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XARELTO and FDA Plaintiff-Attorney Press Releases and Blogs

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

Plaintiff Attorney Press Releases

Xarelto Lawsuit Hotline Established for Bleeding and Injury Claims by McDonaldWorley Law Firm
Mar 18, 2015 | PR News Wire
By McDonald Worley Law Firm

According to an FDA resource about atrial fibrillation and anticoagulant drugs, Xarelto, unlike other anticoagulants such as its alternative warfarin, no reversal agents exist for use when significant bleeding occurs. In addition, an FDA warning letter was issued to the makers of Xarelto advising an update to advertisements alleging they 'minimized the risks' and make 'misleading claims'.
Legal-Bay Lawsuit Settlement Funding Reports Bayer and Johnson & Johnson to Pursue Further FDA Approvals for Xarelto while Cases against the Drug are Consolidated into Multidistrict Litigation
Mar 9, 2015 | PR Newswire
By Legal-Bay LLC

Legal-Bay LLC, The Lawsuit Settlement Funding Company, reports that Bayer and Johnson & Johnson made a recent announcement that they will pursue additional FDA approvals for Xarelto, even as cases against the blood thinner are consolidated into multidistrict litigation (MDL) in two U.S. courts. The announcement was made last month, according to Drug Watch, that Bayer and J&J are seeking further federal approvals for Xarelto for stroke patients.
Bernstein Liebhard LLP Comments on Filing of Class Action Lawsuit in Canada over Alleged Xarelto Bleeding Side Effects
Mar 7, 2015 | PR Web
By Bernstein Liebhard LLP

Xarelto was first cleared for sale in the U.S. by the Food & Drug Administration (FDA) in 2011. The blood thinner's approved uses now include the prevention of strokes in people with atrial fibrillation; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee replacement surgery. Like any anticoagulant, Xarelto can sometimes causes internal bleeding. However, there is currently no approved antidote for reversing Xarelto bleeding.
Ford & Associates Nationwide Legal Services, A.P.C., Comments on Xarelto Lawsuits Upon FDA Revisions
Mar 2, 2015 | Press Release Rocket
By Ford & Associates Nationwide Legal Services, A.P.C

In light of the FDA's approved revisions to the safety label of anticoagulant Xarelto (rivaroxaban) tablets, Ford & Associates Nationwide Legal Services notes that these cautionary revisions may be helpful for future users, but may come too late for individuals who have already allegedly suffered injuries from taking the drug. The FDA has now included the term “thrombocytopenia,” a low blood platelet disorder, under Adverse Reactions on Xarelto's label. The term “cytolytic hepatitis” has also been replaced with “hepatitis (including hepatocellular injury).”
Bayer and Johnson & Johnson Pursue Additional FDA Approvals for Xarelto while Cases against the Blood Thinner are Consolidated into Multidistrict Litigation
Feb 25, 2015 | PR News Wire
By MT Services LLC

MT Services LLC, a Lawsuit Settlement News Reporting Company which operates lawsuitsettlementnews.com, announced today that a recent announcement by Bayer and Johnson & Johnson was made stating that they will pursue additional FDA approvals for Xarelto, their blood thinner drug, despite the fact that lawsuits against them have been consolidated into multidistrict litigation in two U.S. courts. According to Drug Watch, the announcement was made last month by Bayer and J&J, and they seek further federal approvals for Xarelto for stroke patients.
Xarelto Attorneys at Bernstein Liebhard LLP Comment on Survey Detailing Cardiologists’ Attitude Towards New-Generation Blood Thinners
Feb 19, 2015 | PR Web
By Bernstein Liebhard LLP

Xarelto is a new -generation blood thinner that was first approved by the U.S. Food & Drug Administration in 2011. The medication is currently indicated to prevent strokes in people with atrial fibrillation; as a treatment for deep vein thrombosis and pulmonary embolism; and to prevent deep vein thrombosis in patients undergoing hip or knee replacement surgery.** During its first full year on the market, Xarelto was named in 2,081 adverse event reports submitted to the FDA, including at least 151 deaths. Warfarin, which has been in use since the 1950s, was named in only 861 adverse event reports, including 56 fatalities.
Morgan & Morgan’s Michael Goetz Appointed to Plaintiffs’ Steering Committee in Xarelto Litigation
Feb 12, 2015 | PR Web
By Morgan & Morgan

These lawsuits are seeking compensation for past and future medical bills, pain and suffering and, in the event of death, funeral expenses, according to court documents. “My hope is that this litigation will create broader awareness in the medical community, the FDA, and the general public about the dangers of Xarelto as the drug is currently being prescribed,” Goetz said.
GranuFlo, Xarelto, and Morcellator Lawsuits Continue to Rise Due to Complications
Jan 22, 2015 | PR News Wire
By MT Services LLC

GranuFlo and NaturaLyte are chemical dialysis products that are used in dialysis machines to help clean the blood of patients with kidney malfunctions. The products were designed to prevent dangerous acid buildup in the kidneys; however, recent lawsuits against them claim that the ingredients may also increase the risk of cardiac arrest and/or various cardiovascular problems. Serious side effects include: heart attack, cardiopulmonary arrest, cardiovascular death, and stroke. In March of 2012, The U.S. FDA issued a recall of GranuFlo and NaturaLyte products, which the FDA has now declared as a Class I Recall. Currently, there are over 2,000 cases against Fresenius Medical Care Inc., and they have been consolidated into multidistrict litigation (MDL) in Massachusetts Federal Court under U.S. District Judge Douglas P. Woodlock. The first trial is scheduled for January of 2016 with the next trial set to take place a month later (February 2016). Patients, or their family members, who have had a cardiac event in a Fresenius or DaVita Dialysis Center could be awarded large sums of money if the GranuFlo product was defective. Lawsuitsettlementnews.com can provide you with immediate access to a qualified GranuFlo law firm or lawyer that will provide you with a free legal consultation.
Nearly 90 Xarelto Lawsuits Added to Federal Blood Thinner Litigation since December
Jan 18, 2015 | Press Release Rocket
By Bernstein Liebhard, LLP

According to court documents, all the blood thinner lawsuits now pending in the Eastern District of Louisiana accuse Bayer Healthcare and the Johnson & Johnson subsidiary, Janssen Pharmaceuticals of wrongfully promoting the blood thinner as a convenient alternative to the decades-old treatment, warfarin. This medication is used for similar purposes, but requires users to regularly undergo blood level monitoring and adhere to dietary restrictions. Xarelto does not ask patients to take such measures, its manufacturer has insisted since its U.S. Food and Drug Administration (FDA) approval in 2011, but its use may be tied to serious episodes of internal bleeding, according to plaintiffs.*

Plaintiff Attorney Blogs

FDA Says No To Expansion Of Xarelto Use-For The Third Time
Mar 11, 2015 | The Legal Examiner
By Andy Childers

The U.S. Food and Drug Administration (FDA) has rejected three attempts by Johnson & Johnson to expand the approval of its anti-blood clotting drug, Xarelto, according to a report in the Wall Street Journal. Xarelto is approved as a preventative medicine for patients with pulmonary deep vein thrombosis, pulmonary embolism, and to reduce the risk of stroke and blood clots in people with irregular heartbeats not due to heart problems. Johnson & Johnson was hoping to expand the drug’s use to include patients who have had previous heart attacks or other complications due to acute coronary syndrome (ACS). An application by J & J for the expanded approval of Xarelto to reduce the risk of stent thrombosis, a rare condition in which a blood clot forms on a stent, was also rejected by the FDA.
Research Misconduct Involving Xarelto Goes Unreported
Mar 10, 2015 | Drug Reporter
By Ava Lawson

Numerous drug companies, who are charged with proving the safety and efficacy of their products prior to receiving FDA approval, were found to have deviated from proper trial protocols during site visits by the FDA. Common violations included inaccurate record keeping, submission of false data and failure to protect the safety of trial participants. Seife concluded that although the FDA frequently encounters examples of research misconduct and departures from good clinical practice during these site visits, those discoveries are rarely seen in peer-reviewed literature.
Xarelto Class Action Filed by Canadian Attorney Who Predicts More to Come
Mar 9, 2015 | The Xarelto Lawsuit
By Bernstein Liebhard LLP

Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011, and belongs to a class of new-generation anticoagulants referred to as direct thrombin inhibitors. Since then, Bayer and Janssen have marketed the treatment as a convenient alternative to warfarin, a similar drug that has been prescribed for decades.
Pradaxa, Xarelto Bleeding Events More Dangerous To Dialysis Patients
Mar 7, 2015 | Righting Injustice
By Jennifer Walker-Journey

“Our study is the first to evaluate these drugs in the dialysis population, and suggests concern given the increasing use of dabigatran and rivaroxaban in the ESRD (end-stage renal disease) population despite formal FDA warnings of caution in renal failure,” the researchers wrote. “In fact, our secondary analyses suggest excess morbidity and mortality from bleeding are associatively higher with dabigatran and rivaroxaban when compared to warfarin.”
Antidote for Pradaxa Bleeds May Impact Sales of Xarleto
Mar 6, 2015 | About Lawsuits
By Irvin Jackson

According to a press release issued on March 2, Boehringer Ingelheim indicates that it is petitioning the FDA, as well as European and Canadian health agencies, for approval of idarucizumab; an antidote for the blood-thinning effects of Pradaxa.
Xarelto Side Effects Studies May Lack Data Integrity
Mar 4, 2015 | Top Class Actions
By Ashley Vanover

In early February, JAMA Internal Medicine published a report by Charles Seife, of the Arthur L. Carter Institute of Journalism at New York University, revealing that the U.S. Food and Drug Administration (FDA) frequently uncovers clinical trial misconduct and discrepancies in drug studies conducted by drug makers. However, this information is rarely reported to medical journals who publish the research. Consequently, the studies are published in the medical journals without any indication that the FDA found issues such as falsified data, unsafe practices, and a complete disregard for scientific protocols. These events are typically referred to as Official Action Indicated (OAI).
Xarelto Caused Dangerous Internal Bleeding, Plaintiff Alleges
Feb 27, 2015 | Top Class Actions
By Laura Schultz

Xarelto is an anticoagulant, or blood thinning medicine, prescribed to keep blood clots from forming. Xarelto was approved by the FDA in 2011 to reduce risk of blood clots, deep vein thrombosis, and pulmonary embolisms in patients who have undergone knee and hip replacement surgery. Over the next few years, the FDA approved Xarelto for reducing risk of stroke for patients with non-valvular atrial fibrillation and for long-term treatment of patients with deep vein thrombosis and pulmonary embolism.
Study Unveils Xarelto Clinical Trial Misconduct
Feb 25, 2015 | Injury Lawyer
By Laura Woods

Xarelto bleeding complications may have been falsified, according to a recent report on clinical trial misconduct. The report suggests major issues with one early study on the drug, including signs that data regarding the safety of the anticoagulant may have been falsified and subsequently destroyed. In early February, Jama Internal Medicine published a report by Charles Seife, of the Arthur L. Carter Institute of Journalism at New York University, revealing that the FDA frequently uncovers clinical trial misconduct and discrepancies in studies conducted by drug makers. However, this information is rarely reported to medical journals who publish the research
Xarelto Lawsuit Claims In Pennsylvania Consolidated In A Mass Tort Program In Philadelphia State Court
Feb 20, 2015 | Oliver Law Group PC

Xarelto (rivaroxaban) is an oral anticoagulant used to treat blood clots in the leg (deep vein thrombosis) and lungs (pulmonary embolism) and to reduce the risk of stroke and blood clots in patients with atrial fibrillation (irregular hearty rhythms). Xarelto has been marketed as a more convenient blood thinner alternative than warfarin (Coumandin, Jantoven) because Xarelto does not require regular blood tests and regular dosing adjustments as does warfarin. The U.S. Food and Drug Administration (FDA) considers Xarelto, Pradaxa and Eliquis as next generation blood thinners compared to warfarin which has been on the U.S. market for 60 years. However, the older blood thinner, warfarin, uses vitamin K as an antidote for severe bleeding but the newer blood thinners do not have antidotes to reverse the effects of the anticoagulants should significant bleeding occur in patients who take the medication.
Xarelto Drug Causes Irreversible Internal Bleeding
Feb 18, 2015 | Houssiere, Durant & Houssiere LLP

FDA has issued a warning of increased Thrombotic Event (Bleeding and Hemorrhage)! Xarelto is prescribed to prevent strokes in people with arterial fibrillation; as a treatment for deep vein thrombosis and pulmonary embolism; it was first to prevent deep thrombosis in patients undergoing hip or knee replacement surgery.
Bayer, J&J Begin Xarelto Study, Bleeding Lawsuits Consolidated
Mar 18, 2015 | Drug Watch
By The Peterson Firm, LLP.

Bayer and Johnson & Johnson announced late last month they will push for additional Food and Drug Administration (FDA) approvals for the blockbuster blood-thinner Xarelto, even as two U.S. courts consolidated bleeding lawsuits against both companies.
FDA Hides Evidence of Fraud, Misconduct in Medical Trials
Feb 11, 2015 | Public Health Watchdog

As the nation’s regulatory agency, the purpose of the U.S. Food and Drug Administration (FDA) is to protect public health. According to an article published in Slate, however, the agency has a history of covering up fraud and wrongdoing in medical trials. The author of the article is Charles Seife, a journalist and professor at New York University, “For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.” Seife says.
Blood Thinners Xarelto and Pradaxa Lead to Multiple Lawsuits
Feb 8, 2015 | The Keener Law Firm
By Russell Keener

This is something of an ethical minefield and it’s easy to cross a line The New York Times report noted that several manufacturers, including the makers of Xarelto, have already been criticized by the US Food and Drug Administration (FDA) for improper promotion and marketing practices
Xarelto Study Examines Risk Of Uncontrolled Bleeding
Feb 6, 2015 | Top Class Actions
By Ashley Vanover

A study funded by Bayer HealthCare and Janssen Pharmaceuticals, the manufacturers of Xarelto, found that its rate of major bleeding is consistent with rates seen in clinical trials that led to Xarelto’s U.S. Food and Drug Administration (FDA) approval.
Off-label Use of Newer Anticoagulants — What Should a Patient Be Told?
Feb 6, 2015 | MD News
By Martin Clearwater & Bell LLP.

In recent years, new anticoagulants such as Pradaxa (dabigatran), Xarelto (rivaroxaban) and Eliquis (apixaban) have been approved by the FDA. They have benefits over older drugs such as Coumadin (warfarin), as they do not require frequent blood monitoring. Apart from their FDA-approved uses, these drugs are being used “off-label” to address conditions for which they have not been formally tested.
Xarelto: Latest News
Feb 2, 2015 | The Legal Examiner
By Craig Kelley

Xarelto has been approved by the Federal Drug Administration (FDA) for use to reduce stroke risk in those patients who have non-valvular atrial fibrillation; for treatment of deep vein thrombosis; for treatment of pulmonary embolism; for reducing the return of the aforementioned conditions; and for prevention of blood clots following knee or hip replacement surgeries. In fact, Xarelto can increase the risk of blood clots when its therapeutic use is stopped prematurely and it also carries the risk of causing epidural or spinal hematomas that could lead to permanent paralysis when used by those also receiving neuraxial anesthesia or those who undergo spinal puncture. These dangerous risks have led to the FDA issuing Black Box warnings, which are the most serious warnings that the FDA issues, reserved for products that pose a really significant risk of serious to life-threatening effects.
Philadelphia Judge Certifies Xarelto Lawsuits for Mass Tort Docket
Mar 18, 2015 | Product Liability Lawyer Blog
By Law Offices of Jeffrey S. Glassman

It should be noted makers of Xarelto have issued a statement saying they are determined to defend the allegations made in these lawsuits, and that Xarelto is an FDA approved medication for treatment of serious diseases. Xarelto, along with Eliquis and Pradaxa, which are also NOACs, have earned their respective makers windfall profits, and the companies do not want sales to be harmed as result of health concerns or lawsuits. The company also wants people to know an antidote to Xarelto bleeding injuries is in development and has showed promising results in early testing, though this drug is not yet approved by FDA for any patients not in a randomized drug study.
Why We Will Be Hearing More About Xarelto in the Near Future
Jan 21, 2015 | Lawyers and Settlements
By Gordon Gibb

A new mass tort has been created in Philadelphia to consolidate Xarelto liability lawsuits pending against drug makers Johnson & Johnson unit Janssen Pharmaceuticals Inc. and Bayer Corp. Some 73 lawsuits have been filed as of January 14, alleging the blood thinner has caused severe internal bleeding. Are these efforts kosher? Pundits say that doctors and manufacturers are walking a fine line that is very easy to cross. The New York Times report notes that several manufacturers, including the makers of Xarelto, have been faulted by the US Food and Drug Administration (FDA) for improper promotion and marketing practices.
Were Xarelto Manufacturers Wrong Not to Encourage Blood Monitoring?
Jan 20, 2015 | Legal Examiner
By Eric T. Chaffin

For the study, researchers from Japan gave 136 patients rivaroxaban to treat non-valvular atrial fibrillation—a treatment the FDA approved in November 2011. The patients had a mean age of 75 years. The researchers performed blood tests at the beginning of the study and two weeks after the patients started taking the drug, to monitor blood-clotting activity. They found that in some patients, the drug caused a prolonged “thinning” effect, making them more likely to experience serious bleeding events. This effect could be observed in blood tests. The researchers concluded that regular blood monitoring could identify patients at risk for bleeding—a fact that could potentially prevent subsequent bleeding events that could land patients in the hospital.
Xarelto Lawsuits Continue As FDA Approved Label Changes Adding More The Blood Thinner Side-Effects, Reports Wright & Schulte LLC
Jan 20, 2015 | Wright & Schulte LLC

Wright & Schulte Continues To Investigate Xarelto Lawsuits Filed In The U.S. District Court, Eastern District Of Louisiana Alleging The Blood Thinner Caused Serve Uncontrolled Bleeding. As pretrial proceedings move forward for Xarelto bleeding lawsuits, Wright & Schulte LLC reports that the U.S. Food and Drug Administration (FDA) has approved changes to the drug safety label of Xarelto tablets. The revisions on the blood thinner’s label included adding the term, “thrombocytopenia,” a blood and lymphatic system disorder, as an “Adverse Reaction.” The label also included replacing the Adverse Reaction term “cytolytic hepatitis” with “hepatitis (including hepatocellular injury).” According to prescribing information for the Xarelto blood thinner medication, it is not always possible to estimate how frequently these disorders occur or establish a causal relationship to drug exposure because reporting adverse reactions is voluntary, The most common adverse reaction of Xarelto blood thinner medication is bleeding, according to the label.
Xarelto Uncontrollable Bleeding Lawsuit Filed in Louisiana
Jan 14, 2015 | Top Class Actions
By Meredith Friesen

In June 2013, the U.S. Food and Drug Administration, or FDA, required Xarelto makers to cease publishing their promotional materials based on the fact that “the print ad is false or misleading because it minimizes the risks associated with Xarelto.”
First Status Conference Scheduled For Xarelto MDL
Jan 10, 2015 | The Oliver Law Group, P.C.

Xarelto (generically known as rivaroxaban) is an oral anticoagulant approved by the U.S. Food and Drug Administration (FDA) to treat blood clots in the leg (deep vein thrombosis) and lungs (pulmonary embolism) and used to reduce the risk of stroke and blood clots in patients with atrial fibrillation (irregular heart rhythms). The FDA considers Xarelto, along with Pradaxa and Eliquis, as new generation blood thinners compared to warfarin, a FDA-approved blood thinner that has been on the market since 1954. According to the FDA, one of the differences between the new generation of blood thinners and warfarin is the 60-year-old anticoagulant has vitamin K as a reversal agent should severe bleeding occur in patients. Xarelto, Pradaxa and Eliquis do not have antidotes for bleeding.
Xarelto’s Side Effects Could Be Deadly
Jan 9, 2015 | Searcy Denney Scarola Barnhart & Shipley, PA
By Brenda Fulmer

The bleeds associated with Xarelto, known generically as rivaroxaban, are irreversible and can result in death. “A specific antidote for rivaroxaban is not available,” according to the Food and Drug Administration. “Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable….” The FDA also issued the precaution that “premature discontinuation of Xarelto increases the risk of thrombotic events….” The anticoagulant originally was approved for blood-clot prevention in hip- and knee-replacement patients, treating pulmonary embolisms, decreasing stroke risk in cases of atrial fibrillation and several other indications.

Full Text of Stories Below

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

Plaintiff Attorney Press Releases

Xarelto Lawsuit Hotline Established for Bleeding and Injury Claims by McDonaldWorley Law Firm

Mar 18, 2015 | PR News Wire

By McDonald Worley Law Firm

Lead trial attorney Donald S. Worley with the law firm McDonaldWorley has announced the creation of the Xarelto claims hotline. Family members or victims can speak to an attorney at 1-800-397-4046 in order confidentially share what happened with our top lawyers and learn what legal options they have if they qualify to file a claim.
The direct number has been made available for people nationally who allege they suffered the medication caused injuries or side effects ranging from stroke, heart problems, severe bleed events or the death of a loved one.
According to the firm, a number of recent Xarelto users have contacted their attorneys alleging the blood thinning medication caused health problems and seeking the latest information, prompting the creation of the dedicated phone number.
A free legal review is available for people who are have interest in more information regarding filing a Xarelto claim.
"People who may have suffered health complications, or families of those who suffered fatal hemorrhaging deserve to know simply, and clearly if they qualify to file a claim against Xarelto, and how it could impact their lives if they do," stated Donald Worley when asked why the phone hotline was established.
The popular blood thinner has made headlines recently with the announcement of cases of people suing across the nation being centralized and consolidated into a Multi-District Litigation (MDL) in New Orleans (Xarelto Lawsuit Update).
With the added awareness being generated by the multidistrict litigation announcement and the patient information hotline being made available, attorneys with the firm expect more patients to come forward to share how their lives were impacted by Xarelto use.
According to the firm, a number of serious side effects have been alleged in the lawsuit, from life threatening hemorrhages and uncontrolled bleeding events to non-life threatening complications believed related to the use of the popular blood thinner. Concerned parties can read an overview of the case against Xarelto here.
According to an FDA resource about atrial fibrillation and anticoagulant drugs, Xarelto, unlike other anticoagulants such as its alternative warfarin, no reversal agents exist for use when significant bleeding occurs. In addition, an FDA warning letter was issued to the makers of Xarelto advising an update to advertisements alleging they 'minimized the risks' and make 'misleading claims'.
For a time being, the firm's lawyers will be standing by, available via the Xarelto hotline to hear from patients who may have suffered health problems from using the blood thinner—callers are under no-obligation to file a lawsuit claim and their entire conversation is entirely confidential.

"Anyone who believes they were hurt as a result of taking Xarelto, can now call 1-800-397-4046 so the firm's attorneys can review their case and answer their most pressing questions," added Mr. Worley.
Link to press release: http://www.prnewswire.com/news-releases/xarelto-lawsuit-hotline-established-for-bleeding-and-injury-claims-by-mcdonaldworley-law-firm-300048675.html

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Legal-Bay Lawsuit Settlement Funding Reports Bayer and Johnson & Johnson to Pursue Further FDA Approvals for Xarelto while Cases against the Drug are Consolidated into Multidistrict Litigation

Mar 9, 2015 | PR Newswire

By Legal-Bay LLC

Legal-Bay LLC, The Lawsuit Settlement Funding Company, reports that Bayer and Johnson & Johnson made a recent announcement that they will pursue additional FDA approvals for Xarelto, even as cases against the blood thinner are consolidated into multidistrict litigation (MDL) in two U.S. courts. The announcement was made last month, according to Drug Watch, that Bayer and J&J are seeking further federal approvals for Xarelto for stroke patients.
Reports have also come in that plaintiffs have continued to file lawsuits over the blood thinner, and in December and January, judges in both Pennsylvania and Louisiana consolidated the filed cases into multidistrict litigation as well as a mass tort program. Now, more than 100 filed lawsuits are awaiting trial. The lawsuits claim serious health problems and even death as a result of using the blood thinner, Xarelto. In light of the recent announcements, Legal-Bay is reaffirming the fact that they are sufficiently prepared to handle large Xarelto pre-settlement funding requests for those who have experienced complications from using the blood thinner.
Chris Janish, CEO of Legal-Bay, commented on the recent announcement, "We believe off of the last Pradaxa blood thinner settlement that Xarelto is a litigation that is also gaining a lot of traction. The injuries of serious uncontrollable bleeding, as well as death, make the potential liability very high for Xarelto's drug maker. Although Xarelto's maker continues to fight liability, and we expect this litigation to drag on for years, we are already committed to helping plaintiffs with lawsuit funding or assistance with getting a free Xarelto case evaluation from a qualified Xarelto law firm."
In order receive lawsuit funding you must have retained a Xarelto lawyer first. If you need lawsuit money or pre-settlement funding for your Xarelto claim, Legal-Bay is here to help. Legal-Bay is offering pre-settlement and settlement funding for Xarelto cases as well as other blood thinners – such as Pradaxa – and they are also providing free legal consultations for possible plaintiffs who have not yet retained a Xarelto lawyer. To learn more about Xarelto, Pradaxa, and other blood thinner cases, including services in helping you find a Xarelto law firm, visit: http://lawsuitssettlementfunding.com/pradaxa-settlement-funding.php

To speak with a live agent right now to discuss receiving pre-settlement lawsuit money or a free legal consultation on your potential Xarelto or Pradaxa blood thinner lawsuit, call Legal-Bay's toll-free hotline at: 877.571.0405. You may also apply online at: http://lawsuitssettlementfunding.com and an agent will respond to your request shortly.
Link to release: http://www.prnewswire.com/news-releases/legal-bay-lawsuit-settlement-funding-reports-bayer-and-johnson--johnson-to-pursue-further-fda-approvals-for-xarelto-while-cases-against-the-drug-are-consolidated-into-multidistrict-litigation-300046349.html

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Bernstein Liebhard LLP Comments on Filing of Class Action Lawsuit in Canada over Alleged Xarelto Bleeding Side Effects

Mar 7, 2015 | PR Web

By Bernstein Liebhard LLP

A recent report from the Calgary Herald indicates that a Xarleto class action lawsuit (http://www.xareltolawsuit2015.com/) has been filed in Alberta, Canada on behalf of individuals who allegedly experienced uncontrollable bleeding due to their use of the blood thinner. Among other things, the Canadian lawsuit alleges that Xarelto has been implicated in more than 1,000 injuries in the country, including 12 deaths. The Statement of Claim also accuses the drug’s manufacturers of negligence in their marketing of Xarelto, the Herald reported.
According to court documents, more than 200 Xarelto lawsuits have also been filed in U.S. courts that put forth similar allegations. The majority of those cases are currently pending in a federal multidistrict litigation underway in U.S. District Court, Eastern District of West Virginia.( In Re: Xarelto Products Liability Litigation, No. 2592)
“Our Firm is representing a number of U.S. Xarelto plaintiffs who have cases pending in federal court. We are not surprised that Canada has now seen a similar filing, as the bleeding complications allegedly related to Xarelto are quite serious, and can be life-threatening,” says Bernstein Liebhard LLP, a nationwide law firm representing the victims of defective drugs and medical devices. The Firm continues to offer free, no-obligation legal reviews to individuals who allegedly suffered serious injuries from Xarelto, including uncontrollable bleeding, strokes, deep vein thrombosis or pulmonary embolism.
Xarelto Litigation
Xarelto was first cleared for sale in the U.S. by the Food & Drug Administration (FDA) in 2011. The blood thinner's approved uses now include the prevention of strokes in people with atrial fibrillation; the treatment of deep vein thrombosis and pulmonary embolism; and the prevention of deep vein thrombosis in patients undergoing hip or knee replacement surgery. Like any anticoagulant, Xarelto can sometimes causes internal bleeding. However, there is currently no approved antidote for reversing Xarelto bleeding.
According to court documents, the multidistrict litigation established in the Eastern District of Louisiana was created in December 2014 to allow all Xarelto lawsuits filed in U.S. federal courts to undergo coordinated pretrial proceedings. Among other things, plaintiffs claim that the medication was wrongly marketed as an improvement over warfarin, a blood thinner that has been in use for decades. The lawsuits point out that unlike Xarelto, bleeding associated with warfarin can be stopped via the administration of vitamin K. The complaints further note that during its first full year on the market, Xarelto was named in 2,081 adverse event reports submitted to the FDA, including at least 151 deaths. By contrast, warfarin was named in only 861 adverse event reports, including 56 fatalities, during the same period.

Xarelto patients who allegedly experienced life-threatening episodes of internal bleeding and other complications related to its use may be entitled to compensation for medical bills, lost wages, pain and suffering and more. 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 to press release: http://www.prweb.com/releases/xarelto-lawsuit/xarelto-class-action/prweb12567253.htm

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Ford & Associates Nationwide Legal Services, A.P.C., Comments on Xarelto Lawsuits Upon FDA Revisions

Mar 2, 2015 | Press Release Rocket

By Ford & Associates Nationwide Legal Services, A.P.C

In light of the FDA's approved revisions to the safety label of anticoagulant Xarelto (rivaroxaban) tablets, Ford & Associates Nationwide Legal Services notes that these cautionary revisions may be helpful for future users, but may come too late for individuals who have already allegedly suffered injuries from taking the drug. The FDA has now included the term “thrombocytopenia,” a low blood platelet disorder, under Adverse Reactions on Xarelto's label. The term “cytolytic hepatitis” has also been replaced with “hepatitis (including hepatocellular injury).”
Lawsuits against Xarelto allege that Janssen Pharmaceuticals, Inc., the manufacturer of Xarelto, knew of the possibility of internal bleeding and other Xarelto side effects, but didn't adequately warn of such events. According to case documents, individuals who took Xarelto have allegedly experienced severe bleeding, strokes, and fatal injuries leading to death.
“We acknowledge the FDA's Adverse Reactions revisions to Xarelto's labeling, and are interested in talking with people who took Xarelto prior to these revisions, and may have suffered injuries as a result. We are committed to helping people find the best legal representation possible, and encourage them to contact us.” – Mateo Martinez, Ford & Associates Case Manager
Xarelto (rivaroxaban) was on FDA’s 2011 Innovative Drug Approval List as a new anticoagulant used to prevent the formation of blood clots in patients who suffer from deep vein thrombosis (DVT), atrial fibrillation (irregular heart rhythms), pulmonary embolism (PE), and are at high risk of stroke. Xarelto is marketed as superior and easier to use than other anticoagulants, as the drug doesn't require dietary restriction, or tests to monitor the patients’ blood plasma levels.
Although the FDA notes that Xarelto doesn't at present have an antidote to stop severe bleeding if it should occur, Ford & Associates has learned of studies, as reported by Reuters, that an intravenous antidote, andexanet alfa, has been developed, and is being tested for accuracy to reverse the anticoagulation activity associated with Xarelto use. Current trial data indicates that the Portola Pharmaceuticals anti-clotting drug has already experienced a high success rate of reversing internal bleeding associated with Xarelto in healthy patients aged 50-75. More testing details are suspected to be released within the coming year.
Ford & Associates also comments that there are currently 21 Xarelto lawsuits filed and pending against the manufacturers of Xarelto (Case MDL No. 2592). In December of 2014, the U.S. Judicial Panel on Multidistrict Litigation centralized all federally-filed Xarelto lawsuits to the U.S. District Court, Eastern District of Louisiana. The U.S. Judicial Panel stated there were common issues in all Xarelto cases that allowed for centralization, such as “the adequacy of Xarelto’s warning label with respect to the risk of severe bleeding and other injuries, the results of certain clinical studies, and the alleged need for blood monitoring.” (Case MDL No. 2592).
About Ford & Associates Nationwide Legal Services, A.P.C.

Ford & Associates Nationwide Legal Services, A.P.C., is a San Diego based law firm that fights aggressively for the rights of those who cannot fight for themselves. Each case is treated with unparalleled dedication, compassion, and skill, and pursued to the fullest extent as allowed by law until a favorable outcome has been reached.

If you or a loved one believe that you have suffered adverse health conditions from using Xarelto, and are seeking answers to Xarelto lawsuit and/or rivaroxaban lawsuit questions, contact Ford & Associates today at 1-866-242-0905 for a free, no-obligation case review.
Link to press release: http://www.prweb.com/releases/2015/02/prweb12485242.htm

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Bayer and Johnson & Johnson Pursue Additional FDA Approvals for Xarelto while Cases against the Blood Thinner are Consolidated into Multidistrict Litigation

Feb 25, 2015 | PR News Wire

By MT Services LLC

MT Services LLC, a Lawsuit Settlement News Reporting Company which operates lawsuitsettlementnews.com, announced today that a recent announcement by Bayer and Johnson & Johnson was made stating that they will pursue additional FDA approvals for Xarelto, their blood thinner drug, despite the fact that lawsuits against them have been consolidated into multidistrict litigation in two U.S. courts. According to Drug Watch, the announcement was made last month by Bayer and J&J, and they seek further federal approvals for Xarelto for stroke patients.
The public announcement was made amidst the news that plaintiffs have continued to file lawsuits over the companies, and in December and January, judges both in Pennsylvania and Louisiana consolidated cases into multidistrict litigation (MDL) as well as a mass tort program. Over 100 filed lawsuits, with claims of serious health problems and even death as a result of using Xarelto, are now awaiting trial.
Chris Janish, CEO of MTS commented on the recent news regarding Bayer and Johnson & Johnson, "The recent FDA request is one that will be watched carefully by legal experts, especially in light of the fact that Xarelto lawsuit filings continue to rise each month. The blood thinner drug has showed promising results, however, the lawsuit claims being filed will determine at what cost. What the FDA has to say about the new approval request may determine an important direction in the Xarelto mass tort litigation."
MTS is ready and able to assist those who need lawsuit help with finding a qualified Xarelto law firm or Xarelto lawyer to provide a free evaluation on their specific case. To learn more about MTS' services involving Xarelto, Pradaxa, or other blood thinner litigations, please visit:http://www.lawsuitsettlementnews.com/pradaxa-all-blood-thinner-cases
If you already have an attorney and have filed a lawsuit and need a lawsuit funding cash advance, not to be confused with a lawsuit loan or pre-settlement loan, Lawsuit Settlement News can assist you with these services. Injured parties from Pradaxa or Xarelto usage and complications can apply for up to $50K in pre-settlement or settlement lawsuit funding. For a full list of the services that the company provides, visit:http://www.lawsuitsettlementnews.com/about-our-products-and-services
If you, or a loved one, have been injured by Xarelto or Pradaxa and need lawsuit money or lawsuit help, including finding a Xarelto or Pradaxa law firm, call 877.571.0405 to speak with an available agent. You may also fill out a quick application online at: www.lawsuitsettlementnews.com and an agent will contact you shortly.

Disclaimer: MT Services LLC, operator of Lawsuitsettlementnews.com, is not a law firm and cannot provide legal advice on your case; however, MTS works with lawyers involved in mass tort litigations who are willing to provide a free legal consultation at the consumer's request. For a list of full disclosures please visit the company's website disclosure page at:http://www.lawsuitsettlementnews.com/terms-of-service.

Link to press release: http://www.prnewswire.com/news-releases/xarelto-lawsuit-news-bayer-and-johnson--johnson-pursue-additional-fda-approvals-for-xarelto-while-cases-against-the-blood-thinner-are-consolidated-into-multidistrict-litigation-says-lawsuitsettlementnewscom-300041066.html

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Xarelto Attorneys at Bernstein Liebhard LLP Comment on Survey Detailing Cardiologists’ Attitude Towards New-Generation Blood Thinners

Feb 19, 2015 | PR Web

By Bernstein Liebhard LLP

The Xarelto attorneys at Bernstein Liebhard LLP note that a survey conducted this month by the Cardiovascular Institute of Philadelphia produced interesting results regarding the attitude of cardiologists towards new-generation blood thinners. According to the Philadelphia Inquirer, while the physicians were generally pleased that alternatives to warfarin are now available, they expressed concern that there is currently no approved antidote to reverse unwanted internal bleeding that sometimes occurs with Xarelto and other anticoagulants. Warfarin bleeding, by contrast, can be stopped via an injection of vitamin K.*
“The results of this survey are notable, as hundreds of people are currently pursuing Xarelto lawsuits in U.S. courts that seek compensation for internal bleeding and other complications allegedly related to its use. These claims also raise questions about the lack of a reversal agent for Xarelto bleeding. This issue is certainly one that should be discussed with patients before the drug is prescribed,” said Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently representing a number of clients who have filed Xarelto lawsuits, and continues to offer free, no-obligation legal reviews to individuals who allegedly suffered serious injuries from the blood thinner, including uncontrollable bleeding, strokes, deep vein thrombosis or pulmonary embolism.
Xarelto Litigation
Xarelto is a new -generation blood thinner that was first approved by the U.S. Food & Drug Administration in 2011. The medication is currently indicated to prevent strokes in people with atrial fibrillation; as a treatment for deep vein thrombosis and pulmonary embolism; and to prevent deep vein thrombosis in patients undergoing hip or knee replacement surgery.** During its first full year on the market, Xarelto was named in 2,081 adverse event reports submitted to the FDA, including at least 151 deaths. Warfarin, which has been in use since the 1950s, was named in only 861 adverse event reports, including 56 fatalities.***
Court documents indicate that more than 200 Xarelto lawsuits are currently pending in a federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana, all of which put forth similar allegations regarding the drug’s association with uncontrollable bleeding, hemorrhagic stroke, deep vein thrombosis, pulmonary embolism, and other life-threatening complications. Among other things, plaintiffs assert that the manufacturers of Xarelto wrongly marketed the drug as superior to warfarin, given the lack of an approved antidote to stop internal bleeding. In Re: Xarelto Products Liability Litigation, No. 2592)

Xarelto patients who allegedly experienced life-threatening episodes of internal bleeding and other complications related to its use may be entitled to take legal action against the drug’s manufacturers. 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.
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Morgan & Morgan’s Michael Goetz Appointed to Plaintiffs’ Steering Committee in Xarelto Litigation

Feb 12, 2015 | PR Web

By Morgan & Morgan

Morgan & Morgan is proud to announce that the Honorable Judge Eldon E. Fallon has appointed attorney Michael Goetz to the Plaintiffs’ Steering Committee (PSC) in the multidistrict litigation* for the anticoagulant drug Xarelto. As a member of the PSC, Goetz will be responsible for coordinating pre-trial discovery, which includes retaining expert witnesses, taking depositions and managing important document requests. The PSC will also develop an overall case strategy and prepare the very first cases for trial.
“Judge Fallon is widely regarded as one of the very best MDL judges in the country and his track record for efficiently resolving large, complex cases is second to none,” Goetz said. “I am honored that Judge Fallon appointed me to the Xarelto PSC and I am fully committed to making meaningful contributions to this litigation on behalf of all plaintiffs and the Court.”
More than 80 lawsuits are currently pending in the Xarelto MDL, according to the Judicial Panel on Multidistrict Litigation’s most recent statistics report**. According to court documents, these lawsuits allege that Janssen Pharmaceuticals and Bayer Healthcare failed to adequately warn patients and doctors about the risk of life-threatening bleeding with Xarelto. Court documents allege that, unlike other anticoagulant medications on the market, scientists have yet to develop an antidote to reverse the blood-thinning effects of Xarelto.
These lawsuits are seeking compensation for past and future medical bills, pain and suffering and, in the event of death, funeral expenses, according to court documents.
“My hope is that this litigation will create broader awareness in the medical community, the FDA, and the general public about the dangers of Xarelto as the drug is currently being prescribed,” Goetz said.
Attorney Michael Goetz and the team at Morgan & Morgan continue to review potential lawsuits on behalf of Xarelto patients. For a free case review, visit http://www.forthepeople.com/class-action-lawyers/xarelto-lawsuit today.
About Morgan & Morgan

Morgan & Morgan is one of the largest plaintiffs’ law firms in the country with more than 20 offices throughout Florida, Georgia, Mississippi, Tennessee, Kentucky, and New York. The firm handles cases nationally involving personal injury, medical malpractice, consumer class actions, and securities fraud, as well as complex litigation against drug and medical device manufacturers. Visit Morgan & Morgan online at http://www.forthepeople.com/ for a free case evaluation and information about your legal rights.
Link to press release: http://www.prweb.com/releases/2015/02/prweb12514642.htm

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GranuFlo, Xarelto, and Morcellator Lawsuits Continue to Rise Due to Complications

Jan 22, 2015 | PR News Wire

By MT Services LLC

MT Services LLC, a Lawsuit Settlement News Reporting Company which operates lawsuitsettlementnews.com, announced today a primary focus on assisting potential plaintiffs who have dealt with complications as a result of GranuFlo, Xarelto, and/or Morcellator products.
GranuFlo and NaturaLyte are chemical dialysis products that are used in dialysis machines to help clean the blood of patients with kidney malfunctions. The products were designed to prevent dangerous acid buildup in the kidneys; however, recent lawsuits against them claim that the ingredients may also increase the risk of cardiac arrest and/or various cardiovascular problems. Serious side effects include: heart attack, cardiopulmonary arrest, cardiovascular death, and stroke. In March of 2012, The U.S. FDA issued a recall of GranuFlo and NaturaLyte products, which the FDA has now declared as a Class I Recall. Currently, there are over 2,000 cases against Fresenius Medical Care Inc., and they have been consolidated into multidistrict litigation (MDL) in Massachusetts Federal Court under U.S. District Judge Douglas P. Woodlock. The first trial is scheduled for January of 2016 with the next trial set to take place a month later (February 2016). Patients, or their family members, who have had a cardiac event in a Fresenius or DaVita Dialysis Center could be awarded large sums of money if the GranuFlo product was defective. Lawsuitsettlementnews.com can provide you with immediate access to a qualified GranuFlo law firm or lawyer that will provide you with a free legal consultation.
Xarelto is one of the most recent blood thinners on the market. According to Drug Watch, it was initially approved in 2011 and is manufactured by Bayer and is marketed by Johnson & Johnson's subsidiary, Janssen Pharmaceuticals. Dangerous side effects include: internal bleeding, intestinal bleeding, rectal bleeding, blood clots, embolism, brain hemorrhaging, and death caused by uncontrolled bleeding. Hundreds of lawsuits have been filed over blood thinners, including not only Xarelto but Pradaxa as well, and they have been consolidated into multidistrict litigation (MDL). Pradaxa cases have recently settled for an average settlement amount of over $150K, though many cases with serious injuries have recovered substantially more. Lawsuitsettlementnews.com believes patients with Xarelto claims could see settlement amounts in a similar range.

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Nearly 90 Xarelto Lawsuits Added to Federal Blood Thinner Litigation since December

Jan 18, 2015 | Press Release Rocket

By Bernstein Liebhard, LLP

A federal litigation established just last month in the U.S. District Court, Eastern District of Louisiana now includes almost 90 Xarelto lawsuits (http://www.xareltolawsuit2015.com/) that allege similar injuries caused by the blood thinner, Bernstein Liebhard LLP reports.
A Case List updated on January 15th shows 86 filings in the multidistrict litigation established for claims that allege life-threatening and incontrollable episodes of internal bleeding, as well as other complications. This court update comes shortly after a panel of federal judges voted in December 2014 to transfer similar Xarelto lawsuits to the Eastern District of Louisiana for pretrial proceedings. Plaintiffs in cases involving the blood thinner accuse its manufacturer of failing to adequately warn about complications that allegedly stem from use of its product. (In Re: Xarelto Products Liability Litigation, No. 2592)
“Our Firm is representing plaintiffs in Xarelto lawsuits who were allegedly harmed by this blood thinner. We are not surprised to see the newly-established Xarelto litigation continuing to move forward, as we hear regularly from individuals who also claim to have experienced internal bleeding and other side effects allegedly related to its use,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs. The Firm is currently evaluating potential Xarelto lawsuits on behalf of individuals who allegedly sustained life-threatening episodes of internal bleeding, strokes, deep vein thrombosis and/or pulmonary embolism allegedly due to use of Xarelto.
Xarelto Lawsuits
According to court documents, all the blood thinner lawsuits now pending in the Eastern District of Louisiana accuse Bayer Healthcare and the Johnson & Johnson subsidiary, Janssen Pharmaceuticals of wrongfully promoting the blood thinner as a convenient alternative to the decades-old treatment, warfarin. This medication is used for similar purposes, but requires users to regularly undergo blood level monitoring and adhere to dietary restrictions. Xarelto does not ask patients to take such measures, its manufacturer has insisted since its U.S. Food and Drug Administration (FDA) approval in 2011, but its use may be tied to serious episodes of internal bleeding, according to plaintiffs.*
Xarelto bleeding complications may become life-threatening since there is no available antidote to reverse them, plaintiffs further allege, which the drug’s manufacturer allegedly concealed from consumers in its marketing efforts. Warfarin has also been tied to internal bleeding episodes, but they can be reversed via the administration of Vitamin K.
Patients who allegedly sustained life-threatening episodes of Xarelto bleeding and other complications may be eligible to receive compensation for injury-related damages. Learn moreabout Xarelto internal bleeding complications by visiting Bernstein Liebhard LLP’s website, or by calling 800-511-5092 to schedule a free and confidential case review.

*fda.gov/downloads/Drugs/DrugSafety/UCM280333.pdf, FDA, March 2014

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Plaintiff Attorney Blogs

FDA Says No To Expansion Of Xarelto Use-For The Third Time

Mar 11, 2015 | The Legal Examiner

By Andy Childers

The U.S. Food and Drug Administration (FDA) has rejected three attempts by Johnson & Johnson to expand the approval of its anti-blood clotting drug, Xarelto, according to a report in the Wall Street Journal.
Xarelto is approved as a preventative medicine for patients with pulmonary deep vein thrombosis, pulmonary embolism, and to reduce the risk of stroke and blood clots in people with irregular heartbeats not due to heart problems.
Johnson & Johnson was hoping to expand the drug’s use to include patients who have had previous heart attacks or other complications due to acute coronary syndrome (ACS). An application by J & J for the expanded approval of Xarelto to reduce the risk of stent thrombosis, a rare condition in which a blood clot forms on a stent, was also rejected by the FDA.
Why Won’t the FDA Expand its Approval of Xarelto?
Johnson & Johnson first tried to obtain expanded approval of Xarelto for use in patients with ACS in 2011, and last February’s rejections marked the third time the company’s application has been rejected for expanded use in ACS patients, and the second rejection for those with stent thrombosis.
In February 2014, an FDA advisory panel said that a large amount of data was missing from one of the company’s late stage trials in patients with ACS, making the information flawed and unreliable. In August 2014, Johnson & Johnson and Bayer AG announced plans to launch more clinical trials against three new diseases.
Johnson & Johnson isn’t the first company to try to replace warfarin, another anti-clotting drug – Britol-Myers Squibb Co., Pfizer Inc., and Boehringer Ingelheim GmbH all have similar medications currently in development. But while the new blood thinners are generally easier to take than warfarin, there have been numerous concerns voiced that dangerous bleeding episodes linked to the use of those drugs, including Xarelto, may be harder to control.
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 to blog post: http://atlanta.legalexaminer.com/defective-dangerous-products/fda-says-no-to-expansion-of-xarelto-use-for-the-third-time/

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Research Misconduct Involving Xarelto Goes Unreported

Mar 10, 2015 | Drug Reporter

By Ava Lawson

JAMA Internal Medicine recently published a study by Charles Seife that highlights a profound flaw in how consumers obtain information about clinical drug trials. According to the New York University professor, only 4 percent of questionable practices or violations discovered by health regulators during pharmaceutical trials ever reaches the public.
Numerous drug companies, who are charged with proving the safety and efficacy of their products prior to receiving FDA approval, were found to have deviated from proper trial protocols during site visits by the FDA. Common violations included inaccurate record keeping, submission of false data and failure to protect the safety of trial participants. Seife concluded that although the FDA frequently encounters examples of research misconduct and departures from good clinical practice during these site visits, those discoveries are rarely seen in peer-reviewed literature.
Seife questions why the FDA, whose mission it is to protect the health of the public, would withholdevidence of serious drug trial misconduct from the scientific and medical communities. Most medications in the documents he reviewed were blacked out, with the exception of Xarelto(rivaroxaban).
Out of more than a dozen FDA inspections of Xarelto trial sites, signs of deceitful and objectionable behavior were uncovered during eight occasions. These included unauthorized unblinding, submission of falsified data and the discarding of medical records, among other serious issues.
Questionable drug research practices go unreported
“Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection,” said Seife in his report. “No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.”
According to Seife’s research, the Xarelto study known as RECORD 4 was found to be completely unreliable by health regulators, yet the results were later published with no indication of misconduct or problems. Seife urges respected medical journals to take more initiative in ensuring the integrity of their published studies, including information on FDA protocol violations.
Medications like Xarelto have already been associated with life-threatening side effects, the extent of which are now becoming clearer. Just after the blood thinner was launched in 2011, an estimated 350“serious, disabling or fatal” injuries were reported to the FDA. Most of these involved pulmonary, venous, and other forms of thromboembolism, though Xarelto has also been blamed for uncontrolled bleeding events, since there is no approved antidote.
Litigation filed over Xarelto bleeding problems
Throughout the United States, patients who were prescribed Xarelto for their irregular heartbeat have suffered cerebral hemorrhages, gastrointestinal bleeds and other events that have sometimes proved fatal. Unlike Warfarin, which uses therapeutic doses of Vitamin K to stop bleeding, Xarelto bleeds are challenging to stabilize, since no reversal agent has been developed.
Bayer Pharmaceuticals and Janssen are being sued by dozens of plaintiffs who argue that deceptive advertising was employed and that defendants failed to sufficiently warn about Xarelto bleeding problems.

If the outcome of Pradaxa litigation ($650 million settlement) has any bearing on current and futureXarelto lawsuits, plaintiffs may witness similar recourse. Compensation is being sought to account for all related medical bills, lost income, pain and emotional suffering, diminished earnings and, in some cases, wrongful death.
Link to blog post: http://drugreporter.com/2015/03/research-misconduct-involving-xarelto-goes-unreported/

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Xarelto Class Action Filed by Canadian Attorney Who Predicts More to Come

Mar 9, 2015 | The Xarelto Lawsuit

By Bernstein Liebhard LLP

A Xarelto lawsuit alleging episodes of uncontrollable internal bleeding has been filed in Calgary by a Canadian attorney who says that several others will be soon to follow.
He told the Calgary Sun on February 13th that the first class action case has already been filed in Calgary, and is being represented by a woman who nearly suffered cardiac arrest in September 2012 after she began bleeding internally. The Xarelto attorney asserts in the claim that “The health care professionals who were treating Betty for this hemorrhaging had considerable difficulty in stopping her bleeding,” and that the plaintiff could be awarded millions in damages.
Also included in this Xarelto internal bleeding lawsuit are the results of a German report that found 130 Xarelto-related deaths in 2012 and 2013, and more than 1,100 adverse event reports filed in Health Canada’s database. A dozen of the adverse event reports filed with the Canadian regulator mentioned death, the claim states.
In addition to the Xarelto lawsuit in Calgary, a similar action involving the anticoagulant is on the road to being filed in Ontario. There, a 83-year old woman suffered a fatal episode of internal bleeding episode.
Xarelto Litigation Builds in Eastern District of Louisiana
As the litigation surrounding this blood thinner continues to mount in Canada, more claims are being filed in the U.S. A federal litigation involving similar claims over the medication, which is jointly manufactured by Bayer Healthcare and the Johnson & Johnson subsidiary, Janssen Pharmaceuticals, was created in December 2014, court document indicate. There are now more than 220 Xarelto lawsuits now pending in the proceeding, which has been established in the U.S. District Court, Eastern District of Louisiana.
Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011, and belongs to a class of new-generation anticoagulants referred to as direct thrombin inhibitors. Since then, Bayer and Janssen have marketed the treatment as a convenient alternative to warfarin, a similar drug that has been prescribed for decades.
Link to blog post: http://www.thexareltolawsuit.com/xarelto-class-action-filed-by-canadian-attorney-who-predicts-more-to-come/

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Pradaxa, Xarelto Bleeding Events More Dangerous To Dialysis Patients

Mar 7, 2015 | Righting Injustice

By Jennifer Walker-Journey

Newer blood thinners Pradaxa (dabigatran) andXarelto (rivaroxaban), which are eliminated through the kidneys, are not be used in patients undergoingdialysis because the drugs can build up in their bloodstream and cause dangerous bleeding events. However many dialysis patients are being treated with the anticoagulants, according to researchers in the nephrology division at Massachusetts General Hospital and the clinical research division of Fresenius Medical Care North America.
Pradaxa and Xarelto are used to prevent strokes in patients with a common heart malady known as atrial fibrillation. Xarelto is also used to prevent and treat blood clots in other conditions. Both drugs were introduced within the past five years and are from the same new class of blood thinners. While effective in treating blood clots and preventing strokes, the drugs have been linked with serious bleeding events including gastrointestinal bleeds andbrain hemorrhages.
The researchers used data from the Fresenius Medical Care North America End-Stage Renal Disease Database to track the use of Pradaxa and Xarelto in patients between October 2010 and October 2014. A total of 29,277 patients with atrial fibrillation were undergoing dialysis.
In a second analysis, researchers followed a group of patients for two years to assess their bleeding and stroke outcomes. Those tracked included atrial fibrillation patients who were either using the common bloodthinner warfarin, aspirin, Pradaxa or Xarelto. Overall, 5.9 percent of dialysis patients who required blood thinners were prescribed Pradaxa or Xarelto.
Researchers found that dialysis patients who were taking Pradaxa had a rate of 83.1 major bleeding events per 100 patient-years. Dialysis patients taking Xarelto had a rate of 68.4 major bleeding events per 100 patient-years. Patients taking warfarin had a rate of 35.9 events per patient-years. Death rates from bleeding events followed the same trend, withPradax and Xarelto reporting the most deaths compared to patients on warfarin and aspirin.

“Our study is the first to evaluate these drugs in the dialysis population, and suggests concern given the increasing use of dabigatran and rivaroxaban in the ESRD (end-stage renal disease) population despite formal FDA warnings of caution in renal failure,” the researchers wrote. “In fact, our secondary analyses suggest excess morbidity and mortality from bleeding are associatively higher with dabigatran and rivaroxaban when compared to warfarin.”
Link to blog post: http://www.rightinginjustice.com/news/2015/03/07/pradaxa-xarelto-bleeding-events-more-dangerous-to-dialysis-patients/

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Antidote for Pradaxa Bleeds May Impact Sales of Xarleto

Mar 6, 2015 | About Lawsuits

By Irvin Jackson

Boehringer Ingelheim appears set to release an antidote for Pradaxa, which would make it the first manufacturer of a new generation anticoagulant to have a reversal agent available to help doctors address problems of uncontrollable bleeding, which have plagued Pradaxa, Xarelto, Eliquis and other similar medications.
According to a press release issued on March 2, Boehringer Ingelheim indicates that it is petitioning the FDA, as well as European and Canadian health agencies, for approval of idarucizumab; an antidote for the blood-thinning effects of Pradaxa.
If approved, it would make Pradaxa the first novel oral anticoagulant, known as Factor Xa inhibitors, to have an approved reversal agent, potentially providing protection against the risk of severe bleeding problems and providing the medication a major advantage over competitors.
The reversal agent may help Pradaxa reclaim the top spot among the new blood thinners, which quickly became a blockbuster medication after it was introduced in late 2010. However, amid concerns about severe injuries and deaths associated with uncontrollable bleeding, as well as thousands of Pradaxa lawsuits filed on behalf of users throughout the U.S., sales were overtaken by Xarelto.
As similar bleeding problems with Xarelto have surfaced, all manufacturers have been working to identify a safe and effective antidote that doctors may be able to use to reverse the blood thinning effects of the drugs.
“We are once again leading the evolution and innovation of anticoagulation care, and the potential approval would enable us to provide physicians with a specifically targeted reversal agent for PRADAXA patients in rare emergency situations,” Sabine Luik, senior vice president of Medicine & Regulatory Affairs at Boehringer Ingelheim, said in the press release. “If idarucizumab is approved, PRADAXA would be the first and only novel oral anticoagulant with a specifically targeted reversal agent.”Bleeding Problems with Pradaxa, Xarelto, Eliquis
Pradaxa (dabigatran) 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.
All of the medications have been promoted as superior alternatives to warfarin, because they are easier to use and do not require blood level monitoring during treatment. However, doctors are able to give a dose a vitamin K and fresh frozen plasma to users of warfarin who experience bleeding problems, quickly reversing the older drug’s blood thinning effects. No such reversal agents are currently available for Pradaxa, Xarelto or Eliquis.
Within a year after Pradaxa hit the market, it quickly earned the dubious distinction as one of the medications most commonly associated with adverse event reports submitted to the FDA.
Boehringer Ingelheim faced over 4,000 product liability lawsuits alleging that inadequate warnings were provided about the lack of an available reversal agent for their medication, which eventually led to a $650 million Pradaxa settlement last year, with an average of about $150,000 to be awarded to former users who experienced injuries associated with uncontrollable bleeds.
Xarelto (rivaroxaban) was the second member of this new class of anticoagulants to be approved by the FDA, hitting the market about a year after Pradaxa. However, as Boehringer Ingelheim faced mounting lawsuits and publicity over severe bleeding events associated with Pradaxa, Xarelto quickly overtook the top spot among the new medications, with sales exceeding those of Pradaxa in 2013.
A growing number of Xarelto bleeding lawsuits are now being pursued on behalf of former users, 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.Race For An Antidote
To secure the position of dominance in this new class of anticoagulants, Boehringer Ingelheim and the makers of Xarelto, Bayer and Johnson & Johnson, have been each attempting to identify and secure approval for an effective reversal agent for their specific medication.
In June, the FDA granted “breakthrough status” to fast-track the approval process for Boehringer Ingelheim’s possible Pradaxa antidote.
Boehringer Ingelheim has filed for approval of the reversal agent based off of phase 1 clinical trials which the company says indicates that a five-minute infusion of idarucizumab reversed the blood thinning effects of Pradaxa in both young, health individuals and in elderly patients with kidney problems, who are believed to face the highest risk of bleeding events while taking the drug.

A company called Portolo Pharmaceuticals is in the process of developing a reversal agent for Xarelto and several other new blood thinners as well. In January, the drug maker claimed that a clinical trial shows that a drug called andexanet alfa may be an effective Xarelto reversal agent.
Link to blog post: http://www.aboutlawsuits.com/pradaxa-antidote-petition-79035/

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Xarelto Side Effects Studies May Lack Data Integrity

Mar 4, 2015 | Top Class Actions

By Ashley Vanover

According to a recent report on clinical trial misconduct, the seriousness of Xarelto bleeding complications may have been falsified in a clinical Xarelto side effects study. The report suggests that major issues were covered up in one early study on the drug, including signs that data regarding the safety of the anticoagulant may have been falsified and subsequently destroyed.
In early February, JAMA Internal Medicine published a report by Charles Seife, of the Arthur L. Carter Institute of Journalism at New York University, revealing that the U.S. Food and Drug Administration (FDA) frequently uncovers clinical trial misconduct and discrepancies in drug studies conducted by drug makers. However, this information is rarely reported to medical journals who publish the research.
Consequently, the studies are published in the medical journals without any indication that the FDA found issues such as falsified data, unsafe practices, and a complete disregard for scientific protocols. These events are typically referred to as Official Action Indicated (OAI).
Throughout the course of his research, Seife found that most FDA clinical trial inspection records were filled with blacked out sections removing the name of the drugs, companies and researchers, making it difficult to see which clinical trials had major problems — with the exception of Xarelto.

FDA Concerns Over Xarelto Clinical Studies
Janssen Pharmaceuticals, a division of Johnson & Johnson, submitted an approval application for Xarelto (rivaroxaban) to the FDA’s Center for Drug Evaluation and Research in January 2011. Although the FDA ultimately approved Xarelto, the FDA expressed concern over the results of a series of clinical studies, known as the “ROCKET” trials, conducted by the company. Specifically, the FDA found several problems with data integrity.
According to the report, one of the Xarelto side effects study reports — RECORD 4 — of the ROCKET trials was conducted so poorly that the FDA rejected it entirely when deciding whether or not to approve the next-generation anticoagulant. While this particular study states that Xarelto is safe and effective for the prevention of deep vein thrombosis and pulmonary embolism after knee replacement surgery, it fails to reveal that the FDA knew researchers falsified some of the data and destroyed medical records, which was allegedly done to cover up questionable practices.
In 2011, Xarelto received FDA approval for the prevention of strokes among patients with atrial fibrillation. The indication was later expanded to include the prevention of deep vein thrombosis and pulmonary embolism after knee and hip surgery, which is exactly what the RECORD 4 trials aimed to achieve. However, the FDA refused to use the information contained in RECORD 4, claiming the data integrity was so poor it could not be considered in Xarelto’s approval process.
The FDA noted that inspections at five clinical trial sites revealed that researchers did not report adverse Xarelto side effectsexperienced by patients, didn’t maintain adequate medical records, failed to acquire proper consent from subjects, and didn’t report unanticipated risks to human test subjects.
“Eight of 16 FDA inspections of sites involved in a clinical trial of rivaroxaban, a novel anticoagulant, had been rated OAI. These inspections had uncovered evidence of various transgressions, such as ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization,’” Seife wrote.
“Consequently, the entire study, RECORD 4 (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism 4), was deemed unreliably by the FDA. These problems are not mentioned in the article describing the study’s results or in other publications associated with the trial.”
The result of this report and other Xarelto studies and adverse drug reports, many consumers have decided to pursue Xarelot lawsuits.Xarelto Bleeding Complications
These accusations of falsifying Xarelto studies come on the heels of mounting Xarelto class action lawsuits involving uncontrolled internal Xarelto bleeding, for which there is no antidote. Other known Xarelto side effects include:
·         deep vein thrombosisgas
·         trointestinal bleeding
·         pulmonary bleeding

Plaintiffs claim that Xarelto manufacturers downplayed this major risk in an effort to boost sales and this new revelation may confirm that they did indeed put profits before consumer safety.
Link to blog post: http://topclassactions.com/lawsuit-settlements/lawsuit-news/50691-xarelto-side-effects-studies-may-lack-data-integrity/

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Xarelto Caused Dangerous Internal Bleeding, Plaintiff Alleges

Feb 27, 2015 | Top Class Actions

By Laura Schultz

A new Xarelto lawsuit has been filed by Kenneth S. in a Pennsylvania federal court against Janssen Research & Development, Johnson & Johnson, and Bayer Corporation. Kenneth is seeking damages for injuries he allegedly incurred while taking Xarelto.
Kenneth began taking Xarelto on July 1, 2014. His doctor prescribed him the drug to reduce his chance of stroke due to atrial fibrillation, a type of heart arrhythmia. On Aug. 8, 2014, Kenneth reportedly began to suffer from internal and rectal bleeding; he was hospitalized that same day.
Kenneth remained in the hospital for nearly two weeks and had to receive nine units of blood. Due to the ensuing complications, Kenneth can no longer take blood thinners. The Xarelto lawsuit alleges that had Kenneth been properly informed of the risks associated with using Xarelto, he would have chosen a safer alternative.
The Xarelto lawsuit claims that the defendants misinformed the medical community and the general public about the effectiveness of Xarelto and ignored patient safety in their marketing process.
The Xarelto Lawsuit is Case No. 2:15-cv-00119-EEF-MBN, in the U.S. District Court for the Eastern District of Pennsylvania.Overview of Xarelto Lawsuits
Xarelto is an anticoagulant, or blood thinning medicine, prescribed to keep blood clots from forming. Xarelto was approved by the FDA in 2011 to reduce risk of blood clots, deep vein thrombosis, and pulmonary embolisms in patients who have undergone knee and hip replacement surgery. Over the next few years, the FDA approved Xarelto for reducing risk of stroke for patients with non-valvular atrial fibrillation and for long-term treatment of patients with deep vein thrombosis and pulmonary embolism.
The pharmaceutical companies marketing Xarelto claimed that this new anticoagulant is the first and only once-a-day prescription blood thinner that exists for patients without regular blood monitoring. Marketers also claimed that Xarelto, unlike its competitor warfarin, requires no dietary restrictions for its users. According to the Xarelto lawsuit, the drug has been prescribed to over 7 million people across the globe.
Xarelto manufacturers aggressively marketed the drug, resulting in large profits for the defendants. A one-year prescription of Xarelto costs patients approximately $3,000, compared to the generic form of warfarin which is about $300. Based on a World Preview report, Xarelto is estimated to be the 19th best selling drug by the year 2018. Xarelto manufacturers have been warned by the FDA that their advertising is misleading and minimizes the risks associated with taking the anticoagulant.
The side effects associated with taking Xarelto include hemorrhage and potentially serious blood clot related injuries in short term users. Surprisingly, blood clot injuries are the exact condition that Xarelto is meant to prevent. Unlike warfarin, Xarelto has no known antidote to stop uncontrolled bleeding.

Lawsuits against Xarelto are being filed by patients who have allegedly suffered serious Xarelto side effects and family members who may have lost loved ones due to the drug. Many of the Xarelto lawsuits include claims of negligence, fraud and deceit, breach of contract, and products liability. These lawsuits may help patients receive compensation for their medical bills and their pain and suffering allegedly caused by using Xarelto.
Link to blog post: http://topclassactions.com/lawsuit-settlements/lawsuit-news/49891-xarelto-caused-dangerous-internal-bleeding-plaintiff-alleges/

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Study Unveils Xarelto Clinical Trial Misconduct

Feb 25, 2015 | Injury Lawyer

By Laura Woods

Xarelto bleeding complications may have been falsified, according to a recent report on clinical trial misconduct. The report suggests major issues with one early study on the drug, including signs that data regarding the safety of the anticoagulant may have been falsified and subsequently destroyed.
In early February, Jama Internal Medicine published a report by Charles Seife, of the Arthur L. Carter Institute of Journalism at New York University, revealing that the FDA frequently uncovers clinical trial misconduct and discrepancies in studies conducted by drug makers. However, this information is rarely reported to medical journals who publish the research.
Consequently, the studies are published in the medical journals, without any indication that the FDA found issues such as falsified data, unsafe practices and a complete disregard for scientific protocols. These instances are typically referred to as Official Action Indicated (OAI).
Throughout the course of his research, Seife found that most FDA clinical trial inspection records were filled with blacked out sections removing the name of the drugs, companies and researchers, making it difficult to see which clinical trials had major problems — with the exception of Xarelto.RECORD 4 rebuked by FDA
According to the report, one of the Xarelto study reports — RECORD 4 — was conducted so poorly that the FDA rejected it entirely when deciding whether or not to approve the next-generation anticoagulant. However, the report was still published in The Lancet in May 2009. While the publication of the study states that Xarelto is safe and effective for the prevention of deep vein thrombosis and pulmonary embolism after knee replacement surgery, it fails to reveal the FDA knew researchers falsified some of the data and destroyed medical records, which was presumably done to cover up questionable practices.
In 2011, Xarelto received FDA approval for the prevention of strokes among patients with atrial fibrillation. The indication was later expanded to include the prevention of deep vein thrombosis and pulmonary embolism after knee and hip surgery, which is exactly what the four RECORD trials aimed to achieve.
“Eight of 16 FDA inspections of sites involved in a clinical trial of rivaroxaban, a novel anticoagulant, had been rated OAI. These inspections had uncovered evidence of various transgressions, such as ‘systemic discarding of medical records,’ unauthorized unblinding, falsification, and ‘concerns regarding improprieties in randomization’,” Seife wrote.
“Consequently, the entire study, RECORD 4 (Regulation of Coagulation in Orthopedic Surgery to Prevent Deep-Venous Thrombosis and Pulmonary Embolism 4), was deemed unreliably by the FDA. These problems are not mentioned in the article describing the study’s results or in other publications associated with the trial.”Xarelto bleeding complications
In 2011, the FDA refused to use the information contained in RECORD 4, claiming the data integrity was so poor it could not be considered in Xarelto’s approval process. The Agency noted that inspections at five clinical trial sites revealed that researchers did not report adverse effects experienced by patients, didn’t maintain adequate medical records, failed to acquire proper consent from subjects and didn’t report unanticipated risks to human test subjects.
“Inspection of Bayer Pharmaceuticals as the sponsor of the four RECORD 4 studies revealed that the sponsor failed to 1) ensure proper monitoring of the study, 2) ensure the study was conducted in accordance with the protocol and/or investigational plan, and 3) to ensure that FDA and all investigators were promptly informed of significant new adverse effects or risks,” FDA reviewers determined.
In addition to the unreliable data found in RECORD 4, the FDA also found issues with RECORD 2 and RECORD 3. The Xarelto website also sites only RECORDS 1-3, also eliminating the use of RECORD 4.

The findings come on the heels of mounting lawsuits involving uncontrolled Xarelto internal bleeding, for which there is no antidote. Plaintiffs claim that Xarelto manufacturers downplayed this major risk in an effort to boost sales.
Link to blog post: http://injurylawyer-news.com/2015/02/study-unveils-xarelto-clinical-trial-misconduct/

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Xarelto Lawsuit Claims In Pennsylvania Consolidated In A Mass Tort Program In Philadelphia State Court

Feb 20, 2015 | Oliver Law Group PC

The Xarelto attorneys at The Oliver Law Group P.C. report that all Xarelto bleeding lawsuits filed in Pennsylvania have been consolidated in the Philadelphia Court of Common Pleas. Common Pleas Administrative Judge Kevin Dougherty issued an order on January 20 2015 to create a mass tort litigation for the Xarelto complaints filed against Bayer Healthcare Pharmaceuticals, which manufacturers Xarelto, and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, which markets Xarelto. In consolidating the Xarelto lawsuits, Judge Dougherty granted a petition from plaintiffs in Xarelto cases who asked for the consolidation due to the lawsuits having common allegations that Xarelto can cause severe and uncontrollable bleeding that can sometimes be fatal. Court records show Judge Dougherty transferred about 75 Xarelto cases to the court’s Complex Litigation Center. Since the program was created, the court’s case list shows the number of Xarelto lawsuit filings have risen to 111 as of February 18. The Xarelto claims allege that plaintiffs who were prescribed the blood thinner suffered side-effects including uncontrollable or fatal bleeding and the defendants failed to warn that the blood thinner lacks an antidote to reverse the effects of the medication. (In Re: Xarelto Litigation, Case Number 150102349)
The Oliver Law Group P.C. is offering free Xarelto lawsuit evaluations to individuals who allegedly suffered serious internal bleeding and other complications due to their use of the Xarelto blood thinner. Free legal evaluations are also being offered to families of patients who allegedly died as a result of Xarelto bleeding. To learn more about filing a Xarelto lawsuit, please contact our office by calling 800-939-7878 today.
Xarelto (rivaroxaban) is an oral anticoagulant used to treat blood clots in the leg (deep vein thrombosis) and lungs (pulmonary embolism) and to reduce the risk of stroke and blood clots in patients with atrial fibrillation (irregular hearty rhythms). Xarelto has been marketed as a more convenient blood thinner alternative than warfarin (Coumandin, Jantoven) because Xarelto does not require regular blood tests and regular dosing adjustments as does warfarin. The U.S. Food and Drug Administration (FDA) considers Xarelto, Pradaxa and Eliquis as next generation blood thinners compared to warfarin which has been on the U.S. market for 60 years. However, the older blood thinner, warfarin, uses vitamin K as an antidote for severe bleeding but the newer blood thinners do not have antidotes to reverse the effects of the anticoagulants should significant bleeding occur in patients who take the medication.

The consolidation of Xarelto lawsuits in Pennsylvania comes one month after Xarelto lawsuits filed in federal courts nationwide were consolidated in the U.S. District Court, Eastern District of Louisiana. The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated the Xarelto complaints in December as a way to prevent inconsistent rulings and eliminate duplicate discovery as the Xarelto complaints go through the pretrial process. Recently, U.S. District Judge Eldon E. Fallon, who is assigned to manage the federal litigation, appointed 12 attorneys to a plaintiffs’ steering committee. The attorneys will represent all the plaintiffs at hearings, conduct discovery, and negotiate potential stipulations or settlement agreements with the defendants, among other things. There are 220 Xarelto lawsuits pending in the federal litigation as of February 17, that number is up from 86 Xarelto complaints in January. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592)
Court documents indicate that another Xarelto lawsuit was filed recently in the federal litigation in Louisiana that accuses Bayer Healthcare and Janssen Pharmaceuticals of failing to warn the medical community and patients that Xarelto lacked an antidote to reverse severe bleeding. The wrongful death complaint was filed on behalf of a 75-year-old Louisiana man who was prescribed Xarelto and developed severe gastrointestinal bleeding. According to the lawsuit, the man died on January 12, 2014, as a result of the Xarelto bleeding side-effect. The Xarelto complaint contended that the blood thinner’s original safety label did not include a warning regarding the lack of an antidote, “but instead only mentioned this important fact in the overdosage section.” (Case No. 2:15-cv-00041, U.S. District Court of the Eastern District of Louisiana)About The Oliver Law Group P.C. And Filing A Xarelto Lawsuit

The Oliver Law Group P.C. is a different kind of law firm. One that focuses on the needs of the injured first. A compassionate law firm dedicated to fighting for the rights of victims and their families, and doing everything necessary to ensure those rights.
Link to blog post: http://legalactionnow.com/xarelto-lawsuit-claims-pennsylvania-consolidated-mass-tort-program-philadelphia-state-court/6270

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Xarelto Drug Causes Irreversible Internal Bleeding

Feb 18, 2015 | Houssiere, Durant & Houssiere LLP

FDA has issued a warning of increased Thrombotic Event (Bleeding and Hemorrhage)! Xarelto is prescribed to prevent strokes in people with arterial fibrillation; as a treatment for deep vein thrombosis and pulmonary embolism; it was first to prevent deep thrombosis in patients undergoing hip or knee replacement surgery.

Xarelto Blood Thinner is under investigation by the FDA. The FDA has received 68– adverse reports related to the patients using the blood thinner. Doctors state there is no way to reverse the effects of this dangerous drug. The complaints point out that while warfain bleeding can be reversed via the administration of vitamin K, there is no antidote to stop the bleeding that sometimes occurs with Xarelto. Patients can develop internal bleeding. Xarelto patients who experienced uncontrollable internal GI bleeding, deep vein thrombosis, pulmonary embolism, or other serious complication may be able to pursue a legal claim against the drug manufacturers.
Link to the blog post: http://hdhtex.com/index.php/xarelto-drug-causes-irreversible-internal-bleeding/

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Bayer, J&J Begin Xarelto Study, Bleeding Lawsuits Consolidated

Mar 18, 2015 | Drug Watch

By The Peterson Firm, LLP.

Bayer and Johnson & Johnson announced late last month they will push for additional Food and Drug Administration (FDA) approvals for the blockbuster blood-thinner Xarelto, even as two U.S. courts consolidated bleeding lawsuits against both companies.
Part of a class of new anticoagulants called Factor Xa inhibitors, the drug officially overtook its classmates and captured the largest share of the market thanks to its array of approved uses.
The popular blood thinner pulled in $1.5 billion in sales last year, and now, the drug’s makers want to pursue approvals for stroke patients, according to Fierce Pharma Marketing. The medication is facing off against a mainstay of stroke prevention: aspirin.
The latest push for additional federal approval comes amid concerns over a lack of antidote to stop potentially fatal bleeds and an increased number of lawsuits state and federal courts.
A new 7,000-patient trial — called the NAVIGATE-ESUS study — will focus on the effectiveness of Xarelto vs. aspirin in preventing subsequent strokes. Approximately 300,000 people in North America and Europe suffer these strokes annually, potentially broadening Xarelto’s reach, if it gains a wider approval.Xarelto Could Overtake Warfarin
J&J CEO Alex Gorsky said Xarelto already has as customers one-third of former warfarin users and that the medication may be poised to take the remaining two thirds if it gains extra approvals, according to Fierce Pharma Marketing. The company touts Xarelto as having the lowest out-of-pocket costs for patients of all the new blood thinners.
Gorsky didn’t comment on the recent Xarelto lawsuit consolidations in Louisiana and Philadelphia, where a growing number of plaintiffs say drugmakers failed to warn them that Xarelto increasing the risk of severe bleeding.Lead Lawyers Appointed in Xarelto Multidistrict Litigation
As Bayer and J&J pursue more studies, plaintiffs continue to file lawsuits against the Big Pharma giants. In December and January, judges in Louisiana and Pennsylvania gathered several cases into multidistrict litigation (MDL) and a mass tort program, respectively.
Collectively, more than 100 lawsuits filed by patients and their families claiming Xarelto caused serious health problems – and death, in some cases – now await trial. The lawsuits also claim that Xarelto’s lack of bleeding antidote makes the drug more dangerous.
The next step in the MDL process is the appointment of a plaintiff’s steering committee.
Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana appointed a 12-member Plaintiffs’ Steering Committee to be headed by Andy Birchfield, Jr. and Brian H. Barr, the co-lead counsels on the cases. Birchfield is from Beasley Allen in Montgomery, Alabama, Barr from Levin, Papantonio in Pensacola, Florida. Also on the steering committee:
Ellen Relkin, Weitz & Luxenberg, New York
Bradley Honnald, Bartimus Frickleton, Kansas City
Frederick Longer, Levi, Fishbein, Sedran & Berman, Philadelphia
Russell Abney, Ferrer, Poirot & Wansbrough, Atlanta
Dianne Nast, Nast Law, Philadelphia
Roger Denton, Schlicter, Bogard & Denton, St. Louis
Sindhu Daniel, SeegerWeiss, Newark, New Jersey
Michael Goetz, Morgan and Morgan, Tampa
Neil Overholtz, Aylstock, Witkin, Kreis & Overholtz, Pensacola
The steering committee will ensure that litigation of multiple cases moves as swiftly and efficiently as possible, including conducting discovery, exploring settlement options and coordinating trial team selection.

In a hearing last month, Fallon said about 30 percent of U.S.-filed Xarelto civil claims are in an MDL.
Link to the blog post: http://www.drugwatch.com/2015/02/17/xarelto-study-mdl-steering-committee/

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FDA Hides Evidence of Fraud, Misconduct in Medical Trials

Feb 11, 2015 | Public Health Watchdog

As the nation’s regulatory agency, the purpose of the U.S. Food and Drug Administration (FDA) is to protect public health. According to an article published in Slate, however, the agency has a history of covering up fraud and wrongdoing in medical trials. The author of the article is Charles Seife, a journalist and professor at New York University, “For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.” Seife says.
The article points to documents related to an FDA inspection, emphasizing that key components are redacted. The reader is left not knowing what drug was studied, the name of the study and how the data was affected by misconduct. Seife and his students looked at documents related to 600 clinical trials where a researcher failed an FDA inspection. Only in 100 reports were they able to find the study, the drug and the identity of the pharmaceutical company.
Hiding this information impacts both consumers as well as researchers and physicians, who often make decisions based on data clinical trials. Seife says the FDA is aware of dozens of studies with questionable data but has done nothing. He cites the RECORD 4 study, which was one of four large clinical trials used as evidence for the safety and efficacy of the anti-clotting drug Xarelto (rivaroxaban). RECORD 4 involved thousands of patients and clinical sites in more than a dozen countries around the world. The FDA inspected or had access to external audits of 16 sites, the article says. Seife refers to the trial as “a fiasco”. Apparently, the agency found falsified data at Dr. Craig Loucks’ site in Colorado and “systematic discarding of medical records” at Dr. Ricardo Esquivel’s site in Mexico. In half the sites, the FDA found misconduct, fraud, suspicious behavior and other practices that were so questionable the data had to be discarded. “The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire study to be ‘unreliable.’” Seife writes.
A number of lawsuits have bee filed over Xarelto. The drug has come under increased scrutiny amidst reports of uncontrollable bleeding. Plaintiffs allege that the drug was marketed as being superior to warfarin, an older drug that requires blood monitoring. Xarelto has raised safety concerns because unlike warfarin, there is no antidote to reverse bleeding if it occurs.

Despite everything the FDA discovered in the Xarelto RECORD 4 trial, data from RECORD 4 continues to remain in The Lancet without any indication about falsification or wrongdoings. “This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.” says Seife. According to this article, this type of behavior is not simply miscommunication or oversight. Apparently, the agency even resisted attempts by Congress to obtain more information. “Every excuse under the sun has been used to create roadblocks,” said Sen. Charles Grassley in relation to problems with clinical trials of the antibiotic Ketek. “even in the face of congressional subpoenas requesting information and access to FDA employees.”
Link to blog post: http://www.publichealthwatchdog.com/fda-hides-evidence-fraud-misconduct-medical-trials/

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Blood Thinners Xarelto and Pradaxa Lead to Multiple Lawsuits

Feb 8, 2015 | The Keener Law Firm

By Russell Keener

The drug Xarelto may not be a household name yet but we are likely to be hearing a lot more about this anticoagulant over the next year.
That’s because Xarelto is the subject of numerous lawsuits from patients who claimed it caused sudden and unforeseen bleeding. In some cases taking the blood thinning drug proved to be fatal.
The drug’s manufacturers, Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, are facing at least 86 product liability lawsuits over the new-generation anticoagulant. These personal injury and wrongful death claims are pending in 24 different federal courts.
Medical and legal experts expect several thousands of cases will come forward as more people realize this drug may have been to blame for their conditions.
The Xarelto lawsuits have been consolidated into multidistrict litigation. This means that bellwether trials will be starting later this year or next.
There’s another reason why the Xarelto lawsuits will take more prominence. The American population is aging as the Baby Boomer generation retires meaning there is greater demand for anticoagulants such as Xarelto, to help prevent blood clots and strokes.
Xarelto (Rivaroxaban) is one of three fairly new drugs that have arrived on the market to challenge the market dominance of Coumadin (warfarin). Warfarin has been around for five decades and has been the go-to anticoagulant.
The drug companies that manufacture Xarelto have spent big bucks to challenge the dominance of Coumadin and they are spending massive amounts of money in an effort to persuade doctors that drugs like Xarelto have benefits over Coumadin, and are worth giving a try. The bleeding issue could compromise this effort but we know from experience that big drug companies won’t let an issue such as patient safety stand in the way of their making money.
The manufacturers of Xarelto, Pradaxa and Eliquis – three blood thinners that are considered challengers to Coumadin – have spent millions of dollars between them on doctors and teaching hospitals. Such efforts, according to the New York Times, included treating doctors to dinner, remuneration for promotional speeches, consulting jobs and “educational” gifts.
This is something of an ethical minefield and it’s easy to cross a line The New York Times report noted that several manufacturers, including the makers of Xarelto, have already been criticized by the US Food and Drug Administration (FDA) for improper promotion and marketing practices.
The problem with Xarelto can occur when there is an unforeseen and sudden Xarelto Bleeding Issue. Patients on warfarin also have to be aware about the potential for a bleeding issue, caused when blood that has been thinned and is allowed to flow freely through a ruptured blood vessel or a wound loses its capacity to clot, and therefore, halt the bleeding.
However, in the case of Coumadin, Vitamin K can be administered in the midst of a hemorrhage – quickly reversing the thinning properties of Coumadin, helping to halt the bleeding. There is no fallback to reverse Xarelto, according to reports.
In the Xarelto lawsuit plaintiffs have claimed that they were not made aware that some serious Xarelto side fffects such as a serious bleeding issue could not be reversed, as it can with warfarin.
Pradaxa, another anticoagulant has also resulted in lawsuits. Pradaxa is a twice daily pill manufactured by Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010. The drug is intended prevent strokes in patients with an irregular heartbeat which is called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced back in the 1950s.
“The good news is you now have an alternative to warfarin,” said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in California in a Reuters article. “The bad news is you can kill a patient as easily with the new drug as you could with the old drug” if it is not handled properly.”

Drugwatch reported that more than 540 patients died after using Pradaxa, and thousands of other people reported suffering from serious side effects. A settlement was recently reached with more than 4,000 patients who reported very serious side effects from Pradaxa including gastrointestinal, rectal and brain bleeding. They filed lawsuits against Boehringer Ingelheim Pharmaceuticals. Because the drug was marketed heavily as safe and effective, doctors wrote millions of prescriptions for the new blood thinner after the U.S. Food and Drug Administration (FDA) approved it in October 2010.
Link to blog post: http://keenerlaw.com/blood-thinners-xarelto-and-pradaxa-lead-to-multiple-lawsuits/

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Xarelto Study Examines Risk Of Uncontrolled Bleeding

Feb 6, 2015 | Top Class Actions

By Ashley Vanover

A study funded by Bayer HealthCare and Janssen Pharmaceuticals, the manufacturers of Xarelto, found that its rate of major bleeding is consistent with rates seen in clinical trials that led to Xarelto’s U.S. Food and Drug Administration (FDA) approval.
The study was published in Clinical Cardiology by researchers from Baylor College of Medicine in Texas and involved 27,467 people who used Xarelto at some point between Jan. 1, 2013 and March 31, 2014.
During the study, there were 14 deaths caused by severe bleeding. Older adults (average age 78 years) were more likely to experience bleeding than younger patients. Overall, the fatal bleeding rate was 0.08 per 100 person-years. There were 496 major Xarelto bleeding events in 478 patients, for an overall rate of 2.86 incidents per 100 person-years.
Janssen concluded that the results of the study supported Xarelto’s safety profile. They were consistent with findings in clinical trials, which was the cornerstone safety study the FDA used to approve Xarelto in 2011.
This new information comes on the heels of a study published in the Canadian Journal of Cardiology that determined Xarelto was no safer than Warfarin when it came to bleeding events.What is Xarelto?
Xarelto is one of the newest blood thinners developed by Bayer and Janssen Pharmaceuticals. Blood thinners prevent dangerous blood clots that can obstruct the blood flow to the vital organs. Unlike older anticoagulants like Warfarin that require doctors to prescribe specific doses for each individual, Xarelto is prescribed in one uniform dose.
The FDA approved Xarelto for use in patients who have had knee or hip replacement surgery to reduce the risk of blood clots, reducing the risk of stroke in people with atrial fibrillation. Following a fast-track regulatory review, the FDA approved the drug for general treatment of deep vein thrombosis (DVT) and pulmonary bleeding.Xarelto Side Effects
One of the most severe side effects of Xarelto is uncontrolled bleeding. When bleeding occurs near a major organ, such as the brain, lungs or kidneys, blood flow to that organ is interrupted, causing it to lose some or all of its functionality. Because Xarelto prevents clotting, the hemorrhaging will continue until the drug is flushed out of the system.
While all blood thinners carry the risk of internal bleeding, older drugs like Warfarin have emergency antidotes to prevent serious harm. Xarelto does not have an antidote, and the drug cannot be flushed out of the system through dialysis. People who suffer bleeding can end up hospitalized, and the bleed may be fatal.Xarelto Bleeding Lawsuits
A growing number of Xarelto lawsuits have been brought by injured patients and their surviving relatives who accuse the drug makers of putting their financial bottom line ahead of consumer safety by touting Xarelto as a safer blood thinner that does not require monitoring.

Bayer and Janssen are facing over 80 lawsuits involving people who were seriously injured or died from major bleeding after taking Xarelto. The Xarelto lawsuits allege that users of the drug were not adequately warned about the risk of severe, potentially fatal bleeding, or Xarelto’s lack of an effective reversal agent.

Link to blog post: http://topclassactions.com/lawsuit-settlements/lawsuit-news/48533-xarelto-study-examines-risk-of-uncontrolled-bleeding/

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Off-label Use of Newer Anticoagulants — What Should a Patient Be Told?

Feb 6, 2015 | MD News

By Martin Clearwater & Bell LLP.

In recent years, new anticoagulants such as Pradaxa (dabigatran), Xarelto (rivaroxaban) and Eliquis (apixaban) have been approved by the FDA. They have benefits over older drugs such as Coumadin (warfarin), as they do not require frequent blood monitoring. Apart from their FDA-approved uses, these drugs are being used “off-label” to address conditions for which they have not been formally tested.
Dabigatran, for instance, was approved by the FDA for stroke prevention in patients with non-valvular atrial fibrillation and has been found effective off-label for treatment of venous thromboembolism. Although off-label use is prevalent in clinical practice, the valid question exists whether the patient is required to be informed that the drug has not been approved by the FDA for the prescribed purpose.
It is estimated that over 20 percent of all prescription medications are prescribed for an off-label use.1 “Off-label” use of a medication refers to the practice of prescribing a medication for a use that has not been formally approved by the FDA.2 Off-label use of a drug is prevalent, because the medical community’s clinical experience with the potential benefits of a drug will outpace the speed of the FDA approval process. Recognizing the importance of off label use, Congress amended the Food, Drug and Cosmetic Act (the law empowering the FDA) to state that the law does not limit the ability of a physician to prescribe an approved drug for “any condition or disease.”3

To answer the question of whether a patient should be informed that the medication is being used off-label, it is helpful to consider what FDA approval means. The FDA regulates the marketing of drugs and devices, not the practice of medicine. Some drugs never obtain FDA approval for a legitimate indication because the cost of conducting the clinical trials needed for approval outweighs the benefit. A lack of FDA approval for a particular indication does not mean the drug is not safe, and there has been no clear legal requirement imposed on the clinician to specifically inform the patient that a drug is being used off-label unless it is being used for human experimentation or research.
If the off-label use is not “experimental,” general rules of informed consent should apply. While the specific requirements of informed consent vary by state, and exceptions apply, generally the physician is required to inform the patient of the risks, benefits and alternatives of treatment so that the reasonable patient can decide in an informed way as to whether to proceed. How much information needs to be provided depends upon the specific treatment, purpose, degree of need, associated risks, benefit to the patient and other variables. The question of the sufficiency of this information may ultimately be decided by a lay jury with the help of the opinions of medical experts. Clinical experience, significant risks not known to the patient and medical judgment, and not the FDA approval per se, should dictate what information is given to a patient.
Link to blog post: http://lowerhudsonbronx.mdnews.com/articles/LocalArticle?id=42009

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Xarelto: Latest News

Feb 2, 2015 | The Legal Examiner

By Craig Kelley

Xarelto blood thinning medication continues to be the subject of lawsuits due to its dangerous bleeding risks, with no approved antidote to date. Janssen Pharmaceuticals (Johnson & Johnson subsidiary) and Bayer Corporation are now the subjects of consolidated lawsuits on behalf of patients injured by the commonly prescribed drug. Xarelto has been common to complaints of internal bleeding, including gastrointestinal bleeding and brain bleeding, as well as death. Federal judges have found that a large enough number of the lawsuits includes common complains and similar facts, including the possibility that the drugs were not labeled with the dire warning of severe bleeding possibilities as a large side effect.
Xarelto has been approved by the Federal Drug Administration (FDA) for use to reduce stroke risk in those patients who have non-valvular atrial fibrillation; for treatment of deep vein thrombosis; for treatment of pulmonary embolism; for reducing the return of the aforementioned conditions; and for prevention of blood clots following knee or hip replacement surgeries. In fact, Xarelto can increase the risk of blood clots when its therapeutic use is stopped prematurely and it also carries the risk of causing epidural or spinal hematomas that could lead to permanent paralysis when used by those also receiving neuraxial anesthesia or those who undergo spinal puncture. These dangerous risks have led to the FDA issuing Black Box warnings, which are the most serious warnings that the FDA issues, reserved for products that pose a really significant risk of serious to life-threatening effects.

Inserra & Kelley is already a part of the fight waged on behalf of patients injured by Xarelto. If you or a loved one has been affected by a serious or fatal bleeding event with the use of Xarelto, do not hesitate to contact us for timely, caring, expert advice on your individual case.

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Philadelphia Judge Certifies Xarelto Lawsuits for Mass Tort Docket

Mar 18, 2015 | Product Liability Lawyer Blog

By Law Offices of Jeffrey S. Glassman

Xarelto is a relatively new type of blood-thinning medication in a class of drugs called New Oral Anticoagulants (NOACs).
Xarelto is manufactured by Bayer AG and sold in the United States with Bayer's marketing partner, Janssen Pharmaceuticals. Janssen is a subsidiary of Johnson & Johnson.
These companies market Xarelto for patients at high risk of developing serious clotting disorders such as stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE). A PE is deadly health condition in which a clot forms and then dislodges itself and travels through the circulatory system until it reaches the lungs. One in a lung, it can tear a hole in the tissues, causing serious illness or death.
Patients at risk for these conditions normally require a blood thinner such as Warfarin. While Warfarin is generally effective, patients must closely watch their diet and have regular blood tests to control their dosage. If the dosage is off, patients can develop life-threatening side effects. Xarelto, on the other hand, is supposed be as effective without requiring constant dose monitoring.
This is what Janssen wants you to know. What they don't want you to know is Xarelto can cause serious internal bleeding disorders, including bleeding in the brain (intracranial). There is also no approved treatment, antidote, or other way to reverse the potentially fatal side effects of Xarelto.
With thousands of patients becoming ill or dying as a result of Xarelto side effects, lawyers are filing lawsuits all over the country. If you have been injured by as a result of the drug in Boston, a Xarelto injury attorney can explain your rights.
According to a recent news article from the Pennsylvania Record, a judge in Philadelphia has recently created a mass tort docket to consolidate all Xarelto lawsuits in the city. There have already been 75 cases filed separately related to the irreversible and fatal bleeding disorder.
The purpose of creating a mass tort docket is to consolidate the lawsuits so there will less cost to all parties involved in obtaining discovery, holding depositions, and many other aspects of litigation. It will also be much more efficient in terms of court resources.
With the increasing likelihood of a Xarelto case becoming a class action matter, one of the most important things you can do when selecting an attorney is make sure he or she is familiar with large class action lawsuits involving dangerous drugs. These are not typical personal injury cases and require experience and a real understanding of how this type of litigation works.
It should be noted makers of Xarelto have issued a statement saying they are determined to defend the allegations made in these lawsuits, and that Xarelto is an FDA approved medication for treatment of serious diseases.

Xarelto, along with Eliquis and Pradaxa, which are also NOACs, have earned their respective makers windfall profits, and the companies do not want sales to be harmed as result of health concerns or lawsuits. The company also wants people to know an antidote to Xarelto bleeding injuries is in development and has showed promising results in early testing, though this drug is not yet approved by FDA for any patients not in a randomized drug study.
Link to blog post: http://www.productliabilitylawyerblog.com/2015/02/philadelphia-judge-certifies-xarelto-lawsuits-for-mass-tort-docket.html

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Why We Will Be Hearing More About Xarelto in the Near Future

Jan 21, 2015 | Lawyers and Settlements

By Gordon Gibb

There are numerous signs that we’re going to be hearing a lot more about Xarelto in the coming months and years. That’s because the consolidation of Xarelto lawsuits into multidistrict litigation means that bellwether trials will be starting later this year or next. What’s more, the very fact that the American population is aging, places drugs like Xarelto, an anticoagulant, in the forefront of public awareness. With aging baby boomers, more patients than ever before will need the thinning properties of drugs like Xarelto in order to help prevent blood clots and strokes.

But there is another reason why we’ll be hearing a lot more about Xarelto in the coming years. Xarelto (Rivaroxaban) is one of three relatively new drugs that have entered the scene to challenge the market dominance of Coumadin (warfarin). The latter has been around for five decades and has been the defacto go-to drug for patients in need of an ongoing anticoagulant.

The manufacturers of Xarelto and others are on a mission to knock Coumadin off its perch, so much so that manufacturers are spending big dollars to persuade doctors that drugs like Xarelto have benefits over Coumadin, and are worth giving a try.

How much play the potential for a Xarelto bleeding issue has in such marketing and promotion initiatives is unknown. What is known, however, is that in the remaining five months of 2013, the manufacturers of Xarelto, Pradaxa and Eliquis - three blood thinners that are considered heirs to the Coumadin throne - spent $19.4 million between them on doctors and teaching hospitals. Such efforts, according to the New York Times (1/8/15), include treating doctors to dinner, remuneration for promotional speeches, consulting jobs and “educational” gifts.

Are these efforts kosher? Pundits say that doctors and manufacturers are walking a fine line that is very easy to cross. The New York Times report notes that several manufacturers, including the makers of Xarelto, have been faulted by the US Food and Drug Administration (FDA) for improper promotion and marketing practices.

Coumadin has been, and remains, an effective blood thinner - provided patients adhere to rules over strict monitoring and diet limitations. The new crop of blood thinners, including Xarelto, does not need the kind of stringent monitoring required of warfarin use. Additionally, with Xarelto and others of its ilk, there is little need to watch what you eat.

The problem is in the event of an unforeseen and sudden Xarelto Bleeding Issue. Patients on warfarin also have to be careful about the potential for a bleeding issue, caused when blood that has been thinned and is allowed to flow freely through a wound or ruptured blood vessel loses its capacity to clot, and therefore, halt the bleeding.

Coumadin, however, has always had an ace up its sleeve: Vitamin K, which - when administered in the midst of a hemorrhage - can quickly reverse the thinning properties of Coumadin, helping to halt the bleeding.

Where’s the exit strategy?

There is no such option for Xarelto. When a Xarelto Bleedout begins, there is little doctors can do to stop it.

The result can often lead to Xarelto Death.

Manufacturers of Xarelto and its competitors are exploring options for an antidote after the fact. In the meantime, manufacturers are continuing to spend big dollars on new anticoagulants such as Xarelto, touting their efficacy and convenience.

The numbers for drug promotion come through Open Payments, a database administered by the Centers for Medicare and Medicaid Services. The data was analyzed by ProPublica, identified by the New York Times as an independent, not-for-profit newsroom that generates investigative journalism in the public interest.

It was noted that data breaking out just how many promotional and marketing dollars were spent for individual drugs, wasn’t available.

Meanwhile, while all this promotional activity is going on behind the scenes, many a Xarelto lawsuit has claimed that unforeseen Xarelto Bleeding complications compromised an individual’s health or resulted in Xarelto death. Plaintiffs have asserted that they were not made aware that some serious Xarelto Side Effects such as a serious bleeding issue could not be reversed, as it can with warfarin.

In the event of a Xarelto bleeding issue, an exit strategy would be most welcome…

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Were Xarelto Manufacturers Wrong Not to Encourage Blood Monitoring?

Jan 20, 2015 | Legal Examiner

By Eric T. Chaffin

In a recent study published in the Journal of Cardiology, researchers concluded that blood monitoring for patients taking rivaroxaban (Xarelto) could identify those who are at risk of excessive bleeding events.
Yet Xarelto manufacturers advertised their product as being superior to warfarin, the leading anticoagulant, precisely because it didn’t require such monitoring.
Study Suggests Xarelto Blood Monitoring
For the study, researchers from Japan gave 136 patients rivaroxaban to treat non-valvular atrial fibrillation—a treatment the FDA approved in November 2011. The patients had a mean age of 75 years. The researchers performed blood tests at the beginning of the study and two weeks after the patients started taking the drug, to monitor blood-clotting activity.
They found that in some patients, the drug caused a prolonged “thinning” effect, making them more likely to experience serious bleeding events. This effect could be observed in blood tests. The researchers concluded that regular blood monitoring could identify patients at risk for bleeding—a fact that could potentially prevent subsequent bleeding events that could land patients in the hospital.
Manufacturers Advertise Xarelto as More Convenient
Xarelto, a newer generation anticoagulant, was launched onto the market in July 2011, when it was approved to reduce the risk of blood clots after knee and hip replacement surgery. Since then, it has been the subject of adverse event reports regarding excess bleeding. In the Institute for Safe Medication Practices October 2012 QuarterWatch report, the drug was found to have been associated with 158 cases of severe blood clots in only the first quarter of 2012.
Data from the first quarter of 2013 showed that adverse event reports for Xarelto (rivaroxaban) had surpassed those for Pradaxa (dabigatran), mirroring an increase in the number of patients taking the drug. Meanwhile, a number of patients have filed lawsuits against manufacturer Janssen Pharmaceuticals and parent company Johnson & Johnson (J&J), claiming they failed to warn about the dangerous side effects.
Advertising for Xarelto emphasized that it did not require blood monitoring, and thus was a much more convenient option compared to warfarin. As noted in an FDA warning letter to the manufacturers, their materials even stated it explicitly: “Xarelto is the first and only once-a-day prescription blood thinner for patients with AFib not caused by a heart valve problem, that is proven to reduce the risk of stroke—without routine blood monitoring.”
Yet this study suggests that many of the injuries associated with Xarelto may have been prevented had the manufacturers recommended regular blood monitoring, such as that which occurs in patients taking warfarin. The FDA notes in its warning letter that the statement is misleading, for one, because patients with kidney problems may need to be evaluated and the dosage adjusted.
“This overall presentation misleadingly minimizes the risks associated with Xarelto,” the FDA stated, “because it fails to convey this important risk information with a prominence and readability reasonably comparable to the efficacy claims.”
J&J May Have Committed a Grave Error

The conclusions by the researchers of this study may be important evidence in Xarelto lawsuits, as it shows that the manufacturers may have failed to provide not only adequate warnings about their product, but that they may have failed to provide patients and doctors with the proper prescribing information in the first place. If the drug required blood monitoring—even for patients not at risk of renal impairment—that should have been suggested in the beginning, when the drug was first launched.
Link to blog post: http://newyork.legalexaminer.com/defective-dangerous-products/were-xarelto-manufacturers-wrong-not-to-encourage-blood-monitoring/

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Xarelto Lawsuits Continue As FDA Approved Label Changes Adding More The Blood Thinner Side-Effects, Reports Wright & Schulte LLC

Jan 20, 2015 | Wright & Schulte LLC

Wright & Schulte Continues To Investigate Xarelto Lawsuits Filed In The U.S. District Court, Eastern District Of Louisiana Alleging The Blood Thinner Caused Serve Uncontrolled Bleeding. As pretrial proceedings move forward for Xarelto bleeding lawsuits, Wright & Schulte LLC reports that the U.S. Food and Drug Administration (FDA) has approved changes to the drug safety label of Xarelto tablets. The revisions on the blood thinner’s label included adding the term, “thrombocytopenia,” a blood and lymphatic system disorder, as an “Adverse Reaction.” The label also included replacing the Adverse Reaction term “cytolytic hepatitis” with “hepatitis (including hepatocellular injury).” According to prescribing information for the Xarelto blood thinner medication, it is not always possible to estimate how frequently these disorders occur or establish a causal relationship to drug exposure because reporting adverse reactions is voluntary, The most common adverse reaction of Xarelto blood thinner medication is bleeding, according to the label.
Xarelto, generically known as rivaroxaban, is an oral blood thinner approved by the FDA to treat blood clots in the leg (deep vein thrombosis) and lungs (pulmonary embolism), and to reduce the risk of stroke and blood clots in patients with atrial fibrillation (irregular heart rhythms). The FDA considerers Xarelto a new generation blood thinner compared to warfarin (Coumadin, Jantoven) the federal agency approved 60 years ago. Warfarin has vitamin K as an antidote should severe bleeding occur but Xarelto does not have an antidote to reverse the effects of the anticoagulant, according to the FDA. In addition to uncontrollable bleeding, other Xarelto side-effects include: Headaches Dizziness Weakness Bright red or black stools (looks like tar)Red, pink, or brown urine Coughing up blood or blood clots.
The attorneys at Wright & Schulte LLC continue to investigate Xarelto side-effects and offers free legal consultation to people who believe they have experienced uncontrollable bleeding and hemorrhaging as a result of using Xarelto and other blood thinners. To speak with one of the firm experienced attorneys call 1-800-399-0795 or you can visit yourlegalhelp.com for more information on this and other prescription drug lawsuits.
Court records in the Xarelto lawsuit claims indicate that severe bleeding is the most common adverse reaction mentioned in Xarelto lawsuits filed against Bayer AG, Xarelto’s Germany-based manufacturer, and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals Inc., which markets Xarelto. Due to the growing number of Xarelto lawsuit filings, a panel of federal judges in December transferred 21 federally filed Xarelto complaints to the U.S. District Court, Eastern District of Louisiana. The judicial panel consolidated the Xarelto bleeding side-effects claims in the Louisiana court for coordinated pretrial proceedings. In consolidating the Xarelto cases, the judicial panel explained that the lawsuits had common allegations such as the defendants’ failure to warn doctors, patients and consumers about the fatal bleedings risks associated with the anticoagulant and that there is no antidote should severe bleeding occur in those who take the oral blood thinner. There are 86 cases pending in the litigation as of January 15. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592).

Records further show that another Xarelto bleeding-lawsuit complaint was filed recently against Bayer, Janssen Pharmaceuticals and its parent company, Johnson & Johnson. The Xarelto blood thinner complaint was filed on behalf of a man who starting taking the anticoagulant in January 2014 and was hospitalized in February 2014 after suffering a “severe gastrointestinal bleed” allegedly as a result of taking Xarelto. In addition to bleeding, the complaint says the man experienced “dizziness, weakness and fatigue accompanied by black, tarry stools.” According to the Xarelto lawsuit, the man had several blood transfusions as a result of the bleeding disorder in which he suffered pain and emotional distress. The Xarelto complaint contends that the defendants were negligent for concealing the Xarelto side effects from the medical community and the public. The lawsuit was filed December 1, 2014 in the U. S. District Court, Eastern District of Louisiana. (Case No. 2:14-cv-02720)
Link to blog post: http://yourlegalhelp.com/xarelto-lawsuits-continue-fda-approved-label-changes-adding-blood-thinner-side-effects-reports-wright-schulte-llc/4982

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Xarelto Uncontrollable Bleeding Lawsuit Filed in Louisiana

Jan 14, 2015 | Top Class Actions

By Meredith Friesen

A Xarelto lawsuit was filed in Louisiana in December that claimed the blood thinner designed to help atrial fibrillation patients caused severe internal bleeding.
Defendants Janssen, Johnson & Johnson, and Bayer, who were responsible for designing, testing, promoting and selling Xarelto, have faced a number of Xarelto uncontrollable bleeding lawsuits that list severe bleeding as a Xarelto side effect.
Plaintiff Joseph B. began taking Xarelto in January 2014 and stopped on Feb. 3, 2014 when he was hospitalized for “a severe gastrointestinal bleed, dizziness, weakness, and fatigue accompanied by black, tarry stools,” according to the Xarelto lawsuit.
Joseph claims that needed several blood transfusions in order to recover, and he still requires follow-up treatment.
The defendants were accused of “negligently and/or fraudulently” claiming that Xarelto was safe to use and concealing alleged Xarelto side effects from the public and medical community, according to the Xarelto lawsuit.
Xarelto was approved in 2011 to treat atrial fibrillation and to help prevent clotting in patients undergoing knee or hip replacement surgery. It was introduced as an alternative to warfarin, which was the leading anticoagulant for decades. Xarelto was introduced to the market a year after Pradaxa, the first generation in this new wave of medicine. Eliquis followed after Xarelto.
Xarelto was heavily promoted as a treatment that did not require blood monitoring and did not limit a patient’s diet, like warfarin.
It was the most advertised drug. However, “the Defendants’ promotional materials fail to … highlight the increased risk of gastrointestinal bleeding and bleeding that required transfusion, among other serious bleeding concerns,” says the Xarelto lawsuit.
Although allegedly the defendants claimed the drug was safer than warfarin, many have experienced Xarelto bleeding side effects which have resulted in hospitalization.
Furthermore, warfarin has an antidote if bleeding side effects arise. There is no Xarelto antidote, making is especially dangerous if a patient, like Joseph, experiences severe Xarelto side effects.
In June 2013, the U.S. Food and Drug Administration, or FDA, required Xarelto makers to cease publishing their promotional materials based on the fact that “the print ad is false or misleading because it minimizes the risks associated with Xarelto.”
Even though the promotional materials stopped, physicians were allegedly not adequately informed about Xarelto side effects, that Xarelto was not as safe and/or effective as warfarin, and that there is no Xarelto antidote.
Millions have been prescribed Xarelto since its introduction to the American market.
In the fist six months of 2012, over 1,000 adverse events were reported to the FDA. Several of these cases involved death.
By the end of the 2012 fiscal year, an additional 2,000 reports were filed with the FDA. Out of these adverse reports, 151 of these reports were Xarelto deaths. Warfarin only had 56 deaths reported during the same time frame.
Many adverse events are not reported to the FDA. Patients may also not be aware of the source of their medical condition.
Joseph sought compensatory damages for the pain and suffering, emotional distress, medical bills, and several other limitations mentioned in the Xarelto lawsuit. He also asked for damages for loss of care and comfort, loss of earnings and impaired earning capacity, all present and future medical bills caused by Xarelto, attorney fees, and exemplary damages.
Joseph is one of many individuals who have filed a Xarelto lawsuit against these defendants. A Xarelto class action lawsuit investigation has been launched.

This Xarelto Uncontrollable Bleeding Lawsuit is Case No. 2:14-cv-02720 filed in the U.S. District Court of the Eastern District of Louisiana.
Link to blog post: http://topclassactions.com/lawsuit-settlements/lawsuit-news/47311-xarelto-lawsuit-filed-louisiana/

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First Status Conference Scheduled For Xarelto MDL

Jan 10, 2015 | The Oliver Law Group, P.C.

The initial status conference for Xarelto bleeding lawsuits has been scheduled for January 29. Attorneys involved in the Xarelto lawsuits will meet with U.S. District Judge Eldon E. Fallon in New Orleans at the U.S. District Court, District of Louisiana to discuss how the Xarelto litigation will move forward in the pretrial proceedings. In a pretrial order issued on December 17, Judge Fallon asked lawyers for the plaintiffs and defendants to submit a brief written statement by January 20 that indicates their preliminary understanding of the facts involved in the litigation and the critical factual and legal issues. The judge also told attorneys to familiarize themselves with the Manual for Complex Litigation and be prepared at the conference to “suggest procedures that will facilitate the expeditious, economical, and just resolution of this litigation.” (In Re: Xarelto Products Liability Litigation, No. 2592)
This initial status conference comes more than one month after a panel of federal judges transferred all federally filed Xarelto lawsuits to the federal court in Louisiana. The judicial panel assigned Judge Fallon to manage the litigation. The panel consolidated the lawsuits after finding that the Xarelto complaints share common questions of fact and common allegations, such as Germany-based Bayer AG and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals, Inc. did not adequately warn doctors, patients and consumers about the severe or fatal bleeding risks associated with Xarelto and the blood thinner has no reversal agent available to counteract its anticoagulation effects. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592).
The Oliver Law Group P.C. is offering free Xarelto lawsuit reviews to individuals who allegedly suffered serious internal bleeding and other complications due to their use of the blood thinner. Free legal evaluations are also being offered to families of patients who allegedly died as a result of Xarelto bleeding. To learn more about filing a Xarelto lawsuit, please contact our office by calling 800-939-7878 today.
Xarelto (generically known as rivaroxaban) is an oral anticoagulant approved by the U.S. Food and Drug Administration (FDA) to treat blood clots in the leg (deep vein thrombosis) and lungs (pulmonary embolism) and used to reduce the risk of stroke and blood clots in patients with atrial fibrillation (irregular heart rhythms). The FDA considers Xarelto, along with Pradaxa and Eliquis, as new generation blood thinners compared to warfarin, a FDA-approved blood thinner that has been on the market since 1954. According to the FDA, one of the differences between the new generation of blood thinners and warfarin is the 60-year-old anticoagulant has vitamin K as a reversal agent should severe bleeding occur in patients. Xarelto, Pradaxa and Eliquis do not have antidotes for bleeding.
Court documents indicate that one of the lawsuits transferred into MDL 2592 was filed on behalf of a woman who alleges she experienced life-threatening bleeding after using the Xarelto blood thinner. According to the Xarelto complaint, the woman took the blood thinner medication from July 2013 to November 2013, and on November 4, 2013, experienced severe bleeding. The Xarelto bleeding side-effects lawsuit alleges the woman was “severely and permanently injured” due to the bleeding and will require continuous medical monitoring and treatment. The Xarelto complaint purports that Bayer and Janssen misrepresented the bleeding side-effects of the anticoagulant to the medical and healthcare community. The personal injury lawsuit was filed October 27 in the U.S. District Court, Eastern District of New York. (1:2014cv06278)
Link to blog post: http://legalactionnow.com/xarelto-lawsuit-news-first-status-conference-scheduled-xarelto-mdl-oliver-law-group-p-c-reports/6170

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Xarelto’s Side Effects Could Be Deadly

Jan 9, 2015 | Searcy Denney Scarola Barnhart & Shipley, PA

By Brenda Fulmer

The blood-thinner Xarelto has been linked to a slew of serious side effects, including bleeding in the brain, gastrointestinal bleeding and other internal bleeding that can be fatal. As a result, lawsuits have piled up.
Most recently, two dozen such suits were consolidated in a Louisiana federal court against drug maker Johnson & Johnson and subsidiaries Janssen Pharmaceuticals and Bayer Corp. The panel of judges who approved the consolidation said the suits had several similarities, such as alleging the defendants failed to properly publish warnings about the severe-bleeding risks.
In a separate case in West Virginia, a female patient who was prescribed Xarelto for atrial fibrillation and experienced gastrointestinal bleeding is accusing the pharmaceutical companies of the same thing.
“Nova Rose and her husband, William, claim the two pharmaceuticals ignored studies showing Xarelto and rivaroxaban led to increased risk of gastrointestinal bleeding, at times requiring transfusions,” a story in the State Journal reads. “The suit filed by Rose and her husband alleges a number of violations, including negligence, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, violation of the West Virginia Consumer Credit & Protection Act and loss of consortium.”
The bleeds associated with Xarelto, known generically as rivaroxaban, are irreversible and can result in death.
“A specific antidote for rivaroxaban is not available,” according to the Food and Drug Administration. “Because of high plasma protein binding, rivaroxaban is not expected to be dialyzable….”
The FDA also issued the precaution that “premature discontinuation of Xarelto increases the risk of thrombotic events….”
The anticoagulant originally was approved for blood-clot prevention in hip- and knee-replacement patients, treating pulmonary embolisms, decreasing stroke risk in cases of atrial fibrillation and several other indications.
WebMD encourages patients taking the medication to keep an eye out for minor bleeding, such as cuts, nosebleeds and scrapes, and call their doctor if the bleeding persists. It tells patients to seek medical help immediately if they notice signs of severe bleeding, i.e., confusion, disorientation, slurred speech, vision problems and weakness in the body.

“Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects,” according to WebMD. “This medication can cause serious bleeding if it affects your blood clotting proteins too much.”
Link to blog post: http://www.searcymasstort.com/blog/2015/01/09/xareltos-side-effects-deadly/

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