Preview Newsletter
XARELTO Media Monitoring – Week of 12-04-15
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Xarelto Lawsuit Claims Drug Caused Death Of Vermont Man
Nov 30, 2015 | Digital Journal
BloodThinnerHelp.com reports on another Xarelto lawsuit which was filed against the drug’s manufactureres in connection with the death of a Vermont man. The case, number 2:14-cv-00159-CR ,was filed by the daughter of the deceased in a Vermont federal court. Allegations within her suit claim that the uncontrollable bleeding, which led to her father’s death, was caused by the blood thinner Xarelto. -
Xarelto Lawsuit Says Manufacturers Fraudulently Misrepresented The Drug
Dec 1, 2015 | KNDO-TV
By Marc Goldich
BloodThinnerHelp.com reports on another lawsuit filed against Janssen Pharmaceuticals (a division on Johnson & Johnson) and Bayer AG which states that the pharmaceutical giants, as well as their researchers and developers have fraudulently misrepresented the benefits, dangers, and risks of blood-thinning drug Xarelto. This particular 32-count complaint was filed in the St. Clair County Circuit Court under number 15-L-581 on October 13th, 2015. -
Xarelto Lawsuit Update: New Lawsuits Filed in Xarelto MDL
Dec 1, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports today on the increasing number of cases filed in the Xarelto multidistrict litigation. Ever since the Xarelto MDL was established in December 2014 the number of cases filed has grown dramatically. Six months after its establishment, in June 2015, there were approximately 500 lawsuits filed in the MDL. Court documents show that only about six weeks later, on July 15, 2015, the number of lawsuits filed had risen to 805 lawsuits. Currently there are about 1,200 lawsuits filed in the MDL and that number is expected to continually rise as litigation continues. For more detailed information on the Xarelto litigation, visit this page. -
Case Management Order Outlines Xarelto Lawsuit Bellwether Trial Selection Process
Dec 2, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports on recent announcements that bellwether selection for the trials consolidated in Xarelto multidistrict litigation number 2592 are now underway. A case management order from United States District Judge Eldon Fallon dated November 20th outlined the criteria for selecting these trials. Several cases will now be chosen for inclusion in a bellwether discovery pool. These cases are generally chosen based on which appear to be most ready for trial. Initially, the judge asked that both plaintiffs and defendants work together to determine the cases selected for the bellwether pool, however, when they were unable to agree on criteria for their selections, the Judge stepped forward to complete the task. -
Xarelto Lawsuit Claims Drug Caused Ohio Woman’s Gastrointestinal Bleed
Dec 2, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports on a lawsuit filed against blood-thinning drug Xarelto which claims that the drug caused a woman’s gastrointestinal bleeding. The victim, a woman from Ohio, stated in details within the suit that she was given the drug as a preventative measure to avoid any stroke risk that might be caused by her atrial fibrillation condition. Less than a year after starting to take the drug, however, the woman began to experience a gastrointestinal bleed, which she states was caused by the blood thinner. -
Xarelto Lawsuit Alleges Once-A-Day Dosage Caused Stroke
Dec 3, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports on a new and different allegation appearing in a lawsuit filed against Xarelto and manufacturer Janssen Pharmaceuticals in a Pennsylvania State Court. The claim alleges that Janssen’s (a subdivision of Johnson & Johnson) daily dose was not effective for a full 24-hour period, which caused the patient to suffer a stroke. The plaintiff was using Xarelto to prevent a stroke due to his atrial fibrillation condition, however, he ended up suffering from one just days after beginning to take the blood thinner. -
Xarelto Lawsuit Numbers Surpass 2,000 Cases
Dec 3, 2015 | GTN News
By Marc Goldich
BloodThinnerHelp.com reports on recent press announcing that cases involved in the federal Xarelto multidistrict litigation (number 2592) have surpassed 2,000. The cases are being overseen by U.S. District Judge Eldon Fallon, who recently released another case management order concerning the litigation. The judge instructed those involved on the selection of cases for a bellwether pool. Cases are typically selected based on their preparedness for trial. -
Xarelto Lawsuit Alleges Wrongful Death Caused By Blood Thinner
Dec 3, 2015 | KUSA-TV
By Marc Goldich
BloodThinnerHelp.com reports on another development in the Xarelto lawsuit multidistrict litigation. Updates involve the details of a suit filed on behalf of a Georgia man by his son after the man passed away due to serious internal bleeding. The son alleges this internal bleeding was caused by his use of blood thinner Xarelto. The complaint, number 2:15-cv-00886, was filed in the state of Louisiana. -
Lawsuit claims Xarelto Brain Hemorrhage killed Grandmother
Nov 24, 2015 | A Drug Recall
The roughly 1,700 Xarelto lawsuits centralized in a multidistrict litigation in Louisiana continue to increase in numbers. One of the most recent lawsuits to join this MDL was filed by a woman who claims Xarelto intracranial bleeding killed her grandmother. -
Louisiana victims set sights on Xarelto lawsuit
Nov 25, 2015 | Vincent J. DeSalvo Blog
When some Louisianans get a headache, they take an aspirin. When they have allergies, they may pop a different kind of pill. When they have a disease, they likely take prescription medicine. But just because these medications are common and often effective does not mean that they are without risk. To the contrary, many medicines can have serious side effects even when used properly. Sometimes those side effects can be fatal. -
Xarelto Bleeding Lawsuit Filed by Georgia Man
Nov 27, 2015 | Top Class Actions
By Joanna Szabo
A Georgia resident has filed a Xarelto lawsuit against Janssen Research & Development, a subsidiary of pharmaceutical giant Johnson & Johnson. -
More Than 2,000 Xarelto Lawsuits Have Been Filed
Nov 30, 2015 | Xarelto Lawyer
Bloodthinnerhelp.com, which is a website that reports on Xarelto lawsuits, has stated that over 2,000 lawsuits have been filed in the United States. People who have filed lawsuits allege that Xarelto causes uncontrollable bleeding, which often leads to death. Additionally, Xarelto does not have an antidote. This means that if a patient is injured and suffers bleeding, then the physician may not be able to stop the bleeding. -
Xarelto — National Drug Litigation
Dec 1, 2015 | JD Supra Business Advisor
By Brenda Fulmer
November has proven to be a very busy month for Searcy Denney and its Xarelto clients, with the firm filing several new individual lawsuits on behalf of its clients besides participating in the national discovery efforts. Here, I summarize the new complaints filed recently on behalf of injured or deceased Xarelto users and their loved ones. -
Xarelto MDL Bellwether Selection Underway
Dec 1, 2015 | Injury Lawyer News
By Laura Woods
The process for determining which cases from the Xarelto multidistrict litigation in the Eastern District of Louisiana will be included in a bellwether discovery pool has been determined. U.S. District Judge Eldon Fallon issued a case management order on Nov. 20 outlining the selection criteria. Both parties were initially tasked with preparing the pool of bellwether cases, but they failed to come to an agreement on selection criteria, so Judge Fallon was forced to devise his own plan. -
Xarelto Reversal Agent Succeeds in Late-Stage Trial
Dec 2, 2015 | Lopez McHugh LLP
Reuters reports that andexanet alfa, a drug developed by Portola Pharmaceuticals to reverse the bleeding side effects of new oral anticoagulants like Xarelto, has proven successful in a late-stage clinical trial. Portola hopes the new data will help earn the antidote approval from the U.S. Food and Drug Administration. -
AMA Wants to Ban Direct-to-Consumer Marketing of Prescription Drugs – Xarelto Lawsuits Partially to Blame
Dec 2, 2015 | Massachusetts Drug Injury Lawyers Blog
In the wake of almost countless lawsuits against prescription drug manufacturers, physician groups are advocating a ban on direct-to-consumer advertising. This aggressive form of mass marketing encourages patients to request certain prescription drugs, medical devices, and treatments that they may not otherwise seek out. The American Medical Association (AMA) is concerned that this results in unnecessary prescribing and increases potential risks to patients. Earlier this week, the AMA voted to end aggressive marketing campaigns that do not serve to educate physicians or patients, but rather to encourage patients to ask their doctors about specific medications or products. Contact a Boston Drug Injury Lawyer Today. -
Illinois Woman Files Xarelto Bleeding Risks Lawsuit
Dec 3, 2015 | Righting Injustice
By Jennifer Walker-Journey
Chezarea Jones lodged a 32-count complaint against Bayer and Johnson & Johnson’s Janssen Pharmaceuticals alleging the companies did not adequately warn about bleeding risks with their blood thinner Xarelto. The lawsuit was filed in St. Clair County (Illinois) Circuit Court on Oct. 13. -
Xarelto Lawsuit Alleges Blood Thinner Caused GI Bleeding
Dec 4, 2015 | Top Class Actions
By Robert J. Boumis
A plaintiff from Kentucky has joined the larger litigation over alleged Xarelto bleeding incidents. Xarelto is an anticoagulant or blood thinner, a drug designed to make it harder for blood clots to form within the body, reducing the risk of stroke. But this Xarelto lawsuit alleges that Xarelto side effects are a serious risk.
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Plaintiff Attorney Press Releases
Plaintiff Attorney Blog Posts
Full Text of Articles Below
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Xarelto Lawsuit Claims Drug Caused Death Of Vermont Man
Nov 30, 2015 | Digital Journal
BloodThinnerHelp.com reports on another Xarelto lawsuit which was filed against the drug’s manufactureres in connection with the death of a Vermont man. The case, number 2:14-cv-00159-CR ,was filed by the daughter of the deceased in a Vermont federal court. Allegations within her suit claim that the uncontrollable bleeding, which led to her father’s death, was caused by the blood thinner Xarelto.
Details further explaining this case state that the plaintiff’s father was prescribed Xarelto to treat his atrial fibrillation condition. Atrial fibrillation can cause complications such as blood clots and strokes, so blood thinners are commonly prescribed to individuals with this condition in order to prevent these occurrences. After using Xarelto just a short time, the man became injured and started to bleed. He was hospitalized at this time, as physicians diagnosed him with a parenchymal hemorrhage. The medical staff was unable to stop the man’s bleeding due to the fact that he still had active Xarelto in his system. They tried to keep the man alive, which they managed to for just 6 days before he ultimately passed away due to blood loss.
In her complaint, the plaintiff indicates that she and her father had never been made aware of one of the most dangerous aspects of Xarelto: the drug has no corresponding antidote. Because of this, when someone taking the drug begins to bleed, physicians cannot counter the effects and get their blood to clot. In these cases, doctors must resort to life-saving measures such as blood transfusions in an attempt to save the individual’s life. More traditional blood thinners offer the antidote of vitamin K. If someone using a traditional blood thinner begins to bleed, doctors can treat them with vitamin K, which counters the medicine’s effects and allows their blood to clot. For this reason, Xarelto is considered by many to be the most dangerous blood thinner on the market.
This lawsuit was filed against manufacturers Janssen Pharmaceuticals (a division of Johnson & Johnson), and Bayer AG. It alleges that they were reckless and negligent by marketing a drug for which there was no corresponding antidote, and which poses so many uncontrollable bleeding dangers.
At this time, Xarelto lawsuits have surged to number over 1,700 cases in federal court, which have been consolidated to form multidistrict litigation number 2592. As these cases await trial, it is expected that others will be filed. Attorney Joseph Osborne is working to ensure that anyone who has been affected by adverse health effects associated with the drug has the opportunity to explore their legal rights in the matter. These individuals may be entitled to significant compensation. Attorney Osborne is currently offering free legal consultations to those involved.
To obtain additional information on Xarelto lawsuits, or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.digitaljournal.com/pr/2759908#ixzz3tNo7QQNh
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Xarelto Lawsuit Says Manufacturers Fraudulently Misrepresented The Drug
Dec 1, 2015 | KNDO-TV
By Marc Goldich
BloodThinnerHelp.com reports on another lawsuit filed against Janssen Pharmaceuticals (a division on Johnson & Johnson) and Bayer AG which states that the pharmaceutical giants, as well as their researchers and developers have fraudulently misrepresented the benefits, dangers, and risks of blood-thinning drug Xarelto. This particular 32-count complaint was filed in the St. Clair County Circuit Court under number 15-L-581 on October 13th, 2015.
The complaint goes on to state that manufacturers neglected to adequately warn physicians about the dangers and risks that were connected with the new type of anticoagulant. Additionally, it alleged that they knowingly misrepresented the benefits presented by the drug, which the plaintiff believes that the dangers and risks far outweigh. The plaintiff is seeking damages in excess of $50,000 plus coverage for attorney fees and the cost of litigation.
Xarelto has been the topic of many recent lawsuits. Federally, the cases have now surpassed 1,700, and have been consolidated to form multidistrict litigation number 2592. This consolidation was done by the Judicial Panel on Multidistrict Litigation, and should help legal proceedings to run more smoothly and efficiently. Additionally, it will help avoid duplicate discovery or different rulings from multiple judges, and save time and money for everyone involved.
The cases which have been consolidated all share similar allegations that use of the blood thinner can cause dangerous uncontrollable bleeding. Xarelto was released to the market as a new, revolutionary blood thinner, but, as many of the current plaintiffs point out, the drug was released without a corresponding antidote. This means that patients who have Xarelto in their system and begin to bleed are in significant danger. Physicians have no antidote to counter the effects of the medicine and get their blood to clot. In these cases, doctors must resort to life-saving blood transfusions in an attempt to keep the patient from losing too much blood.
Patients taking traditional blood thinners do not have the same issue. When these patients begin to bleed, physicians can treat them with vitamin K, which counters the effects of the medication and allows their blood to clot, potentially saving the life of a the patient.
As the cases involved in the current Xarelto MDL await trial and over 500 others have come together in a mass tort group in Philadelphia. Attorney Joseph Osborne is working to ensure that everyone involved has had the opportunity to explore their legal rights. It is believed that there may be many more individuals who have suffered adverse health effects after using Xarelto, and these individuals may be entitled to legal action and significant compensation. Attorney Osborne is currently offering free legal consultations to those affected.
For additional information on Xarelto bleeding lawsuits, or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.nbcrightnow.com/story/30643969/xarelto-lawsuit-says-manufacturers-fraudulently-misrepresented-the-drug
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Xarelto Lawsuit Update: New Lawsuits Filed in Xarelto MDL
Dec 1, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports today on the increasing number of cases filed in the Xarelto multidistrict litigation. Ever since the Xarelto MDL was established in December 2014 the number of cases filed has grown dramatically. Six months after its establishment, in June 2015, there were approximately 500 lawsuits filed in the MDL. Court documents show that only about six weeks later, on July 15, 2015, the number of lawsuits filed had risen to 805 lawsuits. Currently there are about 1,200 lawsuits filed in the MDL and that number is expected to continually rise as litigation continues. For more detailed information on the Xarelto litigation, visit this page.
Federal Xarelto Lawsuits Consolidated in New Orleans:
These lawsuits are consolidated into an MDL in the United States District Court for the Eastern District of Louisiana located in New Orleans and presided over by Judge Eldon Fallon. The lawsuits are able to be consolidated because they all make similar allegations against the same defendants, the manufacturers of Xarelto, Bayer AG and Janssen Pharmaceuticals. They allege that Xarelto causes serious, uncontrollable internal bleeding that can lead to severe injuries and death, that the manufactures of Xarelto failed to adequately warn patients and doctors about the real dangers of the drug, and that the manufacturers of Xarelto were reckless in releasing a drug onto the market without a corresponding antidote to the drug’s anticoagulant effects.
Lawsuits Allege Xarelto’s Lack of Antidote is Dangerous:
The lawsuits allege that the manufactures released Xarelto onto the market with the knowledge that there was no corresponding antidote available for the drug. This means that if a patient taking Xarelto suffers from an internal bleeding event, there is no way short of serious, lifesaving interventions, to stop the internal bleeding. This uncontrollable internal bleeding has left many patients who were taking Xarelto with serious injuries and many have died due to resulting complications. This situation is a very different one than patients who are taking a traditional blood thinner, such as Warfarin, are in. If a patient who is taking Warfarin suffers from an internal bleed, doctors will simply be able to administer vitamin K and the patient's blood will clot again.
For any questions regarding this press release or the pending Xarelto litigation, please contact Joseph Osborne at (866) 425-8902.
http://www.digitaljournal.com/pr/2762087
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Case Management Order Outlines Xarelto Lawsuit Bellwether Trial Selection Process
Dec 2, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports on recent announcements that bellwether selection for the trials consolidated in Xarelto multidistrict litigation number 2592 are now underway. A case management order from United States District Judge Eldon Fallon dated November 20th outlined the criteria for selecting these trials. Several cases will now be chosen for inclusion in a bellwether discovery pool. These cases are generally chosen based on which appear to be most ready for trial. Initially, the judge asked that both plaintiffs and defendants work together to determine the cases selected for the bellwether pool, however, when they were unable to agree on criteria for their selections, the Judge stepped forward to complete the task.
As requested, a total of 40 cases will be chosen to include in the bellwether pool. At this time, plaintiffs and defendants will each select 10 cases, and the remaining cases will be randomly selected. It has been announced by the judge as well that half of the selected cases will be from the Eastern District of Louisiana, while 7 will be from states selected by the defendants and 7 will be from states selected by the plaintiffs. Additionally, 2 cases in the pool will be from Texas federal court and 4 will be from Mississippi federal court. These states chosen must have had at least 20 eligible cases filed concerning the pending litigation.
The lawsuits consolidated in the MDL all similarly allege that Xarelto can cause episodes of dangerous and sometimes fatal uncontrollable bleeding. Xarelto has become widely considered the most dangerous blood thinner on the market due to the fact that it has no corresponding antidote. This means that if a patient using Xarelto is injured and bleeds, physicians will be unable to get that patient’s blood to clot. In these instances, doctors have to resort to extreme life-saving measures such as blood transfusions. For someone taking a traditional blood thinner, however, there is an antidote available through vitamin K. If an individual taking a traditional blood thinner is injured and bleeding, doctors can treat them with vitamin K, reversing the medicine’s effects and successfully clotting their blood.
The quickly approaching status conference for the Xarelto MDL is set for December 21st, 2015. Judge Fallon has asked that parties involved get together between now and then in order to set the eligibility criteria for case selection and to plan case categories. Additionally, they have been asked to plan selection for the initial 4 cases to go to trial. It is expected that the first trial dates for these cases may be between February and May of 2017.
At this time, the MDL includes over 2,800 cases alleging that defendants Janssen Pharmaceuticals (a subdivision of Johnson & Johnson) and Bayer AG neglected to provide an antidote for their drug and neglected to properly warn consumers of the significant dangers associated with Xarelto use.
As these cases await trial and continue to grow rapidly in number, Attorney Joseph Osborne is working to ensure that individuals who have experienced adverse health effects after using Xarelto have the opportunity to investigate their legal rights. These people may be entitled to significant compensation. Attorney Osborne is currently offering free legal consultations to those involved.
To request additional information regarding Xarelto bleeding lawsuits or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.digitaljournal.com/pr/2763420#ixzz3tNfiqee7
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Xarelto Lawsuit Claims Drug Caused Ohio Woman’s Gastrointestinal Bleed
Dec 2, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports on a lawsuit filed against blood-thinning drug Xarelto which claims that the drug caused a woman’s gastrointestinal bleeding. The victim, a woman from Ohio, stated in details within the suit that she was given the drug as a preventative measure to avoid any stroke risk that might be caused by her atrial fibrillation condition. Less than a year after starting to take the drug, however, the woman began to experience a gastrointestinal bleed, which she states was caused by the blood thinner.
Xarelto was approved by the United States Food and Drug Association in 2011, and it entered the market as a revolutionary new type of blood thinner which, as other blood thinners had in the past, did not require special diets or regular monitoring and dosage adjustments by a physician. These factors contributed to the drug’s initial popularity. After a short time, however, these factors contributed to much of the controversy surrounding the drug as well.
As a one-size-fits-all, one-pill-per-day drug, Xarelto has become the subject of much scrutiny. Today, Xarelto has become widely considered the most dangerous blood thinner on the market. This is primarily because the drug was released to the market without a corresponding antidote, which many plaintiffs allege shows negligence on behalf of the manufacturers.
Because Xarelto is a blood thinner with no antidote, when patients using the drug become injured and bleed, physicians can do nothing to clot the blood. In these situations, they have to resort to extreme life-saving measures such as blood transfusions to try to keep the patients alive. Other traditional blood thinners are able to be countered by vitamin K, so if a patient using these blood thinners is injured, physicians can apply vitamin K, and this will counter the effects of the medicine and allow their blood to clot.
Xarelto lawsuits have seen a recent explosion in number, with over 1,700 cases now federally filed. These cases have been consolidated to form multidistrict litigation number 2592. Those involved in these suits all similarly allege that the drug causes uncontrollable bleeding episodes which are dangerous and sometimes fatal. Plaintiffs state that the manufacturers were negligent by releasing the drug to market without an antidote and by failing to warn consumers of the significant dangers associated with their drug.
Attorney Joseph Osborne is working to ensure that anyone who has suffered from an adverse health event after using Xarelto will have the opportunity to explore their legal rights. It is possible that these individuals may be entitled to take legal action and obtain significant compensation. Attorney Osborne is offering free legal consultations for those involved at this time.
To obtain more information on Xarelto uncontrollable bleeding lawsuits, or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.digitaljournal.com/pr/2763341#ixzz3tNg51b9P
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Xarelto Lawsuit Alleges Once-A-Day Dosage Caused Stroke
Dec 3, 2015 | Digital Journal
By Marc Goldich
BloodThinnerHelp.com reports on a new and different allegation appearing in a lawsuit filed against Xarelto and manufacturer Janssen Pharmaceuticals in a Pennsylvania State Court. The claim alleges that Janssen’s (a subdivision of Johnson & Johnson) daily dose was not effective for a full 24-hour period, which caused the patient to suffer a stroke. The plaintiff was using Xarelto to prevent a stroke due to his atrial fibrillation condition, however, he ended up suffering from one just days after beginning to take the blood thinner.
Xarelto is the only blood thinner currently on the market that offers one pill per day dosing. All other blood thinners require at least two doses per day. Xarelto has been the subject of almost 2,000 lawsuits recently, however, due to the fact that it also has no corresponding antidote. Many other lawsuits surround this fact and detail episodes of uncontrollable bleeding allegedly caused by the drug.
When a patient using Xarelto is injured and begins to bleed, physicians can do nothing to make that individual’s blood clot. In these instances, in order to keep the patient alive, doctors must resort to extreme life-saving measures such as blood transfusions. Even then, these uncontrollable bleeding episodes can end in permanent damage or death.
Patients who use more traditional blood thinners do not have this issue. Traditional blood thinners have an antidote available in vitamin K. This means that if someone using a traditional blood thinner such as warfarin is injured and begins to bleed, doctors are able to administer vitamin K which reverses the effects of the blood thinner and allows their blood to clot--a difference that has the potential to be life-saving.
This particular suit, however, filed on October 8th of 2015, focuses on a new potential issue associated with the anticoagulant. Details of the complaint make it the first of its kind to suggest that the drug was ineffective for a full 24-hour period and was therefore unable to prevent the plaintiff’s stroke. Additionally, the plaintiff alleges that the drug may have even been the cause of his stroke.
As various allegations concerning Xarelto continue to mount, Attorney Joseph Osborne is working to ensure that everyone involved has the opportunity to explore their legal rights. Federal cases alleging Xarelto bleeding dangers have been consolidated to form MDL number 2592. As these consistently growing cases await trial, it is anticipated that they will only continue to grow. Patients who used Xarelto and suffered from adverse health events may be entitled to compensation. Attorney Osborne is offering free legal consultations to those involved.
To ask questions or to request more information concerning the Xarelto lawsuits, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.digitaljournal.com/pr/2765065
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Xarelto Lawsuit Numbers Surpass 2,000 Cases
Dec 3, 2015 | GTN News
By Marc Goldich
BloodThinnerHelp.com reports on recent press announcing that cases involved in the federal Xarelto multidistrict litigation (number 2592) have surpassed 2,000. The cases are being overseen by U.S. District Judge Eldon Fallon, who recently released another case management order concerning the litigation. The judge instructed those involved on the selection of cases for a bellwether pool. Cases are typically selected based on their preparedness for trial.
At this time, the judge has asked that a total of 40 cases be selected to enter the pool. From this pool, four cases will be chosen for initial bellwether trials. The date range for the first bellwether trial is expected to be between February and May of 2017, as much preparation has yet to take place. The next step in the pending litigation will be another status conference which has been set for December 21st of this year.
The lawsuits involved in the Xarelto MDL all similarly allege that the blood-thinner causes an increased risk for episodes of uncontrollable bleeding. For some, these episodes were fatal, for others, terribly damaging. In the midst of all the controversy surrounding the drug, Xarelto has widely been considered the most dangerous blood thinner on the market due to the fact that it has no corresponding antidote. Current plaintiffs have claimed manufacturers were negligent to release the drug to the market without an antidote, putting many lives in danger.
Because Xarelto has no antidote, if a patient it taking it and begins to bleed, physicians will be unable to stop the bleed and clot their blood. In these situations, doctors have to resort to extreme life-saving measures such as blood transfusions in an attempt to save the patient’s life.
Traditional blood thinners do not have this issue, as they have an antidote in vitamin K. If a patient using traditional blood thinners begins to bleed, doctors are able to administer vitamin K which counters the effects of the drug and allows their blood to clot.
The cases in the current MDL have been filed against manufacturers Bayer AG and Janssen Pharmaceuticals (a subdivision of Johnson & Johnson). As these cases await additional preparations for trial, Attorney Joseph Osborne is working to help ensure that anyone who has taken Xarelto and has subsequently experienced adverse side effects will be able to explore their legal rights. These individuals may be entitled to compensation, and Attorney Osborne is currently offering free legal consultations for those involved.
To request more information concerning Xarelto bleeding lawsuits, or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.mygtn.tv/story/30662822/xarelto-lawsuit-numbers-surpass-2000-cases
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Xarelto Lawsuit Alleges Wrongful Death Caused By Blood Thinner
Dec 3, 2015 | KUSA-TV
By Marc Goldich
BloodThinnerHelp.com reports on another development in the Xarelto lawsuit multidistrict litigation. Updates involve the details of a suit filed on behalf of a Georgia man by his son after the man passed away due to serious internal bleeding. The son alleges this internal bleeding was caused by his use of blood thinner Xarelto. The complaint, number 2:15-cv-00886, was filed in the state of Louisiana.
Currently, all Xarelto bleeding lawsuits which were federally filed have been consolidated by the U.S. Judicial Panel on Multidistrict Litigation. At this time, the cases number over 2,000. Additionally, Xarelto lawsuits are the subject of a Mass Tort Group of around 500 cases which has formed in Philadelphia, Pennsylvania. These groupings are formed in order to help the legal process run more smoothly and efficiently. They are possible due to the fact that all of the suits involved include similar allegations against both Janssen Pharmaceuticals (a division of Johnson & Johnson), and Bayer AG, manufacturers of Xarelto.
This particular complaint was filed on March 20th of 2015. In details of the suit, the son explains that his father died from uncontrollable internal bleeding and alleges that this was due to the fact that the father was using Xarelto. The father was prescribed Xarelto to treat his atrial fibrillation, as many are. The plaintiff states that he and his family were unaware of the dangers of the drug, specifically regarding the fact that it was released to the market without a corresponding antidote. Had they known this information, he asserts, they would have chosen a safer alternative treatment.
Xarelto has become widely considered the most dangerous blood thinner currently on the market due to its lack of antidote. Having no antidote means that if a person using Xarelto is injured and begins to bleed, physicians will not be able to stop the bleeding and clot their blood. In these instances, doctors have to resort to emergency, life-saving treatments such as blood transfusions.
Traditional blood thinners have an antidote in vitamin K. If a patient taking a traditional blood thinner becomes injured and bleeds, doctors can treat them with vitamin K which will counteract the medicine’s effects and clot their blood.
As the mounting lawsuits filed against Xarelto await trial, Attorney Joseph Osborne is working to ensure that anyone who has taken the drug and has suffered adverse health effects is able to look into their legal rights fully. These individuals may be entitled to significant compensation. Attorney Osborne is offering free legal consultations for those affected at this time.
To obtain additional information on Xarelto lawsuits, or to ask questions, please contact Joseph Osborne, Esq. by calling (866) 425-8902.
http://www.kusi.com/story/30662824/xarelto-lawsuit-alleges-wrongful-death-caused-by-blood-thinner
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Lawsuit claims Xarelto Brain Hemorrhage killed Grandmother
Nov 24, 2015 | A Drug Recall
The roughly 1,700 Xarelto lawsuits centralized in a multidistrict litigation in Louisiana continue to increase in numbers. One of the most recent lawsuits to join this MDL was filed by a woman who claims Xarelto intracranial bleeding killed her grandmother.
Ashlie Fluitt filed her Xarelto internal bleeding lawsuit on November 12 in the U.S. District Court for the Eastern District of Louisiana, where it will be centralized with similar lawsuits before U.S. District Judge Eldon Fallon. Ms. Fluitt claims that her grandmother, Hattie Deville-Goodwin, died in 2014 due to intracranial bleeding resulting from the anticoagulant effects of Xarelto.
Hattie Deville-Goodwin began to take Xarelto to prevent deep vein thrombosis in September 2014, says her granddaughter. In November 2014, just two months later, Ms. Deville-Goodwin developed a severe brain hemorrhage, and died because doctors were not able to stop the bleeding.
Since 2014, all Xarelto lawsuits filed in federal courts have been centralized before Judge Fallon for pretrial proceedings. In instances where multiple plaintiffs file lawsuits against a common defendant based on similar claims, the formation of an MDL can help to prevent duplicative discovery, avoid contradicting rulings from separate judges, and serve the convenience of all parties involved.
In the Xarelto MDL, plaintiffs allege that the makers of Xarelto, Janssen Pharmaceuticals and Bayer Healthcare, failed to properly warn of the risk of internal bleeding associated with Xarelto as well as of the lack of a reversal agent to stop Xarelto bleeding. Like all blood thinners, Xarelto is designed to prevent dangerous blood clots. However, this also means that the blood may not properly clot in the event of a hemorrhage or internal bleeding. When a patient taking an older blood thinner, warfarin (Coumadin) develops a bleed, doctors may be able to induce clotting with Vitamin K. However, there is currently no approved reversal agent to stop Xarelto internal bleeding. Some plaintiffs claim that they would not have used Xarelto had they known this.
Furthermore, some Xarelto lawsuit plaintiffs claim that the drug makers over-promoted Xarelto based on claims of convenience. Patients taking warfarin must undergo routine blood monitoring to ensure proper dosage, and Xarelto was marketed as a more convenient alternative to warfarin because blood monitoring was not thought necessary. Now, however, some experts claim that blood monitoring could help prevent dangerous or even fatal Xarelto internal bleeding events.
The next step in the Xarelto MDL will be preparation of bellwether cases, a small group of lawsuits representative of a greater number of claims. Though verdicts in bellwether trials are not binding on other claims, they may lead to settlements once potential jury responses to common testimony and evidence are seen.
If you or someone you love suffered serious injury or even wrongful death due to Xarelto internal bleeding, you could have grounds to pursue compensation for your damages in a Xarelto lawsuit. Contact a personal injury lawyer today to schedule a free legal consultation.
http://www.adrugrecall.com/news/lawsuit-claims-xarelto-brain-hemorrhage-killed-grandmother/
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Louisiana victims set sights on Xarelto lawsuit
Nov 25, 2015 | Vincent J. DeSalvo Blog
When some Louisianans get a headache, they take an aspirin. When they have allergies, they may pop a different kind of pill. When they have a disease, they likely take prescription medicine. But just because these medications are common and often effective does not mean that they are without risk. To the contrary, many medicines can have serious side effects even when used properly. Sometimes those side effects can be fatal.
Take, for example, a recent lawsuit. A grandmother took an anticoagulant, Xarelto, to treat deep vein thrombosis in her leg. After a couple of months, her brain began bleeding. Shortly thereafter, she died from an intercranial hemorrhage.
In response, the grandmother's family filed a wrongful death lawsuit against the drug's manufacturers, Bayer Healthcare and Johnson & Johnson's Janssen subsidiary.
The grandmother is not alone. Many others have also been harmed by Xarelto's side effects. So many people have been hurt that all of the cases are being consolidated into one case so that a single court can hear and resolve the issues common to all of the cases. As of now, there are more than 2,200 Xarelto-centric lawsuits waiting to be resolved in the Eastern District of Louisiana.
The side effects from Xarelto are just one danger lurking for Louisianans who take medication. Each has side effects, some more serious than others. If those side effects turn deadly, the family of the deceased may want to consider their legal options for getting compensation. To decide whether that step is right for them, Louisianans may benefit from discussing their situation with an experienced wrongful death attorney.
http://www.louisianamedicalmalpracticeattorneyblog.com/2015/11/louisiana-victims-set-sights-on-xarelto-lawsuit.shtml
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Xarelto Bleeding Lawsuit Filed by Georgia Man
Nov 27, 2015 | Top Class Actions
By Joanna Szabo
A Georgia resident has filed a Xarelto lawsuit against Janssen Research & Development, a subsidiary of pharmaceutical giant Johnson & Johnson.
The plaintiff, Addis J., began taking Xarelto in 2013, as prescribed by his physician as an anticoagulant or blood thinner. Addis’ Xarelto lawsuit alleges that his ingestion of Xarelto directly led to severe bleeding that required medical attention in May 2013.
The plaintiff claims that he suffered from this gastrointestinal bleeding because of Xarelto, and was landed with significant physical damages. The Xarelto lawsuit claims that, had the plaintiff been properly informed of the medication’s potential dangers and side effects, he would not have taken Xarelto.
Addis filed this Xarelto bleeding lawsuit on multiple counts, including failure to warn, defective design, negligence, breach of express and implied warranties, and fraudulent concealment, among several others.
Addis seeks punitive damages against Janssen for their allegedly deceptive and harmful practices regarding the manufacture and marketing of Xarelto.
Xarelto Basics
Xarelto (rivaroxaban) is a popular anticoagulant medication. Janssen, the developer, manufacturer, and marketer of Xarelto, claims that Xarelto has been prescribed to over seven million people across the world, helping prevent dangerous blood clots.
Despite Janssen’s claims that Xarelto is capable of preventing dangerous clotting complications, Addis’ lawsuit – and others like it – allege that the company’s fervent marketing misinformed patients and the medical community.
According to these Xarelto lawsuits, Janssen deliberately underplayed the drug’s safety and efficacy. Rather than being superior to warfarin (an anticoagulant staple drug), Xarelto is allegedly no safer to use, and like warfarin, should require routine blood monitoring to be safe.
Xarelto Bleeding Side Effects
Not all side effects of Xarelto are severe or dangerous, and not all users of Xarelto experience side effects. Those who do, however, can be subject to extremely severe and dangerous bleeding issues that cannot be controlled or reversed, given that there is no antidote to counteract Xarelto’s effects.
Addis’ Xarelto bleeding lawsuit and others like it allege that a series of clinical trials well known in the medical community has revealed a link between Xarelto and major bleeding events, such as gastrointestinal bleeding. The studies indicated that Xarelto had an even higher rate of major bleeding complications than other, similar drugs, including warfarin.
“Major bleeding” indicates that the bleeding involved a critical organ, led to reoperation, or led to fatalities.
Xarelto bleeding lawsuits claim that Janssen was not only aware of these studies and the bleeding risks of Xarelto, but failed to report these major bleeding complications as significant adverse effects. On top of this, the lawsuits allege that Janssen failed to adequately warn consumers and the medical community about the major bleeding risk associated with Xarelto.
Despite the manufacturer’s alleged knowledge of these risks, lawsuits claim, the company continued to market Xarelto in a manner that plaintiffs describe as negligent and misleading, diminishing the concern for the serious risks of the drug.
Xarelto Bleeding Lawsuits
Xarelto is currently facing hundreds of Xarelto bleeding lawsuits filed for patients who, after taking the dug, have experienced gastrointestinal bleeding, hemorrhaging, or other adverse events.
These Xarelto lawsuits claim that the drug makers failed to be completely transparent in the warnings for their product and the Xarelto bleeding side effects. These cases also allege that the drug maker should be held accountable for not providing an approved antidote that could reverse the medication’s effects, given the potentially damaging Xarelto side effects many claim to have suffered.
Plaintiffs claim that the drug manufacturers did not clearly portray the drug’s potentially damaging side effects on their packaging, in their advertising, or to the medical community as a whole.
Plaintiffs further allege that drug makers had a responsibility to provide blood level monitoring for users of their drug, especially after recent studies which have suggested blood level monitoring might significantly assist doctors to care for patients who use Xarelto.
If you or someone you know has experienced Xarelto side effects such as Xarelto bleeding, you may be able to join a class action Xarelto bleeding lawsuit or file an individual lawsuit against the manufactuurer.
The Xarelto Bleeding Lawsuit is Case No. 3:15-cv-00858-JLS-RBB, in the U.S. District Court for the Southern District of California.
http://topclassactions.com/lawsuit-settlements/lawsuit-news/230821-xarelto-bleeding-lawsuit-filed-georgia-man/
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More Than 2,000 Xarelto Lawsuits Have Been Filed
Nov 30, 2015 | Xarelto Lawyer
Bloodthinnerhelp.com, which is a website that reports on Xarelto lawsuits, has stated that over 2,000 lawsuits have been filed in the United States. People who have filed lawsuits allege that Xarelto causes uncontrollable bleeding, which often leads to death. Additionally, Xarelto does not have an antidote. This means that if a patient is injured and suffers bleeding, then the physician may not be able to stop the bleeding.
Excessive blood loss is dangerous, and it can result in death. Many patients who suffer excessive bleeding are required to get a blood transfusion. Other blood-thinners do have an antidote. Vitamin K can be used to counteract bleeding caused by traditional blood thinners. Doctors can administer the vitamin K, which will cause the blood to clot.
Most of the lawsuits have been filed against Jansen Pharmaceuticals, which is the manufacturer of Xarelto. Xarelto is typically prescribed to patients who are at a greater risk of suffering a stroke or blood clots due to atrial fibrillation. In some cases, doctors prescribe Xarelto to patients who are recovering from knee or hip replacement.
There have been several studies done to confirm that Xarelto can potentially cause dangerous side effects. A study done by the American Medical Foundation showed that Xarelto can potentially cause a severe injury to the liver. Another study done by the British Medical Association showed that people who take Xarelto are two times more likely to suffer uncontrollable bleeding than those who take Warfarin, which is another blood thinner.
Many people have stated that if they were aware of all of the dangers associated with taking Xarelto, then they would have never taken the drug. People have also stated that they did not know that there were safer alternatives to Xarelto on the market. Experts are predicting that there will be many more lawsuits filed in the future.
Xarelto can have devastating effects. Fortunately, people who have suffered severe bleeding or other complications due to Xarelto may be able to get compensation. If you have suffered side effects due to Xarelto, then you will need to contact a lawyer as soon as possible.
http://xareltolawyer.com/articles/more-than-2000-xarelto-lawsuits-have-been-filed/
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Xarelto — National Drug Litigation
Dec 1, 2015 | JD Supra Business Advisor
By Brenda Fulmer
November has proven to be a very busy month for Searcy Denney and its Xarelto clients, with the firm filing several new individual lawsuits on behalf of its clients besides participating in the national discovery efforts. Here, I summarize the new complaints filed recently on behalf of injured or deceased Xarelto users and their loved ones:
A wrongful death lawsuit was filed against the manufacturers of Xarelto on behalf of a Naples woman who died after suffering an intracranial hemorrhage caused by the anti-coagulant. The case is being prosecuted by her loving husband on behalf of her estate and survivors. Prior to use of Xarelto, she was an avid golfer and enjoyed an active retirement in Southwest Florida.
A lawsuit for the premature death of an Orlando husband was filed on behalf of his surviving wife and adult children. This patient was prescribed Xarelto for stroke prevention with the promise that the drug would be easier to take than Coumadin. Unfortunately, the decedent suffered a catastrophic Xarelto-induced gastrointestinal bleed, which led to chest pain, kidney failure, elevated blood pressure, fluid in his lungs, respiratory failure, and uncontrolled bleeding.
A personal injury lawsuit was initiated of a 71 year-old Boca Raton woman who suffered a GI bleed after ingesting Xarelto. This has been associated with the use of Xarelto. This plaintiff had to be hospitalized for anemia and active bleeding and required multiple blood transfusions due to her Xarelto-induced bleed.
A wrongful death claim was filed on behalf of the survivors of a 67 year-old Stuart, Florida woman who died after Xarelto caused a subdural hematoma and extensive bleeding in her brain. This patient took Xarelto for slight more than a year for atrial flutter, which is where the heart does not beat normally and is the most common reason for the prescription of Xarelto and other drugs in the same class hoping to reduce a patient’s risk of potential stroke from the abnormal heart rhythm.
A personal injury case was filed in the MDL in New Orleans on behalf of a 65 year-old retiree who resides in Melbourne, Florida. This plaintiff was prescribed Xarelto to prevent strokes in light of his previous diagnosis of atrial fibrillation. He only ingested Xarelto for about six weeks prior to suffering a catastrophic bleeding episode with associated kidney damage. Many of the clients injured by Xarelto have ingested the blood thinner for only a few days or weeks prior to the injury. This is a central issue in the Xarelto litigation, as the plaintiffs contend that the drug manufacturer should warn patients and prescribing physicians of the need for routine blood monitoring of patients before starting Xarelto and while on the drug to determine whether the patient metabolizes the drug consistently. There are many clients who cannot consistently process Xarelto, especially those with underlying kidney issues, such that they are either receive too little of the drug (so the drug is not adequately protecting them from having a stroke) or too much of the drug (which leads to GI bleeds, brain bleeds, and other life-threatening harms). The reality, however, is that no one would want to take Xarelto or other drugs in this class if frequent testing were required (which is counter to the primary selling point of this drug as a “no testing/no hassle” drug), especially because the effectiveness of Xarelto is equivalent to that of Coumadin, especially in light of the lack of an antidote for Xarelto and that the anti-coagulant effects of warfarin can be easily reversed. Much of the discovery that is ongoing at this point in time will focus on the drug manufacturers’ failure to provide adequate information about the need for ongoing patient monitoring and their decision to put profits before safety.
A complaint for personal injuries was filed in MDL 2592 on behalf of a Tennessee woman who spent three weeks in the hospital following bleeding in her brain caused by Xarelto, and drug she had ingested for only six months. This individual lawsuit was also brought on behalf of her husband, to whom she has been married for over 50 years for his loss of support, consortium, companionship and other damages relating to his wife’s brain injury and resulting disability, memory loss, and inability to regain the active life she enjoyed prior to the Xarelto-induced left temporal lobe hematoma.
A lawsuit was filed against Bayer, Janssens and other entities involved in the sale and development of Xarelto on behalf of a Jacksonville, Florida man who developed a GI bleed after taking Xarelto for less than a week. Xarelto had been prescribed for the prevention of a DVT following minor knee surgery, which is an FDA approved use of the drug. Because of his Xarelto-induced injury, he was hospitalized for several days in Central Florida and required blood transfusions to counter the anemia caused by the gastrointestinal bleed caused by rivaroxaban.
A personal injury lawsuit was also filed on behalf of a Gainesville woman prescribed Xarelto to prevent a deep vein thrombosis. Again, as is common with Xarelto plaintiffs, she ingested the drug for only a few weeks before requiring hospitalization for bleeding in her stomach and gastrointestinal tract caused by Xarelto.
The national litigation over Xarelto continues to move at a rapid pace. On November 20, 2015, Judge Fallon, the federal judge based in New Orleans who oversees the national litigation, held his monthly status conference to discuss developments in the cases pending against the manufacturers of Xarelto, one of the most popular blood thinners on the market linked to an excessive number of patient injuries and deaths due to gastrointestinal bleeding, hemorrhagic strokes, intracranial bleeding, cardiac tamponade, and other life-threatening bleeding events.
Xarelto is also known as rivaroxaban, and is the second drug approved by the FDA in the class of drugs known as direct thrombin inhibitors and direct factor Xa inhibitors. Xarelto was developed by German pharmaceutical giant Bayer, and is jointly marketed in the United States with Janssen Pharmaceuticals, a division of Johnson & Johnson. Other drugs in this class include Pradaxa (which was the subject of a confidential settlement in 2014 resolving 4,000 individual lawsuits) and Eliquis (also known as apixaban and marketed by Bristol-Myers Squibb).
At the November hearing in the MDL No. 2592, Judge Fallon was informed there are now over 4,000 individual lawsuits pending in the consolidated federal court proceedings and various state court venues (with nearly 500 individual plaintiffs having sued in state court in Philadelphia, Pennsylvania). We anticipate that several thousand additional lawsuits will be filed in the coming months.
At this November hearing, Judge Fallon again reminded the lawyers and all plaintiffs with pending cases of the judge’s previous orders regarding preservation of evidence. In particular, Pretrial Order #1 requires all parties to preserve medical records, medical bills, letters, diaries, notes, internet searches, marketing materials, and several other paper and electronic documents and files relating to the use of Xarelto. The MDL judge also made further orders (Pretrial Order #15 and Pretrial Order #15B) regarding preservation of electronic evidence, including emails, text messages, voicemails, etc. The next status conference hearings before Judge Fallon are scheduled for December 21, 2015, and January 22, 2016.
At the November of 2015 hearing, Judge Fallon heard arguments from both the plaintiffs and the defendants regarding the plan for selecting the cases that might be included in the first bellwether trials in the MDL. The judge had stated in the past that the plaintiffs whose cases would be eligible to include in these first trials would hail from Louisiana, Mississippi, and Texas, which comprises only about 15% of the plaintiffs who have sued in the MDL proceedings so far. The judge also indicated that half of the cases in the bellwether trial pool would be selected randomly, a process vehemently opposed by the plaintiffs for fear that such a process would cause cases being tried that were not representative of the thousands of pending cases.
The goal of a bellwether trial process in MDL proceedings is to, hopefully, try individual cases that are similar enough to many other pending cases, such that the results will be helpful in predicting the outcome of several pending claims. The parties and Judge Fallon, however, noted that it is not uncommon in a bellwether trial selection process for both sides to want to choose the cases strongest for their side, which, also, may cause cases being tried that are not truly representative either. In particular, the Xarelto plaintiffs were seeking to change the selection process to include a broader range of potential claims that might be more representative of the injuries suffered by all plaintiffs who have cases pending in the MDL. Judge Fallon noted the plaintiffs’ concerns, and within a few hours of conclusion entered an order that represented a compromise that allows the plaintiffs to include a few additional plaintiffs hailing from other states but still retains the plan to select some of the bellwether trial cases randomly.
The first trial in the MDL proceedings is scheduled to begin in February of 2017, and Judge Fallon will preside over that jury trial. It is likely that approximately 40 individual cases will be prepared for this first trial, and that the ultimate case to go to trial will be selected by Judge Fallon in the latter half of 2016. Subsequent trials are scheduled to occur in March, April, and May of 2017. Judge Fallon has clarified that he intends to remand the cases he does not personally try back to local jurisdictions for individual trial settings once these four initial MDL jury trials are completed. The prospect of the remand and transfer of thousands of individual cases back to various jurisdictions around the country is more daunting for the Defendants than the Plaintiffs, and often leads to global settlements. There are no settlement negotiations at this time, nor would any be anticipated until much closer to trial when the strengths and weaknesses of the cases (for both plaintiffs and defendants) are known.
In mid-November, Brenda Fulmer of Searcy Denney had the pleasure of attending a meeting in St. Louis along with lawyers from across the country who are involved in the review of all of the documents that are being produced in the national litigation. So far, about 2.2 million pages of documents have been produced. These documents have been reviewed electronically using sophisticated linguistic software and targeted searches. I am now working with the other lawyers to review those documents that have been identified by the electronic search engines as being the most relevant to critical liability and scientific issues in the litigation. This 2.2 million pages of documents is only the first round of production, and it is likely that we will ultimately receive well in excess of 10 million documents between Janssens Pharmaceutica and Bayer, including a number of documents in foreign languages. We are hopeful to complete the review of all of the documents over the next few months, as depositions will begin in early 2016.
The Plaintiffs are also seeking the production of relevant documents from the Food & Drug Administration as well as Duke Clinical Research Institute, relating to the clinical studies on which the FDA approval of Xarelto was based. It is likely that the Plaintiffs will also conduct depositions of a number of third party witnesses with regard to liability and scientific issues that are pertinent to Xarelto. Some progress has been made with regard to obtaining this critical evidence from these third parties, but the production remains incomplete. Sadly, injured plaintiffs have historically had a very difficult time in obtaining evidence and testimony from the FDA, even in the face of allegations of fraud with regard to clinical trials and serious patient safety issues.
Additional Research Sources:
MDL web site – http://www.laed.uscourts.gov/xarelto/
MDL PTO #1 – http://www.laed.uscourts.gov/xarelto/orders/pto1.pdf
MDL PTO#15 – http://www.laed.uscourts.gov/xarelto/Orders/PTO15.pdf
MDL PTO #15B – http://www.laed.uscourts.gov/xarelto/Orders/PTO15B.pdf
FDA approval history of Xarelto on drugs.com – http://www.drugs.com/history/xarelto.html
What is a GI Bleed – https://www.nlm.nih.gov/medlineplus/ency/article/003133.htm
What is an intracranial hemorrhage – http://emedicine.medscape.com/article/1163977-overview
https://www.searcylaw.com/xarelto-national-drug-litigation/
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Xarelto MDL Bellwether Selection Underway
Dec 1, 2015 | Injury Lawyer News
By Laura Woods
The process for determining which cases from the Xarelto multidistrict litigation in the Eastern District of Louisiana will be included in a bellwether discovery pool has been determined. U.S. District Judge Eldon Fallon issued a case management order on Nov. 20 outlining the selection criteria. Both parties were initially tasked with preparing the pool of bellwether cases, but they failed to come to an agreement on selection criteria, so Judge Fallon was forced to devise his own plan.
In total, 40 cases will be chosen for the bellwether pool, with each side selecting 10 cases and an additional 20 cases chosen at random. Judge Fallon’s plan indicates that half of the cases will have originated in the Eastern District of Louisiana, seven from any states chosen by the plaintiffs, seven from any states selected by the defendants, four from Mississippi federal court and two from Texas federal court. The only criteria for the seven states selected is that each have at least 20 eligible cases pending in the litigation.
Bellwether selection underway
Judge Fallon has set the next status conference for Dec. 21. In the meantime, he has ordered the parties to meet to set case selection eligibility criteria and map out case categories. They have also been ordered to devise a selection plan for the four cases that will be the first to go to trial. He has indicated this method should be in place by June 10, 2016, in preparation for the first trial dates that are expected to be scheduled between February and May 2017.
Currently, more than 2,800 Xarelto lawsuits have been consolidated under MDL 2592, which was established in Dec. 2014. Plaintiffs share common allegations that Bayer and Johnson & Johnson’s Janssen subsidiary knew about bleeding risks linked to the drug, but failed to provide an adequate warning to patients and medical professionals.
The outcome of the Xarelto bellwether trials is not binding on other cases, but may help the parties to reach settlements. If not, each case will be remanded back to its original court for a separate trial.
About Xarelto
Xarelto is a prescription blood thinning medication, used to reduce the risk of blood clots after knee or hip replacement surgery, to lower the risk of stroke in patients with non-valvular atrial fibrillation (not caused by a heart problem) and to treat pulmonary embolism or deep vein thrombosis and help prevent a recurrence. The drug hit the market in 2011 — after receiving approval through the U.S. Food and Drug Administration’s priority review program, which offers an expedited review progress for innovative medications — making it the first oral anti-coagulant since warfarin was approved almost 60 years prior.
In 2014, the FDA rejected a bid from the drugmakers to expand the uses of Xarelto to include preventing new heart attacks and strokes, preventing the clogging of heart stents and death in patients with acute coronary syndrome (ACS). Johnson & Johnson conducted one clinical trial to justify the expanded label and the advisory panel ruled this did not provide enough evidence of its efficacy.
http://injurylawyer-news.com/2015/12/xarelto-mdl-bellwether-selection-underway/
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Xarelto Reversal Agent Succeeds in Late-Stage Trial
Dec 2, 2015 | Lopez McHugh LLP
Reuters reports that andexanet alfa, a drug developed by Portola Pharmaceuticals to reverse the bleeding side effects of new oral anticoagulants like Xarelto, has proven successful in a late-stage clinical trial. Portola hopes the new data will help earn the antidote approval from the U.S. Food and Drug Administration.
Xarelto is a relatively new blood thinner that has made strides in the pharmaceutical industry since its introduction in 2011. The drug’s manufacturers, Janssen Pharmaceuticals and Bayer HealthCare, have marketed Xarelto as a safer and more effective alternative to older anticoagulants like warfarin. But several years of accumulated adverse event reports suggest that new blood thinners like Xarelto still pose a risk of severe bleeding. Moreover, patients have been quick to point out there is no approved remedy for the drug’s side effects. This means bleeding cannot reliably be stopped in the event of emergency surgery. The effects of older anticoagulants, such as warfarin, can be reversed with Vitamin K treatment.
Plaintiffs who have filed Xarelto lawsuits claim that Janssen and Bayer did not do enough to warn patients and doctors of the bleeding risk Xarelto poses. Late last year, the U.S. Judicial Panel on Multidistrict Litigation consolidated all pending federal Xarelto bleeding lawsuits for coordinated pretrial proceedings. While just 100 Xarelto lawsuits were included at the outset, the MDL now contains over 2,000 cases, and that number is expected to increase even more by the time trials begin in early 2017.
With andexanet alfa, Portola hopes to fill the much-needed role of Xarelto reversal agent. Researchers who conducted the late-stage trial report that the drug successfully reversed Xarelto’s anticoagulant effect within minutes and without any observed side effects. Compared with a placebo, andexanet alfa reduced the drug’s blood thinning effects by 97 percent for one to two hours after administration.
Tell your doctor about any health concerns you may have. If you or a loved one suffered from severe bleeding after taking Xarelto, contact the lawyers at Lopez McHugh today to receive a free legal consultation. You may be entitled to compensation through a Xarelto bleeding lawsuit.
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Dec 2, 2015 | Massachusetts Drug Injury Lawyers Blog
In the wake of almost countless lawsuits against prescription drug manufacturers, physician groups are advocating a ban on direct-to-consumer advertising. This aggressive form of mass marketing encourages patients to request certain prescription drugs, medical devices, and treatments that they may not otherwise seek out. The American Medical Association (AMA) is concerned that this results in unnecessary prescribing and increases potential risks to patients. Earlier this week, the AMA voted to end aggressive marketing campaigns that do not serve to educate physicians or patients, but rather to encourage patients to ask their doctors about specific medications or products. Contact a Boston Drug Injury Lawyer Today.
In addition to protecting the health and safety of patients, banning direct-to-consumer advertising would likely also result in a significant decline in health care costs. In a press release following the vote, AMA Board Chair-elect, Dr. Patrice A. Harris, said, “Today’s vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially-driven promotion, and the role that marketing costs play in fueling escalating drug prices.Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.” Approximately $4.5 billion is spent annually on direct-to-consumer advertising, according to the AMA. This is a 30% increase from the previous two years. Interestingly, only the United States and New Zealand allow these types of ads.
Drug Prices Have Spiked 4.7% in the Last Year
The AMA would like to see the creation of a physician task force and an accompanying advocacy campaign that encourages drug pricing transparency. In addition, they wish to see more drug options and an increase in competition among pharmaceutical companies. This year alone, drug prices have escalated by 4.7%. This increase negatively impacts the ability of patients to afford effective drugs, medical products, and treatments. Direct-to-consumer marketing also results in the widespread use of drugs that are sometimes not as effective as another option, and may be altogether unsafe. In fact, a 2014 BBC report revealed that most major pharmaceutical companies spend significantly more on marketing than they do on research.
Johnson & Johnson’s Xarelto Linked to Thousands of Injuries and Deaths
One of the manufacturers highlighted in the BBC report was Johnson & Johnson. The report claims that the pharmaceutical giant spent $8.2 billion last year on research and development, and $17.5 billion on marketing during that same time frame. Johnson & Johnson is currently facing millions of dollars in lawsuits as one of its most popular direct-to-consumer drugs, the anticoagulant Xarelto, has been linked to thousands of serious injuries and even deaths. Promoted as a low-maintenance alternative to warfarin for patients at risk of blood clots, Xarelto’s marketing campaign failed to warn of the increased risk of excessive bleeding. Unfortunately, with no known reversal agent for bleeding problems, many patients who developed hemorrhaging and excessive bleeding were severely injured or died. To date, there is still no approved reversal agent for Xarelto, yet it is still being aggressively marketed to the general public.
http://www.druginjurylawyersblog.com/
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Illinois Woman Files Xarelto Bleeding Risks Lawsuit
Dec 3, 2015 | Righting Injustice
By Jennifer Walker-Journey
Chezarea Jones lodged a 32-count complaint against Bayer and Johnson & Johnson’s Janssen Pharmaceuticals alleging the companies did not adequately warn about bleeding risks with their blood thinner Xarelto. The lawsuit was filed in St. Clair County (Illinois) Circuit Court on Oct. 13.
Jones’ lawsuit is one of hundreds filed against Bayer, Johnson & Johnson andJanssen alleging the companies did not properly warn doctors and health care providers of the dangers associated with Xarelto while knowingly exaggerating the drug’s benefits and uses compared to other drugs.
Xarelto was initially approved by the Food and Drug Administration (FDA) in 2011 and is used to prevent strokes in atrial fibrillation patients, prevent blood clots in patients undergoing knee or hip replacement surgery, and prevent or treat deep veil thrombosis and pulmonary embolism. It is one of four blood thinners in a new class of drugs know as factor Xa inhibitors, which are designed to be a more convenient alternative to the long-used warfarin, known by the brand name Coumadin.
All blood thinners increase the risk for major bleeding events including gastrointestinal bleeds, rectal bleeding, and brain bleeds, which can result in bleeding deaths. The newer class of blood thinners was considered more convenient because the drugs had fewer drug and food interactions than warfarin. Patients on warfarin also had to undergo regular monitoring to check levels of the medication in their blood.
However, one thing warfarin offered that the newer class of blood thinners did not was an antidote to reverse the bleeding effects of the drug in the event of an emergency or uncontrolled bleed. There is still no FDA-approved reversal agent for Xarelto.
Jones’ lawsuit seeks damages, attorney fees and costs of litigation.
Attorneys with Beasley Allen Law Firm are currently investigating cases of bleeding events in patients who have been treated with Xarelto.
http://www.rightinginjustice.com/news/2015/12/03/illinois-woman-files-xarelto-bleeding-risks-lawsuit/
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Xarelto Lawsuit Alleges Blood Thinner Caused GI Bleeding
Dec 4, 2015 | Top Class Actions
By Robert J. Boumis
A plaintiff from Kentucky has joined the larger litigation over alleged Xarelto bleeding incidents.
Xarelto is an anticoagulant or blood thinner, a drug designed to make it harder for blood clots to form within the body, reducing the risk of stroke. But this Xarelto lawsuit alleges that Xarelto side effects are a serious risk.
Plaintiff Linda S. of Kentucky has filed the Xarelto lawsuit. Per the text of her Xarelto lawsuit, Linda S. was prescribed Xarelto and took the drug between Dec. 4, and Dec. 24, 2013, taking the drug for less than a month.
On Dec. 23, the Xarelto lawsuit alleges, Linda S. experienced a gastrointestinal bleed, requiring emergency medical care. The Xarelto lawsuit goes on to state that she required “transfusions, surgery, and extensive hospitalization from the use of Xarelto.” Her claim holds that this was the result of taking the medication.
The Xarelto lawsuit states that the very trials used to approve Xarelto suggested that the drug could be dangerous. In fact, the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism studies, abbreviated RECORD, found that Xarelto had a higher rate of bleeding compared with similar drugs, requiring transfusions.
The Xarelto lawsuit reports that the clinical trial used to approve Xarelto for use in patients at risk for stroke and embolism from atrial fibrillation found that the drug carried a risk of major bleeding. Her lawsuit also noted that Xarelto lacked an “antidote.”
All blood thinners carry some risk of working too well and causing gastrointestinal bleeding and other forms of uncontrollable bleeding. However, as the text of this Xarelto lawsuit points out, older anticoagulants have known reversal agents.
For example, if a patient taking Warfarin suffers from gastrointestinal bleeding, a second drug, an “antidote” or “reversal agent,” can be administered to effectively turn off the drug. The Xarelto lawsuit notes that there is no such fix for Xarelto, and the original US drug information label does not note this in a special warning section.
The Xarelto lawsuit also asserts that despite these alleged risks associated with Xarelto, the drug’s makers aggressively promoted the drug. The Xarelto lawsuit states that the manufacturers spent more than $11 millon in 2013 on ads for Xarelto alone, and pulled in $582 million in global sales the first year Xarelto was on the market.
The Xarelto lawsuit alleges that in the advertising, “defendants [Xarelto’s makers] overstated the efficacy of Xarelto with respect to preventing stroke and systemic embolism, failed to adequately disclose to the patients that there is no drug, agent, or means to reverse the anticoagulation effects of Xarelto, and that such irreversibility could have permanent, disabling, life-threatening, and fatal consequences.”
The Xarelto lawsuit holds that aggressive marketing, coupled with the alleged dangers of Xarelto, led to the drug’s makers enriching themselves while endangering patients like Linda S.
The individual Xarelto Lawsuit is Linda S. vs. Janssen Research and Development LLC, et al, Civil Action No. 1143, filed within the larger MDL In Re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, filed in the United States District Court for the Eastern District of Louisiana.
http://topclassactions.com/lawsuit-settlements/lawsuit-news/232389-xarelto-lawsuit-alleges-gi-bleeding/
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