Digitek is manufactured by Icelandic generic drug-maker Actavis Totowa; it is distributed by Mylan Pharmaceuticals under the label “Bertek and by UDL Laboratories under the label “UDL.” Digitek is medication for patients with mild to moderate heart failure, and control of ventricular response rate in patients with chronic atrial fibrillation. Digitek strengthens the contraction of the heart muscle, slows the heart rate and helps eliminate fluid from body tissues.
Digitek was recalled last month because it is linked to digitalis toxicity, which can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death.
What happened? Apparently, tablets with double the appropriate thickness may have been commercially released. In other words, a patient taking 0.25 mg of Digitek might have received a pill labeled as 0.25 mg., but the pill itself was actually 0.5 mg. These tablets may have contained twice the approved level of active ingredient. It is not known yet exactly what happened, but the most obviously guess is that this is a manufacturing error. (Before you ask, the drug was made in the United States – not China.)
Our lawyers do not pretend to know exactly why Digitek tablets reflected half the dosage patients were actually receiving. But there are not many scenarios one can fathom where this apparent manufacturing error with Digitek was not the result of negligence of Actavis.
November, 2011 Update: These cases ultimately failed. While tablets may have been released that had twice the listed dosage, there was no evidence that any of the 1000+ plaintiffs who brought lawsuits actually had taken a double does pill. Let’s just say this case is not a particularly proud moment for plaintiffs’ lawyers. Everyone got a little too giddy about the fact that there was a recall and did not spend enough time making sure the cases were meritorious.