First Oxbryta Lawsuit Set for Trial in August 2027, Over Recalled Sickle Cell Drug Risks

A global Oxbryta recall was issued last year, after clinical trial data showed an increase in deaths and painful sickle cell crises among users.

A federal judge has scheduled the first Oxbryta recall lawsuit for trial on August 16, 2027, involving class action claims that allege Pfizer marketed a defective sickle cell drug while concealing serious health risks, including stroke, hospitalization and death.

Sickle cell disease (SCD) is a genetic blood disorder that causes red blood cells to become rigid and sickle-shaped, restricting blood flow and leading to severe pain, organ damage and other complications. It primarily affects individuals of African descent and underserved communities, with symptoms often beginning in early childhood.

Oxbryta (voxelotor) was first introduced by Global Blood Therapeutics to address the root cause of SCD, by increasing hemoglobin’s ability to carry oxygen, helping red blood cells maintain their shape. It received accelerated FDA approval in 2019, and was promoted as a breakthrough treatment for adults and children as young as four. Pfizer later acquired the drug for $5.4 billion in 2022, and continued marketing the drug until it announced a global Oxbryta recall in September 2024.

Pfizer Recalled Oxbryta After Fatal Events and VOC Spikes

The decision to withdraw Oxbryta came after post-marketing clinical trial data revealed a statistically significant increase in fatalities and vaso-occlusive crises (VOCs), a hallmark and often life-threatening complication of sickle cell disease. 

VOCs occur when rigid, sickled blood cells block circulation, which can cause excruciating pain, respiratory distress, kidney failure, stroke or even death. Many patients require frequent hospitalization, and long-term damage can result from repeated episodes.

According to the FDA, Pfizer ceased distribution and shut down all ongoing trials and expanded access programs, citing that “the risks outweigh the benefits for the approved patient population.”

Following the recall, several Oxbryta lawsuits have been filed by former users who suffered side effects from the treatments, and at least one class action lawsuit seeks damages for those who have not been injured, alleging that the drug makers placed a desire for profits before the health and safety of individuals with sickle cell disease.

The Oxbryta class action lawsuit was filed in the U.S. District Court for the Northern District of California, involving claims brought by Ricky Jolly from Indiana, Amanda Winbush from Virginia, Darryl Weekly from Illinois and Antonio Johnson from Georgia, who seek to pursue damages on behalf of all former users nationwide. 

Each of the lead plaintiffs in the lawsuit claims they paid out-of-pocket costs for Oxbryta, and would not have done so had Pfizer disclosed the true risks. 

The lawsuit seeks to establish a nationwide class including all individuals in the U.S. who purchased Oxbryta since November 2019, and were exposed to marketing that allegedly misrepresented the drug’s safety.

According to the complaint, Pfizer and its subsidiary Global Blood Therapeutics misbranded Oxbryta and concealed critical safety data, including the increased risk of VOCs, infections, strokes and deaths. Plaintiffs argue that Pfizer continued to promote the medication despite mounting evidence that the drug could worsen the very condition it was designed to treat.

The plaintiffs further accuse Pfizer of exploiting vulnerable populations, noting that Oxbryta was specifically marketed to underserved communities under the guise of addressing long-standing health disparities in sickle cell treatment. The complaint outlines multiple legal claims, including breach of warranty, fraud, unjust enrichment, and violations of consumer protection laws in Indiana, Illinois, Virginia and Georgia.

Pfizer Seeks To Dismiss Oxbryta Class Action Lawsuit

The lawsuit has been assigned to U.S. District Judge Trina Thompson, who issued a case management and scheduling order (PDF) last month, setting the trial to begin on August 16, 2027. 

However, Pfizer filed a motion to dismiss (PDF) the Oxbryta recall lawsuit on April 23, arguing that the plaintiffs failed to adequately plead their claims. The drug maker maintains that the complaint lacks sufficient factual detail to support allegations of fraud, breach of warranty and deceptive marketing, and that it does not meet the legal standards required to proceed under federal rules.

A hearing on Pfizer’s motion to dismiss is scheduled for July 8, 2025, where the court will decide whether the case can move forward. 

If the motion to dismiss is denied, Judge Thompson’s scheduling order indicates that plaintiffs must file a motion for class certification by April 25, 2026, and the drug makers must file any Daubert or other dispositive motions by February 2, 2027.

A final pretrial conference is set for July 15, 2027, if the parties do not reach an Oxbryta settlement agreement to resolve the claims.