Between federal and state courts, more than 20,000 Xarelto® lawsuits have been filed since the blockbuster drug was approved by the U.S. Food and Drug Administration (FDA) in 2011. Xarelto® is the nation’s most-prescribed blood thinner in its class. Drugmakers Johnson & Johnson and Bayer are the companies being sued on claims that knowledge about risks of significant bleeding were consciously concealed for the purpose of boosting sales. The more than 13 million prescriptions of Xarelto® filled since the drug’s release have generated billions of dollars for Johnson & Johnson and Bayer. Though the FDA has said that Xarelto® is associated with as many as 400 deaths, the government agency has not recalled the anticoagulant.
On December 5, 2017, a jury in a state court ordered the two mega-pharmaceuticals to pay plaintiff Lynn Hartman nearly $28 million due to complications such as internal bleeding that she experienced as a result of using Xarelto®. A doctor had prescribed Xarelto® for Hartman in treatment of atrial fibrillation and other health problems. The compensation the jury awarded to Hartman included $1.8 million in compensatory damages and $26 million in punitive damages.
Prior to the Hartman case, there were three bellwether trials in federal courts in which the defense in the Xarelto® lawsuits won. A bellwether trial involves a small consolidation of lawsuits taken from a larger group of cases to be tried first. Such trials often set precedent and help others anticipate how future trials may turn out. They can also help plaintiffs determine the types of legal arguments juries may be inclined to respond to.
What is Xarelto®?
Xarelto®, which is Rivaroxaban in the generic form, is an anticoagulant or blood thinner. An essential component of healing is coagulation, which is thickening or clotting of the blood. Coagulation prevents dangerously excessive blood loss when there is a cut or internal bleeding. Blood clots can also create significant risk, however, potentially causing catastrophic health problems. Blood thinners like Xarelto® are prescribed to help prevent these types of dangerous conditions. Doctors prescribe Xarelto® for the following reasons and more:
- To reduce the risk of blood clots and stroke in individuals with atrial fibrillation that was not caused by a heart valve problem.
- To treat deep vein thrombosis (DVT), which occurs when a blood clot forms in one or more of the body’s deep veins. DVT most commonly develops in the legs.
- To treat a pulmonary embolism (PE), which occurs when a blood clot gets caught in an artery that travels from the heart to the lungs. Pulmonary embolisms usually travel to a deep vein in the leg.
- To reduce the reoccurrence of blood clots in patients who are experiencing a prolonged risk of developing DVT or PE, after blood clot treatments have continued for at least 6 months.
- To reduce the risk of forming a blood clot in the lungs and legs, among people who have just had hip replacement or knee surgery.
Xarelto® Timeline of Events
The many thousands of Xarelto® lawsuits have come as a result of a range of problems with the blood thinner, and signs that the drug can be dangerous emerged quickly. After the 2011 release of Xarelto®, the following is a basic timeline of events related to reported dangers, reported income for Johnson & Johnson and Bayer, and more:
- In 2012 alone, among the “serious adverse events” patients experienced after taking the prescription Xarelto®, 2,081 were reported to and filed with the FDA.
- By 2013, the FDA added a black box warning on packaging for Xarelto®, related to spinal hematomas. The FDA, in other words, acknowledged the risk of the drug causing significant spinal cord compressions, potentially resulting in permanent and irreversible neurologic damage.
- In January 2014, per the FDA, warnings had to be included on the insert of Xarelto® and Rivaroxaban packaging indicating that there is no antidote for Xarelto® bleeding.
- In May 2014, there were settlements of 4,000 lawsuits amounting to $650 million total in cases related to the use of Pradaxa®, a blood thinner similar to Xarelto®.
- By December 2014, there were more than 15,000 Xarelto® lawsuits with pending actions filed in multidistrict litigation (MDL). Judge Eldon Fallon in Eastern Louisiana established MDL.
- In 2014 alone, Xarelto® generated $3.7 billion for Johnson & Johnson.
- In 2016, Xarelto® generated $2.2 billion for Johnson & Johnson.
- Three federal bellwether Xarelto® lawsuits resulted in defense verdicts in May, June, and August 2017. In December 2017, a jury awarded plaintiff Lynn Hartman $27.8 million.
- In January 2018, a state court judge in Pennsylvania overturned the $27.8 million verdict.
- In February 2018, the plaintiff filed an appeal of the reversal, hoping to obtain fair compensation for injuries suffered as a result of taking Xarelto®.
In May 2018, the FDA gave initial approval for the only antidote for uncontrolled bleeding caused by Xarelto. The antidote is called AndrexXa®, and it is expected to be available on the market by early 2019.
Health Complications Caused by taking Xarelto®
People who have taken Xarelto® have experienced a wide range of complications, including death. More than 20,000 Xarelto® lawsuits claim that it is a dangerous drug. The complications and serious side effects patients have experienced from taking Xarelto® include cerebral hemorrhaging, stroke, epidural hemorrhaging, abnormal liver failure, gastrointestinal bleeding, rectal bleeding, stroke, painful urination, spinal hemorrhaging, and abdominal bleeding. Post-surgical complications associated with Xarelto® include infection, hematoma, and rupture. To correct wound complications related to the drug, revision surgery is sometimes necessary.
The common side effects of taking Xarelto® include low blood pressure, nausea and vomiting, muscle pain, edema or swelling, and nose bleed. Other side effects that have regularly been reported after taking the drug include a racing heartbeat, irregular heartbeat, dizziness, fainting, headaches, and pain or weakness in the extremities.
Warning Label & Other Updates
Although many thousands of problems have been reported in association with taking Xarelto®, it has not been recalled by the FDA. Individuals who have suffered serious health issues from taking the blood thinner and who are involved in Xarelto® lawsuits claim that Johnson & Johnson and Bayer have held back important information from the public. Since the drug’s release, there have been various warnings added to the packaging, alerting people of the most prominent risks of taking Xarelto®.
A black-box warning added in August 2013 stated that there was a higher risk for deep vein thrombosis, blood clots, and epidural/spinal hematoma among patients who prematurely discontinued use of the blood thinner.
In January 2014, the FDA issued a warning or precaution that they were aware of a bleeding risk associated with taking Xarelto® or Rivaroxaban. Included in the warning was a recommendation that a patient receive blood replacement or transfusions if blood loss was experienced while taking the anticoagulant.
In addition, the warning discussed the lack of an antidote or reversal agent for Xarelto®. When a patient is taking most other types of blood thinners, doctors can counteract the anticoagulant properties in an emergency by administering protamine sulfate or vitamin K. Xarelto®, however, blocks Thrombin and, as a result, neither of the two antidotes work. This was explained on the page listing Xarelto® Side Effects. Also, the anticoagulant should not be used by anyone with prosthetic heart valves.
In March 2014, patients taking Xarelto® received a directive in the second black box warning for the drug. The warning was specifically for patients undergoing a spinal puncture or epidural treatment. They were instructed to wait until Xarelto® has been flushed form their system before undergoing either of these procedures, due to a concern regarding spinal bleeds.
An Adverse Reaction report on Xarelto® was issued by the FDA in December 2014. The warning was that the blood thinner could cause thrombocytopenia. Thrombocytopenia is a condition in which the body suffers from low blood platelet counts. Because blood platelets are crucial in the formation of blood clots, thrombocytopenia can cause internal bleeding.
On the same report, the FDA changed “cytolytic hepatitis” to “hepatitis” in the descriptions of adverse reactions and included hepatocellular injury, which is major injury to the liver.
The latest FDA warning added to Xarelto® packaging is in regard to dangerous drug interactions with the blood thinning medication. Among the drugs that should not be taken with Xarelto® are SSRI and SNRI antidepressants. The complete list of drugs that the warning said not to take with Xarelto® follows:
- Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Tegretol-XR, and Teril)
- Conivaptan (Vaprisol)
- Indinavir (Crixivan)
- lopinavir (Kaletra)
- Itraconazole (Onmel and Sporanox)
- Phenytoin (Dilantin)
- Rifampin (Rifadin, Rifamate, Rifater, and Rimactane)
- Ritonavir (Norvir)
- John’s wort (Hypericum Perforatum)
The FDA also added a warning that Xarelto® has not been tested in patients who have a prosthetic heart valve and such patients should not take the blood thinner.
Faulty Clinical Trial
Before drugs are approved by the FDA for general use, they must be clinically tested as a way of proving effectiveness and safety. There were some questions related to a clinical trial for Xarelto® because of the use of a device called the Alere INRatio, which was recalled in July 2016. The name of the clinical trial is ROCKET-AF, and it reportedly provided the primary information supporting the FDA’s approval of Xarelto® in 2011.
The recalled device was used for testing of blood clotting during clinical trials. Problems with the device used to establish approval of Xarelto® dated back to 2002. Before the 2016 recall of the Alere INRatio, studies concluded that the device had a propensity to provide false results favorable Xarelto®. The data collected from the faulty device showed that Xarelto® was likely the safer blood thinner for patients with atrial fibrillation, as compared with warfarin. More specifically, the ROCKET-AF study showed that the effects on bleeding, including bleeding in the head, and strokes were minimal among patients taking Xarelto®. That conclusion is in question.
Alternate Studies Not Favorable to Xarelto®
Over-the-counter aspirin has been compared to Xarelto® in various studies, and a common conclusion is that aspirin is as effective as Xarelto® in reducing the risk of systemic embolism and stroke. It has been acknowledged by Bayer as well as Johnson & Johnson’s Janssen Research and Development that Xarelto® failed a trial comparing the drug to aspirin in patients with recent embolic stroke of undetermined source or ESUS. In the study involving 7,214 patients from 31 countries, Xarelto® did not have greater efficacy than aspirin in reducing the risk of stroke and systemic embolism.
The most dangerous side effect of Xarelto® is the risk of unstoppable bleeding, which can be fatal. Since aspirin appears to be as effective, there seems to be no reason to take on the risks associated with Xarelto®.
In comparative studies of patients who had undergone hip or knee replacement surgery, some were given Xarelto® to reduce the risk of pulmonary embolism and deep vein thrombosis. Others received aspirin and compression socks. Patients in the latter group had fewer complications with their wounds than those who were treated with Xarelto®. The studies also showed that post-surgical complications included infection, rupture, hematoma, and the necessity for revision surgery, among those who used Xarelto®.
It has also been discovered through studies that when patients undergoing an epidural anesthetic or spinal tap take Xarelto®, they are at risk of developing a blood clot in the brain or around the spinal cord, leading to a variety of injuries, including stroke and paralysis.
Has Xarelto® Affected You or a Family Member?
If you or a member of your family have experienced issues such as excessive bleeding as a result of taking Xarelto®, contact The Johnston Law Group. Our mission is to hold drug companies accountable for consciously endangering patients by inadequately warning them of known potential health threats.
At The Johnston Law Group, we understand the financial challenges and heartbreak families face as a result of catastrophic prescription drug injury. Contact us today for a free consultation and for filing of a Xarelto® lawsuit.
Written by:
Stephanie McHugh
Stephanie McHugh is a professional writer who specializes in legal articles, technical blogs, and website copy. She is a former Official Court Reporter for a District Court in Houston, Harris County, Texas; newspaper columnist; and teacher. Stephanie is a professional writer with extensive experience reporting on health-related topics for publication. She developed an interest in health-related litigation as a court reporter while taking depositions for a class action lawsuit. Through her writing, she has been glad to help raise awareness about public health threats, to benefit victims.
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