Xarelto (rivaroxaban) is a prescription anticoagulant (blood thinner) approved by the Food and Drug Administration (FDA) in 2011 for the purpose of reducing the risk of blood clots in patients who had knee or hip replacement surgery. It was also approved for general treatment of deep vein thrombosis (DVT) and pulmonary embolism under the FDA’s expedited review program.
Xarelto works by inhibiting a series of proteins and enzymes that would normally trigger the blood-clotting process. Unlike other blood thinners, this drug is prescribed in one uniform dose rather than separate specified doses. At this time, GoldenbergLaw is no longer accepting Xarelto cases.
Case Quick Facts
Naturally, all blood thinners carry the risk of internal bleeding and as a result emergency antidotes are commonly used to keep bleeding under control. Xarelto has no antidote and cannot be flushed out of your system through dialysis. In 2013, the FDA approved a boxed warning on Xarelto. The warning informs doctors and patients that premature discontinuation of the medication could lead to blood clots or hematomas—the occurrence Xarelto was developed to prevent.
What injuries can Xarelto cause?
- Internal bleeding
- Rectal bleeding
- Coughing up or vomiting blood
- Infection associated with hip or knee replacement surgery
- Bleeding in the brain
- Blood clots and hematomas (severe, large blood clots)
It is of the utmost importance to monitor your body’s reaction to Xarelto. Internal bleeding may not be noticeable when it first begins, but if left unaddressed it can be fatal. Since there is currently no antidote available to address the type of internal bleeding potentially caused by Xarelto, it is important to keep a close eye on any side effects that arise while taking the drug.
Xarelto was developed by Bayer and marketed by Janssen Pharmaceuticals — a subsidiary company of Johnson & Johnson. According to CEO Alex Gorsky, Xarelto controlled 15% of the anticoagulant market by 2014. In 2015 alone, Bayer and Janssen Pharmaceuticals reported Xarelto sales totaling $3.9 billion
Lawsuits have been filed against the manufacturers of Xarelto (Janssen Pharmaceuticals, Johnson & Johnson, Bayer Corporation, Ortho-McNeil-Janssen, and other domestic and global parent companies and subsidiaries). The lawsuits include claims that Xarelto is defective and unreasonably dangerous, that the drug was inadequately tested prior to FDA approval in 2011, and that prescribing physicians and consumers have been given inadequate and inaccurate information about the adverse events associated with use of Xarelto. It also looks at Xarelto’s effectiveness and risk profile when compared with Coumadin, a blood thinner that has been used for many decades for stroke prevention in patients with atrial fibrillation. The individual product liability lawsuits include counts for strict liability, negligence, misrepresentation, fraud, and breach of warranty.
These lawsuits will ultimately become part of the multidistrict litigation proceedings (also known as MDL No. 2592) for Xarelto defective drug claims. These claims are pending in federal court in New Orleans, Louisiana before Judge Eldon Fallon. Judge Fallon was appointed to oversee MDL No. 2592 for the Xarelto Products Liability Litigation in late 2014. There are approximately 17,000 individual lawsuits filed and pending before Judge Fallon in the federal court coordinated proceedings.
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