Generic Metoclopramide Lawsuit Dismissed Against Makers of Reglan

A federal judge has dismissed Wyeth, Inc. and Schwarz Pharma, Inc. from a metoclopramide lawsuit filed in Texas over the development of the movement disorder tardive dyskinesia, as plaintiff never used the name brand medication Reglan sold by the drug makers. The case will proceed against only Activis-Elizabeth, L.L.C., which manufactured the generic Reglan version taken by the plaintiff.

The lawsuit was brought by Judith Finnicum last August in the U.S. District Court for the Eastern District of Texas, alleging that she developed uncontrollable movements after taking generic metoclopramide to treat gastrointestinal problems.

While the complaint included Wyeth and Schwarz, which originally developed metoclopramide and sold the medication as Reglan, U.S. District Judge Marcia A. Crone granted a summary judgment motion to dismiss the two drug makers from the litigation, indicating that the case will move forward only against Actavis-Elizabeth. According to a scheduling order in the generic metoclopramide lawsuit, the remaining parties are expected to be ready to try the case by early January 2011.

A number of similar lawsuits over generic metoclopramide and Reglan are pending in various courts throughout the United States against Wyeth, Schwarz and a number of generic drug makers. The cases all involve similar allegations that side effects of metoclopramide caused tardive dyskinesia, and that the drug makers failed to adequately warn about the increased risk associated with long-term use of the medication.

In June 2009, the U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the federal Reglan litigation. Therefore, all federal cases are proceeding as individual cases in courts across the country.

Reglan was originally introduced by Wyeth in 1989, and the drug company continued to market and distribute the drug through late December 2001, when Schwarz acquired the rights to Reglan. Schwarz continued to manufacture and distribute the drug until 2008, when they ceased production, leaving only generic metoclopramide versions. Since the mid-eighties metoclopramide generic has been manufactured by a number of companies.

While metoclopramide is only approved for short-term treatment of gastrointestinal disorders, like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying, it is often prescribed for longer periods of time given the chronic persistence of those ailments. Use of metoclopramide for more than 12 weeks has been shown to increase the risk of tardive dyskinesia and other movement disorders, and plaintiffs allege that Wyeth and Schwarz failed to adequately research their medication and attempted to minimize the risk.

Tardive dyskinesia is a neurological disorder that causes repetitive and involuntary movements of the lower face and limbs. Symptoms can include repeated grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment for the problems from metoclopramide, and the involuntary movements often persist even after use of the drug has stopped, contrary to what was suggested on the warning labels for Reglan and generic metoclopramide drugs.

In February 2009, the FDA required that the manufacturers of all metoclopramide-containing drugs add a “black box” warning about the risk of metoclopramide tardive dyskinesia problems. In addition, the manufacturers were required to develop a mitigation and risk evaluation strategy to help ensure that patients are made aware of the potential side effects of metoclopramide.