers compensate for the lower nicotine by inhaling more deeply or smoking more cigarettes, any claimed health benefit from the brands is inherently fraudulent.
In the drug labeling case, the plaintiff was a guitar player who suffered the career-ending amputation of her right arm after being injected in a hospital with an anti-nausea drug made by Wyeth.
Gangrene and subsequent amputation was a risk from intravenous administration of the drug, Phenergan. The plaintiff, Diana Levine, argues that the federally approved label did not give doctors a specific enough warning about the risks of the method used to give her the drug.
The state courts in Vermont allowed Ms. Levine to sue for damages under state law and upheld a jury verdict of more than $6 million. The manufacturer's Supreme Court appeal, Wyeth v. Levine, No. 06-1249, argues that the lawsuit was pre-empted by the Food and Drug Administration's approval of the label.
The Bush administration, which reversed a longstanding policy against pre-emption in drug cases, is supporting the appeal. In a brief filed this month in response to the Supreme Court's request for its views, the administration said the agency's approval of the Phenergan label "reflects F.D.A.'s expert judgment that the labeling strikes the appropriate balance." The brief added: "Where, as here, F.D.A. was presented with information concerning the relevant risk, a jury's imposition of liability based on a drug's F.D.A.-approved labeling would interfere with F.D.A.'s expert judgment."
Nonetheless, the court's decision to grant Wyeth's appeal at this point was surprising. The administration urged the justices to defer action until they decide, later this term, another medicine-related pre-emption case that was argued last month.
That case, Riegel v. Medtronic Inc., No. 06-179, presents a question under a separate statute, the Medical Device Amendments, which governs the F.D.A.'s premarket approval process for devices like the balloon catheter at issue in the case. There is considerable overlap between that process and the one for approving new drugs under the Food, Drug and Cosmetic Act, which is at issue in the new case.
The court had also agreed to decide a third pre-emption case involving the F.D.A., concerning whether state law can be used to determine whether a manufacturer defrauded the agency in seeking approval for a drug application. That case, Warner-Lambert v. Kent, No. 06-1498, will be argued Feb. 25. The justices have not announced whether they will hear the new case in April or at the start of the new term in October.
The proliferation of pre-emption cases on the court's docket in part reflects the considerable turmoil in the lower courts over the complex issues involved. It also reflects a concerted effort by the business community to push for federal pre-emption as a shield against state courts.
The United States Chamber of Commerce filed a vigorously worded brief in the cigarette case that the court accepted Friday, emphasizing for the justices the "jurisprudential gulf" that separates various lower court rulings on whether federally approved or required product labels should be given pre-emptive effect against state tort liability.
Referring to the lower court's ruling in the cigarette case, the chamber's brief said that "if allowed to stand, the First Circuit's approach would Balkanize cigarette labeling, advertising, and promotion into a state-by-state endeavor," adding that "it is difficult to imagine a more powerful blow to the interest of nationwide uniformity and consistency."
The plaintiffs' brief to the court emphasized the factual allegations of their case: that Philip Morris knew from its own research that based on actual smoking habits, smokers received the same tar and nicotine from "light" cigarettes as from regular brands, but that the company kept this from the F.T.C.