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A Virginia woman has joined the Xarelto multidistrict litigation in the Eastern District of Louisiana. She filed her case on March 20, 2017, and claims that her husband suffered serious injuries and died after taking Xarelto. She seeks $2 million in damages.

Man Suffers from Aortic Aneurysm After Taking Xarelto

According to the complaint, the decedent started taking Xarelto (rivaroxaban) on January 1, 2016. On January 9, 2016, just a few days after he started taking the drug, he suffered an aortic aneurysm. According to the complaint, the decedent was hospitalized and later died on January 13, 2016 as a result of his drug-related injuries. His wife blames Xarelto for his death.

An aortic aneurysm is an abnormal enlargement or bulging that occurs in the wall of the aorta, the largest artery in the body. The aorta takes blood from the heart to the rest of the body, delivering oxygen and nutrients to other cells. An aortic aneurysm may occur in the part of the aorta that runs through the chest, near the heart, or in the part of the aorta that runs through the abdomen. It is unclear from the complaint which the decedent suffered.

Plaintiff Claims Manufacturers Over-Promoted Xarelto

Janssen Pharmaceuticals, parent company Johnson & Johnson and Bayer AG first received FDA approval for Xarelto in 2011.  It was initially approved to help prevent blood clots in patients undergoing knee and hip replacement surgery. The drug was later approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation and to help prevent and treat deep vein thrombosis and pulmonary embolism.

Unlike the traditional blood thinner warfarin, which works by blocking vitamin K proteins, Xarelto is one of a newer class of blood thinners that blocks the action of an enzyme called Factor Xa. Manufacturers advertised the drug as being more convenient to take than warfarin because patients didn’t have to adhere to dietary restrictions or undergo regular blood monitoring.

The manufacturers, however, failed to warn doctors and patients about the lack of readily available antidote to stop a patient’s bleeding if it occurs while taking Xarelto. Patients taking warfarin can be treated with vitamin K injections, but those taking Xarelto have no such antidote. Bleeding events in these patients can be much more dangerous and even deadly.

The plaintiff in this case alleges that the defendants over-promoted Xarelto, spending at least $11 million on advertisements in 2013 alone. She also claims that they overstated the drug’s efficacy in preventing strokes and blood clots.

Xarelto Serious Events Surpass Pradaxa

Since Xarelto reached the market, the FDA has received many reports of adverse events linked to this drug. In the year leading up to June 2012, there were 1,080 Xarelto-associated serious adverse event reports filed with the administration, including at least 65 deaths. By the end of that year, a total of 2,081 reports were filed, including 151 deaths, compared to only 56 deaths associated with warfarin.

In the first quarter of 2013, the number of serious events associated with Xarelto surpassed those associated with Pradaxa, another similar medication. The plaintiff claims that the defendants failed to adequately warn consumers and healthcare professionals about the drug’s dangers. She asserts counts of strict liability, manufacturing and design defect, failure to warn, negligence, breach of warranties, negligent misrepresentation, and fraud. She also seeks compensatory and punitive damages.

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