Heart drug maker faces lawsuits

July 11, 2008 9:56:13 AM PDT
The maker of recalled heart drug Digitek faces at least nine federal lawsuits in New Jersey, including one where a patient died, alleging the drug was dangerous and defective. The lawsuits were filed in U.S. District Court in Newark in recent months against Actavis Totowa LLL of Morristown, N.J., and its Iceland-based parent, Actavis Group, a generic pharmaceutical company.

Actavis Totowa on April 25 started a nationwide recall of all strengths of the Digitek pills, which are distributed by Mylan Pharmaceuticals Inc. and UDL Laboratories Inc. Those two companies also are named as defendants, and similar lawsuits have been filed in West Virginia and California.

Actavis said at the time that some tablets may have been double the usual thickness and so would contain twice the active ingredient, digitalis, posing a risk of toxicity with symptoms from nausea and dizziness to low blood pressure and cardiac instability. The company said in a statement that death can result from excessive digitalis intake and that it had received several reports of injuries.

One of the New Jersey lawsuits, filed by the estate of Margaret Lucille Crooker of Kemp, Texas, claimed the drug caused her "serious physical injury, pain and suffering" and she died on March 15.

"Obviously, nobody would have taken it had they been told there is twice as much active ingredient as there is supposed to be," New York attorney Richard Meadow, who represents Crooker's family, told The Record of Bergen County for Friday's editions.

On Friday, Actavis Totowa spokeswoman Hjordis Arnadottir said that "as a rule, we don't comment on any pending lawsuits."

According to the newspaper, one of the lawsuits brought by a Madison, Ind., woman hospitalized from an allegedly toxic overdose of Digitek in June said that a Food and Drug Administration inspection at an Actavis plant had found deviations from good manufacturing practices that led to adulteration of drugs.

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On the Net: http://www.actavis.us

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Information from: The Record of Bergen County, http://www.northjersey.com


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