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Generic Reglan Makers Lose Appeal Request in Vermont

-Ennislaw.com

04/22/2009 - A federal judge has handed four generic manufacturers of the heartburn medication Reglan another loss in their request to dismiss a product liability suit in Vermont. The ruling by Judge William Sessions of the U.S. District Court for the District of Vermont will not allow Actavis Elizabeth, Teva Pharmaceuticals USA, Pliva and Barr Pharmaceuticals to appeal a ruling that denied their motions for summary judgment and a stay of the proceedings in Ethel Kellogg v. Wyeth, et al., in which they are named among the defendents.

Reglan (metoclopramide) is prescribed for treatment of gastrointestinal disorders, and is only supposed to be used for under 12 weeks. However, it is often taken for extended periods of time. When used for extended periods of time or at high doses, Reglan side effects have been linked to an increased risk tardive dyskinesia. This condition causes repeated movements of the extremities and the face muscles. Some symptoms of tardive dyskinesia are lip smacking, tongue protrusions and rapid eye blinking.

The lawsuit against Reglan alleges that the risk of tardive dyskinesia was not adequately disclosed on the warning label and that the manufacturers were aware of the risks associated with long term use of their medications.

In February 2009, the FDA required that the manufacturers of all metoclopramide-containing drugs add a “black box” warning about the risk of tardive dyskinesia . The manufacturers were also required to develop a strategy to help ensure that patients are made aware of potential side effects of Reglan.

The makers of generic Reglan previously filed a motion for summary judgment in the Vermont case, arguing that they should be dismissed from the litigation because the plaintiff’s failure to warn claims are preempted by FDA regulations that require the generic version of medications to contain the same warning label as the branded version.

In December 2008, U.S. District Judge William K. Sessions III denied the motion to dismiss, and the drug makers filed a request for an interlocutory appeal to immediately challenge the Court’s decision and stay the proceedings.

In an order issued April 10, 2009, Judge Sessions denied the request. The generic drug makers will also be required to participate in discovery and further litigation of the case.

There are currently at least 15 Reglan tardive dyskinesia lawsuits involving similar claims pending throughout several districts in the United States. Plaintiffs in the claims have filed a petition with the U.S. Judicial Panel on Multidistrict Litigation to transfer the cases to one court for consolidated pretrial proceedings as part of an MDL.

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.