Blood clots can be life-threatening, and that is why people who are at-risk often take medications to help thin their blood to prevent abnormal clotting. When people take prescription medications, like blood thinners, they trust that manufacturers created a safe product and have provided fair warning about the risks. Unfortunately, thousands of people who were prescribed the blood thinner Xarelto have had severe bleeding events and have filed lawsuits claiming the manufacturer did not provide enough warning about this danger. If you suffered a severe bleeding event or had a stroke while taking Xarelto, or a loved one died while taking this medication, you may have legal options.
Our drug injury lawyers in Portland can explore your options in a free, no obligation legal consultation. You will not be charged for our services unless you receive compensation at the end of the legal process. We have in-depth knowledge of defective drug cases and what it takes to bring a successful lawsuit. Our goal is to obtain the compensation you deserve, because we know how important compensation can be after getting injured by a defective drug.
Warnings from the FDA
Xarelto came onto the market after it received approval from the U.S. Food and Drug Administration (FDA) in 2011. This drug is approved for the prevention of deep vein thrombosis (DVT) and pulmonary embolism and nonvalvular atrial fibrillation. Xarelto is often prescribed after knee or hip replacement surgery to help prevent DVT.
However, the FDA added a black box warning to the drug's labeling in 2013 – a black box warning is the most serious warning issued by the FDA, indicating one or more of the following scenarios:
- An adverse event linked to the drug is so serious compared to the potential benefit of the drug that it needs to be considered when reviewing the risks and benefits of the drug
- Serious adverse events can be avoided or made less severe by carefully monitoring the patient, taking care with selecting patients, following certain guidelines or using another medication
- There are mandatory restrictions with the drug, such as restrictions on when it can be administered or if the doctor needs extra training to prescribe the medication
The black box warning on Xarelto labels warns about the risk of spinal/epidural hematoma and stopping Xarelto when a patient has nonvalvular atrial fibrillation.
The warning says this side effect has happened with patients who are being treated with Xarelto who receive neuraxial anesthesia or having a spinal puncture procedure. This side effect could cause permanent or long-term paralysis.
The risk of hematoma needs to be considered when patients taking Xarelto are scheduled for spinal procedures. Doctors should also frequently monitor patients for any signs that they have neurological impairment.
Discontinuing Use in Patients with Nonvalvular Atrial Fibrillation
Patients with this condition are at risk for thrombotic events if they stop using Xarelto. In fact, clinical trials have shown an increased rate of stroke for patients with atrial fibrillation who stop taking this medication. The FDA warning says doctors should consider switching to another anticoagulant medication if it is necessary to stop taking Xarelto.
2014 Update by FDA
The black box warning was updated just one year later to notify patients and caregivers about risks and potentially dangerous side effects. This includes the following information:
- Warning about using Xarelto while taking other medications like ritonavir, itraconazole, ketoconazole, conivaptan, lopinavir/ritonavir and indinavir
- Results of a study on renal functionality in patients taking this drug
- Notification that there is no antidote for treating excessive bleeding caused by Xarelto
- Notification about the lack of data on how Xarelto affects heart valves
Unfortunately, these warnings did not help people who suffered side effects before the warnings were issued. These side effects include:
- Hemorrhage in the head
- Bleeding in the abdomen
- Retinal bleeding
- Epidural hemorrhage
- Excessive loss of blood
Signs of serious bleeding problems could include:
- Brown, red or pink urine
- Bright red stool
- Coughing up blood
- Unusual bleeding in the gums
- Vaginal bleeding that is heavier than normal
- Frequent nose bleeds
- Vomit that looks like coffee grounds
If you or a loved one suffered side effects from Xarelto, you may have a case against the manufacturer, Janssen Pharmaceuticals, Inc., which is a subsidiary of Johnson & Johnson.
Contact us today about a Xarelto lawsuit. Call 503.245.5677.
Research on the Dangers of Xarelto
The FDA is not the only organization warning about the dangers of the blood thinner Xarelto. In 2012, not long after the drug came on the market, a report came out about hundreds of reports of severe or fatal injuries caused by Xarelto.
The report, from the Institute for Safe Medication Practices said there were 356 reports of these serious injuries in the first quarter of the year. This number was twice as much as what had been reported in the last quarter of 2011.
In addition to the reports of serious or fatal injuries, there were 121 reports of hemorrhages among patients who had a median age of 66 who were prescribed the drug after a knee or hip replacement.
There was also a study in 2016 that revealed a higher risk of gastrointestinal bleeding in patients who took Xarelto for more than 40 days, compared with patients who took the drug for 40 days or less. The study was from Gastrointestinal Research and Practice.
One year before this study, JAMA Internal Medicine released a study of FDA inspections of clinical sites where trials were conducted. Eight of the 16 inspections of sites involved in a clinical trial of rivaroxaban, the technical name for Xarelto, found evidence of various problems, including the discarding of medical records, falsification of records and problems with the randomization of trials.
This led to an entire study about the effectiveness of Xarelto being called unreliable by the FDA. However, the problems with this trial were not mentioned in the article that explained the results of the study and in other publications related to this trial.
The attorneys at Rizk Law may be able to use these studies and other research to help prove the manufacturer was negligent and you are owed compensation for your damages. Contact us today to discuss filing a Xarelto lawsuit.
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By December 2018, more than 23,000 Xarelto lawsuits were pending in a multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana (MDL-2592). A total of 25,219 legal actions have been part of the MDL at one time or another (some cases were resolved or dismissed). These lawsuits claim Xarelto caused dangerous side effects, such as hemorrhages, blood clots and strokes.
An MDL combines federal cases and transfers them all to one district court. The cases in an MDL all have one or more questions of fact that are the same. This allows discovery and pretrial procedures for all the lawsuits to be handled by one court. This helps save time and money on the legal process.
Some of the cases from the group are selected as bellwether cases. The results of these cases help both sides figure out how juries are likely to rule. This often leads to a settlement offer for the rest of the cases.
By the middle of 2018, more than 1,700 Xarelto lawsuits were also pending in Philadelphia's Complex Litigation Center. One of the cases in this group went to trial and resulted in a verdict of $27.8 million for a couple in Indiana in December 2017 (the wife was taking Xarelto for atrial fibrillation and suffered gastrointestinal bleeding). This was Bayer's first loss in a Xarelto case. However, a judge in the Philadelphia Court of Common Pleas overruled this verdict in January 2018.
The first two bellwether cases in the Xarelto MDL were also decided in favor of Janssen Pharmaceuticals. The first case involved a man who suffered gastrointestinal bleeding, requiring hospitalization. The second case was filed by the husband and children of a woman who was taking Xarelto and died from a stroke.
The judge presiding over the MDL in Louisiana said at a status conference he was ready to come up with an end game for the MDL. This could mean there will be no more bellwether trials. However, that would mean the remaining cases will be sent back to the original courts where they were filed.
If you or a loved one suffered an injury while taking Xarelto, contact our attorneys today about filing a Xarelto lawsuit. We can review your situation and determine if you have a case against the manufacturer.
Schedule a Free Consultation to Discuss a Xarelto Lawsuit
Prescription medications can have many benefits. Unfortunately, the side effects can be life-threatening or result in serious injury. When this happens, victims often wonder if the manufacturer can be held liable for failing to design a safe medication or for not properly warning doctors and patients about the risks.
Our experienced attorneys can review your situation in a free, no obligation legal consultation to determine your options. We may be able to file a Xarelto lawsuit on your behalf to obtain the compensation you deserve for medical expenses and other damages.
Not only is your consultation free, you will not be charged for our services unless you receive compensation. This means there is no risk to you in contacting our reputable lawyers.
Call Rizk Law today at 503.245.5677.