Healthy Skepticism Library item: 13107

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Publication type: report

Sandburg B
Supreme Court Reaches Tie Vote in FDA Preemption Case
2008 Mar 3

Abstract:

The U.S. Supreme Court deadlocked in a case addressing whether FDA drug
approval requirements preempt a state statute governing product liability
suits, thereby allowing litigation to proceed against Warner-Lambert.

Chief Justice John Roberts had recused himself from the case, Warner-Lambert
v. Kent, leaving eight justices to decide the matter. In a one-sentence
ruling, the court said the judgment of the U.S. Court of Appeals for the
Second Circuit “is affirmed by an equally divided court.”

“My clients won the case but no one won the issue,” according to Public
Citizen attorney Allison Zieve, who represented plaintiff respondent
Kimberly Kent. “For my clients, it’s as if the Supreme Court stage of the
case hadn’t happened.”

The plaintiffs claim 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 pulled 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.

Since there is no majority ruling, no precedent will arise from the
decision, added Bert Rein, a partner at Wiley Rein who represented the
Pharmaceutical Research and Manufacturers of America in its amicus brief in
support of Warner-Lambert.

The Supreme Court heard oral arguments on the case Feb. 25. At issue was a
Michigan statute that shields pharmaceutical companies from product
liability suits unless there is evidence the company misrepresented or
withheld material information from FDA in obtaining approval of its drug.
The question before the court was whether Michigan’s exception is impliedly
preempted by federal law.

With a tied ruling, the question remains unanswered. The court is to take up
preemption in a broader sense in Wyeth v. Levine, scheduled for the October
term. Lawyers involved in the litigation do not believe the Warner-Lambert
decision will have any impact on their case as it involves a different
issue.

Levine raises the question of whether state product liability claims can “be
preempted by the constitution,” Rein, who is counsel for Wyeth in that case,
stated. In Kent, the defense was not raised under the Constitution but under
Michigan law.

Warner-Lambert is the second preemption case the court has heard this year.
The first case, Riegel v. Medtronic, addressed whether FDA’s premarket
approval of a device’s design and labeling protects the manufacturer from
product liability suits in state courts. On Feb. 25, the Supreme Court ruled
that the preemption clause in the Medical Device Amendments of 1976 bars
suits challenging the safety and efficacy of devices that have received
premarket approval by FDA.

Drug product liability cases are different from medical device disputes as
there is no comparable preemption language in the law governing drugs. It is
unclear how the court will rule in Wyeth v. Levine although justice Ruth
Bader Ginsberg seems to lean in favor of the plaintiffs. She said courts
that have considered the question “have overwhelmingly held that FDA
approval of a new drug application does not preempt state tort suits.”