Plaintiffs involved in the thousands of individual cases in the Xarelto multidistrict litigation (MDL) are alleging that the blood thinner can induce sudden and uncontrollable internal or external bleeding that has resulted in many injuries and fatalities.
Judge Eldon Fallon is overseeing the MLD in the Eastern District of Louisiana and he has set a target date of spring 2017 for the first four bellwether trials in the MDL. The four representative cases will be selected from a pool of 40 cases, Digital Journal reports. As the MDL moves toward the beginning of the trials, 400 new cases were added in the month of August alone.
Xarelto (rivaroxaban) is produced in the United States by Janssen Pharmaceuticals, a division of health care giant Johnson & Johnson, and in Europe by Bayer AG.
Bellwether trials—involving carefully chosen representative cases—can give the parties a sense of how juries will respond to their evidence and arguments. The outcome of bellwether trials can influence the outcome of the remaining cases. In addition to the cases in the MDL, hundreds of Xarelto cases are grouped in a mass tort program in a Pennsylvania state court. All of these cases claim that the Xarelto manufacturers, Janssen Pharmaceuticals, a unit of Johnson & Johnson, and Bayer AG knowingly put patients at risk for uncontrollable bleeds, according to Lawyers and Settlements
Patients with atrial fibrillation, a type of abnormal heartbeat, usually take a blood thinner to reduce their risk of stroke. Warfarin was the standard treatment for 60 years, before a new generation of blood thinners including Xarelto and Pradaxa came to market. Doctors had been seeking a blood thinner that was more convenient to use. Warfarin users must have regular blood monitoring and they must follow a restrictive diet to prevent interactions that can reduce the drug’s effectiveness.
Blood thinners can help prevent strokes but they can also cause uncontrollable bleeding, which can be fatal. The downside of the new blood thinners is the lack antidotes to administer in the event of major bleeding. An individual taking a blood thinner can experience unexpected internal bleeding or bleeding due to an injury or the person could need emergency surgery. In these situations it is important to be able to restore the blood’s clotting ability. Warfarin does have a readily available antidote but Xarelto does not. The Food and Drug Administration (FDA) only recently approved a drug that reverses the effect of Pradaxa, Health Day reports. Many patients who have been injured by bleeding episodes and the families of people who have died say the drug makers were reckless in bringing the new blood thinners to market without an antidote.
Pradaxa (dabigatran), the first of the new generation of blood thinners, experienced the same scrutiny Xarelto is now receiving. Pradaxa, made by Boehringer Ingelheim, came to market in 2010, a year before Xarelto arrived. Pradaxa was a popular treatment but the drug quickly became the subject of more than 4,000 lawsuits. The FDA received thousands of adverse event reports, including 750 reports of fatalities. Just before the start of the first Pradaxa trial, the manufacturer agreed to a $650 million settlement, according to Digital Journal. Xarelto plaintiffs hope that the Pradaxa settlement will be a model for their situation and the thousands of plaintiffs will not be subjected to protracted court cases.