Press Release January 08, 2014

Goodwin Attorneys Prevail for Teva in Sixth Circuit Generic Drug Appeal

The United States Court of Appeals for the Sixth Circuit recently affirmed the Western District of Tennessee’s grant of a motion to dismiss for Goodwin client Teva Pharmaceuticals USA, Inc. in a products liability action involving the prescription drug metoclopramide. The Sixth Circuit’s ruling was based on the doctrine of federal preemption and, specifically, the United States Supreme Court’s June 2011 decision in PLIVA, Inc. v. Mensing, a victory Goodwin Procter helped achieve for Teva.

The appeal consolidated seven cases comprising the claims of more than two dozen plaintiffs who alleged that they developed a neurological movement disorder known as tardive dyskinesia as a result of using generic metoclopramide. After the Mensing decision was issued, the plaintiffs filed identical amended complaints. The generic manufacturers moved to dismiss the amended complaints, arguing that the plaintiffs’ various claims boiled down to the single claim that the generic manufacturers had failed to provide adequate warnings to medical professionals about the dangers of long-term use of metoclopramide. The generic defendants argued that this claim was preempted under Mensing because federal law prohibits generic manufacturers from unilaterally altering the warnings in their labeling, therefore generic manufacturers cannot simultaneously comply with both federal and state law. The district court agreed that Mensing controlled.

On appeal, the Sixth Circuit affirmed the district court’s dismissal of Teva and the other generic manufacturers, holding that plaintiffs’ claims are preempted based on Mensing, and the subsequent decision of the United States Supreme Court in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013) -- in which Goodwin Procter filed an amicus brief in support of the generic drug manufacturer -- holding design defect claims against generic drug manufacturers preempted. The Sixth Circuit rejected the plaintiffs’ arguments – the same arguments that other plaintiffs are making in jurisdictions across the country – that their claims are not preempted pursuant to Mensing because defendants allegedly failed to communicate the FDA-approved warnings to physicians (e.g., by mailing the package insert to physicians); because defendants could have complied with their obligations under both federal law and state law by suspending sales of metoclopramide; or on a theory of strict-liability design defect.

The Sixth Circuit also affirmed the district court’s dismissal of plaintiffs’ remaining so-called “failure-to-update” claim on a “Twiqbal” analysis. The Court did not reach the issue of whether the failure-to-update claim was preempted because plaintiffs had failed to allege the dates when they used metoclopramide made by specific generic manufacturers -- facts essential to show that a particular generic manufacturer’s label was not updated during the time that a particular plaintiff was using its product.

Goodwin Product Liability and Mass Torts partner Richard Oetheimer argued the Strayhorn appeal in the Sixth Circuit on behalf of Teva and other generic pharmaceutical manufacturers. The Goodwin team also included partner Jonathan Price, and associates Kate Seib and Carla Rose Karp.