As the U.S. Supreme Court took up the first case to address whether federal law preempts state personal injury suits against drug manufacturers, two justices appeared to openly favor preemption.

Justice Stephen Breyer asked whether an expert agency or "12 people pulled randomly for a jury" should decide whether a drug will save people or, on balance, hurt them. "It seems to me [it] is Congress' fundamental choice, and Congress has opted for the agency," Breyer stated during oral arguments on Feb. 25.

Justice Antonin Scalia seemed to agree. "What could be more central to the FDA's job than determining whether the conditions the FDA prescribed for the marketing of the drug have indeed been observed?" he asked.

The case before the court, Warner-Lambert v. Kent, involves a Michigan statute that allows someone to bring a product liability suit only if the manufacturer concealed information from the FDA. Michigan residents claim that Warner-Lambert concealed safety and efficacy information from FDA that would have prevented the diabetes drug Rezulin (troglitazone) from being approved or led to its earlier removal from the market.

At FDA's request, Warner-Lambert withdrew the drug in 2000 after safety data showed it was more toxic to the liver than two other drugs that had recently come on the market.

Conflict In The Courts

A district court had ruled in favor of Warner-Lambert, stating that if plaintiffs could litigate claims of fraud on the FDA, agency personnel could be repeatedly dragged into litigation. But the Second Circuit U.S. Court of Appeals overturned the decision last year.

The Supreme Court previously addressed the issue of fraud-on-the-FDA claims in 2001 in Buckman Co. v. Plaintiffs' Legal Committee. It concluded state claims that a manufacturer had committed fraud on the FDA "conflict with, and are therefore impliedly preempted by, federal law." The high court agreed to revisit the issue as the Second and Sixth Circuit Courts of Appeals have interpreted the opinion differently.

The litigation is one of three cases before the Supreme Court that question whether state product liability suits are barred by federal law. The court ruled in the first case, Riegel v. Medtronic, on Feb. 20, concluding in an 8-1 ruling that the preemption clause in the Medical Device Amendments of 1976 bars suits challenging the safety and efficacy of devices that have been given premarket approval by FDA.

Another case, Wyeth v. Levine, will be heard by the court during its next term. It addresses whether FDA-approved drug labeling provides immunity from litigation (¹ Also see "FDA Preemption Cases Expected To Stay On Top Of Legal Calendar In 2008" - Pink Sheet, 7 January, 2008., p. 20).

Who Decides The Risk-Benefit Ratio?

In the Warner-Lambert case, Justice Breyer framed the debate around the ability of FDA to determine the benefit-risk ratio of a drug.

Addressing Public Citizen attorney Allison Zieve, who argued on behalf of respondent plaintiff Kimberly Kent, Breyer stated: "What you want is to be able to convince the jury that there was fraud in a situation where the agency doesn't say there was fraud. So what you're doing is removing a drug from the market that they want out there. "

Zieve responded that the goal of the case is to get compensation for those who suffered serious liver damage from Rezulin.

Breyer returned to the issue, saying that if a drug is withdrawn "there may be just as many people on the other side who are dying, dead, no breadwinner, etcetera, because they didn't get a necessary drug." What worries me, he added, "is what happens if the jury is wrong."

Justice Ruth Bader Ginsberg, who was the sole dissent in the Riegel case, did not indicate her position on the current dispute. But she questioned whether litigation could interfere with FDA.

She noted that one of the charges in the case was that the original FDA examiner had recommended against approval of Rezulin and was later replaced with an examiner who favored approval. "Isn't that the kind of thing that the FDA would want to police itself and not have state courts look into?" she said.

Ginsburg also asked if taking depositions from examiners to find out what went on at the FDA would disrupt the agency. Zieve said it would be no more disruptive than product liability litigation in other states.

Devices May Lead The Way

The drug preemption cases before the court differ from Riegel since the regulation governing devices includes an explicit preemption provision. It specifies that no state may impose "any requirement" relating to safety and effectiveness of a medical device that "is different from, or in addition to" any requirement under federal law.

The Supreme Court found in Riegel, in an opinion written by Justice Scalia, that a state may provide a damages remedy only for claims "premised on a violation of FDA regulations." In her dissent, Ginsburg stated that Congress did not intend to supersede or modify state law in adopting a preemption clause.

She said the failure of the Medical Device Amendments to create any federal compensatory remedy for consumers injured by devices "further suggests that Congress did not intend broadly to preempt state common-law suits grounded on allegations independent of FDA requirements."

Ginsburg further argued that Congress' experience regulating drugs and additives informed, and in part provided, the model, for its regulation of medical devices. Nothing in the text of the Food, Drug and Cosmetic Act or legislative history "suggested that FDA preclearance would immunize drug manufacturers from common-law tort suits," she stated.

"Courts that have considered the question have overwhelmingly held that FDA approval of a new drug application does not preempt state tort suits," she continued. "Decades of drug regulation thus indicate, contrary to Medtronic's argument, that Congress did not regard FDA regulation and state tort claims as mutually exclusive."

- Brenda Sandburg (b.sandburg@elsevier.com)

Supreme Court Considers Whether Federal Law Blocks State Drug Tort Claims

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