Tardive Dyskinesia Lawsuit Filed Over Reglan Use by Child

A Louisiana mother has filed a lawsuit over Reglan against several generic drug makers, alleging that the popular heartburn drug caused her daughter to develop tardive dyskinesia, which is a rare movement disorder that has been linked to long-term use of the medication. 

The tardive dyskinesia lawsuit was filed on September 27 by Dawn Harris, on behalf of her minor daughter, Coy Callahan in the U.S. District Court for the Eastern District of Louisiana. The complaint names as defendants Pharmaceutical Associates Inc. and its parent company Beach Products, Inc., as well as Morton Grove Pharmaceuticals, Inc. and Wockhardt U.S.A., which bought Morton in 2007.

Harris claims that her daughter took generic Reglan manufactured by Pharmaceutical Associates and Morton, who failed to provide adequate warning that long-term use of their product could cause tardive dyskinesia from side effects of Reglan.

Callahan was prescribed and given generic Reglan for at least two years, from March 2006 through March 2008. Harris claims she was never made aware that the drug was only safe to take for less than 12 weeks. 

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.

Long-term use of Reglan has been associated with an increased risk of tardive dyskinesia, which is a disorder that causes repetitive and involuntary movement, 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 Reglan tardive dyskinesia lawsuit 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. 

Harris’s lawsuit over generic Reglan alleges 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 generic 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.