Pradaxa Settlement Does Not Bar New Lawsuits

Despite a 2014 mass settlement, patients who have suffered bleeding injuries after taking Pradaxa may still qualify to bring a Pradaxa lawsuit.

Pradaxa is one of the newer class of blood-thinning medication prescribed to help prevent blood clots and stroke in patients with atrial fibrillation (a heart rhythm abnormality) or patients who have recently undergone surgery.

Soon after Pradaxa gained Food and Drug Administration (FDA) approval in 2010, the FDA started receiving reports of hemorrhaging, internal bleeding, or other bleeding injuries among those taking Pradaxa, Top Class Actions reports. The FDA reportedly received thousands of reports of bleeding episodes and hundreds of these cases resulted in a patient’s death.

In 2012, patients’ Pradaxa lawsuits were consolidated in a multidistrict litigation (MDL) in federal court in Illinois. The MDL was set up to coordinate pretrial proceedings in the claims related to Pradaxa side effects.

The plaintiffs in these lawsuits alleged that drug maker Boehringer Ingelheim, failed to properly warn them that the side effects of  Pradaxa could include dangerous and possibly deadly bleeding. The plaintiffs also noted that Pradaxa was released to the market without an antidote that could reverse Pradaxa’s anticoagulant effect in case of a bleeding episode. The lawsuits were brought by injured patients and by family members of those who died.

The new class of blood thinners, which also includes Xarelto and Eliquis, was received enthusiastically because these drugs promised greater ease and convenience than warfarin, the blood thinner that has been the standard treatment for 60 years. Warfarin users must have regular blood monitoring to be sure they have an effective amount of the drug in their blood and they must follow a number of dietary restrictions. Pradaxa does not have such restrictions. But Pradaxa users do not have the safety net of an antidote and so they face greater risks in the event of a bleeding episode.

Evidence uncovered in the course of this MDL allegedly showed that Boehringer Ingelheim allegedly knew about the risks of internal bleeding associated with Pradaxa, but kept study results to itself rather than warn the medical community and patients of possibly dangerous Pradaxa side effects.

In May 2014, Boehringer Ingelheim agreed to pay approximately $650 million to settle about 4,000 active claims in the Pradaxa MDL at that time, according to Top Class Actions. The settlement was reached just before the first Pradaxa trials were scheduled to begin.

After the court approved the Pradaxa settlement, the court relieved the plaintiffs’ steering committee in the MDL of its responsibilities and the court stopped accepting new claims in the MDL. But the settlement does not prevent new plaintiffs from filing claims for injuries and deaths that were not covered in the 2014 settlement.

New cases are now emerging from Pradaxa patients whose claims are not covered by the 2014 settlement.


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