Products Liability
On this page our national product liability lawyers will explain the Oxbryta lawsuits. We will look at why these lawsuits are being filed and who is eligible to bring a claim. We will also discuss what we expect the potential settlement value of these cases to be.
If you have been injured by Oxbryta, call us today at 800-553-8082 or contact us online.
About Oxbryta
Oxbryta (voxelotor) is a medication used to treat sickle cell disease, a genetic blood disorder in which red blood cells become misshapen, leading to reduced oxygen delivery throughout the body and causing pain, fatigue, and potential organ damage. Developed by Global Blood Therapeutics, Oxbryta works by increasing hemoglobin’s ability to hold onto oxygen, which helps red blood cells retain their normal shape and reduces sickling. This can improve oxygen levels in the blood, reduce the frequency of sickle cell complications, and improve quality of life for individuals with sickle cell disease.
The U.S. FDA first approved Oxbryta in 2019 for patients aged 12 and older, and in 2021, its use was expanded to children as young as four. It is taken orally, typically once daily, and is considered a disease-modifying therapy, which aims to treat the underlying causes of sickle cell disease rather than just managing symptoms.
Although Oxbryta was originally developed and brought to market by Global Blood Therapeutics (GBT), GBT was acquired by pharmaceutical giant Pfizer back in 2022. This means that Pfizer has now assumed GBT’s liability for Oxbryta.
About Sickle Cell
Sickle cell disease (SCD) is a genetic blood disorder characterized by the production of abnormal hemoglobin, known as hemoglobin S. Hemoglobin is the protein in red blood cells responsible for carrying oxygen throughout the body. In people with sickle cell disease, hemoglobin S causes red blood cells to become stiff, sticky, and shaped like crescents or sickles (hence the name).
Individuals with SCH suffer a variety of symptoms and complications because the sickle-shaped cells are less flexible and can clump together, blocking blood flow in small vessels. This can lead to the following events:
- VOCs (vaso-occlusive crises – occur when blood pathways are blocked causing severe pain)
- Anemia (low red blood cell count, as sickle cells break down faster than normal cells)
- Organ damage (due to reduced blood and oxygen supply)
- Increased risk of infections (because the spleen is often damaged by the disease)
Oxbryta Was Marketed as a Breakthrough for SCD Treatment
Oxbryta was developed specifically for the treatment of SCD and it was marketed as a breakthrough new drug that would help thousands of individuals manage the symptoms of sickle cell disease.
Oxbryta received FDA approval in November 2019 through the agency’s accelerated approval pathway, which allowed for faster review based on promising clinical trial results. This initial approval, granted to Global Blood Therapeutics, was primarily based on findings from the GBT-HOPE trial, which supported the drug’s use for patients aged 12 and older.
In 2021, the HOPE-KIDS trial showed similarly encouraging outcomes, leading the FDA to expand Oxbryta’s approval to include children as young as four. The positive results from the HOPE trials enabled Global Blood Therapeutics to secure approval without undergoing the more extensive review typically required.
Oxbryta Linked to Serious Health Complications and Death
Oxbryta was initially approved to treat sickle cell disease, which carries serious risks, primarily vaso-occlusive crises (VOCs) and death. VOCs, which are extremely painful events caused by blockages in blood flow, are a major complication of the disease. However, shortly after Oxbryta’s market release, concerns arose about its safety profile, as evidence suggested the drug might actually increase the risk of VOCs and death in some patients.
Post-market studies and follow-up clinical trials, including Studies GBT440-032 and GBT440-042, showed a concerning rise in severe adverse events among patients taking Oxbryta. In one study, eight deaths were reported in the Oxbryta group, compared to only two in the placebo group. Another study involving patients with leg ulcers also reported eight deaths in those taking the medication. These unexpected findings raised significant safety concerns, prompting further investigation by regulators and the European Medicines Agency.
Oxbryta Safety Recall September 2024
Just 5 years after Oxbryta was released in the U.S., and 2 years after Pfizer acquired GBT, the evidence showing that Oxbryta actually caused more harm than good was overwhelming. The evidence about the health risks of the drug was so compelling that Pfizer launched a worldwide recall of Oxbryta in September 2024.
Pfizer made the following public statement regarding the recall:
Pfizer’s decision is based on the totality of clinical data that now indicates the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population. The data suggest an imbalance in vaso-occlusive crises and fatal events which require further assessment. Pfizer has notified regulatory authorities about these findings and its decision to voluntarily withdraw OXBRYTA from the market and discontinue distribution and clinical studies while further reviewing the available data and investigating the findings.
The fact that Pfizer recalled Oxbryta is a clear indication that the drug was in fact hurting people.
Oxbryta Lawsuits
The recall of Oxbryta is expected to lead to a surge of product liability lawsuits against Pfizer. Some lawsuits have already been filed, and many more are anticipated. Individuals who experienced adverse effects, like increased vaso-occlusive crises (VOCs) or organ failure after taking Oxbryta, may be eligible to pursue compensation.
These lawsuits allege that the companies failed to provide adequate warnings to patients and healthcare providers about the risks of VOCs, death, and other serious complications linked to the drug. Plaintiffs claim that Global Blood Therapeutics and Pfizer knew or should have known about these risks well before the recall, and their failure to inform both users and prescribers constitutes negligence.
Additionally, claims suggest that the companies’ promotional materials misrepresented Oxbryta’s safety by downplaying serious risks, which led patients to use the drug under the impression that it was safer than it actually was.
Settlement Value of Oxbryta Lawsuits
It’s still early in the litigation process to determine the potential settlement value of Oxbryta lawsuits, but we can make some estimates based on settlements in prior cases involving similar injuries and situations.
There likely won’t be a high volume of these lawsuits, as Oxbryta has been on the market for a relatively short time. This limited number of cases may actually benefit plaintiffs, as Pfizer would be able to pay fair settlements without facing overwhelming financial impact.
Our legal team anticipates that the highest-value Oxbryta cases, involving the most serious injuries, could settle for amounts between $400,000 and $1 million. Cases with less severe health impacts would likely see lower settlement payouts. Overall, we’re optimistic about this litigation, and our attorneys believe that victims stand a good chance of receiving fair compensation.
Contact Us About an Oxbryta Lawsuit
If you suffered injuries or health complications related to Oxbryta, call us today at 800-553-8082 or contact us online.