Tortdeform posted an article entitled “The Digitek Recall Shows Us Once Again That the FDA Can’t Protect Us”, detailing the history of the Digitek diaster. A little history, drug maker Actavis produces a drug called Digitek, which is the trade name for the drug digoxin. Digoxin is used to treat various heart conditions, including heart failure. On April 25, 2008, Actavis recalled 160 lots of Digitek, because the company put a double dose of medication in the pills in that lot. This led to people getting double doses and having serious reactions, including reports of deaths related to the medication.
Justinian’s story at Tort Deform outlines the FDA’s reaction or non-action in the case. The FDA inspected the plant in 2006 and found “significant deficiencies” in the quality control unit of the plant, as well as in the manufacturing unit of the plant. The FDA sent a letter outlining its findings to Actavis in April of 2007. A full year before the recall. Justinian sums up the problem as follows:
One has to wonder just how bad the “significant deficiencies” that the FDA found in Actavis’ quality control unit when one considers what the defect was: Some Digitek tablets were twice as thick as they should be. What kind of quality control program can’t spot pills coming out twice as thick as they should? The FDA found that the quality control department was ignoring some defects. Surely they couldn’t have been so incompetent as to ignore a double-thick tablet, could they?