Generic Reglan Lawsuit Over Tardive Dyskinesia Warnings to Move Forward: NJ Court

A New Jersey appeals court has cleared the way for some failure-to-warn lawsuits against manufacturers of generic Reglan (metoclopramide) to proceed to trial, claiming that the generic drug makers delayed updating the warning label about the risk of users developing involuntary muscle movements, known as tardive dyskinesia.

Reglan and generic metoclopramide are approved for the short-term treatment of gastrointestinal disorders, such as diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, the medication has often been prescribed for longer periods of time due to the often chronic persistence of those ailments.

In 2004 and 2009, the FDA required the manufacturers of all medications containing metoclopramide to update the warning label, providing additional information about the increased risk of tardive dyskinesia associated with use of Reglan at high doses or for a long-period of time.

Following the announcement of the warnings revision, hundreds of Reglan lawsuits were filed against the developer of the drug, as well as several generic drug makers. Most of the litigation was centralized in New Jersey state court.

Following a controversial U.S. Supreme Court ruling issued in 2011, known as Pliva v. Mensing, which found that generic drug makers could not be held liable for failure-to-warn claims since FDA regulations required that generic medications carry the same warnings provided with the brand name version, many of the generic Reglan lawsuits have faced dismissal.

In a decision (PDF) issued on November 12, a three-judge panel from the Appellate Division of the New Jersey Superior Court found that some of the failure-to-warn lawsuits filed by against makers of generic Reglan can move forward.

The appeals court upheld a prior determination by the trial judge, which found that there was a gap between the announcement of new Reglan warnings in 2004 and 2009, and when some generic drug makers actually updated their labels.

“Here, the trial court correctly determined that Mensing did not foreclose plaintiffs from pursuing certain state-law claims based on the alleged failure to provide adequate warnings concerning generic metoclopramide,” the appellate court opinion states. “The court found that plaintiffs were precluded from claiming that the Generic Defendants should have employed ‘different or stronger’ warnings than those approved for Reglan. However, the trial court correctly determined that plaintiffs’ claims based on the Generic Defendants’ failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.”

All of the complaints involve plaintiffs who allege inadequate warnings were provided about the link between side effects Reglan and tardive dyskinesia, which can cause involuntary facial movements, such as grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the socially debilitating disorder, and the involuntary movements can be permanent, persisting even after use of the drug has stopped.

As a result of the U.S. Supreme Court decision in Mensing, hundreds of consumers who experienced the Reglan movement problems prior to the warning update have been precluded from pursuing lawsuits if they only used a generic version of the drug, even though lawsuits allege that the drug makers knew for years that the warnings were insufficient.

A number of lawmakers have been pushing the FDA to address the legal loophole, which even the Supreme Court noted left consumers who use generic equivalents unfairly imperiled, and the agency is in the process of finalizing new generic drug label regulations.