Lawsuits Against Reglan
Reglan®, or metoclopramide, has been on the market for years, primarily as an anti-psychotic drug, before finding a niche as something that could aid in gastrointestinal disorders. The drug became a common prescription for heartburn, particularly for those who had tried other medicines and found them to be relatively ineffective.
Finally, in February 2009, the Food and Drug Administration (FDA) warned against metoclopramide to treat gastrointestinal disorders, saying chronic use of the drug is linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken. Today, multiple Reglan lawsuits have been filed regarding the manufacturer’s failure to provide sufficient warnings about the potential for movement disorders that could result from taking Reglan.
Tarver v. Wyeth
In the Louisiana metoclopramide lawsuit Tarver v. Wyeth, a report was filed stating that in general, therapy with metoclopramide tablets should not exceed 12 weeks in duration, as prolonged therapy and cumulative dose may increase the risk of developing tardive dyskinesia.
“Over the ten-year period from 1995 to 2004, there was a two-fold increase in the number of outpatient prescriptions dispensed for metoclopramide in the U.S. In 1995, the number of prescriptions dispensed for metoclopramide was almost 3.5 million. This number declined to less than 2 million prescriptions dispensed annually from 1997 to 1999, and then increased abruptly in 2000 and reached over 7 million prescriptions dispensed during 2004. The increase in dispensed prescriptions beginning in 2000 is likely due to the withdrawal of cisapride, a treatment for severe nighttime heartburn, from the U.S. market in March 2000. Almost 90% of the metoclopramide products dispensed were in an oral tablet dosage form.”
The report said that from 2000 through 2004 more than half of metoclopramide uses were for gastroenterology-related diagnoses. Elderly patients (aged 65 years and older) accounted for about a third of the visits in which metoclopramide was mentioned from 1995 to 1998, and the pediatric population (aged 0-16 years) increased steadily throughout the 10-year study period and constitute more than 30 percent of these visits in 2004.
Other Lawsuits Against Reglan
Many Reglan-related lawsuits have been filed in the U.S., such as Fields v. Wyeth and Forrester v. Wyeth. The Arkansas Reglan lawsuit, Fields v. Wyeth, was called a failure to warn case as the legal team representing Fields alleged that the black box warning for Reglan should have come sooner. Forrester v. Wyeth, a Georgia lawsuit, alleged that the manufacturer of Reglan, and the manufacturer of a generic metoclopramide product, concealed the side effects of Reglan.
The FDA has now enforced a black-box warning on metoclopramide products but, the warning has come too late for many. Several years passed before the medical community realized the risks associated with these drugs. If you have developed tardive dyskinesia or other side effects from using this drug, seek legal help immediately to protect your rights.