News Tagged ‘claims

Louisiana man sues maker of acid reflux medication Reglan

judge gavelA Louisiana man is suing the manufacturer of the acid reflux medication Reglan (metoclopramide) alleging the medication caused him to develop a debilitating nervous system disorder known as tardive dyskinesia. Isreal Bennett of Jefferson Parish filed the suit against Qualitest Pharmaceuticals on June 11, 2010, in federal court in New Orleans.

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Supreme Court considers whether generic Reglan makers can be sued

judge gavelThe U.S. Supreme Court this week asked the Obama administration to comment on whether it believes generic drug companies can be sued over allegations that they inadequately labeled their products. The question arose after an appeals court reinstated a lawsuit by a woman who claimed she developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan (metoclopramide). The lawsuit had been previously dismissed by a trial judge.

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New Jersey judge calls for consolidation of Reglan lawsuits

judge gavelA New Jersey judge is calling for a statewide consolidation of all lawsuits filed against the makers of the heartburn medication Reglan that involve claims that the drug caused a serious and debilitating movement disorder known as Tardive Dyskinesia. Judge Eugene J. Codey, Jr., of the Essex County Superior Court, filed the request arguing that the New Jersey court system could better handle the mounting number of lawsuits if they were all centralized in one court. The primary defendant in the lawsuits, Wyeth Pharmaceuticals, is headquartered in New Jersey.

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Salix stock soars despite FDA warning letter

salix pharmaceuticals 150x150 Salix stock soars despite FDA warning letterSalix Pharmaceuticals stock rose 5 percent last week despite news that the company received a warning letter from the Food and Drug Administration (FDA) urging the company to clarify information about its new orally dissolving heartburn treatment, Metozolv ODT, according to Local Tech Wire. The FDA said that some of the drug’s marketing materials are “false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”

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FDA warns makers of acid reflux drug to change warning label

salix pharmaceuticals 150x150 FDA warns makers of acid reflux drug to change warning labelThe Food and Drug Administration (FDA) has fired off a warning letter to drug maker Salix Pharmaceuticals arguing that some of its marketing materials for Metozolv, an orally dissolving form of metoclopramide for the treatment of acid reflux conditiosn, “are false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”

The letter goes on to say that “these violations are concerning from a public health perspective because they suggest that Metozolv ODT is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience, and encourage use in circumstance other than those for which the drug has been shown to be safe and effective.”

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Ruling: patients may sue generic drug makers under state law

judge gavelThe 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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Makers of generic Reglan liable for inadequate warning labels

judge gavelMakers of generic drugs who do not adequately label their products to warn consumers of possible risks are not exempt from liability, according to a ruling by the U.S. Court of Appeals for the Eighth Circuit. The court ruled on a product liability lawsuit brought by Gladys Mensing, who was prescribed metoclopramide to treat diabetic gastroparesis, a debilitating condition in which the stomach empties too slowly. Following use of the medication, Mensing developed a serious movement disorder known as Tardive Dyskinesia. Research has shown that the condition can be caused by long-term use of . Mensing sued several makers of generic , known by the brand name Reglan, for not adequately warning consumers of the risk of developing the movement disorder.

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Woman files suit against Reglan for causing serious movement disorder

tablet Woman files suit against Reglan for causing serious movement disorderKecia Neal of Arkansas was prescribed Reglan in 2005 to help her overcome a medical condition that involved the paralysis of stomach muscles. What she didn’t expect is for the medication to make her even sicker.

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Woman with Tardive Dyskinesia sues makers of Reglan

A Missouri woman is seeking more than $600,000 in damages from the makers of Reglan (metoclopramide) for not adequately warning her of the risk of a serious, permanent, disabling neurological condition known as Tardive Dyskinesia.

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