Judge Rules Bayer Could Have Changed Xarelto Label
Before the third Xarelto Bellwether trial began, Bayer and Janssen proposed a motion that they didn’t have the right to change Xarelto’s label. U.S. District Judge Eldon E. Fallon denied their claim, and the third trial will continue as scheduled.
Xarelto Bellwether Trial
The third trial involves Dora Mingo. While on Xarelto in 2015, she developed deep vein thrombosis (DVT) after doctors replaced her hip. Then, she started having gastrointestinal bleeding. Doctors hospitalized her because of it. Mingo insists that Xarelto manufacturer, Bayer knew these problems existed. Yet, they failed to warn patients and doctors.
This trial and the two before it insist that Bayer had a duty to adjust Xarelto’s label. If the label notified doctors to conduct a blood clotting test called Neoplastin PT, it would have saved lives. Bayer’s motion before the third bellwether trial began argued that they couldn’t alter Xarelto’s label. Bayer says it is the FDA’s job to monitor the recommendation. Plus, the manufacturers insist that they wanted to include the proposed warning, but the FDA rejected it.
Judge Fallon disagreed. He said that the company could have found a way to change the label if they knew there was a legitimate safety issue.
“Manufacturers remain the master of their labels even after FDA approval, and there are clear pathways through which a brand name drug manufacturer can make changes to their label without FDA approval,” he said.
Then, Bayer and Janssen tried to argue that design-defect claims should be barred. They insist that the companies would need to unilaterally change Xarelto without FDA oversight.
Judge Fallon disagreed. He felt that design-defect claims are there to help the state use its’ constitutional rights to protect the welfare of its residents. Not doing so would free pharmaceutical companies from state common-law liability.
Xarelto (Rivaroxaban) is a blood thinner, or anticoagulant, introduced in 2011. It is a huge financial success and created a new generation of anticoagulant medication. Despite its short time on the market, Xarelto may already be responsible for hundreds of patient deaths. These incidents involve serious and potentially unstoppable bleeding due to the drug’s method of action: preventing the blood from clotting.
By stopping the blood from clotting, blood-thinners can prevent blood clots in people suffering from conditions such as atrial fibrillation. Due to the risk of unstoppable bleeding, researchers developed an “antidote” to stop this effect in the case of emergency in users of warfarin, the most popular anticoagulant for decades.
Xarelto users aren’t so lucky. There is no antidote to reverse the anti-clotting effect of Xarelto in an emergency. This means doctors and surgeons may have limited options. It means that what could be a treatable injury for most people can be a fatal one for Xarelto users.
If Xarelto Injured You
The Michael Brady Lynch Firm is still taking cases from all 50 states. If Xarelto caused a bleeding event to you or someone you love, a jury may award you compensation. We have decades of experience going up against large pharmaceutical corporations like Bayer and Johnson & Johnson. We have recovered multi-million dollar settlements for our clients. Our leadership expertise is constantly sought after as we have held numerous high-ranking positions in various medical claim cases. When you are injured, you need an experienced firm to know all the legal avenues to process your claim. The Michael Brady Lynch Firm is that firm. Contact us today, 24/7 to speak to a knowledgeable associate.