Supreme Court to Rule on Generic Drug Label Exemption Case


The United States Supreme Court has announced they will hear an appeal brought by generic drug manufacturers of metoclopramide. The appeal claims that federal laws mandating that generic labels mirror the labels of the original brand name drug should exempt them from liability in pharmaceutical injury lawsuits alleging the manufacturer failed to adequately inform consumers about the dangerous side effects of the drug.

Metoclopramide is the generic form of the drug Reglan, which is used to treat patients with gastrointestinal disorders. There has been clear evidence that consumption of Reglan and other metoclopramide drugs leads to an increased risk of developing tardive dyskinesia, a neurological disorder which causes repetitive and involuntary movements in the face and limbs. There is no cure for the disorder. In 2008, Reglan was pulled from the market leaving only generic alternatives.

The issue at hand in the current appeal is whether a generic drug manufacturer has the right to alter the label in order to warn the public of a known health risk not discussed on the label of the original drug. FDA policy requires the manufacturers of generic drugs to keep their labels consistent with the brand name label. However, an appeal in a lower court ruled that these laws do not limit a generic drug manufacturer’s ability to request a label change that warns of a health risk, nor do they prevent the manufacturer from taking other steps to warn consumers of the health risk.

The U.S. solicitor general had requested that the Supreme Court decline the appeal, claiming that the lower court’s ruling should remain. If the Supreme Court were to overturn the original ruling, it could have serious implications on the many pharmaceutical injury lawsuits against generic manufacturers of metoclopramide. Currently, there are hundreds of Reglan lawsuits pending across the country.