Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Caraco Pharmaceutical Laboratories has alerted the Food and Drug Administration (FDA) and is issuing a consumer-level recall of all tablets of the generic medication Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The drugs are being voluntarily recalled. The tablets may differ in size and could contain more or less of the active ingredient, digoxin.

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Individuals suing manufacturers of Digitek heart medicine must fill out lengthy and detailed fact sheets on their medical history and allow no secrets from their past, according to The West Virginia Record.

The fact sheets will be used in court to determine whether Mylan Pharmaceuticals of West Virginia, Actavis US and DUL Laboratories misrepresented Digitek as safe and whether physicians and patients relied on those “misrepresentations and deceptions” in choosing to use the heart medicine.

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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.

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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.

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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.

U.S. District Judge Joseph Goodwin, who is striving to resolve the national litigation over Digitek, wants separate complaints from separate plaintiffs. On December 2, he signed an order stating that all Digitek attorneys who have numerous plaintiffs in single suits must separate the claims.

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John Anthony Conte of Madison County, Kentucky, filed a Digitek lawsuit against a West Virginia pharmaceutical company, Mylan Pharmaceuticals, for his wife’s estate. His wife is believed to have died after taking Digitek. This suit was filed on October 9, 2008.

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U.S. Attorneys in New Jersey are moving to close three Actavis Inc. plants, the company that manufactures Digitek, until they comply with FDA regulations.

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