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Federal Panel Consolidates Darvon, Darvocet Lawsuits

Aug 18, 2011 | Parker Waichman LLP

Federal Darvon and Darvocet lawsuits are heading to the U.S. District Court for the Eastern District of Kentucky (Covington Division), after the U.S. Judicial Panel on Multidistrict Litigation (JPML) ordered that they be consolidated in a multidistrict ligation.  The cases, now deemed IN RE: DARVOCET, DARVON AND PROPOXYPHENE PRODUCTS LIABILITY LITIGATION (MDL 226), will be presided over by Judge Danny C. Reeves.

Darvon and Darvocet are opiod painkillers made with the active ingredient propoxyphene. In November 2010, the U.S. Food & Drug Administration (FDA)  asked the makers of propoxyphene products to pull them from the market, after a study conducted by Xanodyne Pharmaceuticals, the maker of Darvon and Darvocet, found it could cause a serious, and sometimes fatal, irregular heartbeat.   Since the Darvon and Darvocet recall was announced, Xanodyne and other makers of propoxyphene drugs have been named in product liability lawsuits.

In deciding to consolidate the Darvon and Darvocet litigation, the JPML found that the lawsuits shared certain question of fact, including whether Darvocet, Darvon and other medications containing propoxyphene were defectively designed and marketed. Consolidation 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.

A total of 11 plaintiffs had petitioned for consolidation late last year, and they had suggested the Eastern District of New York, the Eastern District of Louisiana, the Western District of Louisiana, the Southern District of Ohio or the Northern District of Georgia as possible venues for the centralized litigation.  While the defendants had opposed centralization, they did suggest the Eastern District of Kentucky - where Xanodyne is based - as a possible venue.  In choosing the Eastern District of Kentucky, the JPML cited its accessibility to parties outside Kentucky, as well as Judge Reeves' "extensive private civil litigation and judicial experience to organize this litigation for a prudent course."

First approved by the FDA in 1957, propoxyphene is sold by prescription under various names both alone (e.g., Darvon) or in combination with acetaminophen (e.g., Darvocet).   Since 1978, the FDA has received two requests from the group Public Citizen proproxyphene from the market. But until last November, the agency had maintained that the benefits of propoxyphene for pain relief outweighed the safety risks of the drug.

The FDA was widely criticized for taking too long to act on Darvon and Darvocet.  The United Kingdom banned propoxyphene in 2005 and the entire European Union followed suit in January of 2009. In January 2009, an FDA advisory panel narrowly voted 14-12 to recommend that the FDA remove Darvon and similar products from the market, but the agency ignored the panel and only mandated new warning labels - that failed to mention heart rhythm problems - for the drugs.  According to Public Citizen, the FDA’s delay in recalling the drugs has likely cost thousands of lives.

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