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XARELTO Media Monitoring – Week of 03-11-16

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Plaintiff Attorney Press Releases

Xarelto Lawsuit Plaintiffs Await Results Of European Regulators Investigation Of Drug’s Clinical Trial Results
Mar 4, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com reports on news from European Regulators, who have announced that they are conducting an investigation into the clinical trial results of new-generation blood-thinning drug, Xarelto. The investigation may have been spurred by recent lawsuit numbers, which are in the thousands, and have been filed against the manufacturers of Xarelto: Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson corporation). Plaintiffs involved in these mounting lawsuits commonly allege that use of the anticoagulant drug caused them spontaneous and dangerous bleeding episodes, and that it puts all patients at increased risk for these occurrences.
Xarelto Lawsuit Plaintiff Claims Studies On Anticoagulant Were Unreliable And Improperly Managed
Mar 4, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com reports on another lawsuit which has been filed against the manufacturers of anticoagulant drug Xarelto: Bayer Healthcare and Janssen Pharmaceuticals (a subdivision of Johnson & Johnson corporation). The lawsuit plaintiff claims that the defendants failed to adequately warn potential patients of the substantial bleeding complications now linked to their drug, and that drug studies published in medical journals and claims used in advertisements were both unreliable and improperly managed. The complaint was filed under case number 2:15-cv-04273 in the United States District Court for the Eastern District of Louisiana.
NJ Resident Files Xarelto Lawsuit Claiming Drug Caused Nearly Fatal Gastrointestinal Bleed
Mar 7, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com reports on another lawsuit filed against Xarelto manufacturers Bayer AG and Janssen Pharmaceuticals claiming adverse events related to the drug. This complaint was filed on November 23rd, 2015 by a New Jersey resident who claims that Bayer and Janssen have failed to adequately warn consumers about potentially severe health risks linked to the use of the anticoagulant.
Plaintiff In Xarelto Lawsuit Seeks $4.35 Million Compensation For Alleged Sudden Bleeding Episode
Mar 9, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com announces the details of another Xarelto-based lawsuit which was filed against pharmaceutical manufacturers Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson), in addition to several other defendants. The lawsuit discusses new-generation anticoagulant drug Xarelto, and potentially dangerous side effects. Allegations made by the plaintiff within the complaint indicate that the blood-thinning drug caused him to suffer from a sudden and dangerous bleeding episode. After its initial filing, the complaint was transferred with all federally-filed Xarelto lawsuits by the U.S. Judicial Panel on Multidistrict Litigation. This consolidation placed more than 2,800 cases in a single court to fast track the litigation. Cases are now a part of MDL No. 2592 in New Orleans, Louisiana. The Honorable Judge Eldon E. Fallon is presiding over all involved cases.
Xarelto Lawsuit Plaintiffs Now Number Over 3,300 Within Just Five Years Time
Mar 9, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com reports on an overview of the now more than 3,300 Xarelto lawsuits which have been filed since 2011 alone. The U.S. Food and Drug Administration approved the new-generation, blood-thinning drug in 2011 to treat patients recovering from hip and knee replacement surgeries, suffering from deep vein thrombosis and pulmonary embolism, or atrial fibrillation. The drug was long-awaited and launched onto the market as a revolutionary new anticoagulant which provided those requiring the use of blood thinners with new freedoms that traditional blood thinners hadn’t offered.
Pradaxa Lawsuit Results Encourage Plaintiffs Involved In Current Xarelto Lawsuits
Mar 10, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com reports on signficant parallels discovered between Xarelto and Pradaxa lawsuits, which now provide Xarelto lawsuit plaintiffs with some comfort as they look ahead to 2017 bellwether trials. Xarelto lawsuit numbers continue to increase on a regular basis. Lawsuits which have been federally filed were consolidated by the U.S. Judicial Panel on Multidistrict Litigation to form MDL No. 2592. These cases now number over 2,800. In addition, another group of more than 600 cases have been consolidated in Philadelphia, Pennsylvania by the Court of Common Pleas to form a mass tort.
Xarelto Lawsuit Plaintiffs Make Note Of BMJ Study Results Showing Possible Twofold Increased Risk Of GI Bleeds
Mar 10, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com reports on several studies from the spring and summer of 2015 which appear to have linked anticoagulant drug Xarelto to the increased risk for the occurrence of dangerous bleeding events, such as eye and gastrointestinal bleeds. As Xarelto continues to stir up new controversies across the United States, and Xarelto lawsuit numbers continue to increase, public attention has turned to multidistrict litigation number 2592 which was created by the U.S. Judicial Panel on Multidistrict Litigation and involves more than 2,800 Xarelto lawsuits. All of the recent attention on the drug and its FDA approval has many consumers discussing its potentially serious side effects. Plaintiffs who have currently filed Xarelto lawsuits have gained some support in their arguments thanks to several 2015 studies which highlight potentially concerning new information.
Pradaxa Lawsuit Results Encourage Plaintiffs Involved In Current Xarelto Lawsuits
Mar 10, 2016 | Blood Thinner Help
By Joseph Osborne

BloodThinnerHelp.com reports on signficant parallels discovered between Xarelto and Pradaxa lawsuits, which now provide Xarelto lawsuit plaintiffs with some comfort as they look ahead to 2017 bellwether trials. Xarelto lawsuit numbers continue to increase on a regular basis. Lawsuits which have been federally filed were consolidated by the U.S. Judicial Panel on Multidistrict Litigation to form MDL No. 2592. These cases now number over 2,800. In addition, another group of more than 600 cases have been consolidated in Philadelphia, Pennsylvania by the Court of Common Pleas to form a mass tort.

Plaintiff Attorney Blog Posts

Xarelto Lawsuit
Mar 3, 2016 | Ken Nunn Law Office

The blood-thinning drug Xarelto has been linked to causing internal bleeding and strokes. If you or a loved one has taken Xarelto and suffered from these potentially grave side effects, don’t hesitate. Call Ken Nunn today to get the legal help you need to recover the compensation you deserve from taking this bad drug.
Xarelto Lawsuit: Blood Thinner Caused Gastrointestinal Bleeding
Mar 4, 2016 | Top Class Actions
By Paul Tassin

A woman from North Carolina added her Xarelto lawsuit to multidistrict litigation currently underway in a Louisiana federal court. Plaintiff Tandy B. says she was prescribed Xarelto in October 2014 and suffered bleeding in gastrointestinal tract soon thereafter in November 2014.
Duke Researchers Omit Xarelto Data Published to The NEJM
Mar 4, 2016 | Legal Reader
By Eric Needs

Duke researchers omit Xarelto data published to the NEJM, and Pharmaceutical companies Bayer and Johnson & Johnson, marketers of Xarelto, the blockbuster blood-thinner that grossed nearly $2 billion in 2015, are being accused of deceiving the leading medical journal, whose assessment may have been crucial in determining the drug’s safety, which so far has been responsible for over 5,000 lawsuits and approximately 500 deaths.
Xarelto Lawsuit Report: Legal Brief Contends Xarelto’s Makers Misled Medical Journal Editors
Mar 5, 2016 | Alsonso Krangle LLP

Xarelto Lawsuit Information: A legal brief filed in a federal Xarelto lawsuit accuses Bayer and Johnson & Johnson of misleading editors of an international medical journal by withholding important laboratory data obtained during the clinical trial of the blockbuster blood thinner, according to The New York Times.
Arizona Xarelto Injury Lawsuit Filed For Hemorrhagic Pericardial Effusion
Mar 5, 2016 | The Legal Examiner
By Shezad Malik MD JD

An Arizonan woman, Margaret Garvy, recently filed a product liability and personal injury lawsuit alleging that side effects of Xarelto caused her to suffer a life threatening hemorrhagic pericardial effusion. Hemorrhagic pericardial effusion, is a serious medical condition where the sac around the heart is filled with blood, preventing the normal contractions of the heart and if left untreated can be deadly.
Information on Xarelto stroke lawsuit
Mar 5, 2016 | Tibet Center Chicago

There are many people who are spending their money in getting treatments to their health issues. There are many people who are facing many problems due to these advanced treatments. There are many people who are trying to solve these problems but they are not getting good results. In addition to that most of these modern people are trying to solve their health issues with help of artificial medicines. There are many side effects that people get with help of these artificial medications. Therefore it is important that people should select best and safe medicines. Xarelto is a medicine which is saving people at rate of their life. That means there is no doubt that people can get rid of their major health problems with help of this medicine.
Some Interesting Revelations Associated with Xarelto Side Effects Concerns
Mar 7, 2016 | LawyersandSettlements.com
By Gordon Gibb

Plaintiffs having filed a Xarelto lawsuit on behalf of themselves or family members whose health may have been compromised by the blockbuster drug, may have been handed a new angle against an anticoagulant that in five years has risen to the top of the blood thinner mountain in spite of criticisms, including lack of an antidote.
Did Xarelto Makers Withhold Data from Medical Journal?
Mar 7, 2016 | Green, Schafle & Gibbs

Almost everyone has heard of the prescription blood thinner, Xarelto; however, most people have not heard about the lawsuits being filed against the two companies that produce Xarelto. A footnote in a recently filed legal briefing claims that the companies, Johnson & Johnson and Bayer, withheld information from researchers in relation to a letter published in the New England Journal of Medicine about the effects of Xarelto.
Potentially Faulty Xarelto Study Data Hid By J&J, Bayer: Report
Mar 7, 2016 | AboutLawsuits.com
By Irvin Jackson

According to documents produced during the discovery process in lawsuits filed over the side effects of Xarelto, reports suggest that a major medical journal was misled about the existence of data that may have made it clear whether controversial clinical trial results were accurate.
Is Xarelto Safe? - Critics Demand an Independent Investigation
Mar 7, 2016 | Glodwater Law Firm

Xarelto, a new type of anticoagulant (blood thinner), was developed as a more convenient alternative to Coumadin, a blood thinner containing warfarin. Also known as rivaroxaban, Xarelto received FDA approval in 2011. However, many patients taking the medication soon began experiencing severe side effects, primarily uncontrolled bleeding. Recent reports indicate that a device used to measure bleeding complications during Xarelto’s clinical trials may have been defective.

Full Text of Stories Below

Client Attorney Privileged/Attorney Work Product/At Request of Counsel

Plaintiff Attorney Press Releases

Xarelto Lawsuit Plaintiffs Await Results Of European Regulators Investigation Of Drug’s Clinical Trial Results

Mar 4, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com reports on news from European Regulators, who have announced that they are conducting an investigation into the clinical trial results of new-generation blood-thinning drug, Xarelto. The investigation may have been spurred by recent lawsuit numbers, which are in the thousands, and have been filed against the manufacturers of Xarelto: Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson corporation). Plaintiffs involved in these mounting lawsuits commonly allege that use of the anticoagulant drug caused them spontaneous and dangerous bleeding episodes, and that it puts all patients at increased risk for these occurrences.
The clinical trial which is the subject of this investigation was conducted at the Duke Institute for Clinical Research. Project on Government Oversight reports note that the official who issued the U.S. Food and Drug Administration’s (FDA) approval of Xarelto in 2011 had additionally expressed concerns regarding the drug. In a statement released by POGO, they noted that “The FDA approved Xarelto in 2011 over the objections of the primary FDA scientists assigned to study its safety and effectiveness. The report by the reviewers argued that patients could be ‘at greater risk of harm from stroke and/or bleeding’ if they took Xarelto than if they were treated skillfully with Warfarin, a blood thinner that has been on the market since the 1950’s.”
In addition, the POGO article stated, “The official who issued the FDA’s decision to approve the drug expressed a series of misgivings about it.” It was noted that this particular official, FDA Deputy Division Director Stephen M. Grant stated, “The decision was made difficult by the limitations in the design and conduct” of Xarelto clinical trials, and that this statement was written in a November 2011 memo.
Today, Xarelto is the topic of over 3,300 lawsuits filed both in a federal court in the Eastern District of Louisiana, and in Philadelphia, Pennsylvania. The Louisiana federally-filed cases are being presided over by Judge Eldon Fallon, and continue to grow in number as they await further preparations for trial. These lawsuits have been consolidated by the U.S. Judicial Panel for Multidistrict Litigation to form MDL No. 2592. The Philadelphia lawsuits were consolidated by the Court of Common Pleas to form a mass tort group. Xarelto has additionally received two ‘black box’ warnings from the FDA. These types of warnings are the most serious warnings possible for a product to receive before being fully removed from the market.
AllGov.org further discussed the EMA’s clinical trial investigation, noting, “The clinical trial relied on blood testing devices that were the subject of two FDA warning letters before the trial began and an FDA recall notice after the trial ended, according to the Project on Government Oversight (POGO). Certain devices in the INRatio product line, the warning notice read, could deliver false test results and that use of those devices may “cause severe or life-threatening injuries, including death.”
The most recent reports on the investigation indicate that the EMA “is currently investigating whether the data generated from the INRatio device could have had any impact on the trial results and the extent of this impact, if applicable.” POGO additionally reported that an FDA staff review of Xarelto clinical trials noted that results appeared to be biased in Xarelto’s favor. As investigations regarding these details progress further, lawsuits filed against Xarelto manufacturers Bayer AG and Janssen Pharmaceuticals continue to appear from across the country.
At this time as well, Attorney Joseph Osborne is working to help ensure that anyone who used Xarelto and believes that they were negatively affected by the drug will be given the important opportunity of investigating their legal rights in full. It is likely that patients who have used Xarelto and have also suffered from dangerous side effects could be entitled to substantial compensation. To help those deserving seek justice, Attorney Osborne is offering complimentary Xarelto consultations to affected parties at this time.
To learn more about Xarelto lawsuits, or to ask questions, contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.digitaljournal.com/pr/2859610#ixzz42bnzpGsX

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Xarelto Lawsuit Plaintiff Claims Studies On Anticoagulant Were Unreliable And Improperly Managed

Mar 4, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com reports on another lawsuit which has been filed against the manufacturers of anticoagulant drug Xarelto: Bayer Healthcare and Janssen Pharmaceuticals (a subdivision of Johnson & Johnson corporation). The lawsuit plaintiff claims that the defendants failed to adequately warn potential patients of the substantial bleeding complications now linked to their drug, and that drug studies published in medical journals and claims used in advertisements were both unreliable and improperly managed. The complaint was filed under case number 2:15-cv-04273 in the United States District Court for the Eastern District of Louisiana.
When it was released as a new-generation anticoagulant, Xarelto was considered quite revolutionary. But reports of patients who took Xarelto and suffered sudden bleeding episodes quickly began to surface, and, as lawsuits filed against the drug have recently reached thousands in number, the public’s stance on the medication is likely changing.
The U.S. Food and Drug Administration approved Xarelto to treat atrial fibrillation, pulmonary embolism, and deep vein thrombosis, as well as patients recovering from knee and hip replacement surgeries. The drug’s intended use is to help prevent the risk of occurrences of blood clots and stroke. The lawsuit also noted that among medical journals from across the country, Xarelto is the most widely advertised blood thinner; journals which are used to keep the medical community abreast of medical advancements and new trends.
The plaintiffs filing this lawsuit now accuse defendants of focusing solely on the positive aspects of Xarelto through both advertisements and studies discussed with the public. The plaintiffs allege, however, that they concealed significant dangers which have been linked to the drug, including potential death due to significant blood loss. There are currently multiple plaintiffs involved in Xarelto lawsuits who have filed on behalf of loved ones who have passed away due to significant bleeding episodes while using the drug. Plaintiffs draw attention to the fact that, across both the U.S. and Germany, there have now been thousands of “adverse events” reported from patients taking Xarelto which have been linked to the drug.
Xarelto lawsuit cases now number over 2,800 federally-filed cases which have been consolidated in Eastern Louisiana. They were consolidated by the United States JPML to form MDL No. 2592, and are being overseen by theHonorable Judge Eldon Fallon. As the involved plaintiffs await further trial preparations, many believe that Xarelto lawsuit numbers will continue to grow.
Attorney Joseph Osborne is now helping to ensure that anyone who believes they were negatively affected by Xarelto will be provided the important opportunity of investigating their legal rights in full. These individuals may be entitled to legal action and substantial compensation. Patients who are looking to seek justice are offered complimentary legal consultations at this time.
To ask questions or request additional information on Xarelto bleeding lawsuits, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
https://www.pressadvantage.com/story/8517-xarelto-lawsuit-plaintiff-claims-studies-on-anticoagulant-were-unreliable-and-improperly-managed

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NJ Resident Files Xarelto Lawsuit Claiming Drug Caused Nearly Fatal Gastrointestinal Bleed

Mar 7, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com reports on another lawsuit filed against Xarelto manufacturers Bayer AG and Janssen Pharmaceuticals claiming adverse events related to the drug. This complaint was filed on November 23rd, 2015 by a New Jersey resident who claims that Bayer and Janssen have failed to adequately warn consumers about potentially severe health risks linked to the use of the anticoagulant.
The lawsuit is now listed under case number 2:15-cv-06264 in the U.S. District Court for the Eastern District of Louisiana, where all federally-filed Xarelto lawsuits have been transferred by the U.S. Judicial Panel on Multidistrict Litigation to form MDL No. 2592. Here, more than 2,800 cases are being presided over by Judge Eldon Fallon. They contain strikingly similar allegations against Xarelto and its manufacturers from plaintiffs from across the United States.
Further details of this specific lawsuit found within court documents indicate that after only six months of taking Xarelto, the plaintiff suddenly suffered from what physicians considered a life-threatening gastrointestinal bleed. Because of this bleeding episode, the plaintiff now claims that he will suffer from long-term health problems, and will, therefore, have years of medical bills ahead of him as well. He is filing to obtain financial assistance for these mounting bills, which he says will likely continue into his distant future.
These 2,800 Xarelto lawsuits are not the only ones, however. In Philadelphia, Pennsylvania, another mass tort group has been formed of more than 550 lawsuits by the Court of Common Pleas. The plaintiffs involved in these lawsuits share the same allegations as well, mainly claiming that anticoagulant drug Xarelto can cause sudden and dangerous bleeding episodes and serious, lasting side effects. Some have filed suits on behalf of loved ones who have actually passed away due to the extent of their bleeding episodes. Plaintiffs claim that manufacturers showed reckless negligence by initially releasing the blood thinner to market for consumer use without any accompanying antidote for emergency bleeding situations, as other traditional blood thinners offered.
Attorney Joseph Osborne has watched as Xarelto lawsuit case numbers continue to increase and is now working to ensure that everyone who feels that their health has been adversely affected by the blood thinner will be provided the important opportunity of investigating their legal rights in full. These individuals may be entitled to legal action and substantial compensation. To help those most deserving pursue justice, Attorney Osborne is offering free Xarelto consultations for qualified individuals at this time.
To ask questions or request additional Xarelto information, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.digitaljournal.com/pr/2861331#ixzz42boHafpJ

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Plaintiff In Xarelto Lawsuit Seeks $4.35 Million Compensation For Alleged Sudden Bleeding Episode

Mar 9, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com announces the details of another Xarelto-based lawsuit which was filed against pharmaceutical manufacturers Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson), in addition to several other defendants. The lawsuit discusses new-generation anticoagulant drug Xarelto, and potentially dangerous side effects. Allegations made by the plaintiff within the complaint indicate that the blood-thinning drug caused him to suffer from a sudden and dangerous bleeding episode. After its initial filing, the complaint was transferred with all federally-filed Xarelto lawsuits by the U.S. Judicial Panel on Multidistrict Litigation. This consolidation placed more than 2,800 cases in a single court to fast track the litigation. Cases are now a part of MDL No. 2592 in New Orleans, Louisiana. The Honorable Judge Eldon E. Fallon is presiding over all involved cases.
This lawsuit is sure to stand out, even among 2,800 others, due to the fact that it involves 90-counts. In addition, the filing plaintiff has requested a large sum of $4.35 million in compensation. He claims that defendants Bayer AG and Janssen (Johnson & Johnson) marketed Xarelto in misleading ways in order to display it as a safe and effective treatment for patients, and also failed to adequately discuss potential dangerous side effects linked to the drug.
In further details of the suit, the plaintiff also claims that manufacturers were likely aware that the anticoagulant may cause increased bleeding risks for patients taking it. Results from several clinical studies completed on the drug, and also several medical studies conducted on it seem to lend support to this argument. The plaintiff stated, “Defendants use the results of the Rocket AF study, the Record studies, and the Einstein studies to promote Xarelto in their promotional materials, including the Xarelto website, which tout the positive results of those studies. However, defendants’ promotional materials fail to similarly highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion among other serious bleeding concerns.”
Previous reports have indicated that Xarelto manufacturers likely spent more than $11 million to promote Xarelto with detailed advertisements, many of which utilized the endorsements of famous sports icons and celebrities. The ads brought in an estimated $582 million in revenue through Xarelto sales during the drug’s first year on the market alone.
Attorney Joseph Osborne is working to help ensure that everyone who believes they may have suffered health problems from using Xarelto will be given the important opportunity to fully investigate their legal rights. These patients and their families may be entitled to significant compensation. To better assist those looking to pursue justice, Attorney Osborne is currently offering complimentary Xarelto consultations for those who qualify.
To request more Xarelto bleeding lawsuit information, or to ask questions, please contact Attorney Osborne by calling (866) 425-8902.
http://www.cbs19.tv/story/31431688/plaintiff-in-xarelto-lawsuit-seeks-435-million-compensation-for-alleged-sudden-bleeding-episode

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Xarelto Lawsuit Plaintiffs Now Number Over 3,300 Within Just Five Years Time

Mar 9, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com reports on an overview of the now more than 3,300 Xarelto lawsuits which have been filed since 2011 alone. The U.S. Food and Drug Administration approved the new-generation, blood-thinning drug in 2011 to treat patients recovering from hip and knee replacement surgeries, suffering from deep vein thrombosis and pulmonary embolism, or atrial fibrillation. The drug was long-awaited and launched onto the market as a revolutionary new anticoagulant which provided those requiring the use of blood thinners with new freedoms that traditional blood thinners hadn’t offered.
Since that time, however, more than 3,300 Xarelto lawsuits have been filed by plaintiffs from across the nation, alleging that the drug poses significant risks to users; most notably sudden bleeding episodes. The lawsuits filed have been consolidated into two major groups. In the Eastern District of Louisiana, the U.S. Judicial Panel on Multidistrict Consolidation transferred federally-filed Xarelto cases to one court. Here they have become MDL No. 2592, and are being overseen by the Honorable Judge Eldon Fallon. These cases number over 2,800 at this time, and are joined by more than 600 others which were consolidated in Philadelphia, Pennsylvania to form a mass tort group by the Court of Common Pleas.
Xarelto lawsuits in MDL 2592 are scheduled for bellwether trials, which are said to take place near the beginning of 2017. At this time, bellwether trial dates have been set for February 6, April 24, and May 30 of 2017. Plaintiffs involved in all of the Xarelto lawsuits share strikingly similar allegations and have filed their complaints against the same defendants: Xarelto manufacturers Bayer AG and Janssen Pharmaceuticals (a division of corporate giant Johnson & Johnson).
Recently, Xarelto has been the subject of even more controversy, however, as the European Regulators announced that they would be conducting an investigation into faulty testing equipment used during clinical trials on the drug, which may have led to its premature FDA approval. In addition, many are currently questioning whether manufacturers left out important information during the FDA approval process; some allege that this information was purposefully excluded.
As Xarelto lawsuit numbers continue to grow and additional investigations are done regarding the drug, Attorney Joseph Osborne is working to help ensure that anyone who feels they may have been harmed by the drug will also be given the important opportunity of exploring their legal rights in full. These individuals and their families may be entitled to legal action and substantial compensation. To better assist those wishing to pursue justice, Attorney Osborne is offering free legal consultations at this time for affected parties.
To ask questions or request additional Xarelto lawsuit information, please contact Attorney Osborne by calling (866) 425-8902.
http://www.cbs19.tv/story/31431686/xarelto-lawsuit-plaintiffs-now-number-over-3300-within-just-five-years-time

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Pradaxa Lawsuit Results Encourage Plaintiffs Involved In Current Xarelto Lawsuits

Mar 10, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com reports on signficant parallels discovered between Xarelto and Pradaxa lawsuits, which now provide Xarelto lawsuit plaintiffs with some comfort as they look ahead to 2017 bellwether trials. Xarelto lawsuit numbers continue to increase on a regular basis. Lawsuits which have been federally filed were consolidated by the U.S. Judicial Panel on Multidistrict Litigation to form MDL No. 2592. These cases now number over 2,800. In addition, another group of more than 600 cases have been consolidated in Philadelphia, Pennsylvania by the Court of Common Pleas to form a mass tort.
Xarelto lawsuits consolidated in the MDL are being overseen in Eastern Louisiana by the Honorable Judge Eldon Fallon. They have all similarly been filed against defendants Bayer AG and Janssen Pharmaceuticals, (a subdivision of Johnson & Johnson corporation), and all plaintiffs filing allege strikingly similar complaints regarding the potential dangers of the drug.
Xarelto is a new-generation blood thinner which was initially released to market without a corresponding antidote. The drug was approved by the U.S. Food and Drug Administration to treat patients who are recovering from knee and hip replacement surgeries, deep vein thrombosis, pulmonary embolism, or atrial fibrillation. It helps to reduce the risk of blood clot formations and strokes in these patients.
Pradaxa is a similar new-generation blood thinner. This drug, however, was marketed by Boehringer Ingelheim in October of 2010. Similarly to Xarelto, it did not take long after its initial market release for the anticoagulant to be surrounded by more than 3,500 adverse event reports. Over 750 of these FDA adverse event reports described fatalities experienced by Pradaxa patients. After only a short time, Pradaxa was the topic of more than 4,000 lawsuits, and plaintiffs involved were anxiously awaiting trial. Instead, however, the evening before the trial was set to begin, defendant Boehringer Ingelheim settled the lawsuits by agreeing to pay $650 million to affected plaintiffs.
Current Xarelto lawsuit plaintiffs look to this occurrence and find hope that their current pursuits will bring them some justice as their cases get closer to trial dates. At this time, Xarelto plaintiffs have heard no talks of settlement from Bayer or Janssen, although controversies surrounding the companies, Xarelto, and the FDA approval process of the drug continue to surge.
Attorney Joseph Osborne is now working to ensure that everyone who feels that they were negatively affected after using Xarelto will be provided the important opportunity of exploring their legal rights. He believes that other plaintiffs will be able to join the current MDL as the cases await further legal proceedings. Patients affected may be entitled to legal action and substantial compensation. In order to help those deserving pursue justice, Attorney Osborne is currently offering free legal consultations for affected parties.
To ask questions about Xarelto or request further information, please contact Attorney Joseph Osborne by calling (866) 425-8902.
http://www.kusi.com/story/31442956/pradaxa-lawsuit-results-encourage-plaintiffs-involved-in-current-xarelto-lawsuits

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Xarelto Lawsuit Plaintiffs Make Note Of BMJ Study Results Showing Possible Twofold Increased Risk Of GI Bleeds

Mar 10, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com reports on several studies from the spring and summer of 2015 which appear to have linked anticoagulant drug Xarelto to the increased risk for the occurrence of dangerous bleeding events, such as eye and gastrointestinal bleeds. As Xarelto continues to stir up new controversies across the United States, and Xarelto lawsuit numbers continue to increase, public attention has turned to multidistrict litigation number 2592 which was created by the U.S. Judicial Panel on Multidistrict Litigation and involves more than 2,800 Xarelto lawsuits. All of the recent attention on the drug and its FDA approval has many consumers discussing its potentially serious side effects. Plaintiffs who have currently filed Xarelto lawsuits have gained some support in their arguments thanks to several 2015 studies which highlight potentially concerning new information.
Xarelto is a new-generation blood thinner which was approved by the FDA to treat patients recovering from hip and knee replacement surgeries, those with deep vein thrombosis or pulmonary embolism, and those with atrial fibrillation. The drug was wildly popular when it launched onto the market, and has since generated billions of dollars worth of sales for manufacturers Bayer AG and Janssen Pharmaceuticals (a division of Johnson & Johnson corporation).
A recent study published by JAMA Ophthalmology on June 25, 2015, indicated that researchers had discovered a possible link between the use of rivaroxaban (generic Xarelto) and an elevated risk for the occurrence of spontaneous vitreous hemorrhage, which is an eye bleed that occurs between the lens and retina. After the study, researchers concluded, “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.”
An additional study conducted just before the JAMA one also threw up some red flags for patients. This study was published in BMJ’s April 2015 issue, and it noted that patients treated with Xarelto (rivaroxaban) may be at almost two times the risk to suffer from gastrointestinal bleeding events as those who instead use warfarin (a traditional blood thinner). These researchers were quoted as stating, “…we cannot rule out…a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin.”
Attorney Joseph Osborne believes that as these cases await 2017 bellwether trials, other cases will continue to be able to join them in the MDL. He is working to assist anyone who has used Xarelto and suffered from health problems that they believe the drug has caused. These patients may be entitled to substantial compensation. To better help those looking to pursue justice, Attorney Osborne is currently offering free legal consultations for qualified parties.
To request more information on Xarelto lawsuits, or to ask questions, please contact attorney Joseph Osborne by calling (866) 425-8902.
http://www.fox8live.com/story/31442966/xarelto-lawsuit-plaintiffs-make-note-of-bmj-study-results-showing-possible-twofold-increased-risk-of-gi-bleeds

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Pradaxa Lawsuit Results Encourage Plaintiffs Involved In Current Xarelto Lawsuits

Mar 10, 2016 | Blood Thinner Help

By Joseph Osborne

BloodThinnerHelp.com reports on signficant parallels discovered between Xarelto and Pradaxa lawsuits, which now provide Xarelto lawsuit plaintiffs with some comfort as they look ahead to 2017 bellwether trials. Xarelto lawsuit numbers continue to increase on a regular basis. Lawsuits which have been federally filed were consolidated by the U.S. Judicial Panel on Multidistrict Litigation to form MDL No. 2592. These cases now number over 2,800. In addition, another group of more than 600 cases have been consolidated in Philadelphia, Pennsylvania by the Court of Common Pleas to form a mass tort.
Xarelto lawsuits consolidated in the MDL are being overseen in Eastern Louisiana by the Honorable Judge Eldon Fallon. They have all similarly been filed against defendants Bayer AG and Janssen Pharmaceuticals, (a subdivision of Johnson & Johnson corporation), and all plaintiffs filing allege strikingly similar complaints regarding the potential dangers of the drug.
Xarelto is a new-generation blood thinner which was initially released to market without a corresponding antidote. The drug was approved by the U.S. Food and Drug Administration to treat patients who are recovering from knee and hip replacement surgeries, deep vein thrombosis, pulmonary embolism, or atrial fibrillation. It helps to reduce the risk of blood clot formations and strokes in these patients.
Pradaxa is a similar new-generation blood thinner. This drug, however, was marketed by Boehringer Ingelheim in October of 2010. Similarly to Xarelto, it did not take long after its initial market release for the anticoagulant to be surrounded by more than 3,500 adverse event reports. Over 750 of these FDA adverse event reports described fatalities experienced by Pradaxa patients. After only a short time, Pradaxa was the topic of more than 4,000 lawsuits, and plaintiffs involved were anxiously awaiting trial. Instead, however, the evening before the trial was set to begin, defendant Boehringer Ingelheim settled the lawsuits by agreeing to pay $650 million to affected plaintiffs.
Current Xarelto lawsuit plaintiffs look to this occurrence and find hope that their current pursuits will bring them some justice as their cases get closer to trial dates. At this time, Xarelto plaintiffs have heard no talks of settlement from Bayer or Janssen, although controversies surrounding the companies, Xarelto, and the FDA approval process of the drug continue to surge.
Attorney Joseph Osborne is now working to ensure that everyone who feels that they were negatively affected after using Xarelto will be provided the important opportunity of exploring their legal rights. He believes that other plaintiffs will be able to join the current MDL as the cases await further legal proceedings. Patients affected may be entitled to legal action and substantial compensation. In order to help those deserving pursue justice, Attorney Osborne is currently offering free legal consultations for affected parties.
To ask questions about Xarelto or request further information, please contact Attorney Joseph Osborne by calling (866) 425-8902.
http://www.digitaljournal.com/pr/2866288#ixzz42boaRNIw

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Plaintiff Attorney Blog Posts

Xarelto Lawsuit

Mar 3, 2016 | Ken Nunn Law Office

e blood-thinning drug Xarelto has been linked to causing internal bleeding and strokes. If you or a loved one has taken Xarelto and suffered from these potentially grave side effects, don’t hesitate. Call Ken Nunn today to get the legal help you need to recover the compensation you deserve from taking this bad drug.Getting You Fair Compensation for Your Xarelto Lawsuit Is Important to Us.
Ken Nunn has been practicing law in Indiana since 1967 and has extensive experience advocating for those suffering the ill-effects of taking bad medications. He is dedicated to getting you every penny you deserve from your Xarelto lawsuit. If you think you’ve been injured from taking this medication, call 1-800-CALL-KEN now or fill out our information form to the right of this page. Your information will be put in front of a lawyer as soon as possible and you can be on your way to finally having peace of mind.
http://kennunn.com/xarelto-lawsuit/

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Xarelto Lawsuit: Blood Thinner Caused Gastrointestinal Bleeding

Mar 4, 2016 | Top Class Actions

By Paul Tassin

A woman from North Carolina added her Xarelto lawsuit to multidistrict litigation currently underway in a Louisiana federal court.
Plaintiff Tandy B. says she was prescribed Xarelto in October 2014 and suffered bleeding in gastrointestinal tract soon thereafter in November 2014.
She now argues her injuries could have been avoided had manufacturer Janssen Pharmaceuticals given a proper warning about the risk of Xarelto bleeding.
According to this blood thinner lawsuit, Xarelto is one of a group of drugs called New Oral Anticoagulants, or NOACs. These drugs entered the market a few years ago as alternatives to warfarin (also known by the brand name Coumadin), which had a decades-long reputation as an established anticoagulant drug.
All of these anticoagulants have found FDA-approved application as preventatives of stroke and systolic embolism in patients with non-valvular atrial fibrillation.
Tandy says that defendants Janssen, Bayer Pharmaceuticals, and Johnson & Johnson over-promoted Xarelto. She says the defendants marketed the drug as being suitable for single daily dosing and as not requiring regular blood testing and dosage adjustment that warfarin requires. These purported advantages were referred to as the “Xarelto Difference,” she says.
But Tandy’s Xarelto lawsuit alleges data from clinical trials calls the safety of the Xarelto Difference into question. She notes that during the FDA approval process, reviewers questioned the safety of once-daily dosing for Xarelto. The reviewers referred to clinical data showing peaks and dips in Xarelto blood levels that they said could have been avoided by using twice-daily dosing.
FDA reviewers also recommended dosage monitoring for Xarelto patients, but the defendants chose not to use that information, Tandy says.
Tandy also cited clinical data that showed an increased risk of bleeding in gastrointestinal tract in patients who took Xarelto. She points to the results of the ROCKET AF study, which found that compared to patients taking warfarin, those who took Xarelto had more frequent instances of gastrointestinal bleeding, bleeding that caused a drop in hemoglobin, and bleeding that required transfusion.
The Xarelto MDL
This blood thinner lawsuit is filed as part of a multidistrict litigation, or MDL, that puts thousands of similar claims under the supervision of a single court. Many plaintiffs like Tandy are claiming Xarelto caused dangerous bleeding in gastrointestinal tract. Some plaintiffs in the MDL are the relatives of persons who died from their bleeding following Xarelto treatment.
The court is in the process of selecting the first few of these thousands of blood thinner lawsuits to go to trial. Judge Eldon E. Fallon has asked each side to choose 10 representative cases each, which the court will then combine with 20 cases of its own selection to make a pool of 40 so-called “bellwether” cases.
While the outcomes of these cases are not binding on the other cases, it should promote settlement of those remaining cases by giving the parties an idea of how a jury will receive the evidence and arguments. Trial in these first Xarelto lawsuits is expected to start in 2017.
The Xarelto Lawsuit is Case No. 2:15-cv-04273 and is filed as part of the Xarelto MDL No. 2592 in the U.S. District Court for the Eastern District of Louisiana.

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Duke Researchers Omit Xarelto Data Published to The NEJM

Mar 4, 2016 | Legal Reader

By Eric Needs

Duke researchers omit Xarelto data published to the NEJM, and Pharmaceutical companies Bayer and Johnson & Johnson, marketers of Xarelto, the blockbuster blood-thinner that grossed nearly $2 billion in 2015, are being accused of deceiving the leading medical journal, whose assessment may have been crucial in determining the drug’s safety, which so far has been responsible for over 5,000 lawsuits and approximately 500 deaths.
The research data, published in the New England Journal of Medicine, was written by Duke researchers hired by Bayer and Johnson & Johnson to conduct a three-year clinical trial for the anti-coagulant drug Xarelto. In a recently filed legal briefing, lawyers argue that the companies consciously remained silent in Duke’s omission of data regarding a blood-testing device, thereby contributing to misleading the NEJM. Both companies contend to sending all the required data to regulators in the United States and Europe.
Starting in 2006, the Xarelto trial began. Dr. Robert M. Califf, the recently appointed chief of the FDA, worked as the trial’s co-director. Titled “Rocket AF,” the clinical trial involved 14,000 patients over a three-year period, during which time the blood-thinner warfarin was used as a control in comparison to rivaroxaban (Xarelto). Five years after drug was brought to market in 2011, the companies notified regulators that a blood-testing device had malfunctioned during its clinical research trial. According to the FDA, this may have led researchers to give patients an incorrect dosage of warfarin, leading to the belief that Xarelto was a more effective drug.
Last week, Duke researchers published a reanalysis of the faulty device’s lab data to the New England Journal of Medicine, concluding the device did not effect the trial’s results.
Independent medical experts responded by questioning Duke’s methodology, stating that without a confirmation of the device’s accuracy, researchers would essentially be required to guess at which patient groups were most likely to be affected by the malfunctioning device. But as it turns out, Duke did compare test results of the device’s readings at a central laboratory, taking blood samples at the 12 and 24 month mark of the trial– they just happened to be, once again, omitted from being published in the NEJM.
“At the time of the published letter, we didn’t know that it existed,” said Dr. Jeffrey M. Drazen, editor in chief of The New England Journal of Medicine.
In a lawsuit against Johnson & Johnson and Bayer last week, lawyers filed a legal brief requesting the judge to examine the Duke researchers’ letter, during which a peer reviewer asked for the laboratory data to allow a comparison of the device’s readings. The three authors of the letter, two Duke researchers and one researcher from the University of Edinburgh, declined to comment.
“There’s so much variation among people that it probably wouldn’t be clinically informative,” said Dr. Drazen, asserting that taking blood-clotting comparisons at only two points during the trial would most likely be of insignificant value.
Given both Bayer and Johnson & Johnson submitted the results of the compared lab data of the blood-testing devices to regulators, independent researchers were surprised that both Duke and the NEJM found no value in publishing the same data sets.
Within the same week that Duke’s reanalysis was published to the New England Journal of Public Medicine, the European Medicines Agency submitted its analysis. It concluded in its findings of the comparative lab data that the devices were highly inaccurate. Nonetheless, the EMA shares the same opinion as Duke, saying the device probably did not effect the outcome of the trial. But as it so happens, the EMA panel that conducted the analysis was majoratively composed of members from the Duke Clinical Research Institute.
Dr. Steven Nissen, a cardiologist at the Cleveland Clinic who served on the FDA’s advisory panel, questioned the fundamental basis of any “after-the-fact” analysis, stating, “Given the device was inaccurate, there is no way anybody can tell you what would have happened in the trial.”
The sequence of these developments creates more questions than answers. First off, if Bayer and Johnson & Johnson did, as they contend, send all required data, including the independent lab comparison of the blood-testing device to regulators, that would mean that regulators either failed to notice or mention the devices were inaccurate, or, the central laboratory simply did not find any inaccuracies in the device.
Regardless of how questionable either possibility may seem, Alere, the manufacturers of the INRatio monitors used in the Xarelto trial, recalled all the blood-testing devices in December of 2014, reporting the devices were generating “clinically significant” errors. Bayer and Johnson & Johnson eventually notified regulators of the devices malfunctioning in the Xarelto trial after a journalist from British Medical Journal sent a letter mentioning it, nearly a year later in September of 2015.
Additionally, the discovery of the “clinically significant” errors among INRatio blood-monitoring devices conflicts with the reanalysis from the Duke Clinical Institute and the EMA (composed mostly of Duke researchers), who assert the errors of the blood-monitoring devices did not lead to notable variations in the trial’s results. Although it is impossible definitively know without actually having done the trial properly, it may very well be true. And yet, given the unexpected extent of variance between the Xarelto trial’s outcomes in comparison to real-world outcomes (5,000 lawsuits and 500 deaths), along with Duke’s successive omittances of published data specifically regarding the blood-testing devices to the NEJM, it would appear, at least superficially, that the malfunctioning devices were to some degree, clinically significant.
http://www.legalreader.com/duke-researchers-omit-data-published-nejm/

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Xarelto Lawsuit Report: Legal Brief Contends Xarelto’s Makers Misled Medical Journal Editors

Mar 5, 2016 | Alsonso Krangle LLP

Xarelto Lawsuit Information: A legal brief filed in a federal Xarelto lawsuit accuses Bayer and Johnson & Johnson of misleading editors of an international medical journal by withholding important laboratory data obtained during the clinical trial of the blockbuster blood thinner, according to The New York Times. Plaintiffs attorneys in the Xarelto bleeding lawsuit contend in their brief that the companies had more than 5,000 blood samples taken from patients and sent to a central laboratory but did not mention the tests to Duke University researchers who oversaw Xarelto’s clinical trial called, ROCKET AF. Researchers recently published a letter about the clinical trial in The New England Journal of Medicine (NEJM) without mentioning the laboratory data. The NEJM editors said in an interview that they did not know about the companies’ laboratory data until asked about it by a New York Times reporter, but they stood by the researchers’ analysis.
[http://www.nytimes.com/2016/03/02/business/document-claims-drug-makers-deceived-a-top-medical-journal.html?_r=1, The New York Times, March 1, 2016]
Duke University researchers’ wrote in their letter that problems that occurred with a blood-monitoring device used in ROCKET AF did not affect the trial results, according to The New York Times. The device that tested for blood clotting malfunctioned during the trial and was later recalled. Bayer and Johnson & Johnson took separate blood samples and compared them to results provided by the faulty device, and then submitted the laboratory data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. Xarelto was approved by both regulatory agencies.
Since last fall, questions have been raised about whether the recalled device affected the trial results. ROCKET AF, which involved 14,264 patients, compared the number of strokes and bleeding events suffered by patients who took Xarelto and patients who took warfarin, a rival blood thinner. The questions focused on whether results due to the malfunctioning blood-monitoring device may have lead doctors to give patients an incorrect dose of warfarin, which could have favored Xarelto, The New York Times reported.
[http://www.nytimes.com/2016/02/23/business/fda-asks-if-faulty-blood-monitor-tainted-xarelto-approval.html?_r=0, The New York Times, February 22, 2016]
Xarelto (rivaroxaban) is an oral blood thinner prescribed to reduce the risk of blood clots and strokes in patients with atrial fibrillation (irregular heart rhythms) and to treat blood clots in the leg and lungs. Xarelto, approved in 2011, is considered a new generation blood thinner compared to warfarin (Coumadin), an anticoagulant that has been sold for 60 years. Xarelto is more convenient to use because it does not require patients to have regular blood monitoring as does warfarin. However, Xarelto does not have an antidote to reverse its effects should internal bleeding occur in patients whereas warfarin uses vitamin K as a reversal agent.
[http://www.fda.gov/Drugs/NewsEvents/ucm405148.htm, July 17, 2014]
Bayer, Johnson & Johnson, and its Janssen Pharmaceuticals Inc., unit, which markets Xarelto, are facing more than 4,600 Xarelto lawsuits nationwide that allege the anti-clotting medication causes dangerous side that include internal bleeding, gastrointestinal hemorrhages, brain bleeds, and blood clots. The Xarelto lawsuit complaints also contend the defendants failed to warn that Xarelto does not have an antidote to reverse bleeding side effects. (Xarelto Lawsuit: In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592) Plaintiffs attorneys have asked U.S. District Judge Eldon Fallon, who is overseeing the federal Xarelto litigation in New Orleans, to unseal documents in the case that would show actions the defendants took during the ROCKET AF clinical trial, according to The New York Times.
About Alonso Krangle LLP And Filing A Xarelto Lawsuit
Alonso Krangle LLP is investigating Xarelto lawsuits. If you or someone you love suffered serious side effects, such as severe bleeding, internal bleeding, blood clots, stroke or heart attack from taking Xarelto, you may be eligible to file a Xarelto lawsuit against the manufacturer of the blood thinner. For more information on the legal options available to you or to file a Xarelto lawsuit, please contact Alonso Krangle LLP by filling out our online form or by calling us at 800-403-6191.
http://fightforvictims.com/4882-2/4882

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Arizona Xarelto Injury Lawsuit Filed For Hemorrhagic Pericardial Effusion

Mar 5, 2016 | The Legal Examiner

By Shezad Malik MD JD

An Arizonan woman, Margaret Garvy, recently filed a product liability and personal injury lawsuit alleging that side effects of Xarelto caused her to suffer a life threatening hemorrhagic pericardial effusion. Hemorrhagic pericardial effusion, is a serious medical condition where the sac around the heart is filled with blood, preventing the normal contractions of the heart and if left untreated can be deadly.
Garvy’s complaint is the latest in several thousand drug injury cases filed against Bayer and Johnson & Johnson over uncontrollable bleeding complications linked to their controversial new anticoagulant medication. Garvy filed her case in the U.S. District Court of the Eastern District of Louisiana.
Louisiana Xarelto Multidistrict Litigation
All Xarelto lawsuits filed in U.S. District Courts nationwide have been consolidated in the Eastern District of Louisiana as part of a federal MDL, or multidistrict litigation (MDL) since December 2014. The MDL litigation is centralized before U.S. District Judge Eldon Fallon for coordinated discovery and pretrial proceedings.
Xarelto Plaintiff Claims Life Threatening Injury
According to Garvy, she took the anticoagulant Xarelto for less than two weeks in May 2014, and she was diagnosed with hemorrhagic pericardial effusion, pericardial tamponade and pleural effusion. Garvy claims that the bleeding around the heart and lungs was from her Xarelto use and the lack of an effective reversal antidote to stop the drug’s anticoagulant or blood thinning effects.
Garvy alleges that Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary knew or should have known about the hemorrhage risks with Xarelto, but withheld information from patients and the doctors about the fact that users may experience uncontrollable bleeding.
Xarelto Increases Hemorrhage Risks
Xarelto (rivaroxoaban) was approved in 2011 as a replacement medication for Coumadin (warfarin), which has been the gold standard anticoagulant treatment for the past 60 years. Xarelto was approved for the treatment of chronic atrial fibrillation, which is a common heart rhythm problem and can lead to strokes if there is no anticoagulant usage.
Xarelto is a new-generation of blood thinners, which have been touted as easier to use than warfarin, because the manufacturers claim that there is no need to measure blood thinning levels.
But, a large number of adverse event reports began to be filed after Xarelto was released, usually involving uncontrollable bleeding that doctors were unable to stop.
All blood thinners carry a risk of bleeding injury, and the side effects of warfarin can be quickly reversed with Vitamin K antidote if bleeding occurs. Unfortunately there is no Xarelto reversal agent and plaintiffs have alleged that the drug manufacturers failed to adequately warn doctors about the lack of an antidote.
Xarelto Bellwether Trials
As is common in the coordinated management of defective drug litigations, Judge Fallon has established a “bellwether” program, where a small group of claims are being prepared for early trial dates.
The Xarelto bellwether trials are scheduled to go in February 2017 and May 2017.
Pradaxa Uncontrollable Bleeding and Death Lawsuits
Pradaxa is a similar newer generation blood thinner made by Boehringer Ingelheim based in Germany. This Xarelto litigation involves similar uncontrollable bleeding claims to those in thousands of Pradaxa lawsuits. The Pradaxa maker ultimately agreed to pay $650 million in Pradaxa settlements in 2014, with an average of about $150,000 per claim.
http://fortworth.legalexaminer.com/fda-prescription-drugs/arizona-xarelto-injury-lawsuit-filed-for-hemorrhagic-pericardial-effusion/

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Information on Xarelto stroke lawsuit

Mar 5, 2016 | Tibet Center Chicago

There are many people who are spending their money in getting treatments to their health issues. There are many people who are facing many problems due to these advanced treatments. There are many people who are trying to solve these problems but they are not getting good results. In addition to that most of these modern people are trying to solve their health issues with help of artificial medicines. There are many side effects that people get with help of these artificial medications. Therefore it is important that people should select best and safe medicines. Xareltois a medicine which is saving people at rate of their life. That means there is no doubt that people can get rid of their major health problems with help of this medicine.
But there is no guarantee that they can stay alive after taking this medicine. This is because there are many people who are facing this problem. They are getting their loved one lost after taking this medicine. They can get rid of all these troubles with help of Xarelto lawsuits filed. By considering all these things, there are some lawyers who are giving great benefits to their customers. With help of these lawyers, people can apply Xarelto lawsuit. With this application they can get great results. But most people have no idea that they can get all these benefits. For all these people there are different websites. These websites are providing great information on how to apply these law suits.
It is required that people should select the best website to get all these details. With help of these Xarelto lawyers, people can enjoy great work. They can get back large amounts of money if they lose their loved ones due to this Xarelto treatment. There are certain conditions that people need to understand before filing lawsuit.
http://tibetcenterchicago.org/information-on-xarelto-stroke-lawsuit/

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Some Interesting Revelations Associated with Xarelto Side Effects Concerns

Mar 7, 2016 | LawyersandSettlements.com

By Gordon Gibb

Plaintiffs having filed a Xarelto lawsuit on behalf of themselves or family members whose health may have been compromised by the blockbuster drug, may have been handed a new angle against an anticoagulant that in five years has risen to the top of the blood thinner mountain in spite of criticisms, including lack of an antidote.

It has now been revealed that a device used in clinical trials gauging the effectiveness of Xarelto (rivaroxaban) when compared with Coumadin (warfarin) may have given an unfair advantage to Xarelto. It should be noted that both the European Medicines Agency and the Duke Clinical Research Institute have concluded through their own analyses that the potentially faulty device did not, after all, affect the outcome of the clinical trials.

But questions remain.

According to the New York Times (02/22/16), the device in question is the INRatio, a medical device reportedly used to assist trial doctors in determining whether trial participants were being given the correct amounts of warfarin. Getting that right was not only integral to the trial - and to the participant - but also remains as the bane of doctors and patients who have longed complained about the tight monitoring of blood, diet and other medications required to ensure optimum levels of warfarin were maintained.

Part of the basket of claims made when Xarelto hit the market was that rivaroxaban did not require the degree of monitoring necessary with the older-generation Coumadin (warfarin). To that end, to fairly gauge the effectiveness of Xarelto v. Coumadin, warfarin levels had to be spot-on.

Doubts began to surface in earnest when the INRatio device was recalled in 2014 over suspicion that the INRatio was understating a patient’s bleeding risk, and how that may compare with a potential Xarelto Bleeding Issue.

And yet, it appears there were questions even before the recall. It has been reported that doctors involved in those first clinical trials were questioning the accuracy of the INRatio device. The New York Times reported that a legal motion filed late last month revealed there were so many complaints about the device that study proponents were motivated to investigate.

And even before that - in 2005 and 2006 - the US Food and Drug Administration (FDA) appears to have had the INRatio device on its radar, sending warning letters to the manufacturer at the time, HemoSense, over concerns of “clinically significant” values that appeared to be erroneous. The FDA was concerned at the time that HemoSense was not undertaking due diligence with regard to investigating the complaints.

At some later time, Alere Inc. acquired HemoSense. In 2014, Alere recalled the suspect INRatio.

Plaintiffs litigating against Johnson & Johnson over Xarelto due to an Xarelto Bleedout or some other serious adverse reaction - including Xarelto Death - have taken J&J to task for bringing Xarelto to market without an obvious antidote akin to warfarin, whose blood-thinning properties can usually be reversed in short order with an infusion of vitamin K. Not only did Xarelto appear without a ready reversing agent, plaintiffs in Xarelto Bleeding complications lawsuits allege the manufacturer was irresponsible in bringing Xarelto to market - and to market supremacy - while claiming the degree of extensive monitoring that is the bastion of warfarin was not needed for Xarelto.

Plaintiffs claim that Xarelto indeed does require close and tight monitoring, especially in the absence of an antidote. To suggest otherwise would only add to the danger inherent with Xarelto Side Effects, or so plaintiffs have alleged.

There is another curious sidebar to these most recent revelations. According to the New York Times, the doctor who led the so-called Rocket AF clinical trial was Dr. Robert M. Califf, who was serving as the director of the Duke Clinical Research Institute. Duke was responsible for conducting the clinical trial that led to the approval of Xarelto, and Califf served as co-chairman of the study.
Having left Duke some time ago, Califf is now a deputy commissioner with the FDA and is the President’s nominee for FDA Commissioner. Late last month, the US Senate confirmed Dr. Califf’s nomination. The New York Times reports Dr. Califf has no role whatsoever in the FDA probe into the Rocket AF trial.

Plaintiffs having suffered Xarelto Bleeding complications and other Xarelto Side Effects might also be interested in knowing that the FDA’s own medical reviewers, in 2011, recommended against approval of Xarelto. The concern at the time - noted by others - remained that patients receiving warfarin during the Rocket AF clinical trial were being inadequately managed.

An outside advisory committee voted to supersede the concerns of the FDA medical reviewers, and gave Xarelto the green light.'
https://www.lawyersandsettlements.com/articles/xarelto/xarelto-lawsuit-death-bleeding-issue-37-21323.html

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Did Xarelto Makers Withhold Data from Medical Journal?

Mar 7, 2016 | Green, Schafle & Gibbs

Did Xarelto Makers Withhold Data from Medical Journal?
Almost everyone has heard of the prescription blood thinner, Xarelto; however, most people have not heard about the lawsuits being filed against the two companies that produce Xarelto. A footnote in a recently filed legal briefing claims that the companies, Johnson & Johnson and Bayer, withheld information from researchers in relation to a letter published in the New England Journal of Medicine about the effects of Xarelto.
Following the revelation that some of the equipment that had originally been used in the clinical trial that led to Xarelto’s FDA approval could have been faulty, Duke’s Clinical Research Institute was asked to do further research into the effects of Xarelto. The focal point of the present issue is that Johnson & Johnson and Bayer withheld key information from Duke’s researchers that might have affected the results of the follow-up study. Furthermore, the lawsuit suggests that the data that was withheld demonstrated that Xarelto was not as effective as warfarin, a cheaper and older blood thinner.
Data Related to Xarelto and Warfarin
The withheld data could have been damning to the producers of Xarelto. During the initial trial, about 5,000 blood samples were taken from a random sample of patients and sent to a central laboratory. Experts say that these samples would have been best used in order to reevaluate the effects of Xarelto compared to warfarin. However, when it came to the follow-up analysis, Duke’s researchers based their findings off of much less concrete research methods. That is not to say that Duke’s research team is at fault. There is evidence that suggests that Duke’s researchers asked the Xarelto producers whether such data existed. The lawyers who filed the legal brief claim that the two Xarelto producers purposefully withheld the fact that those 5,000 samples existed in order to lead the researchers to find the result that the companies desired.
This issue could become very important throughout the course of the lawsuit against the producers of Xarelto. Although it’s unclear what exactly happened during the course of these trials, any passive or active acts meant to conceal risks or overstate the effectiveness of any drug could lead to liability on behalf of the producer.
Xarelto & Dangerous Drug Lawyers
If you or someone you love has suffered a bleeding incident as a result of Xarelto, please contact our mass tort attorneys immediately for a free consultation to discuss your legal rights.
http://greenlegalteam.com/news/2016/3/7/did-xarelto-makers-withhold-data-from-medical-journal

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Potentially Faulty Xarelto Study Data Hid By J&J, Bayer: Report

Mar 7, 2016 | AboutLawsuits.com

By Irvin Jackson

According to documents produced during the discovery process in lawsuits filed over the side effects of Xarelto, reports suggest that a major medical journal was misled about the existence of data that may have made it clear whether controversial clinical trial results were accurate.
A recent New York Times report indicates that Bayer, Johnson & Johnson and those who ran clinical trials at Duke University that eventually led to the FDA approval of the blood thinner, may have lied to editors at the New England Journal of Medicine.
At issue is a device that measured the levels of blood thinner in patients involved in the study, due to concerns that the device was defective and that those running the clinical trial knew it, but failed to reveal that information.
The New York Times reports that documents produced by the drug makers during pending Xarelto lawsuits filed on behalf of individuals who suffered severe bleeding complications after receiving the drug suggest that those running the clinical trial were asked if there were lab tests that confirmed the accuracy of the device. The editors were told there was not, when in actuality there were such tests.
The issue is part of an investigation into the Xarelto studies underway by the FDA, which is focusing on the measurement of the levels of the older blood thinner warfarin in test subjects’ blood. It is now believed that the device was defective and may have compromised the approval process for Xarelto, which has since been promoted as a superior alternative to warfarin.
The Xarelto blood testing problems in the clinical trial were first reported in the medical journal The BMJ in December, with researchers warning that the device may have led to an underestimation of the rate of Xarelto bleeding complications in comparison to warfarin.
The ROCKET-AF clinical trials compared the rate of bleeding events between Xarelto (rivaroxaban) and Coumadin (warfarin). The potentially defective blood testing device, known as the INRatio by Alere, was used to measure the levels of warfarin in patients’ blood and was used to adjust their dosage. However, an INRatio recall has since been issued after it was discovered that the device may return results that were falsely low. The recall came after Alere received nearly 19,000 reports of malfunctions, 14 of which resulted in serious injuries.
The recall could affect the ROCKET-AF results, because falsely low readings may have resulted in warfarin patients being given too high a dose, increasing their risk of bleeding. If the device caused excessive bleeding among warfarin patients, it could have given the false impression that Xarelto had a lower rate of bleeding problems.
Researchers reportedly said that the best way to evaluate whether the device was working properly would be a comparison of the device’s readings with tests conducted at a central laboratory. That happened twice in the clinical trials, involving samples from 5,000 patients given warfarin at 12 weeks and 24 weeks in the clinical trial.
Editors with the New England Journal of Medicine indicate that they were never shown or told about the results, even though the Xarelto clinical trial researchers were asked directly about it by a peer reviewer.
The clinical trials, led by Dr. Robert Califf, who is now the FDA commissioner, have come under intense criticism for a variety of reasons since Xarelto was approved, as the drug has been linked to a surprising number of adverse event reports involving severe and uncontrollable bleeding problems. Due to a lack of a reversal agent for Xarelto, doctors have often been unable to stop bleeding problems that occur among users of the drug, increasing the risk of severe injury or death.
Xarelto Lawsuits Over Bleeding Problems
Xarelto (rivaroxaban) is part of a new class of blood thinners introduced in recent years as a replacement for warfarin, which had been the go-to anticoagulation treatment for decades. Since it was approved in 2011, this new-generation treatment has been commonly prescribed instead of warfarin for reduction of the risk of blood clots and strokes among patients with atrial fibrillation, or following hip or knee replacement surgery.
Amid allegations that the drug makers failed to adequately warn about the risk of bleeding on Xarelto, more than 4,000 lawsuits are currently pending in courts throughout the U.S., alleging that plaintiffs suffered severe and often fatal injuries due to uncontrollable bleeding while on the medication.
While users of warfarin can be given a dose of vitamin K to reduce the blood thinning effects of the medication, there were no similar reversal agents available for Xarelto at the time it was introduced, placing doctors in a position where they were unable to control many bleeding problems.
Lawsuits also allege that the drug makers provided false and misleading information about the importance of blood monitoring on Xarelto, marketing the drug as easier to use and indicating that it does not require close testing like warfarin. However, independent studies published after the medication was introduced have suggested that Xarelto monitoring may help identify patients at greater risk of bleeds.
As part of the coordinated proceedings in the federal Xarelto litigation, a small group of “bellwether” cases are being prepared for early trial dates, which are expected to begin early next year to help gauge how juries may respond to certain evidence that has been obtained during the discovery process.
While the outcome of these early bellwether trials will not be binding in other cases, they may facilitate Xarelto settlement negotiations that will avoid the need for hundreds of individual cases to go to trial nationwide.
http://www.aboutlawsuits.com/xarelto-trial-data-questions-96159/#sthash.xORX1qPB.dpuf

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Is Xarelto Safe? - Critics Demand an Independent Investigation

Mar 7, 2016 | Glodwater Law Firm

Xarelto, a new type of anticoagulant (blood thinner), was developed as a more convenient alternative to Coumadin, a blood thinner containing warfarin. Also known as rivaroxaban, Xarelto received FDA approval in 2011. However, many patients taking the medication soon began experiencing severe side effects, primarily uncontrolled bleeding. Recent reports indicate that a device used to measure bleeding complications during Xarelto’s clinical trials may have been defective.
Xarelto is manufactured by Bayer and marketed in the United States by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. The product is marketed as safer than Coumadin, even though studies suggest that patients taking rivaroxaban suffer from an increased risk of gastrointestinal bleeding than those receiving warfarin. In addition, if excessive bleeding occurs while a patient is taking warfarin, there is an antidote to stop the bleeding. Xarelto has no such antidote.INRATIO, BY ALERE
InRatio, the device in question, is manufactured by Alere. It was used in clinical trials of Xarelto and Coumadin to compare the bleeding event rate in the two drugs. InRatio measured warfarin levels in the user’s blood, and dosage adjustment was based on the results. In December, 2014, the device was recalled after it was discovered that certain results were returning with inaccurately low numbers. Alere received approximately 19,000 malfunction reports, a small percentage of which resulted in severe patient complications. Critics are demanding an independent investigation into InRatio’s false low readings, and the associated consequences.XARELTO VS. COUMADIN
Both medications are used to treat or prevent blood clots in patients. These patients are generally diagnosed with stroke, deep vein thrombosis, pulmonary embolism, or atrial fibrillation. Patients scheduled for certain types of surgery, especially knee and hip replacements, are often prescribed blood thinners as these surgeries increase blood clot risk. Xarelto, supposedly safer, may have been prescribed more often because of clinical trial results. If the InRatio device was malfunctioning, patients taking warfarin may have received too much medication during the trials, thus affecting the safety data comparing the two blood thinners.SIDE EFFECTS
Xarelto’s most serious side effect is uncontrolled bleeding, which can kill. Besides severe gastrointestinal bleeding, hemorrhaging may also occur inside the head or in the eyes. If a patient begins bleeding due to warfarin, a doctor will administer Vitamin K as an antidote. Xarelto has no antidote. Xarelto lawsuits claim that Johnson & Johnson did not suitably train healthcare workers in methods of treating Xarelto patients during an emergency. Other side effects include:Respiratory issuesHeadachesBack painIncreased menstrual flowParalysisInfectionsBloody, tarry feces.
Patients who stop taking Xarelto suddenly are actually at increased risk for blood clots, the condition the drug was designed to prevent.LONG HOSPITAL STAYS
Patients who survive severe bleeding resulting from Xarelto often spend weeks or months in the hospital. Even those with good health insurance may face financial disaster, especially as they are unable to work during that period and during at-home convalescence.THE GOLDWATER LAW FIRM – NATIONWIDE DRUG INJURY LAWYERS
People experiencing complications from Xarelto use may be eligible to seek compensation for their medical bills, and damages for pain and suffering. Our drug injury attorneys will evaluate the case details and make sure you understand your rights and options before moving forward with litigation. Contact us today for a free consultation about your case.\
http://goldwaterlawfirm.com/2016/03/07/xarelto-safe-critics-demand-independent-investigation/

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