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Generic Reglan Tardive Dyskinesia Lawsuit : Not Preempted Judge Rules in Appeal Case

 

-Ennislaw

01/11/2010 -A federal appeals court said Friday that patients may sue generic drugmakers under state law for failing to provide adequate warnings about their medications potential side effects, extending a 2009 U.S. Supreme Court ruling governing makers of name-brand drugs.

The U.S. Court of Appeals for the Firth Circuit rejected the argument by a generic drug maker that federal law preempts a state-law failure-to-warn claim filed by a user of their generic Reglan, who developed a rare neurological disorder known as Tardive Dyskinesia.

The appeal involved a lawsuit filed by Julie Demahy against Actavis, Inc., which marketed a generic version of the brand name drug Reglan (metoclopramide) for treatment of gastrointestinal disorders. Demahy claimed that side effects of generic Reglan caused her to develop Tardive Dyskinesia.

Several other Reglan Tardive Dyskinesia lawsuits have been filed in courts throughout the United States. Plaintiffs allege that the manufacturers failed to adequately warn about the potential risk associated with long-term use of Reglan and its generic forms. Actavis and other generic drug makers have argued that the claims are preempted by federal laws governing generic drug labeling, which require that generic drugs carry the same label as the brand name medication.

In a decision filed on Friday, the U.S. Court of Appeals for the Fifth Circuit rejected Actavis’ argument, affirming the lower court’s finding that Dehamy’s state-law failure to warn claims are not preempted.

Brand-name Reglan was originally formulated and marketed by Wyeth, but it is currently only available as generic metoclopramide. Although the drug is only approved for short-term use, extended use has been linked to an increased risk of Tardive Dyskinesia. Symptoms may include uncontrolled lip smacking, grimacing, repetitive chewing, rapid eye movements and blinking, pursing and puckering of the lips, tongue protrusion, impaired finger movements and involuntary movements of the extremities. In some cases, the movement disorder disappears when the user stops taking the drug, but in other cases has been irreversible and permanent. There is no known cure for Tardive Dyskinesia.

In February 2009, the FDA required that manufacturers of all variations of generic metoclopramide add a black box warning about the risk of Tardive Dyskinesia. The drug makers were also required to develop mitigation and risk evaluation strategies to help ensure patients are aware of the potential metoclopramide side effect.

Tardive Dyskinesia Lawsuits: Reglan (Metoclopramide) Side Effects Lawyer:

The Attorneys at Ennis & Ennis, P.A. are actively accepting cases of Tardive Dyskinesia caused by Reglan (Metoclopramide) as well as other medications. If you or a loved one have suffered Tardive Dyskinesia as a result of a medication side effect you may be entitled to compensation. Contact the Tardive Dyskinesia Lawyers of Ennis & Ennis, P.A. today about your potential Tardive Dyskinesia lawsuit by calling toll-free or filling out our free case evaluation form on this page.

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