Friday, October 21, 2011

Kentucky MDL Establishes Conference to Structure Litigation


All Darvon lawsuits and Darvocet lawsuits filed in federal district courts throughout the United States by users who suffered heart rhythm problems will be consolidated for pretrial proceedings as part of a multidistrict litigation, or MDL, which will be centralized in the U.S. District Court for the Eastern District of Kentucky. All of the lawsuits over Darvocet and Darvon allege that the drug makers failed to adequately warn consumers or the medical community about the risk of serious and potentially fatal heart rhythm problems, such as Darvocet heart arrhythmia. Xanodyne and other defendant drug makers opposed consolidation of the litigation, arguing that much of the evidence and discovery in the cases will focus on the individual health of each plaintiff.

In November 2010, a Darvon and Darvocet recall was announced after the FDA concluded that side effects of propoxyphene can cause significant changes to the electrical activity of the heart.  The heart problems may increase the risk of heart arrythmias, myocardial infarction and sudden death. Both the brand name drugs and their generic equivalents were pulled from the market. Darvocet was a popular pain medication that combines acetaminophen with propoxyphene, the active ingredient in the similar painkiller Darvon. The drugs were sold by Eli Lilly for about 40 years before distribution rights for the name brand version of the drug were sold to AAIPharma in 2002, and it was subsequently purchased by Xanodyne Pharmaceuticals in 2005. Generic versions of the medications are also available from a number of different drug makers
Darvon and Darvocet problems were linked to over 2,110 deaths between 1981 and 1999, accounting for 5.6% of all drug deaths during the time. The U.S. Judicial Panel on Multidistrict Litigation issued an order establishing the Darvocet MDL on August 16, which will result in the transfer of at least 17 cases that have been filed so far. The MDL allows lawsuits associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.

1 comment:

  1. Very interesting situation. I guess the studies were quite relevant on that.



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