Digitek is a medication used to treat heart failure and abnormal heart rhythm. Actavis Totowa LLC, a wholly owned subsidiary of Actavis, Inc., a Delaware corporation, manufactured, packaged and labeled Digitek, an FDA approved version of the generic drug Digoxin, at its plant in Little Falls, New Jersey. This drug was distributed and sold on the wholesale level by Mylan, Inc. and its other corporate subsidiaries including UDL Laboratories, Inc., an Illinois corporation. The other defendant subsidiaries are located in Iceland, Morristown, New Jersey and Elizabeth, New Jersey, Pennsylvania, West Virginia and Texas.
The complaints seek damages, medical monitoring and other relief due to the purchase or ingestion of allegedly defective Digitek tablets which the plaintiffs claim were released with as much as twice the appropriate thickness.
The complaints further allege that unsuspecting patients were thus taking twice the intended dosage. A Class I recall was initiated by the defendants after receiving numerous reports of severe illness and injuries consistent with overdoses of Digitek. A Class I recall is used when a pharmaceutical carries a risk of serious or fatal injury. Overdoses of this medication result in digitalis toxicity.
It is alleged that this condition is dangerous especially among individuals suffering from renal failure because the Digitek may accumulate in the body of such individuals, rather than be excreted normally in urine. Digitalis toxicity is presented by symptoms including nausea, vomiting, dizziness, low blood pressure and bradycardia (a slow heart rate). Bradycardia in individuals with cardiac problems can cause further strain to the heart and can result in the need for a pacemaker. The prognosis depends upon the condition of the individual and the progression of the strain on the heart.
On August 13, 2008, the Digitek actions pending in the federal courts were consolidated under MDL No. 1968 in the Western District of Virginia and assigned to Judge Joseph R. Goodwin.