New Xarelto Lawsuits Emerge as Pradaxa Antidote Is Approved

Drug SuitNew lawsuits are emerging in the ongoing Xarelto saga. The new suits allege that the drug’s manufacturers misrepresented its benefits, risks and dangers and that the drug has caused uncontrollable bleeding episodes that have led to multiple patient deaths.

Developed jointly by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary and Bayer Healthcare, Xarelto was approved by the FDA to aid in preventing strokes in 2011. Thousands of lawsuits have emerged alleging that Xarelto was improperly marketed as a safer alternative to other anticoagulant drugs, marketed without an antidote and has led to many instances of massive uncontrollable bleeding events.

Since December of 2014, Xarelto lawsuits against Bayer and Johnson & Johnson have largely been consolidated in two courts, a Multi District Litigation (MDL) court in Louisiana and a mass tort litigation court in Philadelphia. These two cases alone represent more than 2,000 lawsuits. However, new lawsuits continue to emerge, and in 2014 alone 3,331 incidents associated with Xarelto bleeding problems were reported. 379 of those suits involve patient deaths.

Xarelto was created in order to provide an alternative to warfarin, a drug introduced in the 1950s that’s frequently prescribed to those who require a blood thinner to prevent strokes. Taking warfarin can lead to day-to-day challenges, as it requires the need for frequent blood checks, loses its effectiveness when combined with Vitamin K-intensive foods and is incompatible with many over-the-counter medications.

Xarelto faces competition from Pradaxa (Dabigataran), another drug created to serve as a warfarin replacement that was developed in 2010. Pradaxa is produced by Boehringer Ingelheim and works by directly inhibiting thrombin, which is a different clotting factor than the one Xarelto inhibits. More than 3.7 million U.S. patients had filled prescriptions for Pradaxa by August of 2012

While Xarelto and Pradaxa were marketed as more patient-friendly alternatives, neither had an FDA-approved antidote when first introduced. This made major bleeding episodes extraordinarily dangerous for people taking Pradaxa or Xarelto as, unlike warfarin, there was nothing available to rapidly reverse their anticoagulant properties. In May 2014, Boehringer Ingelheim agreed to pay a $650 million settlement for all state and federal lawsuits pertaining to Pradaxa, which yielded an average of $162,500 per claimant.

Recently, the FDA approved Praxbind as the first reversal agent for Pradaxa. Portola Pharmaceuticals is in “final stage program testing” for a reversal drug that would serve as an antidote for Xarelto, though it is not yet FDA-approved. For thousands of patients, these antidotes came too late for those who’ve already suffered from uncontrollable bleeding events.

If you or a loved one has taken Xarelto or Pradaxa and suffered a serious personal injury, you can learn more about these drugs and their corresponding lawsuits by visiting Sheff Law’s Pradaxa and Xarelto FAQ page

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January 21st, 2016 | Posted in