Articles Tagged with bleeding

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Xarelto MDL Louisiana federal courtAfter more than three years of litigation, and with no settlement agreement in sight, Judge Eldon Fallon has issued a court ruling to move hundreds of cases along in the next several months. Just to recap, the federal court in Louisiana was chosen as the multi-district litigation (MDL) site for plaintiffs filing lawsuits for injuries suffered after taking the blood-thinning drug Xarelto. In 2017 Janssen, Bayer and Johnson & Johnson, manufacturers and sellers of Xarelto, won three “bellwether trials” in this MDL, which you can read about here. Nevertheless, studies and evidence show Xarelto can cause uncontrollable bleeding in patients, and there is no available antidote once the bleeding starts. But with the defense winning three cases last year, the drug companies have (so far) not been willing to agree to a global settlement of the remaining 21,000+ cases. In an effort to wind down the litigation and encourage settlement, Judge Fallon has chosen to move things along:

Case Management Order No. 6

On February 27, 2018, Judge Fallon issued Case Management Order No. 6 (CMO No. 6) in the Xarelto MDL. This Order sets out the procedure for the selection of 1,200 Xarelto cases over the next six months. These cases will enter rigorous individual discovery and will be prepared for trials in the plaintiffs’ home districts. Among other things, the plaintiffs chosen in these 1,200 cases will be responsible for completion of an extensive “Plaintiff Fact Sheet,” which is essentially a comprehensive questionnaire on all salient facts about the Plaintiff, the Plaintiff’s use of Xarelto, the injuries suffered, and other relevant information. The defendants will also have to submit a “Defendant Fact Sheet.”

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Third Xarelto Bellwether Trial
Last Friday in the third Xarelto bellwether trial, a jury in Jackson, Mississippi reached a verdict in favor of defendants. The defendants have now won three straight Xarelto bellwether cases. Plainly, the defense has had a good year. But remember, the MDL judge and the executive committees selected 40 cases for discovery and consideration as bellwethers, not three. As I tell my daughter when she comes home after the third day of school and announces she doesn’t like her teacher: “It’s too soon to have an opinion. Give it more time.”

Let’s take a look:

Third Xarelto Bellwether Trial  

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On June 12, 2017, a jury in New Orleans reached a verdict in favor of defendants in the second Xarelto bellwether trial. This verdict follows a defense verdict in the first bellwether trial. Let’s take a closer look.

The Second Xarelto Bellwether Trial  

Neoplastin PT Blood Test for Xarelto PatientsTo recap briefly, Xarelto (rivaroxaban) was first approved by the FDA for sale in 2011. As an anticoagulant, it was supposed to prevent pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and other serious conditions. And it was easier to take than warfarin. In studies, however, Xarelto caused a higher rate of complications from internal bleeding; but unlike other anticoagulant drugs, there is no “antidote” for stopping internal bleeding in patients. People bleed and often can’t stop bleeding.

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A new study published in December 2016 has shed more light on the potential dangers of taking direct oral anticoagulant (DOAC) drugs, and in particular, the drug Xarelto (rivaroxaban).

First a Little Background on Xarelto

New Xarelto StudyXarelto was first approved by the FDA for sale in July 2011. It was supposed to represent a major advancement in blood thinning (anticoagulant) medication. Xarelto was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anticoagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. Xarelto was also intended to help those patients with atrial fibrillation, a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE, DVT and atrial fibrillation.

In studies, however, Xarelto appeared to cause a higher rate of internal bleeding. And while other anticoagulant drugs may also cause internal bleeding, it appears there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. With warfarin, vitamin K has been shown to stop bleeding. But there is no vitamin K “parallel” for people taking Xarelto. For Xarelto, it can take 24 hours for a dose to get out of the body. That means that if internal bleeding starts, the patient may simply have it wait it out and hope it stops on its own.

Now a new study indicates that Xarelto causes more internal bleeding than other leading anticoagulant drugs.

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Two recent news stories shed more light on the anticoagulant Xarelto, the risks those who use it face and the problems that arose during a study comparing it to an older drug, warfarin. Xarelto is the subject of lawsuits by some users and surviving family members of users whose deaths may be related to the drug. The legal claims are largely based on incidents of uncontrolled bleeding that caused serious injuries or deaths.

People with an abnormal heartbeat known as atrial fibrillation who use Xarelto may be running a slightly greater chance of serious bleeding compared to those using the competing anticoagulant Pradaxa, according to WebMD. Many patients with atrial fibrillation use an anticoagulant to lessen the chance of suffering a stroke. Their downside is a risk of potentially fatal, uncontrollable bleeding.

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XareltoYou’ve probably seen the commercials. The most vivid to me was the one with Arnold Palmer, Kevin Nealon, and Brian Vickers. They are playing a round of golf and speaking to each other in shockingly sophisticated ways about the many benefits and occasional side effects of the drug Xarelto. These guys sound like pharmacists or physicians, not athletes and comedians. It is a perfect example of direct-to-consumer pharmaceutical marketing.

Xarelto quickly became a blockbuster drug when it hit the market in 2011. Xarelto (or rivaroxaban) was approved for sale by the FDA in July 2011. It was supposed to represent the next major advancement in blood thinning (anti-coagulant) medication. Xarelto was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anti-coagulant, it was intended to prevent pulmonary embolism (PE) and deep vein thrombosis (DVT) and strokes. The patients Xarelto was intended to help were those with atrial fibrillation (or irregular heartbeat), who were a group of people more vulnerable to PE, DVT, and stroke after surgery. Eventually, the FDA expanded approval of Xarelto to treat all patients with PE and DVT and atrial fibrillation.

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