The Current Status of the Xarelto® Lawsuit

Judge Eldon Fallon selected four bellwether cases from over 2,800 federal lawsuits transferred to multidistrict litigation (MDL) in Louisiana. The first and the second trial, which is set for March 13th, will be held at the Eastern District of Louisiana federal court. An April 24th trial is scheduled at a venue in Mississippi, and the last case is scheduled for May 30, 2017, in Texas. The federal MDL cases are in addition to a mass tort in Pennsylvania, which now includes over 650 state cases.

Bellwether trials are considered test cases. They are specifically chosen because they are believed to be highly representative of many similarly situated plaintiffs. The verdicts from these trials will be of interest to parties on both sides of the issue, and can influence future settlement decisions.

As the first Xarelto® cases move toward trial, investigative discovery is continuing to uncover evidence that may confirm plaintiff’s claims of negligence on the part of the defendants.

MDL is an optimal way to handle multiple federal cases filed against a common defendant. It increases the speed and efficiency of the proceedings, yet allows plaintiffs to obtain individual verdicts and settlements. If you would like to speak to a qualified Xarelto® attorney about participating in the MDL, please contact our legal team today.

Xarelto® Lawsuit Progress

Since the first filing in 2014, Xarelto® plaintiffs continue to come forward from all over the U.S., with many more individual lawsuits anticipated. A recent example is a complaint filed in February 2016, on behalf of multiple plaintiffs from six different states. The lawsuit includes three wrongful death claims and four personal injury allegations, all related to similar uncontrolled bleeding events.

As the first Xarelto® cases move toward trial, investigative discovery is continuing to uncover evidence that may confirm plaintiff’s claims of negligence on the part of the defendants – and liability for an unsafe drug. Xarelto® (the brand name for rivaroxaban) has been marketed as an effective, convenient alternative to other anticoagulant medications, specifically Warfarin (coumadin), which has been in use since 1954. Anticoagulants (blood thinners) are commonly prescribed for patients who are at risk of blood clots, which can lead to stroke and pulmonary embolism (blockage of an artery to the lung).

Xarelto® is different, according to the manufacturer, because patients can be treated without regular blood monitoring, dietary restrictions, or frequent dosage adjustments. “One less thing to worry about,” the product website proclaims. However, it turns out that Xarelto® patients do have a few things to worry about. Lack of blood testing and dosage adjustments may be contributing to adverse events, including strokes and blood clots.

Additionally, there is no antidote to dangerous internal bleeding for Xarelto® users. Excessive bleeding is a known complication with all blood thinners, but Warfarin bleeding events are treatable with high doses of Vitamin K.

The MDL court judge appointed a 12-attorney steering committee to manage Xarelto® case discovery. Attorney Ellen Relkin, a member of the committee, was interviewed in a podcast released in May 2015. She discussed bleeding events in Xarelto® patients, which she said can be caused by trauma from an accident, or there may be spontaneous bleeding in the brain or gastrointestinal tract.

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If a patient is taking an anticoagulant, any bleeding event is potentially deadly, and more questions are being raised about dosage and blood level monitoring for Xarelto® patients. Ms. Relkin mentioned Xarelto®’s low therapeutic index, stating, “It can be safe at a certain point and dangerous within a very close range.” A drug’s therapeutic index, or safety window, is a comparison between the amount that produces therapeutic effects and the amount that causes toxicity.

Ms. Relkin said, "Someone can be 110 pounds or 200 pounds, old or young, with varying kidney functions, and get the same dose and have a very different impact. Unlike the traditional blood thinner, coumadin, where you have monitoring of the drug, where the patient gets their blood checked periodically so the doctor can assess whether the levels are appropriate - you don’t do that with Xarelto®.”

The nonprofit Institute for Safe Medication Practices (ISMP) addressed dosing problems with Xarelto® in their Annual Report issued in September 2015. They have been tracking the medication’s complication reports to the FDA since 2012, and remain concerned about the associated dangers. Of rivaroxaban, the report states, “once-a-day dosing results in higher maximum concentrations and higher bleeding risk on one hand, and an extended period each day when concentrations may be suboptimal for preventing stroke.”  

Food and Drug Administration (FDA) Updates

The FDA initially approved Xarelto® in 2011, but had received numerous reports of adverse patient outcomes by the end of 2012. The ISMP tallied 2,081 serious adverse Xarelto® events reported to the FDA in 2012, including 151 patient deaths. Recently, the FDA has been taking steps to deal with the complications.

A Drug Safety Evaluation Summaries report posted on the FDA website states that Xarelto® is currently being evaluated for thrombocytopenia and thromboembolic events to determine if regulatory action is required. The FDA website also recently posted a new Medication Guide for Xarelto® patients. It warns that “Xarelto® can cause bleeding which can be serious, and rarely may lead to death,” and mentions complication risks for patients who go off of the drug, including stroke and blood clotting events.

A disturbing report was also posted on the FDA website in December. Dr. Thomas Marciniak has been tracking patients using anticoagulants to validate a theory connecting increased risk of cancer to use of these drugs. His research indicates rivaroxaban may increase the risk of solid cancers, primarily colon cancer. He specifically stated, “The FDA should provide practitioners and patients with the data regarding the association between bleeding and solid cancers as soon as possible.”

Lawsuit Allegations

Many of the early Xarelto® lawsuits focused on the fact that the defendants failed to warn patients and doctors about the lack of an antidote to stop internal bleeding. Increasingly, allegations have also targeted misleading marketing tactics used for Xarelto®, specifically the promotion of the drug requiring less monitoring than Warfarin. Plaintiffs complain that without an effective antidote for potentially deadly hemorrhaging, the need for monitoring is actually more important.

These cases also send an important message to pharmaceutical corporations who make billions of dollars selling medications that can have a tragic impact on the lives of unsuspecting patients.

The FDA accused Johnson & Johnson, the parent company of Janssen, of false or misleading advertising in a 2013 letter. The letter focused on a print ad in WebMD Magazine, calling it false or misleading because it minimized risks associated with Xarelto® and claimed the medication requires “no dosage adjustments.”

Civil complaints in the Xarelto® lawsuit accuse Janssen Pharmaceuticals and Bayer of numerous specific claims, including:

• Manufacturing Defects
• Design Defects
• Negligence
• Failure to Warn,
• Breach of Express Warranty
• Breach of Implied Warranty
• Negligent Misrepresentation
• Fraud
• Violation of Consumer Protection Laws
• Wrongful Death

Plaintiffs are seeking damages for their medical costs, loss of wages, and pain and suffering.

If You Have Suffered Xarelto® Complications

If you or a loved one have taken Xarelto® and experienced a serious complication, you may be entitled to significant compensation. In addition to securing financial compensation for your losses, these cases also send an important message to pharmaceutical corporations who make billions of dollars selling medications that can have a tragic impact on the lives of unsuspecting patients.

It is important to act before the statute of limitations expires on your claim. Our team of pharmaceutical liability attorneys offers free case evaluations. If you would like more information about Xarelto® litigation, please schedule a consultation today.