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An Arizonan woman, Margaret Garvy, recently filed a product liability and personal injury lawsuit alleging that side effects of Xarelto caused her to suffer a life threatening hemorrhagic pericardial effusion. Hemorrhagic pericardial effusion, is a serious medical condition where the sac around the heart is filled with blood, preventing the normal contractions of the heart and if left untreated can be deadly.

Garvy’s complaint is the latest in several thousand drug injury cases filed against Bayer and Johnson & Johnson over uncontrollable bleeding complications linked to their controversial new anticoagulant medication. Garvy filed her case in the U.S. District Court of the Eastern District of Louisiana.

Louisiana Xarelto Multidistrict Litigation

All Xarelto lawsuits filed in U.S. District Courts nationwide have been consolidated in the Eastern District of Louisiana as part of a federal MDL, or multidistrict litigation (MDL) since December 2014. The MDL litigation is centralized before U.S. District Judge Eldon Fallon for coordinated discovery and pretrial proceedings.

Xarelto Plaintiff Claims Life Threatening Injury

According to Garvy, she took the anticoagulant Xarelto for less than two weeks in May 2014, and she was diagnosed with hemorrhagic pericardial effusion, pericardial tamponade and pleural effusion. Garvy claims that the bleeding around the heart and lungs was from her Xarelto use and the lack of an effective reversal antidote to stop the drug’s anticoagulant or blood thinning effects.

Garvy alleges that Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary knew or should have known about the hemorrhage risks with Xarelto, but withheld information from patients and the doctors about the fact that users may experience uncontrollable bleeding.

Xarelto Increases Hemorrhage Risks

Xarelto (rivaroxoaban) was approved in 2011 as a replacement medication for Coumadin (warfarin), which has been the gold standard anticoagulant treatment for the past 60 years. Xarelto was approved for the treatment of chronic atrial fibrillation, which is a common heart rhythm problem and can lead to strokes if there is no anticoagulant usage.

Xarelto is a new-generation of blood thinners, which have been touted as easier to use than warfarin, because the manufacturers claim that there is no need to measure blood thinning levels.

But, a large number of adverse event reports began to be filed after Xarelto was released, usually involving uncontrollable bleeding that doctors were unable to stop.

All blood thinners carry a risk of bleeding injury, and the side effects of warfarin can be quickly reversed with Vitamin K antidote if bleeding occurs. Unfortunately there is no Xarelto reversal agent and plaintiffs have alleged that the drug manufacturers failed to adequately warn doctors about the lack of an antidote.

Xarelto Bellwether Trials

As is common in the coordinated management of defective drug litigations, Judge Fallon has established a “bellwether” program, where a small group of claims are being prepared for early trial dates.

The Xarelto bellwether trials are scheduled to go in February 2017 and May 2017.

Pradaxa Uncontrollable Bleeding and Death Lawsuits

Pradaxa is a similar newer generation blood thinner made by Boehringer Ingelheim based in Germany. This Xarelto litigation involves similar uncontrollable bleeding claims to those in thousands of Pradaxa lawsuits. The Pradaxa maker ultimately agreed to pay $650 million in Pradaxa settlements in 2014, with an average of about $150,000 per claim.

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