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Xarelto Bellwether Trial Update

Xarelto Bellwether Trial Update

For more information, please contact The Ahearne Law Firm, PLLC for a free initial consultation and case evaluation. Call nationwide at (845) 986-2777.

The first bellwether trial out of 17,000 Xarelto lawsuits will begin on April 24th unless lawyers can negotiate a settlement. Two years ago, a similar litigation involving Pradaxa ended with a $162 million settlement just before trials began, for an average payout of $162,500. Pradaxa manufacturer Boehringer Ingelheim was named as a defendant in approximately 4,000 lawsuits from people who were injured or died from bleeding. Just before the first bellwether trials were about to begin, the company settled for $650 million.

There are now over 15,611 federal Xarelto lawsuits in Louisiana. All of the lawsuits involve people who experienced severe bleeding and related complications after taking Xarelto.

The federal lawsuits are centralized in MDL No. 2592 under United States District Judge Eldon E. Fallon in Louisiana. The MDL process uses bellwether trials to help lawyers determine how a jury might respond to evidence and gauge the settlement value of similar lawsuits.

  • The first Xarelto bellwether trial will be located in the U.S. District Court for the Eastern District of Louisiana. The plaintiff, Joseph Boudreaux, Jr., used Xarelto for about a month before he developed severe gastrointestinal bleeding. Mr. Boudreaux was prescribed Xarelto to reduce the risk of stroke from atrial fibrillation. He was forced to undergo several transfusions due to the bleeding event he experienced, and was hospitalized for five days. He has since required follow-up medical care (Case No. 2:14-cv-02720).
  • The second trial will also be in the U.S. District Court for the Eastern District of Louisiana. The plaintiff, Joseph Orr, is the husband of a woman who died of a cerebral hemorrhage, or uncontrollable bleeding in the brain, after taking Xarelto for one month (Case No. 2:15-cv-03708).

Two more trials will be scheduled in June 2017.

  • The third trial will be located in in the U.S. District Court for the Southern District of Mississippi and it will involve Dora Mingo, a woman who suffered gastrointestinal bleeding after taking Xarelto to prevent blood clots.
  • The fourth trial will involve William Henry, a man who died of gastrointestinal bleeding after taking Xarelto for atrial fibrillation. The trial will be located in the U.S. District Court for the Northern District of Texas.

Over 1,343 lawsuits have been filed at the state level in Philadelphia in the Xarelto program at the Complex Litigation Center (CLC) in Philadelphia, overseen by Judge Arnold New. The first lawsuits there were filed in February 2014, and previously-reported indications point toward a bellwether case being heard in sometime later in 2017. Most of the filed lawsuits are from out-of-state plaintiffs. CLC Director Stanley Thompson previously said resolutions reached during the MDL proceedings may prove helpful, but those case outcomes may not necessarily affect how things proceed for Xarelto litigation in Philadelphia.

The Xarelto lawsuits allege that the drug’s manufacturers — Bayer Healthcare and Johnson & Johnson subsidiary Janssen Pharmaceuticals — failed to warn about Xarelto’s potential risks, most notably, uncontrollable bleeding. Further, plaintiffs have alleged that (i) they were unaware that Xarelto was brought to market without an effective antidote, or reversing agent, which can help stem a Xarelto bleeding issue that could lead to death, and (ii) it was irresponsible of the manufacturers to claim less monitoring of patients on Xarelto was needed when, in the absence of an antidote, more monitoring would be required, all while the manufacturers aggressively marketed Xarelto in the race to replace Coumadin (warfarin). Warfarin was approved in the 1950s and it was the standard of care for decades. Warfarin is de-activated with a dose of Vitamin K, but patients cannot eat any foods that contain Vitamin K or warfarin will not work.

Xarelto is one of the three major direct oral anticoagulants (DOACs) poised to replace warfarin, together with Eliquis and Pradaxa. The Food and Drug Administration (FDA) approved Xarelto for use in patients who had knee or total hip replacement surgery to reduce the risk of blood clots, and also to reduce the risk of stroke in people with atrial fibrillation. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). When first released, the manufacturers advertised Xarelto as being the “first and only once-a-day prescription blood thinner”.

The FDA started approving these blood-thinning drugs in 2010, starting with Pradaxa (dabigatran) and followed by Xarelto (rivaroxaban) in 2011. At the time, neither drug had any type of reversal agent to de-activate their blood-thinning effects in an emergency. Primary care doctors prescribed these drugs because they were easy for patients to take, but emergency room doctors struggled to stop bleeding.

All blood thinners pose a risk for bleeding given the need to thin blood in an effort to avoid stroke-inducing blood clots which may form following some types of surgery or in relation to atrial fibrillation. Accordingly, strict monitoring of diet and other blood factors has been required to ensure that anti-coagulants are maintained at optimum levels to help mitigate stroke risk and the formation of blood clots.

For patients on Coumadin, careful management of diet and other blood properties has been essential. Further, personalizing doses of warfarin through genetic testing helped reduce the risk of combined adverse events in patients undergoing elective orthopedic surgery, according to data recently presented at the American College of Cardiology’s 66th Annual Scientific Session. Genetic and clinical dosing algorithms could be potentially beneficial in managing warfarin doses and preventing adverse events associated with the treatment, especially if dosing recommendations become readily accessible to providers in electronic medical records.

#Xarelto #Warfarin #Eliquis #pharma

If you or a family member have taken Xarelto (with or without experiencing side effects or related conditions), you and/or your family member may be entitled to money damages.

For more information, please contact The Ahearne Law Firm, PLLC for a free initial consultation and case evaluation. Call nationwide at (845) 986-2777.

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