In a recent product liability lawsuit, a plaintiff has alleged that Pfizer Inc. failed to warn customers of adverse drug reactions. Specifically, the plaintiff alleged that Pfizer Inc. did not warn customers about its arthritis drug, Xeljanz. Allegedly, the medicine can cause sepsis, requiring an amputation. The Food and Drug Administration reviewed reports from several clinical trials of the drug. After their review, they required Pfizer Inc. to place “black box” warnings on the packaging of the drug and text that highlights the risks of developing sepsis after taking the drug for an extended period of time.
The Arthritis Drug Xeljanz Has Been Linked To SepsisAccording to a recent product liability lawsuit filed against Pfizer Inc., an Arkansas woman claims that she developed a dangerous sepsis case after taking the arthritis drug, Xeljanz. Her sepsis case spread all over her body, and eventually, surgeons had to remove all four of her limbs to save her life. After taking Xeljanz for four years, she started to experience nausea, pain, and a fever. Doctors later diagnosed her with multi-organ failure, septic shock, gangrene, and Group A Streptococcus. At this point, surgeons had no choice but to make her a quadruple amputee.
In her lawsuit she claims that elderly patients, those with pre-existing conditions, and women, could be at an increased risk of developing sepsis after taking Xeljanz for an extended period of time. Her lawsuit alleges that Pfizer knew about the dangers of sepsis in some patients who take Xeljanz for extended periods, but they failed to warn doctors and patients of these risks.
Why Do Doctors Prescribe Xeljanz?Xeljanz is a drug manufactured and sold by Pfizer that the FDA approved in 2012. The FDA approved Xeljanz for the treatment of rheumatoid arthritis in patients with moderate to severe symptoms. Many Americans have arthritis, and over 350 million people throughout the world suffer from the condition. While we do not know exactly how many patients have used Xeljanz for an extended period of time, we can reasonably assume that many Americans have been taking, or have taken the drug, as it is one of the most popular medications prescribed for rheumatoid arthritis. Pfizer Inc. has also spent an enormous amount of money marketing the drug.
Failure To Warn of The Dangers of XeljanzThe packaging for the drug Xeljanz in Australia, Canada, the European Union, and other countries, contains a warning that the use of Xeljanz comes with a risk of developing sepsis as a serious side effect. When Pfizer Inc. initially applied for approval of the sale of their drug, Xeljanz, in the European Union, the European Union rejected their application, in part, because they were worried about the link between the drug and the development of sepsis in users. Interestingly, Pfizer Inc. previously manufactured Enbrel, which contained a warning on its packaging about the link between sepsis and use of the drug.
The FDA Has Updated Its Warnings on Packaging of Xeljanz and Xeljanz XRThere has not been an outright FDA recall of the drugs Xeljanz and Xeljanz XR; however, the FDA recently stated that they require Pfizer Inc. to place the highest “black box” warning label on these drugs. The FDA has reviewed drug studies and concluded that patients who have an increased risk of blood clots and death, take the twice-daily dose of these drugs. The FDA concluded that, “the 10 mg twice-daily dose of tofacitinib is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and long-term use in limited situations.”
Proving Negligence in Xeljanz LawsuitsUnder North Carolina law, patients who suffered injuries caused by defective products, including medication, can bring a lawsuit against the manufacturer. Plaintiffs in product liability lawsuits need to prove that the drug manufacturer knew, or reasonably should have known, that taking their drug comes with the risk of dangerous side effects. In this case, plaintiffs claim that Pfizer knew about the hazardous risk between Xeljanz and sepsis and still refused to warn patients of this risk.
Contact A Personal Injury Lawyer TodayIf you or your loved one have been diagnosed with sepsis after taking Xeljanz for an extended period of time, you may be entitled to compensation. Our team of personal injury lawyers can evaluate the circumstances of your case and help you decide the best way to move forward. For your convenience and safety, we offer video and phone conferencing. If you prefer an in-person consultation, we have three easy to reach offices in Uptown Charlotte, Monroe and Mooresville. Contact Arnold & Smith, PLLC today to schedule your free consultation.