Pharmaceutical

Makers of generic Reglan liable for inadequate warning labels

Makers of generic drugs who do not adequately label their products to warn consumers of possible risks are not exempt from liability, according to a ruling by the U.S. Court of Appeals for the Eighth Circuit. The court ruled on a product liability lawsuit brought by Gladys Mensing, who was prescribed metoclopramide to treat diabetic gastroparesis, a debilitating condition in which the stomach empties too slowly. Following use of the medication, Mensing developed a serious movement disorder known as Tardive Dyskinesia. Research has shown that the condition can be caused by long-term use of metoclopramide. Mensing sued several makers of generic metoclopramide, known by the brand name Reglan, for not adequately warning consumers of the risk of developing the movement disorder.

Generic drug makers successfully argued in district court that a Food and Drug Administration  (FDA) regulation that required generic drugs to carry the same labels as their brand-name equivalents conflicted with the failure-to-warn claims. However, the Eighth Circuit Court overturned the dismissal resulting in a victory for Mensing.

It proved too late for Mensing, but earlier this year the FDA issued a black box warning for Reglan (metoclopramide), advising physicians to avoid long-term use of the drug except in rare cases where the benefit outweighs the risks. Long-term users and elderly patients, especially women, are at an increased risk for developing the serious movement disorder. There is no known cure for Tardive Dyskinesia, even after the medication has been discontinued.

Patients currently taking Reglan or the generic metoclopramide should discuss any risks or side effects with their health care provider.