Divided Supreme Court Affirms Decision In FDA Preemption Case

David Lowe

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In the wake of last month's Supreme Court decision in Riegel v. Medtronic, holding that Federal Drug Administration approval of medical devices shielded manufacturers from product liability lawsuits by injured patients, concerns have mounted that the Court will confer similar protection to drug manufacturers whose products have received FDA approval. This would leave injured consumers to the protection of the understaffed and underfunded FDA, whose lapses in the approval of drugs such as Ketek and Trasylol have been discussed here.

Today, in a four to four split decision, with Chief Justice Roberts not participating, the Supreme Court affirmed the decision of the Second Circuit in Warner Lambert v. Kent,which held that a drug manufacturer that failed to warn the public about the dangers of its product -- and may have concealed key information from the FDA regarding the risks of the drug -- cannot hide behind a Michigan state law that provides immunity to prescription drug manufacturers. Oral argument in the Kent case was heard only last week.

Kent raised the preemption issue in the context of Michigan's somewhat unique statute that shields drug manufactures from product liability lawsuits if the drug was approved by the FDA unless it could be shown that the FDA was defrauded during the approval process. The drug involved in Kent was Rezulin, a diabetes drug that was withdrawn from the market after widespread reports of liver damage and deaths. Its manufacturer argued that federal law pre-empted the Michigan statute's statutory exception for instances where fraud was perpetrated on the federal agency. The Public Justice organization provided important assistance in the defense of the injured consumer. The amicus brief it filed in the Supreme Court can be viewed here.

Because of the 4-4 split and per curiam affirmance, the Kent case will be a minor footnote next to a more important case looming on the coming year's docket, Wyeth v. Levine, in which the Supreme Court has agreed to decide whether a musician who lost her arm after receiving the anti-nausea drug Phenergan via an off-label injection method may recover under Vermont tort law despite FDA approval of the drug's label. The Vermont Supreme Court ruled that the state court product liability lawsuit was not preempted by the FDA approval of the drug's label, a significant ruling for those seeking to preserve consumer rights. The Levine case is the likely forum for the definitive word on the implied preemption issue in pharmeceutical litigation. We'll be following the case closely.