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The new generation anticoagulant Xarelto is the subject of a wrongful death lawsuit filed last month by the family of a Vermont man who died on August 1, 2012 as the result of a fatal brain hemorrhage. According to court documents, the man died after using the drug for less than 10 days.

Ruth McGowen filed the claim against Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary on July 25 in the U.S. District Court for the District of Vermont. McGowen’s father, Thomas C. Dunkley, was prescribed Xarelto to treat atrial fibrillation to reduce his risk of sustaining an embolic stroke.

What is Xarelto?

Xarelto (generic name rivaroxaban) was originally approved by the U.S. Food and Drug Administration in 2011 to reduce the risk of deep vein thrombosis and pulmonary embolus from occurring after hip or knee replacement surgery, and also to reduce the risk of stroke in people who have a type of abnormal heart rhythm known as non-valvular atrial fibrillation.

Xarelto was the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since warfarin was approved almost 60 years before, and works by blocking certain clotting proteins in the blood. A request by Bayer and Johnson & Johnson to market Xarelto for wider uses, including the prevention of new heart attacks, strokes, and deaths in patients with acute coronary syndrome and to prevent the clogging of heart stents was rejected by the FDA in February 2014.

Side Effects

Like other anti-clotting drugs, Xarelto’s main side effect is bleeding. As is the case with Pradaxa, another anticoagulant, Xarelto does not have an approval reversal agent to stop its blood thinning effects. An antidote exists for warfarin.

The lawsuit alleges that the drug makers withheld information about the lack of an antidote from consumers and doctors and put profits before patient safety. Bayer and Janssen are said to have spent $11 million promoting Xarelto in 2013 in medical journals alone, advertising the drug as a preferable alternative to warfarin. As a result of aggressive marketing, Xarelto generated $582 million in sales worldwide during its first year on the market, with sales totaling $2 billion in 2013.

If you or a loved one has suffered serious, uncontrollable bleeding while on Xarelto, you should speak with Childers, Schlueter & Smith today about seeking compensation. It may be the only way to alleviate the financial hardship that has been placed upon you.

Consultations are free and without obligation.

One Comment

  1. Gravatar for Linda Fisher
    Linda Fisher

    Andy - Thanks for distributing this information. What's crazy is that this weekend (9/1/2014), I saw another ad for Xarelto. It seems like the manufacturer would pause all advertising if there were serious consequences.

    Just a little more information, Xarelto is a part of a new class of anticoagulants known as direct prothrombin inhibitors which are designed as an alternative to Warfarin. Xarelto® is co-distributed by Johnson & Johnson and Bayer and is marketed as not requiring the routine INR monitoring that patients treated with Warfarin require.

    As you stated about, this new blood thinner is alleged to cause serious, uncontrolled internal gastrointestinal bleeding resulting in life-threatening injuries.

    I thought I'd share to hopefully clarify to your readers the difference between Xarelto and Warfarin.

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