Following Digitek Recall, Class Action Suits have been filed

At least two class action suits have been filed on behalf of individuals who used the heart drug Digitek (digoxin). The suits come less than three weeks after all lots of Digitek were recalled on April 25th when it was discovered that some tablets sold over the past year could be twice as thick as is appropriate and contain double the approved amount of active ingredient.

Digitek is a medication approved for treatment of heart failure and abnormal heart rhythms, such as atrial fibrillation. The recall applied to generic forms of digitalis manufactured by Icelandic drug maker Actavis Totowa, a division of Actavis Group. The drug was sold in the United States by Mylan Pharmaceuticals, Inc. under the “Bertek” brand and by UDL Laboratories, Inc. under the “UDL” brand.

Exposure to excessive amounts of digitalis may increase the risk of a condition known as digitalis toxicity. This could cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia or death. The risk of this serious illness is greatest among those with renal failure or impaired kidney function, which could even include those who are dehydrated.

The Digitek class action suits allege that Actavis, Mylan and UDL were negligent in allowing pills with twice the approved level of active ingredients to be sold. The plaintiffs claim that drug makers knew or had reason to know that Digitek was defective since at least 2006 and failed to warn of the dangers that could accelerate the risk of Digitalis toxicity.

On behalf of all individuals who were prescribed Digitek, the lawsuits attempt to establish the following classes:

• Digitek Refund Class: For those who purchased the heart drug.
• Digitek Personal Injury Class: For those who suffered adverse effects.
• Digitek Medical Monitoring Class: To provide medical screening, services, research and a registry to assure those who took Digitek receive prompt and proper medical treatment if needed.

In addition to the class action claims, it is expected that hundreds of people who suffered severe side effects from the double dose tablets will file individual Digitek lawsuits in the coming months.