When taking an anticoagulant to prevent blood clots, one may accept some risk. However, patients who took Xarelto (rivaroxaban), a blood thinner, have frequently been subject to uncontrolled bleeding for which there is no antidote. Uncontrolled bleeding is dangerous, and in many cases has proved fatal.
Currently, more than 7,000 plaintiffs have filed suit against Bayer, the manufacturer of Xarelto, and Johnson & Johnson, whose Janssen Pharmaceuticals subsidiary marketed Xarelto. The suits allege that the side effects of Xarelto caused uncontrolled bleeding, which led to injury and death. The suits also allege that the plaintiffs were not made aware that there was no antidote to the drug.
Xarelto was introduced as an improvement over the long-time anticoagulant market leader, warfarin. However, in 2012, Xarelto users suffered three times the deaths from adverse events than users of warfarin. Bonsignore Trial Lawyers are highly concerned about reports of uncontrolled bleeding, and ready to investigate potential lawsuits stemming from use of Xarelto. We will aggressively pursue fair and just compensation on behalf of you and your family members.
What Is Xarelto?
Xarelto is a one of a new class of anticoagulant known as Factor Xa inhibitors. They are prescribed to thin blood so that clots do not form when patients are postoperative and at other times when patients are likely to be inactive for prolonged periods.
Who Makes Xarelto?
Xarelto was developed by Bayer and marketed via the Janssen Pharmaceuticals subsidiary of Johnson & Johnson. It was approved by the FDA in 2011.
Xarelto Side Effects
Shortly after Xarelto was introduced, reports of side effects began to occur. Current plaintiffs report, among other side effects, episodes of uncontrolled bleeding from stomach, eyes, and rectum for which no other possible cause exists. The drug has also been reported to cause blood clots, which it is explicitly prescribed to prevent. There are also concerns that it causes a much higher degree of infections in patients who have undergone hip or knee replacement surgery than other therapeutics.
Side effects include:
- Eye hemorrhaging
- Gastrointestinal bleeding
- Irregular heartbeat
- Liver failure
- Low blood pressure
- Muscle pain
- Nose bleeds
- Rectal bleeding
Xarelto Bleeding Risk
Plaintiffs have alleged that the warnings currently available about Xarelto internal bleeding and other side effects are insufficient. They also note that they were not aware there was no antidote for Xarelto. There is an antidote for warfarin, which is also frequently prescribed for blood clots.
The FDA expressed initial concerns about the data on Xarelto, although it ultimately approved the drug for use. Since then, the FDA has issued a number of warnings on Xarelto and required Johnson & Johnson to update the prescribing information. In 2014, the warnings included an update regarding the lack of an antidote for excessive bleeding caused by Xarelto’s blood-thinning effects.
Xarelto Reversal Agent
There is currently no available reversal agent for the excessive bleeding.
Portola Pharmaceuticals has developed a reversal agent for Xarelto, called AndexXa. In late August, the FDA issued a Complete Response Letter (CRL), delaying its approval until receipt of further data.
Thousands of plaintiffs have filed product liability claims, alleging injuries and deaths due to excessive bleeding caused by Xarelto. Their claims focus on inadequate warnings about excessive bleeding and lack of warning about the lack of a reversal agent.
The then-pending Federal Xarelto lawsuits were consolidated in December 2014 by the U.S. Judicial Panel on Multidistrict Litigation. Many other lawsuits have since been filed and in this litigation. Two sets of lawsuits are the result of this consolidation: the multidistrict litigation proceeding (MDL) overseen by Judge Eldon E. Fallon of the United States District Court for the Eastern District of Louisiana and a mass tort track in the First Judicial District of Pennsylvania. (A mass tort is intended to streamline the volume of cases.)
In mid-August, Judge Fallon selected four cases out of the more than 7,200 before the court to serve as bellwether cases. The series of trials concerning the bellwether cases is slated to begin in February 2017.
The reason for the bellwether cases is that questions of fact and law in the thousands of claims are similar, and coordinated discovery and pretrial phases will expedite the cases.
The outcome of the bellwether case trials is not binding on other cases, but will doubtless be followed closely. The outcome of bellwether cases can be predictive of jury response, damages, and outcomes for other cases given the commonality of facts in the claims.
If you or a family member has suffered injury or death as a result of Xarelto use, you need a legal team dedicated to redressing your wrongs and helping you win just compensation for damages. Bonsignore Trial Lawyers specialize in complex litigation and consumer protection. We will work valiantly on your behalf.
We help our clients receive:
- Payment for related medical expenses, both in the present and the future
- Compensation for pain and suffering
- Compensation for lost quality of life
- Wages lost and reduction in potential future earnings or earnings capacity
- Cost of funerals
- Loss of financial contribution
If you are contemplating filing a lawsuit against the makers of Xarelto, please put our expertise and concern to work for you.
We will review your case at no charge and then discuss the legal recourse available.
Experienced Xarelto Problems? Here Are Some Resources: