Xeljanz Stroke Lawsuit Filed Against Pfizer for Gross Negligence in Failing to Warn About Drug Risks

Pfizer was grossly negligent in failing to warn patients and the medical community about the side effects of Xeljanz, according to allegations raised in a lawsuit brought by a woman who suffered a stroke while taking the rheumatoid arthritis drug.

The complaint (PDF) was filed by Cathy Romero in the U.S. District Court for the Eastern District of Kentucky on March 31, indicating Pfizer knew or should have known about the cardiovascular risks associated with Xeljanz, but provided false and misleading information about the safety of their product.

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.

Following a review of data from a post-marketing study, the FDA required a Xeljanz warning label update in September 2021, indicating that users face an increased risk of strokes, heart attacks, blood clots, cancer and death. However, Romero alleges this information should have been disclosed much earlier.

Romero was diagnosed with rheumatoid arthritis in March 2017, and indicates that she was prescribed Xeljanz from August 2019 until April 2021, when she suffered a stroke, temporarily losing control of the right side of her body.

The lawsuit indicates Pfizer failed to provide adequate warning about Xeljanz stroke risks.

“Pfizer entirely failed its duty to adequately warn of the hazards of Xeljanz which was a direct and proximate cause of Ms. Romero’s injuries and associated damages,” her lawsuit states. “Pfizer’s conduct was fraudulent and constitutes gross negligence.”

The FDA first issued a safety communication about a potential link between Xeljanz and cancer, heart attacks and other cardiovascular heart risks in February 2021, 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.

Romero now joins a growing number of former users pursuing a Xeljanz lawsuit against Pfizer, alleging that serious and life-threatening injuries could have been avoided if adequate warnings and information about the health risks had been disclosed by the drug makers before they took the medication.