As a newer drug on the market, blood thinner Xarelto has not been the subject of as many lawsuits as some of its competitors. However, the number of Xarelto lawsuits being filed against Bayer and Janssen Pharmaceuticals, a division of Johnson & Johnson, continues to grow steadily. More people are realizing that the drug has caused them harm or maybe implicated in the death of a loved one who took it.
Xarelto is among the handful of new blood thinners that are supposed to be safer and easier to use than older anticoagulants. And yet, these drugs are proving to be damaging and people are losing their lives over them. If you have taken Xarelto and suffered from excessive bleeding, or you lost a loved one who was taking this drug and started bleeding uncontrollably, you may have a case to make. You may be able to join the others who are suing for both punitive damages and compensation.
Xarelto and the New Blood Thinners
Blood thinners, also known as anticoagulants, are drugs that are given to patients at risk for developing blood clots, or sometimes to treat those clots that have already formed. For example, people having surgery may develop clots, and often need to be on a blood thinner for a period of time. Blood clots are dangerous because they can cause blockages in the heart, brain, or lungs, which can quickly be fatal.
Xarelto is a newer blood thinner, developed and manufactured by Bayer, but marketed in the U.S. by Janssen. The generic name of the drug is rivaroxaban and it has been approved to prevent blood clots, but also to specifically prevent clots in patients with atrial fibrillation.
This is one of a handful of newer drugs designed to be safer and easier to use than warfarin, an old stand-by used to prevent clots. Warfarin is problematic because each patient needs a unique dose and must be monitored carefully by a doctor to get it right. Not doing so can quickly lead to dangerous bleeding. Warfarin does have an antidote to reverse its effect, but bleeding is still a risk that has to be watched.
Janssen and Johnson & Johnson have marketed Xarelto as an alternative to warfarin that can be given in one or two doses that work for everyone and that does not need to be monitored as closely. Whether this is true or not, all blood thinners come with the risk of excessive bleeding. And unlike warfarin, Xarelto has no antidote to reverse bleeding. This combined with potentially misleading marketing means that some people have been harmed and even killed and lawsuits are now mounting over Xarelto.
FDA Actions
The U.S. Food and Drug Administration (FDA) approved Xarelto in 2011, so even among the newer blood thinners Bayer and Janssen’s contribution to the market is very new. The FDA has tracked incidents and analyzed research into the safety of blood thinners, and has added a black box warning to Xarelto. This is the agency’s strongest warning and it states that patients taking Xarelto may actually be at risk of forming blood clots, exactly what it is supposed to prevent. Exactly why this happens is not certain, but may be related to patients stopping use of the drug without a doctor’s supervision.
Xarelto and Negligence
Many people are filing lawsuits against Bayer, Janssen, and Johnson & Johnson because they believe these companies were negligent in the death of a loved one or in harm to themselves after taking Xarelto. A drug that could replace warfarin and be safer, easier, and more effective would be a huge boon. By marketing Xarelto as this new and wonderful blood thinner, the drug companies may have gone too far and promised something they couldn’t actually deliver.
The drug companies have made billions on Xarelto, but patients have suffered and plaintiffs in lawsuits may be able to prove negligence. To earn those billions and to boost profits on Xarelto as much as possible, Janssen and Bayer have been accused of hiding information about the risks of the drug. In one clinical trial that involved 14,000 patients, the researchers investigated those patients between 2006 and 2010.
Before that trial was published, a peer reviewer requested more of the data from the experiment, but was not give everything. This is one reason that plaintiffs and others are accusing the companies of hiding information about Xarelto. It was also later found that the measurements taken in the experiment were read with a device that had been recalled. All of the data could be compromised because of that mistake.
Ongoing Lawsuits
The people suing over Xarelto have yet to get an answer as to whether the drug companies will be punished or whether they will get compensation in the form of a settlement. The cases are all currently ongoing and in them the plaintiffs are accusing Janssen, Johnson & Johnson, and Bayer of hiding important information from clinical trials, marketing a product misleadingly and representing it as safer than it really is, and of failing to warn the public about the risks of its drug.
The thousands of cases against Xarelto have been grouped together into a multidistrict litigation in Louisiana. This simplifies the proceedings, but each individual still gets a chance to seek justice against the drug companies. Some of the individuals involved include a woman who lost her father to a stroke after taking Xarelto for a month and a woman who lost her husband to excessive bleeding in the brain after taking it for several months. These are just a couple of the many, many people who believe that the drug companies need to pay for the loss of their loved ones.
Similar Lawsuits
If you lost a loved one to Xarelto you may want to consider filing a lawsuit. While cases are currently still unresolved, settlements in similar lawsuits have been promising and have encouraged those working against Xarelto. Pradaxa, a very similar blood thinner made by German company Boehringer Ingelheim came on the market just a year before Xarelto and has caused similar problems. This company has also faced thousands of lawsuits from loved ones of those who died while taking it.
The Pradaxa suits were settled in 2014 when Boehringer Ingelheim agreed to pay out $650 million to resolve over 4,000 cases. The plaintiffs in that case stated that the company had failed to warn them of the potentially fatal bleeding that can occur without an antidote to reverse it. While the drug maker refused to acknowledge any wrongdoing, it did agree to the settlement, which gives hope to those still battling over Xarelto in the courts.
Sources
- http://www.wdrb.com/story/31736544/xarelto-lawsuit-plaintiffs-highlight-controversies-and-draw-public-attention-to-alternative-therapeutic-treatment-options
- https://www.xareltohcp.com/shared/product/xarelto/prescribing-information.pdf
- http://www.drugs.com/history/xarelto.html
- http://www.businessinsider.com/xarelto-lawsuit-data-controversy-2016-3
- http://www.ncbi.nlm.nih.gov/pubmed/22832942
- http://www.nytimes.com/2014/05/29/business/international/german-drug-company-to-pay-650-million-to-settle-blood-thinner-lawsuits.html?_r=0