Reglan Litigation Will Not Be Consolidated in MDL

The U.S. Judicial Panel on Multidistrict Litigation denied a request to consolidate the federal Reglan litigation over tardive dyskinesia and other neurological injuries associated with the long-term use of metoclopramide drugs.

Following a hearing on May 28, 2009, the panel issued an order on June 3 indicating that they were not persuaded that centralization of 11 different Reglan lawsuits before one judge for coordinated handling during pretrial litigation was appropriate.

Reglan (metoclopramide) is a drug approved for the short-term treatment of gastrointestinal disorders like diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. However, it is often prescribed for longer periods of time due to the often chronic persistence of those ailments, which has been shown to increase the risk of tardive dyskinesia and other injuries.

Tardive dyskinesia is a neurological disorder that causes repetitive and involuntary movements of the lower face and limbs. Symptoms can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the disorder, and involuntary movements can become permanent, persisting after use of the drug has stopped.

The lawsuits over Reglan all involve common allegations that the manufacturers failed to adequately investigate and study their drugs, or warn about the potential tardive dyskinesia side effects of Reglan associated with use over longer periods of time.

Plaintiffs were seeking to consolidate the Reglan litigation during pretrial proceedings in an MDL, or Multidistrict Litigation, to eliminate duplicative discovery, avoid conflicting rulings and serve the convenience of the parties, witnesses, attorneys and the courts.

The order denying transfer indicated that while the cases do involve common factual issues about whether Reglan causes tardive dyskinesia, there is no single common defendant and many of the generic drug makers are only involved in a few of the cases. In addition, they were not convinced that the remaining common questions or fact were sufficiently complex or numerous to justify consolidation.

“Metoclopramide litigation has a lengthy history, and record indicates that a significant amount of the common discovery has already taken place,” the panel’s ruling stated, siding with defendants, who argued against the formation of an MDL at the hearing.

The drug makers told the panel that consolidation was not necessary, pointing to more than 20 years of Reglan litigation since the first case was filed in 1998. Since then, more than 70 Reglan lawsuits have been filed in state and federal courts throughout the United States, and the manufacturers pointed out to the panel that 80% of those cases have been resolved.

In February 2009, the FDA required the manufacturers to place a “black box” warning about the Reglan tardive dyskinesia risk, and a medication guide will be distributed with the drug informing patients about the potential side effects.

Reglan lawyers who are investigating potential cases on behalf of individuals diagnosed with tardive dyskinesia suggested that the new warnings will likely lead to an increase in the number of lawsuits that will be filed. However, without an MDL, those future cases will proceed as individual lawsuits and will not be formally coordinated.