Digitek Trial in Federal MDL Scheduled to Begin January 2011

A federal judge presiding over the consolidated Digitek litigation, which is centralized in the U.S. District Court for the Southern District of West Virginia, has scheduled the first trial over the recalled heart drug to being in January 2011.

There are currently more than 200 Digitek lawsuits pending in the federal MDL, which all involve similar allegations that Actavis Totowa and their distributors sold over-sized Digitek pills, which caused users to suffer a variety of serious and potentially life-threatening injuries associated with receiving too much of the heart medication.

According to a pretrial order issued Tuesday by Chief Judge Joseph R. Goodwin, the first “bellwether” Digitek trial is scheduled to begin on January 31, 2011. Five cases were selected last month for early trials in the MDL, but the order does not indicate which of those lawsuits will be the first case presented to a jury.

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.

In addition to the cases pending before Judge Goodwin in federal court, there are also many similar lawsuits pending in various state courts. According to an order issued in December, the judges presiding over those state court cases will join Judge Goodwin for a joint hearing in October 2009 to address the scientific and technical issues presented in the Digitek recall lawsuits. Following the joint hearing, each judge will give a seperate ruling as they relate to the cases they are presiding over.