The manufacturer of Digitek, Actavis Totowa LLC, issued a nationwide Class 1 recall of all strengths of Digitek tablets on April 25, 2008. The Class 1 recall was issued on the basis that the product poses a substantial risk of serious injury or death.The Digitek tablets were distributed by UDL Laboratories, under a UDL label and by Mylan Pharmaceuticals, with a ?Bertek? label. For information with regard to
the Digitek litigation The following is a summary of the basis for liability against Activis for the manufacturing defect which is believed to result in patient injury and death. For complete information with regard to the Digitek litigation you may refer to our discussion of the respective merits of class action lawsuits and individual lawsuits against the manufacturer.
Digitek is the Actavis brand name for Digoxin tablets, commonly prescribed as treatment for abnormal heart rhythms and heart failure. The manufacturer issued the Class 1 national recall because Digitek tablets were distributed to pharmacies with double the thickness and it is presumed, twice the indicated dosage of the active ingredient. The Food and Drug administration has received adverse reaction reports of illness and injury resulting from ingestion of Digitek tablets, and many others have come forward across the nation with symptoms typical of digitalis toxicity. Our have arrived at the conclusion that the double strength Digitek tablets pose the serious risk of toxicity, including the risk of death, particularly in patients with renal failure and those who are on dialysis.
It appears from the notice of Class 1 recall that the Digitek manufacturer has acknowledged the manufacturing defect, specifically the inclusion of twice the indicated dosage of the drug, which is also, in our opinion, persuasive evidence of manufacturer negligence. The high dosages of Digitek can result in Digitalis toxicity, which can lead to low blood pressure, cardiac instability, bradycardia, meaning a slow heartbeat, and death, often presenting also with nausea, vomiting,
