March 30, 2018 – Xarelto Reversal Agent Approval Will Be Delayed Pending More Trials
AndexXa is Portola Pharmaceuticals’ antidote to the blood thinner Xarelto. The company has been trying to obtain FDA approval for almost two years. The reversal agent was already denied FDA approval in 2016 and Xarelto has been without an antidote since its release in 2011. Portola had been hoping for an FDA approval by May 4 of this year but this now seems unlikely. Reports indicate that the FDA will probably require a full randomized clinical trial to be conducted before approval which would take a significant amount of time.
February 28, 2018 – New Study Suggests Aspirin May Be As Effective As Xarelto In Preventing Blood Clots After Knee Or Hip Surgery
A new study was published in the New England Journal of Medicine in which Canadian researchers conducted a clinical trial involving 3,424 patients who had had either a total hip or knee arthroplasty. They discovered when comparing the outcomes with aspirin and Xarelto that there is little difference between the two in terms of preventing venous thromboembolism events, such as a pulmonary embolism.
January 4, 2018 – Future Of Xarelto Lawsuits To Be Determined Later This Month
After mixed results from the Xarelto bellwether trials that have taken place, Judge Fallon issued a court order on December 18. The order called for parties to submit briefs by January 15 which outline how the MDL should proceed. Then oral arguments will be considered after a status conference on January 30. There are currently over 18,000 lawsuits pending in federal court regarding injuries that resulted from the side effects of Xarelto.
December 6, 2017 – First Loss For Drugmakers In Xarelto Lawsuits
After three federal cases went to the defense in Xarelto lawsuits tried in Louisiana and Mississippi, the defense suffered their first loss in Philadelphia. On Tuesday, December 5, a Philadelphia jury concluded that Xarelto manufacturers J & J and Bayer AG are responsible for the plaintiffs’ injuries connected to the anticoagulant, Xarelto. The plaintiff had suffered gastrointestinal bleeding and was hospitalized in 2014 after taking the drug for over a year. The verdict has the drugmakers jointly paying $1.8 million in actual damages and $26 million in punitive damages.
November 28, 2017 – Opening Statements Focus On Labeling In Philadelphia Xarelto Trial
On Monday, November 6, the opening statements for the first Xarelto trial in Philadelphia were made. The focus of the statements made by the plaintiffs’ attorneys was on the drug warning label and the drugmakers Janssen and Bayer’s downplaying of the risks in order to increase sales. The attorneys told the jury that the label for the blood thinner was “grossly inadequate” and that it didn’t take into account the level of risks involved with the medication. A federal multidistrict litigation has more than 18,000 cases regarding Xarelto pending across the country of which 1,500 cases are pending in Philadelphia.
October 11, 2017 – Xarelto Manufacturers Terminate Large Trial Early
When Xarelto was first released on the market in 2011 until just recently it made up more than half of the oral blood thinner market, bringing in $1.16 billion in just the first 6 months of 2016. Recently though, other anticoagulants such as Eliquis, have moved onto the market and grown in popularity and revenue. Xarelto manufacturers Bayer and Johnson & Johnson have sought to solidify their drug’s position in the market by finding positive results in clinical studies that would make Xarelto a better choice than its competitors. Yet, after a third party reviewed the clinical study NAVIGATE ESUS and stated that Xarelto would be unlikely to outperform standard of care, the manufacturers opted to end the large and expensive study early.
September 8, 2017 – New Study Results Indicate Higher Risk Of Bleeding For Vascular Disease With Xarelto Than Aspirin
A new study was recently published in the New England Journal of Medicine which suggests that Xarelto may pose a higher amount of bleeding risks for those with artherosclerotic vascular disease than aspirin. The research was designed to specifically compare the Xarelto, aspirin combination to the use of aspirin alone. The study was a double-blind clinical trial involving more than 27,000 participants and researchers looked at rates of cardiovascular death, stroke or heart attack. The results showed that there were fewer cardiovascular problems with the combination of Xarelto and aspirin but 70% more of a likelihood to suffer a bleeding event. The group that only took Xarelto had the same rate of heart problems as those that only took aspirin but suffered far more major bleeding events.
August 24, 2017 – Verdict In Third Xarelto Bellwether Trial Goes To The Defense
The third bellwether trial in the Xarelto MDL resulted in a win for the defendants last week. The lawsuit alleged that Bayer and Janssen, makers of anticoagulant Xarelto, did not give appropriate warnings regarding the risks of uncontrollable bleeding to consumers and the medical community. The plaintiff in this suit suffered acute gastrointestinal bleeding after using Xarelto for only 1 month. The federal jury in Jackson, Mississippi found that the companies were not liable for the injuries suffered by the plaintiff. There are still over 18,000 Xarelto lawsuits pending and while the bellwether trials are supposed to gauge how juries will respond to certain testimony and evidence that would be repeated through thousands of lawsuits, the outcomes are not binding for the other lawsuits.
July 14, 2017 – Thousands Of Deaths In 2016 Linked To Xarelto And Similar Anticoagulants According To New Report
Xarelto and other similar anticoagulants were indicated to have been linked to over 3,000 adverse event reports involving death in 2016 according to the Quarterwatch Report. Data in this report was released by the Institute for Safe Medication Practices (ISMP) which reviews all adverse event reports submitted to the FDA from last year. The conclusion of the report was that harm from blood thinners was the highest priority in 2016 drug safety problems. Several factors contributed to this conclusion such as the seriousness of injuries, high rate of injury, and widespread use. Of all the blood thinners examined, bleeding problems with Xarelto were the most common. There were 21,996 adverse event reports last year which involved serious injuries with anticoagulants, and 68.4% of those reports, or 15,043 reports, were linked to Xarelto.
June 29, 2017 – Second Xarelto Bellwether Trial Goes To The Defense
The second bellwether trial for the Xarelto MDL began late last month in New Orleans. The trial was a wrongful death lawsuit over a woman who died in May 2015 after suffering bleeding problems which the plaintiffs’ allege could have been avoided if the manufacturers of the anticoagulant had provided proper warnings about the possible side effects of the drug. The verdict was returned in favor of the defense in this case. The next bellwether trial is taking place this month in Mississippi and the fourth is set to begin in July in Texas.
May 1, 2017 – First Bellwether Trial Jury Selections Begin
Jury selections for the first bellwether trial in the Xarelto MDL began last week. The first trial will be for a man who took Xarelto to reduce his risk of a stroke due to atrial fibrillation and suffered a severe gastrointestinal bleed which he alleges was caused by the drug. Testimony for the case is expected to begin this week and last about 4 weeks. The second bellwether trial is scheduled to begin on May 30, and other bellwether trials will take place this summer in Texas and Mississippi.
April 4, 2017 – Xarelto Lawsuit Filed For Wrongful Death
On March 20, 2017, a complaint was filed in the U.S. District Court for the Eastern District of Louisiana. The suit was filed after a Virginia man died when he suffered an aortic aneurysm which the complaint claims was a side effect of Xarelto. The man died on January 13, 2016, after suffering the aneurysm on January 9th. He had taken Xarelto just a week prior to the incident and the manufacturers of the drug, Johnson & Johnson, it’s subsidiary Janssen, and Bayer Healthcare, are named as defendants in the complaint. The suit alleges that the manufacturers failed to adequately warn the medical community and users of the link between bleeding risks and injuries associated with Xarelto.
March 8, 2017- Xarelto Pushed By Drug Companies For Heart Attack Prevention Despite Lawsuits
Bayer Healthcare and Janssen Pharmaceuticals reported on February 8 that Phase 3 Compass clinical trials for Xarelto were stopped early because it showed great success. The trials were meant to determine if the drug could be used to prevent cardiac events in patients. The companies are currently faced with thousands of lawsuits regarding the severe bleeding side effects connected to Xarelto. Despite these suits, they indicated in a statement that they would be looking to obtain FDA approval for the anticoagulant to be promoted as a heart attack prevention drug.
February 7, 2017 – New Lawsuit Alleging Death From Drug Side Effects Joins Xarelto MDL
Another lawsuit regarding Xarelto has joined MDL 2592. The children of a deceased woman have filed suit alleging that the manufacturers failed to warn consumers, medical professionals, and the FDA of the serious, life-threatening side effects associated with the drug. In particular, these plaintiffs reference the negligence of the companies to release the anticoagulant without an antidote to reverse the effects of the drug in the case of emergency bleeding. The plaintiffs, in this case, allege that as a result of Xarelto, their mother suffered life-threatening bleeding, anemia, sepsis and kidney failure before she passed away in January of 2016. The first of the four bellwether trials for MDL 2592 is scheduled to begin in March of this year.
January 24, 2017 – Study Finds Xarelto To Be Least Favorable Among New Blood Thinners
A new study was published on December 31, 2016, in the medical journal Gastroenterology in which Mayo Clinic researchers compared the safety profiles of Xarelto, Eliquis, and Pradaxa. All of the anticoagulants looked at are fairly new and have been developed as replacements to the traditional warfarin. All three drugs have had reports of uncontrollable bleeding and complications as well as thousands of lawsuits claiming injury or wrongful death. Researchers found in the population-based study that Xarelto had higher bleeding rates than the other two anticoagulants studied and it was the least favorable. Drugmakers are still seeking a reversal agent for Xarelto which would make it much safer.
December 2, 2016 – Woman’s Suit Added To Xarelto Litigation
A woman filed a complaint on November 14 against numerous defendants, including Bayer AG, in Cook County Circuit Court. The plaintiff alleges that due to her use of the anticoagulant, Xarelto, she suffered severe physical injuries. Her complaint also alleges that the defendants who manufacture and distribute the drug were responsible for her injuries because they failed to warn consumers of the possible side effects of the drug. The plaintiff seeks compensation greater than $50,000.
November 7, 2016 – Bellwether Selection Process Determined For Philadelphia Xarelto Mass Tort Program
The Philadelphia mass tort program consists of about 1,000 pending Xarelto lawsuits which are similar to the over 7,000 Xarelto lawsuits consolidated in an MDL in the Eastern District of Louisiana. A judge recently ruled how bellwether cases will be selected for trial. Selection of bellwether trial cases will begin in the summer of 2017 and a total of 24 cases will be selected. Trials are scheduled to begin in September and December of 2017. Bellwether cases for the Louisiana MDL have already been selected and are scheduled to begin in early 2017.
October 6, 2016 – Higher Bleeding Risk Found With Xarelto When Compared To Pradaxa
According to study findings published in the journal JAMA Internal Medicine, Xarelto has a “slight increased risk of bleeding” in comparison to Pradaxa in patients with atrial fibrillation. For the study which was conducted at the FDA’s Center for Drug Evaluation and Research, data was collected on close to 119, 000 Medicare patients with atrial fibrillation treated with either Xarelto or Pradaxa. Little difference was found in stroke risk but a statistically significant increase of stomach and brain bleeding was found in patients taking Xarelto.
September 19, 2016 – Judge Fallon Extends Deadline To File Xarelto Lawsuits Another 90 Days
In mid-August, weeks after the bellwether cases were selected for trial in the MDL, a deadline extension of 90 days was allowed for some plaintiffs to file Xarelto lawsuits. Judge Fallon explained that the extension was made due to the high influx of complaints seen by the clerk’s office. The first bellwether trial is scheduled to occur in February and there are currently over 7,000 lawsuits consolidated in the MDL. Meanwhile, in Philadelphia, the first trials in the mass tort program are expected to begin next year, in August, as a bellwether program is being negotiated.
August 19, 2016 – Trials For Xarelto Litigation Have Been Selected And Scheduled
Judge Eldon Fallon, who is overseeing the Xarelto MDL 2592, has indicated that four cases will be going to trial starting in February of next year. These four cases are part of the bellwether trials selected in order to streamline the litigation which is now comprised of over 6,400 lawsuits. The first trial will include plaintiffs who originally filed in Louisiana and suffered a bleeding event while between the ages of 50 to 90 years old. The second trial will have plaintiffs who suffered a brain bleed, a stroke, or an injury that resulted in death. The third trial will include plaintiffs who filed in Mississippi originally, suffered gastrointestinal bleeding, and were between the ages of 40 to 80 years old when the event occurred. The fourth trial will take place in Texas involving a bleeding event.
April 14, 2016- Xarelto Litigation Plaintiffs Band Together To Jointly File A Lawsuit
A group of 10 Xarelto litigation plaintiffs from various states have banded together to jointly file a lawsuit. The reason they are doing this is due to the resemblances in their allegations towards the adverse results, mainly death, suffered from using Xarelto. Those filing this litigation are groups of family members who represent deceased loved ones, who died due to serious medical complications they had while using Xarelto. The lawsuits were jointly filed on November 20, 2015.
March 16, 2016- Xarelto Bellwether Cases Due To Be Chosen
A total of 40 cases are set to be chosen for the Xarelto bellwether pool, this is by order issued by U.S. District Judge Eldon Fallon. Selection of the cases will be made with each side choosing 10 cases and a further 20 cases that will be selected randomly. In December 2014, Xarelto lawsuits were combined into a multi-district litigation (MDL).