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First Xarelto Stroke Lawsuit Filed as Total Case Number Grows

Doctors examine X-ray results

Hundreds of people filed lawsuits against Bayer and Johnson & Johnson claiming their blood-thinning drug Xarelto (rivaroxaban) caused them to suffer negative side effects like uncontrollable bleeding.

Now, the daughter of a Florida man who died from a stroke four days after he began taking Xarelto filed a lawsuit in Philadelphia claiming the drug did not work as advertised. It’s the first lawsuit claiming Xarelto failed to prevent a stroke in a patient with atrial fibrillation (abnormal heartbeat).

The U.S. Food and Drug Administration approved Xarelto to reduce the risk of stroke in patients with atrial fibrillation in 2011, but one FDA reviewer recommended against the drug’s approval.

“The data do not convincingly demonstrate that rivaroxaban (Xarelto) is as effective in preventing strokes and systemic emboli (blood clots) as warfarin when warfarin is used skillfully,” the reviewer wrote to the advisory committee in 2011. “If rivaroxaban is approved, patients taking it might be at greater risk of harm from stroke and/or bleeding.”

The lawsuit alleges Xarelto’s once-a-day dosing leaves patients vulnerable to blood clots and strokes for a portion of the day. Other anticoagulants are taken twice a day to improve the balance of the amount of the drug in the body throughout the day.

A 2014 study found the amount of Xarelto in a patient’s body fluctuated more than three times as much as a comparable anticoagulant, Eliquis (apixaban), taken twice daily.

Meanwhile, the number of lawsuits claiming Xarelto caused irreversible bleeding side effects continues to grow.

Total Xarelto Lawsuit Number Continues to Grow

Lawsuits against Bayer and Johnson & Johnson are consolidated in two courts, a multidistrict litigation court in the Eastern District of Louisiana and a mass tort litigation court in Philadelphia.

The MDL in Louisiana contains 1,698 federal lawsuits, and the mass tort in Philadelphia contains more than 400 state lawsuits.

The first bellwether trial date is set for Feb. 6, 2017. Three additional trials are scheduled for the following March, April and May. Bellwether trials are the first cases to go before a jury. They often include cases that are representative of the claims made by other cases, so plaintiffs and defendants can determine how future trials will play out.

If defendants lose multiple bellwether trials, they usually look to settle large numbers of cases to avoid additional negative jury verdicts. If defendants know they have a weak case, they may settle bellwether cases before trials begin.

There are reports of more potential cases claiming Xarelto failed to prevent a stroke in patients with atrial fibrillation, but it’s too soon to know if the claims will be as widespread as the irreversible bleeding claims.

Chris Elkins
Written By Chris Elkins Writer

Chris Elkins's expertise is in health communication. He worked with respected health communication scholar Athena du Pré on the textbook Communicating About Health: Current Issues and Perspectives: 5th Edition. He holds six certificates from the Centers for Disease Control and Prevention. Some of his qualifications include:

  • Graduate-level certificate in health communication leadership
  • Master's degree in strategic communication and leadership
  • Bachelor's degree in journalism

5 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. First Judicial District of Pennsylvania. (2015). Xarelto case list. Retrieved from:
  2. Frost, C. (2014). A randomized direct comparison of the pharmacokinetics and pharmacodynamics of apixaban and rivaroxaban. Clinical Pharmacology, 6, 179-187. Retrieved from:
  3. Judicial Panel on Multidistrict Litigation. (2015, October 15). MDL statistics report – Distribution of pending MDL dockets by district. Retrieved from:
  4. U.S. Food and Drug Administration. (2011, September 8). FDA draft briefing document for the Cardiovascular and Renal Drugs Advisory Committee (CRDAC). Retrieved from:
  5. Walker, E. (2011, September 6). FDA reviewer slams Xarelto for stroke prevention in Afib. MedPageToday. Retrieved from:
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