Digitek Manufacturers Face Three Suits to date
Following the recall of the high dose double thick tablets of the Actavis drug Digitek, a lawsuit has been launched. The suit is on behalf of the lead plaintiffs including a Pennsylvania man who said the drug caused kidney damage and an Illinois woman who said she suffered nausea, dizziness and cardiac symptoms. The three drug companies facing the lawsuits are Actavis Totowa, distributor Mylan Pharmaceuticals and UDL Laboratories. Lawyers have filed three lawsuits thus far, but expect more to follow. The lawsuits argue that the pills were manufactured with undetected high doses of digitalis, an active ingredient that led to serious illness and even death in some cases. Digitek is used to treat heart failure and abnormal heart rhythms, but excessive doses can lead to digitalis toxicity, which in extreme cases can lead to cardiac arrest according to the FDA recall notice. “It was supposed to treat the symptoms of congestive heart failure, and the tragic thing is that it turned around and caused congestive heart failure in some cases,” said lawyer James Peterson, one of the attorneys involved in the case. The initial recall was announced April 25 and said that the tablets may contain twice the appropriate level of digitalis. At the time of the recall, Actavis knew of 11 people who had reported becoming ill after taking the drug. Tony O'Dell another lawyer involved in the case, points to a 2007 Food and Drug Administration letter to Actavis as indication of persistent problems. The letter, based on inspections in the summer of 2006, concludes in part that “significant deficiencies were found in the operations of your firm's quality control unit.” In response O’Dell said, “It's going to be difficult for this company to argue they were unaware of quality control problems at their plant.
