Plaintiff Ethel Kellog alleges that Wyeth, manufacturer of Reglan, knowingly wrote a false and misleading label for the medication. According to court documents, "The package inserts for metoclopramide products, and the PDR monograph for Reglan, contained false and/or misleading statements and omitted information material to the foreseeable and ordinary contemplated uses of the products."
The warning label states that certain reactions to metoclopramide (Reglan) are comparatively rare. However, those reactions are actually common when metoclopromide is used long-term—and Kellogg asserts that Wyeth and other makers of metoclopramide knew that the medication was commonly prescribed for long-term use.
The plaintiff says she was prescribed generic metoclopramide for GERD for approximately four years. She reportedly stopped taking metoclopramide when she developed tardive dyskinesia, a neurological disorder characterized by grimacing, lip twisting, difficulty swallowing and difficulty controlling the hands and feet.
Kellogg also alleges that Wyeth used misleading language when speaking about long-term use of metoclopramide. The drugmaker says, for example, that the risk of tardive dyskinesia is "believed" to increase with duration, implying that the statement is not supported by scientific evidence.
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Kellogg's lawsuit is notable because it preceded Wyeth v. Levine in dismissing the manufacturers' claims that the lawsuit should be dismissed because of preemption. Specifically, the manufacturers argued that they were prevented from changing the label because FDA regulations require that they use exactly the same label as the one approved by the FDA. Judge William K. Sessions disagreed with the defendants and denied the motions for dismissal.