More and more cases continue to be filed involving Xarelto®, the Janssen pharmaceutical blood thinner that has been found to result in serious side effects and in some cases even death. Xarelto® first came to market in 2011 as a competitor to existing blood-thinning drugs such as warfarin. The drug focused on patients with deep vein thrombosis and pulmonary embolism or for those recovering from hip or knee surgeries. Later, the drug’s use extended to stroke prevention. Over 13,000 patients have been prescribed Xarelto®.
While this drug received FDA approval, Xarelto® may result in uncontrollable bleeding that has no antidote. The only way to stop the symptoms from Xarelto® is for the drug to leave the individual’s system. Xarelto® does not even have to be used for an extended period of time before it has its devastating results. For some, the uncontrollable bleeding appeared after only 10 days of using Xarelto®.
As of July 15, 2016, there were an estimated 6,457 lawsuits consolidated for pretrial proceedings in MDL 2592. All these claims share the similarity that the plaintiff experienced uncontrollable bleeding after taking Xarelto. Plaintiffs claim the Xarelto manufacturers failed to properly warn patients about the risks for gastrointestinal and cranial bleeding when the drug is taken daily. Judge Eldon Fallon recently issued case management orders describing the criteria for the bellwether cases. The defendants and plaintiffs are each asked to select ten cases from the claims filed. In addition, there will be twenty more randomly selected cases heard from the same pool for a total of forty cases heard regarding the drug, Xarelto. The first two Bellwether cases have been scheduled in the Eastern District of Louisiana for February 6, 2017 and March 13, 2017. The final two trials will be heard on April 24, 2017 and May 30, 2017.
Since the indication that Xarelto may lead to fatal side effects, both doctors and researchers have conducted numerous studies on the drug. One study looked at numerous anticoagulants and their effects on patients. This study is especially noteworthy because it used a sample size of 46,000 patients when making observations. The result concluded that there was as much as a twofold (100%) increase in the risk of gastrointestinal bleeding compared to Xarelto’s competitor, Warfarin.
In February, concerns rose that the initial testing of Xarelto by the manufacturer may have been false. The device, INRatio, used to test for blood clotting during the clinical trial was faulty and has actually been recalled by the manufacturer in December, 2014. The medical device produced falsely low results in regards to the risk of blood clots. This device flaw may have skewed the study results, resulting in Xarelto appearing safer than warfarin as a blood-thinner. A comparison of blood samples of more than 5,000 patients found that 35% of the time INRatio readings were clinically significant in difference from the results received from the central laboratory test.
Even with these new results regarding the drug, Janssen Pharmaceuticals still stands by their product. Xarelto now has two black box warnings issued by the FDA on its label, which is the strictest warning level before drug recall. Instead of trying to appeal to doctors who have rising concerns about the drug, Janssen Pharmaceuticals has chosen to invest hundreds of millions of dollars in advertisement so that Xarelto is a household name among patients. Doctors are more likely than not to prescribe a drug specifically requested by the patient for treatment. Thus, as long as patients keep hearing about Xarelto from advertisements, the more often the drug will be prescribed.
If you have taken Xarelto and have experienced bleeding, you may have a claim. Attorneys at Keane Law LLC can ensure you receive the justice you deserve. Contact us today for a free consultation.