Digitek Class Action
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Digitek Class Action
Digitek is a brand name for the generic drug digoxin, commonly given to cardiac patients who are in some stage of congestive heart failure or who have cardiac arrhythmia. The product is manufactured by Actavis Totowa, an Iceland based pharmaceutical firm. Their Digitek production facility is in New Jersey.
On April 28, 2008 the FDA and Actavis issued a Class I recall for Digitek, because it had become evident that batches of the tablets had been produced with twice the dosage of digoxin as was specified by the packaging. All dosages of the medication were recalled from all regions of the country. Class I means that the recall is for a product that can do significant, serious harm and extends all the way to the consumer. Many pharmaceutical recalls carry only as far as the pharmacy, which must clear its shelves. Recalled products that have already been sold are often left in circulation. That was not the case with Digitek.
Two weeks after the recall, the first Digitek class action suit was filed in a New Jersey court. While the filing contains names of certain plaintiffs, the speed of the filing suggests that the law firm expects to add plaintiffs to the case where possible. It is not clear yet how widespread the harm is that these double-dose pills may have caused. Actavis claims to have received eleven complaints prior to the recall. The FDA has not specified how many complaints prompted their concern.
Individual Digitek liability cases have also been filed against Actavis. Perhaps the first of them was filed in Birmingham, Alabama by a plaintiff who claims to have suffered temporary blindness as a side effect and who has had cardiac surgery since experiencing the side effects because of the impact of the overdose on her heart.
However digoxin in general and Digitek in particular are in widespread use for treatment of congestive heart failure. Used properly, digoxin can be an effective medication for failing hearts - and in fact has been in use since the eighteenth century. It was taken from the foxglove plant and used by earlier healers.
Because of its wide circulation, it is likely that the Digitek manufacturing failure will result in additional class action suits. Heart disease is the number one cause of fatalities in this country, and is probably the number one disease being treated by American physicians as well. A Class I recall does not occur in a vacuum; the FDA may well have concluded that many more complaints were likely to surface in the near future.
