Reglan Makers Dismissed from Generic Metoclopramide Lawsuit

A federal judge has dismissed the manufacturers of brand name Reglan from a tardive dyskinesia lawsuit filed by a plaintiff who only took generic forms of metoclopramide. 

U.S. District Judge James J. Brady granted a Motion for Summary Judgment, allowing Wyeth and Schwarz Pharma, which developed the medication and sold the brand name version of Reglan, to be removed from a generic metoclopramide lawsuit brought by Robert S. Cooper in the U.S. District Court for the Middle District of Louisiana. The original complaint, which was filed in October 2009, also included several generic drug makers as defendants.

Judge Brady ruled that the plaintiffs can only recover damages from the manufacturer who actually made the product that caused them injury, even if that generic metoclopramide is nearly identical to Reglan, first made and marketed by Wyeth and Schwarz.

Similar rulings have been issued by other federal district courts in lawsuits over generic Reglan. In all of the cases, users claim that long-term use of generic metoclopramide caused them to develop a rare movement disorder known as tardive dyskinesia, and allege that the drug makers failed to adequately research the side effects of Reglan or warn about the risks associated with use over long periods of time.

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.

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.

All Reglan lawsuits pending in federal court against Wyeth, Schwarz and generic drug makers are not consolidated as part of an MDL, or multidistrict litigation. The U.S. Judicial Panel on Multidistrict Litigation denied a request to centralize the lawsuits last year, citing the number of different drug makers involved in the Reglan litigation. Therefore, all of the lawsuits are proceeding as individual claims in federal district courts throughout the country, with different judges sometimes ruling in conflicting ways on pretrial motions.