In a landmark move, an Alabama court is allowing a patient to sue the brand maker of acid reflux medication, Reglan (metoclopramide), over injuries he allegedly suffered over the generic version of the drug.
Last week, the Alabama Supreme Court ruled that the patient can sue Wyeth, the maker of Reglan, even though the injuries he allegedly suffered involved a generic version of the drug, said The New York Times. The man claims the brand name manufacturers neglected to warn about the drug’s risks.
The plaintiff, Danny Weeks, claims he developed tardive dyskinesia, a movement disorder, after taking generic versions of Reglan for his acid reflux. In addition to Wyeth, the developer of the brand name version, Reglan, Weeks also sued generic makers, Actavis and Teva, said The Times.
For now, the decision only applies to Alabama; however, attorneys with similar pending cases who have been barred from suing generic companies due to a United States Supreme Court Ruling, will likely be reading the decision, The Times pointed out. The 2011 Supreme Court decision was Pliva v. Mensing and the ruling stated that generic drug companies did not have control over their labels’ verbiage and were protected against being sued for failure to advise patients about their drugs’ risks, The Times explained. For the most part, generic makers must use the same labeling as their counterparts’ brand labeling.
In its decision, the Alabama Supreme Court ruled that “an omission or defect in the labeling for the brand-name drug would necessarily be repeated in the generic labeling, foreseeably causing harm to a patient who ingested the generic product,” according to The Times.
As we’ve previously written, symptoms of tardive dyskinesia include involuntary/repetitive movements of the extremities; facial tics; lip smacking, pursing, and puckering; face grimacing; tongue protrusion; rapid eye movements or blinking; impaired movement of the fingers; and Restless Leg Syndrome (RLS). There is no treatment or cure for tardive dyskinesia. Stopping Reglan or any of its generic versions may relieve some symptoms in some patients, in others, symptoms actually worsen when the drug is discontinued; the longer the treatment, the greater the risk, especially in senior women.
The Reglan and its generic versions work by helping to speed food through the stomach and intestines. In February 2009, the U.S. Food & Drug Administration (FDA) mandated that the makers of metoclopramide add a black box warning to its label regarding the risk of tardive dyskinesia associated with chronic, long-term use. The FDA’s mandate followed the publication of analyses that suggested that Reglan is the most common cause of drug-induced movement disorders. A black box is the FDA’s strictest safety warning. Metoclopramide treatment beyond 12 weeks should be avoided, unless the benefit is judged to outweigh the risk.
Tardive dyskinesia may not be easy to recognize in early stages and is more likely to be irreversible with long-term treatment (over 12 weeks) and, less frequently, can develop with short-term treatment at low doses. In these cases, the symptoms are likelier to disappear either partially or completely over time, once treatment has been stopped.
Scores of people from around the country have filed tardive dyskinesia lawsuits against Wyeth Pharmaceuticals, the maker of Reglan. Reglan tardive dyskinesia lawsuits allege that Wyeth Pharmaceuticals knew of a widespread tendency among physicians to misprescribe Reglan and promoted the drug for longer use despite the lack of safety data to support such uses.