Generic Reglan Lawsuits Spring Up

Boston, MAMuch has been made about the link between Reglan and tardive dyskinesia. However, it was only recently that lawsuits concerning generic versions of Reglan began springing up, forcing the courts to make tough decisions.

Currently the courts must decide whether or not the makers of the generic Reglan are immune from liability. The generic drug manufacturers appealed a decision against them in the case Mensing v. Wyeth, claiming that federal regulation of pharmaceuticals preempts lawsuits in state courts. The judges disagreed, saying federal law required generic manufacturers to warn consumers about new safety hazards.

The US Supreme Court has asked the Obama administration for its opinion on whether manufacturers of generic drugs can be sued for allegedly inadequately labeling their products.

According to Dow Jones Newswires on 5/27/10, the lawsuit in question was filed by a woman who claimed to have developed a neurological movement disorder after using generic versions of Reglan. The plaintiff alleges that the risks associated with the drug were more serious than indicated on the label. Although the lawsuit was dismissed, an appeals court reinstated it.

Generic drug manufacturers Teva Pharmaceutical Industries Ltd. and Mylan Inc.'s UDL Laboratories argue the lawsuit is preempted by federal law because changing the label would force them to write labels that are different from those that appear on the brand name label.

Earlier in May 2010, the US Food and Drug Administration announced that a federal court ruled that Wyeth, maker of Reglan, cannot be held liable for injuries sustained by a patient who used generic Reglan. The US District Court for the Eastern District of Texas found that the plaintiff had only used generic Reglan, and therefore determined the manufacturers of brand-name Reglan could not be held liable for injuries.

The lawsuit against generic drug maker Activis-Elizabeth, LLC., is allowed to move forward. The lawsuit is expected to begin in early January 2011.

Lawsuits against both the brand name and generic Reglan manufacturers allege the defendants failed to properly warn patients about the risk of tardive dyskinesia associated with the medications. Plaintiffs further allege they were not warned about the risks associated with long-term use of the medications.