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June 27, 2008

California Plaintiffs Sue Digitek Companies after FDA Recall

Following the Food and Drug Administration’s Class I recall of the heart drug Digitek a class action lawsuit has now been filed in California. The plaintiffs include a California man and other individuals suffering from heart disease who unknowingly took a double dose of Digitek causing a dangerous elevation in their heart rate. The lawsuit has been filed against the manufacturers, distributors and marketers of Digitek: Actavis Totowa, LLC in New Jersey, Actavis Group PTC in Iceland, and Mylan Bertek Pharmaceuticals in Texas. According to the lawsuit, neither the male patient nor his physician knew the Digitek medication was twice the standard dosage. The class action law suit alleges that, “Digitek is defective and unreasonably dangerous to consumers.” It also alleges that the defendants “sold, released, produced, and distributed of Digitek without making proper and sufficient tests to determine the drug's strength/dose,” and that they were “negligently representing that the recalled Digitek was safe for use for its intended purpose, when, in fact, it was not.” Digitek is used by millions of heart patients worldwide. Digitek is a brand name of the generic drug digoxin (also known as Digitalis). Digoxin is a purified cardiac glycoside extracted from the foxglove plant, Digitalis lanata. Digoxin toxicity can cause potentially life-threatening heart rhythm disturbances, as well as nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, visual disturbances, low blood pressure, cardiac instability, irregular pulse, heart palpitations and bradycardia. At its most severe, death can result from excessive digoxin intake.

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