A proposed settlement may resolve thousands of Reglan lawsuits filed by individuals nationwide who have been left with a severe movement disorder, known as tardive dyskinesia, after using the gastrointestinal drug.
Details of the agreement have not yet been disclosed, The Legal Intelligencer reports that the parties have reached a settlement that may resolve several thousand cases filed over risks associated with Reglan, including generic equivalents manufactured by Teva Pharmaceuticals, Pliva and Watson Laboratories.
Reglan and generic metoclopramide are approved for the short-term treatment of gastrointestinal disorders, such as diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, the medication has often been prescribed for longer periods of time due to the often chronic persistence of those ailments.
In 2004 and 2009, the FDA required the manufacturers of all medications containing metoclopramide to update the warning label, providing additional information about the increased risk of tardive dyskinesia associated with use of Reglan at high doses or for a long-period of time, which may cause users to experience involuntary muscle movements involving their face, lips, tongue, eyes, arms or legs.
Following the new tardive dyskinesia warnings, thousands of product liability lawsuits were filed against the developer of the drug, as well as several generic drug makers, alleging that information was previously withheld from consumers and the medical community about the potential Reglan side effects
Most of the claims have been filed against Teva Pharmaceuticals and its subsidiaries, Pliva, and Watson Laboratories, with about 2,000 cases pending in various different courts nationwide.
Following a controversial U.S. Supreme Court ruling issued in 2011, known as Pliva v. Mensing, which found that generic drug makers could not be held liable for failure-to-warn claims, since FDA regulations required that generic medications carry the same warnings provided with the brand name version, many of the generic Reglan lawsuits have faced dismissal.
It is unclear how broadly the Reglan settlement will be applied and who will be able to participate.