Digitek was a medication prescribed to treat a series of heart conditions such as congestive heart failure and atrial fibrillation / atrial flutter (fast heartbeats). The medication was recalled in 2008 because an accidental quantity of medication containing twice the recommended dosage was incorrectly labelled and sold. Plaintiffs’ lawyers saw an opportunity to sue the manufacturer but as it was later found out, only 20 double dose pills were ever made, putting the probability of all Digitek patients to have ever accidentally ingested one of the double-dose pills close to zero.
Why a Digitek Overdose Could Be Fatal
An overdose of Digitek can cause digitalis toxicity, a potentially fatal condition that is accompanied by low blood pressure, dizziness, nausea, vomiting, cardiac instability, bradycardia, irregular heartbeats (too slow or too fast), hallucinations and seizures.
Lesser symptoms include fatigue and lowered appetite. Patients who are currently taking Digitek should call their doctor immediately if they experience any of these symptoms.
Digitek is manufactured by Actavis Totowa LLC, and distributed by Mylan Pharmaceuticals, Inc. On April 25th, 2008, the FDA released a press release alerting the public to the Class I Drug recall of Digitek which was initiated as a result of some of the pills being released in double-dosage, mislabeled as a standard dosage. It took two weeks for a class-action lawsuit to be filed against the manufacturer.
Digitek, a brand of digoxin, is prescribed to heart patients in order to treat heart failure and cardiac arrhythmia. A 2008 study concluded that the active ingredient, digoxin, had beneficial properties not only for the cardiac system but also could lower the risk of certain types of cancers.
Why Were The Digitek Pills Recalled?
According to the manufacturer, Digitek tablets with double-thickness and thus double-strength may have been accidentally released. As Actavis Totowa said in the FDA press release, people could have accidentally taken a Digitek pill that was labeled as 0.25 mg when in fact they were taking 0.50 mg of the drug.
Beyond the official FDA release, little information exists that would indicate the scope and extent of the problem. Plaintiffs were unable to produce any evidence that would link their symptoms to taking the “horse sized” pills as one put it. It was speculated that the number of batches of double-thickness Digitek produced was insignificant enough that it never turned up on the market.
However, this is not the first problem the drug ever had. In August 2006, the FDA released a warning letter to one Digitek manufacturing plant in New Jersey for failing to provide safety reports. But this isn’t the only drug that has had to be recalled because of mislabeled double-strength batches. In 2008, ETHEX, issued a recall for its morphine sulfate pills, which had the same manufacturing error as the Digitek pills and contained double the standard dosage. It would seem that quality control is not as strong as it should be considering the fact that we are talking about powerful heart medicine.
MDL judge dismisses Digitek lawsuit
In August 2008, Digitek lawsuits were transferred to MDL, consolidated in West Virginia under Judge Joseph R. Goodwin.
However none of the Digitek plaintiffs’ could produce evidence for any of the mislabeled double-strength pills and so the judge dismissed the last two remaning cases in November 2011, saying that “the plaintiffs’ theory comes down to an attempt to use speculation about a defect to prove causation and speculation about causation to prove a defect”. Many plaintiffs sued Actavis without any evidence of medical injury, seeking financial compensation for something that did not happen.
The few remaining cases were settled by Actavis for $10 million and $3 million in federal cases and court cases respectively. As it was hard to provide evidence that linked symptoms to the Digitek drug, most law firms had stopped taking Digitek cases after Judge Goodwin’s decision.
photo credit: Jill A. Brown