SOUTHEAST TEXAS RECORD

Actavis, UDL Laboratories and Mylan Pharmaceuticals are being sued by at least three different plaintiffs who claim they or their deceased relative took a prescription drug for heart problems that contained twice the approved level of its active ingredient.

Barry Bennett of Eddins and Bennet and Michael R. McGown of Beckenstein, Norvell and Nathan in Beaumont will be representing each of the three plaintiffs in separate lawsuits filed July 20 in Jefferson County District Courts.

Plaintiffs in the three suits � Virginia Robinson, Helen Keltz and A.B. Belrose, on behalf of decedent Glenda Belrose � claim they or the deceased were taking Digitek. The drug is normally prescribed to treat various heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure, before it was recalled on April 25, 2008.

The complaints claim that little information has been released about the recalled Digitek, which reportedly contained twice the approved level of an active ingredient that can cause digitalis toxicity.

Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia, according to a warning the FDA issued about the drug.

Class I recalls are only instituted when there exists a reasonable probability that the drug will cause serious injury or death, the complaints say.

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

On Aug. 15, 2006, the FDA sent a warning letter to the defendants about their violations of adverse medical event reporting obligations by marketing drugs without clearance and by causing at least 26 adverse drug experiences by not submitting safety reports, the plaintiffs say.

The plaintiffs say they have experienced pain and suffering, mental anguish, physical impairment and a loss of earning capacity, plus incurred medical expenses because of their ingestion of the drug.

They are asking the court to issue an order authorizing an international service company to serve Actavis Group.

In addition to the Jefferson County lawsuit, Mylan and Actavis are facing multiple lawsuits in St. Clair County District Court in Illinois in which plaintiffs are complaining of the same overdose problems with the drug Digitek.

The Jefferson County plaintiffs are seeking actual and exemplary damages, plus pre- and post-judgment interest, costs and other relief to which they may be entitled.

Jefferson County District Court case numbers:E184-522 ,B184-523, B184-524.