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High Court sides with generic drug makers in narrow ruling
By Bill Mears, CNN Supreme Court Producer
June 23, 2011 6:04 p.m. EDT

Washington (CNN) -- Two women who say they suffered severe medical complications from a generic drug lost their Supreme Court appeal Thursday, essentially ending their separate lawsuits against pharmaceutical manufacturers.

The justices in a 5-4 ruling said generic drug companies do not share the same level of responsibility as makers of brand-name equivalents, to update their warning labels when significant new risks emerge.

Gladys Mensing of Minnesota and Julie Demahy of Louisiana both were prescribed metoclopramide -- marketed as Reglan by Wyeth Pharmaceuticals -- to treat their heartburn and acid reflux. Their pharmacists separately filled the prescription with a generic equivalent made by PLIVA, Inc. and Actavis, Inc.

After four years of taking the drugs, the women each developed tardive dyskinesia, a severe longterm neurological disorder that causes involuntary muscle movements.

They sued the generic manufacturers of the metoclopramide, claiming that inadequate warnings were provided about the long-term risks of taking the medicine. It was also alleged there was growing evidence of the dangers posed by the drug, but that the companies took no steps to change the warning labels.

In 2009, the FDA acted on its own and issued an order to the makers of both brand-name and generic versions of metoclopramide to add a specific warning about the increased risks of developing tardive dyskinesia.

The American Association of Justice -- representing trial attorneys -- said the ruling was "disastrous" for consumers. "Patients will now be taking generic drugs at their own risk," said the group's president Gibson Vance. "It is absurd that doctors and patients will have to make medical decisions knowing that only brand-name drug manufacturers -- not generics -- can be held accountable for their drugs' dangerous side-effects."