Thousands of patients and their loved ones say Xarelto is an unreasonably dangerous drug. The popular blood thinner has been linked to higher rates of gastrointestinal bleeding and major bleeding events than traditional anticoagulants.
- More than 18,000 Xarelto bleeding lawsuits
- Patient injuries and wrongful death
- No available reversal agent
If you or a family member suffered severe injuries after being prescribed Xarelto, contact our experienced personal injury attorneys now for a free consultation.
We believe thousands of patients and families are still eligible to file Xarelto lawsuits.
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Bayer’s blockbuster blood-thinner Xarelto may be more dangerous, and less effective, than traditional treatment options like warfarin. While the drug was marketed as a revolutionary alternative for patients at risk for blood clots, Xarelto has been linked to severe side effects, including an increased risk for serious internal bleeding.
Here’s Why Patients Are Filing Xarelto Lawsuits.
Thousands of Xarelto lawsuits have already been filed. In fact, as of October 2017, nearly 19,000 patients and families have filed suit against Bayer and Johnson & Johnson-subsidiary Janssen Pharmaceutical, the drug’s co-marketer in the United States. In their complaints, patients and their loved ones claim the drug’s manufacturers failed to notify us of the blood thinner’s risks.
Crucially, Plaintiffs say Bayer and Janssen downplayed the fact that Xarelto was approved without an antidote to reverse its blood thinning effects. Warfarin, an anticoagulant that has been used for more than 60 years, can be quickly reversed in emergency situations, or prior to surgery. Xarelto does not share the same distinction, which makes the blood thinner far more dangerous, on a practical level, than traditional anticoagulants, patients argue.
Most of the cases involve severe internal bleeding events in patients who took Xarelto for only several months. Tragically, many of the lawsuits have been filed by surviving loved ones, on behalf of deceased spouses for whom bleeds were uncontrollable. Gastrointestinal bleeding seems to be particularly common, but numerous claims have also been filed in relation to intracranial hemorrhage, in which blood pools between the brain and skull.
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Internal Bleeding: How High Is The Risk?
Xarelto’s approval for atrial fibrillation (AFib) was based on a major clinical trial called ROCKET AF. At issue were the potential benefits and risks Xarelto poses in comparison to warfarin. This is crucial to understand. In order to judge whether a drug should be approved, medical researchers need to measure its effects against a baseline. In ROCKET AF, that baseline was warfarin, a drug that has effectively reduced blood clot risks for decades.
The question? Whether or not Xarelto worked better than warfarin. The answer? It’s complicated. Across 3 key measures, Xarelto fared far worse than warfarin. For the 14,264 patients entered in the study, Xarelto caused more:
- Major bleeding events of all types
- Gastrointestinal bleeding
- Bleeding incidents that required a blood transfusion
But in relation to cerebral hemorrhage, fatal bleeding events and bleeding in “critical anatomical sites” (major organs), Xarelto was judged the safer option. As we said, it’s complicated.
Was Crucial Study Marred By Errors?
However, the results of ROCKET AF have been called into question by numerous experts, including one of the three FDA reviewers who scoured the study’s data.
Among ROCKET AF’s published findings was that Xarelto is just as effective as warfarin at preventing strokes in patients with atrial fibrillation. Was that true? One of the FDA’s own reviewers disputed that finding, critiquing the study’s administrators for improperly prescribing warfarin to many patients. The amount of warfarin prescribed to control patients was inconsistent, the researcher says, which makes it impossible to evaluate the study’s results. While the reviewer argued against approving the drug, Xarelto was eventually cleared to reduce the risk of stroke in patients with AFib.
A follow-up study, funded by Bayer and published in the journal Clinical Cardiology, came to similarly mixed conclusions about the side effects of Xarelto. More recently, a 2015 study published in the British Medical Journal was unable to rule out a “more than twofold higher risk of [gastrointestinal] bleeding with rivaroxaban [Xarelto’s active ingredient] compared with warfarin.” That’s perfectly consistent with the initial results of ROCKET AF, which found that Xarelto patients are more likely to suffer GI bleeds.
Wound Complications: Another Side Effect Identified
More legal trouble may lie in wait for Bayer and Johnson & Johnson.
In 2012, physicians early to adopt Xarelto for patients with deep vein thrombosis noticed an increased risk of wound complications after knee and hip implants. Severe infections and leakage were landing their patients right back in the hospital shortly after surgery.
British researchers followed up on these warning signs, tracking the progress of thousands of patients after they received knee or hip implants. Patients taking Xarelto were at a much higher rate for wound complications than those taking heparin, a traditional blood thinner.
There’s Still No Way To Stop Bleeding.
As we’ve seen, Xarelto causes more major bleeding events than warfarin. But in the minds of plaintiffs, that’s only the beginning of the drug’s risks.
What all the clinical trials have failed to take into account, and what patients say is of primary importance, is that Xarelto has no antidote. Through a quick injection of vitamin K, or infusion of donor plasma, warfarin’s anticoagulant effect can be reversed. That’s a lifesaving option, both for patients about to undergo surgery or those who have suffered a traumatic accident and require emergency medical attention.
Xarelto doesn’t offer that option. While San Franciso’s Portola Pharmaceuticals has worked tirelessly to create an antidote for the drug, the company’s solution, AndexXa, was denied approval by the FDA, Fierce Pharma reports. That leaves Xarelto patients and their physicians with no way of controlling serious bleeds, and makes the drug a far risker choice than warfarin, according to Xarelto lawsuits.
How MDL Will Change Things
In 2014, the explosion of early legal action involving Xarelto became so pronounced that a federal panel of judges decided to take action. On December 17, 2014, the Judicial Panel on Multi-District Litigation officially transferred dozens of Xarelto lawsuits from courts across the country to Louisiana.
The pace of the Xarelto litigation saw a stunning increase after that. Between January and December of 2015, the number of filed Xarelto lawsuits grew by a factor of 2,650%, from only 80 to more than 2,200.
The lawsuits are now consolidated in the US District Court for the Eastern District of Louisiana. Today, upwards of 18,600 Xarelto lawsuits are pending in New Orleans, where the cases have gone through pre-trial proceedings together, including the all-important stage of discovery, in which evidence is gathered.
Is This A Class Action?
Multi-District Litigation, or MDL, is a different way of handling multiple lawsuits that involve similar allegations. In a class action, one “representative” plaintiff files suit on behalf of other people who have been harmed in the same way. But none of those other plaintiffs have any control over the case. In fact, most won’t even know that it’s been filed until they’re notified of a resolution.
MDL begins differently, with multiple individual plaintiffs filing their own personal injury lawsuits in different courts across the country. Multi-District Litigation allows these people to come together, in a central court, to work alongside one another in preparing their cases. But none of those lawsuits are “lumped together”; they’re still independent legal actions.
After pre-trial proceedings, the cases can be remanded (sent back) to their original courts to go to trial.
MDL Can Impact Settlement Negotiations
Multi-District Litigation allows multiple plaintiffs to benefit from sharing their resources, while also allowing them to maintain control over their own cases. It could also increase the likelihood of Xarelto lawsuit settlements.
How? The answer often comes in the form of bellwether trials. These are real trials, scheduled by the federal judge presiding over the MDL, that help plaintiffs and defendants better understand where they stand. In the Xarelto MDL, Judge Eldon Fallon has slated 40 bellwether trials to proceed to trial before all of the others. The results of these trials will go to inform settlement negotiations.
Have Any Bellwether Trials Been Held Yet?
Yes. Federal juries in Mississippi and Louisiana have now heard three bellwether trials from the Xarelto MDL. In each of these cases, the jury has found in favor of Bayer and Johnson & Johnson, holding that neither company lied to the public about the blood thinner’s risks. No plaintiff, at this point, has been awarded financial compensation for their alleged injuries.
These initial losses, however, are not a reason to despair. 37 bellwether plaintiffs are still awaiting their day in court and no one can predict how these future cases will proceed, especially given the valuable lessons plaintiffs’ attorneys have learned from their defeats.
It’s also important to remember that almost 19,000 Xarelto lawsuits have already been filed. Are Johnson & Johnson and Bayer prepared to litigate each one of these cases individually? Most legal experts would call that possibility extremely unlikely, simply because taking each lawsuit to trial would be very expensive. But that’s exactly what they would have to do, since this isn’t a class action. What, then, are the defendants’ other options? Either they can find a formidable legal argument and have all the cases dismissed at once or they can settle the remaining actions. We’ll just have to wait and see how this litigation moves ahead.
What Is Xarelto?
Xarelto is an oral anticoagulant manufactured by Bayer and the Johnson & Johnson subsidiary Janssen Pharmaceuticals.
Approved in 2011 to prevent blood clots in patients after hip and knee replacement surgeries, its approval was extended to cover patients with atrial fibrillation, or AFib, an irregular heart rhythm.
How Does It Work?
Blood only clots inside the body after a series of chemicals have undergone numerous transformations. This series is called the “coagulation cascade,” and it begins with little fragments of blood cells known as platelets.
After an injury to a blood vessel, platelets swarm the wound, effectively blocking blood flow. But they won’t stay there of their own accord. To form a complete clot, the platelets need to bind together somehow. Good thing blood clotting factors, a number of chemicals, are also being produced near the wound to get the job done.
One blood clotting factor in particular, thrombin, is especially important to this process. Thrombin takes a chemical called fibrinogen, which is usually dissolved in the blood, and turns it into fibrin. Once activated, fibrin creates strands that wrap around the forming blood clot, holding the platelets together.
This is where Xarelto comes in. The drug’s active ingredient, rivaroxaban, interrupts the cascade. Binding to a clotting factor called factor Xa, Xarelto stops thrombin from being formed in the first place. Without thrombin, there’s no fibrin, and thus no blood clot.
One Dose For All: The Promise
Bayer and Johnson & Johnson have made a number of claims about Xarelto’s safety and effectiveness. The companies say their drug is both safer and more effective at preventing blood clots than warfarin, the industry standard blood thinner.
We’ve already covered the evidence that calls those claims into question. But Xarelto’s manufacturers relied on another marketing line to promote the drug.
Warfarin is effective, but like all blood thinners it presents a risk of excessive bleeding. In order to reduce this risk, doctors have to be extremely careful. Physicians monitor patients on warfarin regularly, making sure that its blood clotting effect doesn’t get out of control. That can be a pain for patients, who also have to watch their eating habits closely.
Xarelto, on the other hand, doesn’t require frequent monitoring. In fact, its manufacturers have labeled it a “one size fits all” option for patients at risk of blood clots. That distinction was a huge plus, one that allowed Bayer and Johnson & Johnson to capitalize on an anticoagulant market estimated to be in the tens of billions.
Latest Xarelto News
By Laurence P. Banville
February 28, 2018 – Aspirin May Be As Effective As Xarelto In Preventing Blood Clots After Knee Or Hip Surgery According To Study
In order to prevent blood clots after hip or knee replacement surgery, patients may be prescribed a blood thinner such as Xarelto. A new study was published in the New England Journal of Medicine in which Canadian researchers found that there is little difference between the safety and efficacy of aspirin and Xarelto when used after knee or hip surgeries to prevent venous thromboembolism events.
January 12, 2018 – Pennsylvania Judge Overturns Xarelto Verdict
A recent Xarelto bellwether trial resulted in a jury verdict of $28 million to the plaintiff who suffered severe gastrointestinal bleeding as a side effect of using the anticoagulant. The trial was held in Pennsylvania but this week a PA judge overturned the verdict. The judge did, however, find that there was enough evidence to have the drug manufacturers, Bayer and Johnson & Johnson, pay the punitive damages. The results of the bellwether trials do not determine the outcomes of the other trials but could influence possible Xarelto settlements.
December 6, 2017 – Xarelto Manufacturers Suffer First Loss In Philadelphia Trial
Bayer AG and Johnson & Johnson, manufacturers of the blood thinner Xarelto have just suffered their first trial loss in the Xarelto litigation. On Tuesday, December 5, a Philadelphia jury has ordered the drugmakers to pay $1.8 million in compensatory and $26 million in punitive damages after an Indiana woman suffered gastrointestinal bleeding linked to her year-long usage of Xarelto. Both companies plan to appeal the verdict and have previously won 3 other federal Xarelto cases in Louisiana and Mississippi.
November 6, 2017 – New Dosage Of Xarelto Approved By The FDA
On October 30, Janssen Pharmaceuticals announced that the FDA approved the company’s 10 mg once daily dose of Xarelto for the treatment of those at risk of Venous Thromboembolism (VTE). This approval was based off of data from Einstein Choice, a clinical study which was the only study to find Xarelto superior to aspirin in reducing the risk of VTE.
October 11, 2017 – Large Xarelto Study Ended Prematurely By Manufacturers
Xarelto used to make up over half of the oral blood thinner market just a few short years ago but recently competitors, such as Eliquis, have taken some of that business. Xarelto manufacturers Johnson & Johnson and Bayer were looking for positive results in clinical studies to use against competitors. The companies decided to end a large study entitled NAVIGATE ESUS when a third party reviewed it and found that Xarelto was unlikely to outperform standard of care. These types are studies are extremely expensive and the companies are still dealing with lawsuits regarding bleeding events and Xarelto.
September 7, 2017 – Third Xarelto Bellwether Verdict Goes To The Defense
Last month a federal jury in Jackson, Mississippi determined that the makers of the anticoagulant Xarelto were not liable for injuries suffered by the plaintiff, who had suffered acute gastrointestinal bleeding after 1 month of drug use. The lawsuit is the third bellwether trial in the Xarelto MDL which still has over 18,000 lawsuits pending in courts across the country. These lawsuits all similarly allege that the makers of the drug did not adequately warn consumers or the medical community of the risks of uncontrollable bleeding when taking the blood thinner. The bellwether trials are meant to gauge how juries will respond to certain testimony or pieces of evidence that would be repeated in thousands of lawsuits yet the outcomes of the bellwether trials are not binding in the other suits.
August 4, 2017 – Xarelto And Similar Anticoagulants Linked To Thousands Of 2016 Deaths
The QuarterWatch Report was released by the ISMP on Wednesday, July 12. This report outlines the group’s annual review of all adverse event reports from the previous year that were submitted to the FDA. The report indicates that Xarelto and other similar blood thinners have potentially serious risks associated with them, having been linked to over 3,000 deaths in adverse event reports. In 2016 the FDA received a total of 21,996 reports of severe injuries related to anticoagulants and the report indicates that harm from blood thinners is the highest priority drug safety problem for 2016. Out of all the injuries related to anticoagulants 68.4% or 15,043 were linked to Xarelto.
July 7, 2017 – Despite Bleeding Lawsuits Low-Dose Version Of Xarelto Considered
Johnson & Johnson subsidiary, Janssen, continues to face thousands of lawsuits alleging their anticoagulant, Xarelto, caused users to suffer life-threatening uncontrollable bleeding. Despite these ongoing suits, the company announced plans in a June 28 press release to release a low-dose version of the drug which would be marketed as a once-daily 10mg version of Xarelto. The FDA has granted priority review to this new version of the drug, which means that it shortens the review period for the drug from 10 months to 6 months based on the assumption that it would have significant health benefits.
June 29, 2017 – Verdict Goes To The Defense In Second Xarelto Bellwether Trial
The second Xarelto MDL bellwether trial ended with the verdict going to the defense. The case in this trial was a wrongful death suit filed by the family of a woman who died in May 2015 after suffering bleeding problems. The family claimed these problems could have been avoided had the manufacturers of the blood thinner provided adequate warnings of the possible side effects of the drug. The third bellwether trial is taking place this month in Mississippi and the fourth is set to begin in Texas in July.
May 17, 2017 – Woman Filed Xarelto Lawsuit Alleging Side Effects Caused Hematuria
A new Xarelto lawsuit was filed earlier this month in the U.S. District Court for the Eastern District of Louisiana. While bellwether trials have already begun for the Xarelto MDL, new lawsuits continue to be filed alleging individuals who used the drug suffered serious life-threatening bleeding situations due to the side effects of the anticoagulant. This lawsuit states that the plaintiff took Xarelto from Dec. 2013 to Sept. 2016 when she suffered hematuria. The suit alleges that Bayer and Janssen, a Johnson & Johnson subsidiary, failed to warn the medical community and consumers of the potential side effects of the drug. This lawsuit will be consolidated with the federal Xarelto litigation.
April 18, 2017 – Woman Files Xarelto Lawsuit Alleging Injuries From Side Effects
A New York woman filed a Xarelto lawsuit in the U.S. District Court for the Eastern District of Louisiana on April 7. The suit alleges that the defendants, Janssen Pharmaceuticals, and Bayer Healthcare, failed to warn consumers of the potential side effects of Xarelto. According to the complaint, the plaintiff suffered anemia and a severe upper gastrointestinal bleed which she claims was directly caused by her use of the anticoagulant. She began taking Xarelto in April 2013 and continued use until March 2015. She suffered her injuries in July 2013. The case is very similar to about 15,000 others which it will join in the MDL located in New Orleans.
March 14, 2017 – New Xarelto Study Results To Be Presented At ACC Meeting
Makers of the anticoagulant Xarelto, Janssen Pharmaceuticals, announced in early March with development partner Bayer, that the company will present new research on the drug at the American College of Cardiology’s 66th Annual Scientific Session. The meeting will take place in Washington D.C. from March 17-19, 2017. Results from the Phase 3 Einstein Choice study and Phase 2 Gemini-ACS-1 study will be presented. Both of these studies were part of the EXPLORER clinical research program for Xarelto.
February 13, 2017 – Heart Attack Prevention Could Be A New Use For Xarelto In The Future
Bayer Healthcare and Janssen Pharmaceuticals, the makers of the anticoagulant Xarelto, reported on February 8th that the third phase of clinical trials was completed. The Compass trials were designed to test if Xarelto could be effective in preventing cardiac events. These trials, according to the companies’ press release were stopped because they reached the pre-specified criteria needed to prove effectiveness. It also indicates that the companies would like to seek FDA approval to promote the drug for such use. There are currently still thousands of lawsuits connected to Xarelto pending in federal court.
January 31, 2017 – Study Finds Xarelto Least Favorable Of New Anticoagulants
A new study was published in the medical journal Gastroenterology in which researchers from the Mayo Clinic studied and compared Xarelto, Pradaxa, and Eliquis’ safety profiles. All of these anticoagulants are new drugs which have been introduced fairly recently as replacements to the traditional blood thinner, warfarin. There have been many lawsuits filed against the manufacturers of all three drugs alleging personal injury and/or death as well as reports of uncontrollable bleeding and complications for all three. After conducting the population-based study researchers found that Xarelto had higher bleeding rates than Pradaxa and Eliquis and it was least favorable. There is still no reversal agent for Xarelto. Drugmakers are actively working to obtain an FDA-approved reversal agent, which would make the anticoagulant much safer.
December 29, 2016 – Doctors Have Concerns With Proposed Xarelto Reversal Agent
A recent edition of The England Journal of Medicine included letters to the editor in which doctors cautioned people from getting too enthusiastic over the proposed reversal agent, andexanet alfa, for the anticoagulants Xarelto and Eliquis. The antidote was already submitted for FDA approval but it failed to gain it. The FDA stated that additional information was needed about the manufacturing of the drug, and now some doctors are calling for placebo-controlled trials to give a better assessment of the drug’s efficacy. Drug makers are seeking an antidote for these anticoagulants especially since both Xarelto and Eliquis are at the center of many product liability lawsuits against the manufacturers which allege that the drugs caused consumers to suffer injury or death from their side effects.
November 22, 2016 – Xarelto Lawsuit Filed In St. Clair County Circuit Court
A man filed a lawsuit on September 1st in St. Clair County Court which alleges that after using the oral anticoagulant, Xarelto, the plaintiff suffered injury. The suit goes on to claim that the creators falsely advertised the drug, misleading the public to believe it was safer than it actually is. The suit also claims the plaintiff was not made aware of the dangerous side effects that could occur, especially since the drug was not released with an antidote for emergency bleeding situations, which caused him to suffer life-threatening damages.
October 19, 2016 – Xarelto Cleared By FDA Despite Faulty Trial Device
The INRatio device used during the Rocket-AF study, which compared warfarin and Xarelto, was recalled due to the potential for it to show inaccurate results. The recall caused great concern for many who questioned the FDA approval of Xarelto and it’s effectiveness. The FDA analyzed the impact of the device on the study in a variety of ways and posted a statement on their website stating “The Agency has determined that effects on strokes or bleeding, including bleeding in the head, were minimal.”
September 26, 2016 – Extension To File Given To Xarelto Victims
Judge Eldon Fallon gave a pretrial order on August 18, which extended the filing deadline an additional 90 days for certain plaintiffs intending to join the Xarelto MDL. Judge Fallon explained that this order was given due to the overwhelming number of recently filed lawsuits that have inundated the clerk’s office. Xarelto manufacturers are currently facing over 7,000 lawsuits with much more expected to join in the litigation. The bellwether trials have already been selected and scheduled to begin in early 2017 for the MDL and the Philadelphia mass tort program’s first trials are scheduled to begin August 2017.
August 12, 2016- Over Five Thousand Lawsuits Consolidated In Xarelto Litigation
Xarelto plaintiffs are waiting to see if a bellwether trial will be heard for Xarelto considering that nearly 6,000 lawsuits have been consolidated for pretrial proceedings. More lawsuits are being filed regularly. Bellwether cases will set the tone for future Xarelto litigation. The Judicial Panel on Multi-District Litigation stated that as of June 15, 2016, over 5,853 lawsuits were consolidated for pretrial proceedings in MDL 2592.
July 6, 2016- Xarelto Clinical Trial Likened To Science Fair Project
When the first Xarelto trials begin in Philadelphia courtrooms, one of the key issues likely to be considered is the quality and depth of the clinical trials. The first trial of over 800 lawsuits is expected to start next year. Attorneys representing Xarelto victims disagree with the drug’s manufacturers over the trials conducted before the drug was approved by the Food and Drug Administration (FDA). The drug trials were called “a total mess” and likened to a school science fair project by a Philadelphia medical malpractice attorney.
June 3, 2016- Man Claims Xarelto Usage Caused His Heart Attack
A man from St. Tammany Parish has alleged that Xarelto he used to treat deep vein thrombosis, as well as other medical problems, caused him to have a heart attack. The man filed a complaint against Janssen Research & Development LLC, Janssen Ortho LLC, Jansen Pharmaceuticals Inc., Bayer Healthcare Pharmaceuticals Inc., et al. stating, among other things, product liability and breach of express warranty. The complainant alleges that he used Xarelto from February 2015 up until, possibly, May 2015 and this caused him to suffer a life-threatening heart attack on May 15, 2015.
May 31, 2016- Xarelto Lawsuits Increase Despite Rapid Sales
Johnson & Johnson and Bayer’s blood thinner drug Xarelto is continuing to post high sales figures, despite the increase in the number of people filing lawsuits against the makers of the drug. Thousands of people who have filed claims against J & J and Bayer have stated that the drug makers did not disclose the danger of uncontrolled bleeding and had misleading advertising.
May 26, 2016- May 20 Deadline Reached For Xarelto Multiple Parties Lawsuit Filing
May 20, 2016, marked the deadline for filing joint Xarelto lawsuits. The U.S. District Judge ruling over all federal Xarelto lawsuits indicated that the filing of joint litigations involving multiple plaintiffs will no longer be applicable after May 20. What this means is that each person who experienced the adverse side effects linked to Xarelto usage will have to file a separate lawsuit in the federal Multi-District Litigation (MDL).
April 29, 2016- Man From Pennsylvania Claims Xarelto Usage Caused Injuries
A Xarelto lawsuit was filed on April 8, 2016, in the U.S. District Court for the Eastern District of Louisiana against the makers of the drug Xarelto, by a man from Pennsylvania who states that the drug caused him injuries. The plaintiff alleges that he started using the drug at his physician’s recommendation, but he ended up experiencing gastrointestinal bleeding, rectal bleeding, and anemia which caused him to be hospitalized. The plaintiff holds the defendants responsible for the pain and anguish he also suffered due to this drug, and for their failure to thoroughly investigate this drug.
March 3, 2016- Xarelto Manufacturers Allegedly Deceived A Prestigious Medical Journal
The makers of Xarelto have once again come under scrutiny for allegedly misleading editors of the New England Journal of Medicine about the real side effects of their drug. It is believed that Johnson & Johnson and Bayer remained silent when a letter was published in the New England Journal Of Medicine, written by Duke University researchers, that did not include critical laboratory information.
February 26, 2016- 3,000 Xarelto Lawsuits Filed In Just Five Years
From the time Xarelto was approved by the Food and Drug Administration (FDA) there have been over 3,000 lawsuits filed in connection with the drug’s adverse effects. In the Eastern District of Louisiana, the judge overseeing a multi-district litigation has chosen four bellwether cases that are due to go on trial starting February 2017.
February 4, 2016- New Questions Emerge Over Xarelto Clinical Trial
There have been new questions that have emerged about the Xarelto clinical trial. An independent investigation is being called for, following findings that a medical device that was used during the initial study was actually faulty and later recalled. U.S. and European drug regulators are finding out more information about whether or not a defective blood clotting test device may have affected Bayer’s Xarelto trial. It is believed that the device’s defect may have affected the clotting results in some patients when compared with the other blood thinner Warfarin.