Digitek Recall

Digitek, a medication for patients with certain heart conditions, was recalled because an unknown quality of medication was incorrectly labeled and sold containing twice the recommended dosage. Plaintiffs' lawyers started tripped over themselves fighting for the cases. But, as discussed below, it may be that only 20 double dose pills were made and it may be that no patient every took a double dose pill.

An overdose of Digitek can cause digitalis toxicity, a potentially fatal condition that can also cause excessively low blood pressure, dizziness, nausea, vomiting, cardiac instability, bradycardia, irregular heartbeats, excessively slow or fast heartbeats, hallucinations, confusion, and seizures. Less severe symptoms include decreased appetite and fatigue. Obviously, patients on Digitek with these symptoms or other concerns should contact their doctor immediately.

Digitek is manufactured by Icelandic generic drug-maker Actavis Totowa and distributed in the United States by Mylan Pharmaceuticals under the label "Bertek” and by UDL Laboratories under the label "UDL."

Specifically, Digitekis is prescribed for heart patients with mild to moderate heart failure and patients prone to atrial fibrillation (accelerated heart rate). Digitek has a good history of helping patients by strengthening the contraction of the heart muscle which slows down a patient’s heart rate.

According to Actavis Totowa, Digitek tablets with double the appropriate thickness may have been commercially released. “These tablets may contain twice the approved level of active ingredient” than is appropriate, states an Actavis Totowa news release posted on the FDA's website. In other words, people are taking Digitek labeled, for example, as 0.25 mg. when in fact the pill contained 0.50 mg.

Beyond this, there is little information available to the extent and scope of the problem. We do not know how many Digitek lots or batches contain the incorrect dosage of Digitek. From the response that our lawyers and other law firms we work with are experiencing from clients reporting problems with Digitek, we expect that it is a significant number of lots that have been released, but the full extent and scope of the Digitek problem is a mystery.

We do know this is not the first problem with Digitek. The FDA issued a warning letter back in August 2006 for failing to provide safety reports at a Digitek manufacturing plant in New Jersey. Digitek is not the only prescription drug to have a double overdose problem. In June 2008, ETHEX issued a recall this weekend of its morphine sulfate pills after it was discovered that what was most likely a manufacturing error (our lawyers' view) caused some morphine sulfate pils to have twice their safe dosage - the exact same problem with have with Digitek. Who is in charge of quality control at these companies is anyone guess.

The Digitek MDL cases went into an MDL which is a "sort of" class action lawsuit that consolidated Digitek cases for discovery. It is clear that a mistake was made. Even the company Iwould likely agree with that.

But none of the Digitek plaintiffs could produce a tablets that had one of these double doses. It might just be that only 20 tablets with the double dose were produced.

In November 2011, the MDL judge dismissed the last two remaining cases. He wrote: "The plaintiffs' theory comes down to an attempt to use speculation about a defect to prove causation and speculation about causation to prove a defect" and granted summary judgment to Actavis and Mylan in two wrongful death suits, the final remaining cases.

Accordingly, these cases have largely ended. Over 5,000 over them settled but not for anything significant. Our law firm is not taking Digitek cases.

• More Information on Digitek Recall
• Digitek MDL Information (update on the Digitek class action lawsuit)
• More Digitek Problems (May 13, 2009 Update)