Preview Newsletter
Xarelto Media Monitoring Week of 5/1/2015
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New Xarelto Lawsuits Given Direct Filing Privileges in MDL
Apr 29, 2015 | PR Web
By The Onder Law Firm
New Xarelto lawsuits no longer need to be filed in federal district courts to be considered for inclusion in the national Xarelto multidistrict litigation*, according to a recent Pre-Trial order accessed by attorneys representing internal bleeding claims. These Xarelto attorneys provide regular news updates and no-costXarelto lawsuit case evaluation at XareltoContingencyLawsuit.com. -
Xarelto Lawsuits Move Forward Nationwide, with Scheduling of May Conferences in Federal, State Litigations
Apr 28, 2015 | PR Web
By Bernstein Liebhard LLP
Consolidated ligations established for Xarelto lawsuits (http://www.xareltolawsuit2015.com/) are moving forward nationwide, as courts overseeing proceedings in Louisiana and Pennsylvania prepare to convene conferences next month. According to court documents issued in the U.S. District Court, Eastern District of Louisiana, the next status conference in the federal Xarelto litigation will take place on May 13th at 9:00 a.m. C.S.T. (In Re: Xarelto Products Liability Litigation, No. 2592) -
Xarelto Litigation Proceeding in MDL and Mass Tort
May 1, 2015 | The Legal Examiner
By Roopal Luhana
The most recent status conference concerning the Xarelto MDL, currently proceeding in the Eastern District of Louisiana, took place on April 1, 2015. The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the MDL in December 2014. *Note: This article was sponsored by Chaffin Luhana LLP. -
Xarelto Lawsuits Charge That Defendant Failed to Warn of Drug’s Risks
Apr 30, 2015 | The Legal Examiner
By Steven Davis
More than 400 lawsuits are currently pending in the Xarelto Multidistrict Lawsuit (MDL), in the Eastern District of Louisiana, with U.S. District Judge Eldon E. Fallon presiding. These lawsuits were first consolidated in December 2014 under the name Xarelto (Rivaroxaban) Products Liability Litigation (MDL No. 2592), according to court documents. -
New Xarelto Lawsuits Charge Drug Manufacturer of Putting Profits Before Patients
Apr 30, 2015 | Childers, Schlueter & Smith, LLC
Dozens of Xarelto lawsuits have been consolidated into a multidistrict litigation, but more and more plaintiffs are deciding to file their own lawsuits against the drug’s makers. -
Potential Damages Available in a Xarelto Lawsuit
Apr 30, 2015 | Jones Ward PLC
By Jones Ward
Damages available in a Xarelto lawsuit may include reimbursement for medical and other expenses, such as lost wages, incurred as a result of your Xarelto use. Damages might also be available to you for the pain and suffering you have experienced. -
Gastrointestinal Bleeding Risks with Xarelto, Pradaxa May Be Higher Than Warfarin: Study
Apr 28, 2015 | About Lawsuits
By Irvin Jackson
New research suggests that the blood thinners Xarelto and Pradaxa may carry an increased risk of gastrointestinal bleeding when compared to older blood thinners, such as warfarin. -
Xarelto Litigation Update – Jacksonville Filing
Apr 27, 2015 | JD Supra Business Advisor
By C. Calvin Warriner III
Brenda S. Fulmer, a 21-year veteran of drug and medical device litigation and a partner with Searcy Denney, filed an indivdual lawsuit against the manufacturers of Xarelto in federal court in Jacksonvillle this week. The case is a wrongful death claim filed against a number of domestic and foreign drug corporations that are part of Johnson & Johnson and Bayer Corporation, the manufacturers and marketers of the blood thinner Xarelto. This lawsuit was filed on behalf of the surviving famliy members of a Green Cove Springs resident who died in 2013 after suffering a Xarelto-induced bleeding event. *Note: This article is sponsored by Searcy Denney Scarola Barnhart & Shipley -
California Man Files Xarelto Lawsuit
Apr 27, 2015 | The Legal Examiner
By Sheller, P.C.
Several pharmaceutical manufacturers are being sued by a California man over the drug Xarelto for product liability. The suit seeks damages in excess of $50,000 plus attorney fees and costs. -
How Soon Could Pradaxa Have an Antidote?
Apr 30, 2015 | Lawyers and Settlements
By Heidi Turner
One of the biggest concerns about Pradaxa side effects, and the side effects of other new generation anticoagulants, is that there is no approved antidote for certain adverse events. Pradaxa lawsuits have alleged that the maker of the drug did not warn patients about the lack of an antidote, putting them at risk of Pradaxa bleeding events. Now comes word that a Pradaxa antidote could be along in the near future. -
Pradaxa Antidote Granted Breakthrough Designation
Apr 29, 2015 | Righting Injustice
By Jennifer Walker-Journey
The Food and Drug Administration (FDA) has granted breakthrough designation forBoehringer Ingelheim’s idarucizumab, a reversal agent to its blockbuster blood thinner Pradaxa. The accelerated review process will cut about four months off the review process for the medication. *Note: This site is sponsored by Beasley Allen Law Firm. -
‘Science Day’ Scheduled in Xarelto Bleeding Lawsuits
Apr 28, 2015 | Top Class Actions
By Melissa Clyne
The federal judge overseeing the expansive multidistrict litigation of hundreds of Xarelto bleeding lawsuits has issued an order setting a so-called “Science Day,” where lawyers for both the plaintiffs and the defendants will address scientific and medical issues relevant to the cases. -
Science! Xarelto Plaintiffs Looking to Science Day in June
Apr 25, 2015 | Lawyers and Settlements
By Gordon Gibb
This is the time of year when students put the finishing touches on their science experiments, hoping for inclusion into a bigger competition. To that end, litigants and lawyers embroiled in lawsuits over Xarelto Bleeding Complications are looking to June as the next date on the Xarelto Lawsuit Calendar.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Plaintiff Attorney Press Releases
Plaintiff Attorney Blog
Reversal Agent
Science Day
Full Text of Stories Below
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New Xarelto Lawsuits Given Direct Filing Privileges in MDL
Apr 29, 2015 | PR Web
By The Onder Law Firm
New Xarelto lawsuits no longer need to be filed in federal district courts to be considered for inclusion in the national Xarelto multidistrict litigation*, according to a recent Pre-Trial order accessed by attorneys representing internal bleeding claims. These Xarelto attorneys provide regular news updates and no-costXarelto lawsuit case evaluation at XareltoContingencyLawsuit.com.
Direct Filing is a legal procedure that enables new cases making identical claims to be filed directly with a pending multidistrict litigation in order to eliminate delays and promote judicial efficiency, according to court documents. Persons who reside in the United States and who purchased Xarelto in the United States, may be eligible for this status, according to court documents.
Plaintiffs having already filed Xarelto lawsuits that have been consolidated for pretrial proceedings already number over 400, according to the Judicial Panel on Multidistrict Litigation’s record. Each Xarelto case makes common allegations, saying the pharmaceutical company Janssen Research & Development knew or should have known of the increased risk of serious internal bleeding caused by Xarelto, according to court documents. Persons who have filed Xarelto lawsuits say they were not warned of the alleged bleeding risk, or the fact that there is no antidote to bleeding caused by Xarelto, according to court documents.
Xarelto lawsuits attempt to recover damages for individuals and families who have suffered or lost a loved one as a result of bleeding or another related medical condition they attribute to Xarelto. Attorneys handling Xarelto lawsuitsthroughout the United States are now accepting claims from persons and their loved ones who suffered from severe internal bleeding or hemorrhagic stroke while taking Xarelto. Lawyers are investigating these inquiries for possible Xarelto lawsuits. The Onder Law Firm is renowned for its achievements in product and consumer safety litigation, with a strong track record of winning meaningful settlements for clients. The firm is nationally-renowned for its work on window blind strangulation, and has notable expertise in fighting on behalf of individuals against powerful corporations. Individuals and the family members of individuals who have suffered from internal bleeding and have taken Xarelto are eligible for a no-cost, no-obligation Xarelto lawsuit case review, and may contact the firm through its Xarelto Contingency Lawsuit website.
The Onder Law Firm also welcomes Xarelto lawsuit inquiries from other law firms, either to handle these inquiries or work as co-counsel.
About The Onder Law Firm
Onder, Shelton, O’Leary & Peterson, LLC is a St. Louis based personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. Onder, Shelton, O’Leary & Peterson has represented clients throughout the United States, and other firms throughout the nation often seek its experience and expertise on complex litigation. It is a recognized leader in products liability cases such as window blind cord strangulation and pharmaceutical litigation. The Onder Law Firms Xarelto attorneys provide information to the public at http://www.XareltoContingencyLawsuit.com.*Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, United States District Court, Eastern District of Louisiana
Link: http://www.prweb.com/releases/xarelto-bleeding/lawsuit/prweb12686502.htm
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Apr 28, 2015 | PR Web
By Bernstein Liebhard LLP
Consolidated ligations established for Xarelto lawsuits (http://www.xareltolawsuit2015.com/) are moving forward nationwide, as courts overseeing proceedings in Louisiana and Pennsylvania prepare to convene conferences next month. According to court documents issued in the U.S. District Court, Eastern District of Louisiana, the next status conference in the federal Xarelto litigation will take place on May 13th at 9:00 a.m. C.S.T. (In Re: Xarelto Products Liability Litigation, No. 2592)
Court records indicate that the Xarelto mass tort litigation underway in Pennsylvania’s Philadelphia Court of Common Pleas will convene its next monthly meeting one week later, on May 20th at 10:00 a.m. E.S.T. (In Re: Xarelto Litigation, Case ID 150102349)
“Our Firm is representing a number of Xarelto lawsuit plaintiffs in U.S. courts, and we are pleased with the progress thus far in the federal and state litigations. We are looking forward to the upcoming conferences in Pennsylvania and Louisiana, as the courts could provide updates regarding the status of discovery, coordination between state and federal proceedings, and other important developments that may prove relevant to our clients cases,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs. The Firm is currently offering legal consults to individuals who allegedly experienced uncontrollable internal bleeding and other serious Xarelto complications.
Xarelto Litigation
Court documents indicate that more than 600 Xarelto lawsuits have been filed on behalf of individuals who allegedly suffered life-threatening episodes of internal bleeding and other serious side effects while using this blood-thinning medication. This includes just over 400 claims pending in the federal litigation underway in the Eastern District of Louisiana, and 209 cases that have been filed in the mass tort program underway in Pennsylvania. Both of these consolidated litigations were established to allow similar product liability claims involving Xarelto to undergo coordinated pretrial proceedings, thereby conserving the resources of the courts, parties and witnesses.According to court records, all of the Xarelto lawsuits pending in these two proceedings accuse the manufacturers of the blood-thinning medication of failing to warn the public of its alleged association with uncontrollable internal bleeding and other life-threatening complications, including stroke, deep vein thrombosis, and pulmonary embolism. They also allege that Xarelto was misleadingly marketed as a superior alternative to warfarin, and point out that hemorrhaging caused by this older blood thinner can be stopped via the administration of vitamin K. By contrast, there currently exists no approved antidote to reverse Xarelto bleeding.
Individuals who allegedly experienced internal bleeding and other complications related to Xarelto may be entitled to compensation for medical bills and other damages related to their injuries. Learn more about filing a Xarelto lawsuit by visiting Bernstein Liebhard LLP’s website, or by calling 800-511-5092 to schedule a free, no obligation case review.
LInk: http://www.prweb.com/releases/xarelto-lawsuit/xarelto-litigation/prweb12686237.htm
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Xarelto Litigation Proceeding in MDL and Mass Tort
May 1, 2015 | The Legal Examiner
By Roopal Luhana
The most recent status conference concerning the Xarelto MDL, currently proceeding in the Eastern District of Louisiana, took place on April 1, 2015. The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the MDL in December 2014.
According to minutes from the meeting, both the plaintiffs and the defendants are working toward coordination between the established MDL and state court actions, which includes a Xarelto mass tort in Pennsylvania.
More Than 300 Xarelto Lawsuits Proceeding in MDL
This early in the proceedings, the parties are still busy completing forms, discussing software for fact sheets, creating and reviewing various orders (preservation order, document production protocol order, protective order, etc.), and establishing a “science day” where the medical facts of Xarelto will be explained and explored. The next status conference is scheduled for May 13, 2015.
At last count, more than 300 Xarelto lawsuits had been filed in the MDL. An additional 170 or so were pending in the Pennsylvania mass tort, which was established in January 2015 by Philadelphia Court of Common Pleas Administrative Judge Kevin Dougherty.
In most all cases, plaintiffs claim that after taking Xarelto, they suffered serious side effects, including uncontrollable bleeding. Some lawsuits have been filed by the families of victims who died due to Xarelto bleeding.
Xarelto Advertised as “More Convenient”
The FDA approved Xarelto for reducing the risk of blood clots in those going through hip and knee replacement surgery in 2011, and later that same year to reduce the risk of stroke in patients with non-valvular atrial fibrillation. They added approval for the treatment of deep vein thrombosis and pulmonary embolism in 2012.
Xarelto is one of the so-called “new generation” anticoagulants, along with Pradaxa, which was approved in 2010. Both were advertised as alternatives to warfarin, the leading blood thinner for decades, because they didn’t require dietary changes or regular blood monitoring.
Later studies questioned this logic for Xarelto, as it was discovered that Japanese patients and those with kidney problems could have benefitted from blood monitoring. It would have indicated which ones were at risk of uncontrolled bleeding.
The Institute for Safe Medication Practices also noted in its QuarterWatch publication for the first quarter of 2012, that even during the FDA’s approval process, reviewers raised concerns about the once-a-day dosing of Xarelto, saying that the drugs’ “peaks and troughs” could be eliminated with twice-a-day dosing.
Once it was on the market, Xarelto was linked to serious side effects, including gastrointestinal bleeding that led to hospitalization and in some cases, death. In the year leading up to June 30, 2012, over 1,000 cases were reported to the FDA, including 65 deaths. In the first quarter of 2013, the number of adverse events linked to Xarelto overtook those of Pradaxa.
Companies Failed to Provide Adequate Warnings
Plaintiffs who are involved in Xarelto litigation claim the manufacturers, Janssen Pharmaceuticals and Bayer, exaggerated the benefits of the drug when advertising it to consumers, while downplaying the potential risks.
They add that the companies failed to provide adequate warnings about the dangers associated with Xarelto, including the fact that there was no readily available antidote for excessive bleeding. Whereas doctors can stop bleeding caused by warfarin with injections of vitamin K, they have no similar solution for Xarelto bleeding. Patients suffering such bleeding have a higher risk of lasting injury and death.
Link: http://newyork.legalexaminer.com/defective-dangerous-products/xarelto-litigation-proceeding-in-mdl-and-mass-tort/
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Xarelto Lawsuits Charge That Defendant Failed to Warn of Drug’s Risks
Apr 30, 2015 | The Legal Examiner
By Steven Davis
More than 400 lawsuits are currently pending in the Xarelto Multidistrict Lawsuit (MDL), in the Eastern District of Louisiana, with U.S. District Judge Eldon E. Fallon presiding. These lawsuits were first consolidated in December 2014 under the name Xarelto (Rivaroxaban) Products Liability Litigation (MDL No. 2592), according to court documents.
One such lawsuit alleges that Xarelto’s maker, Janssen Research and Development, wrongfully represented the drug by failing to share knowledge about Xarelto’s safety risks. The plaintiff in the case allegedly suffered severe internal bleeding and other life-threatening side effects as a result of Xarelto use, according to court documents.
Another Xarelto case involves a Tennessee resident who filed a wrongful death lawsuit on behalf of his father, who died in 2013 from uncontrollable internal bleeding after using Xarelto to reduce his risk of stroke. The case alleges that the drug maker failed to warn the plaintiff’s father about the risks of Xarelto use, and seeks compensatory and punitive damages.
Xarelto Lawsuit Allegations
The Xarelto lawsuits all have similar allegations, which include:Failure to warnDesign defectsNegligenceNegligent designNegligent misrepresentationBreach of warranty
The lack of a reversal agent is a major part of the Xarelto lawsuits, along with concerns about the reliability of the data obtained from limited clinical trials submitted to the U.S. Food and Drug Administration (FDA) in support of the approval of Xarelto in the U.S.
Xarelto was first approved by the FDA in 2011 and is jointly marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson, and Bayer Corporation. It was heralded as an improvement over Coumadin (warfarin), which has been used for decades to prevent strokes, but requires frequent blood testing.
Link: http://chicago-land.legalexaminer.com/fda-prescription-drugs/xarelto-lawsuits-charge-that-defendant-failed-to-warn-of-drugs-risks/
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New Xarelto Lawsuits Charge Drug Manufacturer of Putting Profits Before Patients
Apr 30, 2015 | Childers, Schlueter & Smith, LLC
Dozens of Xarelto lawsuits have been consolidated into a multidistrict litigation, but more and more plaintiffs are deciding to file their own lawsuits against the drug’s makers.
One such lawsuit filed in January 2105 alleges that Xarelto prevented the plaintiff’s blood from congealing properly, and charges that Janssen Research and Development and Bayer Healthcare Pharmaceuticals, the makers of Xarelto, downplayed the risks of the drug, particularly the risk of gastrointestinal bleeding.
Another Xarelto lawsuit was filed March 20, 2015 by a dozen plaintiffs in California, who are suing the drug’s maker of putting consumers’ health at risk while continuing to market Xarelto. This particular lawsuit notes that unlike Coumadin (warfarin), Xarelto does not require any rigorous and ongoing monitoring.
Xarelto plaintiffs’ allege that Janssen and Bayer should have been more proactive in warning the public about the drug’s potential side effects, which include irreversible brain bleeding and uncontrollable hemorrhaging. The suits charge that the marketing of Xarelto wrongly communicated to health care providers that follow-up testing was not necessary, according to court documents. As of January 2015 there were 73 lawsuits alleging injury from Xarelto bleeding events.
What is Xarelto?
Xarelto is an anticoagulant that works by blocking certain clotting proteins in the blood. It is used to prevent blood clots from forming due to an irregular heartbeat, xarelto imageafter hip or knee replacement surgery, and to treat deep vein thrombosis and to prevent clots from forming again.
Doctors have been searching for many years for an anticoagulant that didn’t require the stringent scrutinizing that warfarin does, and thought Xarelto might be the answer – until it was discovered that the blood thinner had become associated with numerous severe bleeding events. Vitamin K will swiftly counteract the blood thinning properties of warfarin, but as of yet there is no effective antidote for Xarelto.
Get Help
If you or a loved one has suffered serious, uncontrollable bleeding while on Xarelto, you should speak with Childers, Schlueter & Smith today about seeking compensation. It may be the only way to alleviate the financial hardship that has been placed upon you.
Consultations are free and without obligation.
Link: http://www.cssfirm.com/2015/04/30/new-xarelto-lawsuits-charge-drug-manufacturer-of-putting-profits-before-patients/
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Potential Damages Available in a Xarelto Lawsuit
Apr 30, 2015 | Jones Ward PLC
By Jones Ward
Damages available in a Xarelto lawsuit may include reimbursement for medical and other expenses, such as lost wages, incurred as a result of your Xarelto use. Damages might also be available to you for the pain and suffering you have experienced.
In the event that your medical and other costs and pain and suffering are likely to continue, you might also be entitled to future medical and other expenses. You might also be entitled to damages for future pain and suffering you have endured as the result of your use of Xarelto.How Much Will my Xarelto Damages Be?
The amount of your award of damages will depend on the particular facts and circumstances of your Xarelto lawsuit. For those who have incurred the most expenses and endured the most pain and suffering, the amount of their award will be the greatest. Those with lesser amounts of expenses and pain and suffering will be awarded damages in proportion to those expenses and pain and suffering.
One way to gauge the approximate amount of your award is to compare other cases that have been settled or tried in cases similar to your own. These Xarelto lawsuits could be ones filed before yours.in the court where your lawsuit has been brought. They could also be Xarelto lawsuits that had been brought in other courts. For example, there are multiple Xarelto lawsuits which have been brought in a New Jersey state court and in a federal court in New Orleans. All these lawsuits have been brought recently, so you can expect it will take some time before any lawsuit has reached a settlement or a verdict.
Another way to estimate a potential award is the amounts being awarded in lawsuits involving products similar to Xarelto. As Xarelto is an anticoagulant, or blood thinner drug, other blood thinner drug lawsuits will provide a way to estimate the amount available for your damages. There is in fact such a lawsuit involving Pradaxa, a blood thinning drug with properties similar to Xarelto. The Pradaxa lawsuit was filed 2 years before Xarelto, and individual Pradaxa lawsuits have been settled. These settled lawsuits provide valuable information as to how much a Xarelto lawsuit might be worth.. Pradaxa, has already led to a number of lawsuits filed against its manufacturer, Boehringer Ingelheim, for complications such as excessive bleeding and death. Its maker has paid approximately $650 million dollars to settle about 4,000 claims.
Another factor that could affect the amount of your award is the amount of money the Xarelto Defendants have. Fortunately, the Xarelto Defendants are among the largest pharmaceutical companies in the world. and among the most well endowed.
One other factor that will affect the size of your award is whether or not the court allows punitive damages. As its name suggests, punitive damages are meant to punish a civil defendant for reprehensible conduct. Punitive damages might be awarded in a case if the Xarelto Defendants were shown to have sold Xarelto despite having knowledge that Xarelto posed a high risk of causing serious injury or death.
Link: http://www.jonesward.com/potential-damages-available-in-a-xarelto-lawsuit/
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Gastrointestinal Bleeding Risks with Xarelto, Pradaxa May Be Higher Than Warfarin: Study
Apr 28, 2015 | About Lawsuits
By Irvin Jackson
New research suggests that the blood thinners Xarelto and Pradaxa may carry an increased risk of gastrointestinal bleeding when compared to older blood thinners, such as warfarin.
In a study published by the BMJ (British Medical Journal) on April 24, researchers from Johns Hopkins indicate that Xarelto (rivaroxaban) may carry up to twice the risk of gastrointestinal bleeding of warfarin, and Pradaxa (dabigatran) may increase the risk of such bleeds by as much as 50%.
Researchers looked at data on more than 46,000 patients who were prescribed warfarin (sold under the brand name Coumadin), Pradaxa or Xarelto between October 2010 and March 2012.
While warfarin has been used to prevent strokes among patients with atrial fibrillation for decades, Pradaxa and Xarelto are part of a new generation of blood thinners introduced in recent years as superior alternatives, since the drug makers claim they require less frequent blood monitoring.
Since the new drugs hit the market, they have been linked to thousands of reports involving severe and uncontrollable bleeding, since there are no approved reversal agents available. Unlike warfarin, where doctors can quickly stop the blood thinning effects of the medication if bleeding develops, there are currently no approved antidotes for Pradaxa or Xarelto, leaving many health providers unable to control bleeding events.
In this latest study, researchers note that the findings do not demonstrate a statistically significant difference in the risk of bleeding between Pradaxa and warfarin, or between Xarelto and warfarin users. However, they warn that they were unable to rule out that both drugs may carry increased risks of bleeding over warfarin.
Several studies have previously found increased risks of gastrointestinal bleeding from Pradaxa side effects, the researchers note. They said that the differences between the findings of their study and those of other studies may rest in the differences in study populations. This most recent study involved a younger population.
Researchers concede that the bleeding risk with Pradaxa may be age-dependent and concentrated among elderly users, which was not a population that was well-represented in their study.
“Although rates of gastrointestinal bleeding seem to be similar in this commercially insured sample of adults in the United States, we cannot rule out as much as a 50% increase in the risk of gastrointestinal bleeding with dabigatran compared with warfarin or a more than twofold higher risk of bleeding with rivaroxaban compared with warfarin,” they concluded.Bleeding Problems with Pradaxa, Xarelto
Pradaxa was the first member of this new generation of anticoagulants to hit the market, designed to replace Coumadin (warfarin) as the “go-to” medication for prevention of strokes due to atrial fibrillation. Other members of this new class introduced after Pradaxa include Xarelto and Eliquis.
Within a year after Pradaxa was introduced, it quickly earned the dubious distinction as one of the medications most commonly associated with adverse event reports submitted to the FDA.
In recent years, more than 4,000 Pradaxa bleeding lawsuits were filed against Boehringer Ingelheim, alleging that the drug maker failed to adequately warn about the risks associated with the medication or the lack of an effective reversal agent. Following several years of litigation, the drug maker eventually agreed to pay about $650 million in Pradaxa settlements, with an average of about $150,000 awarded to former users who experienced severe and sometimes fatal bleeds.
Amid the mounting litigation over Pradaxa, Xarelto quickly overtook the top spot among the new generation of anticoagulants, with sales exceeding those of Pradaxa in 2013. However, similar bleeding problems with Xarelto soon surfaced.
Over the past year, a growing number of Xarelto lawsuits have been filed involving bleeding injuries, raising similar allegations that inadequate warnings were provided about the lack of an approved reversal agent and claiming that the drug makers should have never introduced the medication without an antidote to allow doctors to reverse bleeding events.
Both drug makers are currently working on identifying a safe and effective reversal agent, with Boehringer Ingelheim announcing last week that the FDA granted fast-track review for a potential reversal agent for Pradaxa.
Link: http://www.aboutlawsuits.com/gastrointestinal-bleeding-risk-xarelto-pradaxa-81334/
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Xarelto Litigation Update – Jacksonville Filing
Apr 27, 2015 | JD Supra Business Advisor
By C. Calvin Warriner III
Brenda S. Fulmer, a 21-year veteran of drug and medical device litigation and a partner with Searcy Denney, filed an indivdual lawsuit against the manufacturers of Xarelto in federal court in Jacksonvillle this week. The case is a wrongful death claim filed against a number of domestic and foreign drug corporations that are part of Johnson & Johnson and Bayer Corporation, the manufacturers and marketers of the blood thinner Xarelto. This lawsuit was filed on behalf of the surviving famliy members of a Green Cove Springs resident who died in 2013 after suffering a Xarelto-induced bleeding event.
Xarelto was first approved for sale in the United States on July 1, 2011. The drug is jointly marketed by Janssen Pharmaceuticals, a division of Johnson & Johnson, and Bayer Corporation (including the U.S. based subsidiary as well as the German parent company). Xarelto was the second drug in this class of anti-coagulants to be approved; the first was Pradaxa (approved by the FDA in the fall of 2010), which is manufactured by Boehringer Ingelheim, another German pharmaceutical manufacturer.
This new class of anti-coagulants directly impact thrombin and Factor Xa (a protein involved in the clotting process). They were heralded as an improvement over Coumadin (also known as warfarin), which has been used for decades to prevent strokes, but requires frequent blood testing of drug levels as other medications and foods can interfere with how Coumadin works in the body. Coumadin disrupts vitamin K levels, which is essential to the body’s clotting functions. Xarelto was approved for stroke prevention in patients with atrial fibrillation, and for the prevention of blood clots in patients following surgical procedures.
In late 2014, a request was filed before the Judicial Panel on Multidistrict Litigation (JPML) to establish national coordination of the personal injury and wrongful death lawsuits that have been filed against Bayer and Janssen Pharmaceuticals relating to Xarelto. At the time of filing the request for establishment of multidistrict litigation (referred to as an “MDL”), there were 21 individual lawsuits pending in 10 federal district courts in Alabama, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, New York, Utah, Vermont, and West Virginia involving plaintiffs who suffered bleeding-related injuries following their ingestion of Xarelto.
At the hearing before the JPML held in early December in Charleston, the panel of federal judges heard arguments from both plaintiffs and defense counsel regarding the need for establishment of an MDL as well as recommendations as to the best federal court and judge for supervising the MDL proceedings for the Xarelto cases. The defendants requested that the cases be sent to a federal court in New Jersey, and most of the plaintiffs advocated for the cases to be sent to Judge Herndon in the East St. Louis, Illinois. Judge Herndon also oversees two other MDLs: the Yaz and Yasmin birth control lawsuits (which also involve Bayer as a Defendant) and the Pradaxa blood thinner cases (a drug in the same class as Xarelto that has also been the subject of several thousand lawsuits).
Ultimately, the Judicial Panel issued its order establishing MDL No. 2592 on December 12, 2014, which is referred to as “In Re: Xarelto (Rivaroxaban Products Liability Litigation.” The JPML chose United States District Court Judge Eldon E. Fallon in New Orleans to oversee this new coordinated national litigation effort. Judge Fallon is highly-regarded for his successful work in previous MDL pharmaceutical cases involving Propulsid (a heart drug also manufactured by Janssen) and Vioxx (Merck’s popular anti-inflammatory medication). We are thrilled with Judge Fallon’s selection, as he is considered to be one of the best MDL judges in recent history and is industrious and does not tolerate delays or gamesmanship.
In an MDL, individual lawsuits that are pending in federal courts across the country are transferred to a single federal judge who oversees pretrial discovery, the first trials in the national litigation, settlement negotiations, and preparation of the cases for future trials in local federal courts. This process is used to coordinate a number of different types of complex litigation and mass torts where many plaintiffs have been injured by a single event or product. MDL coordination is usually ordered for cases involving pharmaceuticals and medical devices and has also been used for the BP oil spill, hotel fires, airline crashes, and litigation involving the 9/11 terrorist attacks.
The focus of the Xarelto litigation is on the insufficiency of the drug warning labels in several key areas:The warning labels fail to properly inform patients and prescribing physicians that certain patients are at higher risk for bleeding events (such as those with a pre-existing history of a bleeding event as well as those with impaired kidney function)The warning label downplays the incidence of bleeding events caused by Xarelto while overstating the benefits of XareltoThe package insert and professional information fails to inform physicians of the need for routine monitoring of blood levels of Xarelto (which obviates the primary reason why Xarelto would be taken over Coumadin)
The lack of a reversal agent for Xarelto is also a part of the liability case, but less of an issue than the failure to inform physicians and patients of the need for testing to determine how a patient metabolizes Xarelto (in hopes of identifying patients with an intolerance to the drug before they experience a build-up of toxic levels and suffer a bleeding event). There are also concerns about the data from the ROCKET and RECORD studies, which were the limited clinical trials submitted to the FDA in support of the approval of Xarelto in the United States. Similar allegations were made in the litigation over Pradaxa, which began in 2012, and resulted in a $650 million global settlement last year. Pradaxa was also approved after a single clinical trial (Re-LY), and the reliability of the data from that study was a primary focus of that litigation effort.
As of April 15, 2015, the Judicial Panel on Multidistrict Litigation reported that more than 400 indivdiual lawsuits have been direct-filed or transferred into MDL No. 2592, the coordinated proceedings that are pending before Judge Fallon in federal court in New Orleans. There are also parallel state court proceedings pending in Pennsylvania state court in Philadelphia, which is where some of the defendant drug companies are headquartered. These indivdiual lawsuits have been filed on behalf of patients and their survivors who have suferred personal injuries or died due to GI bleeds, intracranial hemorrhages, and other significant bleeding injuries while taking Xarelto. An order was signed in January establishing a mass tort consolidation in Pennsylvania state court, which resembles the MDL process that Judge Fallon will be presiding over for the Xarelto cases.
Janssen and Bayer objected to the coordination of the Xarelto cases in Philadelphia, and claimed that the judge lacks jurisdiction as the drug manufacturers are based in New Jersey rather than Pennsylvania and most of the plaintiffs who filed cases in Pennsylvania reside in other states. Undoubtedly, the first several months of the coordinated litigation in Pennsylvania will be focused on these threshold jurisdictional and venue issues. It is common to have both state and federal court proceedings that are operating on parallel tracks in pharmaceutical litigation involving thousands of injured plaintiffs. Although having too many judges can be detrimental to the efficiency of the litigation process, it is certainly a good idea to have more than just one judge. Having multiple jurisdictions also allows more individual cases to be scheduled for trial, and, at times, allows us to pursue different avenues for discovery. The MDL process specifically directs the assigned federal judge to coordinate with state court judges to ensure that the cases are moving as efficiently as possible in state and federal courts around the country.
Link: http://www.jdsupra.com/legalnews/xarelto-litigation-update-jacksonville-22211/
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California Man Files Xarelto Lawsuit
Apr 27, 2015 | The Legal Examiner
By Sheller, P.C.
Several pharmaceutical manufacturers are being sued by a California man over the drug Xarelto for product liability. The suit seeks damages in excess of $50,000 plus attorney fees and costs.
The lawsuit was filed by Kenneth Niemeir on March 31 in St. Clair County Circuit Court against Janssen Research & Development and several others.
The complaint alleges the defendants manufactured, marketed and distributed Xarelto as a product intended to reduce stroke risk and embolism in certain patients, but study results have raised questions about the dosage and highlighted that in the case of adverse side effects, there is no antidote to reverse the drug’s effects. Niemeir contends the defendants overstated the efficacy of the drug which misleads consumers.
Xarelto Background
Xarelto is a prescription anticoagulant (blood thinner) that treats and prevents blood clots from forming and traveling to the brain which can lead to a stroke.
Xarelto Safety Warnings
Xarelto may cause stomach bleeding. Daily use of alcohol while using this medicine will increase your risk for stomach bleeding. Limit alcoholic beverages.
Xarelto can cause bleeding. To lower the chance of getting cut, bruised, or injured, use great caution with sharp objects like safety razors and nail cutters. Use an electric razor when shaving and a soft toothbrush when brushing your teeth. Avoid activities such as contact sports. If you fall or injure yourself, especially if you hit your head, contact your doctor immediately. Your doctor may need to check you for hidden bleeding that could be serious.
An estimated one million prescriptions of Xarelto are written each quarter, a 240% increase from last year. America’s Institute for Safe Medicine Practices (ISMP) says, “Anticoagulant drugs are a high-risk treatment and cause bleeding in approximately 15% of patients with atrial fibrillation exposed for a year”.
News reports blame Xarelto for 1,400 deaths.
In three years on the U.S. market, Xarelto has been prescribed to more than 2 million patients to date.
If you are taking this drug and have experienced any adverse side effects please contact your doctor immediately and seek medical attention.
Link: http://philadelphia.legalexaminer.com/fda-prescription-drugs/california-man-files-xarelto-lawsuit/
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How Soon Could Pradaxa Have an Antidote?
Apr 30, 2015 | Lawyers and Settlements
By Heidi Turner
One of the biggest concerns about Pradaxa side effects, and the side effects of other new generation anticoagulants, is that there is no approved antidote for certain adverse events. Pradaxa lawsuits have alleged that the maker of the drug did not warn patients about the lack of an antidote, putting them at risk of Pradaxa bleeding events. Now comes word that a Pradaxa antidote could be along in the near future.
Anticoagulants lower the occurrence of blood clots, preventing strokes from occurring. Because they thin the blood, however, they also prevent blood from clotting under normal circumstances, increasing the risk of an uncontrolled bleeding event. Warfarin, an older anticoagulant, had an antidote in the form of vitamin K, which could be used to reverse the anticoagulant effects and stop bleeding events.
Newer generation anticoagulants do not have a widely accepted antidote, which means when a bleeding event occurs, the patient is at risk of uncontrolled bleeding causing serious injury or even death. Lawsuits have been filed concerning Pradaxa and Xarelto, with approximately 4,000 Pradaxa claims settled by Boehringer Ingelheim for $650 million in May 2014.
According to a press release from Boehringer Ingelheim, an antidote to Pradaxa is on the horizon. The drug, called idarucizumab, is reportedly on the FDA’s fast track for accelerated approval and would make Pradaxa the first newer-generation anticoagulant to have a reversal agent.Idarucizumab’s safety and effectiveness have not been established. Early data shows no “clinically relevant adverse reactions” to idarucizumab. Boehringer Ingelheim says it is conducting a study in patients in more than 35 countries since May 2014. The antidote could help Pradaxa’s sales, which have been stagnant according to Reuters (4/22/15). Pradaxa has recently faced pressure from similar drugs, Xarelto and Eliquis, but Pradaxa’s antidote would likely be the first available, giving it an advantage over the other anticoagulants.
“If approved, idarucizumab has the potential to be a significant evolution in care by providing physicians with an option for PRADAXA patients in rare emergency situations that may require rapid reversal of the anticoagulation effect of dabitagran,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Phramaceuticals, Inc.
Despite the settlement in 2014, there are still more than 1,600 Pradaxa lawsuits consolidated before US District Judge David Herndon under MDL 2385 in the Southern District of Illinois as of April 15, 2015.Link: http://www.lawyersandsettlements.com/articles/pradaxa-side-effects-dabigatran/pradaxa-side-effects-lawsuits-heart-14-20609.html#.VUPOgyFVhBc
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Pradaxa Antidote Granted Breakthrough Designation
Apr 29, 2015 | Righting Injustice
By Jennifer Walker-Journey
The Food and Drug Administration (FDA) has granted breakthrough designation forBoehringer Ingelheim’s idarucizumab, a reversal agent to its blockbuster blood thinner Pradaxa. The accelerated review process will cut about four months off the review process for the medication.
Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA can grant breakthrough designation to specific drugs that meet set criteria such as therapies that are used individually or in combination with other drugs to treat a serious or life threatening disease or condition, or those in which preliminary data shows evidence that the medication may provide substantial improvement over existing therapies.
The breakthrough designation does not guarantee market approval. It only speeds up the agency’s review process in an effort to get these much-needed medications on the market sooner.
Pradaxa is a blood thinner that is used to prevent strokes in patients with a common heart rhythm abnormality known as atrial fibrillation. It was approved in 2010 as the first-in-class alternative to the long-used warfarin. Patients treated with warfarin require regular monitoring whereas patients taking Pradaxa do not need monitoring. A year later, Xareltobecame the second medication in this new class of blood thinners.
All blood thinners carry bleeding side effects, meaning patients can suffer uncontrolled and sometimes fatal bleeding events while being treated with these medications. However, unlike warfarin, there are no antidotes to reverse the blood thinning qualities of Pradaxa or Xarelto. This has led to numerous lawsuits against makers of both drugs.
In May, Pradaxa manufacturer Boehringer Ingelheim agreed to pay $650 million to resolve about 4,000 stat and federal lawsuits involving bleeding events. Now, Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer are facing similar lawsuits with Xarelto.
Link: http://www.rightinginjustice.com/news/2015/04/29/pradaxa-antidote-granted-breakthrough-designation/
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‘Science Day’ Scheduled in Xarelto Bleeding Lawsuits
Apr 28, 2015 | Top Class Actions
By Melissa Clyne
The federal judge overseeing the expansive multidistrict litigation of hundreds of Xarelto bleeding lawsuits has issued an order setting a so-called “Science Day,” where lawyers for both the plaintiffs and the defendants will address scientific and medical issues relevant to the cases.
U.S. District Judge Eldon Fallon in the U.S. District Court in the Eastern District of Louisiana has set aside June 11 for the parties to address pertinent information expected to be raised in the cases. Litigants accuse Xarelto manufacturer Janssen Pharmaceuticals (a division of Johnson & Johnson) of failing to provide adequate warnings about the risk of severe Xarelto injury, including irreversible bleeding and the lack of an approved reversal agent for the new-generation blood-thinner.Xarelto “Science Day”
“Science Day” presentations typically take place in complex pharmaceutical litigation that involves multiple claims of a similar nature. It allows for each of the parties to present to the court its information in a non-adversarial setting well in advance of a trial.
The Xarelto Science Day is likely to include information about blood thinners and how they prevent blood clots and strokes as well as information and data about serious injuries and deaths from Xarelto and the bleeding risks associated with the medication.What is Xarelto?
Since receiving FDA approval in 2011, Xarelto has been widely prescribed to prevent blood clots in patients suffering from atrial fibrillation (arrhythmia of the heart), deep vein thrombosis (blood clots deep within the body), pulmonary embolism (blood clots in the lungs), stroke, and patients who have recently undergone a knee or hip replacement surgery.
It is viewed as an alternative to Warfarin (Coumadin), a blood thinner that has been used in the United States for 50 years. Severe internal bleeding and death are Xarelto’s most commonly reported side effects, but others include thrombosis (blood clots), decreased hemoglobin (a substance that carries oxygen in red blood cells), cerebrovascular accidents (an event that leads to a cerebral hemorrhage), hematoma (a semisolid mass in the blood), peripheral edema (swelling of the lower limbs), and dyspnea (difficulty breathing).
Johnson & Johnson and Bayer have marketed Xarelto as a superior blood thinner alternative to Coumadin for anticoagulant therapy. Patients taking Coumadin must adhere to dietary restrictions and regularly have their blood checked.
But internal bleeding episodes while on Coumadin can be reversed by administering vitamin K. No approved antidote exists to reverse Xarelto bleeding.Xarelto Lawsuits
Plaintiffs who have filed Xarelto lawsuits claim that they were not made aware that Xarelto bleeding events could not be reversed similarly to Coumadin, with vitamin K.
Xarelto is in the same class of drugs as Pradaxa, another of the newer anticoagulants which is also a defendant in a slew of lawsuits where plaintiffs have alleged bleeding complications. Pradaxa manufacturers reached a $650 million settlement with thousands of plaintiffs.
Link: http://topclassactions.com/lawsuit-settlements/lawsuit-news/54620-science-day-scheduled-xarelto-bleeding-lawsuits/
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Science! Xarelto Plaintiffs Looking to Science Day in June
Apr 25, 2015 | Lawyers and Settlements
By Gordon Gibb
This is the time of year when students put the finishing touches on their science experiments, hoping for inclusion into a bigger competition. To that end, litigants and lawyers embroiled in lawsuits over Xarelto Bleeding Complications are looking to June as the next date on the Xarelto Lawsuit Calendar.
The so-called Xarelto “Science Day” is coming up on June 11, and it’s an opportunity for attorneys to apprise the Court as to scientific and medical issues relevant to plaintiff claims. The session, mandated through an order that was brought down earlier this month, relates to federal multidistrict litigation (In Re: Xarelto Products Liability Litigation, No. 2592).
Not to suggest there will be desks set up with Bristol board drawings and other displays akin to the science displays of our youth. The US District Court for the Eastern District of Louisiana will be properly sporting the guise of a legal hall rather than a classroom. But it’s the thought that counts. And with the Xarelto Bleeding Issue having fostered so many lawsuits, science is an important factor.
Much like manufacturing and technology, the pharmaceutical industry is constantly evolving, fueled by a medical community and patient constituency always on the hunt for newer, better, faster, more effective and more convenient drugs.
Xarelto is certainly newer than the decades-old Coumadin (warfarin). But is it better? The jury is still out on that one.
Science will be a big part of any lawsuit dealing with Xarelto Side Effects. That’s because of the differences that separate Xarelto and warfarin. The latter has been the gold standard for some 50 years, in spite of the decades-long obligatory comparisons to rat poison that has dogged warfarin all this time.
There is no question that warfarin, as blood thinner, is effective. But it’s also a lot of work. There are dietary restrictions. There is also constant monitoring needed to ward against hemorrhaging. The unfortunate byproduct of a medication that thins the blood and helps to ward against strokes and other cardiovascular events is blood that fails to effectively clot when a bleed-out occurs. Careful monitoring has been necessary to help prevent and mitigate hemorrhages before they even start.
For years, patients and their doctors have been looking for a better way. Then finally, along comes Xarelto (and prior to it, Pradaxa) - a new-age anticoagulant that is purported not to require the constant monitoring needed to ward against Xarelto Bleeding Complications. Yes, it’s more expensive. But less monitoring translates to a lesser demand on resources - doctors and nurses - with a reduced need for patients to watch their diets and constantly monitor their blood.
Little wonder that patients and their doctors turned to new-age blood thinners like Xarelto in droves.
But there’s a caveat. There always is - and this is where events such as the upcoming Science Day for the Xarelto MDL come in. With Coumadin, a bleed-out that occurs in spite of careful monitoring and dietary restrictions can be lessened or reversed with the immediate administration of vitamin K. It’s a tool in the kit that can turn a dire situation into one that is potentially survivable.
Xarelto doesn’t have that feature - and this is the basis of many a Xarelto lawsuit. Plaintiffs, who have survived a Xarelto Bleed-out, or the estates of those who have been silenced through Xarelto death, claim that they were not made aware that Xarelto can’t be reversed in the same way that the thinning properties of warfarin can with the application of vitamin K.Xarelto Side Effects plaintiffs allege that the manufacturer of Xarelto failed to provide adequate warnings regarding its association with serious side effects, including internal bleeding, strokes, deep vein thrombosis and pulmonary embolism. There are also allegations over misleading marketing related to the positioning of Xarelto as being superior to warfarin in spite of the lack of an effective reversing agent.
Thus, Science Day in June is an important day on the Xarelto Lawsuit calendar.
More than 300 Xarelto Bleeding Issue lawsuits are on the books in the federal MDL pipeline in Louisiana, with another 180 lawsuits as part of a mass tort in the Philadelphia Court of Common Pleas (In Re: Xarelto Litigation, Case ID 150102349).Link: http://www.lawyersandsettlements.com/articles/xarelto/xarelto-lawsuit-death-bleeding-issue-16-20596.html
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