05/27/2010 12:11 pm ET Updated Nov 17, 2011

Reglan Lawsuits Spark Debate Over Generic Preemption, Corporate Immunity

The U.S. Supreme Court asked the Obama administration this week for its position on an appeal filed by generic drug manufacturers who argue that federal law provides them complete immunity from state lawsuits, even when their products cause serious harm to patients.

The request stems from an appeal filed by generic Reglan (metoclopramide) manufacturers following an Eighth Circuit decision in Mensing v. Wyeth last November. The generic manufacturers had claimed that federal regulation of pharmaceuticals preempts any lawsuits in state courts against their manufacturers. But in its opinion, the three-judge panel cited the 2008 Wyeth v. Levine Supreme Court decision, writing, "far from prohibiting [generic manufacturers] from taking steps to warn their consumers of new safety hazards, federal law requires such action."

The Food & Drug Administration approved Reglan for short term use - no longer than three months - in 1979 as a treatment for various gastrointestinal disorders. But last year, the FDA issued a black box warning, the strongest of its kind, for the drug and its generic forms, stating that the medication had "been linked to tardive dyskinesia." In fact, Reglan (metoclopramide) has been identified as the leading cause of TD among patients with the disorder in the United States.

Prior to the FDA's action last year, the very serious risks posed by the drug were not made clear to the public on its labeling. As a result, several lawsuits have been filed across the country against the drug's manufacturer. But because Reglan has been on the market for over three decades, there are generic versions of the drug available as well. In many lawsuits, the makers of these generic versions were named along with Wyeth, the name-brand manufacturer.

During the Bush administration, drug and device manufacturers had pushed preemption as a defense from lawsuits that arose in state courts, claiming that federal regulation by the Food & Drug Administration preempted any state tort claims attempting to hold them accountable for dangerous or defective products.

In Reigel v. Medtronic, the Supreme Court supported that claim, but the following year, the Court decided in Wyeth that, despite the FDA's role in approving prescription drug labels, manufacturers are responsible for updating those labels as new safety information becomes available.

Now, generic Reglan manufacturers are campaigning for complete immunity for themselves, appealing the Eighth Circuit's decision in Mensing. And while the Obama administration has not supported such claims in the past, it has pushed generic drugs as way to lower health care costs. As such, it is unclear where the administration will come down on generic manufacturers' claims of preemption now.

All drug manufacturers, whether name-brand or generic, must be responsible for the safety of their products. And when those products cause serious harm to patients, those victims must have access to the civil justice system. The Eighth Circuit, along with the Fifth Circuit in Demahy v. Actavis, has supported this view. Let us hope that the Obama administration does as well.

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