MADISON - ST. CLAIR RECORD

Actavis and Mylan Pharmaceuticals are being sued by 97 people in St. Clair County Circuit Court who claim they took a prescription drug for their heart problems that contained twice the approved level of its active ingredient.

Lloyd M. Cueto of Belleville and John J. Driscoll of St. Louis will be representing them.

Digitek, which is normally prescribed to treat various heart conditions, including atrial fibrillation, atrial flutter and congestive heart failure, was recalled on April 25, 2008, according to the complaint filed April 24 in St. Clair County Circuit Court.

The suit claims 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 complaint says.

"Digoxin overdose and digitalis toxicity can cause serious and life-threatening personal injury, and death," the suit states.

Before placing Digitek on the market, Actavis and Mylan should have implemented adequate safeguards and tests to ensure the accuracy of the drug's strength, the plaintiffs say.

The plaintiffs say they have already experienced or face an increased risk of developing severe injuries and dangerous side effects from the drug.

They are asking Actavis and Mylan to pay for medical monitoring to determine whether they are prone to death and serious health complications.

"As a direct result of Defendants' actions, omission, and negligence, Plaintiff has been put at a heightened risk of very serious health complications," the suit states. "The risk of death and serious health complications requires diagnostic medical examinations."

Because of the plaintiffs' ingestion of Digitek, they have incurred damages of more than $7 million, they say.

The international pharmaceutical companies should not be able to impose a statute of limitations claim against the plaintiffs' allegations because it was only recently that the plaintiffs discovered the harm of the drug, according to the complaint.

"Plaintiffs had no knowledge that Defendants were engaged in the wrongdoing alleged herein," the suit states. "Because of the fraudulent acts of concealment of wrongdoing by the Defendants, the Plaintiff could not have reasonably discovered the wrongdoing at any time prior to April 25, 2008."

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

In the 10-count suit, the St. Clair County plaintiffs are seeking unspecified equitable, injunctive and declaratory relief, unspecified statutory, treble, exemplary and punitive damages, disgorgement of Actavis's and Mylan's profits from the sale of Digitek, a refund of any purchase paid price, medical monitoring, plus pre- and post-judgment interest, costs and other relief to which they may be entitled.

St. Clair County Circuit Court case number: 09-L-0215.