Oxbryta Class Action Lawsuit Filed by Former Users of Sickle Cell Disease Drug Recalled in 2024

Lawsuit seeks damages for all users of the recalled sickle cell disease drug, even if they were not physically injured by Oxbryta side effects.

Pfizer faces an Oxbryta class action lawsuit brought by a group of former users of the sickle cell disease drug, who claim that the manufacturers knew or should have known about serious health risks associated with the treatment long before it was recalled earlier this year.

The complaint (PDF) was filed in the U.S. District Court for the Northern District of California on December 23, by Rick Jolly, Amanda Winbush, Darryl Weekly and Antonio Johnson, seeking class action status to pursue damages for anyone in the U.S. who used Oxbryta since November 1, 2019, and paid at least partially out-of-pocket.

Oxbryta (voxelotor) was first introduced by Global Blood Therapeutics in late 2019, after it was granted accelerated approval by the U.S. Food and Drug Administration (FDA). The expensive drug was promoted as the first medication to treat the root cause of sickle cell disease, by improving hemoglobin levels in the body and helping the blood cells retain more oxygen. Pfizer acquired Global Blood Therapeutics for $5.4 billion in 2022.

However, following a large number of reports involving users experiencing painful sickle cell complications and deaths, Pfizer announced a global Oxbryta recall in September 2024, acknowledging that the risks associated with the treatment outweigh any potential benefits.

Since then, several Oxbryta lawsuits have been filed by former users who suffered side effects from the treatments, but this latest complaint seeks damages even 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.

Plaintiffs who filed this Oxbryta class action lawsuit argue that Pfizer failed to provide adequate warnings about potential side effects users may face, and targeted underserved communities before the Oxbryta recall, indicating that data has linked the drug to an increase in vaso-occlusive crises for years.

Vaso-occlusive crises (VOC) 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 suffer death following a vaso-occlusive event.

None of the plaintiffs named in this class action complaint claim that they suffered physical injuries due to Oxbryta, but argue that neither they nor others would have purchased the expensive drug if they had been informed about the true health risks.

“For purposes of inducing consumers to purchase Oxbryta, Defendants: (a) affirmatively misrepresented the most important and material facts directly to consumers regarding the safety of Oxbryta; and/or (b) misbranded Oxbryta; and/or (c) fraudulently concealed from and/or failed to disclose to consumers material facts regarding the safety of Oxbryta,” the lawsuit states. “Federal law requires Defendants to ensure that their drug labels remain accurate, and when new scientific information renders their labels inaccurate, federal law requires Defendants to act. Failure to do so renders Oxbryta misbranded.”

The lawsuit presents claims of breach of warranty, violation of the Magnuson-Moss Act, common law fraud, unjust enrichment, and violations of fair trade and consumer fraud laws in Georgia, Indiana and Illinois.