Thursday, June 30, 2011

Darvocet Recall Came Too Late For a Generation

The company that manufacturers Darvon and Darvocet (which also contains acetaminophen), Xanodyne Pharmaceuticals, Inc., has agreed to comply with the FDA’s demands, and generic makers of the drug are expected to do the same. At the time the market withdrawal request was issued, an estimated 10 million patients nationwide were taking a pain medication containing propoxyphene. It is likely that hundreds, if not thousands, of Darvocet lawsuits will be filed against not only Xanodyne, but other manufacturers of the drug. Xanodyne Pharmaceuticals, the manufacturer of the name-brand versions of Darvon and Darvocet, has 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 addition, the company points out that many of the cases involve generic versions of Darvocet or Darvon, which is available from a number of different drug makers.

Medical experts have been questioning the safety of Darvocet and Darvon for years, with the first petition for the FDA to issue a propoxyphene recall filed in 1978, after data suggested that the drug may cause potentially harmful toxins to build up in the heart. Although Darvon and Darvocet were recalled in the U.K. in 2005 due to an increased risk of Darvocet suicide and overdose, it remained available in the United States. The consumer group Public Citizen filed a new petition in 2006, and filed a Darvocet lawsuit against the FDA in 2008 over their failure to act on their petition to ban the drug in the United States.


Following a hearing in March, a panel of federal judges has decided not to make a decision yet about whether to consolidate all federal Darvocet lawsuits and Darvon lawsuits as part of an MDL, or multidistrict litigation. A decision has been deferred until further arguments are heard at a hearing in July 2011. The plaintiffs seek to have the cases consolidated since all of the Darvon and Darvocet suits contain similar allegations that the manufacturer failed to adequately research the side effects of Darvocet and Darvon and failed to warn doctors and patients that propoxyphene-based drugs caused heart rhythm problems that could sometimes be fatal.Darvocet Patients who are concerned about side effects they may have experienced should talk to both a physician and an experienced Darvocet lawyers to determine their best options in pursuing legal action.

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