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Shezad Malik MD JD
Shezad Malik MD JD
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The Untold Story About Xarelto and Pradaxa Bleeding Injuries

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According to court documents, the number of Xarelto bleeding injury lawsuits have exploded, with 400 cases being filed in the month of August alone. And the numbers of claims will continue to rise..

Xarelto Injury LawsuitsSince December 2014, all federal product liability lawsuits filed against Bayer and Johnson & Johnson over the bleeding side effects of Xarelto have been centralized and consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana as part of an MDL, or multidistrict litigation.

Lawsuits against Bayer and Johnson & Johnson are consolidated in two courts, a multidistrict litigation court in the Eastern District of Louisiana and a mass tort litigation court in Philadelphia.

The MDL in Louisiana contains 1,698 federal lawsuits, and the mass tort in Philadelphia contains more than 400 state lawsuits.

4 Xarelto Bellwether Trials Set

Judge Fallon set a series of four bellwether trials to go before juries in the Spring of 2017. As of September 15, according the data provided by the Judicial Panel Multidistrict Litigation (JPML) there are 1,710 Xarelto injury lawsuits in the Eastern District of Louisiana.

The number of Xarelto lawsuits continue to be filed by individuals across the United States, alleging severe and deadly bleeding complications.

Bellwether Trials in Louisiana, Mississippi and Texas

The first two trials will be held in the Eastern District of Louisiana, on February 6 and March 13, 2017. The third trial will be held in Mississippi on April 24, 2017 and the fourth trial will be held in Texas on May 30, 2017.

According to Judge Fallon’s order, the cases that will go before juries on these dates will be pulled from a pool of 40 lawsuits to be selected in January 2016. These cases will be trial ready, with case-specific discovery, including depositions of plaintiffs, prescribing doctors, treating physicians and sales representatives of the drug makers.

What is Xarelto?

Xarelto (rivaroxoaban) was released and approved for sale in 2011 as a superior replacement for Coumadin (warfarin). Xarelto is used to reduce the risk of blood clots among patients at risk for deep vein thrombosis, pulmonary embolism and those patients at risk for a stroke with atrial fibrillation.

Atrial fibrillation is a common heart rhythm problem, which leads to embolic strokes, from blood clots that develop in the heart and travel up to the brain.

Xarelto was developed and sold jointly by Johnson & Johnson’s Janssen Pharmaceuticals subsidiary and Bayer Healthcare. Xarelto is a “direct thrombin inhibitor,” and Xarelto was released to compete with Boehringer Ingelheim’s Pradaxa, another new type of anticoagulant. Both drugs were touted as being superior and easier to use than the older blood thinner warfarin, also known as Coumadin. Coumadin was the gold standard for anticoagulants and dominated the blood thinner market for several decades.

Xarelto has the largest share of the market for anticoagulants and is considered a blockbuster drug, with annual sales over $1 Billion in the United States.

Big Problem: No Xarelto Antidote

All anticoagulants or blood thinners have a risk of bleeding and injury, but Xarelto has been linked to a significant number of injuries involving catastrophic and uncontrollable bleeds, including death.

Xarelto has been advertised heavily as being easier to use than warfarin, since it does not require regular blood monitoring. According to  several recent studies, those claims may be in doubt.  Medical researchers have indicated that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.

Plaintiffs are filing bleeding lawsuits claiming that the drug manufacturers suppressed information about the lack of a reversal agent. Warfarin’s blooding thinning effects can be quickly reversed in an emergency, there is no antidote for Xarelto.

Similar Lawsuits Claims Settled For Pradaxa

Pradaxa, is another new-generation anticoagulant introduced by Boehringer Ingelheim in October 2010. In 2014, there were 3,592 serious adverse event reports involving Pradaxa, with 752 involving the death of the patient, compared with 3,331 reports associated to Xarelto bleeding problems, with 379 involving a patient death.

Similar allegations of a lack of an antidote, were raised in more than 4,000 Pradaxa lawsuits. On the eve of trial, Boehringer Ingelheim agreed to pay $650 million in Pradaxa settlements, with an average of about $150,000 per claim.