A recent lawsuit has put the spotlight on the popular arthritis drug Xeljanz and the potential risks it poses for sepsis and amputations resulting from sepsis. A 68-year-old woman in Arkansas named Marilyn Stube claims that she got sepsis from using the drug and the sepsis resulted in the amputation of all four of her limbs. While lawsuits against Pfizer are common, this lawsuit is worth paying attention to because of certain details—like the fact that Pfizer includes warnings about the risk of sepsis on the drug’s labels in the European Union, Canada, and Australia. The fact that Pfizer chose not to put the same label on its product in the U.S. is a reason to be suspicious and to increase the possibility that the lawsuit could be successful.
If you or someone you know is taking Xeljanz for arthritis, it could be beneficial to learn more about the lawsuit in Arkansas and the risk of sepsis posed by the drug. If you are taking Xeljanz and have gotten sepsis and possibly had to have a limb amputated, talking to an experienced attorney at Rosenfeld Injury Lawyers LLC could help you understand your legal options moving forward. As with all of our pharmaceutical litigation matters, we handle Xaljanz lawsuits on a contingency fee basis—where there is never a fee charged unless there is a financial recovery for you.
What is Sepsis?
According to the Centers for Disease Control and Prevention (CDC), “Sepsis is the body’s extreme response to an infection. It is a life-threatening medical emergency. Sepsis happens when an infection you already have —in your skin, lungs, urinary tract, or somewhere else—triggers a chain reaction throughout your body. Without timely treatment, sepsis can rapidly lead to tissue damage, organ failure, and death.”
Sepsis is exceptionally dangerous, which is why medical professionals and caregivers are trained to prevent sepsis as much as possible. When a drug carries an increased risk of sepsis, it is vital that the drug maker include that information in labeling. Only with proper labeling and warnings can health care providers and their patients make informed decisions about taking such drugs.
What is Xeljanz?
Xeljanz is a drug produced by Pfizer that was approved by the FDA in 2012. The drug was approved for the treatment of rheumatoid arthritis for those with moderate to severe symptoms.
According to the Arthritis Foundation, arthritis is a disease that affects over 50 million people in the United States. It is estimated that approximately 350 million people throughout the world suffer from the condition. While it is difficult to get an exact number for how many people take Xeljanz for arthritis, it is reasonable to assume that many, many people are taking the drug—and many of them may not be aware of the risks it poses for sepsis.
What Happened to Marilyn Stube After Taking Xeljanz?
When Marilyn Stube’s doctor prescribed her Xeljanz for her rheumatoid arthritis, neither of them had any idea that the drug carried the risk of causing sepsis. In fact, according to the complaint filed by the plaintiff, her doctor has signed a sworn declaration stating that if he had been aware of the risks posed by Xeljanz, he would have never prescribed her the medication.
Her doctor would have known about the risks if Pfizer had used the same label for the drug that is used in other countries like the EU and Canada. But Pfizer avoided using the same label in the U.S. Because of the lack of warning provided by Pfizer, Marilyn Stube’s doctor prescribed her Xeljanz and she took it for the next four years.
In March 2017, after four years of taking Xeljanz, Marylin Stube began to experience symptoms that included pain, nausea, and fever. Just a month later, in April of 2017, her health care provider diagnosed her with septic shock. Along with septic shock, she was also diagnosed with multiple organ failure, Group A Streptococcus, and gangrene. The damage was so severe that surgeons had to amputate her arms and her legs.
Although the lawsuit does not lay out the details of what happened after, it is reasonable to assume that she contacted an attorney, or an attorney contacted her. They discovered that sepsis was included on the warning labels of Xeljanz in other countries. The lawsuit claims that the drug carries an increased risk to women, the elderly, and those with pre-existing conditions when they take the drug over a long period of time—just like Marilyn Stube did.
How was Pfizer Negligent in Warnings Placed on Xeljanz?
The claims of negligence made by the lawsuit include the fact that Pfizer did not maintain consistency with its labels across the different countries where it sold the drug—particularly the way that the labels in the U.S. were not the same as they were in the European Union and other countries.
The lawsuit does get into more detail about the specific ways that Pfizer made mistakes that were likely well-understood by the company. For one, Pfizer sold another drug for arthritis known as Enbrel that included a warning for sepsis on the label. For another, the first application the company submitted to the European Union for Xeljanz was denied by the EU government. The application was rejected for several reasons, one of them being the fact that the label for the drug did not include a warning for sepsis.
Marilyn Stube and her legal representation also claim that Pfizer was aware of the risk of sepsis and resulting amputation from clinical trials. When conducting trials that they would use as part of their FDA application, the lawsuit claims that Pfizer avoided including those that had pre-existing infections—the kind of patients that would be more likely to get sepsis while taking the drug.
Xeljanz, Sepsis, and You
Whether Marilyn Stube’s lawsuit will be successful or not remains to be seen. The fact that Pfizer did not use the same labels in the U.S. as it did in other countries does not bode well for Pfizer’s defense.
If you or someone you know has been taking Xeljanz and developed sepsis, you should speak to an attorney. The team at Rosenfeld Injury Lawyers LLC can help you determine if you have a case, and we can help you move forward with that case. We can work together with you to hold Pfizer responsible for your injuries. Please contact us now to get started.