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› $4.85 Billion settlement in drug case
A woman from Texas claims that her husband died in January 2007 as a result of his Digitek medication containing twice the active ingredient. On Jan. 23, 2008, Vickie Butts, representing the estate of her deceased husband, Donnie Butts, filed a product liability lawsuit against Actavis, the drug manufacturer, and Mylan, the distributor.
Nicholas Chandler, a 23-year-old resident of Alabama, died after consuming Digitek (Digozin) on Jan. 9, 2009. His doctor prescribed Digitek (Digozin) in order to correct his heart condition that could not be corrected by other medications. Chandler suffered toxicity after taking the medication.
Chandler’s wife Barbara Chandler deems the defendants negligent because Digitek was distributed to the public with twice the amount of the active ingredient, according to the West Virginia Record.
The paper reports, “Digitek (Digozin) has a narrow therapeutic index and has a limited margin between effectiveness and toxicity. Chandler, as administratix of the estate is seeking judgment, jointly and severly, (sic.) from all defendants, pre and post judgment interest and costs.”
The drug company Actavis, producer of the heart drug Digitek, agreed to close several plants in New Jersey and will not resume operations at these plants until U.S. standards for testing and manufacturing have been met by the FDA. According to Pharma Tech Live, the FDA has filed a consent degree, banning Actavis from distributing drugs in Totowa and Little Falls, N.J. The agreement also gives the FDA the right to close the plants if violations persist and to fine the company $15,000 a day afterward.
Actavis Inc. has made an agreement with the FDA not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced.
According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment.
Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug.
Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not.
According to reports filed to the FDA and consumers, the Center for Public Integrity has found that Digitek is responsible for 667 consumers’ deaths from April through June 2008. Pharma Live says health experts believe the FDA should have made more “aggressive warnings” to the public. The number of deaths associated with Digitek consumers have increased since the last reporting period.
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On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled.
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