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Women suffering from movement disorder sues Reglan maker Wyeth
October 22nd, 2009 by Jennifer Walker-Journey
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.
But the warnings came too late for Conte, and for her doctor, who she alleges was unaware of the risks because Reglan’s maker, Wyeth, disseminated misleading and/or incomplete warnings about the drug’s side effects. She sued Wyeth, claiming the company knew of a widespread tendency among physicians to mis-prescribe Reglan and generic metoclopramide for long periods of time even though the medication is only approved for 12 months of use. The drug’s labeling, her lawsuit claimed, substantially understated the risks of serious side effects from extended use.
Initially, the trial court ruled in favor of Wyeth, which argued that it was the physician’s duty to warn patients of any ill effects drugs may have on patients. Conte appealed, arguing the drug’s manufacturer should be responsible. The Court of Appeal concluded that Wyeth was obligated to disseminate accurate product warning labels.
Source: Sierra Sun
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