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Pfizer Oxbryta Lawsuit Overview

Last Updated: May 4, 2025

In September 2024, Pfizer issued a global recall of Oxbryta, which is a medication used to treat sickle cell disease, after studies reported serious safety concerns over its use. Since then, several lawsuits have been filed against Pfizer and its subsidiary, Global Blood Therapeutics. Several claimants in the lawsuits allege that taking Oxbryta has caused increased incidences of VOCs (vaso-occlusive crises), an often painful and potentially fatal medical events where sickled red blood cells block blood flow. The lawsuits claim both Pfizer and Global Blood Therapeutics, which Pfizer acquired in 2021, failed to warn patients about the dangers of Oxbryta. Right now, law firms are asking for more people who have suffered adverse reactions to Oxbryta to come forward and join the lawsuits.

Pfizer Oxbryta LawsuitPfizer Oxbryta Lawsuit
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Oxbryta Lawsuit News

May 4, 2025

As of May 2025, no new lawsuits have been filed. Previous concerns about the drug’s approval process and marketing practices are being reviewed, but no major legal action has progressed recently.

April 16, 2025

Pfizer issued a worldwide recall of Oxbryta - a medication used to treat symptoms of sickle cells disease.

April 10, 2025

Oxbryta has set a June 2027 trial date as a preliminary.

April 7, 2025

Oxbryta is linked to severe health risks and adverse side effects. Many patients have filed lawsuits against its manufacturer. This section will explain what a Oxbryta suit is and why patients have taken legal action.

April 1, 2025

As litigation over the recalled sickle cell drug Oxbryta progresses, patients now have an alternative therapy. The FDA recently approved a new medication, crizanlizumab, as the first targeted treatment for vaso-occlusive crises in sickle cell disease. The approval may influence future cases by highlighting differences in drug efficacy and safety for patients managing this chronic condition.

March 27, 2025

Experts have stated that Oxbryta's safety and effectiveness may have depended on the severity of each patient's sickle cell. According to Dr. Jeffrey Glassberg, professor and director of the Center for Sickle Cell Disease at the Icahn School of Medicine at Mount Sinai Hospital, Oxbryta worked best for patients with mild to moderate sickle cell anemia, but provided little benefit for those with severe forms of the condition. He also stated that he noticed some patients would become critically ill when they missed a dose of their medication, and encouraged them to stockpile Oxbryta.

March 25, 2025

Lawsuits against the manufacturers of Oxbryta, a recalled sickle cell disease drug, continue to emerge, with cases filed in both state and federal courts. Plaintiffs claim the medication caused severe health complications, including life-threatening blood flow issues. As litigation progresses, early settlement discussions are underway, and the outcome of upcoming trials may shape broader resolutions.

March 20, 2025

It is official: sickle cell anemia has been cured. The 21-year-old New York man who received the gene therapy treatment at Cohen Children's Medical Center has been cured of the condition.

March 16, 2025

New sickle cell treatments continue to hold promise for those affected by the disease. A 21-year-old New York man is the first patient in the state to receive the newest gene therapy treatment for sickle cell anemia. Dr. Jeffery Lipton, the director of pediatric hematology, oncology, and stem cell plantation at Cohen Children's Medical Center, oversaw the procedure and stated that he believes this type of treatment will replace all other currently available sickle cell procedures.

March 13, 2025

Oxbryta is a treatment used to treat sickle cell. It has been linked with severe side effects including strokes, organ failure and even death. If you've suffered any of these side effects, you may be eligible for legal compensation.

March 9, 2025

Sickle cell anemia research continues to drive forward, providing hope for those who were negatively affected by Oxbryta. A press release from the American Red Cross has detailed the story of Jasmine and Jordan Davis, twins who were born with sickle cell anemia, grew up requiring frequent blood transfusions while taking sickle cell medication in an attempt to control the pain related to sickle cell anemia. Each twin received a bone marrow transplant—Jasmine's from their mother, and Jordan's from their father—and today, both twins are considered to be free from sickle cell.

March 5, 2025

A new treatment for sickle cell anemia, CASGEVY, is offering hope to those who haven't experiences success with other types of treatment. While many people are already using the treatment, it will still take between five and ten years for widespread access to become available.

March 3, 2025

A new bone marrow transplant method may unlock new options for people with sickle cell anemia at a cost far lower than currently-available gene therapies. In a recent study, 42 adults severely affected by sickle cell diesaes underwent reduced intensity haploidentical bone marrow transplantation. Two years later, 95% of participants were still living, and 88% were considered cured of sickle cell anemia. This option provides hope for patients who were previously relying on Oxbryta for sickle cell treatment.

March 1, 2025

Marcia Smith, the mother of Oxbryta victim Marissa Smith, has followed a lawsuit on behalf of her deceased daughter's estate. Marissa's case is one of the first cases to name Global Blood Therapeutics, Inc., the manufacturer of now-recalled sickle cell anemia drug Oxbryta, as responsible for the death of a sickle cell anemia patient.

February 24, 2025

New gene therapy treatments for sickle cell disease are helping people with the condition begin to live normal lives for the first time. This much-needed treatment is a leap from previously-used therapies like Oxbryta, a now off-the-market drug that actually increased the death rate in people with sickle cell anemia compared to a placebo. While gene therapy is proving effective, insurance companies are scrambling to figure out how to pay for gene therapy, as it currently costs approximately $2 million over the course of treatment for each sickle cell patient.

February 19, 2025

New developments continue to promise hope for patients with sickle cell disease. The Medical University of South Carolina is expanding access to new therapies, allowing more patients to try transformative gene therapies designed to modify the disease.

February 12, 2025

Early detection is key in helping people who have sickle cell anemia, and the sickle cell anemia testing and screening market is growing fast. According to Ameco Research, the sickle cell testing and screening market will reach $383 million by 2030. Early detection can help people diagnosed with sickle cell anemia get the treatment they need to avoid organ damage and other life-threatening complications. Increased testing availability is a breath of fresh air for those with sickle cell disease, many of whom have been devastatingly affected by the side effects of Oxbryta, a drug that was discontinued in September of 2024 due to reports of vaso-occlusive crises, organ failure, stroke, and/or death in people who took the drug.

February 9, 2025

In recent sickle cell news, research showed that there is no evidence to support a connection between physical exertion/heat injury and sudden death in people who have sickle cell anemia. This new research goes against the previously held belief of a connection between exertion/heat related injury and sudden death in people diagnosed with sickle cell anemia.

February 6, 2025

A bill providing funding for sickle cell anemia research, education, and care improvements has passed Virginia's House Appropriations Committee. Claimants in the Oxybryta lawsuit are hopful that the passage of the bill will lead to new, effective sickle cell treatment options.

February 1, 2025

Legal actions concerning Oxbryta (voxelotor), a medication developed for sickle cell disease, are progressing following its global withdrawal in September 2024 due to safety concerns. Patients have reported severe complications, including increased vaso-occlusive crises (VOCs), organ damage, and fatalities, leading to numerous lawsuits against the manufacturer, Pfizer.

January 27, 2025

New research published on sickle cell anemia makes the fight for effective treatment even more urgent. The new study showed that people who have sickle cell anemia have brains that appear to be 14 years older than their chronological age, potentially making them more likely to develop Alzheimer's disease and other neurological illnesses over time.

January 26, 2025

In addition to vaso-occusive crises, or VOC, many people who took Oxbryta for sickle cell anemia experience severe side effects, including arthritis, stroke, organ failure, and death. Pfizer, the company that made Oxbryta, failed to fully warn patients about the potential risks of using the drug, despite knowing about the severe side effects of Oxbryta use.

January 21, 2025

The effectiveness of Oxbryta has been brought into question by a recent study after more than half of the participants dropped out of the trial process. Because the data is so limited, people are questioning the reliability of the study and what it might mean for future regulatory decisions. With such a small sample size, the impact of the study on the drug's recall is uncertain, but speculation continues about the possibility of a change in the recall status of the drug.

January 12, 2025

Pfizer voluntarily removed Oxbryta, a medication used to treat sickle-cell disease (SCD), from the global market in 2024 because of serious safety concerns. Pfizer voluntarily recalled Oxbryta (voxelotor), a medication developed to treat sickle cell disease (SCD), from global markets in 2024 due to serious safety concerns.

January 7, 2025

Pfizer Inc., and its subsidiary Global Blood Therapeutics Inc., should have known their now-recalled treatment for sickle cells disease Oxbryta may cause complications and even lead to death. This is what a patient claimed in a recent lawsuit.

According to the complaint filed on Thursday at the US District Court of Northern District of California, plaintiff Tirrell Allen claimed that he had a higher incidence of vaso occlusive crises, a disease-related complication.

January 1, 2025

Sickle Cell Disease Treatment Oxbryta (voxelotor) The insurer denied coverage for Oxbryta (voxelotor) The denial is overturned This is an adult male with a history of sickle cell disease and iron deficiency.

A few months after Pfizer made the decision to recall Oxbryta globally, lawsuits against the company have been gathering momentum. Right now, lawyers are still in the early stages of fact-gathering, including the potential scale of people impacted. Several lawsuits have been organized, including recent filings in Illinois and California. The number of lawsuits is expected to increase in the coming months after media campaigns have raised awareness of the issue.

What is Oxbryta and how does it work?

Oxbryta is the brand name for the drug voxelotor. It is used as a hemoglobin polymerization inhibitor to treat sickle-cell disease (SCD). The drug works in several ways: It binds to hemoglobin, increasing its ability to carry oxygen; it prevents red blood cells from sickling (mutating into the sickle shape that characterizes SCD); it improves blood flow; and it increases overall hemoglobin levels.

Oxbryta was approved by the FDA in 2019 – it gained approval through its fast-track program – for SCD patients aged 12 or over. Unfortunately, Oxbryta has been associated with causing VOCs, which has led to fatalities. This was backed up by further “post-market” studies, leading to Pfizer’s decision to recall the drug and admission that the dangers may outweigh the benefits of using it to treat SCD.

What is Oxbryta and how does it work?What is Oxbryta and how does it work?

What is Sickle Cell Disease?

Sickle cell disease is a genetic blood disorder. It is caused by changes in the HBB gene, which encodes hemoglobin, creating a mutated form of hemoglobin that encounters difficulty when carrying oxygen around the body. With SCD, the red blood cells mutate into a kind of crescent or sickle shape, hence the name sickle cell disease. There is no universal cure for sickle cell disease, although treatments can manage symptoms and reduce complications. Oxbryta was, however, seen as a breakthrough drug as it tackled the root cause of sickle cell disease.

What is Sickle Cell Disease? What is Sickle Cell Disease?
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Oxbryta Lawsuits Timeline

2019: After several years of development by Global Blood Therapeutics, Oxbryta was given FDA approval. It gained approval through the FDA’s Accelerated Approval Pathway, which fast-tracks drugs that have an impact on life-threatening diseases. Initially, the approval was for patients aged 12 or over, but this was extended to those 4 years and over in 2021.

2022: Pfizer acquires Global Blood Therapeutics, taking over the production and marketing of Oxbryta.

2023: The first safety concerns begin to emerge over Oxbryta. These concerns were a mixture of individual patient reports and post-market studies, i.e., investigations into the drug’s effects after it was brought to the market.

September 2024: Pfizer launches its global recall of Oxbryta, noting that the drug has led to adverse events in patients, including death.

October 2024: The first of several lawsuits is initiated in California against Pfizer & Global Blood Therapeutics.

November 2024: More lawsuits are launched nationwide. Law firms begin campaigning for more people who have suffered from complications after taking Oxbryta to come forward.

Oxbryta Side Effects

Alongside VOCs, there have been many reported side effects from patients taking Oxbryta. These include:

  • Headache
  • Diarrhea
  • Abdominal pain
  • Nausea
  • Rash or hives
  • Fever
  • Fatigue
  • Vomiting
  • Organ damage
  • Acute Chest Syndrome
  • DVT/PE
  • Priapism
  • Splenic Sequestration
  • Death
Pfizer Oxbryta LawsuitPfizer Oxbryta Lawsuit

Oxbryta Deaths

Unfortunately, there have been several deaths associated with Oxbryta. These include 16 deaths during the clinical trials of the drug. 

Oxbryta FDA Approval

Oxbryta first gained approval from the FDA in 2019. This approval was given to sickle cell disease patients aged 12 and over. The approval was extended to sickle cell patients aged four and over in 2021.

Oxbryta FDA Recall

The recall of Oxbryta by Pfizer in September 2024 was voluntary, meaning the company was not compelled to do so by the FDA. The FDA later published information about Oxbryta to warn people of its dangers.

Oxbryta FDA RecallOxbryta FDA Recall

Pfizer Oxbryta Recall

Pfizer made the decision to recall Oxbryta globally in late September 2024. While voluntary, the decision was made among growing pressure in the media and growing concern over the safety of Oxbryta. Pfizer itself was unequivocal in its statement, noting that “the overall benefit of OXBRYTA no longer outweighs the risk in the approved sickle cell patient population,” adding, “The data suggest an imbalance in vaso-occlusive crises and fatal events.”

Oxbryta Lawsuit Settlement

The Oxbryta lawsuits are still at an early stage, so it is unclear how much compensation would be paid to any claimants in a lawsuit settlement. The key issue is what Pfizer and Global Blood Therapeutics knew about the safety of Oxbryta and whether they could have done more to warn patients and healthcare professionals about its risks. Nonetheless, as more people come forward to join the lawsuits, we will get a better idea of the scale of the issue and perhaps get some insight into how much Pfizer will agree to in a potential financial settlement.

Oxbryta Lawsuit FAQs

What Is Oxbryta?

Oxbryta is the brand name for the drug voxelotor.

What Is Oxbryta Used For?

Oxbryta is used to treat people with sickle cell disease.

Who Makes Oxbryta?

Pfizer took over production of Oxbryta in 2022. Before then, it was developed and produced by Global Blood Therapeutics, which Pfizer acquired.

Is Oxbryta Safe?

It seems that Oxbryta is not safe. Pfizer admits that the complications with the drug, including the potential to cause death, outweigh the benefits.

When Was Oxbryta Approved by the FDA?

It was approved by the FDA in November of 2019.

Who is Eligible to File an Oxbryta Lawsuit?

Anyone who has been prescribed Oxbryta to treat sickle cell disease and has suffered an adverse impact, including VOCs, should contact a lawyer for more advice on joining the lawsuits. Families of loved ones who have died or suffered serious injury after using Oxbryta may also be eligible to join the lawsuits.

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If you believe that you or a loved one was harmed by Oxbryta, we can help you fight for your rights and compensation.

We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.
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