Oxbryta Recall Lawsuit Alleges Sickle Cell Drug Increased Frequency of Dangerous VOCs

Oxbryta was recalled in September 2024, following multiple reports of injuries and deaths.

A New Jersey man has filed a lawsuit, which claims that he suffered multiple injuries and hospitalizations due to what he, and federal regulators, say was the defective nature of the sickle cell disease drug, Oxbryta.

The complaint (PDF) was brought by Maurice Fraizier in the U.S. District Court for the Northern District of California on May 8, naming Pfizer, Inc. and Global Blood Therapeutics, Inc. as the defendants. The lawsuit claims the defendants should have known about the defective nature of the drug before it hit the market, but failed to adequately test the formulation and provide adequate warnings about the risks.

Originally introduced by Global Blood Therapeutics in 2019, Oxbryta (voxelotor) was designed as the first medication to treat the root cause of sickle cell disease, which its designers claimed it would do by improving hemoglobin levels in the body, and helping the blood cells retain more oxygen. Pfizer purchased the company and the drug in 2022, and sold the treatment for about $88,000 per year, per patient.

However, following numerous reports of users experiencing worsening sickle cell side effects, complications and deaths, Pfizer announced a global Oxbryta recall in September 2024. An increasing number of Oxbryta lawsuits have followed in the recall’s wake.

One of the primary Oxbryta side effects reported by Frazier and other users is an alleged increased rate of sickle cell disease-related incidents, known as vaso-occlusive crises (VOCs).

Vaso-occlusive crises occur when the red blood cells block blood flow, and the tissues become deprived of oxygen. This can cause an inflammatory response, which can lead to symptoms like pain in the chest, back and limbs, as well as fever. Patients often have to be hospitalized and can suffer kidney failure and stroke. Additionally, many patients can die following a vaso-occlusive event.

According to his lawsuit, Frazier began taking the drug in November 2023. He has been diagnosed with sickle cell disease (SCD) since he was a child.

While taking the drug, Frazier suffered a number of side effects, including an increase in VOCs which led to hospitalizations in January 2024, May 2024, September 2024 (the same month Oxbryta was recalled) and October 2024. During the last two incidents, he also developed pneumonia.

“At no time did Defendants provide any warning or information to Plaintiff Maurice Frazier’s prescribing physicians, or to the medical community generally, about the dangerous nature of Oxbryta,” the lawsuit states. “Had Defendants or Plaintiff Maurice Frazier’s prescribing physicians informed Plaintiff Maurice Frazier of the dangers of Oxbryta, Plaintiff Maurice Frazier would have refused to use Oxbryta.”

Frazier presents claims of design defect, failure to warn, negligence, negligent misrepresentation, breach of warranty, unjust enrichment and violations of the New Jersey Consumer Fraud Act.