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Eric T. Chaffin
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Man Suffers Life-Threatening Brain Hemorrhage; Sues Xarelto Manufacturers

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On September 3, 2014, plaintiffs James J. Brien and Dolly S. Brien filed a new Xarelto lawsuit against manufacturers Janssen Pharmaceuticals and Bayer Pharma AG. The case was filed in the U.S. District Court for the Eastern District of Louisiana.

The plaintiffs claimed that after James took Xarelto as prescribed, he suffered serious and life-threatening injuries. They seek in excess of $75,000 in damages.

Plaintiff Suffers Severe Brain Hemorrhage

According to the complaint, James J. Brien started taking Xarelto—an anticoagulant drug—on April 19, 2013. He was prescribed the medication to treat his non-valvular atrial fibrillation, and to reduce his risk of stroke. He was unaware of the risks of excessive and severe internal bleeding at the time.

Brien claims that he took the medication as directed. He had no initial reactions to the drug, but then on September 7, 2014, he suffered a serious brain hemorrhage and was rushed to the hospital. He was there for two days of treatment, and subsequently suffered temporary paralysis on his left side. He had to undergo several months of recovery, during which he needed the assistance of a cane to walk.

It was after his injury that Brien became aware that some patients taking Xarelto are apparently at an increased risk for serious bleeding events. He stopped taking the medication and later filed this lawsuit in an effort to recover damages.

Companies Downplayed Xarelto Risks

The FDA first approved Xarelto (rivaroxaban) in July 2011 to help reduce the risk of blood clots in patients undergoing hip and knee replacement surgeries. They later expanded that approval to include patients suffering from non-valvular atrial fibrillation (to reduce risk of heart attack and stroke) and to treat deep vein thrombosis and pulmonary embolism.

Clinical studies used to gain approval for the drug showed that Xarelto provided a similar benefit to warfarin, the leading anticoagulant drug. Excessive bleeding, particularly from gastrointestinal sites, however, occurred more frequently with Xarelto than with warfarin.

Brien claims the manufacturers did not appropriately highlight this fact in their product warnings. Like other plaintiffs, he also claims that the companies overpromoted the drug as a more convenient option to warfarin, since it doesn’t require blood monitoring or dietary changes, and comes in a once-daily dose.

The Institute for Safe Medication Practices stated in their October 3, 2012 QuarterWatch, “Reviewers also questioned the convenient once-a-day dosing scheme, saying blood level studies had shown peaks and troughs that could be eliminated by twice-a-day dosing.”

What the manufacturers failed to mention in their marketing materials was that there is no readily available antidote for Xarelto bleeding. Whereas doctors can administer vitamin K injections to stop bleeding in patients taking warfarin, there is no similar solution for patients on Xarelto. Patients simply have to wait until the drug leaves the system, which can take 24 hours.

Meanwhile, Xarelto bleeding can cause life-threatening complications.

Manufacturers Failed to Warn

Brien claims that the defendants had the responsibility to warn the public about all possible effects of Xarelto, but failed to do so. Had he known about the risks, he states he would never have taken the medication.

The plaintiffs bring counts of negligence, concealing information, misrepresentation, and false advertisement.