Reglan Lawsuit Alleges Warning Was False and Misleading

Montpelier, VTA lawsuit filed in 2009 against Wyeth alleges consumers were not adequately warned about Reglan side effects. The lawsuit, which claims that the plaintiff developed tardive dyskinesia after taking the medication for a few years, has already had an impact on other lawsuits against drug manufacturers because the judge was asked to rule on preemption in this case.

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.

The lawsuit alleges that Wyeth and other companies involved in Reglan's marketing promoted the medication as safe and effective for long-term use. Court documents claim the companies were involved in "the sponsoring of talks and seminars with company sponsored speakers, who would discuss the supposed benefits and safety of longer term use; and the ghost-authoring, company-sponsored publication, and further dissemination of at least one junk science study calculated to 'demonstrate' the safety of long-term metoclopramide use."

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.