For those who have doubted the serious nature of adverse health complications
associated with the blood-thinning drug Xarelto, consider there are now
more than 7,000 lawsuits filed against the manufacturer of Xarelto. Pharmaceutical
giant Bayer manufacturers Xarelto, although it is sold by Janssen, a subsidiary
of another pharmaceutical giant, Johnson & Johnson. As of the third
week in July there were more than 6,660 lawsuits filed in the U.S. District
Court for the Eastern District of Louisiana, plus additional lawsuits
filed in state and federal courts.
Xarelto Requires No Monitoring Like Warfarin
Xarelto is the follow-up drug to older drug-thinners such as Coumadin and
Warfarin which have been used for decades for those who have a high risk
of stroke or other cardiovascular issues. Unfortunately, these older drugs
require a regimen of strict monitoring to ensure there are no episodes
of uncontrolled bleeding. Further, patients on Warfarin and Coumadin require
frequent diet monitoring as the drugs cannot be taken with certain foods
as well as some other prescription and non-prescription drugs. Despite
the monitoring requirements, Warfarin and Coumadin have worked well to
prevent blood clots, stroke and other heart-related issues.
No Antidote to Uncontrolled Bleeding with Xarelto
Then in 2010, after receiving FDA approval, Pradaxa, followed quickly by
Xarelto in 2011, burst onto the scene as the newest blood-thinning drugs
requiring virtually no monitoring of any kind. If it sounded almost too
good to be true, well, it was. There was one problem with Xarelto and
other similar drugs, in that when a patient developed an uncontrolled
bleed, there was no antidote, and therefore no way to stop or reverse
the bleed. In sharp contrast, an uncontrolled bleed in a patient taking
Warfarin can be stopped by administering a dose of Vitamin K. An infusion
of Vitamin K in a patient taking Warfarin who experiences an uncontrolled
bleed can reverse the effects of Warfarin, allowing the blood to clot.
In those taking Xarelto, there is no such “safety,” meaning
a patient can literally bleed to death with medical staff watching who
are unable to stop the bleeding.
Although research is in the works that would find an antidote to Xarelto
similar to the way Vitamin K works in patients taking Warfarin, so far
no such antidote has been approved. Nancy Packard, one of the many plaintiffs
in Xarelto lawsuits, claims her husband used Xarelto for six months to
treat his diagnosis of atrial fibrillation before suffering a brain bleed.
With no available antidote, Packard’s husband lost his life. Many
of the current lawsuits allege Xarelto should never have been marketed
without an antidote to a potential uncontrolled bleed.
Xarelto Bellwether Trials to Begin in 2017
Medical reviewers initially voted against the approval of Xarelto, however
an FDA advisory committee overruled them, and Xarelto gained approval.
Years after that approval, it was found that one of the blood monitoring
devices used in the Xarelto clinical trials, had been recalled due to
erroneous readings. Clinical trials which will more accurately measure
the side effects of Xarelto are not scheduled to begin until early 2017.
In the meantime, out of the 20 Xarelto lawsuits selected by defendants
and plaintiffs, the federal Louisiana judge has selected two lawsuits
to serve as bellwether trials.
The first bellwether trial is slated to begin in February 2017, and the
second in mid-March of 2017. The next two bellwether trials will take
place on April 24th and May 30th of 2017. The first bellwether case involves claims from a Louisiana man
that he developed gastrointestinal bleeding after taking Xarelto. Many
of the Xarelto lawsuits are claiming internal bleeding, rectal bleeding,
blood clots in the lungs, stroke, heart attack, epidural hematoma, brain
hemorrhages and gastrointestinal bleeding. If you or a loved one suffered
an uncontrolled bleeding incident after taking Xarelto, it is important
that you contact an experienced personal injury attorney as soon as possible.
If you have suffered injury or uncontrolled bleeding after taking Xarelto,
it is important to speak to an experienced Xarelto attorney, who can ensure
your rights are fully protected.
To learn more about your legal options or to schedule a free consultation, call Golomb & Honik, P.C. today at (215) 278-4449. We represent clients
in Pennsylvania and throughout the United States.