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U.S. Regulators Sue to Shut Down Heart Drug Manufacturer

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The U.S. Department of Justice has sued drug manufacturer Actavis, seeking a permanent injunction against its subsidiary that makes the recalled heart drug Digitek. According to this Bloomberg News report U.S. regulators took the action on behalf of the Food and Drug Administration against the Actavis Totowa LLS subsidiary in Little Falls, New Jersey.

In April the Iceland-based drug manufacturer recalled all of its lots of prescription heart drug, Digitek or Digoxin tablets, because some of the tablets might contain twice the approved level of the active ingredient. Hundreds have reported suffering serious injuries. Families have reported losing loved ones to this defective drug, which was normally prescribed to treat heart failure and abnormal heart rhythms. Actavis makes the drug for Mylan Inc., which distributes the drug under its Bertek and UDL brands. Actavis has said it has been working to meet the FDA’s manufacturing standards for its New Jersey facility.

I’m glad that federal regulators have filed this lawsuit. Federal safety officials, even before this drug safety recall, had warned the New Jersey facility that their quality control measures did not comply with federal safety standards. The damage that this defective drug had done has been significant. Hundreds of lawsuits have already been filed across the country by those who have suffered injuries or families of those patients who have died from taking Digitek.

Our office has also been receiving calls from such injured victims. We have a number of clients who have suffered serious side effects as a result of this defective drug. We are in the process of gathering the medical evidence to support their pharmaceutical litigation cases before filing our lawsuits. An overdose of this drug may cause serious side effects such as nausea, vomiting and dizziness to high blood pressure, cardiac instability or even death.

If you or a loved one has suffered adverse reactions from taking Digitek and would like to be kept informed about the most recent developments, news or to discuss your legal options, please call my office. We will answer your questions, put you on a list to update you with information or schedule a free consultation should you wish to pursue your rights.

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