Preview Newsletter
Xarelto Media Scan 7-31-15
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Xarelto Lawsuit Claims Center
Jul 24, 2015 | Berbstein Liebhard LLP
Some Xarelto lawsuit plaintiffs could see their cases head to trial as early as next summer. According to court records, dates for bellwether trials were discussed last month during a teleconference convened by the federal court overseeing hundreds of injury claims involving the blood-thinning medication. -
Xarelto Lawsuit: First Trials Scheduled In Dangerous Side Effects Litigation
Jul 25, 2015 | The Legal Examiner
By Marc Goldich
The first trials in the Xarelto Multidistrict Litigation (MDL) are scheduled to commence in August of 2016. These trials will be used to test the arguments of both sides and could be crucial in moving the overall litigation forward. -
Lawsuit Claims Extreme Risks of Xarelto Outweigh Benefits
Jul 27, 2015 | American Injury Attorney Group
Xarelto lawyers note a widow’s lawsuit filed against Bayer Healthcare and Janssen Pharmaceuticals alleging that the severe risks of Xarelto internal bleeding and other complications outweigh any benefits of the drug. The woman’s lawsuit also claims that her husband was killed from complications caused by Xarelto, and that the drug makers failed to adequately warn the public about the risks associated with the widely used blood thinner. -
XARELTO & REVERSAL DRUGS
Jul 29, 2015 | Schmidt National Law Group
By Erica Arvanitis
The New England Journal of Medicine published a study where 80 healthy volunteers received a dose of an oral blood thinner called Xarelto, followed by an intravenous dose of another drug, PER977, at various doses. The results showed that PER977 reversed the blood thinning effect of the oral drug within 10 minutes of dosing, as shown by a clotting test. -
Xarelto Lawsuit for Wrongful Death Filed by Widow in Missouri
Jul 24, 2015 | The Legal Herald
The prescription Xarelto has become a controversial topic after recently published studies have shown a link between the drug and severe side effects including uncontrollable bleeding. Xarelto Brain BleedThe dangerous side effects linked with the use of Xarelto have led to many individuals and families across the country filing lawsuits against several different companies involved in the manufacturing and distribution of Xarelto in the US. The pending lawsuits allege that these companies acted negligently and knowingly by failing to warn the public of significant risks associated with Xarelto. -
Elderly Patients Taking Xarelto At Greater Risk Of Major Bleeds
Jul 24, 2015 | Righting Injustice
By Jennifer Walker-Journey
Elderly patients with a common irregular heart rhythm known as atrial fibrillation treated with the blood thinner Xarelto are far more likely than any other age group to experience major bleeding events, according to a post-marketing study investigating the safety risks with the popular new anticoagulant. The multi-year study involved medical records of 31,883 atrial fibrillation patients ages 19 to 105 prescribed Xarelto for stroke prevention. Researchers used a validated case-finding algorithm to detect major bleeds, which matched diagnosis codes related to bleeding with patient identities. Patient demographics were identified, as was usage of other medications, treatment for bleeding, and fatalities. -
Pradaxa, Xarelto Should Not Be Used In Patients With Chronic Kidney Disease, Doctors Warn
Jul 24, 2015 | AboutLawsuits.com
By Irvin Jackson
New clinical guidelines on managing anticoagulation in patients with atrial fibrillation warn that some newer blood thinners may be too dangerous for patients with kidney problems. The Journal for the American Medical Association (JAMA) published a synopsis this week of clinical guidelines issued by several professional medical groups regarding the management of patients with atrial fibrillation, including warnings against the use of medications like Xarelto, Pradaxa and Eliquis among patients with end-stage chronic kidney disease (CKD). -
New Xarelto Lawsuits Filed in 2015
Jul 27, 2015 | Xarelto Problems
21 cases from 10 districts over the blood-thinning drug Xarelto were consolidated into a multidistrict litigation (“MDL”) for pretrial proceedings before Judge Fallon in New Orleans. Meanwhile, more Xarelto lawsuits continue to mount, with 86 suits pending, according to the Judicial Panel on Multidistrict Litigation’s January 15, 2015 monthly report. -
More Patients Being Treated For Atrial Fibrillation
Jul 27, 2015 | Righting Injustice
By Jennifer Walker-Journey
More patients than ever are being treated with blood thinners for the common irregular heart rhythm condition atrial fibrillation, thanks in part to direct-to-consumer advertising from the newest anticoagulants on the market. According to a study conducted by researchers with the University of Michigan Frankel Cardiovascular Center, doctors prescribed more than 2.83 million blood thinners in the last quarter of 2014, up about 800,000 from the start of 2009. -
Xarelto Trials Set for 2016
Jul 27, 2015 | Product Liability Reporter
By Mark Zamora
Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. It is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot. -
Bayer Hit With Xarelto Wrongful Death Lawsuit
Jul 27, 2015 | Top Class Actions
By Meredith Friesen
A wrongful death Xarelto lawsuit was filed on behalf of a woman who allegedly died due to uncontrollable Xarelto bleeding. Xarelto, an anticoagulant, has been named in hundreds of lawsuits claiming that Janssen Pharmaceuticals failed to warn against the potentially deadly Xarelto side effects that could follow. -
As Xarelto MDL Grows, Study Suggests Link with Hemorrhage
Jul 28, 2015 | LawyersandSettlements.com
By Heidi Turner
As the number of Xarelto lawsuits included in the multidistrict litigation grows, a new study has been published suggesting a link between the use of rivaroxaban (the generic of Xarelto) and spontaneous eye hemorrhage, also known as bleeding in the eye. Lawsuits have been filed against the makers of Xarelto, alleging patients were not adequately warned about the risks associated with taking the drug. -
Xarelto Causes Severe Damage
Jul 28, 2015 | The Alamo Journal
Xarelto was first created by Bayer and Johnson & Johnson, and is an oral medication known as an anticoagulant, or a blood thinner. The difference between Xarelto and other blood thinners that are already on the market, is that Xarelto is a “one size fits all” pill. Unlike other blood thinner medications, the patient’s blood is monitored on a regular basis and given a dosage on how much their bodies can handle. They are also put on a rigorous diet, constantly watching what they eat because the blood thinner has an effect on the food one consumes. -
Xarelto Dosing Under Scrutiny Amid Bleeding Concerns
Jul 29, 2015 | Top Class Actions
Xarelto, a new generation blood thinner, is currently under closer examination for its safety following numerous reports of serious side effects. Upon its release to the market, experts claimed that Xarelto was superior to Coumadin (warfarin), the previous gold-standard of treatment for use as an anticoagulant. Manufacturers asserted the new drug’s advantages included its apparent safety and the ease of using less frequent blood monitoring as compared to the former drug option. -
Study Raises Additional Concerns About Xarelto’s Use in Pregnant Women
Jul 30, 2015 | The Legal Examiner
By Roopal Luhana
The newer-generation anticoagulant Xarelto (rivaroxaban) has ended up in the news lately because of its connection to serious side effects like gastrointestinal bleeding, brain hemorrhaging, blood clots, and stroke. A recent study, however, has now raised additional concerns that Xarelto may be dangerous when taken by pregnant women. Results showed evidence that the drug crosses the human placenta, where it could potentially affect the unborn child. -
The Sickening Side Effect of New Age Blood Thinner Marketing
Jul 29, 2015 | The Legal Examiner
By Angus Hinson
All you have to do is watch primetime television to recognize the fierce competition in the new age blood thinner industry. Bristol Myers Squib’s Eliqis® and Johnson & Johnson’s Xarelto® are dueling it out for market share supremacy in one of the largest pharmaceutical markets in America. It is estimated that Americans spend more than $10 billion per year on blood thinners, or anti-coagulants.
Plaintiff Attorney Press Releases
Plaintiff Attorney Blog Posts
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Jul 24, 2015 | Berbstein Liebhard LLP
Some Xarelto lawsuit plaintiffs could see their cases head to trial as early as next summer. According to court records, dates for bellwether trials were discussed last month during a teleconference convened by the federal court overseeing hundreds of injury claims involving the blood-thinning medication.
For Xarelto Trials Proposed
More than 500 Xarelto cases are currently pending in the federal multidistrict litigation underway in the U.S. District Court, Eastern District of Louisiana. All of the complaints were filed on behalf of patients who allegedly experienced life-threatening episodes of internal bleeding and other serious side effects allegedly related to its use. Bellwether trials are a standard part of multidistrict litigations, as findings in these representative cases are intended to provide insight into how juries might rule in similar lawsuits.
During the June 22nd teleconference, a bellwether program was proposed that would consist of four jury trials. The first two would get underway on August 1 and August 22, 2016 in the Eastern District of Louisiana. The third would begin on September 12, 2016 in the Southern District of Texas, and the fourth would be convened on October 17, 2016 in the Southern District of Mississippi.
All four trial cases would be selected from a discovery pool consisting of 50 Xarelto lawsuits.
The federal Xarelto litigation also held its regular monthly Status Conference on July 9th. Among other things, the Court directed the parties to participate in regular teleconferences in order to address any disputes pertaining to discovery. The first teleconference was to be held on July 23rd, with additional conferences to follow on a bi-weekly basis through December 22, 2015.
Xarelto Side Effects
Xarelto is a new-generation blood thinner that has been available in the U.S. since 2011. Since its launch, the drug has been marketed as a superior alternative to warfarin, as it purportedly does not require patients to undergo regular blood monitoring to ensure proper dosage. However, Xarelto lawsuit plaintiffs dispute those marketing claims, and argue that patients would actually benefit from a testing regimen. They also point out that there currently exists no readily available antidote to reverse Xarelto bleeding side effects. However, internal bleeding associated with warfarin can be stopped with the administration of vitamin K.
Xarelto patients who suffered internal bleeding and other serious complications may be entitled to compensation for their related medical expenses and other damages. To learn more about filing a Xarelto lawsuit, please call (877) 784-0151.
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Xarelto Lawsuit: First Trials Scheduled In Dangerous Side Effects Litigation
Jul 25, 2015 | The Legal Examiner
By Marc Goldich
The first trials in the Xarelto Multidistrict Litigation (MDL) are scheduled to commence in August of 2016.
These trials will be used to test the arguments of both sides and could be crucial in moving the overall litigation forward.
About The Xarelto MDL
Xarelto is a popular blood thinner drug which is prescribed to treat various medical conditions including deep vein thrombosis and pulmonary embolism. It is also used to prevent blood clots in patients undergoing knee or hip replacement surgery.
The blockbuster drug has been prescribed more than 11 million times in the US since its initial FDA approval in 2011. However, Xarelto has become highly controversial after a number recent of studies linked the drug to dangerous side effects including severe internal bleeding.
Individuals and families from across the country are now filing lawsuits in relation to the allegedly dangerous side effects of Xarelto, claiming that companies involved in manufacturing and selling the drug acted negligently.
In October 2014, dozens of existing Xarelto lawsuits were consolidated into a Multidistrict Litigation in the US District Court for the Eastern District of Louisiana. The number of complaints involved in the MDL has since grown to more than 500 cases.
In a recent status meeting, the Judge presiding over the Xarelto MDL announced the dates of the first three bellwether trials. According to minute entries from the status meeting, the first trial will begin on August 1st, 2016 and will be followed by two more trials beginning on August 22nd and September 17th.
It was also noted that the first two trials will be held in the Eastern District of Louisiana, while the third trial will be held in the Southern District of Texas.
Xarelto Lawyers
Xarelto lawyer Marc Goldich commented on the importance of the first trials saying, “The outcomes of the bellwether trials will help parties on both sides of this litigation in making decisions going forward and should help to speed up future litigation.”
Goldich is a sponsor of BloodThinnerHelp.com which provides helpful information about Xarelto litigation and access to legal representation for those who may have been harmed by Xarelto’s side effects.
For more information about this press release please contact Marc Goldich at (866) 425-8902.
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Lawsuit Claims Extreme Risks of Xarelto Outweigh Benefits
Jul 27, 2015 | American Injury Attorney Group
Xarelto lawyers note a widow’s lawsuit filed against Bayer Healthcare and Janssen Pharmaceuticals alleging that the severe risks of Xarelto internal bleeding and other complications outweigh any benefits of the drug. The woman’s lawsuit also claims that her husband was killed from complications caused by Xarelto, and that the drug makers failed to adequately warn the public about the risks associated with the widely used blood thinner.
If you or a loved one took Xarelto and suffered complications, contact the American Injury Attorney Group today to learn more about your options. We can answer your questions in a free, confidential, no-obligation consultation, and if you wish to pursue a claim, we can connect you with an affiliated Xarelto lawsuit attorney.
Important: The time you have to pursue a claim is limited. Contact us for more information.
Widow Claims Drug Makers Failed to Warn of Potentially Fatal Bleeding
According to the widow’s lawsuit, Xarelto use is associated with an increased risk of irreversible internal bleeding. She alleges that Bayer and Janssen failed to adequately warn the public of the severe risks of Xarelto, and, because of those risks, she claims they “failed to exercise ordinary care in the designing, researching, manufacturing, marketing, supplying, promoting, packaging, sale, testing, quality assurance, quality control, and distribution of Xarelto…”
The woman claims that Xarelto puts patients at an “unreasonable risk” of injury and death, and that it was the drug makers’ negligence that ultimately led to her husband’s death. The woman also claims that the drug makers:
“Wantonly and with malice withheld knowledge” of the drug’s dangers.
Concealed the drug’s risks from the public in order to prevent FDA approval delays or rejection of the product.
Continued to promote Xarelto with the knowledge that the product is associated with irreversible bleeds.
Injured Patients May Be Entitled to Compensation
If a drug maker fails to fulfill its duty to provide safe drugs and to warn of potentially harmful side effects that may be associated with its medication, it could be held liable for any injuries that may result. Patients who have been injured by Xarelto may be entitled to compensation for damages, including:
Medical expenses
Pain and suffering from an injury
Loss of income or ability to work
If a patient dies from complications after taking Xarelto, his or her family members may be able to pursue claims for their loved one’s wrongful death. Compensation may include:
Pain, suffering, and mental anguish from the loss of a loved one
Loss of a loved one’s financial support
Funeral expenses
Medical expenses attributable to the fatal injury
Contact Us For More Information
If you or a loved one took Xarelto and suffered complications, including internal bleeding, contact the American Injury Attorney Group for more information. You can fill out the form on this page, call us at the number listed at the top of the page, or email us at info@attorneygroup.com.
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.
See our Frequently Asked Questions page for more information, and contact the American Injury Attorney Group today.
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Jul 29, 2015 | Schmidt National Law Group
By Erica Arvanitis
The New England Journal of Medicine published a study where 80 healthy volunteers received a dose of an oral blood thinner called Xarelto, followed by an intravenous dose of another drug, PER977, at various doses. The results showed that PER977 reversed the blood thinning effect of the oral drug within 10 minutes of dosing, as shown by a clotting test.
Three Antidotes in Development May Make Xarelto More Safe
Currently, there is no available reversal agent for if major bleeding occurs or for urgent reversal for surgery. Here are some of the reversal drugs that are still in development:
Aripazine
Aripazine is a synthetic, small molecule which has broad activity against old and new oral blood thinners. It’s being developed by the company Perosphere and could potentially reverse the effects of Xarelto and other blood thinner drugs.
Andexanet
Andexanet is a modified face Xa molecule that is being developed as a direct reversal agent for patients receiving Factor-Xa inhibitor blood thinners. These patients could suffer from major bleeding episodes or require immediate surgery. It soaks up the anti-blood thinner, making a patient’s own clotting factor able to work again. The company Portola is currently developing Andexanet.
Idarucizumab
Idarucizumab is a humanized, antibody fragment directed against Pradaxa, a blood thinner. It’s generated from the antibodies of a mouse and is being developed by the company Boehringer-Ingelheim.
If you or a loved one have been prescribed Xarelto, talk to your doctor before completely stopping this drug.
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Xarelto Lawsuit for Wrongful Death Filed by Widow in Missouri
Jul 24, 2015 | The Legal Herald
The prescription Xarelto has become a controversial topic after recently published studies have shown a link between the drug and severe side effects including uncontrollable bleeding.
The dangerous side effects linked with the use of Xarelto have led to many individuals and families across the country filing lawsuits against several different companies involved in the manufacturing and distribution of Xarelto in the US. The pending lawsuits allege that these companies acted negligently and knowingly by failing to warn the public of significant risks associated with Xarelto.
Xarelto is a popular prescribed blood thinner used for reducing the risks of blood clots in patients undergoing knee or hip replacement surgery. Xarelto is also prescribed for patients with Atrial Fibrillation, Deep Vein Thrombosis or Pulmonary Embolism.
Complaint Alleges Drug Caused Cerebral Hemorrhage Leading To Death
On May 22nd, 2015 a lawsuit filed by the deceased’s widow, alleges that Xarelto was the direct cause of internal bleeding which eventually resulted in his wrongful death.
Stated in the complaint, the deceased man was prescribed Xarelto by his physician in December of 2012. The man was then hospitalized on May 8th, 2013 for a cerebral hemorrhage and was later transferred to the Intensive Care Unit to be treated for his condition.
Unfortunately, the man passed away on May 22nd, 2013 from medical complications that were allegedly caused by Xarelto side effects.
“This case adds to the growing number of complaints which allege that Xarelto’s side effects caused injury or death,” commented Marc Goldich, Esq. of Sheller P.C.
Goldich continued, “Many people are just learning that Xarelto may have been involved in a loved one’s injury or death and we are currently doing everything we can to help these people seek justice.”
Sheller P.C. is the sponsor of BloodThinnerHelp.com, an online resource providing helpful information and updates on the pending Xarelto litigation.
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Elderly Patients Taking Xarelto At Greater Risk Of Major Bleeds
Jul 24, 2015 | Righting Injustice
By Jennifer Walker-Journey
Elderly patients with a common irregular heart rhythm known as atrial fibrillation treated with the blood thinner Xarelto are far more likely than any other age group to experience major bleeding events, according to a post-marketing study investigating the safety risks with the popular new anticoagulant.
The multi-year study involved medical records of 31,883 atrial fibrillation patients ages 19 to 105 prescribed Xarelto for stroke prevention. Researchers used a validated case-finding algorithm to detect major bleeds, which matched diagnosis codes related to bleeding with patient identities. Patient demographics were identified, as was usage of other medications, treatment for bleeding, and fatalities.
Of the patients studied, 622 experienced a major bleed. Twenty of those patients died from their injury. Researchers found this risk to be just less than 1 for every 100 patient years.
The data, researchers said, reaffirmed the safety and efficacy profile that was used to gain approval from the Food and Drug Administration (FDA) in 2011. But the data showed the bleeding risk was far greater among patients who were aged 75 and older. In fact, nearly three quarters of the major bleeding events occurred in patients from this age group. Twenty-one percent of patients 65 years of age and older experienced major bleeds.
The most common type of bleeding events with Xarelto were by far gastrointestinal bleeds followed distantly byintracranial bleeds, or brain hemorrhages.
The Xarelto safety study is ongoing and will include more than 74,000 patients, reserachers say.
Bayer and Johnson & Johnson subsidiary Janssen Pharmaceuticals face numerous lawsuits from people who claim the companies did not adequately warn of bleeding risks associated with Xarelto.
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Pradaxa, Xarelto Should Not Be Used In Patients With Chronic Kidney Disease, Doctors Warn
Jul 24, 2015 | AboutLawsuits.com
By Irvin Jackson
New clinical guidelines on managing anticoagulation in patients with atrial fibrillation warn that some newer blood thinners may be too dangerous for patients with kidney problems.
The Journal for the American Medical Association (JAMA) published a synopsis this week of clinical guidelines issued by several professional medical groups regarding the management of patients with atrial fibrillation, including warnings against the use of medications like Xarelto, Pradaxa and Eliquis among patients with end-stage chronic kidney disease (CKD).
The guidelines target all patients with atrial fibrillation and were developed last year by the American College of Cardiology (ACC) and the American Heart Association (AHA) in collaboration with the Society of Thoracic Surgeons.
Researchers looked at the long-established blood thinner Coumadin (warfarin), as well as new novel oral anticoagulants introduced in recent years, such as Xarelto (rivaroxaban), Pradaxa (dabigatran), and Eliquis (apixaban).
In one of two major recommendations comprising the guidelines, the groups warned of cautious use of all blood thinners in patients with chronic kidney disease. The guidelines set specific instructions on how to use warfarin for all patients with CKD. However, it called for reduced doses of Pradaxa, Xarelto, and Eliquis in moderate to severe CKD, and warned that neither Pradaxa nor Xarelto should be given to patients with end-stage CKD.
New Blood Thinner Bleeding Risks
Pradaxa was introduced by Boehringer Ingelheim in late 2010 as the first member of a new class of anticoagulants. Xarelto was introduced by Bayer and Janssen Pharmaceuticals in 2011, as the second member of this class. Eliquis was introduced by Pfizer last year.
While all blood thinners carry a risk of bleeding injury, Pradaxa and Xarelto have been linked to a surprising number of problems as more and more patients are switched from warfarin to the new anticoagulants.
Unlike warfarin, where doctors can quickly reverse the blood thinning effects of the medication if bleeding problems develop, Pradaxa, Xarelto and Eliquis were introduced without an effective reversal agent. As a result, many doctors have reported being unable to stop or control hemorrhaging or bleeding that develops among users of the drugs.
Several recent studies have also raised questions about the marketing claims made by the makers of these new anticoagulants, suggesting that blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.
In July 2014, an investigative report published by The BMJ suggested that the makers of Pradaxa failed to provide the FDA with important clinical trial data that suggested users may benefit from regular blood monitoring to make sure the drug did not build up in their bloodstream, increasing the risk of bleeds.
In another study published by the Journal of Cardiology in October 2014, researchers indicated that Xarelto monitoring may have helped doctors understand the effects of the drug on a particular patient and their associated bleeding risk.
Thousands of Pradaxa lawsuits and Xarelto lawsuits have been pursued against the drug makers, alleging that inadequate warnings were provided about the bleeding risks, and that all potential reversal agents should have been explored before the drug was introduced, which would have made the medication safer.
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New Xarelto Lawsuits Filed in 2015
Jul 27, 2015 | Xarelto Problems
21 cases from 10 districts over the blood-thinning drug Xarelto were consolidated into a multidistrict litigation (“MDL”) for pretrial proceedings before Judge Fallon in New Orleans. Meanwhile, more Xarelto lawsuits continue to mount, with 86 suits pending, according to the Judicial Panel on Multidistrict Litigation’s January 15, 2015 monthlyreport. All contend that the anticoagulant manufactured and marketed to safely and effectively clot blood has failed to do so, causing uncontrolled, sometimes fatal, bleeding. Consolidating the initial 21 suits allows the court to more efficiently address the nearly identical claims that Xarelto’s manufacturers, Bayer Healthcare and Janssen Pharmaceuticals, did not properly communicate the risks associated with Xarelto, including the fact that there is no known bleeding antidote for the drug. As the bellwether trials near, more lawsuits are likely to join the 86 suits pending in the MDL.
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More Patients Being Treated For Atrial Fibrillation
Jul 27, 2015 | Righting Injustice
By Jennifer Walker-Journey
More patients than ever are being treated with blood thinners for the common irregular heart rhythm condition atrial fibrillation, thanks in part to direct-to-consumer advertising from the newest anticoagulants on the market.
According to a study conducted by researchers with the University of MichiganFrankel Cardiovascular Center, doctors prescribed more than 2.83 million blood thinners in the last quarter of 2014, up about 800,000 from the start of 2009.
Blood thinners are used to prevent strokes in patients with atrial fibrillation. They are also used to prevent or treat blood clots in the legs and lungs, a condition known as venous thromboembolism.
For decades, warfarin was the anticoagulant used to treat atrial fibrillation. But it was inconvenient. Patients taking warfarin had to be regularly monitored and be aware of food and drug contraindications. Warfarin was also associated withmajor bleeding events that could be fatal.
In 2010, the Food and Drug Administration (FDA) approved Pradaxa, the first from a new class of blood thinners with far fewer contraindications. Patients also did not have to be monitored while on Pradaxa. The popularity of Pradaxa grew quickly and, by 2012, the majority of prescriptions written for atrial fibrillation treatment were for Pradaxa.
The popularity of Pradaxa didn’t last long. Just as Xarelto, the second blood thinner in the new class hit the market, news of major bleeding events with Pradaxa began to surface. The drug’s maker, Boehringer Ingelheim, was slapped with hundreds of lawsuits, and last year the company agreed to pay about $650 million to settle many of those cases.
By 2014, Xarelto became the most prescribed oral anticoagulant for atrial fibrillation treatment. However, Xarelto appears to be meeting the same fate as Pradaxa. The drug has been linked to serious bleeding events including gastrointestinal bleeds, brain hemorrhages and bleeding deaths. Xarelto makers Johnson & Johnson subsidiary Janssen Pharmaceuticalsand Bayer are now facing mounting lawsuits claiming the company did not adequately test its drug for safety and efficacy, and failed to adequately warn patients of serious bleeding risks.
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Jul 27, 2015 | Product Liability Reporter
By Mark Zamora
Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. It is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.
Now, more than 500 Xarelto lawsuits have been consolidated and are currently pending in federal district court in the Eastern District of Louisiana, and District Court Judge Fallon recently announced that the first bellwether trial is scheduled for August 1, 2016.
Besides the Xarelto trial set for August 1, 2016, the court also scheduled three more bellwether trials for August 22, September 12, and October 17, 2016. The first two trials will take place in the Eastern District of Louisiana, the third will be held in the Southern District of Texas, and the fourth is scheduled for the Southern District of Mississippi.
You can also find the Order regarding case-specific discovery here: http://www.laed.uscourts.gov/Xarelto/Orders/PTO14.pdf
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Bayer Hit With Xarelto Wrongful Death Lawsuit
Jul 27, 2015 | Top Class Actions
By Meredith Friesen
A wrongful death Xarelto lawsuit was filed on behalf of a woman who allegedly died due to uncontrollable Xarelto bleeding.
Xarelto, an anticoagulant, has been named in hundreds of lawsuits claiming that Janssen Pharmaceuticals failed to warn against the potentially deadly Xarelto side effects that could follow.
The Xarelto lawsuit was filed by Richard R., on behalf of his wife Clara R., who allegedly suffered from extreme Xarelto bleeding and died of a subdural hematoma on April 27, 2013.
The Xarelto lawsuit stated, “Plaintiff has suffered and incurred damages, including medical expenses and economic and non-economic damages, and has suffered loss of consortium” as a result of Janssen Pharmaceutical’s actions.
Xarelto Side Effects
Xarelto belongs to a new class of anticoagulants that was created to be an alternative to warfarin. Warfarin is a blood thinner that requires its users to adhere to a strict diet and to get their blood checked regularly.
Xarelto was marketed as an “easy to use” alternative. It is most commonly prescribed to patients who undergo certain surgeries to prevent the risk of stroke in patients with non-valvular atrial fibrillation.
However, since its introduction to the market in 2011, hundreds of individuals have suffered from Xarelto bleeding. The internal bleeding caused by this drug has been described as uncontrollable because there is no antidote that doctors can give patients to slow the bleeding. Instead, they must simply wait until the drug has left the patient’s system.
Janssen Pharmaceuticals allegedly failed to adequately warn not only about the Xarelto bleeding that could occur but also about the lack of antidote.
If a warfarin patient suffers from internal bleeding, there is an antidote that can be applied. Xarelto bleeding is believed to be considerably more dangerous because of the lack of antidote.
Janssen is currently working on an antidote, but it has not yet been approved by the Food and Drug Administration (FDA).
Xarelto Lawsuit
This Xarelto lawsuit included claims of wrongful death, strict product liability, negligence, defective design, manufacturing defect, failure to warn, breach of express and implied warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, loss of consortium, and more.
The Xarelto lawsuit suggested that Clara’s life could have been extended if not for Xarelto side effects. It has also been claimed that had Janssen Pharmaceuticals warned against the risk of Xarelto bleeding and the lack of antidote that many patients, including Clara, may not have taken that drug.
This Xarelto Lawsuit is Case No. 2:15-cv-01339 and is part of the Xarelto MDL: In Re: Xarelto (rivaroxaban) Products Liability Litigation MDL No. 2592, filed in the U.S. District Court of the Eastern District of Louisiana.
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As Xarelto MDL Grows, Study Suggests Link with Hemorrhage
Jul 28, 2015 | LawyersandSettlements.com
By Heidi Turner
Laguna Hills, CA: As the number of Xarelto lawsuits included in the multidistrict litigation grows, a new study has been published suggesting a link between the use of rivaroxaban (the generic of Xarelto) and spontaneous eye hemorrhage, also known as bleeding in the eye. Lawsuits have been filed against the makers of Xarelto, alleging patients were not adequately warned about the risks associated with taking the drug.
The most recent study was published June 25 in JAMA Ophthalmology. Researchers found a correlation between use of rivaroxaban and a risk of spontaneous vitreous hemorrhage, although they noted that all three patients who developed the eye hemorrhage were also taking an additional anticoagulant at the time.
“The risk of hemorrhage may be particularly elevated during the transition period when patients are switched from baseline anticoagulant to rivaroxaban therapy and are taking both anticoagulants simultaneously,” researchers wrote.
According to Reuters (6/26/15), all three patients who experienced vitreous hemorrhage were males over the age of 70 who experienced the hemorrhage in their right eye. All three were taking warfarin and rivaroxaban at the same time and all three discontinued the warfarin when the hemorrhage developed. All three recovered from the hemorrhage within two months of the event and did not suffer any significant vision damage.
Meanwhile, a study published in BMJ in April suggests patients who are treated with rivaroxaban could be at as much as double the risk of gastrointestinal bleeding compared with patients who take warfarin. Researchers noted that when they didn’t adjust for other factors, there was no statistically significant difference in the rate of bleeding between the two groups.
“Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out…a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.”
As lawsuits filed against the makers of Xarelto work their way through the courts, more lawsuits are being added to the multidistrict litigation. As of July 15, 2015, 805 lawsuits had been consolidated in MDL 2592 (In Re: Xarelto Products Liability Litigation) before US District Judge Eldon E. Fallon. In June there were 552 such lawsuits consolidated. Consolidation for pretrial proceedings is not a comment on the merits of the lawsuits, it is an acknowledgement that the lawsuits share similar questions of fact.
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Jul 28, 2015 | The Alamo Journal
Xarelto was first created by Bayer and Johnson & Johnson, and is an oral medication known as an anticoagulant, or a blood thinner. The difference between Xarelto and other blood thinners that are already on the market, is that Xarelto is a “one size fits all” pill. Unlike other blood thinner medications, the patient’s blood is monitored on a regular basis and given a dosage on how much their bodies can handle. They are also put on a rigorous diet, constantly watching what they eat because the blood thinner has an effect on the food one consumes. Xarelto on the other hand does the complete opposite. A person taking Xarelto does not need to have a routine check up to see if their blood is normal, their diet does not change, and the dosage is the same for every person young, old, male, or female. The same amount of dosage is prescribed which makes this medication extremely dangerous.
Many people who have taken Xarelto have experienced blood clotting, hemorrhaging, internal bleeding, and embolism. Even though Xarelto is supposed to prevent blood clots, it does the complete opposite. Many who have taken this medication post-surgery have experienced wound infections, leakage, and have to return to the hospital for more surgery to stop the bleeding. A woman filed a lawsuit against Bayer and Johnson & Johnson for compensation on behalf of her dead father. He had taken Xarelto for a month after his surgery, who then suffered serious bleeding in his brain.
The FDA approved Xarelto to only treat patients who had knee or hip replacement surgery to reduce blood clots, and reduce the risk of stroke. But then the medication was later approved, by the FDA, to treat deep vein thrombosis and pulmonary embolism. And in 2011, the New England Journal of Medicine published a study that compared Xarelto to Warfarin, a drug that has been used for over 50 years. Xarelto was more dangerous than warfarin because it causes more abdominal bleeding than warfarin, and warfarin has an antidote if severe bleeding does occur. Xarelto does not have an antidote, and 73% of the 16,041 participants who took one dose of Xarelto in a study had some sort of side effect with anemia and bleeding.
Many people who have taken Xarelto and have experienced severe bleeding, hemorrhaging, or any of the other side effects from this product have filed a claim against Bayer and Johnson & Johnson. Many people have suffered severe health problems and are seeking compensation. Here in Texas, the law offices of Bobby Garcia can offer free consultations, and won’t charge unless the case is won. Justice is sought for by not only the victims who have taken Xarelto, but by Bobby Garcia as well.
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Xarelto Dosing Under Scrutiny Amid Bleeding Concerns
Jul 29, 2015 | Top Class Actions
Xarelto, a new generation blood thinner, is currently under closer examination for its safety following numerous reports of serious side effects.
Upon its release to the market, experts claimed that Xarelto was superior to Coumadin (warfarin), the previous gold-standard of treatment for use as an anticoagulant. Manufacturers asserted the new drug’s advantages included its apparent safety and the ease of using less frequent blood monitoring as compared to the former drug option.
In a recent editorial in the Journal of the American Medical Association (JAMA), Dr. J Robert Powell questioned the safety of Xarelto and other new direct-acting oral anticoagualants (DAOCs), including Eliquis and Pradaxa. He noted that the current marketing of the newer drugs that highlights their safety and ease of use could actually be counterproductive in its efforts by potentially undermining patient safety.
Drug trials for newer generation blood thinners like Xarelto have been tainted with controversy. Pradaxa was the first of the DOACs to be approved after the RE-LY clinical trial. Some grave concerns emerged following the trial including the questioning of the trial’s accuracy, removed data suggesting that frequent monitoring could have prevented the risk of fatal bleeding complications, and the missing reports of bleeding events the manufacturer Boehringer Ingelheim Pharmaceuticals admitted to leaving out of the initial results.
According to Dr. Powell, information provided by Boehringer Ingelheim Pharmaceuticals after their initial clinical trial report suggested that dose individualization was just as effective for patients and could potentially lessen the adverse bleeding events and enhance safety for patients. Dr. Powell also advocated for more close blood monitoring of patients as a step in the right direction for improved patient outcome and protection from adverse drug effects.
Xarelto Internal Bleeding
Xarelto and its predecessor warfarin are used as blood thinning agents to prevent strokes caused by atrial fibrillation.
The most severe side effect reported from Xarelto and new-generation blood thinners is severe internal bleeding. While internal bleeding was also a concern for the older anticoagulant warfarin, there was an antidote to the blood-thinning effects of the drug.
Physicians are able to administer intravenous vitamin K along with fresh frozen plasma to stabilize warfarin-induced bleeding. Xarelto, however, has no effective reversal agent, so there is no way to quickly and safely stop the bleeding once it has started. Like Xarelto, the other new drugs Pradaxa and Eliquis also lack an effective antidote to bleeding complications as a result of their use.
Ongoing Safety Concerns for Xarelto and New Blood Thinners
Pradaxa was the first new anticoagulant to be approved for use as an alternative to warfarin, followed by Xarelto and Eliquis. In its first year of use, Pradaxa gained notoriety as a pharmaceutical laden with reports to the FDA regarding adverse effects. Affected consumers believed there were inadequate safety warnings on the new pharmaceutical’s lack of a reversal agent. Xarelto lawsuits regarding drug safety were subsequently filed, with manufacturer Boehringer Ingelheim Pharmaceuticals paying out $650 million in Xarelto lawsuit settlements in 2014.
While physicians and patients began questioning Pradaxa’s safety, Xarelto began to be prescribed more often in its place, and the drug exceeded sales of Pradaxa in 2013. However, with more widespread use of Xarelto came more adverse reactions reported on its use as well. Currently, Xarelto lawsuits are being filed against the drug’s manufacturers for also failing to have inadequate safety warnings.
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Study Raises Additional Concerns About Xarelto’s Use in Pregnant Women
Jul 30, 2015 | The Legal Examiner
By Roopal Luhana
The newer-generation anticoagulant Xarelto (rivaroxaban) has ended up in the news lately because of its connection to serious side effects like gastrointestinal bleeding, brain hemorrhaging, blood clots, and stroke.
A recent study, however, has now raised additional concerns that Xarelto may be dangerous when taken by pregnant women. Results showed evidence that the drug crosses the human placenta, where it could potentially affect the unborn child.
Study Finds Xarelto Crosses the Placenta
For the study, researchers from The Motherisk Program at the Hospital for Sick Children in Toronto used an ex-vivo placenta perfusion model, adding 250 ng/mL of rivaroxaban to the maternal or fetal circulation. They then measured concentrations of the drug using liquid chromatography-tandem mass spectrometry.
Results showed that “there was rapid transfer of rivaroxaban across the human placenta in both the maternal-to-fetal and fetal-to-maternal directions” after three hours. The concentrations of the drug remained relatively constant.
Researchers concluded that “rivaroxaban rapidly crosses the placental barrier via passive diffusion.” They added that since the drug is “highly bound” to blood proteins, the amount of unbound drug that may reach the actual fetus is “likely much lower.” They recommended additional safety studies be completed before administering Xarelto to pregnant women.
Xarelto Effects Irreversible
Currently, Xarelto pregnancy warnings advise women of reproductive age who require blood thinning medications to discuss with their doctors any plans for having a family. They note that there are no data on the drug in human pregnancy, and advise patients to use it “with caution in pregnancy because of the potential for pregnancy-related hemorrhage and/or emergent delivery with an anticoagulant that is not reversible.”
Indeed, this irreversibility of Xarelto’s blood-thinning effects has been at issue in litigation, with plaintiffs noting that the manufacturers Janssen Pharmaceuticals and Bayer AG failed to warn that Xarelto has no readily available antidote. Unlike warfarin, the leading anticoagulant for decades, which can be counteracted with injections of vitamin K, rivaroxaban has no such solution, making bleeding events much more dangerous and potentially deadly.
Because so many patients have filed complaints relating to their injuries caused by Xarelto, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal cases into one court in the Eastern District of Louisiana in December 2014. Currently, over 500 cases are pending in the MDL and the mass tort proceeding in Pennsylvania.
Xarelto Not Recommended in Pregnant Women
The FDA classifies Xarelto as pregnancy category C, which means that animal studies have shown the drug to have adverse effects on the fetus. So far, we have no well-controlled studies in humans, though this new study concerning the drug’s ability to cross the placenta raises additional concerns. Though the current drug warnings note that “potential benefits may warrant use of the drug in pregnant women despite potential risks,” this study suggests that the drug may be best limited only in women using adequate methods of contraception.
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The Sickening Side Effect of New Age Blood Thinner Marketing
Jul 29, 2015 | The Legal Examiner
By Angus Hinson
All you have to do is watch primetime television to recognize the fierce competition in the new age blood thinner industry. Bristol Myers Squib’s Eliqis® and Johnson & Johnson’s Xarelto® are dueling it out for market share supremacy in one of the largest pharmaceutical markets in America. It is estimated that Americans spend more than $10 billion per year on blood thinners, or anti-coagulants.
Coumadin®, generically known as Warfarin, still accounts for most prescription sales. However, there are a number of dietary restrictions that come along with taking Warfarin. Specifically, foods rich in vitamin K are to be limited. Why? Vitamin K serves as an antidote to Warfarin, meaning it reduces the anti-coagulant effect of the drug. That means your diet is limited in leafy, green vegetables, basically.
The new age blood thinners, namely Xarelto®, Eliquis®, and Pradaxa®, come without such prohibition against foods with vitamin K. In fact, if you pay close attention to the television ads they run, you will notice that people on the commercials are stuffing their faces with salads and other foods rich in Vitamin K.
The reason you are free to eat what you like on these new age blood thinners is that there is nothing that reduces the anti-coagulant effects of these prescription drugs. Did you catch what I just said? THERE IS NOTHING THAT REDUCES THEIR ANTI-COAGULANT EFFECT.
Suffer an internal bleeding event on Warfarin? Medical personnel can pump you full of vitamin K to stop the bleed.
Suffer an internal bleeding event on Xarelto®, Eliquis®, or Pradaxa®? There is nothing that counteracts the medicines to stop you from bleeding.
Despite the medicines hurting (and in some cases killing) thousands of people, Xarelto®, Eliquis®, or Pradaxa® continue to be some of the biggest marketing engines in the pharmaceutical industry. Their manufacturers know the winner of the new age blood thinner race stands to rope in billions of dollars in profits in the coming years. The biggest expense of these manufacturers is just the lives of the patients prescribed these drugs.
Sickening.
Thousands of people are coming forward with stories of uncontrollable bleeding while on Xarelto®, Eliquis®, or Pradaxa®. These people are not lawsuit happy types of people. They simply want the world to know that the dangers of these drugs are real. Our job, as lawyers representing people injured by dangerous medicines, is to broadcast these stories on behalf of these clients in hopes that others will not suffer the same injuries.
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