Supreme Court to consider preemption in generic drug case

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January 6, 2011

Supreme Court to consider preemption in generic drug case 

Without a circuit conflict to resolve and against the advice of the U.S. Solicitor General’s Office, the Supreme Court has agreed to determine whether state law products liability claims against generic drug makers are preempted by federal law. The Court’s 2009 holding in Wyeth v. Levine finding no preemption in name-brand drug cases “would be substantially undermined if [the Court] held that it did not apply to generic manufacturers,” said Lou Bograd of the Center for Constitutional Litigation, who represents the plaintiffs.

Allison Torres Burtka

The Supreme Court held in Wyeth v. Levine in 2009 that state law products liability claims against name-brand drug manufacturers are not preempted by federal law. Now, the question is whether that decision applies to claims against generic drug makers.

The Court decided to hear Pliva, Inc. v. Mensing even though the two circuit courts that have decided the issue agreed that the claims were not preempted, and even though the U.S. Solicitor General’s Office—in a brief filed at the Court’s request—advised the Court not to take up the case. (No. 09-993 (Dec. 10, 2010).)

“The Court’s holding in Levine would be substantially undermined if [the Supreme Court] held that it did not apply to generic manufacturers,” said Lou Bograd, senior litigation counsel with the Center for Constitutional Litigation in Washington, D.C., who represents the plaintiffs.

In granting certiorari, the Court consolidated two cases: one involving Gladys Mensing from the Eighth Circuit, and one involving Julie Demahy from the Fifth Circuit. Both women developed tardive dyskinesia, a neurological movement disorder, from long-term use of metoclopramide, the generic version of Reglan.

The plaintiffs argue that the generic drug makers should have taken action to warn of this risk. “Despite mounting evidence that the risks of tardive dyskinesia were much greater than reflected in the product label, no manufacturer of metoclopramide ever proposed to the Food and Drug Administration (FDA) that the warnings on the metoclopramide label should be changed to reflect that greater risk,” Mensing argued in her brief in opposition to the petition for certiorari. The FDA began requiring a stronger warning on metoclopramide labels in 2009.

“Petitioners seek a special immunity from liability for generic drug companies … that is not available to name-brand drug companies or other manufacturers,” Mensing argued.

The defendants contend that because the Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act require the generic label to match that of the name-brand drug, they could not have changed their labels.

Because 70 percent of prescriptions are filled with generic drugs, the stakes are high. The plaintiffs say that if their claims are preempted, consumers injured by generic drugs would be left without a remedy, although a remedy is available to people injured by name-brand drugs.

The manufacturers argued in their brief that a ruling for the plaintiffs could “dismantle the very industry intended by Congress when it passed the Hatch-Waxman Amendments and frustrate the congressional design of Hatch-Waxman to make low-cost generic drugs widely available.”

The Fifth and Eighth circuits applied Levine and found no preemption. Mensing’s brief noted that every court to take up the issue since Levine has agreed.

Although the lower courts and the solicitor general agreed that the claims are not preempted, “there was disagreement about exactly what steps were available to the generic manufacturer,” Bograd said. The Supreme Court may have taken the case “to resolve what it perceived as confusion about the options the generic manufacturers had” to strengthen their labels, he said. These options included proposing a label change through the “changes being effected” process and through the prior approval process, providing information to the FDA, and sending “dear doctor” letters.

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