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Xarelto: Woman With Internal Bleeding Loses Third Bellwether Trial

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  

In 2015, Plaintiff Dora Mingo had hip replacement surgery, and soon after she developed deep vein thrombosis (DVT). Ms. Mingo was prescribed the blood thinner to treat DVT. Shortly after taking Xarelto she suffered gastrointestinal bleeding and anemia. She had to be hospitalized. In her lawsuit Ms. Mingo alleged that Janssen, Bayer, and Johnson & Johnson knew of the risks of internal bleeding when taking Xarelto but failed to adequately warn patients and doctors. This failure to warn, she alleged, was the proximate cause of her injuries.

A primary allegation in the trial was that a lab test analyzing a patient’s risk of internal bleeding while taking Xarelto could have prevented many uncontrolled bleeding events, including the plaintiff’s. The test is called a Prothrombin Time (PT) test. Ms. Mingo alleged that defendants did not explain the importance of this PT test to doctors and the medical community who prescribe the blood-thinning medication.

The jury, on August 18, 2017, disagreed. The jury found that Ms. Mingo had not established her failure to warn claim. That’s my lawyerly way of saying that Dora Mingo lost her case.

The First and Second Bellwether Cases

In the first bellwether trial, Joseph Boudreaux alleged that he began taking Xarelto in 2014 to manage symptoms of atrial fibrillation (aFib). A few weeks after taking the medication he was hospitalized for severe gastrointestional bleeding, which ultimately required blood transfusions. Boudreaux stated in his lawsuit that Janssen and Bayer misrepresented the drug’s safety to patients. By the time of trial, Boudreaux’s claims were down to one: that defendants failed to give sufficient instruction to doctors to perform a blood-clotting test on patients before prescribing Xarelto. The jury found that the defendants did not fail to supply Boudreaux’s doctors with sufficient instruction for prescribing Xarelto.

The second bellwether trial involved a widower who sued defendants after his wife died of a stroke in 2015. Joseph Orr alleged that Sharyn Orr died as a result of taking the drug Xarelto, and that the drugmakers failed to warn doctors appropriately about the risks of taking the drug. The issue in that case was whether the warning labels for Xarelto were adequate to inform a doctor about the risks so the doctor could adequately warn patients. The jury concluded that the warning labels on the Xarelto packaging were not inadequate.

Understanding Bellwether Cases

Bellwether CasesIt is important to keep in mind what a bellwether case is supposed to accomplish. Some people misunderstand bellwether cases to be the “best of the bunch.” This is not accurate. Rather, the word bellwether is defined as “an indicator or predictor of something.” In multidistrict litigation, the bellwethers are chosen based on the way they represent a large number of other cases. Which means the bellwether cases should by definition and category be average cases. In the artificial hip MDLs, for example, a plaintiff who suffered three revision surgeries, two infections, and finally a leg amputation would not be chosen as a representative “bellwether” case.

My point is this: with bellwether cases, you have to withhold judgment until several jury verdicts are rendered. If Bayer, Janssen, and Johnson & Johnson win the next five or ten cases, I will begin to accept that the Xarelto cases may not have a viable path forward for the plaintiffs. But we are just not there yet. The Xarelto MDL judge accepted 40 cases for discovery for a reason. It would be irresponsible to assume, on the basis of three jury verdicts, that the defense has established that Xarelto is safe and that the 18,500 lawsuits filed against the defendants are without merit.

What’s Next?

The fourth bellwether trial in the MDL has not been set, but should be held in the next few months. As a product liability lawyer representing plaintiffs, I am looking forward to this case. As I wrote a few months ago, we need to get five, ten, fifteen bellwether trials to verdict and then see where we are.

Remember . . . 

Xarelto (rivaroxaban) was first approved by the FDA for sale in July 2011. It was developed to prevent serious conditions that sometimes arise after surgeries (such as artificial hip and knee surgeries). As an anticoagulant, it was supposed to prevent pulmonary embolism (PE), deep vein thrombosis (DVT), strokes, and other serious conditions. Xarelto was also intended to help those patients with atrial fibrillation, a group of people more vulnerable to PE, DVT, and stroke after surgery. Plus, it is easier to take than warfarin. In studies, however, Xarelto caused higher rates of internal bleeding, and there is no available “antidote” for stopping internal bleeding in patients taking Xarelto. For people taking Xarelto it can take 24 hours for a dose to get out of the body. That means if internal bleeding starts, the patient may simply have it wait it out and hope it stops on its own.

Xarelto is Bayer’s best-selling drug. The company made $3.4 billion on the drug in 2016, and Johnson & Johnson reported revenues of $2.2 billion from Xarelto last year.

Give me a call if you have taken Xarelto and believe you were injured by the medication.