Xarelto Cases Near 14,000

The litigation regarding the drug Xarelto has been ongoing for several years, with more and more consumers submitting claims for internal bleeding injuries—13,727 claims at present.

When the Xarelto MDL was first established in December 2014, there were only twenty-one lawsuits. Two years ago, all federal Xarelto claims were consolidated into the Eastern District of Louisiana.

Did Johnson & Johnson, Bayer and Janssen Exhibit a Failure to Warn?

According to the lawsuits, manufacturers Johnson & Johnson, Bayer and Janssen failed to warn patients about the potential for the blood-thinning drug to cause dangerous, uncontrollable bleeds. The older blood-thinning drug, Warfarin, has an antidote in the case of an uncontrolled bleed.

A shot of Vitamin K will reverse the effects of Warfarin, meaning a dangerous bleeding incident can be controlled. Xarelto has no such antidote to uncontrolled bleeds, although there are claims that such an antidote is in the works.

How Xarelto Became So Popular So Quickly

The FDA initially approved Xarelto in 2011, as a means of treating those with blood clots, atrial fibrillation, or for those who recently underwent knee replacement surgery. Because Warfarin cannot be taken with certain foods, and requires regular blood monitoring, Xarelto, quickly became a popular choice for patients.

Xarelto’s predecessor, Pradaxa, was facing many similar complaints of uncontrolled bleeding events when Xarelto was released, yet there were no patient warnings accompanying the drug.

Problems with Xarelto

While studies have shown a number of adverse issues related to Xarelto, the current lawsuits claim the following side effects from Xarelto:

  • Cardiac problems;
  • Topical hemorrhages;
  • Rectal bleeding;
  • Deep vein thrombosis;
  • Cerebral hemorrhaging;
  • Gastrointestinal disorders and bleeding,
  • and Clotting problems.

History of Xarelto

Soon after the FDA approved Xarelto, Reuters published a report that showed the first signs of concerns from doctors about uncontrolled bleeding events among patients taking the drug. In early January, 2013, FDA MedWatch showed 593 adverse event reports of uncontrolled bleeds linked to Xarelto.

By March 2013, a report in Gastro Journal suggested newer blood-thinning drugs such as Xarelto and Pradaxa had a 48 percent higher risk of gastrointestinal bleeds than Warfarin and Coumadin. Yet, by July of the same year, sales of Xarelto topped $827 million for the first two-quarters.

Also in 2013, the FDA issued an advisory letter to Johnson & Johnson on behalf of its subsidiary, Janssen Pharmaceuticals, warning the company about making misleading claims to doctors and healthcare practitioners regarding the health risks of the drug. In October 2013, Xarelto and other similar anticoagulants were ranked among the most dangerous drugs on the market by the Institute for Safe Medication Practices, and by April 2014, the Journal of the American Medical Association suggested Xarelto and similar blood thinning drugs could double the risk of an uncontrolled bleed when taken with aspirin.

Despite these issues, sales of Xarelto topped $1 billion in 2014. In early 2015, one study found doctors were paid as much as $20 million to promote Xarelto and other blood-thinning drugs in the last five months of 2013 alone. Xarelto Black Box Warning Xarelto has a Black Box warning—the most severe label warning the FDA uses—which cautions patients about dangerous spinal bleeding which could result in blood pooling outside the spinal vessels, resulting in patient paralysis. Cerebral hemorrhages (brain bleeds) can also occur, leading to serious complications, and, in some cases fatalities.

Xarelto Bellwether Trials The first Xarelto bellwether trial is scheduled for March 2017. Bellwether cases are chosen as being representative of the majority of the cases. The results of the bellwether cases tell both sides how they want to proceed and oftentimes result in resolution of the entire litigation.

If you have been injured by the blood-thinning drug Xarelto, it is important that you speak to a knowledgeable product liability attorney who can help you file a claim to obtain the compensation you are entitled to. You may have many questions that you need answers to, and may have many medical expenses related to your Xarelto injuries.

National Dangerous Drug Lawyers

If you have suffered medical complications, pain, or excessive bleeding after using Xarelto, your injuries may be the result of a drug manufacturer's negligence. To learn more about your legal options or to schedule a free consultation, call the Philadelphia class action lawyers at Golomb Legal today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential Contact Form.

The national dangerous drug lawyers at Golomb Legal have successfully represented individuals in Philadelphia, Pennsylvania, New Jersey, and throughout the United States.