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In May of 2014, the makers of Pradaxa settled an initial round of internal bleeding and death cases for $650 million.

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Pradaxa Lawsuit Information

The blood thinner Pradaxa is prescribed to prevent blood clots and stroke in those patients with atrial fibrillation and who have undergone surgery. Unfortunately, it has made headlines after repeated warnings that it can cause severe internal bleeding.

In recent years, thousands of those injured or who lost a loved one filed a Pradaxa lawsuit. The maker of the drug, Boehringer Ingelheim, has now been forced to pay hundreds of millions of dollars in compensation for not warning patients there was no reversal agent to stop bleeding.

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.

Due to the number of legal claims filed, Pradaxa cases were consolidated to a special federal Multi-District Litigation court in Illinois. The case was known as MDL No. 2385, IN RE: Pradaxa Product Liability Litigation, Southern District of Illinois.

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, Pradaxa has no reversal agent to stop bleeding as is available 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 Pradaxa Settlement

In May of 2014, as Boehringer Ingelheim faced the start of trials over Pradaxa internal bleeding, they opted to pay approximately $650 million to settle all pending cases. The administration of this settlement is expected to be completed in December of 2014.

The Pradaxa settlement only accounted for lawsuits that had been filed by the effective date of the agreement. At this time, DrugNews is not aware of any other legal action for subsequent bleeding victims, or any lawyers handling these cases.

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.

For more information on the side effects or warnings related to the drug Pradaxa, contact us today. We are available 24 hours a day to provide help.

pradaxa settlement
view sources

Holster, L. New Oral Anticoagulants Increase Risk for Gastrointestinal Bleeding: A Systematic Review and Meta-analysis. Gastroenterology. (March 7, 2013). Retrieved from www.gastrojournal.org

QuarterWatch. Update on Anticoagulants dabigatran (PRADAXA) and rivaroxaban (XARELTO). Institute for Safe Medication Practices. (January 9, 2013). Retrieved from www.ismp.org

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