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Digitek Recall Sparks Class Action Lawsuit

May 12, 2008 | Parker Waichman LLP

A Digitek class action lawsuit has been filed in US District Court in New Jersey against the Icelandic drug maker, Actavis Group.  Actavis recalled Digitek, its generic version of digoxin,  two weeks ago because some batches of the medicine may have contained tablets that were twice the normal thickness and strength.  The plaintiffs in the Digitek lawsuit are seeking compensation for their injuries, as well as the costs of medical monitoring in case they experience future health problems. In addition to Actavis, the Digitek lawsuit also names Mylan Pharmaceuticals Inc. and UDL Laboratories, which distributed the medication, as defendants.

Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. The medication is sold generically as digoxin by several companies. On April 25, 2008, Actavis recalled Digitek tablets because there existed a possibility that tablets with double the appropriate thickness may have been commercially released. The Food & Drug Administration (FDA) deemed the Digitek recall a Class I recall, meaning that the defective Digitek tables could cause serious health problems or death.   A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure.  Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia.   

There has been very little information available about the scope of the Digitek problems.  When it announced the recall, the FDA said it had received several reports of illnesses and injuries in patient taking Digitek.  Actavis said it had 11 such reports.  Actavis also said it did not know how many defective batches of Digitek were actually distributed.  

According to the Digitek lawsuit, the FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. The suit alleges that some of the faulty generic Digitek came out of that plant. The suit also claims that an FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency.

At least one of the plaintiffs in the Digitek class action lawsuit alleges she experienced “changed cardiac symptom episodes of nausea, and dizziness” from her Digitek consumption. Another plaintiff alleges he may have suffered serious personal injuries, including kidney damage, after taking the defective drug.  

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