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First Xarelto Bleeding Cases Scheduled for Trial in Early 2017

Aug 9, 2016

Thousands of personal injury and wrongful death lawsuits before Judge Eldon Fallon in the Eastern District of Louisiana claim that the blood-thinning drug Xarelto caused severe and often fatal bleeding side effects.

The first trials, known as bellwether trials, in the Xarelto multidistrict litigation are scheduled to begin in February 2017, the Legal Examiner reports. Bellwether trials are common in drug and medical device litigation. The bellwether cases are chosen as representative cases, and the outcome of these trials can pave a way to a settlement program.

The Xarelto bellwether case will be chosen from cases originally filed in Louisiana. The plaintiffs in the first bellwether trial will be people who were 50 to 90 years old at the time of the bleeding event, the Legal Examiner reports. For the second bellwether trial, the plaintiffs will be patients who suffered a brain bleed, or hemorrhagic stroke, which ended in injury or death. The third trial will include plaintiffs who were 40 to 80 years old and developed gastrointestinal bleeding. The fourth Xarelto bleeding case selected will go to trial in Texas.

Xarelto (rivaroxaban), released in 2011, is one of a new class of anticoagulants seen as an alternative to warfarin, the standard anticoagulant treatment for more than 60 years. Xarelto prevents blood clots in patients at risk for deep vein thrombosis in the legs or pulmonary embolism (blood clot to the lung). Xarelto is also used to prevent strokes in patients who suffer from atrial fibrillation, a heart rhythm problem.

Xarelto has been heavily promoted as easier and more convenient to use than warfarin. Xarelto does not require monthly blood tests to measure effectiveness, or a restricted diet. But many Xarelto patients have reported severe and fatal bleeding complications with Xarelto and other new blood thinners, including Pradaxa and Eliquis.

Court documents in the Xarelto lawsuits say that patients and their doctors were not adequately warned about the possibility of uncontrollable bleeding with Xarelto. Although there are restrictions on warfarin use, warfarin does have a readily available antidote to help control bleeding. Xarelto has no known antidote that will reverse the blood thinning effects of the drug and quickly stop a bleeding episode. Plaintiffs claim that Bayer and Johnson & Johnson failed to adequately warn doctors about the lack of a reversal agent. A number of plaintiffs say they would have accepted the inconvenience of warfarin if they had known of the serious dangers of Xarelto.

Pradaxa (dabigatran) came to market in 2010, a year earlier than Xarelto. More than 4,000 Pradaxa patients filed lawsuits over bleeding and injuries and deaths like those blamed on Xarelto. After years of litigation, Boeringer Ingelheim agreed to pay $650 million in Pradaxa settlements. The average payment per claim is about $150,000, according to the Legal Examiner.

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