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 & Honik today at 1-800-355-3300 or 1-215-985-9177 or fill out our confidential
national dangerous drug lawyers at Golomb & Honik have successfully represented individuals in Philadelphia,
Pennsylvania, New Jersey, and throughout the United States.