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
not have a warning about the disorder, which causes involuntary muscle movements, when the women started using metoclopramide, but cautions were added to the drug’s label in 2009. As a result of misrepresentations on the warning label and a failure to warn about the dangers of prescribing the drug long-term, many in the doctors in the medical community have remained unaware that they could be exposing their patients to the risk of a permanent and disabling neurological condition by continuing them on the medication.

Long-term or high dose use of dopamine antagonists like metoclopramide, the drug contained in Reglan and its generic equivalents, substantially increase the risk of Tardive Dyskinesia side effects. In 2009, the FDA began requiring the makers of Reglan drugs containing metoclopramide to place a "black box" Tardive Dyskinesia warning, indicating that Reglan (metoclopramide) side effects have: "been shown to cause spasms and tics when used for long periods of time or at high doses.  The problems include uncontrollable movements of the limbs, face and tongue, and are usually irreversible, even after the patients stop taking the drug." Although the first Reglan lawsuit was filed in 1998, the number of claims has increased since the black box warning was added. The ruling is likely to have an impact on thousands of generic Reglan lawsuits that are pending in cases throughout the United States.