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 Legaltoday at (215) 278-4449. We represent clients in Pennsylvania and throughout the United States.