The U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguments today about whether to consolidate all lawsuits involving Reglan and generic metoclopramide drugs, which have been linked to an increased risk of a serious movement disorder known as tardive dyskinesia.
A motion to form an MDL, or Multidistrict Litigation, was filed on behalf of plaintiffs in 15 Reglan lawsuits pending in 11 different district courts throughout the United States, asking the Panel to consolidate all cases before one judge for pretrial proceedings to eliminate duplicative discovery, avoid conflicting rulings and serve the convenience of the parties, witnesses, attorneys and the courts.
Reglan is the brand name for metoclopramide, which is prescribed to treat gastrointestinal disorders like diabetic gastroparesis, GERD (gastroesphageal reflux and delayed gastrict emptying. Although the medication is only approved for short term use of up to 12 weeks, it is often prescribed for longer periods and at higher doses, which substantially increases the risk of Reglan tardive dyskinesia side effects.
Tardive dyskinesia is a neurological disorder that causes involuntary and repetitive movements of the lower face and limbs, such as lip smacking and pursing, chewing, grimacing, rapid eye movements and impaired finger movements. The condition is often permanent and there is no known effective treatment available.
The plaintiffs’ request for Reglan lawsuit consolidation is being opposed by the various pharmaceutical companies involved in the litigation, including Wyeth, who manufactured the brand name Reglan products, and several manufacturers of generic versions, such as Baxter, Pliva, Barr, Duramed, Actavis, Teva and Scwarz Pharma.
The drug makers have indicated that consolidation is not necessary, pointing to more than 20 years of Reglan litigation since the first case was filed in 1998. More than 70 metoclopramide lawsuits have been filed in federal and state courts, of which 80% have been resolved.
In oppositions filed before the hearing, the defendants pointed out that of the 15 Reglan lawsuits referenced in the motion filed by the plaintiffs, only 11 are at issue at this time, as four have been resolved. In addition, of the remaining cases, three are already “trial ready” with 2009 trial dates and another 5 cases have 2010 trial dates.
Transfer of the remaining cases would hinder the continued efficient resolution of the remaining cases, according to the defendants. In addition, with most of the generic discovery from the pharmaceutical defendants already complete, the drug makers point out that an MDL is not necessary.
In February 2009, the FDA announced that they are requiring that a new “black box” warning be added to all metoclopramide drugs about the tardive dyskinesia risks with Reglan, which some have speculated will lead to an increase in the number of lawsuits filed. However, the drug makers indicate that they believe the impact of the new warning will be minimal since the content was already on the label elsewhere.
Following today’s hearing, the Judical Panel on Multidistrict Litigation will determine whether consolidation is warranted and, if so, determine which jurisdiction the cases should be transferred to. The plaintiffs have suggested that the District of Nevada would be the best location. However, the defendants have proposed various other districts if the Panel establishes the MDL.