The blood thinner Pradaxa, which is prescribed to many with atrial fibrillation, has made headlines after repeated warnings that it can cause severe internal bleeding.
So far, hundreds of those affected by injury or loss of a loved one have filed a Pradaxa lawsuit. The maker of the drug, Boehringer Ingelheim, faces liability since they did not warn patients that there is no reversal agent to stop bleeding.
Authored by Chris Schroeder
The FDA approved Pradax in 2010, and within six months, patients were reporting serious bleeding events. Although the agency has received over 4,000 reports of side effects and 542 deaths among users, they have not issued a recall. However, those injured can get legal help.
A federal judge recently ruled that patients injured by internal bleeding can file a Pradaxa lawsuit for their loss. Due to the number of expected claims, the cases have been consolidated to a special federal Multi-District Litigation court in Illinois. The case is known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.
In recent months, the number of claims filed by patients or families of those lost have nearly tripled to almost 700 cases. However, experts believe that thousands could eventually file a Pradaxa lawsuit as news spreads of the drug's risks and the legal options for those affected.
If you have been affected by these serious Pradaxa side effects, it is your right to seek compensation. Lawyers are currently helping victims file claims against the manufacturer. A Pradaxa lawsuit can be filed individually, instead of as one class action suit. For victims, this is often more advantageous.
If you or a loved one suffered internal bleeding while taking Pradaxa, you may be entitled to substantial compensation. Contact us today to speak with a lawyer about whether your case qualifies and how long you have to act.
The adverse events associated with Pradaxa include internal bleeding in the brain, intestines and kidneys, as well as heart attacks.
Although all blood thinning drugs can cause internal bleeding, the maker of Pradaxa faces liability because they did not warn patients that there is no reversal agent to stop bleeding as there is with other drugs like Coumadin or Warfarin.
And yet, according to an August 27, 2012 report in the Berlin Ad Hoc News, manufacturer Boehringer Ingelheim claims Pradaxa has been prescribed in more than 70 countries.
The FDA has not recalled Pradaxa, so it is still on the market. Experts fear that many more injuries or deaths will be caused by this drug. The top public health and medical organizations have published their warnings. The European Medicines Agency, The Journal for the American Medical Association, and others have issued warnings on internal bleeding risks.
The Journal for The American Medical Association has warned that the FDA may have rushed approval of Pradaxa. In the September 5, 2012 article, “The Safety Risks of Innovation,” authors state the new FDA Expedited Drug Development Pathway may have overlooked key dangers, such as early trials showing Pradaxa had no reversal agent for internal bleeding.
However, in November 2012, the FDA updated its warnings to say that, for now, testing shows Pradaxa carries the same risks as warfarin and Coumadin. There is no evidence the FDA will recall this drug. Experts are concerned that many patients are taking Pradaxa without knowing the risks.
Despite the continued risk of the drug, those affected have legal options. Lawyers are available to discuss your case. However, when choosing a lawyer for these complex federal MDL cases, make sure they are specialzed in this type of lawsuit and have experience fighting large drug companies.
The DrugNews Resource Center works solely with law firms that specialize in defective drug claims and have handled numerous Pradaxa lawsuits
For more information on the side effects, warnings and legal action related to the drug Pradaxa, or to speak with a lawyer, contact us today. We are available 24 hours a day to provide help.
Last Modified: Monday, March 10, 2014