Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The U.S. Fifth Circuit Court of Appeals has found in favor with a lower court that patients may sue generic drug makers under state law for failing to provide adequate warnings about potential side effects with their drugs. The ruling extends a 2009 U.S. Supreme Court ruling governing makers of name-brand drugs. The issue of whether generic drug companies should be held liable for not adequately warning consumers has divided several district courts, which can increase the odds of a Supreme Court review in the future, according to U.S. Circuit Judge Patrick Higginbotham.

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Elizabeth Conte was prescribed Reglan, a brand-name of metoclopramide used to treat gastrointestinal conditions such as heartburn, GERD and gastroparesis. For four years she took the medication, unaware that she was slowly developing a debilitating and incurable movement disorder known as Tardive Dyskinesia. What she soon found out is that her involuntary head jerks and facial twitches were caused by long-term use of metoclopramide.

More and more cases of consumers taking metoclopramide and subsequently developing Tardive Dyskinesia were reported to the Food and Drug Administration (FDA), and by early 2009, the agency had ordered a black box warning be placed on the medication. New warnings and precautions were written into the drug’s packaging that included an up to 20 percent risk of patients developing Tardive Dyskinesia during long-term use of the medication.

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The Food and Drug Administration (FDA) has approved the safety labeling changes of the heartburn and gastroparesis medication Reglan (metoclopramide) which includes a black box warning of a serious and often irreversible movement disorder called Tardive Dyskinesia. The warning includes Reglan (metoclopramide) tablets, ODT (orally disintegrating tablets), and injection.

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