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Xarelto and
Internal Bleeding

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.

Case Quick Facts

The Problem

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.

The Injuries

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.

The Defendant(s)

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

GoldenbergLaw Can Help

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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Bellwether Trials

There have now been four bellwether trials. The defense has won three, and the plaintiffs just succeeded for the first time.

The first Xarelto bellwether trial took place in the U.S. District Court for the Eastern District of Louisiana. The plaintiff, Joseph Boudreaux, Jr., used Xarelto for about a month before he developed severe gastrointestinal bleeding. Mr. Boudreaux was prescribed Xarelto to reduce the risk of stroke from atrial fibrillation. He was hospitalized for five days and forced to undergo several transfusions due to the bleeding event he experienced. He has since required follow-up medical care (Case No. 2:14-cv-02720). This case resulted in a defense verdict.

The second trial also took place in the U.S. District Court for the Eastern District of Louisiana. The plaintiff was Joseph Orr. He is the husband of a woman who died of a cerebral hemorrhage, or uncontrollable bleeding in the brain, after taking Xarelto for one month (Case No. 2:15-cv-03708). This case resulted in a defense verdict.

The third bellwether trial took place in August 2017 again in the U.S. District Court for the Eastern District of Louisiana. The plaintiff was Dora Mingo, who asserted that Xarelto was defectively designed and required warnings because the Defendants failed to instruct physicians to use Neoplastin PT at the initiation of therapy to identify patients at an increased risk of bleeding. This resulted in the defense verdict.

The fourth bellwether finished on December 5, 2017 in Philadelphia with a plaintiff’s verdict against Bayer in the amount of $28 Million in damages against J&J and Bayer. The jury found the companies had provided inadequate warnings about the risks of bleeding associated with Xarelto. The Plaintiff was Lynn Hartman who took Xarelto for more than a year before suffering a gastrointestinal bleed.

There are more than 20,000 cases pending and still more trials to come.

While the trials have not yet gone the plaintiff’s way, jurors have yet to be presented with a case where a patient was put on Xarelto prophylactically, without having a previous history of blood clots. Many clients were prescribed the drug in this manner, and it changes the risk-benefit analysis for the drug if the clients did not have an active risk of a blood clot.

Why Choose GoldenbergLaw?

If you think that you are in need of a Xarelto injury lawyer, our Minneapolis team is available and eager to take a look at your case. We have years of experience working with drug and pharmaceutical cases, and when you combine this with our passion for helping out those facing injustice, you get a skilled and dedicated team.

Thousands of Successful Settlements

Leadership Positions in Numerous MDLs

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