Preview Newsletter
XARELTO Media Monitoring – Week of 6-24-16
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Xarelto Lawsuit Plaintiffs Note Allegations Against Duke University Regarding Clinical Trials
Jun 17, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on a 3-year long clinical trial that the makers of Xarelto hired Duke University to undertake for Xarelto, a then newly developed blood-thinning drug. Xarelto trials began in 2006 and reviewed the blood-thinning effects in a sample of 14,000 patients of a Xarelto compared to warfarin, a more traditional blood thinner. There is currently an investigation underway about this particular clinical trial. Many are questioning the use of a defective testing device during the trials that would have erroneously influenced the results. Those results ultimately indicated that Xarelto was more effective since the defective device in question allegedly gave patients the wrong dosage of warfarin. -
Public Discontent Over Anticoagulant Mounts As Number Of Xarelto Lawsuit Filings Grow
Jun 17, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on the initial excitement over the release of Xarelto, a new-generation blood-thinning drug. The U.S. Food and Drug Administration (FDA) approved the drug in 2011 to treat knee and hip replacement surgery patients, as well as those suffering from a number of medical conditions such as deep vein thrombosis, pulmonary embolism, and atrial fibrillation, a common heart ailment. Xarelto was unlike other blood-thinning drugs before it because it allowed patients who took it more freedoms. -
Xarelto Lawsuit Plaintiffs Await Bellwether Trials As More Details Emerge About Clinical Trial Data
Jun 17, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on the surging controversy surrounding Duke University Clinical Trials for Xarelto, a new-generation blood-thinning drug manufactured by Janssen Pharmaceuticals, a Johnson and Johnson Corporation subsidiary, and Bayer AG. The clinical trial was commissioned by the manufacturers, which are now being accused of deceptive and misleading actions by knowingly allowing the omission of data related to a faulty blood testing device, thus allowing incomplete data to be sent to U.S. and European regulators. Additionally, this data was also sent to the very well-respected New England Journal of Medicine (NEJM) that made an assessment of Xarelto based upon faulty data. Subsequently, the Journal’s review of the drug, in all likelihood, contributed to the FDA approving the drug for release onto the consumer market. -
As IVC Filter Lawsuit Cases Increase FDA Safety Statement Increases Public Scrutiny For IVC Filters
Jun 18, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on a recent public safety statement issued by the U.S. Food and Drug Administration (FDA) in regard to IVC filters and the potential health risks associated with their use. IVC filters were approved by the FDA in 1979. When approved for use in 1979 only 2,000 devices were implanted but have increased dramatically to 167,000 in 2007. The IVC filter is designed for those people who are at risk of blood clots but are unable to use traditional blood-thinning drugs. -
Xarelto Lawsuit Plaintiffs Forge Ahead as Investigations Over Omission of Clinical Trial Data Related to Faulty Medical Device Begin
Jun 20, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on Xarelto and the ongoing controversy surrounding the drug. When Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011, it was a widely popular blood-thinning treatment. The blood thinner drug is now, however, the focus of investigations that are looking into its initial approval stages and whether integral data obtained during clinical trials was omitted when information was sent to reputable medical journals. -
Xarelto Lawsuit Plaintiffs Note New Evidence Of Possible Withheld Clinical Trial Data
Jun 22, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on a recently published article from Business Insider (BI) that details both lawsuits against and controversies surrounding the anticoagulant drug, Xarelto. In 2011, the FDA granted approval to Xarelto. However, according to BI, a deluge of public concern has recently swamped the courts. The outcry was largely prompted by the release of a document claiming that Bayer AG and Janssen Pharmaceuticals intentionally failed to disclose crucial data to a medical journal during clinical trials of the drug. -
Xarelto Lawsuit Plaintiffs Continue Their Legal Battle As They Await Results Of Report Related To Duke Clinical Trials
Jun 22, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on ongoing investigations related to the results of clinical trials for Xarelto, a blood-thinning drug approved by the U.S. Food and Drug Administration (FDA) in 2011. One such investigation is being undertaken by European regulators related to the clinical trial conducted at the Duke Institute for Clinical Research. -
Flaws In Research Design Come To Light As Xarelto Lawsuit Filings Grow In Number
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com comments on a recently published article from Business Insider (BI) detailing new evidence in the case against Xarelto. The FDA approved the new-generation anticoagulant from Bayer AG and the Johnson & Johnson subsidiary company, Janssen Pharmaceuticals, in 2011. However, an increasing number of lawsuits claiming increased risk of internal bleeding associated with Xarelto has drawn scrutiny from both public and official quarters. -
Xarelto Lawsuit Plaintiffs Claim Manufacturers Used Misleading Advertisements
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.comdetails the rising public concern over the safety of the anticoagulant drug, Xarelto. Following its FDA approval in 2011, it is often used to treat patients suffering from deep vein thrombosis and pulmonary embolism. Physicians also prescribe it to individuals recovering from knee or hip surgery, in order to prevent the formation of clots and to those at risk for strokes. Its popularity largely stems from the fact that, unlike other blood thinners, it does not require extensive monitoring, changes in diet, or constant dosage adjustments. -
As Xarelto Lawsuit Filings Continue New Evidence Surfaces Surrounding Clinical Trials
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com explores evidence detailed in an article from Business Insider (BI) that bolsters claims of an exacerbated risk of bleeding associated with Xarelto. While the new-generation anticoagulant from Bayer AG and Janssen Pharmaceuticals received FDA approval in 2011, complications with its use have led to intense scrutiny from both public and private sectors. -
Xarelto Lawsuit Plaintiffs Allege Drug Puts Patients At Risk For Serious Bleeding Episodes
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on the increased number of lawsuits regarding the blood thinner, Xarelto. Following its FDA approval in 2011, it became a popular treatment for patients suffering from pulmonary embolism or deep vein thrombosis. Physicians also used it to prevent strokes and the formation of blood clots in the legs of those recovering from knee or hip surgery. Because it did not require extensive monitoring, dosage adjustment, or changes in diet, many consumers felt it was a better choice than other anticoagulant treatments. -
Xarelto Lawsuit Plaintiffs Note Lack Of Antidote At Time Of Drugs Release To Market
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com announces that case selection in the mass litigation against Xarelto began earlier this year. The bellwether action brings the more than 2,200 suits represented by multidistrict litigation (MDL) 2952 before Judge Eldon Fallon, presiding in the Eastern District of Louisiana, who will determine the nature of the allegations against the new-generation anticoagulant. -
Xarelto Lawsuit Plaintiffs Await Bellwether Trials As More Details Emerge About Clinical Trial Data
Jun 17, 2016 | The Legal Examiner
By Laurence Banville
TheProductLawyers.com reports on the surging controversy surrounding Duke University Clinical Trials for Xarelto, a new-generation blood-thinning drug manufactured by Janssen Pharmaceuticals, a Johnson and Johnson Corporation subsidiary, and Bayer AG. The clinical trial was commissioned by the manufacturers, which are now being accused of deceptive and misleading actions by knowingly allowing the omission of data related to a faulty blood testing device, thus allowing incomplete data to be sent to U.S. and European regulators. -
Couple Files Xarelto Side Effects Lawsuit
Jun 20, 2016 | Righting Injustice
By Jennifer Walker-Journey
David Rowell claims he was prescribed and began taking Xarelto on or around June 19, 2015. On June 29, 2015, he suffered from uncontrolled bleeding. He claims the drug companies are at fault for not properly investigating, researching, studying or defining the drug’s profile and failing to adequately test or warn of Xarelto side effects. -
Xarelto Lawsuit Plaintiffs Note Discovery Of Flawed Data
Jun 22, 2016 | The Legal Examiner
By Laurence Banville
TheProductLawyers.com announces new evidence disclosed in a recent article for Business Insider (BI). Bayer AG and the Johnson & Johnson subsidiary company, Janssen Pharmaceuticals, have lately been the subject of mounting litigation alleging a heightened risk of bleeding associated with their drug, Xarelto. The anticoagulant is a new-generation blood-thinner, which received FDA approval in 2011.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Plaintiff Attorney Press Releases
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Full Text of Stories Below
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Xarelto Lawsuit Plaintiffs Note Allegations Against Duke University Regarding Clinical Trials
Jun 17, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on a 3-year long clinical trial that the makers of Xarelto hired Duke University to undertake for Xarelto, a then newly developed blood-thinning drug. Xarelto trials began in 2006 and reviewed the blood-thinning effects in a sample of 14,000 patients of a Xarelto compared to warfarin, a more traditional blood thinner. There is currently an investigation underway about this particular clinical trial. Many are questioning the use of a defective testing device during the trials that would have erroneously influenced the results. Those results ultimately indicated that Xarelto was more effective since the defective device in question allegedly gave patients the wrong dosage of warfarin.
A recent Business Insider article has stated that Xarelto has become the focus of more than 5,000 lawsuits, as well as 500 allegations of fatalities. Plaintiffs in these cases and others now question whether the erroneous data would have made a difference in assessing the safety of the drug.
It is also being reported that Duke Researchers may have failed to provide all the requisite data of the trial for publishing in the New England Journal of Medicine (NEJM). As a result, the manufacturers, Janssen Pharmaceuticals, a subsidiary of the Johnson and Johnson Corporation, and Bayer AG, are being accused of intentional deception by not giving the NEJM all the necessary data for its assessment, which most likely contributed to the FDA approval of the drug and its subsequent release on the market.
Lawyers in a legal briefing recently filed allege that the makers of Xarelto did not say anything after noticing Duke’s omitted data related to a recalled blood testing device used in the trial, as well as remaining quiet as the information about the drug was sent to the US and European regulators. By doing so, Janssen and Bayer in effect misled the NEJM and the many readers who rely on the journal’s information, as well at the patients who would eventually use the drug.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.fox5vegas.com/story/32251098/xarelto-lawsuit-plaintiffs-note-allegations-against-duke-university-regarding-clinical-trials
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Public Discontent Over Anticoagulant Mounts As Number Of Xarelto Lawsuit Filings Grow
Jun 17, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.comreports on the initial excitement over the release of Xarelto, a new-generation blood-thinning drug. The U.S. Food and Drug Administration (FDA) approved the drug in 2011 to treat knee and hip replacement surgery patients, as well as those suffering from a number of medical conditions such as deep vein thrombosis, pulmonary embolism, and atrial fibrillation, a common heart ailment. Xarelto was unlike other blood-thinning drugs before it because it allowed patients who took it more freedoms.
Since its release, however, the drug has become the focus of controversy on numerous fronts. First and foremost, over 3,400 lawsuits have been filed against the makers of the drug, Janssen Pharmaceuticals, a subsidiary company of the Johnson and Johnson Corporation, and Bayer AG. This multitude of complaints has been consolidated into two primary groups. In Philadelphia, PA, the Court of Common Pleas consolidated over 600 cases in a mass tort program. In Louisiana, another group of more than 2,800 federal cases has been consolidated by the U.S. Judicial Panel on Multidistrict Litigation (JPML) and assigned number 2592. The multidistrict litigation (MDL) has been placed under the administrative oversight of the Honorable Judge Eldon Fallon. The cases were consolidated in both of these instances due to similar allegations over the dangerous risks of the drug and the fact that the defendants were the same in all of the individual lawsuits filed.
Additionally, the controversy surrounding the drug has been compounded by two other factors. The first are the investigations currently underway related to the drug’s clinical trials and a medical device that has been alleged to be potentially defective which was used during the clinical trials. The other issue fanning the flames of discontent with Xarelto is the FDA’s issuance of two black box warnings for the drug. These warnings are very severe and are the harshest warnings that can be given to a product. These warnings could ultimately result in the product’s complete removal from the consumer market.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.wdrb.com/story/32247263/public-discontent-over-anticoagulant-mounts-as-number-of-xarelto-lawsuit-filings-grow
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Xarelto Lawsuit Plaintiffs Await Bellwether Trials As More Details Emerge About Clinical Trial Data
Jun 17, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on the surging controversy surrounding Duke University Clinical Trials for Xarelto, a new-generation blood-thinning drug manufactured by Janssen Pharmaceuticals, a Johnson and Johnson Corporation subsidiary, and Bayer AG. The clinical trial was commissioned by the manufacturers, which are now being accused of deceptive and misleading actions by knowingly allowing the omission of data related to a faulty blood testing device, thus allowing incomplete data to be sent to U.S. and European regulators. Additionally, this data was also sent to the very well-respected New England Journal of Medicine (NEJM) that made an assessment of Xarelto based upon faulty data. Subsequently, the Journal’s review of the drug, in all likelihood, contributed to the FDA approving the drug for release onto the consumer market.
A Faulty Device In The Clinical Trials
An investigation of the 2006 Duke University Clinical Trial is underway and controversy has begun to surge over its details. While reviewing the effects of Xarelto on 14,000 patients, as compared with warfarin, a preceding anticoagulant, it has been alleged that a faulty blood testing device was used that caused Xarelto to appear more effective than it really was. The reason given is that the device did not provide the patients participating in the clinical trial with a sufficient dose of warfarin. As this investigation proceeds, many other factors are emerging in relation to the data collection process.
The Allegations Surrounding The Drug
A Business Insider article has shed some light on the extent of the issues related to Xarelto. In more than 5,000 lawsuits Xarelto has been the focus of allegations claiming that the drug caused uncontrollable bleeding, along with 500 allegations of patients dying from using the drug. Plaintiffs in these cases are patiently waiting for the first bellwether trials to begin in 2017. It is expected that more cases will be filed, thus increasing the number of active lawsuits.
http://newyorkcity.legalexaminer.com/fda-prescription-drugs/xarelto-lawsuit-plaintiffs-await-bellwether-trials-as-more-details-emerge-about-clinical-trial-data/
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As IVC Filter Lawsuit Cases Increase FDA Safety Statement Increases Public Scrutiny For IVC Filters
Jun 18, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on a recent public safety statement issued by the U.S. Food and Drug Administration (FDA) in regard to IVC filters and the potential health risks associated with their use. IVC filters were approved by the FDA in 1979. When approved for use in 1979 only 2,000 devices were implanted but have increased dramatically to 167,000 in 2007. The IVC filter is designed for those people who are at risk of blood clots but are unable to use traditional blood-thinning drugs.
The IVC filter is a small cage-like structure that is implanted into the patient's inferior vena cava veins, with the purpose of capturing blood clots before they reach the heart and lungs, thus reducing the risk of pulmonary embolism.
The FDA, in its public statement, and as reported by NBC News, has stated that the implants have the potential to fracture while inside the body. When this occurs the pieces can travel through the bloodstream to other more sensitive areas of the body such as organs and veins, thus possibly puncturing them. The pieces can also lodge in the intestines and other high-risk areas where the pieces cannot be surgically removed. Any such migration of pieces of the IVC filter could potentially cause serious health problems for the patient.
Due to the increasing number of incidences of fracturing of the filter, many patients have filed lawsuits against the numerous manufacturers of these devices, such as Cook Medical and C.R. Bard, alleging that the filters were designed defectively. As many await their day in court, more news is emerging about IVC filters that seem to be adding to the controversy and debate over whether or not the devices are safe to use.
https://www.pressadvantage.com/story/10787-as-ivc-filter-lawsuit-cases-increase-fda-safety-statement-increases-public-scrutiny-for-ivc-filters
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Jun 20, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on Xarelto and the ongoing controversy surrounding the drug. When Xarelto was approved by the U.S. Food and Drug Administration (FDA) in 2011, it was a widely popular blood-thinning treatment. The blood thinner drug is now, however, the focus of investigations that are looking into its initial approval stages and whether integral data obtained during clinical trials was omitted when information was sent to reputable medical journals.
In addition to these new allegations related to the clinical trials, Xarelto is also currently at the heart of over 3,000 lawsuits, with 2,800 of these being federally-filed lawsuits consolidated by the U.S. Judicial Panel on Multidistrict Litigation (JPML) to form MDL 2592 under the administrative oversight of a Federal Judge in Eastern Louisiana. In Philadelphia, PA, the Court of Common Pleas has consolidated another 600 or more cases into a mass tort program. There is an expectation that the numbers of cases in both of these groups will increase in the future.
Plaintiffs in these cases are alleging that the manufacturers of the drug, Janssen Pharmaceuticals, a subsidiary company of the Johnson and Johnson Corporation, and Bayer AG, purposefully and intentionally misled the public about the drug in its public media campaign to promote its sale. The plaintiffs also claim that Xarelto is dangerous in that it can cause instances of severe and sometimes fatal uncontrollable bleeding.
http://www.fox5vegas.com/story/32267120/xarelto-lawsuit-plaintiffs-forge-ahead-as-investigations-over-omission-of-clinical-trial-data-related-to-faulty-medical-device-begin#ixzz4CE6EqcDs
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Xarelto Lawsuit Plaintiffs Note New Evidence Of Possible Withheld Clinical Trial Data
Jun 22, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on a recently published article from Business Insider (BI) that details both lawsuits against and controversies surrounding the anticoagulant drug, Xarelto. In 2011, the FDA granted approval to Xarelto. However, according to BI, a deluge of public concern has recently swamped the courts. The outcry was largely prompted by the release of a document claiming that Bayer AG and Janssen Pharmaceuticals intentionally failed to disclose crucial data to a medical journal during clinical trials of the drug.
At first, physicians and patients embraced the new generation anticoagulant, since it required little monitoring or dosage alteration and no dietary restrictions. Doctors frequently prescribed it to individuals who had deep vein thrombosis or were at risk of pulmonary embolism. It was also approved as a preventative therapy for those with increased risk for stroke and individuals recovering from hip or knee surgery because Xarelto is designed to prevent the development of blood clots and related complications.
This warm welcome translated into more than $1.8 billion in sales for the U.S. division. However, as the article from BI indicates, prospects are now distinctly less rosy for the manufacturers of the anticoagulant. To date, lawsuits alleging grievous harm as a direct result of using Xarelto have mounted to more than 5,000. Of these, ten percent claim patient fatality.
Business Insider also cited work by Katie Thomas of the New York Times. Drawn from a footnote of a federal legal brief, there is evidence that critical data may have been intentionally withheld from a peer-reviewed article in the New England Journal of Medicine. Public concern has been compounded by the results of a clinical trial of the drug.
It was revealed that the findings were based upon a monitoring device that has since been recalled, and that this flawed blood testing device may have skewed the results in favor of Xarelto’s efficacy. Such findings have prompted both the FDA and the European Medicine Agency to conduct investigations into the legitimacy of the FDA’s initial approval.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.wave3.com/story/32287675/xarelto-lawsuit-plaintiffs-note-new-evidence-of-possible-withheld-clinical-trial-data
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Jun 22, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on ongoing investigations related to the results of clinical trials for Xarelto, a blood-thinning drug approved by the U.S. Food and Drug Administration (FDA) in 2011. One such investigation is being undertaken by European regulators related to the clinical trial conducted at the Duke Institute for Clinical Research.
As per AllGov.org, the clinical trial that European regulators are looking into relied on blood testing devices that were the subject of FDA warnings prior to the start of the clinical trial, with an FDA recall notice being issued for the device after the trial was completed. The FDA warning notice stated that the blood testing devices had the potential of reporting false negatives and that the use of said devices could cause life-threatening risks, including death.
Another issue with the clinical trial in question, according to an article in the New York Times, is that the FDA representative that initially issued the approval for Xarelto, in fact, actually expressed serious concerns over the approval, as per reports by the Project on Government Oversight (POGO). POGO reports that the approval was granted regardless of objections expressed by the primary FDA scientist that was in charge of study the drug’s safety and effectiveness. The POGO report states that the reviewer’s assessment concluded that patients taking Xarelto could be at a higher risk for stroke and/or internal bleeding than if they took warfarin, a predecessor blood-thinning drug that has been on the market since the ’50’s.
Xarelto has been the subject of lawsuits now in excess of 3,300 filed against the manufacturers of the drug, Janssen Pharmaceuticals, a subsidiary company of the Johnson and Johnson Corporation, and Bayer AG. Plaintiffs in all of the cases generally allege that the blood thinner drug put them at serious risk for sudden and potentially life-threatening bleeding, which proved fatal in many cases, for whom some family members have filed suit on their behalf.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.newschannel6now.com/story/32287679/xarelto-lawsuit-plaintiffs-continue-their-legal-battle-as-they-await-results-of-report-related-to-duke-clinical-trials
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Flaws In Research Design Come To Light As Xarelto Lawsuit Filings Grow In Number
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com comments on a recently published article from Business Insider (BI) detailing new evidence in the case against Xarelto. The FDA approved the new-generation anticoagulant from Bayer AG and the Johnson & Johnson subsidiary company, Janssen Pharmaceuticals, in 2011. However, an increasing number of lawsuits claiming increased risk of internal bleeding associated with Xarelto has drawn scrutiny from both public and official quarters.
Initially, the drug was heralded as a major breakthrough in the treatment of patients who suffered from pulmonary embolism or deep vein thrombosis. Physicians also prescribed it to those at an increased risk of stroke or patients recovering from hip and knee surgery precisely because of its purported clot prohibiting qualities. It was preferred by many over anticoagulants with a longer history of use, primarily because it did not require the intensive monitoring, dosage alteration, and dietary restrictions associated with more established drugs.
The $1.8 billion in profits drawn by the pharmaceutical giants in 2015 is overshadowed by the large number of lawsuits filed against them. BI reports that more than 5,000 lawsuits have been brought against the companies, with allegations of serious harm. Of those, a staggering ten percent allege that use of the drug caused death. According to the article, a recently released document suggests that the manufacturers of the drug knowingly withheld key data from clinical trials, thus falsifying the findings of peer-reviewed research.
esults reported to the New England Journal of Medicine were based on a subsequently recalled blood-monitoring device, according to Katie Thomas of the New York Times. If the federal legal brief from which she gleaned this information is accurate, such a revelation calls into serious question the accuracy of the reported clinical tests conducted by the manufacturers.
As the lawsuits move forward, the findings have caused both the FDA and the European Medicine Agency to delve more deeply into the matter. Reviews of the available data are expected, as well as official consideration of whether the 2011 approval of Xarelto was premature.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.fox5vegas.com/story/32297200/flaws-in-research-design-come-to-light-as-xarelto-lawsuit-filings-grow-in-number
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Xarelto Lawsuit Plaintiffs Claim Manufacturers Used Misleading Advertisements
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.comdetails the rising public concern over the safety of the anticoagulant drug, Xarelto. Following its FDA approval in 2011, it is often used to treat patients suffering from deep vein thrombosis and pulmonary embolism. Physicians also prescribe it to individuals recovering from knee or hip surgery, in order to prevent the formation of clots and to those at risk for strokes. Its popularity largely stems from the fact that, unlike other blood thinners, it does not require extensive monitoring, changes in diet, or constant dosage adjustments.
However, problems with the drug became apparent. The FDA has issued two black box warnings to Xarelto. Barring outright recall, this is the most stringent corrective action at the avail of the agency. Patients have reported that if they did not slowly reduce their use of Xarelto and replace it with an alternative anticoagulant regimen, they frequently developed blood clots. In studies subsequent to its widespread use, patients shifting from another anticoagulant to Xarelto often bled from the stomach or the eyes.
More than 3,000 lawsuits have been brought against Janssen Pharmaceuticals and Bayer AG. The Philadelphia Court of Common Pleas has combined 550 suits into a mass tort program. On an even larger scale, the U.S. Judicial Panel for Multidistrict Litigation consolidated 2,800 suits to form MDL No. 2592. In common, the plaintiffs seek reparations from the drug companies based on alleged dishonest business practices that concealed the negative features of the drug. Plaintiffs aver that the companies promoted the positive features of the drug to doctors and the public.
Additionally, the members of MDL No. 2592 claim that the companies placed individuals at a heightened risk for sudden and catastrophic bleeding events, without providing necessary product information. Four bellwether trials have been set for early in 2017. Preparation for these trials spanned from December 2015 to January 2016. Any further developments in regards to these trials will be discussed during monthly status conferences.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.wdrb.com/story/32287684/xarelto-lawsuit-plaintiffs-claim-manufacturers-used-misleading-advertisements
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As Xarelto Lawsuit Filings Continue New Evidence Surfaces Surrounding Clinical Trials
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com explores evidence detailed in an article from Business Insider (BI) that bolsters claims of an exacerbated risk of bleeding associated with Xarelto. While the new-generation anticoagulant from Bayer AG and Janssen Pharmaceuticals received FDA approval in 2011, complications with its use have led to intense scrutiny from both public and private sectors.
Initially, both patients and doctors welcomed the new-generation anticoagulant. It lacked the dietary restrictions that accompanied the old guard of blood-thinning medications and required none of the meticulous dosage adjustments or constant monitoring. Physicians prescribed it to those recovering from hip or knee surgeries and individuals with an increased potential for stroke because it acted to prevent clotting in the bloodstream. This also made it ideal for patients who suffered from deep vein thrombosis or pulmonary embolism.
Since 2011, Bayer AG and Janssen Pharmaceuticals have reaped the considerable benefits of this wunderkind, drawing $1.8 billion from the U.S. market alone in 2015. However, the mounting litigation has exceeded 5,000 individual suits, according to BI. Among those lawsuits, ten percent extend the claim of harm to that of death.
According to the article, the controversy surrounding Xarelto surged dramatically following the revelation that the manufacturers potentially falsified clinical trial data. Tests were conducted using a subsequently recalled blood-monitoring device. Katie Thomas of the New York Timesasserts that there’s also evidence that the pharmaceutical companies knowingly withheld crucial data from peer reviewers at the New England Journal of Medicine. This accusation is neither made nor taken lightly, and sets an ominous tone for future inquiries.
While the investigation is ongoing, revealed flaws in the clinical trials of Xarelto have brought official scrutiny to bear. Both the U.S. FDA and the European Medicine Agency are probing deeply into the data, as well as the role of the recalled blood-monitoring device in the integrity of the trials. Pending the results of their inquiries, it may also call into question the legitimacy of the 2011 FDA approval.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.kltv.com/story/32297198/as-xarelto-lawsuit-filings-continue-new-evidence-surfaces-surrounding-clinical-trials
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Xarelto Lawsuit Plaintiffs Allege Drug Puts Patients At Risk For Serious Bleeding Episodes
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com reports on the increased number of lawsuits regarding the blood thinner, Xarelto. Following its FDA approval in 2011, it became a popular treatment for patients suffering from pulmonary embolism or deep vein thrombosis. Physicians also used it to prevent strokes and the formation of blood clots in the legs of those recovering from knee or hip surgery. Because it did not require extensive monitoring, dosage adjustment, or changes in diet, many consumers felt it was a better choice than other anticoagulant treatments.
However, as its use became widespread, troubling symptoms developed. The FDA issued two black box warnings to Xarelto, which precede a complete product recall. Several patients reported that if they suddenly stopped using the drug or did not replace it with another anticoagulant therapy, they had a tendency to develop blood clots. Studies conducted following the first signs of alarm also showed that those switching to a Xarelto regimen from another therapy frequently developed bleeding from the eyes or stomach as a result.
Bayer AG and Janssen Pharmaceuticals are the subjects of more than 3,000 lawsuits. Due to similarities in allegations and the massive number of plaintiffs, the U.S. Judicial Panel for Multidistrict Litigation has consolidated 2,800 suits into MDL No. 2592. The Court of Common Pleas in Philadelphia, Pennsylvania has also consolidated suits into a mass tort program, comprising 550 cases.
MDL No. 2592 against Bayer AG and Janssen Pharmaceuticals alleges that the companies promoted the positive attributes of the drug, while using unsound business practices to conceal the negative side effects. Further, they claim that the companies placed individuals at increased risk for sudden and potentially deadly bleeding events.
Four bellwether trials are slated to begin in the first months of 2017. During the months of December 2015 and January 2016, there was extensive preparation for these trials. Any and all developments related to the 2017 trials will be reviewed in monthly status conferences.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
https://www.pressadvantage.com/story/10927-xarelto-lawsuit-plaintiffs-allege-drug-puts-patients-at-risk-for-serious-bleeding-episodes
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Xarelto Lawsuit Plaintiffs Note Lack Of Antidote At Time Of Drugs Release To Market
Jun 23, 2016 | TheProductLawyers.com
By Banville Law
TheProductLawyers.com announces that case selection in the mass litigation against Xarelto began earlier this year. The bellwether action brings the more than 2,200 suits represented by multidistrict litigation (MDL) 2952 before Judge Eldon Fallon, presiding in the Eastern District of Louisiana, who will determine the nature of the allegations against the new-generation anticoagulant.
Initially hailed as a breakthrough in the treatment of blood clots and attendant complications, critics now call Xarelto the most dangerous blood thinner on the market today. In many ways, the anticoagulant stood above the more established treatment options because it offered patients more freedoms than the previous blood thinners before it. Unfortunately, when Xarelto was released to the market it did not have an accompanying antidote as other anticoagulants had.
If a bleeding event occurs, the physician administering a traditional blood thinner can treat their patient with vitamin K. This reverses the drug’s impact and permits the body to clot blood. While blood clots in the circulatory system can be fatal, inability to clot a wound or internal rupture can also be deadly.
Physicians treating patients on Xarelto had to consider surgery or other drastic, life-saving measures in the event of bleeding because the impact of the drug could not be counteracted. This meant that clotting could not occur and a catastrophic bleeding episode could result in death. Xarelto was on the market for several years without a corresponding antidote, a point that many plaintiffs involved in the MDL note. Plaintiffs involved in Xarelto multidistrict litigation also allege that the drug put them at an increased risk for dangerous, uncontrollable bleeding.
While selection for the bellwether case began earlier in 2016, information about the potential issues involved with Xarelto use is becoming more widespread. This may result in additional cases being brought against the manufacturers of the anticoagulant in the coming year, as those who claim to have suffered harm while on Xarelto seek damages.
The attorneys of Banville Law, the firm behind TheProductLawyers.com, are offering complimentary consultations to anyone who suffered injury or hospitalization after a bleed while on Xarelto. For more information about this release or the Xarelto litigation call 888-997-3792.
http://www.newschannel10.com/story/32297468/xarelto-lawsuit-plaintiffs-note-lack-of-antidote-at-time-of-drugs-release-to-market
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Xarelto Lawsuit Plaintiffs Await Bellwether Trials As More Details Emerge About Clinical Trial Data
Jun 17, 2016 | The Legal Examiner
By Laurence Banville
TheProductLawyers.com reports on the surging controversy surrounding Duke University Clinical Trials for Xarelto, a new-generation blood-thinning drug manufactured by Janssen Pharmaceuticals, a Johnson and Johnson Corporation subsidiary, and Bayer AG. The clinical trial was commissioned by the manufacturers, which are now being accused of deceptive and misleading actions by knowingly allowing the omission of data related to a faulty blood testing device, thus allowing incomplete data to be sent to U.S. and European regulators. Additionally, this data was also sent to the very well-respected New England Journal of Medicine (NEJM) that made an assessment of Xarelto based upon faulty data. Subsequently, the Journal’s review of the drug, in all likelihood, contributed to the FDA approving the drug for release onto the consumer market.
A Faulty Device In The Clinical Trials
An investigation of the 2006 Duke University Clinical Trial is underway and controversy has begun to surge over its details. While reviewing the effects of Xarelto on 14,000 patients, as compared with warfarin, a preceding anticoagulant, it has been alleged that a faulty blood testing device was used that caused Xarelto to appear more effective than it really was. The reason given is that the device did not provide the patients participating in the clinical trial with a sufficient dose of warfarin. As this investigation proceeds, many other factors are emerging in relation to the data collection process.
The Allegations Surrounding The Drug
A Business Insider article has shed some light on the extent of the issues related to Xarelto. In more than 5,000 lawsuits Xarelto has been the focus of allegations claiming that the drug caused uncontrollable bleeding, along with 500 allegations of patients dying from using the drug. Plaintiffs in these cases are patiently waiting for the first bellwether trials to begin in 2017. It is expected that more cases will be filed, thus increasing the number of active lawsuits.
http://newyorkcity.legalexaminer.com/fda-prescription-drugs/xarelto-lawsuit-plaintiffs-await-bellwether-trials-as-more-details-emerge-about-clinical-trial-data/
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Couple Files Xarelto Side Effects Lawsuit
Jun 20, 2016 | Righting Injustice
By Jennifer Walker-Journey
David Rowell and his wife Rebecca are suing the makers of the blood thinnerXarelto claiming that 10 days after starting the medication David suffered life-threatening internal bleeding that left him with permanent injuries.
The Rowell’s lawsuit was filed in the U.S. District Court for the Eastern District ofLouisiana against Johnson & Johnson, its subsidiary Janssen Pharmaceuticals,Bayer Healthcare Pharmaceuticals, and their associated companies.
David Rowell claims he was prescribed and began taking Xarelto on or around June 19, 2015. On June 29, 2015, he suffered from uncontrolled bleeding. He claims the drug companies are at fault for not properly investigating, researching, studying or defining the drug’s profile and failing to adequately test or warn of Xarelto side effects.
Xarelto is an anticoagulant used to prevent strokes in patients with atrial fibrillation, to treat deep vein thrombosis and pulmonary embolism, and to prevent blood clots in patients who have recently undergone hip or knee replacement surgery. The medication is designed as a more convenient alternative to the long-used warfarin because it has far fewer food and drug contraindications. However, unlike warfarin, there is no antidote available to reverse the blood thinning effects of Xarelto in the event of a bleeding emergency.
Xarelto has been liked to gastrointestinal bleeds, rectal bleeds, brain hemorrhages and bleeding deaths. Johnson & Johnson, Janssen, and Bayer face a growing number of lawsuits alleging the companies did not adequately warn the public of Xarelto bleeding risks.
The Rowells are requesting a trial by jury and seeking compensatory damages for their pain and suffering.
http://www.rightinginjustice.com/news/2016/06/20/couple-files-xarelto-side-effects-lawsuit/
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Xarelto Lawsuit Plaintiffs Note Discovery Of Flawed Data
Jun 22, 2016 | The Legal Examiner
By Laurence Banville
TheProductLawyers.com announces new evidence disclosed in a recent article for Business Insider (BI). Bayer AG and the Johnson & Johnson subsidiary company, Janssen Pharmaceuticals, have lately been the subject of mounting litigation alleging a heightened risk of bleeding associated with their drug, Xarelto. The anticoagulant is a new-generation blood-thinner, which received FDA approval in 2011. It offered advantages over other, more established medications for the treatment of clot formation. While the public initially lauded it—because it doesn’t require extensive monitoring, dosage adjustment, and dietary restrictions—new evidence included in the BI article may prove to be fatal to that success.
What Are The Approved Uses Of Xarelto?
In 2015, the manufacturers have reaped more than $1.8 billion in profits from the US market alone. This is largely due to the multiple applications of the anticoagulant. Physicians often prescribed it to patients who suffered from deep vein thrombosis or pulmonary embolism. It was also utilized as a preventative therapy for those at greater risk for stroke or patients recovering from hip or knee surgery.
Concerns Regarding Missing Data
Drawing from an account penned by Katie Thomas of the New York Times, it appears that the manufacturers may have withheld key data from a peer-reviewed study of the drug’s performance published in the New England Journal of Medicine. It now appears that the glowing efficacy of Xarelto may have been based on a blood-monitoring device that has since been recalled, throwing those results into serious doubt.
Unresolved Issues
When paired with the more than 5,000 lawsuits that claim detriment as a direct result of using the drug, the public outcry assumes an ominous tone. According to BI, ten percent of those lawsuits also claim patient fatality as a result of Xarelto use. This massive legal response and the suspicious flaws in the Xarelto clinical data, resulted in both the FDA and the European Medicine Agency to probe more deeply and request more thorough answers. To date, although the situation remains unresolved, investigations indicate that the FDA approval may have been premature.
http://newyorkcity.legalexaminer.com/fda-prescription-drugs/xarelto-lawsuit-plaintiffs-note-discovery-of-flawed-data/
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