What is Xarelto and why is it used?

Xarelto is an anticoagulant which works by blocking a single blood clotting factor, Factor Xa, thereby reducing the risk of deep vein thrombosis (DVT) and blood clots.  The drug was first approved by the FDA in July 2011 to aid in the prevention of blood clots in patients undergoing hip and knee replacement surgery.  The American Joint  Replacement Registry reported over 860,000 hip and knee replacements in 2017.  These surgeries carry an increased risk of DVT and a subsequent pulmonary embolism (PE), which can ultimately lead to death.  

 

Four months later, Xarelto went on to be approved by the FDA to reduce the risk of stroke in patients who suffer from non-valvular atrial fibrillation, a condition impacting more than 2 million Americans.  In this condition, the two upper chambers of the heart (the atria) beat irregularly, causing blood to pool and creating the potential for clots.  If a clot travels to the brain and blocks blood flow, a stroke occurs.

 

One year later, in November 2012, the FDA further approved Xarelto to be used to prevent the recurrence of DVT and PE.  It was the first new drug to receive approval for the prevention of recurring DVT and PE in 60 years. 

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What types of injuries and side-effects have occurred with Xarelto?

Studies published by the National Institute of Health (NIH) in 2012 and by The Journal of Arthroplasty in 2016 respectively found Xarelto caused a significant increase in deep surgical site infections and wound complications.  Platelet deficiencies, hepatitis, and a serious skin condition known as Stevens-Johnson Syndrome have also been reported as side effects.

 

However, Xarelto's most dangerous adverse effect is internal bleeding.  Factor Xa inhibitor drugs including Xarelto have caused nearly 2,000 deaths per month according to Portola Pharmaceuticals, Inc.  Portola received clearance from the FDA in May of 2018 for its drug, Andexxa, which is an antidote to internal bleeding.   Until the introduction of Andexxa, no reversal agent existed to stop the serious to life-threatening consequences of massive internal bleeding caused by drugs such as Xarelto.

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Why are lawsuits being filed against Xarelto manufacturer, Janssen Pharmaceuticals, Inc., parent company Johnson & Johnson, and marketer Bayer AG?

Over 21,000 lawsuits against Janssen, Johnson & Johnson, and Bayer were pending in U.S. courts as of January 2018.  Plaintiffs in these cases contend Xarelto was unreasonably dangerous and the manufacturing and marketing companies did not adequately warn of the drug's potential to cause irreversible, extensive internal bleeding.  Existing lawsuits also allege the defendants did not clarify the lack of an antidote for the drug and the need for monitoring while the drug is being taken, did not provide adequate information to physicians to safely prescribe Xarelto, and omitted trial results on the warning label.

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How is The Crouch Firm, PLLC involved in the litigation against Xarelto manufacturer Janssen Pharmaceuticals, Inc. & parent company Johnson & Johnson?

The Crouch Firm is currently assisting individuals who have sustained injuries as a result of Xarelto seek damages.