Xeljanz Lawsuit Filed Over Failure to Warn About Risk of Blood Clots, Pulmonary Embolisms

A product liability lawsuit has been filed against Pfizer, alleging that side effects of Xeljanz caused a life-threatening blood clot, which resulted in the need for aortic valve replacement and bypass surgery.

The complaint (PDF) was filed on February 17 by Allan J. Tortorice and his wife, Laura, in the U.S. District Court for the Eastern District of Tennessee, indicating that consumers and the medical community were not warned that Xeljanz was dangerous and known to cause blood clots, heart attacks, strokes, cancer and death.

Xeljanz (tofacitinib) was introduced by Pfizer in 2012, as the first member of a new class of medications, known as JAK inhibitors, which generate billions in sales for treatment of rheumatoid arthritis, psoriatic arthritis and ulcerative colitis.

In a drug safety communication issued in September, the FDA indicated it had completed a review of the Xeljanz heart risks, evaluating data from a large randomized clinical trial that found users of the drug experienced more cardiovascular events, as well as cancers, pulmonary embolism and death. As a result of the findings, the agency issued a warning for users of Xeljanz, as well as all other drugs in the same new class of medications as well.

The Xeljanz lawsuit indicates Tortorice was diagnosed with rheumatoid arthritis in 2008, and was prescribed Xeljanz from January 2017 until February 2021. After experiencing symptoms of bloating, loss of appetite, and fatigue, he was diagnosed as suffering from a blood clot, which resulted in hospitalization and the need for an aortic valve replacement and bypass surgery.

“At no time during his use of Xeljanz did Allen J. Tortorice know or have reason to know that serious heart-related events such as heart attack or stroke, cancer, blood clots, and death were related to Xeljanz use,” the lawsuit states. “Plaintiff Allen J. Tortorice recently discovered that his injuries are related to his Xeljanz use and is still engaged in extensive rehabilitation as a direct result of Pfizer’s negligent, misleading, fraudulent and other wrongful acts and omissions in connection with the sale, labeling, pharmacovigilance and false and misleading promotion of its drug, Xeljanz.”

The lawsuit claims Pfizer was “fully aware” of Xeljanz safety risks, but deliberately used its label, marketing and promotions to mislead consumers.

“Pfizer knew that it could turn a profit by convincing physicians and consumers that Xeljanz came without certain, harmful risks,” Tortorice states in the lawsuit. “Pfizer further knew that full disclosure of the true risks of Xeljanz would limit the amount of money it would make selling the drug.”

After Xeljanz was introduced, Pfizer aggressively marketed the drug, joining a lucrative market for rheumatoid arthritis treatments, which already included blockbuster drugs like Humira, Enbrel and other similar medications, known as tumor necrosis factor (TNF) inhibitors. Xeljanz was advertised as a safer and more convenient treatment option, and quickly grew to become a top selling drug, with annual sales of more than $2 billion worldwide. However, data from a recently completed study raised questions about serious Xeljanz side effects that were not adequately described on the drug’s warning label.

In February 2021, the FDA issued a safety communication about a potential link between Xeljanz and cancer, heart attacks and other cardiovascular heart risks, following a preliminary review of data from a recently completed post-marketing study.

The FDA warning requirements came following months of speculation after the agency held up approval of other JAK inhibitors, requiring more study data from the manufacturers.

A growing number of former users like Tortorice are now pursuing Xeljanz lawsuits, alleging that they could have avoided serious and life-threatening injuries if adequate warnings and information about the health risks had been disclosed by the drug makers before they took the medication.