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CASE UPDATE: $775 Million Dollar Settlement Announced
March 25, 2019 - A $775 million dollar settlement was announced Monday morning by Bayer and Janssen Pharmaceuticals. The deal will settle about 25,000 lawsuits alleging Xarelto caused internal bleeding risks and the manufacturer failed to warn about the risks.
Xarelto (Rivaroxaban) was developed by Bayer Pharmaceuticals and is now marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit. Gaining FDA approval in 2011, Xarelto is prescribed to block clotting of the blood, specifically, a particular type of blood clot called deep vein thrombosis (DVT). It is also used in individuals with atrial fibrillation to decrease the risk of stroke caused by a blood clot.
Patients prescribed Xarelto or other new oral anticoagulants need to understand that taking these drugs comes with some risk.
In instances of an emergency situation, traumatic accident, or cerebral hemorrhage, bleeding can be difficult to stop in patients taking Xarelto. As of January 2018, an antidote has still not been released to prevent the severe, uncontrollable bleeding from occurring. The uncontrollable severe bleeding events, including gastrointestinal bleeds, could lead to blood transfusions, hospitalization, or even death. However, there is a drug, AndexXa, currently undergoing an approval process by the FDA that would cease potentially fatal Xarelto bleeding side effects. More information on the approval process should be released in May 2018.
According to the Institute for Safe Medicine Practices (ISMP), a watchdog group, anticoagulant drugs are a “high-risk treatment” and cause bleeding in approximately 15% of patients with atrial fibrillation. Many physicians are wary of the newer anticoagulants since there is limited data on how to manage bleeding in patients taking them.
The pharmaceutical companies that produced Xarelto are now under fire for not only causing side effects in individuals but for failing to provide adequate warnings of the risks.
Bayer AG and Johnson & Johnson pharmaceuticals pulled the plug in 2017 on an in-house study on Xarelto’s benefits weighed against a potentially life-threatening Xarelto side effect. The NAVIGATE ESUS trial was suspended following the release of findings from a third-party research group, which indicated that Xarelto’s use in secondary stroke prevention performed no better than normal standard of care.
The independent research showed that as compared to standard of care, preventing secondary stroke with use of aspirin or similar over-the-counter medication, Xarelto faired the same in terms of efficacy.
NAVIGATE ESUS is scheduled to resume in 2018, but there are certain deterrents that could eventually halt the manufacturer’s research permanently.
While there is no indication that Xarelto offers any greater benefit to patients than more standard forms of care, the drug seems to pose substantial health risks to users. Internal bleeding, a Xarelto side effect which J&J failed to warn consumers of, is one of these risks.
According to the FDA, the blood thinner medication has been linked to more than 370 deaths related to internal bleeding.
Xarelto is Bayer’s highest sales product, producing $5.74 billion in the last two years alone. Cutting Xarelto from the U.S. market would decimate the manufacturer’s sales. But with the growing number of Xarelto bleeding lawsuit litigations, along with independent research that indicates that safer and cheaper over-the-counter medications are as equally effective, it will be difficult for Bayer to downplay the imbalance between Xarelto side effects and benefits.
For now, Bayer AG and J&J will regroup. The manufacturers are left with the difficult decision of either accepting that Xarelto is inefficient – and accepting the lost sales — or continuing with the NAVIGATE ESUS study in 2018, hoping to disprove the independent research and extenuate the life-threatening Xarelto side effect with some potential benefits.
The below injuries are commonly associated with Xarelto use:
More than 20,000 plaintiffs allege that Xarelto, an anticoagulant, caused them to suffer from uncontrollable bleeding and that the manufacturers of the drug failed to provide adequate warnings of the deadly side effects that could occur. The Xarelto lawsuits have been consolidated into multidistrict litigation in Louisiana.
Similar lawsuits involved Boehringer Ingelheim’s blood thinner Pradaxa. Tor Hoerman was a co-lead attorney in the Pradaxa litigation that resulted in the settlement of $650 million to individuals injured as a result of their Pradaxa use.
The lawyers pursuing the Xarelto lawsuit believe that Bayer Pharmaceuticals and Johnson & Johnson’s Janssen Pharmaceuticals may also find themselves defending Xarelto as Boehringer Ingelheim Pharmaceuticals Inc. did in the case of Pradaxa. Xarelto is now the top prescribed anticoagulant in the U.S and has shown similar serious injuries as in the case of Pradaxa.
At this time, TorHoerman Law is no longer accepting Xarelto cases.
February 2019 - There are more than 20,000 cases on file. Two waves of 600 cases each have been selected for preliminary trial work-up, including three of our cases. We expect the judge to send the 1,200 cases out for trial at some point in 2019. If no settlement is worked out by that point then we expect more cases to be selected for work-up.
August 2018 - The first 600 potential trial cases have been selected, and are being prepared for trial. Another 600 such cases will be selected before the end of the year.
February 20, 2015 - Numerous lawsuits filed against Bayer and Johnson & Johnson's subsidiary, Janssen Pharmaceuticals over the blood thinner, Xarelto, have been consolidated into multidistrict litigation (MDL) in the Eastern District of Louisiana. Judge Eldon E. Fallon, who is familiar with complex pharmaceutical drug liability cases, will be presiding over the MDL. The MDL will simplify the process of pretrial work due to the growing number of lawsuits.
The MDL in Louisiana will manage all pretrial proceedings for Xarelto lawsuits across the country. Plaintiffs who become a part of the MDL will get to keep their own lawyers and have their suits treated individually. If the cases are not settled after pretrial, they will return to their home districts where the lawsuits were filed to proceed for trial.
On February 9, 2015, Judge Fallon established a Plaintiffs’ Steering Committee consisting of 12 attorneys. This committee is responsible for pretrial discovery, including introducing evidence and examining witnesses, on behalf of all the Plaintiffs. Following the creation of the Xarelto MDL in Louisiana, a Xarelto mass tort program was created in Pennsylvania.
July 12, 2012 - When a new drug is introduced and the manufacturer claims that the drug is supposed to either offer a major advancement in treatment or provide a treatment where no adequate treatment exists, the U.S. Food and Drug Administration gives the drug "priority review" status, meaning more FDA resources will be directed towards reviewing the drug, more than the average, with the goal of completing review of the drug in six months rather than the ten to twelve months the FDA usually spends reviewing standard drugs.
Xarelto, like its competitor Pradaxa, has been in a race to grab the potentially lucrative $10 billion market to replace the generic blood thinner, Warfarin, which is used in the treatment of atrial fibrillation – a rapid, irregular heart rhythm. Boehringer Ingelheim's blockbuster drug, Pradaxa, got a leg up on the market when it was approved in 2010. Xarelto, licensed by Janssen Pharmaceuticals from Bayer, followed closely by receiving FDA approval in 2011. Eliquis, an effort from Pfizer and BMS, is the third drug in the new-generation blood thinner market but has fallen behind with word from the FDA that more information would be needed before it could be approved.
Janssen now looks to expand the Xarelto market with additional indications for use in the treatment of deep vein thrombosis (DVT) and pulmonary embolism. But is Xarelto really a major advancement in the treatment of DVT?
The treatment of DVT requires an anticoagulant to prevent a blood clot from getting bigger. Two different types of anticoagulants have been used to treat DVT for years – Heparin and Warfarin. Heparin is generally prescribed first because it works immediately to prevent further clotting. After the initial Heparin treatment, Warfarin may also be prescribed to prevent another blood clot from forming.
Manufacturers of new drugs, such as Xarelto and Pradaxa, seek to capture the Warfarin market for DVT treatment. Although the manufacturers point to improvements over Warfarin, Warfarin still has one major advantage that can't be ignored - the blood thinning action of Warfarin can be quickly reversed in patients who suffer bleeds by administering vitamin K. On the other hand, each of the three of the new-generation blood thinners lacks a way to reverse the drug's intended action, leading some top cardiologists to say that they are not ready to prescribe any of the new thinners.
The lack of a reversal agent is part of the reason lawsuits have been brought against Pradaxa's manufacturer Boehringer Ingelheim since Pradaxa hit the market in 2010. Many people are worried that Xarelto may be following the same path. According to the Adverse Events Monitor, a report that tracks the FDA's Adverse Event Reporting System, Xarelto was the subject of 990 primary suspect reports in the first two quarters of 2012, with the top reported adverse event being a pulmonary embolism.
Given the extent of adverse events associated with Xarelto, the FDA's allocation of additional resources to investigate the drug prior to approving it for additional uses is warranted. It seems far from certain that Xarelto is really a major advancement from Warfarin, and because it lacks a reversal agent, presents risks similar to those that have resulted in litigation over Boehringer Ingelheim's Pradaxa.
If you have experienced side effects such as unusual bruising, vomiting blood, blood in the urine or stool please contact your doctor to consider your medical options.
March 2018 – Litigation continues. The federal judge in charge of the MDL has initiated a plan to select 1200 cases for trial work-up. The first 600 of those will be announced this spring.
January 9, 2018 – A Pennsylvania state court judge overturned the verdict that awarded $28.7 million to a plaintiff.
December 5, 2017 – A Pennsylvania jury awarded $28.7 million to a plaintiff who claimed that Xarelto manufacturers failed to warn consumers of the adverse health risks associated with the blood thinner. The verdict consisted of $1.78 million in compensatory damages and $26 million in punitive damages.
Xarelto Video Update - Attorney Steven Davis
The jury found the manufacturers at fault for providing inadequate warnings about the risks of bleeding associated with the blood thinner medication. This is the first Xarelto loss. Juries in three previous bellwether cases this year decided in favor of the drug makers.
There are currently more than 1,500 cases pending as part of mass tort in the Philadelphia County Court to consolidate product liability claims against Xarelto. The case that was decided on this afternoon was part of that consolidation.
Lynn Hartman, an Indiana woman, suffered a major gastrointestinal bleed while using Xarelto. Hartman claimed that Janssen Pharmaceuticals Inc. and Bayer Healthcare Pharmaceuticals Inc. failed to warn her of the potential health risks involved with Xarelto, including the increased risk of bleeding events observed in clinical trials, especially in U.S. patients as compared to patients abroad.
Hartman's argument included evidence showing that the rate of bleeding events for U.S. patients was 8.1% annually versus 3.6% annually among patients outside of the U.S.
Hartman argued that the manufacturers failed to warn consumers about the increased risk of bleeding events for Xarelto users who are also taking aspirin. The plaintiff also argued that the manufacturers failed to inform healthcare professionals that some patients run an increased risk of higher levels of medication in their bloodstream than other patients when using Xarelto.
Furthermore, the plaintiff argued that Xarelto's health risks were significantly greater than comparable forms of medication, such as Eliquis and Pradaxa.
Hartman's claims were supported by former Food & Drug Administration chief David Kessler, who stated during the trial that he believed Xarelto's warning label to be insufficient, lacking complete information about the potential health risks associated with Xarelto.
The defense argued that by including "can cause serious and fatal bleeding", the warning labels adequately informed consumers of the potential adverse health risks. Their argument was ultimately unsuccessful.
While this Xarelto loss is a major advance for plaintiffs in the mass tort, there is still a long road ahead for the plaintiffs.
According to court records, the next case is scheduled to go to trial in the same court in January 2018.
August 18, 2017 – In the third bellwether trial, a jury once again ruled in favor of Xarelto's manufacturers.
June 12, 2017 – A New Orleans jury ruled in favor of Xarelto manufacturers in the second bellwether trial in the multidistrict litigation.
May 3, 2017 – In the first of four bellwether trials, a jury in the Eastern District of Louisiana ruled in favor of the defense, rejecting the plaintiff's claim that the defendants had failed to notify the plaintiff's doctor of the risks associated with Xarelto.
August 2013 – A black box warning, the strongest warning required by the FDA, was added to Xarelto packaging. The warning cautioned particular individuals against taking the medication if undergoing certain procedures or taking certain medications in conjunction with Xarelto.
June 6, 2013 – The FDA sent a warning letter to Johnson & Johnson and its partner, Bayer Pharmaceuticals, after determining the companies failed to adequately warn individuals of the potentially serious side effects associated with Xarelto.
The FDA took issue with certain marketing material. One print advertisement called into question was an advertisement published on WebMD which the FDA said failed to properly draw attention to the drug's side effects while claiming the efficacy of Xarelto "appeared to be disassociated with the risks."
May 2012 – Xarelto was approved for extended use, including the treatment of deep vein thrombosis and pulmonary embolism by the FDA.
November 2011 – The U.S. Food & Drug Administration (FDA) approved Xarelto to reduce the risk of stroke and systemic embolism in people with non-valvular atrial fibrillation.
Cheung, Ka-Shing, and Wai K Leung. "Gastrointestinal Bleeding in Patients on Novel Oral Anticoagulants: Risk, Prevention and Management." World Journal of Gastroenterology, U.S. National Library of Medicine National Institutes of Health, 21 Mar. 2017, www.ncbi.nlm.nih.gov/pmc/articles/PMC5360636/.
Depp, Aurora. "FDA Delays AndexXa Antidote for Xarelto Bleeding · MedTruth." MedTruth, 24 Jan. 2018, medtruth.com/fda-andexxa-antidote-xarelto-bleeding/.
"FDA Warnings & Safety Communications for Xarelto Users." Recall Center, RecallCenter, www.recallcenter.com/xarelto/fda-news/.
Raymond, Nate, and Tina Bellon. "Bayer, J&J Win Reversal of $28 Million Verdict in Xarelto Lawsuit." Reuters, Reuters, 2018, www.reuters.com/article/us-bayer-xarelto/bayer-jj-win-reversal-of-28-million-verdict-in-xarelto-lawsuit-idUSKBN1EZ08M.
Thomas J Moore, Michael R Cohen, Curt D Furberg. "Perspective on Drug Hypersensitivity." QuarterWatch: Monitoring FDA MedWatch Reports, www.ismp.org/quarterwatch/pdfs/2013Q1.pdf
"United States District Court." MDL - 2592 Xarelto Products Liability Litigation | Eastern District of Louisiana | United States District Court, United States District Court - Eastern District of Louisana, 27 Feb. 2018, www.laed.uscourts.gov/xarelto
"Xarelto Uses, Dosage, Side Effects & Warnings." Drugs.com, Drugs.com, www.drugs.com/xarelto.html.
Last Modified: July 23rd, 2019 @ 03:15 pm
Xarelto is a prescription anticoagulant used to prevent blood clots in individuals who suffer from atrial fibrillation or are susceptible to deep vein thrombosis (DVT) or pulmonary embolism (PE). However, the drug can lead to uncontrollable bleeding, which can lead to a blood transfusion, hospitalization, or even death. The lawsuits alleged the manufacturer failed to warn individuals of the bleeding risks involved. At this time, TorHoerman Law is no longer accepting Xarelto cases.
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