Pradaxa is a drug that many thought would almost completely replace Warfarin (Coumadin), a blood thinner that has been tried and true for over 60 years. It is used for patients with atrial fibrillation, also known as irregular heartbeats. Warfarin contains the same risks of bleeding and hemorrhaging, but those effects are easily counteracted by administration of vitamin K. With Pradaxa, however, there is no quick way to stop the drug from working. Patients on Pradaxa who must have emergency surgery are at a high risk of complications that may lead to death.
The FDA announced a safety review of Pradaxa in December of 2011. That investigation is continuing, and is the result of an overwhelming amount of adverse drug reports. Between January 2011 and March 2011, there were over 505 reports of internal bleeding or hemorrhaging, and 120 Pradaxa-related deaths.
On May 25, 2012, the European Medicines Agency recommended a significant change to the Pradaxa warnings http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000829/smops/Positive/human_smop_000386.jsp&mid=WC0b01ac058001d127. The EMA wants doctors and patients to have more information about the drug’s dangers.
Pradaxa Lawsuit Status
A motion was filed on May 30, 2012 by victims in the United States District Court for the Southern District of Illinois, asking for permission to consolidate all federal Pradaxa injury cases into one class action-like case, known as multidistrict litigation (MDL). Cases that are combined into an MDL have the advantage of efficiency—there is one judge assigned to all of the cases, and that judge combines and coordinates pretrial discovery, which prevents duplicative effort and expense. After discovery, the judges sometimes order a few test trials to take place, and that provides the parties a good idea of how successful the lawsuits would be. At that point, many individual drug injury lawsuits will settle, usually for a significant amount of money.
The motion was filed on May 30, and included at least 21 associated Pradaxa cases that would be included (more are being filed almost daily). The court has set a briefing schedule, and a hearing date will be set soon.
If you or a loved one has been prescribed Pradaxa and has had problems with bleeding or hemorrhaging, contact our Pradaxa injury lawyers at 800.553.8082, or online here.