The oral anticoagulant Rivaroxaban, otherwise known as Xarelto, is yet another blood thinner at the center of a mass-tort action for its harmful effects on patients.
Close to 3,000 lawsuits filed across the country have been consolidated into a multidistrict litigation, assigning the case to U.S. District Judge Eldon E. Fallon in Louisiana. Bellwether trials have been set to begin early in 2017 pursuant to a judicial order issued in September 2015.
According to the FDA, over 3 million Americans suffer from atrial fibrillation. This is a cardiac condition where a problem in the heart’s electrical system causes an irregular heartbeat. This leads to a range of complications. Health conditions associated with atrial fibrillation include heart palpitations, tightness and pain in the chest, lightheadedness, dizziness and shortness of breath. However, the most serious and potentially fatal health risk posed by atrial fibrillation is the formation of cardiac blood clots. These can travel to the brain through the bloodstream and cause strokes. Oral anticoagulants have been widely used as a primary treatment to prevent blood clotting in patients with atrial fibrillation.
When Xarelto hit the market, it was considered a revolutionary drug. This was due to the fact that it didn’t require special diets or constant physician monitoring during use. It was also the only blood thinner that required one daily dose for all patients. Though effective in preventing blood clots, and widely considered a better alternative to its predecessor drug Warfarin – which has been on the market since 1954 – Xarelto also has an extremely dangerous side effect. This could be uncontrollable bleeding that, in some cases, can be fatal. Additional complications from the use of Xarelto include gastrointestinal bleeding, brain bleeding, spinal bleeding, colon bleeding, pulmonary embolism and hemorrhagic stroke.
Prescription anticoagulants like Xarelto impede blood’s clotting ability by blocking thrombin, a protein necessary for coagulation. This can cause the kind of uncontrollable bleeding suffered by plaintiffs in the lawsuit. Xarelto is 1 of 4 new oral anticoagulant drugs approved by the FDA since 2010. It was approved along with Pradaxa, Savaysa, and Eliquis- which is also at the center of a class-action lawsuit for similar harmful effects in patients. The current market for anticoagulant drugs is $10 billion dollars a year. The sales of Xarelto alone are expected to reach nearly $3 billion.
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The most effective remedy to curtail bleeding caused by anticoagulants is through the use of “reversal agents”. These are antidotes that counter the effects of blood thinners in life-threatening situations. Vitamin K is the reversal agent for Warfarin. In addition, the FDA has recently approved a reversal agent called Praxbind for one of the newer drugs, Pradaxa. However, reversal agents are still not available some of the newer blood thinners, including Xarelto. As of November 2015, there have been reports of a reversal agent for Xarelto called “Portola”. However it is not yet ready for review by the FDA and has only been successful in late stages of clinical testing.
The FDA has defended their approval of Xarelto despite the lack of a corresponding antidote. In a report on the FDA’s website from October 2015 the administration notes “[w]ith reversal agents now available for Pradaxa and Warfarin, we have been asked if FDA should continue to allow marketing of anticoagulant drugs that do not have a reversal agent. The short answer to that question is yes…[w]e recognize, however, that patients with severe, life-threatening bleeding require immediate therapy, and these patients might benefit from a reversal agent.”
However, despite the FDA’s insistence that the benefits of Xarelto outweigh the dangers, the agency is now investigating whether a faulty blood-testing device could have tainted the results of the clinical trial trial that led to the drug’s approval, according to a recent New York Times article. Participants in that clinical trial, known as the Rocket AF trial, have recently filed a separate lawsuit in federal court earlier this year. They are claiming to have injuries suffered from exposure to the drug during the trials.
Despite their investigation, the FDA has continued to defend Xarelto. They’re claiming it “provides an important health benefit when used as directed.”
The first complaints in the MDL involving Xarelto were filed early in 2014. Now, with the number of lawsuits in the thousands, the U.S. Judicial Panel on Multidistrict Litigation has consolidated the class-action suit into an MDL. The bellwether actions will consist of 4 separate trials. These were chosen from a pool of 40 cases that best represent common causes of action brought by thousands of plaintiffs. The outcome of the bellwether trials will undoubtedly have an effect on the outstanding lawsuits pending against the pharmaceutical giants. Verdicts for the plaintiffs increases the likelihood that the defendant companies will opt for legal settlement in the remaining cases.
The MDL panel transferred the cases to the U.S. District Court for the Eastern District of Louisiana where presiding Judge Eldon Fallon has recently set several important dates for the upcoming trials. The first two trials are set for February 6, 2017 and March 13, 2017. Both are taking place in the Eastern District of Louisiana. The third trial is set for April 24, 2017 in Mississippi. The fourth trial is set for May 30, 2017 in Texas.
In a case management order dated September 17, 2015, Judge Fallon provided a detailed timeline for expert witness disclosures and reports, since the trials will likely involve testimony from multitude of experts from both sides in a variety of fields. Hematologists, pathologists, pharmacologists, cardiologists and FDA experts on clinical trials are just a few examples of the kinds of experts that may be included in a mass-tort litigation involving a drug like Xarelto. Judge Fallon has ordered that plaintiffs designate and provide expert reports by September 30, 2016. Defendants must also submit their expert reports by October 28, 2016. All expert depositions must be concluded by November 22, 2016.
On March 21st, Judge Fallon issued Pretrial Order #11E , vacating the terms of a previous judicial order from May 2015 that allowed up to 100 plaintiffs to bundle their complaints with a single filing fee “[i]n an effort to minimize the expenses of the parties, and to promote judicial efficiency.” However, as the litigation enters into its next phase, the new pretrial order dictates that any additional complaints must be filed in accordance with the Federal Rules of Civil Procedure and no later than May 20th, 2016. In February 2015, the Court issued Pretrial Order #7, announcing the 12 members of the plaintiffs’ steering committee. Officially renamed In re: Xarelto (Rivaroxaban) Products Liability Litigation by the MDL judicial panel upon consolidation, these bellwether trials against Bayer and Johnson & Johnson will be important cases to watch in the upcoming year.
