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Several Digitek class actions have been initiated against the makers of Digitek, Actavis. The oral form of Digitek was recalled in the U.S. in April 2008, based on a manufacturing mistake that produced Digitek with twice the intended level of active ingredient, creating a grave risk of toxicity.
A class action is a lawsuit in which one or more individuals sue the defendant on behalf of a larger group of people who were similarly injured, in this case by Digitek.
The potential Digitek side effects include:
At the time when the recall was announced, the U.S. Food and Drug Administration (FDA) stated that it had already received reports of injuries and illnesses among people treated with Digitek, and Actavis admitted that it also had received similar reports.
The Digitek class actions note that Actavis had been warned by the FDA about its manufacturing practices back in August 2006. The Actavis plant in Little Falls, New Jersey was cited for failing to provide the required periodic safety reports. The FDA also questioned Actavis’ reporting of adverse medical events.
The Digitek recall was “Class I,” meaning that the FDA considered the recalled product quite dangerous. All lots and all dosages of tablet-form Digitek were recalled. However, the recall may have come too late for some patients treated with Digitek; plaintiffs in the Digitek class actions have described experiencing episodes of severe dizziness and nausea, and kidney damage that may be due to the Digitek treatment.
Individuals with impaired kidney function are especially vulnerable to the recalled, double-strength Digitek, and several such individuals are among the plaintiffs in the Digitek class actions.
If you or your family members have been impacted by the side effects of recall of double-dose Digitek, contact a Digitek Lawyer to discuss your concerns and your legal options.
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