Generic Reglan Lawsuits In Question While Brand Name Lawsuits Still In Court

In a devastating opinion for consumers, the Supreme Court has ruled that generic drug companies cannot be held liable for failing to warn about known side effects of medications they sell, so long as their labels are identical to those of the original brand-name product.  The ruling may have an impact on thousands of generic drug lawsuits filed throughout the United States, involving problems with generic versions of drugs like Reglan, Accutane, Darvocet, Zocor and others. In the recent Reglan lawsuit brought to trial,  the 5-4 decision in Pliva Inc. v. Mensing was handed down by the Supreme Court today, split along ideological lines among the justices.

The case before the court, Pliva Inc. v. Mensing, involved metoclopramide, which is sold under the brand name Reglan. Reglan was approved in 1980 as a treatment for digestive track problems. Two women had sued Croatia-based Pliva Inc. and other generic drug manufacturers for failing to provide warnings about Reglan tardive dyskinesia. Reglan did

Metoclopramide and Reglan Lead to Most Common Drug-Induced Movement Disorders

Although Reglan is marketed for treatment of conditions that are often chronic and long-term problems, the medication is only approved for use of less than 12 weeks, however many patients experience long term side effects of Reglan.  Since there is little benefit in treating a long term condition with a short-term treatment, many doctors continue their patients on the medications for more than three months.  In fact, about 30% of all prescribed metoclopramide drugs are taken for more than 12 months. Long-term or high dose use of Reglan, as well as other drugs containing dopamine antagonists like metoclopramide, substantially increase the risk of Reglan Tardive Dyskinesia.

The term "Tardive Dyskinesia" was first introduced in 1964, referring to repetitive, involuntary and purposeless movements.  The condition

Canada Raises Warning For Tardive Dyskinesia Risk With Reglan

Canadian health officials are requiring stronger warnings about the risk of movement disorders as side effects of Reglan, which is sold as generic metoclopramide. Reglan (metaclopramide) is designed for 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 left many users with the movement disorder. Reglan side effects have been linked to a risk of Tardive Dyskinesia, a permanent and disabling condition which causes repetitive, involuntary and purposeless movements, such as: grimacing, puckerinig or pursing of the lips, tongue protrusion or lip smacking, rapid eye movements and blinking and uncontrolled Movements of the Extremities and Fingers.

The new metoclopramide warnings were announced by Health Canada on July 20, providing additional information about the link between long-term use of Reglan and an increased risk of tardive dyskinesia, stating that “Tardive dyskinesia may develop in patients treated with metoclopramide. The elderly, especially elderly women, appear to be at increased risk. The risk appears to increase with treatment length and the total amount of drug taken. Reglan tardive dyskinesia is more likely to