Eligible for a Oxbryta lawsuit?
Oxbryta Lawsuit
UPDATES AND RECALL INFORMATION
LAWSUIT STATUS: New Cases Being Investigated
Yes. Oxbryta lawsuits are being investigated after Pfizer withdrew its sickle cell disease drug from the market after a number of patients experienced vaso-occlusive crises (VCO) and other serious side effects.
Financial compensation may be available through an Oxbryta recall settlement for individuals who experienced any of the following injuries:
- Vaso-occlusive crises (VOCs)
- Stroke
- Severe pain and swelling
- Wrongful Death
UPDATED: December 2024
Oxbryta Lawsuit Overview
Oxbryta (voxelotor) is a prescription drug introduced in 2019 for the treatment of sickle cell anemia, which is a genetic disorder that affects red blood cells, causing them to assume a sickle shape that blocks blood flow and leads to severe pain and potential organ damage.
The drug was approved by the U.S. Food and Drug Administration (FDA) through an accelerated approval process after it was developed by Global Blood Therapeutics, Inc., which was acquired by Pfizer in October 2022.
Following a number of deaths and other life-threatening injuries, an Oxbryta recall was announced by Pfizer in September 2024, warning that a number of sickle cell patients have experienced vaso-occlusive crises (VOCs) and other side effects.
Oxbryta recall lawsuits are now being investigated by lawyers nationwide, alleging that the manufacturers failed to adequately investigate the safety of the drug, indicating that Pfizer and Global Blood Therapeutics knew, or should have known, about the serious risks and potential for VOC side effects from Oxbryta.
Who is Eligible for an Oxbryta Lawsuit?
Lawyers are pursuing Oxbryta lawsuit settlements for individuals who were prescribed the drug for the treatment of sickle cell disease and developed any of the following side effects, injuries, or severe complications:
- Vaso-occlusive crises (VOCs)
- Stroke
- Severe pain and swelling
- Death
Oxbryta Lawsuit
Were you prescribed Oxbryta?
Oxbryta lawsuits are being filed for sickle cell disease patients who developed vaso-occlusive crises (VOCs), strokes and other side effects caused by recalled Oxbryta.
SEE IF YOU QUALIFY FOR COMPENSATION2024 Oxbryta Lawsuit Updates
November 13, 2024 Update: According to the FDA’s Adverse Event Reporting System (FAERS), a total of 307 deaths have been linked to Oxbryta since the drug became available on the market in 2019, with the total number of reported Oxbryta fatalities remaining significant each year since the drug was introduced. While clinical trials have recently shed light on the risk of Oxbryta fatalities, critics have speculated that the drug manufacturers may have been aware of Oxbryta deaths for years before the recall was issued.
November 1, 2024 Update: As many Oxbryta patients are just now learning about the potential side effects of the sickle cell disease drug following the September 2024 recall, individuals are continuing to seek legal advice to determine whether they may qualify for an Oxbryta recall lawsuit. If you took Oxbryta and suffered side effects, submit information for review by a lawyer who will provide a free consultation to help you understand you options.
October 23, 2024 Update: The first of what is expected to be many Oxbryta lawsuits was filed this week by a California man, who claims that his use of the sickle cell disease drug caused him to develop vaso-occlusive crises, and a stroke that has left him with vision and loss of the ability to drive or perform normal daily activities.
October 2, 2024 Update: Following the Oxbryta recall issued last week, lawyers are now investigating Oxbryta lawsuits over the drug manufacturer’s potential failure to adequately warn about the risks of vascular injuries.
September 25, 2024 Update: Pfizer has issued a global market withdrawal of its sickle cell disease drug, Oxbryta, following a rising number of individuals developing vaso-occlusive crises (VOCs) and other life-threatening injuries.
Oxbryta Recall Over Serious Risks and Side Effects
Pfizer announced the Oxbryta recall on September 25, 2024, after emerging data revealed an increased occurrence of vaso-occlusive crises and fatal events among patients taking the medication, stating:
“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.”
According to an FDA drug alert notice issued just a day later, postmarketing clinical trials have identified that patients taking Oxbryta for sickle cell disease treatment experienced a higher rate of vaso-occlusive crises compared to those receiving a placebo.
Additionally, the FDA announced that it has been monitoring Oxbryta side effects from real-world registry studies, as well as postmarketing data from the FDA Adverse Event Reporting System (FAERS), and confirmed that the number of deaths was greater in the Oxbryta treatment group than in the placebo group.
Oxbryta Side Effects
Oxbryta lawsuits claim that the drug manufacturer was aware of the risks of VOCs and death associated with Oxbryta. However, rather than warning users and the medical community, the drug makers continued to engage in misleading marketing and advertising by claiming that Oxbryta would lead to “less sickling.”
Oxbryta Vaso-Occlusive Crisis Side Effects
Vaso-Occlusive Crisis (VOC) is a severe complication associated with sickle cell disease, where sickled red blood cells, which are rigid and crescent-shaped, block blood flow through tiny blood vessels. In contrast, normal red blood cells are round and flexible, allowing for effective movement through blood vessels and efficient oxygen delivery throughout the body.
This blockage disrupts normal blood flow and oxygen delivery, leading to pain and potential damage to tissues and organs.
Sickle cell crisis are the most common reason for emergency hospital admissions among patients with sickle cell disease, due to the intense pain and complications they can cause.
Lawsuits claim that Oxbryta was purported to help manage sickle cell disease by increasing the affinity of hemoglobin for oxygen, which theoretically should help prevent the sickling of red blood cells.
However, lawsuits claim that Oxbryta failed to prevent, and potentially exacerbated, the occurrence of vaso-occlusive crises and potentially fatal outcomes associated with these events but did not adequately warn users of these risks.
Symptoms of Vaso-Occlusive Crises include:
- Severe pain, often described as sharp, intense, or stabbing, typically occurring in the chest, abdomen, limbs, and joints.
- Swelling, particularly in the hands and feet, due to blocked blood flow.
- Fever, as a response to inflammation or infection secondary to tissue damage from blocked blood flow.
- Fatigue, due to anemia and the body’s effort to manage the crisis.
- Pale skin or jaundice, indicating liver involvement or excessive breakdown of red blood cells.
- Shortness of breath, due to decreased oxygen delivery and potential acute chest syndrome, a serious lung-related complication.
Oxbryta Stroke Side Effects
A stroke is a serious medical condition that occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. Brain cells can begin to die within minutes.
In patients with the genetic blood disorder sickle cell disease, strokes can be a consequence of vaso-occlusive crises (VOCs), where the sickled cells block the small blood vessels leading to the brain, causing an ischemic stroke.
Lawsuits claim that Oxbryta not only failed to prevent strokes, which are a known severe complication of sickle cell disease, but may have actually increased the risk of their occurrence, as well as the development of subsequent adverse health effects following a stroke.
Symptoms of Stroke from Oxbryta may include:
- Sudden numbness or weakness in the face, arm, or leg, especially on one side of the body.
- Confusion, trouble speaking, or difficulty understanding speech.
- Trouble seeing in one or both eyes.
- Trouble walking, dizziness, loss of balance, or lack of coordination.
- Severe headache with no known cause.
- Sudden severe alteration in consciousness or responsiveness.
Oxbryta Pain and Swelling Side Effects
Severe pain and swelling are commonly associated with sickle cell disease due to vaso-occlusive crises (VOCs), where sickled red blood cells block blood flow, causing tissue ischemia and inflammation.
Oxbryta lawsuits claim that the drug not only failed to alleviate these symptoms but may have exacerbated them due to the increase in VOC occurrences or other adverse effects on the body’s vascular and immune systems.
Symptoms of Severe Pain and Swelling from Oxbryta include:
- Intense, sharp pain typically occurring in the bones, joints, and soft tissues.
- Swelling in extremities or joints, often accompanied by tenderness.
- Increased warmth in the swollen areas, sometimes associated with redness.
- Reduced mobility in affected areas due to pain and swelling.
- Prolonged duration of painful episodes, potentially lasting for hours to days.
Share Your Story
Did you suffer injuries while taking Oxbryta? Share your story with AboutLawsuits.com and have your comments reviewed by a lawyer to determine if you may be eligible for a lawsuit.
Oxbryta Lawsuit Examples
Oxbryta VOC and Stroke Lawsuit
Trebor Hardiman filed an Oxbryta lawsuit against Global Blood Therapeutics, Inc., in the Superior Court of the State of California for the County of San Francisco on October 23, 2024, naming Global Blood Therapeutics, Inc. as the defendant.
In the complaint, Hardiman alleges that Oxbryta caused him to develop severe health issues, including multiple vaso-occlusive crises and a stroke. The complaint presents claims of strict liability for design defect and failure to warn, negligence, breach of warranties, unjust enrichment, and false advertising.
The lawsuit seeks compensatory and punitive damages, claiming that the drug maker knew or should have known about the potential risks of Oxbryta side effects, but failed to adequately inform consumers.
Oxbryta Lawsuit FAQ’s
What is sickle cell anemia?
Sickle cell disease is a group of inherited red blood cell disorders characterized by the presence of an abnormal form of hemoglobin called hemoglobin S. In sickle cell disease, the red blood cells become hard and sticky and are shaped like a sickle. These cells can block blood flow, causing pain and potential damage to organs.
What causes sickle cell disease?
Sickle cell disease is a genetic blood disorder caused by a mutation in the gene that tells the body how to make hemoglobin, the protein in red blood cells that carries oxygen. The disease is inherited in an autosomal recessive pattern, which means both parents must pass on the faulty gene for their child to be affected.
What are the symptoms of sickle cell disease?
Symptoms of sickle cell disease can vary and may include severe pain, anemia, swelling in the hands and feet, frequent infections, delayed growth, and vision problems. The severity of symptoms can differ from one person to another and can lead to life-threatening complications.
How is sickle cell disease diagnosed?
Sickle cell disease is typically diagnosed through a blood test that checks for the presence of hemoglobin S. In many countries, this screening is part of routine newborn screening tests. Diagnosis can also be done before birth through prenatal testing.
What are the treatments for sickle cell disease?
Treatment options for sickle cell disease include a variety of medications such as Hydroxyurea, Endari (L-glutamine oral powder), and Oxbryta (voxelotor), which are used to manage the disease and its symptoms.
Blood transfusions and, in some cases, a bone marrow or stem cell transplant, are also potential treatments. Managing pain, preventing infections, and conducting regular medical checkups are crucial parts of managing sickle cell disease. These treatments aim to reduce the frequency of pain crises, minimize organ damage, and improve the quality of life for those affected.
What is Oxbryta?
Oxbryta (voxelotor) was a prescription medication approved by the FDA in 2019 for the treatment of sickle cell disease in adults and children aged 4 years and older. It works by modifying hemoglobin, the protein in red blood cells that carries oxygen, to increase its affinity for oxygen.
This action helps prevent the red blood cells from assuming a sickle shape and blocking blood vessels, which is a common issue in sickle cell disease. Oxbryta is designed to reduce the occurrence of vaso-occlusive crises, which are painful episodes caused by blocked blood flow due to sickled cells.
In September 2024, Oxbryta was recalled from the market due to serious health side effects.
How Does Oxbryta Work?
Oxbryta (voxelotor) addressed sickle cell disease by interacting with hemoglobin, the oxygen-carrying protein in red blood cells. In sickle cell disease, hemoglobin tends to clump together once it releases oxygen, which makes the red blood cells rigid and deformed into a sickle shape. These malformed cells can obstruct blood vessels, leading to vaso-occlusive crises characterized by intense pain and potential organ damage.
The drug works by binding to hemoglobin, increasing its affinity for oxygen and thereby stabilizing its oxygenated form. This interaction is intended to reduce the clumping of hemoglobin molecules, preventing the red blood cells from adopting their characteristic sickle shape. Although this process theoretically helps maintain red blood cells in a more normal, flexible state to promote smoother blood flow, concerns have been raised about its effectiveness and safety in preventing complications traditionally associated with sickle cell disease, such as vaso-occlusive events.
What are the common side effects of Oxbryta?
Oxbryta (voxelotor) is used to treat sickle cell disease, and like any medication, it can cause side effects. Some of the known side effects of Oxbryta include:
- Headache – This is one of the most commonly reported side effects.
- Diarrhea – Some patients may experience gastrointestinal disturbances.
- Fatigue – Patients may feel unusually tired or weak.
- Nausea – This can occur with or without vomiting.
- Rash – Some patients might notice skin rashes.
- Fever – Elevated body temperature may occasionally occur.
- Abdominal Pain – Discomfort or pain in the abdomen has been reported.
- Jaundice – Yellowing of the skin or eyes due to elevated bilirubin levels.
- Itching – Generalized itching without a rash is another possible side effect.
- Dizziness – Some patients might feel light-headed or dizzy.
In September 2024, an Oxbryta recall was issued due to the risk that users may face an increased risk of vaso-occlusive crises (VOC) side effects, which are rare, but may cause life-threatening injuries.
What compensation can I claim in the Oxbryta lawsuit?
Plaintiffs pursuing Oxbryta lawsuits may be eligible for compensation for medical expenses, pain and suffering, lost wages, and other damages resulting from VOCs or strokes caused by the drug. The exact compensation will depend on the individual case details.
How long do I have to file a claim regarding Oxbryta side effects?
The time limit to file an Oxbryta lawsuit, known as the statute of limitations, varies by state. It is crucial to consult with a legal professional promptly to ensure your claim is filed within the legal deadlines applicable in your jurisdiction.
Oxbryta Lawyers Reviewing Cases Nationwide
Oxbryta lawyers provide free consultations and claim evaluations for individuals who have suffered injuries caused by Oxbryta.
To determine whether you or a loved one may be eligible for an Oxbryta lawsuit, submit information about your potential claim for review by a personal injury lawyer to determine whether a settlement or lawsuit payout may be available. There are no fees or expenses unless a recovery is obtained in your case.
Free Case Evaluation
If you or a loved one developed side effects from Oxbryta, submit information for review by a lawyer to determine if you may be eligible for an Oxbryta lawsuit settlement.
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