Court Finds Makers of Generic Reglan Liable for Label Warnings

By Jim Greene

Published on January 29, 2010

Federal regulations do not excuse makers of the generic prescription drug metoclopramide from liability for its label warnings, according to the U.S. Court of Appeals for the Eighth District. The companies asked to be dismissed from a product liability/personal injury lawsuit by asserting that the makers of brand name Reglan® were solely responsible for label contents.

Generic makers argued that federal regulations require them to copy label warnings created by brand name makers. The court ruled that the labels on generics could deviate from those on brand names, making those who sold the generics independently liable.

The plaintiff in the case claims various makers of Reglan® and generic metoclopramide, typically prescribed for gastric disorders, were negligent in failing to adequately warn patients that taking the drug might cause tardive dyskinesia, a neurological disorder that she developed after four years on the medication.

Generic defendants are Pliva, Inc., Teva Pharmaceuticals, USA, Inc., Alpharma, Inc., UDL Laboratories, Inc.; Actavis Elizabeth, LLC, Purepac Pharmaceutical Company, and Wyeth, Inc. Brand name defendants are Schwarz Pharma, Inc. and Wyeth, Inc., which is included in both groups because it sells metoclopramide both as Reglan® and as a generic.

The U.S. District Court for the District of Minnesota dismissed the generic defendants by accepting their argument that their label warnings are dictated by those of the brand name defendants. The court effectively ruled that no one was liable in the case by dismissing the brand name defendants because the plaintiff had used only generics.

On appeal, the higher court ruled that regulations allow generic makers to deviate from the labels created by brand name makers, and that each company has a separate responsibility to ensure that labels are accurate and up to date. The generic makers were reinstated as defendants; the brand name makers were not.

If you developed tardive dyskinesia after taking metoclopramide, either as Reglan® or in generic form, contact an experienced product liability/personal injury attorney right away. You may be eligible for financial compensation for medical care, loss of income, and pain and suffering.

Comment on this article →