Digitek Patients Sue Drug’s Makers for Oversized Heart Pills

Nearly 100 people have sued the makers of Digitek heart pills for failing to release information about the pills after they were recalled last year when officials feared they contained life-threatening double doses of the active ingredient.

Actavis and Mylan Pharmaceuticals are named in the lawsuit, which was filed April 24, 2009 in St. Clair County Circuit Court. The plaintiffs say the companies failed to protect them from harm and mishandled the April 2008 recall of Digitek pills.

FDA Orders Class I Recall

All Digitek tablets were recalled after at least a dozen reports were received of patients dying or suffering injuries after taking defectively large pills. The Food and Drug Administration ordered a Class I recall, which means there is a reasonable probability that the drug will cause serious injury or death, according to the lawsuit.

Digitek, a drug containing the active ingredient digoxin, is prescribed to treat various heart disorders, including congestive heart failure, atrial fibrillation, and atrial flutter. Too much digoxin in the body may cause a life-threatening condition called digitalis toxicity, which results in heart instability, low blood pressure, nausea, vomiting, dizziness, and other severe symptoms.

Lawsuit Alleges Failure to Protect Consumers

The lawsuit claims Actavis and Mylan failed to implement adequate safeguards and quality-control testing to better ensure that the proper amount of active ingredient was included in the pills. The plaintiffs want the drug companies to pay for medical monitoring to determine whether they are more likely to die or suffer serious health complications as a result of taking the double-dosed Digitek pills.

Millions in Damages Sought

The plaintiffs also are seeking unspecified financial damages, the return of profits earned by the companies from the sale of Digitek, and other legal relief. They claim damages of at least $7 million.

“As a direct result of Defendants’ actions, omission, and negligence, Plaintiff(s have) been put at a heightened risk of very serious health complications,” the lawsuit states. “The risk of death and serious health complications requires diagnostic medical examinations.”

Mylan also faces other lawsuits filed in Texas by patients who say they suffered similar overdose injuries from taking defective Digitek pills.

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