Preview Newsletter
XARELTO Media Monitoring Week of 4/24/2015
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The Past Month Saw Dozens of New Xarelto Lawsuits Filed in State and Federal Litigations
Apr 23, 2015 | PR Web
By Bernstein Liebhard LLP
The products liability litigation involving Xarelto (http://www.xareltolawsuit2015.com/) continues to grow, as court records indicate that dozens of new lawsuits were filed in state and federal proceedings over the past month. According to an updated docket report issued by the U.S. Judicial Panel on Multidistrict Litigation on April 17th, 402 Xarelto lawsuits are now pending in a multidistrict litigation underway in U.S. District Court, Eastern District of Louisiana, where all federally filed claims involving the blood thinner have been consolidated for coordinated pretrial proceedings. Court records indicate that this represents an increase of about 100 cases since March 16th, when the Panel issued its previous report. -
Law Firm Starts Two Suits for Deaths of Users of Xarelto
Apr 21, 2015 | PR Newswire
By Rheingold, Valet, Rheingold, McCartney & Giuffra LLP
The New York City law firm of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP this week commenced two wrongful death lawsuits, each involving the death of a user of the blood thinner Xarelto. In each case it is alleged that the drug is misleadingly marketed as a "one size fits all" for patients, and without a disclosure that there is no reversal agent available to arrest bleeding once it starts. -
Another Study Raises Concerns About One-Size-Fits-All Xarelto Dose
Apr 24, 2015 | The Legal Examiner
By Roopal Luhana
The FDA approved the use of Xarelto (rivaroxaban) in 2011 for reducing the risk of blood clots in patients undergoing knee and hip replacement surgery, and later that same year for reducing the risk of blood clots and stroke in patients with non-valvular atrial fibrillation. *Note: This article is sponsored by Chaffin Luhana LLP. -
Grieving Son Files Xarelto Wrongful Death Lawsuit
Apr 22, 2015 | The Legal Examiner
By Roopal Luhana
On March 20, 2015, Tennessee resident Danny Julian filed a Xarelto wrongful death lawsuit on behalf of his father, Tommy Julien. The Plaintiff claims that his father died after using the anticoagulant drug. He names manufacturers Bayer Healthcare Pharmaceuticals, Janssen Pharmaceuticals, and parent company Johnson & Johnson as Defendants, and seeks in excess of $75,000 in damages. *Note: This article is sponsored by Chaffin Luhana LLP. -
Xarelto Side-Effects Lawsuit Claims Filings Continue To Grow In Federal Litigation
Apr 22, 2015 | Wright & Schulte LLC
As the lawyers at Wright & Schulte LLC continue to represent clients in product liability lawsuits, the firm reports that that over 90 Xarelto side-effects lawsuit claims have been filed within the past month in the U.S. District Court, Eastern District of Louisiana. The U.S. Judicial Panel on Multidistrict Litigation’s (JPML) recently updated its docket to reflect Xarelto complaints increased from 311 as of March 17 to 402 as of April 15. Court documents show that the JPML established the Xarelto litigation in December by transferring 21 federally filed Xarelto complaints to the Eastern Louisiana district court. The Xarelto complaints are filed on behalf of men and women who allege that they suffered serious bleeding events due to using the Xarelto blood thinner medication. In some cases, survivors of Xarelto users filed wrongful death Xarelto lawsuits. -
Xarelto Lawsuit Alleges Severe Bleeding Injuries
Apr 22, 2015 | Top Class Actions
By Amanda Antell
A Georgia man filed a Xarelto lawsuit against Bayer and Jansen Pharmaceuticals, after suffering severe internal bleeding injuries. -
Xarelto Lawsuits Consolidated, Move Ahead
Apr 21, 2015 | Legal Examiner
By Steven Davis
Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary are currently facing over 170 product liability lawsuits over their new-generation anti-coagulant, Xarelto. Late in 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) announced that all nationwide Xarelto lawsuits filed in federal courts, including the Southern District of Illinois and the Northern District of Illinois, would be consolidated in the Eastern District of Louisiana. According to Xarelto lawyers, an additional five to ten cases are being added to the MDL per week by individuals that believe Xarelto severely injured them since there is currently no antidote to stop the bleeding. Experts estimate that eventually several thousand cases will be transferred into the MDL. *Note: This article is sponsored by TorHoerman Law LLC. -
Over 400 Xarelto Lawsuits Filed in Federal MDL
Apr 21, 2015 | Schmidt Law
Federal judges have reported big gains in the size of theXarelto litigation, with another 100 cases filed in the last month. -
Xarelto Litigation Joined by Illinois Couple
Apr 20, 2015 | Top Class Actions
By Paul Tassin
An Illinois couple has added their claim to the multidistrict litigation against Janssen Pharmaceuticals and related companies over the prescription drug Xarelto, which has been linked to fatal internal bleeding events. -
Life-Threatening GI Bleed Subject of Xarelto Lawsuit
Apr 20, 2015 | Injury Lawyer News
By Ava Lawson
Cheryl Butler is one of the most recent plaintiffs to seek damages against Janssen Pharmaceuticals and Bayer HealthCare for injuries allegedly caused by Xarelto side effects. Her product liability complaint was filed in the US District Court for the Eastern District of Louisiana, where similar claims have been consolidated under MDL no. 2592. The claimant, who resides in Bedford Park, Illinois is demanding compensatory, treble and punitive damages from the defendants in an amount exceeding $75,000. *Note: Site is sponsored by Eisbrouch Marsh, LLC. -
Xarelto patient alleges fraud, negligence
Apr 20, 2015 | The Madison-St. Clair Record
A California man is suing a number of pharmaceutical manufacturers in St. Clair County over the drug Xarelto. -
Xarelto Bleeding Lawsuit Complaints Benefit From Recent Developments In Xarelto Litigation In Federal And State Courts
Apr 20, 2015 | The Oliver Law Group PC
The Xarelto bleeding lawsuit attorneys at The Oliver Law Group P.C. report that litigation of Xarelto bleeding side-effects lawsuits in state and federal courts are moving forward more efficiently due to new developments in the pretrial proceedings. Court documents show that Xarelto complaints can now be filed directly into the multidistrict litigation established for Xarelto complaints in the U.S. District Court, Eastern District of Louisiana. U.S. District Court Judge Eldon E. Fallon, who is overseeing the federal Xarelto litigation, said in a recently issued order that filing Xarelto complaints directly into the mulitidistrict litigation will eliminate delays associated with transferring the cases filed in other federal courts to the Eastern Louisiana federal court. According to the order, this action will not only prevent delays but promote judicial efficiency. -
Xarelto Lawsuit Filed in California District Court
Apr 17, 2015 | Injury Lawyer News
By Stephanie Reid
On January 21, 2015, a Xarelto lawsuit was filed in the United States District Court for the Southern District of California alleging severe and life-threatening complications with the drug, requiring immediate medical attention. The lawsuit names several defendants, including Janssen Pharmaceuticals, Johnson & Johnson, and the Bayer Corporation. Xarelto, a powerful blood thinner, has been named in a number of recent state and federal lawsuits, including several involving the alleged wrongful death of the patient. *Note: This site is sponsored by Eisbrouch Marsh, LLC -
Lawsuit Questions Xarelto Safety
Apr 17, 2015 | Drug Reporter
By Jacky Gale
Another lawsuit has been transferred to the Xarelto multidistrict litigation (MDL) No. 2592, which is pending in the U.S. District Court for the Eastern District of Louisiana under Judge Fallon. The plaintiff, Cheryl Butler, claims the defendants, Janssen Pharmaceuticals, Bayer Healthcare Pharmaceuticals, et al. fraudulently misrepresented the safety of the medication, Xarelto, and that the drug led to the plaintiff’s life-threatening medical problems. *Note: This site is sponsored by Eisbrouch Marsh, LLC,.
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Full Text of Stories Below
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The Past Month Saw Dozens of New Xarelto Lawsuits Filed in State and Federal Litigations
Apr 23, 2015 | PR Web
By Bernstein Liebhard LLP
The products liability litigation involving Xarelto (http://www.xareltolawsuit2015.com/) continues to grow, as court records indicate that dozens of new lawsuits were filed in state and federal proceedings over the past month. According to an updated docket report issued by the U.S. Judicial Panel on Multidistrict Litigation on April 17th, 402 Xarelto lawsuits are now pending in a multidistrict litigation underway in U.S. District Court, Eastern District of Louisiana, where all federally filed claims involving the blood thinner have been consolidated for coordinated pretrial proceedings. Court records indicate that this represents an increase of about 100 cases since March 16th, when the Panel issued its previous report. (In Re: Xarelto Products Liability Litigation, No. 2592)
A Case List released by Pennsylvania’s Philadelphia Court of Common Pleas on April 23rd shows that at least 204 Xarelto lawsuits are currently pending in the state’s mass tort proceeding. According to court documents, some 50 new filings were added to the proceeding in March. (In Re: Xarelto Litigation, Case ID 150102349)
“Our Firm is representing a number of Xarelto plaintiffs in U.S. courts who allegedly suffered serious internal bleeding and other complications related to its use. We also continue to receive inquiries from potential plaintiffs who claim to have experienced similar injuries, so we are not at all surprised that these lawsuits continue to mount,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices and drugs.
Xarelto Lawsuit Allegations
Xarelto (rivaroxaban) 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.*All of the Xarelto lawsuits currently pending in the state and federal litigations involve similar allegations regarding its association with serious internal bleeding and related complications, including stroke, deep vein thrombosis and pulmonary embolism. Plaintiffs further allege that the medication was wrongly marketed as an improvement over warfarin, and point out that bleeding associated with this much older blood thinner can be stopped via the administration of vitamin K. The complaints further note that during its first full year on the market, Xarelto was named in 2,081 adverse event reports submitted to the FDA, including at least 151 deaths. By contrast, warfarin was named in only 861 adverse event reports, including 56 fatalities, during the same period.***
“The consolidated litigations underway in Pennsylvania and Louisiana were established to allow Xarelto lawsuits that put forth similar allegations of fact to move more efficiently through the court system. Considering the number of new filings both proceedings have seen in the past month, it appears that the consolidation of these claims was well warranted,” says Sandy A. Liebhard.
Xarelto patients who allegedly experienced life-threatening episodes of internal bleeding and other complications related to its use may be entitled to compensation for medical bills, lost wages, pain and suffering and more. Learn more about filing a Xarelto lawsuit by visiting Bernstein Liebhard LLP’s website, or by calling 800-511-5092 to schedule a free, no obligation case review.
*fda.gov/downloads/Drugs/DrugSafety/UCM280333.pdf, FDA, March 2014
**ismp.org/QuarterWatch/pdfs/2012Q4.pdf, ISMP, October 2013Link: http://www.prweb.com/releases/xarelto-bleeding-lawsuit/xarelto-litigation/prweb12677254.htm
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Law Firm Starts Two Suits for Deaths of Users of Xarelto
Apr 21, 2015 | PR Newswire
By Rheingold, Valet, Rheingold, McCartney & Giuffra LLP
The New York City law firm of Rheingold, Valet, Rheingold, McCartney & Giuffra LLP this week commenced two wrongful death lawsuits, each involving the death of a user of the blood thinner Xarelto. In each case it is alleged that the drug is misleadingly marketed as a "one size fits all" for patients, and without a disclosure that there is no reversal agent available to arrest bleeding once it starts.
Both of the firm's clients had been recently started on Xarelto and rapidly developed bleeding in the brain. Although hospital doctors tried to use standard methods to reverse the bleeding, there turned out not to be a remedy for a Xarelto-induced bleed, as there is for the more established drug used to control clotting, Coumadin (warfarin).
The defendants in both cases are the manufacturers and suppliers of Xarelto, Johnson & Johnson Pharmaceutical, its Janssen division, and also Bayer Healthcare Pharmaceuticals, Inc. The generic name of the drug is rivaroxaban.
One of the two cases, Padrick v. Janssen Research & Development, LLC, et al, D.N.J., 3:15-cv-02774-MAS-DEA, Graham Padrick, age 76, was switched to Xarelto from Coumadin for treatment of atrial fibrillation January 2013. The next month he developed a subdural hematoma and died February 14, 2013. He left a widow and three children.
In the second case, Romano v. Janssen Research & Development, LLC, et al, 15 CV 3111, S.D.N.Y., Ladson Romano, age 67, was placed on Xarelto November 2014 because of the potential for development of a deep vein thrombosis. He shortly thereafter developed hemorrhaging in the brain stem, and died December 20, 2014. His widow is the plaintiff in the suit.
Xarelto, along with Pradaxa and Eliquis, are in the category of new direct action oral anticoagulants.
In addition to liability asserted in these complaints based upon the lack of a reversal agent, liability is also claimed based upon the promotion of Xarelto as a blood thinner which does not need frequent patient monitoring. Also, it is asserted that the one daily dose of Xarelto, not tailored to the need of individual patients, presents an excessive risk of bleeding, since patients differ in age, weight and liver function.
RVRMG is a national firm located in New York City, handling personal injury cases including mass torts, a field which includes the Xarelto litigation. Partner Paul D. Rheingold commented: "We expect these two cases to join others already filed around the country in a multidistrict litigation which has been established in New Orleans, the Eastern District of Louisiana."
The Rheingold law firm is also investigating a separate type of injury attributable to the use of Xarelto: hepatocellular liver damage. A recent medical article in the JAMA Internal Medicine magazine reported on two cases associated with the use of the drug.
Link: http://www.prnewswire.com/news-releases/law-firm-starts-two-suits-for-deaths-of-users-of-xarelto-300069740.html
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Another Study Raises Concerns About One-Size-Fits-All Xarelto Dose
Apr 24, 2015 | The Legal Examiner
By Roopal Luhana
The FDA approved the use of Xarelto (rivaroxaban) in 2011 for reducing the risk of blood clots in patients undergoing knee and hip replacement surgery, and later that same year for reducing the risk of blood clots and stroke in patients with non-valvular atrial fibrillation.
Manufacturers advertised the medication as being more convenient than the number-one selling anticoagulant for decades, warfarin, because it required no blood monitoring. But recent research has questioned the wisdom of the one-size-fits-all dose. In February 2015, scientists found that in certain high-risk patients, Xarelto raised the risk of serious bleeding events more than expected. Following up with these patients to check on the effects of the medication in the blood could potentially reduce the risk of serious and potentially fatal bleeding.
Recent Study Raises Concerns About Xarelto Side Effects
In 2012, the FDA approved Xarelto to treat patients with deep vein thrombosis (DVT) and pulmonary embolism, as well as for the ongoing treatment to prevent recurrence. According to the recent study, published in Academic Emergency Medicine, Xarelto (rivaroxaban) worked as predicted in PE patients with a low to moderate risk of blood clots, but in those with a high risk, it presented a danger of significant side effects greater than expected.
Adverse events included blood clots, fatal pulmonary embolism, and major bleeding, sometimes leading to death. Those patients at higher risk for PE were more about two times as likely to suffer from these events. Overall risks, however, were lower than with other forms of PE therapy.
One-Sizes-Fits-All Dose Questioned
Other studies have raised similar concerns about Xarelto side effects. In 2014, for example, researchers noted that “questions have emerged relating to the responsible use of rivaroxaban in day-to-day clinical practice, including patient selection, dosing, treatment of patients with renal impairment,” and more. They stated that patients with kidney malfunction were more at risk of side effects, and should undergo regular blood monitoring to be sure they weren’t getting too much of the drug.
In 2012, Reuters ran a feature on top U.S. cardiologists who had concerns about modern anticoagulants like Xarelto. Though these medications were designed to give patients more convenient options to warfarin, doctors were concerned about prescribing them to patients without frequent follow-up that could help prevent blood clots, stroke, and uncontrolled bleeding. Reports of deaths associated with both Xarelto and Pradaxa exacerbated these concerns.
In the Institute for Safe Medication Practices (ISMP) Quarter Watch 2013 (Quarter 1), adverse events with Xarelto (680) outnumbered those with Pradaxa (528), mainly because of the increase in prescriptions for Xarelto, which numbered near one million at the time.
The ISMP added that Pradaxa (dabigatran—a newer generation blood thinner similar to Xarelto) was an “extremely poor candidate for a one-dose-fits-all strategy.” A single dose, they noted, could result in inhibition of blood clotting that varied more than 5-fold between individuals.
Xarelto Lawsuits Consolidated in Louisiana
In December 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Xarelto lawsuits into one court in the Eastern District of Louisiana. Plaintiffs claim that manufacturers Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) and Bayer failed to provide adequate warnings concerning the serious side effects, and should have conducted more testing before releasing the product on the market.
Link: http://newyork.legalexaminer.com/defective-dangerous-products/another-study-raises-concerns-about-one-size-fits-all-xarelto-dose/
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Grieving Son Files Xarelto Wrongful Death Lawsuit
Apr 22, 2015 | The Legal Examiner
By Roopal Luhana
On March 20, 2015, Tennessee resident Danny Julian filed a Xarelto wrongful death lawsuit on behalf of his father, Tommy Julien. The Plaintiff claims that his father died after using the anticoagulant drug. He names manufacturers Bayer Healthcare Pharmaceuticals, Janssen Pharmaceuticals, and parent company Johnson & Johnson as Defendants, and seeks in excess of $75,000 in damages.
The case joins the current MDL proceeding in the Eastern District of Louisiana.
Patient Dies of Xarelto Internal Bleeding
According to the Complaint, Tommy Julien began taking Xarelto around November 13, 2012. His doctor prescribed it for him to help reduce his risk of stroke, as he had non-valvular atrial fibrillation, which naturally increases the risk of stroke.
The FDA approved Xarelto for the treatment of patients with non-valvular atrial fibrillation on November 4, 2011. This was after they had already approved it in July 2011 to help reduce the risk of blood clots in patients who had gone through knee or hip replacement surgery.
At the time, the manufacturers advertised the drug as being the only once-a-day prescription blood thinner that could reduce the risk of stroke without routine blood monitoring, such as what is required in patients using warfarin—the leading anticoagulant for decades.
On March 27, 2013, only a few months after he started taking Xarelto, Mr. Julien suffered from internal bleeding. This bleeding could not be stopped and he later died of his injuries on March 29, 2013.
Defendants Failed to Warn About Serious Xarelto Side Effects
The Plaintiff states that had the Defendants warned about the risks of using Xarelto, Tommy Julien would have never have taken it. He notes that the boxed warning on the drug did not address the risk for serious and fatal bleeding, despite the fact that during early clinical trials, Xarelto caused more gastrointestinal bleeds than warfarin. Plaintiffs taking Xarelto also required more blood transfusions than patients taking warfarin.
In the Institute for Safe Medication Practices Quarter Watch, October 3, 2012, Xarelto was linked with serious blood clot related injuries, most frequently pulmonary embolism. The report also noted that about 44 percent of adverse event reports concerning Xarelto involved a lack of efficacy for patients who used it after hip and knee replacement surgery.
The Plaintiff addS that the Defendants failed to warn about the lack of an adequate antidote to reverse cases of uncontrolled bleeding caused by Xarelto. Whereas patients taking warfarin may be treated with injections of vitamin K, there is no such remedy for Xarelto bleeding, which can make it more serious and potentially deadly.
“Defendants merely indicated that there was a risk for bleeding,” the Plaintiffs states in his Complaint, “and side-stepped the important issue of reversing the effects of Xarelto should a bleed occur.”
Plaintiff Seeks Punitive Damages
Plaintiff brings counts of failure to warn, design defect, negligence, negligent design, negligent misrepresentation, breach of warranties, fraud, violation of consumer protection laws, and wrongful death. He seeks compensatory and punitive damages.
Currently, about 300 similar lawsuits are pending in the Xarelto MDL, with U.S. District Judge Eldon E. Fallon presiding.
Link: http://newyork.legalexaminer.com/defective-dangerous-products/grieving-son-files-xarelto-wrongful-death-lawsuit/
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Xarelto Side-Effects Lawsuit Claims Filings Continue To Grow In Federal Litigation
Apr 22, 2015 | Wright & Schulte LLC
As the lawyers at Wright & Schulte LLC continue to represent clients in product liability lawsuits, the firm reports that that over 90 Xarelto side-effects lawsuit claims have been filed within the past month in the U.S. District Court, Eastern District of Louisiana. The U.S. Judicial Panel on Multidistrict Litigation’s (JPML) recently updated its docket to reflect Xarelto complaints increased from 311 as of March 17 to 402 as of April 15. Court documents show that the JPML established the Xarelto litigation in December by transferring 21 federally filed Xarelto complaints to the Eastern Louisiana district court. The Xarelto complaints are filed on behalf of men and women who allege that they suffered serious bleeding events due to using the Xarelto blood thinner medication. In some cases, survivors of Xarelto users filed wrongful death Xarelto lawsuits.
All of the Xarelto bleeding side-effects complaints assert that Xarelto’s manufacturer and marketer, Bayer Healthcare and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals Inc., failed to warn physicians and their patients that Xarelto does not have an antidote to reverse the blood thinner’s anticoagulant effects. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592)
“The rapid increase in the number of Xarelto complaints is not surprising given the allegations made by the plaintiffs of suffering life-threatening bleeding events allegedly due to using Xarelto which does not have an antidote to stop the bleeding,” says the attorneys at Wright & Schulte LLC who are representing plaintiffs in the Xarelto litigation as well as other individuals who have suffered from the effects of harmful drugs. The law firm continues to offer free legal evaluations of potential Xarelto bleeding side-effects lawsuits to individuals, or surviving family members, who have suffered significant bleeding episodes or died allegedly as a result of using new generation blood thinner medications, such as Xarelto, Pradaxa or Eliquis, that do not have an antidote to reverse bleeding.
Accornding to court documents, Xarelto (rivaroxaban) is a blood-thinner medication that helps to keep blood clots from forming, according to the Xarelto complaints in MDL 2592. The court documents state that the U.S. Food and Drug Administration (FDA) first approved Xarelto in July 2011 to reduce the risk of blood clots and pulmonary embolism following knee and hip replacement surgery. In November 2011, the FDA approved the blood thinner to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation not caused by a heart valve problem. One year later, the FDA expanded the use of Xarelto to treat patients with deep vein thrombosis and pulmonary embolism, as well as long-term treatment to prevent recurrence of these two conditions, according to the Xarelto complaints. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592)
The Xarelto side-effects lawsuit claims further purport that Xarelto’s marketing and informational materials claimed that Xarelto users did not need to have regular blood monitoring and there are no dietary restrictions. The Xarelto side-effects complaints allege that due to the defendants’ “intense” marketing of the drug, including its convenient use, about 130,000 prescriptions were filled in the United States in the first three months of 2012, “resulting in large profits.” However, the Xarelto lawsuits further allege that Xarelto is “defective” since patients who use the medication are at increased risk for developing life-threatening bleeds.
Court documents also indicate that in addition to the U.S. District Court, Eastern District of Louisiana, Xarelto lawsuits are also consolidated in a Pennsylvania state court. Xarelto lawsuits filed in Pennsylvania have been consolidated in a mass tort program in the Philadelphia Court of Common Pleas. According to court records, all Xarelto bleeding side-effects lawsuits filed against Bayer and Janssen Pharmaceuticals have been centralized in the Pennsylvania state court for coordinated pretrial proceedings. As of April 15, 189 Xarelto lawsuits are pending in the mass tort program that have similar allegations as the Xarelto complaints in the federal litigation regarding the bleeding risks associated with the blood thinner medication and the lack of a reversal agent to stop the bleeding.
Link: http://yourlegalhelp.com/xarelto-side-effects-lawsuit-claims-filings-continue-to-grow-in-federal-litigation/5341
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Xarelto Lawsuit Alleges Severe Bleeding Injuries
Apr 22, 2015 | Top Class Actions
By Amanda Antell
A Georgia man filed a Xarelto lawsuit against Bayer and Jansen Pharmaceuticals, after suffering severe internal bleeding injuries.
Plaintiff Ronnie H. claims in hisXarelto bleeding lawsuit that as a direct result of using the blood thinner Xarelto, he developed life-threatening bleeding injuries that required hospitalization.
Xarelto is prescribed as a preventative treatment for those with non-valvular atrial fibrillation “to reduct the risk of stroke and systemic embolism.”
On April 19, 2013, Ronnie began taking Xarelto in accordance with the drug’s label and had followed the advice of his physician. Despite this, he had suffered an internal bleeding event several days later on April 22, 2013 and had promptly ceased taking Xarelto.
Diagnostic testing revealed that the cause of the internal bleeding was related to Xarelto. Hospital records indicate that Ronnie’s spleen had ruptured, and had required an emergency splenectomy, and he needed several weeks of hospital recovery time.
After recovering from the Xarelto bleeding episode, Ronnie had learned of Xarelto’s tendency to cause uncontrollable bleeding injuries in patients.
Xarelto currently has no reversal agent, which would have stopped his severe hematoma. However, Ronnie and his physician had not been aware of this at the time he was prescribed Xarelto, and were not informed of it after his bleeding event.
Ronnie had discovered the risk of Xarelto bleeding through FDA warnings and advertisements. Therefore, Ronnie is filed this Xarelto lawsuit against Bayer and Jansen for failing to protect him against the adverse effects of their product and for failing to warn him of the possibility of Xarelto bleeding.
At no point before or after Ronnie was prescribed Xarelto, did the defendants notify him or his physician of the complication or about any relevant studies.
The Xarelto bleeding lawsuit states that the pharmaceutical companies had the civil responsibility of warning him and other Xarelto patients of any risks related to their product. Ronnie insists that he never would have taken Xarelto if he had known about the risk of uncontrollable internal bleeding.
So for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous drug, Ronnie is suing Jansen Pharmaceuticals and Bayer Pharmaceuticals. The charges include: negligence, false advertising, concealing information, and misrepresenting a product.
This Xarelto Lawsuit is Case No. 2;15-cv-01132-EEF-MBM. It was added to the Xarelto MDL: In Re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL No. 2592, both in the U.S. District Court of Eastern Louisiana.Overview of Xarelto Bleeding Complications
Xarelto was approved for sale in the United States in 2011, to be a treatment option for patients who suffer from atrial fibrillation and are at high risk for stroke. It was released as a joint effort between Bayer Pharmaceuticals and Johnson & Johnson’s subsidiary, Jansen Pharmaceuticals, in order to breakthrough the exclusive anticoagulant market.
As of now, there are only four anticoagulants available in the United States which includes the original blood-thinner Warfarin, and fellow new-generation anticoagulants: Pradaxa and Eliquis. Pradaxa had been approved a year prior in 2010, with Eliquis only approved recently in 2012.
While each of the anticoagulants come with similar treatment mechanisms, the new generation anticoagulants reportedly work much faster than Warfarin, but lack apparent safety features. Patients who are prescribed Warfarin, are required to undergo frequent medical checkups and dose adjustments.
Additionally, Warfarin comes with a reversal agent in the case of internal bleeding, which ultimately prevents avoidable deaths and emergency hospital visits. In contrast, all of the new-generation anticoagulants are prescribed on a constant dosing schedule, but no reversal agents are available in the case of internal bleeding.
In 2012, Xarelto had garnered $658 million in sales, and had breached $1 billion in 2013. This had earned Xarelto blockbuster status in the pharmaceutical market.
Despite its initial success, the complication of Xarelto bleeding has led to thousands of lawsuits, with each of the plaintiffs claiming that the manufacturing companies had prioritized Xarelto’s market value, over their safety.
Link: http://topclassactions.com/lawsuit-settlements/lawsuit-news/54278-xarelto-lawsuit-alleges-severe-bleeding-injuries/
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Xarelto Lawsuits Consolidated, Move Ahead
Apr 21, 2015 | Legal Examiner
By Steven Davis
Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary are currently facing over 170 product liability lawsuits over their new-generation anti-coagulant, Xarelto. Late in 2014, the U.S. Judicial Panel on Multidistrict Litigation (MDL) announced that all nationwide Xarelto lawsuits filed in federal courts, including the Southern District of Illinois and the Northern District of Illinois, would be consolidated in the Eastern District of Louisiana. According to Xarelto lawyers, an additional five to ten cases are being added to the MDL per week by individuals that believe Xarelto severely injured them since there is currently no antidote to stop the bleeding. Experts estimate that eventually several thousand cases will be transferred into the MDL.
An MDL is intended to streamline the litigation process, help avoid repetitive discovery and conflicting pre-trial motions, and allow bellwether trials to be set that will potentially determine the strength of the plaintiffs’ claims.
What is Xarelto?
Xarelto was developed in 2011 by Bayer and Janssen Pharmaceuticals as a new generation anticoagulant meant to be a superior and more convenient alternative to Coumadin (warfarin) in terms of better prevention of strokes and non-central nervous system embolism and the absence of a requirement for regular blood monitoring.
Although all blood thinners have side effects and increase the risk of bleeding problems, Xarelto has been associated with a particularly high number of adverse reports involving injuries associated with uncontrollable bleeding. While the effects of warfarin can be quickly reversed in an emergency situation through the use of vitamin K and blood transfusions, there is no approvedantidote available for Xarelto, and side effects from the drug have resulted in devastating consequences when doctors were unable to control the bleeding.
Xarelto Lawsuits
All the Xarelto lawsuits make essentially the same allegations: drug manufacturers failed to warn consumers and medical professionals about the potentially dangerous side effects of Xarelto, which include:Uncontrollable bleedingThe need for blood transfusionsDeath in severe cases
Severe injuries and deaths could have been avoided had the pharmaceutical companies not provided misleading information about blood monitoring, and if stronger warnings had been issued concerning the lack of a reversal agent or antidote, according to court documents.
Link: http://chicago-land.legalexaminer.com/fda-prescription-drugs/xarelto-lawsuits-consolidated-move-ahead/
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Over 400 Xarelto Lawsuits Filed in Federal MDL
Apr 21, 2015 | Schmidt Law
Federal judges have reported big gains in the size of theXarelto litigation, with another 100 cases filed in the last month.
Over 400 lawsuits involving uncontrollable bleeding from Xarelto are now centralized under Judge Eldon E. Fallon in one federal court in Louisiana, Multi-District Litigation (MDL No. 2592).
An additional 180 cases are pending at the state-court level in Pennsylvania.
Lawsuits accuse Bayer HealthCare and Janssen Pharmaceuticals of aggressively marketing Xarelto as a “one-size-fits-all” blood-thinner, while downplaying the risk of irreversible bleeding.
Marketing materials continue to promote Xarelto with claims that “there is no need for routine blood tests” to adjust the dosage. However, an editorial published in JAMA last month recommended that “patient safety can be further improved through individualized dosing.”
A major difference between Xarelto and older blood-thinners, such as Coumadin (warfarin), is that it lacks an effective reversal agent. If a patient on Xarelto is injured or needs emergency surgery, it may be extremely difficult for a doctor to de-activate the blood-thinning effects of Xarelto.
Another major difference between Xarelto and warfarin is price. In the United States, an annual prescription for warfarin costs $80-100, whereas Xarelto costs $3,000.
Bayer and Janssen are accused of downplaying Xarelto’s bleeding risks to boost corporate profits and “prevent any chances of their product’s registrations being delayed or rejected by the FDA.”
Link: http://www.schmidtlaw.com/over-400-xarelto-lawsuits-filed-in-federal-mdl/
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Xarelto Litigation Joined by Illinois Couple
Apr 20, 2015 | Top Class Actions
By Paul Tassin
An Illinois couple has added their claim to the multidistrict litigation against Janssen Pharmaceuticals and related companies over the prescription drug Xarelto, which has been linked to fatal internal bleeding events.
Plaintiff John F. began taking Xarelto in April 2013. In early October of that year, John suffered from a life-threatening bleed with blood in his urine and low levels of hemoglobin and red blood cells. His complications required surgery and blood transfusions that necessitated an extended hospital stay.
John alleges Xarelto caused that excessive bleeding and is therefore defective. He also alleges Janssen failed to properly test Xarelto for safety, intentionally concealed knowledge of Xarelto’s defects, and misrepresented Xarelto as safe for its indicated use.Xarelto and Gastrointestinal Bleeding
Xarelto is an anticoagulant medication used to treat and prevent certain circulatory conditions. The FDA first approved Xarelto in July 2011 for use to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery. In November 2011, the FDA granted additional approval for use to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
In its relatively few years on the market, Xarelto has been a commercial success. Sales in its first year on the market were in the hundreds of millions of dollars, and by 2013 annual worldwide sales reached $2 billion.
However, studies of Xarelto showed it came with an increased risk of excessive and uncontrollable bleeding. The clinical trials for the 2011 FDA approvals consistently showed Xarelto (studied under its generic name rivaroxaban) led to more instances of bleeding, particularly gastrointestinal bleeding, that resulted in low hemoglobin levels and required blood transfusions. John’s Xarelto lawsuit says Janssen failed to address this increased risk of bleeding in their promotional materials.
Janssen’s marketing of Xarelto has also received negative attention.
Janssen spent at least $11 million in 2013 on marketing for Xarelto, much of it direct-to-consumer. In June of that year, the FDA ordered Janssen to stop distributing certain promotional material for Xarelto, saying that material minimized risks associated with Xarelto dose adjustments in a way that was false or misleading.
Much of Janssen’s marketing also portrayed Xarelto as an improvement over warfarin, an older anticoagulant considered relatively safe. However, while warfarin has a complementary medication, known as a “reversal agent,” that can stop excessive bleeding once it starts, there is no such reversal agent that can stop Xarelto bleeding.
Indeed, in the U.S. and Germany, government regulators have received reports of thousands of adverse events related to Xarelto bleeding, several dozens of which have resulted in death. John alleges that Janssen failed to warn of the lack of a reversal agent in its marketing.
John’s Xarelto lawsuit raises claims for negligence, defects in design and manufacture, breach of warranty, misrepresentation, withholding of important safety information, fraud, and violation of consumer protection laws.
John and his wife Mary G., also a plaintiff, both seek compensation for the effect of John’s Xarelto side effects on their marriage. They seek compensation for pain and suffering, medical and related expenses, punitive damages, and costs of the litigation including attorney’s fees.
This Xarelto lawsuit is pending in the U.S. District Court for the Eastern District of Louisiana under case no. 2:15-CV-01093-EEF-MBN. It’s part of the Xarelto multidistrict litigation titled In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL no. 2592.
Link: http://topclassactions.com/lawsuit-settlements/lawsuit-news/54037-xarelto-litigation-joined-illinois-couple/
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Life-Threatening GI Bleed Subject of Xarelto Lawsuit
Apr 20, 2015 | Injury Lawyer News
By Ava Lawson
Cheryl Butler is one of the most recent plaintiffs to seek damages against Janssen Pharmaceuticals and Bayer HealthCare for injuries allegedly caused by Xarelto side effects. Her product liability complaint was filed in the US District Court for the Eastern District of Louisiana, where similar claims have been consolidated under MDL no. 2592. The claimant, who resides in Bedford Park, Illinois is demanding compensatory, treble and punitive damages from the defendants in an amount exceeding $75,000.
According to allegations leveled in her case, the plaintiff’s use of Xarelto caused her to suffer life-threatening bleeding in addition to other personal injuries, which she says are permanent and lasting in nature. As a result, Ms. Butler has incurred mental anguish and physical pain and has suffered a diminished enjoyment of life.Xarelto allegedly caused life-threatening GI bleed
Xarelto is an oral anticoagulant that is FDA approved to reduce the risk of stroke and embolism in patients with nonvalvular atrial fibrillation (AF). The blood thinner is also indicated to help reduce the risks of developing deep vein thrombosis in patients having knee or hip replacement surgery, as well as treating recurrence of DVT and or pulmonary embolism.
In her Xarelto lawsuit, Butler states that she began taking the medication in 2013, under the direction of her doctor, for the treatment of a right lower extremity deep venous thrombosis and saddle pulmonary artery embolism. She continued taking the drug through approximately April 12, 2013, at which time she suffered a severe gastrointestinal bleed. The bleeding incident was life-threatening in nature, as the hemorrhage was irreversible without an effective antidote available.
The defendants, argues the plaintiff, used the results of the ROCKET AF study, the RECORD studies, and the EINSTEIN studies to promote Xarelto as a superior alternative to other blood thinners, such as Warfarin. However, this promotional campaign failed to adequately highlight the increased risk of gastrointestinal bleeding events and/or hemorrhages that required transfusion, says Butler.
The defendants emphasized the benefits of its blockbuster drug, calling it the “Xarelto Difference,” based on claims that patients no longer needed blood tests or rigorous dietary changes as they would with Warfarin. Their “aggressive marketing tactics,” alleges the complaint, garnered the defendants some $582 million in annual worldwide sales. In terms of global sales, Xarelto is rated the leading anticoagulant.No antidote for Xarelto bleeding events
The lawsuit cites staggering numbers of Xarelto-related “Serious Adverse Event” (SAE) reports in recent years. By the end of 2012, 2,081 SAEs had been filed with the FDA, of which 151 proved fatal, compared to 56 Warfarin-associated deaths that same year. And by the first quarter of 2013, an estimated 680 adverse events associated with Xarelto were logged, eclipsing those of Pradaxa – another anticoagulant that had previously ranked as the number one reported drug in terms of SAEs.
It is argued that the defendants promoted Xarelto for its simplicity and convenience, but failed to disclose to patients and the medical community that there is no agent or means to reverse the blood thinning effects of Xarelto, which could lead to life-threatening and fatal consequences.
Butler’s complaint contends that she would have never taken the medication had there been a boxed warning concerning serious bleeding events associated with Xarelto. She is suing on multiple counts, including defective design, manufacturing defect, failure to warn, negligence and breach of implied and express warranties.
The case joins hundreds of others in the Eastern District of Louisiana, where MDL proceedings are being managed by Judge Fallon, who also presided over consolidated Avandia litigation.
Link: http://injurylawyer-news.com/2015/04/life-threatening-gi-bleed-subject-xarelto-lawsuit/
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Xarelto patient alleges fraud, negligence
Apr 20, 2015 | The Madison-St. Clair Record
A California man is suing a number of pharmaceutical manufacturers in St. Clair County over the drug Xarelto.
Kenneth Niemeier filed a lawsuit March 31 in St. Clair County Circuit Court against Janssen Research & Development, formerly known as Johnson and Johnson Pharmaceutical Research and Development; Janssen Ortho; Janssen Pharmaceuticals Inc., formerly known as Janssen Pharmaceutica Inc.; Bayer Healthcare Pharmaceuticals Inc.; Bayer Pharma AG ofGermany; Bayer Corporation; Bayer Healthcare; and Bayer Healthcare AG and Bayer AG of Germany, alleging product liability.
According to the complaint, the defendants manufactured, marketed and distributed Xarelto as a product intended to reduce the risk of stroke and embolism in certain patients but study results have raised questions about dosage and pointed out that in the case of adverse side effects, there is no antidote to reverse the drug’s effects. Niemeier maintains the defendants overstated the efficacy of the drug, misleading consumers.
Niemeier alleges the defendants failed to: fully research Xarelto’s safety or provide adequate instructions, disclosures, and warnings, and knowingly concealed its defects from the public. He says he suffered health consequences including physical pain, mental anguish, diminished enjoyment of life, loss of earnings and medical expenses.
The plaintiff claims product liability, intentional and negligent infliction of emotional distress, common law fraud, negligent and fraudulent misrepresentation and breach of warranty.
Janssen spokesperson Kristina Chang issued a statement regarding Xarelto.
“Xarelto is an important anticoagulant used to treat and reduce the risk of life-threatening blood clots,” Chang stated.
“After more than three years on the U.S. market, and more than 2 million patients prescribed in the U.S. to date, the benefit-risk profile of Xarelto remains favorable and consistent with the clinical trials. All anticoagulants, or blood thinners, carry the risk of bleeding, and the prescribing information for Xarelto has always warned of these risks. Blood thinners are important and potentially life-saving medicines that should be taken by patients as prescribed by a doctor and should not be discontinued without a discussion with a doctor. We will continue to defend against the claims raised in the litigation.”
Niemeier seeks damages in excess of $50,000, plus attorney fees and costs. He is represented by attorneys John Driscoll and Christopher Quinn of The Driscoll Firm in St. Louis.
Link: http://madisonrecord.com/issues/895-product-liability/270227-xarelto-patient-alleges-fraud-negligence
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Apr 20, 2015 | The Oliver Law Group PC
The Xarelto bleeding lawsuit attorneys at The Oliver Law Group P.C. report that litigation of Xarelto bleeding side-effects lawsuits in state and federal courts are moving forward more efficiently due to new developments in the pretrial proceedings. Court documents show that Xarelto complaints can now be filed directly into the multidistrict litigation established for Xarelto complaints in the U.S. District Court, Eastern District of Louisiana. U.S. District Court Judge Eldon E. Fallon, who is overseeing the federal Xarelto litigation, said in a recently issued order that filing Xarelto complaints directly into the mulitidistrict litigation will eliminate delays associated with transferring the cases filed in other federal courts to the Eastern Louisiana federal court. According to the order, this action will not only prevent delays but promote judicial efficiency.
The Xarelto claims being filed against Bayer Healthcare and Johnson & Johnson’s subsidiary, Janssen Pharmaceutical Inc., allege that the blood thinner causes such side effects, such as uncontrollable and fatal bleeding, and the defendants failed to warn physicians and their patients that there is no antidote to reverse Xarelto’s anticoagulant effects. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592)
Court documents show that attorneys for plaintiffs and defendants in the Xarelto litigation established in the Philadelphia Court of Common Pleas have approved a Master Long Form Complaint and a Short Form Complaint for plaintiffs to use to file their Xarelto lawsuits. Court records indicate that a mass tort program was recently established in the Pennsylvania state court for Xarelto bleeding lawsuits. According to court documents, all Xarelto complaints filed in Pennsylvania are now consolidated in the Philadelphia Court of Common Pleas for coordinated pretrial proceedings. (In Re: Xarelto Litigation, Case Number 150102349)
“Creating master long forms and short forms makes it more convenient for plaintiffs to file their Xarelto lawsuits,” says The Oliver Law Group, P.C., which represents individuals who have been injured by harmful drugs. “We commend the actions taken in Louisiana and Pennsylvania which help the coordinated proceedings in both courts move forward more efficiently.”
According to the Xarelto complaints filed in the federal and state litigations, Xarelto (rivaroxaban) is a blood-thinner that prevents blood clots from forming. The medication received approval from the U.S. Food and Drug Administration (FDA) to treat pulmonary embolism, deep vein thrombosis and to prevent blood clots and strokes in patients with atrial fibrillation not caused by a heart valve problem, the Xarelto complaints say. The Xarelto lawsuits contend that Xarelto has been marketed as being more convenient to use than warfarin (Coumadin), an FDA-approved blood thinner that has been on the market for 60 years, because Xarelto does not require routine blood monitoring.
According to the Xarelto bleeding side-effects lawsuits, warfarin uses vitamin K as an antidote to reverse bleeding but Bayer and Janssen failed to warn that Xarelto does not have a reversal agent to stop uncontrolled and excessive bleeding in patients who use the blood thinner. The Xarelto complaints purport that not having an antidote leaves emergency room doctors without any effective means to treat and stabilize patients suffering from serious bleeding episodes. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592) (In Re: Xarelto Litigation, Case Number 150102349)
Court records indicate that the federal legislation for the Xarelto complaints was established in December by the U.S. Judicial Panel on Multidistrict Litigation (JPML). According to the federal panel’s transfer order, centralizing Xarelto lawsuits filed nationwide for coordinated pretrial proceedings will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of all the parties, including the Court. (In re: Xarelto (Rivaroxaban) Products Liability Litigation, MDL 2592)
In January, Philadelphia Court of Common Pleas Administrative Judge Kevin Dougherty issued an order that created a mass tort litigation for Xarelto complaints filed in Pennsylvania. Court documents indicate that plaintiffs involved in Xarelto complaints filed a petition asking Judge Dougherty to consolidate Xarelto complaints because the lawsuits have common allegations of the Xarelto blood thinner medication causes severe and uncontrollable bleeding that can sometimes be fatal. (In Re: Xarelto Litigation, Case Number 150102349)
Link: http://legalactionnow.com/xarelto-bleeding-lawsuit-complaints-benefit-from-recent-developments-in-xarelto-litigation-in-federal-and-state-courts/6410
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Xarelto Lawsuit Filed in California District Court
Apr 17, 2015 | Injury Lawyer News
By Stephanie Reid
On January 21, 2015, a Xarelto lawsuit was filed in the United States District Court for the Southern District of California alleging severe and life-threatening complications with the drug, requiring immediate medical attention. The lawsuit names several defendants, including Janssen Pharmaceuticals, Johnson & Johnson, and the Bayer Corporation. Xarelto, a powerful blood thinner, has been named in a number of recent state and federal lawsuits, including several involving the alleged wrongful death of the patient.
In early 2013, the plaintiff was prescribed the drug Xarelto in order to treat an ongoing medical condition. On or about February 4, 2013, the plaintiff developed sudden andunexpected bleeding in his eye, which required medical attention and a painful recovery. The plaintiff asserts that, had he known the truth about the risks associated with Xarelto, he would not have chosen to take the drug and would have elected an alternative course of treatment.Bleeding dangers known by drug makers
Xarelto is approved by the Food and Drug Administration for the treatment of atrial fibrillation, blood clots, deep vein thrombosis and pulmonary embolism. The drug is an anti-coagulant and is designed to thin the blood to avoid life-threatening clots. Unlike its predecessor warfarin, the drug does not respond to an antidote in the event of an adverse reaction or bleeding episode, thereby leaving patients especially vulnerable to internal bleeding – which may go undetected until the issue becomes critical.
According to the plaintiff’s allegations, the defendants have unabashedly marketed Xarelto as a “one size fits all” drug requiring little blood monitoring and eliminating the imposition of dietary restrictions. However, these “fervent” marketing tactics have done little to warn patients of the other side of the coin: an alleged significant risk of gastrointestinal and other internal bleeding, sometimes leading to patient death.Plaintiff alleges several causes of action
Following the plaintiff’s factual allegations, several causes of action are presented to address the “simply inadequate” warnings accompanying the allegedly misleading praises of Xarelto. The plaintiff first begins by addressing the procedural obstacle known as the statute of limitations – which places a time limit on plaintiffs alleging personal injury.
The plaintiff contends that any proposed argument by the defendants against the Xarelto injury claims based on an expired statute of limitations should be overruled due to the fact the defendants allegedly concealed the truth about Xarelto side effects and risks, thereby making it impossible for a plaintiff to properly raise a claim.
Link: http://injurylawyer-news.com/2015/04/xarelto-lawsuit-filed-california-district-court/ -
Lawsuit Questions Xarelto Safety
Apr 17, 2015 | Drug Reporter
By Jacky Gale
Another lawsuit has been transferred to the Xarelto multidistrict litigation (MDL) No. 2592, which is pending in the U.S. District Court for the Eastern District of Louisiana under Judge Fallon. The plaintiff, Cheryl Butler, claims the defendants, Janssen Pharmaceuticals, Bayer Healthcare Pharmaceuticals, et al. fraudulently misrepresented the safety of the medication, Xarelto, and that the drug led to the plaintiff’s life-threatening medical problems.
As part of the MDL, the plaintiff’s Xarelto lawsuit will be subject to uniform pretrial rulings. MDLs also serve to avoid the possibility of duplicative discovery, streamlining the process for all parties. However, Ms. Butler will retain her right to an individual trial by jury. If her case is not settled while joined to the MDL, it is expected to be remanded back to her home district for trial.Plaintiff alleges life-threatening medical problems
On February 27, 2013, the plaintiff was prescribed Xarelto (rivaroxaban) for the treatment of saddle pulmonary artery embolism and a right lower extremity deep vein thrombosis (DVT). She used the medication as directed until April 12, 2013. At that point, she was diagnosed with a severe gastrointestinal bleeding event. The plaintiff is demanding damages for life-threatening and irreversible bleeding, physical pain, mental anguish, shortened life expectancy, and diminished enjoyment of life. She claims that her Xarelto bleeding injuries are expected to be permanent. The plaintiff also demands compensatory damages for her hospitalization, medical treatment, and lost wages.Study finds more frequent bleeding events
Xarelto was approved by the FDA in 2011 for the treatment of DVT and pulmonary embolism (PE) in patients who were undergoing joint replacement surgery. Later, FDA approval was granted for the use of Xarelto to reduce the risk of systemic embolism and stroke in patients who were diagnosed with non-valvular atrial fibrillation. Further approval for PE and DVT treatment and reduction in recurrence followed shortly.
Xarelto is an anticoagulant, or blood-thinning drug, that works by inhibiting the blood’s ability to clot. The plaintiff’s lawsuit claims that the defendants did not conduct adequate safety studies on the drug. However, studies that were conducted are known as the Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism (RECORD studies). The results of the RECORD studies indicated that Xarelto was not necessarily an inferior alternative to warfarin, long considered to be the gold standard of blood-thinning therapy. However, the lawsuit goes on to note that, “the studies also showed a greater incidence with Xarelto of bleeding leading to decreased hemoglobin levels and transfusion of blood.”
Furthermore, unlike warfarin, there is no reversal agent available to treat patients who are taking Xarelto and suffer a major bleeding event. This means that doctors are essentially helpless to mitigate the effects of the drug, should a problem develop.Lawsuit raises questions regarding defendants’ marketing
Ms. Butler’s lawsuit questions the defendants’ aggressive marketing campaign, which relied on the RECORD studies and others for the promotion of the drug. The plaintiff alleges that the marketing campaign emphasizes the potential benefits of the drug while failing to call attention to the potential for life-threatening bleeding events. The defendants’ marketing efforts highlighted what they referred to as the “Xarelto Difference,” which is the supposed superior convenience of the drug, as it does not require frequent blood monitoring, it has no known dietary requirements, and patients can take a dose once per day.
However, FDA reviewers questioned the so-called convenience of Xarelto, noting that the once-a-day dosage schedule resulted in peaks and troughs in studied blood samples, which could be avoided through twice-per-day dosing. The plaintiff claims that the defendants’ aggressive promotional materials played a significant role in her use of Xarelto.
Link: http://drugreporter.com/2015/04/lawsuit-questions-xarelto-safety/
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