Editorial: Give patients proper drug info
Metoclopramide, a digestion drug that brought about a lawsuit about generic drugs Credit: Getty/Scimat
If you get the generic version of a drug when you have a prescription filled, you may lose your right to sue for compensation if it harms your health.
That's what two women discovered after metoclopramide, a drug each took for digestive problems, left them with tardive dyskinesia, a permanent neurological disorder characterized by uncontrollable muscle movements. Sufferers typically move their jaws as if chewing, repeatedly stick out their tongues, smack their lips and puff up their cheeks.
Gladys Mensing and Julie Demahy separately sued the companies that made the generics they took in 2001 and 2002, respectively, claiming their labels failed to provide adequate warnings about the side effects. Neither label reflected mounting evidence that long-term use carries a serious risk of tardive dyskinesia.
The U.S. Supreme Court dismissed their lawsuits in June. It found the companies can't be liable because the Food and Drug Administration requires them to use the same labeling as the equivalent brand-name drug and bars any changes. Had the women used the brand-name drug, Reglan, their lawsuits wouldn't have been tossed.
Congress or the FDA must close this loophole. A bill introduced Wednesday would permit makers of generic drugs to update warnings on their products. It's one possible approach.
About 80 percent of prescriptions in the United States are filled with generics. Congress encouraged their use with a 1984 law that allows generics manufacturers to skip the costly FDA approval process for a new drug if a generic is equivalent to an approved brand-name drug. The goal was to control costs, and it worked.
Generics saved consumers $931 billion from 2001 to 2010, according to the Generic Pharmaceutical Association, including $158 billion in 2010 alone. But unless the liability loophole is closed, consumers will be left with two bad choices: Either lose legal protections or shun generics in favor of more expensive brandname drugs.
To spare consumers that choice and to continue reaping savings from generics, Congress or the FDA must ensure someone is accountable when warning labels on generic drugs don't really warn.
