Preview Newsletter
XARELTO Media Monitoring Week of 2/6/15
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McPhadden Samac Tuovi LLP Commences Xarelto Class Action Against Bayer and Janssen
Feb 6, 2015 | Market Wired
By McPhadden Samac Tuovi LLP
Toronto law firm McPhadden Samac Tuovi LLP announced today that it has commenced a Xarelto class action law suit. The defendants are Johnson & Johnson and Bayer companies. Xarelto was developed, is marketed and manufactured by Bayer and Janssen, a subsidiary of Johnson & Johnson. The lawsuit has been filed in the Alberta Court of Queen's Bench. -
Xarelto Lawsuit News: Bernstein Liebhard LLP Comments on Filing of New Bleeding Claim in Illinois
Feb 5, 2015 | PR Web
By Bernstein Liebhard LLP
Xarelto lawsuits (http://www.xareltolawsuit2015.com/) filed on behalf of individuals who were allegedly harmed by the medication continue to mount in state and federal courts around the country, Bernstein Liebhard LLP reports. According to court documents, an Illinois woman filed one such claim on January 22nd in St. Clair County Circuit Court, after she allegedly suffered serious injuries due to her use of the blood thinning medication. Among other things, the complaint claims that as a result of taking Xarelto, the Plaintiff’s blood was not able to congeal in a timely manner. The lawsuit further alleges that marketing materials for Xarelto failed to highlight data from clinical trials that suggested the medication posed serious bleeding concerns, including an increased risk of gastrointestinal bleeding and bleeding that required transfusion.(Case No. 15-L-35) -
National Attorneys Review New Claims for Xarelto Lawsuit MDL
Feb 5, 2015 | PR Web
By Gudeman Group
Attorneys representing clients nationwide in Xarelto lawsuits that have been consolidated at a multidistrict litigation* announce the MDL is moving forward routinely and new claims are still being accepted. “Many people assume that once the MDL procedure moves forward, it is too late to join. However, our attorneys would like to assure the public there is still a window of opportunity in this particular litigation,” said Jim Onder. The Onder Law Firm provides no-cost, no-obligation Xarelto lawsuit case review for individuals and the family members of individuals who have suffered from internal bleeding or hemorrhagic stroke and have a history of taking Xarelto. -
Xarelto MDL Sent to Eastern District of Louisiana; City of St. Louis Xarelto Litigation Expected to Begin Soon
Feb 4, 2015 | PR Web
By Niemeyer, Grebel & Kruse, LLC
According to court documents, on December 12, 2014 the United States Judicial Panel on Multi-District Litigation (JPML) entered an Order transferring all of the federal court Xarelto lawsuits to the Eastern District of Louisiana. The Xarelto MDL has been given MDL number 2592. The JPML decided on the Eastern District of Louisiana because it found it to be a geographically central forum for nationwide Xarelto lawsuits. -
Sanders Phillips Grossman, LLC Launches a Nationwide Campaign to Represent People Harmed by Xarelto®
Feb 4, 2015 | PR Web
By Sanders Phillips Grossman LLC
The national law firm of Sanders Phillips Grossman, LLC is joining the fight to seek compensation for those who have been seriously harmed by the usage of Xarelto. The number of lawsuits filed against the manufacturers and marketers of Xarelto is on the rise, as more people who have suffered severe bleeding events after taking the blood thinner continue to come forward. -
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 Peter T. Crean and Daniel L. Freidlin
*This article is sponsored 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 MDL has first status conference
Feb 6, 2015 | Legal Reader
By Amber Pang Parra
*This article is sponsored by Justinian PLLC The first conference in the Xarelto MDL (In Re: Xarelto (Rivoroxaban) Products Liability Litigation,MDL 2592, proceeding in the Eastern District of Louisiana, before the Hon. Eldon E. Fallon, took place on January 29, 2015. Judge Fallon, an experienced MDL presiding judge, has already set up a website for the MDL (http://www.laed.uscourts.gov/xarelto), with posts of orders and other pertinent information. -
Xarelto: Latest News
Feb 5, 2015 | The Legal Examiner
By Craig Kelley
*This article is sponsored by Inserra & Kelley LLP. 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 Litigation Goes to Judge Fallon in New Orleans
Feb 3, 2015 | A Georgia Lawyer
By Mark Zamora
*This article is sponsored by the Law Offices of Mark Zamora Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. Xarelto is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.Xarelto lawsuits continue to be filed on behalf of people who suffered serious bleeds as a result of taking Xarelto. In light of how many lawsuits have been filed, the Judicial Panel on Multidistrict Litigation (JPML) elected to coordinate the litigation in front of a single federal judge. The JPML transferred the Xarelto litigation to Judge Eldon E. Fallon of the Eastern District of Louisiana.Judge Fallon is a well-respected judge who has extensive experience handling large scale products liability litigation. Over the next several months, Judge Fallon will get orders in place appointing Plaintiff's counsel leadership and determining issues affecting confidentiality, document production, scheduling, and discovery among other issues. It is expected that the Xarelto litigation (entitled In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592) will continue to grow exponentially with more cases being filed every month. -
Philadelphia Judge Certifies Xarelto Lawsuits for Mass Tort Docket
Feb 1, 2015 | Product Liability Lawyer Blog
By Law Offices of Jeffrey S. Glassman
*This article is sponsored by the 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. -
Xarelto Bleeding Lawsuits Moving Ahead
Jan 31, 2015 | The Legal Examiner
By Shezad Malik MD JD
*This article is sponsored by Dr. Shezad Malik Law Firm Late last year, the U.S. Judicial Panel on Multidistrict Litigation announced consolidation and centralization of all nationwide Xarelto lawsuits filed in federal courts before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Plaintiff Attorney Press Releases
Plaintiff Attorney Blogs
Full Text of Stories Below
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McPhadden Samac Tuovi LLP Commences Xarelto Class Action Against Bayer and Janssen
Feb 6, 2015 | Market Wired
By McPhadden Samac Tuovi LLP
Toronto law firm McPhadden Samac Tuovi LLP announced today that it has commenced a Xarelto class action law suit. The defendants are Johnson & Johnson and Bayer companies. Xarelto was developed, is marketed and manufactured by Bayer and Janssen, a subsidiary of Johnson & Johnson. The lawsuit has been filed in the Alberta Court of Queen's Bench.
Xarelto is an anticoagulant. It was first approved in Canada for venous thromboembolism (VTE) in 2008 and in 2012 was approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Since its introduction, Xarelto has been prescribed to millions of people in Canada and around the world.
The legal proceeding alleges that the defendants failed to adequately warn of the lack of a way to reverse the anticoagulant of Xarelto. Should a patient on Xarelto suffer a bleeding event, excessive bleeding may result because of Xarelto's irreversible anticoagulant effects. In extreme cases, the patient can bleed to death.
Xarelto is intended as a replacement for warfarin, a blood thinner in use for decades. Patients on warfarin require frequent monitoring by health care professionals. Xarelto is promoted as not requiring routine monitoring. The law suit challenges those claims.
The plaintiff lives near London, Ontario and suffered her severe bleeding event while residing in Alberta. The lawsuit is on behalf of all residents of Canada who suffered personal injury as a consequence of an excessive bleeding event while taking Xarelto.
As the legal proceeding was just commenced, the defendants have not yet been served with the claim and the allegations identified above have not been proven in court.
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Xarelto Lawsuit News: Bernstein Liebhard LLP Comments on Filing of New Bleeding Claim in Illinois
Feb 5, 2015 | PR Web
By Bernstein Liebhard LLP
Xarelto lawsuits (http://www.xareltolawsuit2015.com/) filed on behalf of individuals who were allegedly harmed by the medication continue to mount in state and federal courts around the country, Bernstein Liebhard LLP reports. According to court documents, an Illinois woman filed one such claim on January 22nd in St. Clair County Circuit Court, after she allegedly suffered serious injuries due to her use of the blood thinning medication. Among other things, the complaint claims that as a result of taking Xarelto, the Plaintiff’s blood was not able to congeal in a timely manner. The lawsuit further alleges that marketing materials for Xarelto failed to highlight data from clinical trials that suggested the medication posed serious bleeding concerns, including an increased risk of gastrointestinal bleeding and bleeding that required transfusion.(Case No. 15-L-35)
“Our Firm is representing a number of clients who have filed Xarelto lawsuits that put forth similar allegations regarding its association with uncontrollable internal bleeding, and we continue to receive inquiries from individuals who claim to have experienced similar complications. It is not surprising that the litigation surrounding this drug continues to grow,” said Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free, no-obligation Xarelto case reviews to people who allegedly suffered serious injuries from the blood thinner, including uncontrollable bleeding, strokes, deep vein thrombosis or pulmonary embolism.
Xarelto Litigation
Xarelto was approved by the U.S. Food & Drug Administration in 2011, and 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. Like all blood thinners, Xarelto can sometimes cause patients to experience internal hemorrhaging. However, no antidote has yet been approved to reverse Xarelto bleeding.*Court documents indicate that the Xarelto lawsuit pending in Illinois is just one of dozens of similar claims that have recently been filed in U.S. courts. In December 2014, all federal cases involving the drug were consolidated in a multidistrict litigation and transferred to the U.S. District Court, Eastern District of Louisiana. Among other things, these lawsuits allege the drugs’ manufacturers wrongly marketed Xarelto as a superior alternative to warfarin, a blood thinner that has been on the market for decades. According to court records, nearly 90 Xarelto bleeding claims have been filed in the proceeding thus far. (In Re: Xarelto Products Liability Litigation, No. 2592)
Individuals who suffered uncontrollable episodes of internal bleeding allegedly associated with Xarelto may be entitled to take legal action against the drug’s manufacturers. Learn more about filing a Xarelto lawsuit by visitingBernstein Liebhard LLP’s website, or by calling 800-511-5092 to schedule a free, no obligation case review.
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National Attorneys Review New Claims for Xarelto Lawsuit MDL
Feb 5, 2015 | PR Web
By Gudeman Group
Attorneys representing clients nationwide in Xarelto lawsuits that have been consolidated at a multidistrict litigation* announce the MDL is moving forward routinely and new claims are still being accepted. “Many people assume that once the MDL procedure moves forward, it is too late to join. However, our attorneys would like to assure the public there is still a window of opportunity in this particular litigation,” said Jim Onder. The Onder Law Firm provides no-cost, no-obligation Xarelto lawsuit case review for individuals and the family members of individuals who have suffered from internal bleeding or hemorrhagic stroke and have a history of taking Xarelto.
During January 2015, Pretrial Orders #2 and #3 were issued. Both official court documents, the Pretrial Orders establish routine elements in the early process of a multidistrict litigation. Coordinating the counsel is a significant task when the number of plaintiffs swells; as of January 15, 2015, there were 86 Xarelto lawsuits included in the litigation in Louisiana, according to a pending MDL list available from the JPML.** The Pretrial Orders establish mutual understanding regarding the procedures that will take place as the litigation moves forward; Orders 2 and 3 specifically establish one or more individuals as Plaintiffs’ Liaison Counsel (Gerald E. Meunier and Leonard A. Davis) and Defendants’ Liaison Counsel (James B. Irwin), according to the respective court documents.
Xarelto, or rivaroxaban, is an oral anticoagulant or blood thinner commonly prescribed to patients who suffer from a heart condition known as atrial fibrillation and patients recovering from hip or knee replacement surgery, according to court documents. Xarelto lawsuits allege that Xarelto puts patients at risk for life-threatening internal bleeding and hemorrhagic stroke, and further asserts that patients were not adequately warned of these risks. In consolidating the Xarelto lawsuits, the Judicial Panel on Multidistrict Litigation named the following as the commonalities across all the cases: “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”, as written in the transfer order, a court document.
Attorneys handling national Xarelto lawsuits for the Onder Law Firm are now accepting claims from persons and the family members of persons who sustained severe internal bleeding or hemorrhagic stroke while taking the oral blood thinner Xarelto. Lawyers are investigating these inquiries for possible inclusion in the Xarelto lawsuit MDL. The Onder Law Firm is recognized or its achievements in product and consumer safety litigation, with a strong track record of winning meaningful settlements for clients. The firm is nationally-renowned for its work on window blind strangulation, and has notable expertise in fighting on behalf of individuals against powerful corporations. Individuals and the family members of individuals who have suffered from internal bleeding and have taken Xarelto are eligible for a no-cost, no-obligation Xarelto lawsuit case review, and may contact the firm through its Xarelto Contingency Lawsuit website where the firm provides information on bleeding warnings and Xarelto lawsuit news.
The Onder Law Firm also welcomes Xarelto lawsuit inquiries from other law firms, either to handle these inquiries or work as co-counsel.
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Feb 4, 2015 | PR Web
By Niemeyer, Grebel & Kruse, LLC
According to court documents, on December 12, 2014 the United States Judicial Panel on Multi-District Litigation (JPML) entered an Order transferring all of the federal court Xarelto lawsuits to the Eastern District of Louisiana. The Xarelto MDL has been given MDL number 2592. The JPML decided on the Eastern District of Louisiana because it found it to be a geographically central forum for nationwide Xarelto lawsuits. Additionally, it determined that Judge Eldon Fallon, who presides over the Xarelto lawsuit MDL, is an experienced transferee judge with the willingness and ability to manage the Xarelto lawsuit litigation efficiently. The JPML also cited that Judge Fallon is “well versed in multi-district litigation,” and the JPML was “confident he will steer this matter on a prudent course.” A complete copy of the JPML court’s Xarelto MDL order can be found athttp://www.jpml.uscourts.gov/sites/jpml/files/MDL-2592-Initial_Transfer-12-14.pdf
According to the court’s order, the Xarelto lawsuit Plaintiffs had proposed several locations for the consolidation of the nationwide Xarelto lawsuits, including the Southern District of Illinois, the Northern District of Georgia, the Northern District of Illinois, and the Eastern District of Louisiana, among other locations. The Xarelto lawsuit Defendants had opposed the creation of an MDL, and had alternatively suggested the District of New Jersey would be an appropriate transferee district. The Xarelto lawsuit Defendants include various Bayer Corporation entities, as well as Janssen Pharmaceutical affiliates, with the addition of Johnson & Johnson affiliates as well. Despite the Xarelto lawsuit Defendants’ argument that the litigation lacks merit, the JPML determined that the creation of MDL in the Eastern District of Louisiana is in the best interest of all concerned.http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2592-Initial_Transfer-12-14.pdf
To date, NGK Law has filed a Xarelto lawsuit in the U.S. District Court for the Southern District of Illinois, Williams v. Janssen Research & Development, LLC et. al, Cause no. 3:14 cv-01278, which will be transferred into the MDL. A St. Louis litigation also benefits its clients, as it gives clients a state court litigation separate from the federal MDL litigation. NGK Law’s goal is to provide the best and most efficient forum for its clients’ Xarelto lawsuits, and believes that by expanding into St. Louis state court litigation, this can be obtained for Xarelto lawsuit clients. NGK Law is actively litigating other pharmaceutical cases in St. Louis, including cases involving Androgel prescription testosterone gel, Hebron v. Abbvie, et. al, Cause no. 1422-CC09740-01.
The law firm of Niemeyer, Grebel & Kruse, LLC, has created a website calledhttp://www.xareltorivaroxabanlawcenter.com, which is devoted to helping those allegedly injured by the blood thinning medication Xarelto to understand their avenues for pursuing a Xarelto lawsuit.
NGK Law is evaluating cases for individuals, or family members of individuals, that have suffered from serious bleeding events, including hemorrhagic strokes and gastrointestinal bleeds, allegedly while taking Xarelto.
About Niemeyer, Grebel & Kruse, LLC
Niemeyer, Grebel & Kruse, LLC is a St. Louis based mass tort and personal injury law firm handling pharmaceutical and medical device injury and death cases around the United States. Its track record of assisting those injured by dangerous drugs and medical devices shows its unending commitment to its clients and to holding pharmaceutical drug manufacturers and medical device manufacturers accountable for their dangerous products. Given its experience and accomplishment in being recognized by federal courts to lead litigation on behalf of thousands of individuals, NGK Law is considered a nationwide leader in pharmaceutical and drug litigation. The NGK Law Firm Xarelto lawyers provide information to the public at http://www.xareltorivaroxabanlawcenter.com.
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Sanders Phillips Grossman, LLC Launches a Nationwide Campaign to Represent People Harmed by Xarelto®
Feb 4, 2015 | PR Web
By Sanders Phillips Grossman LLC
The national law firm of Sanders Phillips Grossman, LLC is joining the fight to seek compensation for those who have been seriously harmed by the usage of Xarelto. The number of lawsuits filed against the manufacturers and marketers of Xarelto is on the rise, as more people who have suffered severe bleeding events after taking the blood thinner continue to come forward.
The oral anti-coagulant known as Xarelto was first approved by the FDA in 2011. It is currently used to treat patients who suffer from an irregular heartbeat known as Atrial Fibrillation, to treat those who have suffered a deep vein thrombosis or pulmonary embolism and to prevent blood clots in patients whom have had surgery. Xarelto stops clotting by inhibiting a protein called factor Xa, which is a protein involved in the process of coagulation, this in turn prevents the protein thrombin from forming.
The makers of Xarelto market the drug as a better alternative to other blood thinners by touting the fact that it is a once a day medication that does not require regular blood monitoring or dietary restrictions . However, as with all blood thinners Xarelto carries a risk of internal bleeding, but unlike other blood thinners on the market, there is no known antidote for internal bleeding caused by Xarelto. The lack of a known antidote can make bleeding events on Xarelto more dangerous and potentially fatal.
The occurrence of severe and sometimes fatal bleeding events in patients taking Xarelto has led to multiple lawsuits being filed across the country. Plaintiffs in these litigations are claiming that patients are not adequately warned about the danger of internal bleeding caused by Xarelto. The plaintiffs further allege that the makers of Xarelto were aware or at least should have been aware of the serious risk of dangerous and potentially deadly internal bleeding that comes with taking Xarelto. According to the pleadings from these cases, victims have suffered from brain bleeding, gastrointestinal bleeding, internal bleeding and even death.
With the number of lawsuits filed throughout the country and the prospect of more to be filed, a Xarelto multidistrict litigation (MDL) was issued transferring a number of cases into a consolidated action in the U.S. District Court for the Eastern District of Louisiana. Since that initial order many more cases have been transferred into MDL No. 2592.
Sanders Phillips Grossman, a national pharmaceutical litigation firm handling defective drug and medical device litigations is currently taking cases for people who have suffered internal bleeding events while on Xarelto. Sanders Phillips Grossman offers free and confidential consultations for people seeking representation for harm to themselves or a loved one caused by Xarelto. Those who are interested in exploring their legal rights in regards to Xarelto injuries may contact Sanders Phillips Grossman via the Xarelto website they have established athttp://xareltodruginjurylawsuit.com/
About Sanders Phillips Grossman
Sanders Phillips Grossman, LLC is a joint ventured between Phillips Law Firm and Sanders Viener Grossman. We have combined our efforts in order to help people from across the nation pursue injury claims against the manufacturers of defective drugs and medical devices. Sanders Phillips Grossman was formed with the express purpose of fighting for the rights of those who have been injured by defective products. Sanders Phillips Grossman has offices in Seattle, Washington; New York, New York; Los Angeles, California and San Juan, Puerto Rico, which allows us to represent individuals from all 50 states and Puerto Rico in claims for serious personal injury or wrongful death as a result of a defective product. -
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.
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Off-label Use of Newer Anticoagulants — What Should a Patient Be Told?
Feb 6, 2015 | MD News
By Peter T. Crean and Daniel L. Freidlin
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.4 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.
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Xarelto MDL has first status conference
Feb 6, 2015 | Legal Reader
By Amber Pang Parra
The first conference in the Xarelto MDL (In Re: Xarelto (Rivoroxaban) Products Liability Litigation,MDL 2592, proceeding in the Eastern District of Louisiana, before the Hon. Eldon E. Fallon, took place on January 29, 2015. Judge Fallon, an experienced MDL presiding judge, has already set up a website for the MDL (http://www.laed.uscourts.gov/xarelto), with posts of orders and other pertinent information. This Court appointed liaison counsel, and such counsel have already acted proactively in investigating the use of a commercial provider for service of process and the use of software for completing and submitting plaintiff fact sheets online. The Court set deadlines for applications to the leadership committees for plaintiffs’ and defendants’ counsel and indicated that upon appointments to the committees, a meeting will be held to discuss the initial disclosures of the parties and information requested for inclusion in forms and fact sheets.
These developments set the tone for an orderly and organized MDL process. In addition the EDLA provides that attorneys admitted to practice and in good standing in any United States District Court are admitted pro hac vice in this litigation. As such, association of local counsel is not required. This is good news for all parties involved in the litigation, as streamlined procedures lowers the costs of litigation and makes timely and expedition litigation and resolution of claims a much more achievable goal.
The next status conference is set for late February. We look forward to hearing more about this case.
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Feb 5, 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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Xarelto Litigation Goes to Judge Fallon in New Orleans
Feb 3, 2015 | A Georgia Lawyer
By Mark Zamora
Xarelto (rivaroxaban) is an anticoagulant (blood thinner) that prevents the formation of blood clots. Xarelto is used to prevent or treat a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism). A DVT can occur after certain types of surgery. Xarelto is also used in people with atrial fibrillation (a heart rhythm disorder) to lower the risk of stroke caused by a blood clot.Xarelto lawsuits continue to be filed on behalf of people who suffered serious bleeds as a result of taking Xarelto. In light of how many lawsuits have been filed, the Judicial Panel on Multidistrict Litigation (JPML) elected to coordinate the litigation in front of a single federal judge. The JPML transferred the Xarelto litigation to Judge Eldon E. Fallon of the Eastern District of Louisiana.Judge Fallon is a well-respected judge who has extensive experience handling large scale products liability litigation. Over the next several months, Judge Fallon will get orders in place appointing Plaintiff's counsel leadership and determining issues affecting confidentiality, document production, scheduling, and discovery among other issues. It is expected that the Xarelto litigation (entitled In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592) will continue to grow exponentially with more cases being filed every month. -
Philadelphia Judge Certifies Xarelto Lawsuits for Mass Tort Docket
Feb 1, 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.
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Xarelto Bleeding Lawsuits Moving Ahead
Jan 31, 2015 | The Legal Examiner
By Shezad Malik MD JD
Late last year, the U.S. Judicial Panel on Multidistrict Litigation announced consolidation and centralization of all nationwide Xarelto lawsuits filed in federal courts before U.S. District Judge Eldon E. Fallon in the Eastern District of Louisiana.
Over 86 Federal Xarelto Lawsuits
Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary are exposed to at least 86 product liability lawsuits over their new-generation anticoagulant. These personal injury and wrongful death claims are pending in 24 different federal courts.
According to experts, as Xarelto injury cases mount involving patients who experienced uncontrollable bleeding, it is anticipated that eventually several thousand cases will be transferred into the MDL.
Xarelto Uncontrollable Bleeding Allegations
The complaints all share the same allegations that the drug manufacturers failed to warn about the potential side effects of Xarelto, which caused patients to develop uncontrollable bleeding that resulted in hospitalizations, the need for blood transfusions and in severe cases death.
According to the claims, severe injuries and deaths were avoidable if the pharmaceutical companies had not provided misleading information about the blood monitoring, and if stronger warnings had been provided about the lack of a Xarelto reversal agent or antidote.
MDL Centralized in Eastern District of Louisiana
The Xarelto litigation has been centralized before Judge Fallon, who oversaw the MDL proceedings for thousands of Avandia lawsuits, Chinese drywall lawsuits and several other complex product liability claims.
In complex pharmaceutical claims coordinated pretrial proceedings are established where a large number of lawsuits are filed over personal injuries. The MDL has an important role in streamlining the litigation process, as all plaintiffs and defendants are under one roof, coordinate discovery and the bellwether trials can be set to determine the strength of the claims.
If the parties fail to negotiate a settlement or resolve the litigation following pretrial proceedings, Judge Fallon may remand cases back to the U.S. Districts where they were originally filed for separate trial dates in the future.
What is Xarelto?
Xarelto (rivaroxoaban) was developed by Bayer and Janssen Pharmaceuticals in 2011, a new generation anticoagulant touted as a superior alternative to Coumadin (warfarin).
Xarelto was the second in a new-generation of anticoagulants recently released as a superior replacement for Coumadin, which has been the “gold standard” drug for prevention of blood clots and strokes in patients with atrial fibrillation.
Pradaxa was the first in this class, released by Boehringer Ingelheim in 2010. The medication rapidly achieved blockbuster status because the doctors embraced the drug wholeheartedly. Unfortunately, Pradaxa was also most commonly associated with FDA adverse event reports.
While all blood thinners have side effects and increased risk of bleeding problems, Xarelto has been associated with an increasing number of adverse event reports involving uncontrollable bleeding injuries.
Xarelto: No Antidote
Warfarin, can be quickly reversed in the case of an emergency, with vitamin K and blood transfusions. There is no approved antidote available for patients using Xarelto, and many of the bleeding side effects have resulted in catastrophic outcomes, after doctors were unable to control the bleeds.
Xarelto drug makers claim that it is easier to use, since it does not require regular blood monitoring. Some medical experts however suggest that Xarelto blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.
Recent Xarelto Complaints
Recently Harriet Ibanez, filed a claim in the U.S. District Court for the Eastern District of Louisiana. According to Ibanez, she was prescribed Xarelto to prevent strokes from atrial fibrillation in October 2013, and required hospitalization for severe bleeding and blood transfusions.
Also Ann Hartman, filed a claim in the U.S. District Court for the Central District of Illinois. According to Hartman, she suffered severe rectal bleeding after being prescribed Xarelto for treatment of deep vein thrombosis (DVT) and pulmonary embolism, also requiring hospitalization and blood transfusions.
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