Preview Newsletter

Xarelto Media Scan 8-14-15

Plaintiff Attorney Press Releases

Seeger Weiss LLP Reports On A New Study Warning Of Potential Risk With Xarelto In Pregnant Patients
Aug 14, 2015 | PR Newswire
By Seeger Weiss LLP

Seeger Weiss LLP is reporting on a recent study by researchers from The Motherisk Program at the Hospital for Sick Children in Toronto which shows that the anticoagulant Xarelto crosses the human placenta. These results mean that the medication, when taken by pregnant women, could potentially affect unborn children. The researchers note that there is no data on Xarelto in human pregnancy and recommend that additional safety studies be conducted before administering the drug to pregnant women.

Plaintiff Attorney Blog Posts

Xarelto, Pradaxa Bleeding Risks The Same As Warfarin: Study
Aug 10, 2015 | AboutLawsuits.com
By Irvin Jackson

New research suggests that the blood thinners Xarelto and Pradaxa are no safer than warfarin when it comes to bleeding and arterial thromboembolic events like heart attacks and strokes. The findings raise further concerns about the new-generation anticoagulants, as they lack an approved reversal agent, which makes it harder for doctors to stop bleeding events that do occur.
Two Recent Studies Question Xarelto's Safety
Aug 8, 2015 | Texas Injury Law Blog
By Majed Nachawati

Xarelto, the blockbuster anticoagulant that was approved by the FDA in 2011, has continued to come under scrutiny by parts of the medical community. Initially, the drug was approved to help reduce the risk of blood clots in patients who had undergone knee or hip replacement. Later, Xarelto was approved to help patients with deep vein thrombosis (DVT) and pulmonary embolism. Unfortunately, hundreds of patients who have taken the drug have experience negative side effects, including uncontrollable internal bleeding that has no antidote.
Xarelto Suit Claims Tenn. Woman Suffered Internal Bleeding
Aug 10, 2015 | Top Class Actions
By Karina Basso

Janssen Research & Development LLC, Johnson & Johnson, Bayer Healthcare, and a number of their subsidiaries and partners are being sued in a Xarelto lawsuit by a Tennessee woman, who alleges she sustained injuries from using their anticoagulant medication, Xarelto. Xarelto is a popular blood thinning medication that has recently come under legal fire for causing many individuals to suffer from painful and sometimes fatal bleeding complications.
Lawsuit Alleges Xarelto Side Effects Led To Wrongful Death
Aug 10, 2015 | The Legal Herald
By Marc Goldich

A lawsuit has been filed against drug companies Janssen Pharmaceuticals and Bayer AG in relation to the allegedly dangerous side effects of their popular prescription drug Xarelto. A woman from Vermont brings the action against these drug companies after her father passed away from an life-threatening internal bleed which she (the plaintiff) claims was a result of her father’s exposure to Xarelto.
Indiana Man Adds Another Xarelto Bleeding Lawsuit to MDL
Aug 12, 2015 | Top Class Actions
By Melissa LaFreniere

An Indiana man is the latest to join the growing Xarelto multidistrict litigation (MDL) centralized in Louisiana. Plaintiff David L. added his Xarelto bleeding lawsuit to the Xarelto MDL, which is addressing the numerous complaints filed by plaintiffs alleging they experienced serious health complications after taking the blood thinner.
Xarelto Lawsuit Alleges Severe Injuries, Fatalities
Aug 12, 2015 | Drug Reporter
By Jacky Gale

Thirteen plaintiffs have filed a lawsuit against multiple defendants, claiming that Xarelto, a blood-thinning medication, caused serious and sometimes fatal internal bleeding. The lawsuit names as defendants Janssen Research & Development LLC, Janssen Pharmaceuticals, Johnson & Johnson, and Bayer Healthcare Pharmaceuticals and demands that these parties be held accountable for serious complications allegedly caused by Xarelto.
First Xarelto Bellwether Trials Set for August 2016
Aug 13, 2015 | The Legal Examiner
By Steven Davis

A series of Xarelto bellwether trials before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana may begin as soon as August 2016. The cases are part of a federal multidistrict litigation (MDL), a consolidation of approximately 550 product liability complaints filed in federal court involving bleeding problems with Xarelto. More cases are expected to be filed.
New Study: Xarelto May Be Dangerous for Pregnant Women
Aug 14, 2015 | Lopez McHugh LLP

Xarelto has long been associated with severe bleeding, but according to a new study, the popular blood thinner may also pose a risk to pregnant women and their unborn babies. The study, published last month by the American Journal of Obstetrics and Gynecology, examined the way in which rivaroxaban (Xarelto) is transported across the placenta of a pregnant woman.
Xarelto Linked to Serious Bleeding, Complications, and Death
Aug 13, 2015 | Morgan & Morgan

Since the FDA approved Xarelto in 2012, the agency has received hundreds of adverse event reports regarding the blood-thinner—alleging “serious, disabling or fatal” injuries. The primary reason for this, according to a report from the Institute for Safe Medication Practices, is a failure to prevent the serious blood clot related events the drug was intended to treat. Dangerous blood clots can increase an already at-risk patient’s chances of suffering from a hematoma or stroke.
Xarelto Bleeding Lawsuits Pile Up as MDL Talks Continue
Aug 14, 2015 | Top Class Actions
By Amanda Antell

Nearly 200 new Xarelto bleeding plaintiffs are part of lawsuits consolidated in a multidistrict litigation (MDL) to manage the high volume of cases. The latest influx of cases came as U.S. District Judge Eldon Fallon, who is overseeing the MDL in the Eastern Louisiana District Court, met with lawyers over the status of the mass litigation. Four Xarelto bleeding lawsuits with varying amounts of plaintiffs accounted for the addition of the latest 198 alleged victims of the blood-thinning medicine.

Plaintiff Attorney Blog Posts – Milwaukee Journal Sentinel and MedPage Today Investigative Series Coverage

Xarelto Sales Spike Linked to Groups, Doc Paid by Big Pharma
Aug 10, 2015 | The Legal Examiner
By Sheller, P.C.

In an article co-authored by writers from the Milwaukee Journal Sentinel and Medpage Today, a closer look is taken at the concerns surrounding the influence of pharmaceutical companies on medical professionals who prescribe their medicines. However, it’s not just doctors who benefit from the billions of dollars spent annually by drug makers. Medical associations that create the guidelines can also influence which meds are in favor at any given time.
Pradaxa Antidote May be Approved By End of 2015
Aug 12, 2015 | The Legal Examiner
By Steven Davis

Early results from a new study indicate that an experimental drug is able to successfully reverse the blood-thinning effects of the anticoagulant drug Pradaxa, and may be ready for release toward the end of 2015. In April 2015, the U.S. Food and Drug Administration (FDA) said it would conduct a priority review of the application to approve idarucizumab once the current study is complete.

Plaintiff Attorney Blog Posts – Pradaxa Antidote

Plaintiff Attorney Press Releases

Seeger Weiss LLP Reports On A New Study Warning Of Potential Risk With Xarelto In Pregnant Patients

Aug 14, 2015 | PR Newswire

By Seeger Weiss LLP

NEW YORK, Aug. 14, 2015 /PRNewswire/ -- Seeger Weiss LLP is reporting on a recent study by researchers from The Motherisk Program at the Hospital for Sick Children in Toronto which shows that the anticoagulant Xarelto crosses the human placenta. These results mean that the medication, when taken by pregnant women, could potentially affect unborn children.
The researchers note that there is no data on Xarelto in human pregnancy and recommend that additional safety studies be conducted before administering the drug to pregnant women.
Xarelto has been previously connected to serious health issues such as gastrointestinal bleeding, brain hemorrhaging, blood clots, and stroke and the researchers advise pregnant patients to use it with caution. Currently, over 500 cases are pending in state and federal courts across the United States. In these cases, plaintiffs have alleged in part that the defendants responsible for developing and marketing Xarelto, Bayer Healthcare, Janssen Pharmaceuticals, and Johnson & Johnson, failed to warn doctors and patients that patients on Xarelto would need medical monitoring and that they were at an increased risk for certain types of bleeding events. Further, plaintiffs claim the manufacturers failed to notify patients that there was no reversal agent that could quickly stop the anticoagulant effects of Xarelto, thereby increasing the risk ofuncontrolled bleeding in some patients.
Several partners at Seeger Weiss LLP serve as leadership in this multidistrict litigation based in the US District Court for the Eastern District of Louisiana.
Seeger Weiss LLP is one of the nation's leading trial law firms handling complex individual, mass and class action litigation on behalf of consumers, investors, injured persons and whistleblowers. The firm, with offices in New York, Philadelphia and New Jersey, represents plaintiffs throughout litigation and as trial counsel in a variety of practice areas, including financial, securities and investment fraud, pharmaceutical injury, consumer protection, qui tam (whistleblower cases), environmental and asbestos exposures, personal injury and medical malpractice, product defect, antitrust, and commercial disputes. For more information, go towww.seegerweiss.com.
For more information on Xarelto or if you believe you have been injured by using Xarelto, go to our Xarelto lawsuit page.
http://www.prnewswire.com/news-releases/seeger-weiss-llp-reports-on-a-new-study-warning-of-potential-risk-with-xarelto-in-pregnant-patients-300128753.html

Return to headline | Return to top

Plaintiff Attorney Blog Posts

Xarelto, Pradaxa Bleeding Risks The Same As Warfarin: Study

Aug 10, 2015 | AboutLawsuits.com

By Irvin Jackson

New research suggests that the blood thinners Xarelto and Pradaxa are no safer than warfarin when it comes to bleeding and arterial thromboembolic events like heart attacks and strokes. The findings raise further concerns about the new-generation anticoagulants, as they lack an approved reversal agent, which makes it harder for doctors to stop bleeding events that do occur.
In a study published in the American Heart Association’s medical journal Circulation on July 21, researchers from the France’s National Health Insurance Strategy and Research Department report that they found no significant difference in the rate of bleeding events, strokes or heart attacks among patients using either Xarelto, Pradaxa or some form of vitamin K agonist (VKA), which is an older class of blood thinners that includes Coumadin (warfarin).
Researchers were specifically looking at the safety and efficacy of the drugs during the early phases of treatment, when patients first begin using them as a preventative measure to avoid strokes caused by nonvalvular atrial fibrillation. The nationwide cohort study used data on 19,713 VKA users, 8,443 Pradaxa users, and 4,651 Xarelto patients.
Pradaxa and Xarelto are two of a group of new blood thinners, often referred to as novel oral anticoagulants (NOACs), which are promoted as superior to warfarin since they require less testing, and are advertised as safer. However, they have come under fire for not being released with a reversal agent, meaning that when bleeding events do occur, doctors often find them hard to stop.
The blood thinning effect of warfarin and other vitamin K agonists can be quickly stopped through the use of an antidote. However, doctors have reported more serious bleeding events on Xarelto and Pradaxa, due to the lack of an effective reversal agent.
Researchers found no statistically significant difference in the risk of bleeding events or arterial thromboembolism events between any of the three groups for the first 90 days of use. They said that while that appears to back up some claims made by previous studies suggesting that the newer drugs were safe, the findings also raised some concerns specifically due to the lack of a reversal agent, or antidote, and the decision not to monitor patients given Pradaxa and Xarelto.
“NOAC cannot be considered to be safer than VKA during the early phase of treatment,” the researchers concluded. “On the contrary, the clinical implications of our results are that physicians must be just as cautious when initiating NOAC as when initiating VKA, particularly in view of the absence of an antidote and objective monitoring of the extent of anticoagulation.”
New Blood Thinner Bleeding Risks
Pradaxa was introduced by Boehringer Ingelheim in late 2010 as the first member of a new class of anticoagulants. Xarelto was introduced by Bayer and Janssen Pharmaceuticals in 2011, as the second member of this class.
While all blood thinners carry a risk of bleeding injury, Pradaxa and Xarelto have been linked to a surprising number of problems as more and more patients are switched from warfarin to the new anticoagulants.
In addition to the lack of a reversal agent, several recent studies have also raised questions about the marketing claims made by the makers of these new anticoagulants, suggesting that blood monitoring may actually help doctors identify patients at the greatest risk of bleeding.
In July 2014, an investigative report published by The BMJ suggested that the makers of Pradaxa failed to provide the FDA with important clinical trial data that suggested users may benefit from regular blood monitoring to make sure the drug did not build up in their bloodstream, increasing the risk of bleeds.
In another study published by the Journal of Cardiology in October 2014, researchers indicated that Xarelto monitoring may have helped doctors understand the effects of the drug on a particular patient and their associated bleeding risk.
Boehringer Ingelheim faced more than 4,000 Pradaxa lawsuits that allege inadequate warnings were provided about the lack of an available reversal agent for their medication. Following several years of litigation, the drug maker agreed to pay $650 million in Pradaxa settlements last year, with an average of about $150,000 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 has overtaken 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.
http://www.aboutlawsuits.com/xarelto-pradaxa-bleeding-study-85765/

Return to headline | Return to top
Two Recent Studies Question Xarelto's Safety

Aug 8, 2015 | Texas Injury Law Blog

By Majed Nachawati

Xarelto, the blockbuster anticoagulant that was approved by the FDA in 2011, has continued to come under scrutiny by parts of the medical community. Initially, the drug was approved to help reduce the risk of blood clots in patients who had undergone knee or hip replacement. Later, Xarelto was approved to help patients with deep vein thrombosis (DVT) and pulmonary embolism. Unfortunately, hundreds of patients who have taken the drug have experience negative side effects, including uncontrollable internal bleeding that has no antidote.
One recent study, led by doctors Judy H. Hun and John C. Hwang, linked usage of the drug to an increased incidence of spontaneous vitreous hemorrhage, or eye bleeding, and noted that it was most notable when patients switched from one blood thinner to Xarelto. A second study compared the safety of Xarelto and Pradaxa to warfarin, the more traditional anticoagulant in the market today. Their study suggested a link between Xarelto and Pradaxa usage to a 50% increased risk of gastrointestinal bleeding. There are more than 500 Xarelto-related lawsuits pending in consolidated state and federal courts.
Legal Commentary
Xarelto attorneys within our firm are studying, examining and investigating current Xarelto claims on behalf of people and their families who may have been injured by the drug. Some of the side effects include hemorrhaging, internal bleeding, stroke and or death. If you or a loved one has experienced any side effects while taking Xarelto, contact our Xarelto lawyers to discuss the facts of your potential case. We are available by phone for a free consultation at1.866.705.7584 or by email at mn@fnlawfirm.com.
http://www.txinjuryblog.com/2015/08/articles/dangerous-drugs/two-recent-studies-question-xareltos-safety/

Return to headline | Return to top
Xarelto Suit Claims Tenn. Woman Suffered Internal Bleeding

Aug 10, 2015 | Top Class Actions

By Karina Basso

Janssen Research & Development LLC, Johnson & Johnson, Bayer Healthcare, and a number of their subsidiaries and partners are being sued in a Xarelto lawsuit by a Tennessee woman, who alleges she sustained injuries from using their anticoagulant medication, Xarelto.
Xarelto is a popular blood thinning medication that has recently come under legal fire for causing many individuals to suffer from painful and sometimes fatal bleeding complications.
Background on Xarelto Lawsuit
According to the Xarelto lawsuit, plaintiff Patsy G. was diagnosed with Inferior Vena Cava (IVC) thrombus in 2013, meaning that she is at an increased risk of suffering blood clots. To reduce the risk of clotting, Patsy was prescribed Xarelto by her physician in March of the same year. The plaintiff claims she took this prescription for two months as instructed and when she visited her doctor again in June 2014, she was given yet another Xarelto prescription for 20 mg doses.
The Xarelto lawsuit claims that two months after starting her second Xarelto prescription, Patsy suffered bleeding problems in her gums and also experienced fatigue. She immediately reported these Xarelto side effects to her physician.
In September 2014, Patsy claims she had abdominal cramps followed by bloody bowel movements, leaving her weak and causing her to lose a significant amount of blood. In light of these Xarelto bleeding complications, she was admitted to Holston Valley Medical Center, where Patsy was diagnosed with gastrointestinal bleeding.
The Xarelto lawsuit states:
“While she was at Holston Valley Medical, [Patsy’s] Physicians noted that there was no reversal agent on the market for Xarelto, but to treat her with units of plasma and blood to help replenish the blood she had lost and reduce the effects of the Xarelto . . . As a result of being prescribed and properly using Defendants’ Xarelto, [Patsy] was caused to suffer a severe bleed requiring blood and plasma transfusions, several CT and PET scans, a colonoscopy, and hospitalization.”
Patsy was discharged from her local hospital a few days after she was hospitalized for her Xarelto internal bleeding complications. She claims in this Xarelto bleeding lawsuit that had she known of the risks associated with the anticoagulant medication, she would not have used Xarelto.
Because of the blood thinner, Patsy claims she suffered serious and dangerous side effects, like severe bleeding, and has sustained personal injuries, including: physical pain and mental anguish, decreased enjoyment of life, and hospitalization/medical treatment financial expenses.
Xarelto Litigation Claims
This Xarelto lawsuit brings several allegations against the defending pharmaceutical companies responsible for creating, marketing, and selling the Xarelto blood thinner. These claims include: negligence, strict liabilities as to warnings, breach of express warranty, breach of implied warranties, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, violation of the Tennessee Consumer Protection Act, and punitive damages.
Patsy has asked the court for relief in the form of compensatory damages, special or economic damages, punitive damages, pre and post-judgment interest, award of attorney’s fees, leave to amend the complaint, and any other forms of relief deemed fit by the court.
The Xarelto Lawsuit is Case No. 2:15-cv-00205-JRG-MCLC, in the U.S. District Court for the Eastern District of Tennessee.
http://topclassactions.com/lawsuit-settlements/lawsuit-news/86964-xarelto-suit-claims-tenn-woman-suffered-internal-bleeding/

Return to headline | Return to top
Lawsuit Alleges Xarelto Side Effects Led To Wrongful Death

Aug 10, 2015 | The Legal Herald

By Marc Goldich

A lawsuit has been filed against drug companies Janssen Pharmaceuticals and Bayer AG in relation to the allegedly dangerous side effects of their popular prescription drug Xarelto.
A woman from Vermont brings the action against these drug companies after her father passed away from an life-threatening internal bleed which she (the plaintiff) claims was a result of her father’s exposure to Xarelto.
The complaint states that the decedent began taking Xarelto on July 17th, 2012 after being prescribed the drug by a medical professional for the treatment of atrial fibrillation. The decedent continued to take Xarelto as prescribed through approximately July 26th, 2012 at which point he suffered a life-threatening parenchymal hemorrhage, a type of bleeding within the brain.
The lawsuit alleges that the man’s irreversible bleeding injury was caused by his use of Xarelto and was a proximate cause in his premature death on August 1st, 2012.
In addition to several other allegations, this specific complaint claims that the defendants were negligent in their representation of Xarelto with regard to its efficacy and safety. The lawsuit also asserts that the defendants did not perform proper safety testing on Xarelto prior to its release.
The case was originally filed in the US District Court for the District of Vermont and has since been consolidated into the multidistrict litigation based in the US District Court for the Eastern District of Louisiana. To read the full complaint filed under case number 2:14-cv-00159, click here.
Xarelto: The #1 Blood Thinner In Its Class
Xarelto is a relatively new type of blood thinner drug (or anticoagulant) known as a Novel Oral Anticoagulant (NOAC) and has been prescribed more than 11 million times in America.
The drug was initially received approval from the Food and Drug Administration (FDA) on July 1st, 2011 for the treatment of deep vein thrombosis and pulmonary embolism in patients undergoing a knee or hip replacement surgery. Xarelto later received FDA approval for several other uses and is now approved for a total of six indications.
However, several medical studies have been published recently which link Xarelto to severe side effects such as uncontrollable internal bleeding.
About Xarelto Lawsuits
Recent discoveries of Xarelto’s allegedly harmful side effects have led many to take legal action against drug companies involved in the drug’s production, marketing and sales in the US.
Attorney Stephen A. Sheller, Esq. commented, “We are being contacted by individuals across the country who either suffered an injury while taking Xarelto or lost a loved one who had been taking Xarelto.”
“We are currently assisting these people in their pursuit of justice by helping file Xarelto lawsuit or by helping them find legal representation,” concluded Sheller of BloodThinnerHelp.com.
http://legalherald.com/lawsuit-alleges-xarelto-side-effects-wrongful-death/

Return to headline | Return to top
Indiana Man Adds Another Xarelto Bleeding Lawsuit to MDL

Aug 12, 2015 | Top Class Actions

By Melissa LaFreniere

An Indiana man is the latest to join the growing Xarelto multidistrict litigation (MDL) centralized in Louisiana.
Plaintiff David L. added hisXarelto bleeding lawsuit to the Xarelto MDL, which is addressing the numerous complaints filed by plaintiffs alleging they experienced serious health complications after taking the blood thinner.
Some of the most common allegations include internal bleeding such as gastrointestinal bleeding and pulmonary bleeding.
Xarelto Internal Bleeding Complications
Xarelto was approved by the Food and Drug Administration (FDA) in 2011 to be used as a blood clot treatment after hip or knee replacement surgery or for patients with atrial fibrillation.
Within just a few short years, the widely prescribed new anticoagulant quickly gained in popularity. Xarelto manufacturers tout claims that its the #1 blood thinner in its class with 11 million prescriptions in the United States alone.
Originally, Xarelto was marketed to consumers as a more convenient blood thinner when compared to the traditional anticoagulant Warfarin (coumadin). Unlike Coumadin users, Xarelto patients do not require monthly blood tests or have any dietary restrictions.
However, within only months of being on the market, the FDA began receiving reports of Xarelto bleeding complications. Since that time, Xarelto has been named in thousands of adverse event reports, hundreds of which claimed the medication resulted in a hemorrhage-related death.
Bleeding risks may occur with any blood thinner, however most consumers claim they were not aware that there was no antidote for excessive Xarelto bleeding.
With Coumadin, patients who experience a bleeding incident can be given a dose of vitamin K to get it under control. Unlike Xarelto patients, who have no known reversal agent and must endure multiple blood transfusions as the only way to stop Xarelto internal bleeding is to remove the medication from the blood system.
Xarelto Study
Xarelto was recently compared with Warfarin in a study published in the British Medical Journal. Researchers followed more than 45,000 patients taking a blood thinner to try to determine, which posed a greater risk of internal bleeding.
The study determined that Xarelto patients carry twice the risk of gastrointestinal bleeding when compared to those taking Warfarin.
While Xarelto is indicated to double the risks of gastrointestinal bleeding, it has also been reported to have other serious side effects including: brain hemorrhaging, bruising, abnormal liver function, low blood pressure, rectal bleeding, reduced platelet levels, rapid heartbeat, nose bleeds, dizziness and hemorrhaging in the eyes.
Xarelto Bleeding Lawsuits
The Xarelto multidistrict litigation names manufacturers Johnson & Johnson’s subsidiary Janssen Pharmaceuticals and Bayer Healthcare Pharmaceuticals as the defendants responsible for manufacturing the anticoagulant.
Xarelto manufacturers face several hundred bleeding lawsuits and are expected to reach more than 1,000 claims before the MDL trial begins.
In general, Xarelto lawsuits claim that plaintiffs were not adequately warned that should an internal bleeding event occur, there would be no antidote to stop it. Often times, plaintiffs allege that had they been informed of the serious bleeding risks involved, they would have not taken Xarelto.
http://topclassactions.com/lawsuit-settlements/lawsuit-news/89635-ind-man-adds-another-complaint-growing-xarelto-mdl/

Return to headline | Return to top
Xarelto Lawsuit Alleges Severe Injuries, Fatalities

Aug 12, 2015 | Drug Reporter

By Jacky Gale

Thirteen plaintiffs have filed a lawsuit against multiple defendants, claiming that Xarelto, a blood-thinning medication, caused serious and sometimes fatal internal bleeding. The lawsuit names as defendants Janssen Research & Development LLC, Janssen Pharmaceuticals, Johnson & Johnson, and Bayer Healthcare Pharmaceuticals and demands that these parties be held accountable for serious complications allegedly caused by Xarelto.
This complaint was filed on August 6, 2015 in the U.S. District Court for the Eastern District of Louisiana. Pursuant the Transfer Order of the U.S. Judicial Panel on Multidistrict Litigation (JPML), the lawsuit has been filed into multidistrict litigation (MDL) No. 2592. This MDL, which is proceeding under Judge Eldon E. Fallon, was created for the purpose of consolidating Xarelto lawsuits that alleged internal bleeding and were filed in federal courts across the country. The centralized cases will share coordinated pretrial proceedings to streamline the litigation process and prevent the possibility of duplicative discovery or contradictory rulings.
Common allegations regarding Xarelto
Quite often, a lawsuit only lists one or two plaintiffs. However, joinder of parties may occur when multiple plaintiffs share common facts or questions of law pertaining to the claim, and if the claims are linked to the same occurrence. In this case, joinder of parties was considered appropriate because all of the plaintiffs either used Xarelto or they represent the estate of someone who did take Xarelto. Additionally, they all claim that this blood-thinning medication, which was designed, manufactured, and marketed by the defendants, was the cause of severe internal bleeding.
The plaintiffs report being diagnosed with serious medical problems such as severe gastrointestinal bleeding, brain hemorrhage, acute blood loss anemia, hematuria, and death. These 13 plaintiffs who have recently had their lawsuit consolidated with the Xarelto MDL have a high likelihood of resolving their claims with a settlement deal, which means that the lawsuit would not be remanded back to its home district following the coordinated proceedings of the MDL.
Some of the plaintiffs are:
Debra Mawyer, who is representing the estate of her father, Charles F. Longerbeam, Sr. and has power of attorney over Grace Longerbeam, the surviving spouse. Mawyer alleges that Xarelto caused the decedent to suffer fatal gastrointestinal bleeding and brain hemorrhage.
Alan R. Rudolph, the surviving spouse and personal representative of the estate of Erlinda C. Rudolph. The decedent passed on September 26, 2014 after suffering from internal bleeding following the use of Xarelto.
Tommie M. Varnadoe, a North Carolina resident who used Xarelto for approximately two years and suffered from severe internal bleeding, including gastrointestinal bleeding and anemia.
Plaintiffs claim inadequate testing, failure to warn
Among the many allegations listed in the Xarelto internal bleeding lawsuit, the plaintiffs claim that the defendants failed to adequately test the anticogaulant before they filed the application for FDA approval. They further allege that the defendants did not issue adequate warnings to the plaintiffs, the decedents, or their healthcare providers that the drug had the potential to cause life-threatening internal bleeding. The plaintiffs demand compensation for medical care, hospitalization, personal injuries, physical pain, mental anguish, diminished enjoyment of life, and death.
http://drugreporter.com/2015/08/xarelto-lawsuit-alleges-severe-injuries-fatalities/

Return to headline | Return to top
First Xarelto Bellwether Trials Set for August 2016

Aug 13, 2015 | The Legal Examiner

By Steven Davis

A series of Xarelto bellwether trials before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana may begin as soon as August 2016. The cases are part of a federal multidistrict litigation (MDL), a consolidation of approximately 550 product liability complaints filed in federal court involving bleeding problems with Xarelto. More cases are expected to be filed.
Judge Fallon has proposed that 50 Xarelto plaintiffs be selected for a pool of bellwether cases. Although the outcomes of these trials will not be binding upon other lawsuits, these cases will be tried to help the parties gauge how juries might respond to certain evidence and testimony that will likely be presented throughout the litigation. At the suggestion of the court, the first two trials will take place in the Eastern District of Louisiana, the third in the South District of Texas, and the fourth in the Southern District of Mississippi.
Xarelto Intended to Lower Stroke and Blood Clot Risk
Xarelto was developed to reduce the risk of stroke and blood clots associated with non-valvular atrial fibrillation, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of DVT and PE in patients undergoing knee or hip replacement surgery.
The medication works by inhibiting the enzyme in the blood that causes it to clot, but with no approved antidote available to quickly reduce the blood thinning effects of Xarelto, serious and even fatal bleeding events have occurred among the medication’s users.
Xarelto Lawsuit Allegations
The Xarelto lawsuits all involve similar allegations that the drug’s makers, Janssen Research and Development and Bayer Healthcare Pharmaceuticals, failed to provide adequate warnings about the potential side effects of Xarelto, which include irreversible brain and gastrointestinal bleeding and uncontrollable hemorrhaging.
Like all anticoagulants, the Xarelto label contains warnings about the medication’s potential risk of bleeding events, but the lawsuits allege that the information provided is insufficient and fails to convey the serious and potentially deadly nature of the medication’s side effects.
http://chicago-land.legalexaminer.com/fda-prescription-drugs/first-xarelto-bellwether-trials-set-for-august-2016/

Return to headline | Return to top
New Study: Xarelto May Be Dangerous for Pregnant Women

Aug 14, 2015 | Lopez McHugh LLP

Xarelto has long been associated with severe bleeding, but according to a new study, the popular blood thinner may also pose a risk to pregnant women and their unborn babies. The study, published last month by the American Journal of Obstetrics and Gynecology, examined the way in which rivaroxaban (Xarelto) is transported across the placenta of a pregnant woman.
Current Xarelto lawsuits focus on the risk severe bleeding, which Bayer and Janssen Pharmaceutical allegedly knew about but did not tell doctors. Plaintiffs in Xarelto lawsuits claim that the blood thinner can lead to potentially fatal bleeding in the brain, intestines, or rectum. Furthermore, Xarelto has no known antidote to combat serious bleeding, unlike other blood thinners such as warfarin, which can be treated with vitamin K. Xarelto lawsuits allege that Xarelto’s manufacturers did not adequately test their product before release, and that certain side effects were downplayed or concealed from patients and doctors in the interest of sales.
These Xarelto lawsuits were consolidated earlier this year in a multidistrict litigation in the U.S. District Court for the Eastern District of Louisianna.
During pregnancy, certain nutrients and waste products are transferred between the fetus and the mother’s body. In the new study, Toronto researchers utilized an ex vivo placenta model to analyze the movement of Xarelto across the placental “barrier.” They found that there was “rapid transfer of rivaroxaban across the human placenta in both the maternal-to-fetal and fetal-to-maternal directions.” According to the researchers, only a small, unbounded portion of the drug passes across the placenta—around 5 percent of the concentration present. The study concludes that more research needs to be done to assess the safety of administering Xarelto to pregnant women.
If you or someone you know experienced a severe bleeding event after taking Xarelto, contact the offices of Lopez McHugh now for a free legal consultation with an experienced Xarelto lawyer. You may be eligible to receive compensation through a Xarelto lawsuit.
http://lopezmchugh.com/2015/08/13/new-study-xarelto-may-dangerous-pregnant-women/index.html

Return to headline | Return to top
Xarelto Linked to Serious Bleeding, Complications, and Death

Aug 13, 2015 | Morgan & Morgan

Since the FDA approved Xarelto in 2012, the agency has received hundreds of adverse event reports regarding the blood-thinner—alleging “serious, disabling or fatal” injuries. The primary reason for this, according to a report from the Institute for Safe Medication Practices, is a failure to prevent the serious blood clot related events the drug was intended to treat. Dangerous blood clots can increase an already at-risk patient’s chances of suffering from a hematoma or stroke.
Aside from blood-clotting related injuries, Xarelto, the market leader of blood-thinners, has come under scrutiny for potentially posing life-threatening safety risks for its users. Xarelto’s anticoagulation effects and lack of a “reversal agent” has been linked to numerous other complications including internal bleeding, wound infection, intracranial hemorrhaging, and excessive blood loss. These conditions can lead to pain, suffering, disease, permanent disability or death.
If you or a loved one has suffered from a bleeding problem or complication after taking Xarelto, please contact us today. Our attorneys are investigating whether a class action lawsuit can be filed against Bayer and Johnson & Johnson’s Janssen Pharmaceuticals, Inc. for potential dangers associated with their anticoagulant.
The National Center for Health Statistics estimates that over 10% of Americans over the age of 75 use blood-thinners. The potential risks of both internal bleeding and surgical complications should have been made known to Xarelto users. This is the basis of the major Xarelto lawsuits currently being brought against the manufacturers, Bayer and Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, who developed the drug.
There is no antidote available for Xarelto.
The oral medication rivaroxaban, sold under the brand name Xarelto, is an anticoagulant (more commonly known as a blood-thinner) intended to prevent blood clots from forming due to a certain irregular heartbeat (atrial fibrillation) or after certain surgeries. In addition, it can be used to treat existing blood clots, such as pulmonary embolus or deep vein thrombosis.
Anticoagulants work by inhibiting the body’s ability to form clots. Because of this, all anticoagulants pose some risk of serious and even fatal bleeding. It is currently being alleged that Xarelto puts patients at an increased risk for serious irreversible bleeding because the drug, unlike others available, has no antidote to act as a reversal agent to counter its anticlotting effects in case of emergency. Typically, when an individual taking an anticoagulant begins to bleed, a doctor would administer a dose of Vitamin K to reverse the anti-clotting effects of the drug to slow the bleeding. However, no such “antidote” exists for Xarelto.
Neither vitamin K nor any other standard treatment options have proven successful in solving this complication for Xarelto users who have begun to bleed excessively. The last remaining option for these patients is emergency dialysis—a treatment doctors say is not practical for individuals who are experiencing life-threatening bleeding.
The potential dangers of Xarelto do not end after surgery.
Although the alleged risks of excessive bleeding in patients using Xarelto are becoming widely known, reports of other complications resulting from an otherwise successful surgery have begun to arise. One such potential complication is that the blood-thinning effects of Xarelto could affect a patient’s ability to heal a surgical wound post-operation. What is being alleged is an increase in wound leakage, which drastically increases the risk of a wound infection.
Wound leakage can ultimately lead to deep infections in and around the surgical site, which can spread throughout the body. This not only drastically jeopardizes the patient’s health, but in the case of implant surgery, may also require the surgery be reset and performed again. The consequences of a wound infection are serious and Xarelto users must be aware of potential risks.
The FDA has received many reports of adverse events from those taking rivaroxaban / Xarelto.
If the allegations prove true, by failing to warn users of potential risks to their health the makers of Xarelto placed more value on their profits than on working to minimize the serious and fatal injuries that could result from using the drug.
Additional complaints against Bayer and Janssen allege:
Xarelto was marketed as a superior anticoagulant in the market despite initial studies showing higher rates of gastrointestinal (GI tract) bleeding and transfusions than those in competitors.
Patients were not properly warned of the risks of suffering life-threatening bleeding events.
Doctors were not properly advised on methods to treat and stabilize Xarelto users in the event of excessive bleeding.
Xarelto continues to be marketed as safe and effective.
Users of Xarelto must be aware of the side-effects and risks.
Aside from the risk of stroke or blood clots (which the drug is intended to treat) and excessive, unstoppable bleeding, there are other symptoms and warning signs a Xarelto user needs to be aware of.
Xarelto users should immediately contact emergency medical assistance if they encounter any of the following**:
Signs of an allergic reaction such as difficulty breathing, swelling in parts of the face/neck/throat or hives
Unusual bleeding or bruising
Unusually heavy menstrual periods
Signs of blood in urine (red or pink coloring) or stool (black or bloody)
Vomiting, or coughing blood or a “coffee-ground”-like substance
Numbness, muscle weakness or loss of movement of parts of the body
Dizziness, weakness or confusion
Two studies, published in April and June of 2015, further exposed the potential risks of Xarelto use. The studies found an increased risk of eye bleeding (vitreous hemorrhage) of Xarelto and a doubling of the risk of stomach bleeding for users of Xarelto compared to users of non-Xarelto anticoagulants.
**This list is not exhaustive or authoritative. If you are encountering any adverse symptoms seek medical advice immediately.
What should I do next?
If you or a loved one has taken Xarelto and suffered a serious bleeding problem, you should contact Morgan & Morgan immediately to discuss your options, as there are time limitations to filing a claim.
Consultations are free of charge and always 100% confidential.
Some of the damages you may be entitled to include:
Cost of rehabilitationReduced enjoyment of life
Permanent disabilityLoss of income, including past and future wages
Medical costs—including hospital and doctor fees, prescription medications and the cost of surgery
Physical or emotional pain and suffering
Morgan & Morgan’s Complex Litigation Department is reviewing the claims of patients who took or are taking the blood thinner Xarelto (rivaroxaban) and have suffered bleeding complications. Although, bleeding is a common side effect of blood thinners, it has been alleged that Xarelto is more dangerous than traditional anticoagulants because no reversal agent or “antidote” exists to reverse the blood-thinning effects. This can lead to life-threatening bleeding events in the case of trauma or emergency medical procedures or other internal bleeding occurrences.
The manufactures of Xarelto have a legal responsibility to ensure their products are reasonably safe for use and liability may attach if they fail to do so or conceal known risks. If you or a loved one are taking or have taken Xarelto and experienced medical problems as a result, contact us today to have your case reviewed, free of charge, you may be entitled to compensation.
http://www.forthepeople.com/blog/xarelto-linked-to-serious-bleeding-complications-and-death/

Return to headline | Return to top
Xarelto Bleeding Lawsuits Pile Up as MDL Talks Continue

Aug 14, 2015 | Top Class Actions

By Amanda Antell

Nearly 200 new Xarelto bleeding plaintiffs are part of lawsuits consolidated in a multidistrict litigation (MDL) to manage the high volume of cases.
The latest influx of cases came as U.S. District Judge Eldon Fallon, who is overseeing the MDL in the Eastern Louisiana District Court, met with lawyers over the status of the mass litigation. Four Xarelto bleeding lawsuits with varying amounts of plaintiffs accounted for the addition of the latest 198 alleged victims of the blood-thinning medicine.
The MDL was formed in December 2014 to consolidate lawsuits claiming that Bayer Pharmaceuticals and Jansen Pharmaceuticals, (along with parent company Johnson & Johnson) attempted to cover up the risk of Xarelto bleeding complications.
In addition to the possible internal bleeding complication, the plaintiffs allege that the companies misled consumers about the safety of the products and failed to mention that there was no reversal agent available to stop internal bleeding.
New-generation anticoagulants, including Xarelto and Pradaxa, do not have a reversal agent. This contrasts with the original anticoagulant, Wafarin (coumadin), whose effects are reversed with Vitamin K.
Those using coumadin must have regular blood monitoring to establish dosing levels. Experts argue that if Xarelto and the other new-generation anticoagulants had these same requirements, then the number of Xarelto bleeding incidents would be much smaller.
When Xarelto was released in 2011, it was meant to directly compete with Warfarin and the first new-generation anticoagulant, Pradaxa. It was advertised to be more convenient than Warfarin and more efficient than Pradaxa.
The internal bleeding injuries mentioned in the most recent Xarelto lawsuits include: hematuria, subdural hematoma, cerebral hemorrhaging, other internal bleeding complications, and several wrongful death claims.
The first Xarelto trials are expected to begin in August 2016. While the results of bellwether trials do not affect individual Xarelto lawsuits, they may influence settlement negotiations, and help gauge how juries may react to certain evidence or testimony.
http://topclassactions.com/lawsuit-settlements/lawsuit-news/92770-xarelto-bleeding-lawsuits-pile-up-as-mdl-talks-continue/

Return to headline | Return to top

Plaintiff Attorney Blog Posts – Milwaukee Journal Sentinel and MedPage Today Investigative Series Coverage

Xarelto Sales Spike Linked to Groups, Doc Paid by Big Pharma

Aug 10, 2015 | The Legal Examiner

By Sheller, P.C.

In an article co-authored by writers from the Milwaukee Journal Sentinel and Medpage Today, a closer look is taken at the concerns surrounding the influence of pharmaceutical companies on medical professionals who prescribe their medicines. However, it’s not just doctors who benefit from the billions of dollars spent annually by drug makers. Medical associations that create the guidelines can also influence which meds are in favor at any given time.
"An investigation into these financial ties by the Milwaukee Journal Sentinel and MedPage Today uses as an example the new-gen anticoagulants that have replaced warfarin as the standard of care, even though they came on the market with no antidote for the bleeding risks that they carry. New guidelines favoring their use have been issued by a number of organizations. Using federal Open Payments data, the news groups found that the companies that make the drug often contribute handsomely to the groups whose endorsements would be important, $40 million in three years."
The article goes on to say that organizations within Europe and the U.S. that issued new guidelines received millions of dollars from several drug makers including Pfizer and Bristol-Myers Squibb, marketers of the drug Eliquis, and also Bayer and Johnson & Johnson which co-market the drug Xarelto. Also, in one case, the guidelines redefined, “who should receive the anticoagulants to prevent stroke and heart attack,” a move that surged potential patients from 3.7 million to 4.7 million Americans.
Another example found in the investigation involved The American Heart Association, which approved new guidelines last year for treating atrial fibrillation, and benefited more than $13 million in three years from anticoagulant makers. Moreover, several news groups report that from the period of August 2013 through August 2014, 9 members of guideline committees for different groups endorsing the use of this class of drugs were beneficiaries of $400,000, an average of $44,440 each, for food travel and various other things.
Doctors as well as organizations hotly deny that these payments convince them to favor or promote drugs they would have otherwise turned away. Opponents to these types of payments argue that, “the kind of money being thrown around is certain to have an influence on medical practice that might not always be good for patients.”
"[Dr. Gregory] Lip has received payments from at least 12 drug-makers since 2006, including five companies that market or make the new anticoagulants, according to notations on papers and panels reviewed by the Milwaukee Journal Sentinel/MedPage Today..."
Independent experts say the financial relationships highlight concerns about the influence of pharmaceutical money on medicine.
‘It seems to be a poster child for everything that is wrong with how we create guidelines,’ Dr. Jerome Hoffman, an emergency medicine physician and emeritus professor of medicine at the University of California, Los Angeles, told the Journal. Dr. Hoffman writes about conflicts of interest in treatment guidelines.
The Sunshine Act Solution?
Some argue Sunshine Act data, which was publicly posted last year, gives patients and others a way to see who gets what payments and what amount so they can decide for themselves if they feel a doctor has been influenced to push one med over another– arguably a daunting task for anyone given that includes, “$3.5 billion in payments to 546,000 doctors and 1,360 research institutions in just 5 months.”
Critics, however, point out the database doesn’t list payments to newer categories of healthcare professionals, such as nurse practitioners, that are playing a growing role in the system.
"Dr. Walid Gellad, co-director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing, told NPR: “If the purpose of the act is to shine a light on the relationship between industry and the healthcare sector, then you’ve left out an important component of that sector."
Finally, in addition to the article focusing primarily on the investigation into the flow of money from drug companies to doctors and medical societies who influence prescription guidelines, the Journal Sentinel published two other anticoagulant stories as part of a “Risk/Reward” series. Links to each story in the series can be found below:
New anticoagulant drugs provide stroke prevention with dose of danger
Doctor with financial ties to drug-makers at center of sales boom of new anticoagulants
Eliquis claim about reduced deaths questioned by FDA reviewer
http://philadelphia.legalexaminer.com/fda-prescription-drugs/xarelto-sales-spike-linked-to-groups-doc-paid-by-big-pharma/

Return to headline | Return to top
Pradaxa Antidote May be Approved By End of 2015

Aug 12, 2015 | The Legal Examiner

By Steven Davis

Early results from a new study indicate that an experimental drug is able to successfully reverse the blood-thinning effects of the anticoagulant drug Pradaxa, and may be ready for release toward the end of 2015. In April 2015, the U.S. Food and Drug Administration (FDA) said it would conduct apriority review of the application to approve idarucizumab once the current study is complete.
The ongoing study, published recently in the New England Journal of Medicine, is being conducted to determine how the new drug, idarucizumab, works in real-life emergency situations when patients need immediate surgery or are suffering life-threatening bleeding as a result of anticoagulation. Although dangerous bleeding is relatively rare, it occurs in approximately 1.5 percent of Pradaxa patients every year.
According to the study, idarucizumab works by binding to Pradaxa and neutralizing its blood thinning activity. Reversal effects with the drug were immediate, normal blood clotting was restored within minutes, and idarucizumab did not appear to promote blood clotting.
Bleeding Events Related to Pradaxa
Serious bleeding events related to Pradaxa use have accounted for thousands of adverse effects and hundreds of deaths since the FDA approved the medication in 2010. One of the biggest concerns surrounding Pradaxa and other new oral anticoagulants is the fear that if a patient has a serious bleeding event, there is no specific antidote available to reverse the medication’s effects, unlike warfarin, currently the only oral anticoagulant drug with an approved reversal agent, vitamin K.
Although Pradaxa and other newer oral anticoagulants like Xarelto and Eliquis appear to offer advantages over warfarin in terms of preventing stroke in patients with non-valvular atrial fibrillation, major bleeding remains a significant risk associated with these medications, prompting thousands of lawsuits.
In May 2014, TorHoerman Law announced that the Pradaxa litigation that it helped spearhead was settled in the amount of $650,000,000, compensating nearly 4,000 claimants. TorHoerman Law is currently filing lawsuits on behalf of individuals that experienced uncontrollable bleeding incidents while using Xarelto and Eliquis.
http://chicago-land.legalexaminer.com/fda-prescription-drugs/pradaxa-antidote-may-be-approved-by-end-of-2015/

Return to headline | Return to top

Plaintiff Attorney Blog Posts – Pradaxa Antidote

Add recipients

Suggested