Jefferson County suit alleges Digitek contamination

Kelly Holleran May 3, 2010, 8:00am

In a recent lawsuit filed in Jefferson County, a woman alleges her husband's heart medicine contained a deadly dose of its active ingredient.

Kathy Baker claims her husband, Charles Baker, was prescribed the drug Digitek and ingested an adulterated form of the medication, according to the suit filed April 19 against Mylan Pharmaceuticals, UDL Laboratories and Actavis.

The drug, which is normally prescribed to treat various heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure, was recalled on April 25, 2008. The recalled Digitek apparently contained twice the approved level of the active ingredient, which poses a risk of digitalis toxicity, the suit states.

"Digitek has a narrow therapeutic index, and thus, has a limited margin between effectiveness and toxicity," the complaint says. "Digitek, manufactured and produced with an amount of digoxin in excess of the labeled dose are not approved for sale or distribution in the United States and can cause health problems, up to and including, death."

Digitek was placed into the stream of commerce in a condition that was defective and unreasonably dangerous, which is a breach of the defendants' warranty, according to the complaint.

"Defendants placed into the stream of commerce the drug Digitek and recommended its use to physicians, the FDA and consumers without adequately warning physicians, the FDA and consumers including Plaintiff, of the risks associated with the use of the drug and that it contained an amount of digoxin exceeding the labeled dose and sometimes exceeding the approved dose for ingestion," the suit states.

The plaintiff alleges the "defendants "have a history of releasing drug products for human consumption that have been adulterated as well as a history of failing to reliably establish the identity, strength, quality and purity of drug products they release for public consumption," the complaint says.

Because of the excess amount of digoxin in the medication, Charles Baker suffered physical pain, mental anguish, disability and physical impairment before his death, according to the complaint.

Because of her husband's death, Kathy Baker has incurred medical costs and funeral and burial expenses, the suit states.

Kathy Baker is seeking actual and exemplary damages, pre- and post-judgment interest, costs and other damages to which she may be entitled.

She is represented by Barry Bennett of Eddins and Bennett in Beaumont and by Michael R. McGown of Benckenstein, Norvell and Nathan of Beaumont.

The case has been assigned to Judge Gary Sanderson, 60th District Court.

Jefferson County case number: B186-610.

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