A settlement has been reached that will resolve all outstanding state and federal Digitek lawsuits, according to federal court records.
On September 1, attorneys for plaintiffs and defendants informed U.S. District Judge Joseph Goodwin that they have reached an agreement to settle Digitek lawsuits brought on behalf of hundreds of people who allege they suffered an injury as a result of a Digitek overdose. The cases stem from a 2008 Digitek recall that was issued after the drug maker allegedly distributed pills that contained too much of the drug.
Details of the Digitek settlement were not provided in the initial filing.
Hundreds of Digitek lawsuits have been filed in state courts and federal district courts throughout the United States. The federal Digitek litigation is consolidated and centralized before Judge Goodwin in the U.S. District Court for the Southern District of West Virginia as part of a multidistrict litigation, or MDL.
On September 1, Goodwin assigned a “Special Master” who will be key in determining how much compensation each plaintiff will receive from the settlement. The Special Master will resolve claims for both federal and state cases.
Digitek is a generic version of the drug digoxin, used to treat congestive heart failure, abnormal heart rhythms, atrial flutter and atrial fibrillation. The medication is extremely dose-specific with a narrow therapeutic index. If too little of drug is prescribed it can be ineffective, and if too much is prescribed it can lead to a Digitek overdose, where the drug builds up in the system. This can result in a serious and potentially life-threatening condition known as digitalis toxicity.
In April 2008, Actavis Totowa issued a Digitek recall for all lots of the heart drug after it was discovered that some tablets may have been commercially released that were twice as thick as they were supposed to be. The error potentially exposed thousands of users to a risk of digoxin overdose or poisoning.
According to a December 2008 report released by the non-profit Center for Public Justice, the FDA received reports of at least 667 Digitek overdose deaths tied to the recalled pills between April 2008 and June 2008.