Articles Tagged with “Tardive Dyskinesia”

The Sixth Circuit Court of Appeals has recently submitted a question to the Food and Drug Administration requesting a response to its position on immunity. At issue is the claim by manufacturers that because the FDA regulates prescription drugs, once the drugs they make have received FDA “approval,” drug manufacturers cannot be held liable for the harm – sometimes life threatening – these products cause.

In the landmark case, Wyeth v. Levine, the U.S. Supreme Court determined that federal regulation of prescription drug labels does not grant manufacturers liability.

Makers of Reglan, a generic drug used to treat Gastroesohageal reflux (GER) and Gastroesophaegeal reflus disease (GERD) are now trying to use preemption arguments to avoid liability for harm caused by use of their dangerous products.

Reglan poses the threat of developing Tardive Dyskinesia (TD), a disabling and permanent movement disorder often characterized by shaking spells, blinking and slurred speech. Users have claimed that the generic drug’s label failed to warn consumers of the risks of use.

Last year, the Eight Circuit determined that generic manufactures must provide warnings, even if the name-brand drug label doesn’t contain the warning.
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Reglan is a presciption drug pushed by pharmaceutical companies to patients to treat Gastroesophageal relfux (GER) Gastroesophaegeal reflux disease (GERD). Many studies dating back from the 1970s, have shown that Reglan is ineffective in resolving GER and GERD. A 2006 study published in Nature Clinical Practice: Gastroenterology & Hepatology concluded that “the evidence base for the use of [metoclopramide for GERD] is weak, with little or no sustained effect on acid exposure or healing of esophagitis.” The studies also indicate patients suffer from irreversible side effect if used for longer than a 12 week period called Tardive Dyskinesia. TD is a tragic life-long medical condition that causes involuntary and abnormal body movement.

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