Lawsuits Over Generic Reglan Filed For Abnormal Movements

Two new lawsuits over generic Reglan have been filed by Louisiana residents who claim that the anti-nausea drug caused them to develop abnormal movements as part of a disorder known as tardive dyskinesia.  

The lawsuits were filed last month in the U.S. District Court for the Eastern District of Louisiana by Leslie Kiefer and Ellen Austin. Kiefer’s lawsuit was filed against generic Reglan manufacturer Qualitest Pharmaceiticals, Inc., and Austin’s lawsuit was filed against Actavis, Inc. and Watson Pharmaceuticals, Inc., who also make generic versions of Reglan. Both complaints allege that the companies failed to adequately warn that Reglan can cause tardive dyskinesia when used over long periods of time.

Reglan (metoclopramide) is approved for the short-term treatment of gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it is often prescribed for longer periods of time due to the often chronic persistence of those ailments, which has been shown to increase the risk of the rare abnormal movement disorder tardive dyskinesia.

Abnormal movements from tardive dyskinesia are repetitive and involuntary, usually involving the lower face and limbs. Symptoms can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the disorder, and the abnormal movements can become permanent, persisting even after use of the drug has stopped.

Although the first tardive dyskinesia lawsuit over Reglan was filed in 1998, the number of cases began to spike after the FDA required the manufacturers of all metoclopramide-containing drugs to add a “black box” warning about the potential Reglan problems in February 2009.

Reglan was originally developed by Wyeth, Inc. in 1989, and the drug company continued to market and distribute the drug through late December 2001, when Schwarz acquired the rights. Schwarz continued to manufacture and distribute the drug until 2008, when they ceased production, leaving only generic metoclopramide versions made by a number of different pharmaceutical companies. 

Generic Reglan lawsuits over abnormal movements claim that the drug manufacturers had access to data by Wyeth and Schwarz Pharma that showed that Reglan was linked to tardive dyskinesia. However, the generic drug makers allegedly ignored that information and promoted Reglan as safe for long-term use. The lawsuits say the companies knew or should have known about the side effects of Reglan and should have provided stronger label warnings regarding the risks. 

The lawsuits over generic Reglan claim that both Kiefer and Austin were unaware of Reglan tardive dyskinesia risks until they saw commercials in August 2009.