Solicitor General Asks Supreme Ct. to Reject Generic Reglan Lawsuit Appeal

The U.S. Solicitor General has argued that the U.S. Supreme Court should reject an appeal by pharmaceutical companies in a generic Reglan lawsuit filed over a failure to adequately warn about the risk of tardive dyskinesia, a rare movement order associated with the gastrointestinal drug.

The manufacturers of generic metoclopramide are attempting to get the Supreme Court to reverse a decision by the 8th Circuit Court of Appeals and hold that they can not be held liable through the product liability lawsuit, as federal law prevents them from adding generic Reglan tardive dyskinesia warnings that were not on the original label for the name brand name product.

Earlier this year, the Supreme Court asked the U.S. Solicitor General to give its opinion in the generic Reglan appeal about whether generic drug makers should be held accountable for failing to adequately warn about side effects associated with their drugs, despite the fact that most are simply copying the label warnings from the original medication.

In an amicus brief (pdf) in response to the invitation, the U.S. Solicitor General supported the 8th Circuit’s ruling and asked the high court to reject the appeal.

“The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted, because a generic manufacturer, can (and indeed, must) inform FDA of new information about risks that may require a change in the labeling of its drug,” the Solicitor General stated. The brief also warns that there are a number of factors that make the lawsuit, originally brought by Gladys Mensing, of Minnesota, a poor test case for generic manufacturer preemption, and urged the court to decline to hear the appeal on those grounds as well.

Mensing claims in her lawsuit that long-term use of generic Reglan caused her to develop tardive dyskinesia, and the generic manufacturers failed to warn about the risks associated with extended use of the medication.

Tardive dyskinesia is a rare movement disorder associated with repetitive and involuntary movements, particularly involving the lower face and limbs. Symptoms can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. Long-term use of Reglan has been linked to an increased risk of tardive dyskinesia and there is no known effective treatment of the disorder, with the involuntary movements often persisting even after use of the drug has stopped.

At issue in the appeal is whether a generic drug manufacturer can change the label or otherwise warn the public of a health risk that was not placed on the label by the original manufacturer of the drug. FDA regulations require that generics seeking approval have the same label as the brand name manufacturer, and it also stipulates that the generic’s label has to remain consistent with the brand name label. However, the lower appeals court ruled that the regulations do not prevent generics from requesting a label change to warn of a health risk, nor do they prevent the drug company from other methods of warning the public, such as sending out a “Dear Healthcare Professionals” letter to warn of potential risks.

A number of similar tardive dyskinesia lawsuits over Reglan are pending in courts throughout the United States against generic drug makers. Brand-name Reglan was originally formulated and marketed by Wyeth, but it is currently only available as a generic metoclopramide.

In February 2009, the FDA required that manufacturers of all variations of generic metoclopramide add a black box warning about the Reglan tardive dyskinesia risk, which is the strongest warning that can be placed on a prescription medication. The generic drug makers were also required to develop mitigation and risk evaluation strategies to help ensure patients are aware of the potential metoclopramide side effect.

Although the first Reglan tardive dyskinesia lawsuit was filed in 1998, the number of claims has increased since the black box warning was added.

Last year, the U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the Reglan litigation for pretrial proceedings, finding that centralization in an MDL, or multidistrict litigation, was not appropriate because there is no single common defendant and many of the generic drug makers are only involved in a few cases. Therefore, claims being pursued by Reglan lawyers throughout the country are proceeding as individual claims in various courts throughout the United States.