Generic Reglan Lawsuit Appeal Request Denied in Vermont

Four generic drug makers named as defendants in a Reglan lawsuit pending in the U.S. District Court for the District of Vermont have been denied the opportunity to pursue an immediate appeal the Court’s decision not to grant their motion for summary judgment, which was filed on the basis that they did not develop the drug’s warning label.

The lawsuit was filed on behalf of Ethel Kellogg against Wyeth, which manufactured the drug metoclopramide under the brand name Reglan, as well as four manufacturers who produce generic metoclopramide, including Teva Pharmaceuticals USA, Actavis Elizabeth, Barr Pharmaceuticals and Pliva.

Reglan (metoclopramide) is prescribed for short-term 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 and some estimates suggest that over 30% of all prescriptions are for more than three months.

When used for extended periods of time or at high doses, Reglan side effects have been linked to an increased risk of the user developing an involuntary movement disorder known as tardive dyskinesia. This socially disabling condition cause repeated movements of the extremities and the lower face, with symptoms like lip smacking, tongue protrusions, rapid blinking and impaired finger movements.

The generic Reglan lawsuit 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, yet they took no actions to discourage it.

In February 2009, the FDA required that the manufacturers of all metoclopramide-containing drugs add a “black box” warning about the risk of Reglan tardive dyskinesia problems. In addition, the manufacturers were required to develop a mitigation and risk evaluation strategy to help ensure that patients are made aware of the 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, which will require the generic drug makers to participate in discovery and further litigation of the case.

There are currently at least 15 Reglan tardive dyskinesia lawsuits pending in different districts throughout the United States involving similar claims. 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.

Plaintiffs argue that consolidation will allow all of the different cases to be handled in a coordinated manner, which will help prevent conflicting rulings by different judges, eliminate duplicative discovery and serve the convenience of the parties, the witnesses, the attorneys and the court.