Supreme Court Considering Generic Reglan Tardive Dyskinesia Appeal

The U.S. Supreme Court has asked the Obama Administration for its opinion 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 they are cloning. The request comes as the justices consider whether to hear an appeal in a tardive dyskinesia lawsuit over generic Reglan. 

The appeal is being pursued by generic drug makers including Teva Pharmaceuticals, Actavis Elizabeth and UDL Laboratories, who are attempting to be dismissed from lawsuits over generic Reglan (metoclopramide).

In the complaints, users allege that the drug makers failed to adequately warn about the risk of movement problems, such as tardive dyskinesia, from side effects of Reglan. Actavis and the other generic drug makers argue that the claims should be preempted by federal laws governing generic drug labeling, which require generic drugs to carry the same label as the brand name medication.

In an order issued this week, the Supreme Court invited the Solicitor General to file briefs in the cases expressing the views of the United States.

At issue on appeal is whether a generic drug manufacturer can change its label or otherwise warn the public of a health risk before the maker of the brand name 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.

Brand-name Reglan was originally formulated and marketed by Wyeth, but it is currently only available as generic metoclopramide. Although the drug is only approved for short-term use, taking the drug over longer periods of time has been linked to an increased risk of tardive dyskinesia from Reglan, with symptoms that can include uncontrolled lip smacking, grimacing, repetitive chewing, rapid eye movements and blinking, pursuing and puckering of the lips, tongue protrusion, impaired finger movements and involuntary movements of the extremities. The movement disorder can be permanent and irreversible in many cases.

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.

There are a large number of generic Reglan lawsuits over tardive dyskinesia warnings pending in state and federal courts throughout the United States. 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, all lawsuits over Reglan are proceeding as individual claims in various courts throughout the United States.