Lawsuit Information Center
This page looks at Oxbryta lawsuits and their potential settlement value.
Oxbryta is a prescription drug made by Pfizer that was recalled in September 2024 after evidence revealed that it caused a number of very serious and potentially fatal health problems, including vaso-occlusive crisis and organ damage.
Our firm is currently accepting Oxbryta lawsuits across the country. If you took Oxbryta and suffered serious health complications, contact us today at 800-553-8082 or contact us online.
Oxbryta Lawsuit Timeline
November 30, 2024: Many Saw This Coming
Pfizer’s recent decision to withdraw Oxbryta from global markets is the cap on an ongoing concern about whether this drug is safe. For years before this withdrawal, regulatory agencies and health authorities expressed concerns about Oxbryta’s performance, particularly regarding its cost-effectiveness and clinical benefits.
One of the most vocal agencies was the National Institute for Health and Care Excellence (NICE) in England, which scrutinized Oxbryta during its approval process. In July 2023, NICE rejected the drug for use by Britain’s National Health Service, citing insufficient evidence from clinical trials to justify its cost and efficacy. Even after Pfizer addressed some of these concerns, NICE’s updated draft guidance in February 2024 indicated that issues remained unresolved.
The drug’s market struggles culminated in September 2024, when Pfizer voluntarily withdrew Oxbryta globally, just months after NICE’s updated recommendations. This decision underscores long-standing doubts about the drug’s real-world performance, including its ability to provide meaningful and measurable benefits for patients with sickle cell disease. While Oxbryta was initially heralded as a breakthrough treatment—doctors and patients were overjoyed when Oxbryta came on the market—the drug consistently failed demonstrate, even setting aside the awful risks, significant long-term advantages over existing therapies.
For victims pursuing a Oxbryta’s side effects lawsuit, there is ample fodder to support many viable compensation claims.
November 19, 2024: European Ban
November 9, 2024: New Oxbryta Lawsuit Filed in California
In a new Oxbryta lawsuit filed on Thursday in federal court in California, a plaintiff claims that the sickle cell disease (SCD) medication Oxbryta, developed and marketed by Global Blood Therapeutics. and Pfizer, caused severe health complications,. Specifically, for this man, he experienced an increase in vaso-occlusive crises (VOCs) and a stroke.
According to the complaint, the plaintiff began taking Oxbryta in August 2024 to manage SCD symptoms but soon experienced a worsening of VOCs—painful episodes resulting from blood vessel blockages—which ultimately led to hospitalization following a stroke in September 2024.
The lawsuit alleges that while Pfizer recently recalled Oxbryta due to concerns about its safety, stating that it posed a risk of increased VOCs and fatal outcomes, the manufacturers had known or should have known for some time that the drug could cause such adverse effects.
The plaintiff accuses the defendants of failing to adequately warn or inform the public and prescribers about these risks, claiming that promotional materials misrepresented Oxbryta as a safe treatment option. Seeking damages for strict liability, negligence, breach of warranty, unjust enrichment, and violations of California consumer protection laws, the plaintiff’s counsel aims to hold the defendants accountable for damages related to severe physical and economic harm caused by voxelotor’s design flaws and insufficient warnings. The plaintiff demands compensatory and punitive damages, as well as injunctive relief to prevent further harm to other patients.
November 3, 2024: New Video on Oxbryta Lawsuits and Potential Settlement Amounts
This video discusses these lawsuits and estimates Oxbryta settlement amounts.
September 25, 2024: New Oxbryta Recall
Pfizer announced a voluntary recall of Oxbryta due to emerging data on increased risks of VOCs and fatal events, impacting patients with sickle cell disease.
This decision follows the discovery of troubling new evidence suggesting that Oxbryta may worsen these dangerous complications for some patients.
Oxbryta
Oxbryta (voxelotor) is a prescription medication used to treat individuals with sickle cell disease (SCD). It introduced a novel approach by acting as a hemoglobin S polymerization inhibitor, aiming to prevent red blood cells from sickling by targeting the root cause of the disease. It hard to understand how exciting a development this was for patients and their families when Oxbryta was first introduced.
Available in tablet or liquid form, Oxbryta did not have a generic equivalent. It was developed to reduce complications associated with SCD, a group of inherited red blood cell disorders passed down from a parent.
Oxbryta was granted FDA approval under the accelerated approval pathway in November 2019 for the treatment of SCD in adults and children ages 12 and older. In 2021, it was also approved for children ages 4 to 11. In 2022, GBT was acquired by Pfizer, one of the largest pharmaceutical companies in the world.
It hard, as many of you know first-hand, how exciting a development this was for patients and their families when Oxbryta was first introduced. It was marketed as a “first-of-its-kind” treatment that would address sickling directly by altering hemoglobin. Targeted toward patients aged four and up, it was expected to offer significant quality-of-life improvements and potentially prevent the painful episodes (vaso-occlusive crises or VOCs) common in sickle cell disease. The company really pumped up these benefits. The selling point was that Oxbryta could potentially transform sickle cell disease management by reducing complications like blood clots and organ damage.
Sickle Cell Disease
Sickle cell disease (SCD) is a hereditary blood disorder that affects the hemoglobin within red blood cells. Hemoglobin is a protein responsible for carrying oxygen throughout the body. In individuals with SCD, the hemoglobin is abnormal—called hemoglobin S—leading to red blood cells becoming rigid, sticky, and shaped like a crescent or “sickle” instead of the usual round, flexible shape. These sickle-shaped cells have trouble moving through blood vessels, which can cause blockages and reduce the flow of oxygen to various organs and tissues.
The consequences of these blockages can be severe and wide-ranging. SCD is known to cause extreme pain crises (also called vaso-occlusive crises or VOCs), strokes, organ damage, chronic anemia, and even premature death. Common complications of SCD include acute chest syndrome, where blocked blood vessels in the lungs lead to shortness of breath, chest pain, and fever; organ failure, especially of the spleen, liver, and kidneys; and frequent infections due to a weakened immune system.
Treatment for SCD has traditionally focused on managing symptoms and preventing complications. This includes pain management, blood transfusions, and medications like hydroxycarbamide, which can reduce the frequency of painful episodes. However, there is no universal cure for SCD. Advances in gene therapy and other targeted treatments offer hope for the future, but for many, the disease remains a life-long struggle requiring complex, multi-faceted care.
Oxbryta Was Thought to Be A Huge Innovation
Oxbryta was developed as a potential treatment to help manage these complications by targeting hemoglobin polymerization, which prevents the abnormal sickling of red blood cells. The drug’s goal was to improve the flexibility of red blood cells and reduce the blockages that cause pain and other symptoms. Often prescribed in combination with hydroxycarbamide, a chemotherapy drug used to lessen painful episodes and reduce blood transfusion needs, Oxbryta aimed to improve blood flow and reduce the serious risks associated with sickle cell disease.
The active ingredient in Oxbryta, voxelotor, works by binding to hemoglobin to stabilize it, thereby preventing clumping and promoting normal red blood cell function. This would theoretically improve circulation, lower blood viscosity, and reduce the debilitating complications of SCD.
So Oxbryta was marketed as a first-of-its-kind oral medication that could reduce sickling, improving patient quality of life by addressing sickling at its source. It was touted as reducing the number of sickle cells in the bloodstream and helping with oxygen transport.
Oxbryta’s FDA Approval Process
In 2021, the FDA further expanded Oxbryta’s approval to include children as young as 4 years old after reviewing data from another trial, the HOPE-KIDS study. This study showed similarly encouraging outcomes, demonstrating the drug’s effectiveness and safety in younger patients. The success of the HOPE clinical trials enabled GBT to bypass some of the more detailed scrutiny and prolonged investigation typically required during the FDA’s traditional drug approval process.
There was a price to be paid for this accelerated process. While this expedited pathway allowed for earlier access to a potentially life-changing treatment for sickle cell disease, it also meant that certain long-term safety and efficacy data might not have been fully explored at the time of its initial approval.
Evidence Links Oxbryta to Serious Health Problems
Oxbryta was approved for the treatment of sickle cell disease. Again, the two primary health risks of sickle cell disease are vaso-occlusive crises (VOCs) and death. VOCs are a serious and very painful complication caused by sickle cell blood flow blockages. Not long after the release of Oxbryta, however, it became very clear that the drug actually increased the risk of VOCs and death in patients.
Concerns emerged almost immediately after Oxbryta was released on the market. Data from post-marketing studies and clinical trials indicated that Oxbryta’s risks might outweigh its benefits. Notably, these studies revealed a higher rate of VOCs and even deaths among patients taking Oxbryta.
Post-release clinical trials, including Study GBT440-032 and Study GBT440-042, showed that patients on Oxbryta experienced an increase in severe adverse events. Specifically, in one trial, eight deaths were reported in the Oxbryta group compared to just two in the placebo group.
In another study involving patients with leg ulcers, there were eight reported deaths. These findings indicated a significant and unexpected safety risk, prompting regulators and the European Medicines Agency to investigate further.
Oxbryta Recall
The concerning findings in the post-release studies and from patient data prompted Pfizer to voluntarily recall all lots of Oxbryta worldwide in September 2024. Pfizer also suspended both distribution and clinical trials, explaining that recent data showed an imbalance of vaso-occlusive crises and “fatal events” that necessitated further assessment.
So, essentially, Pfizer recalled all lots of Oxbryta after clinical data revealed that the risks associated with the treatment no longer outweighed its benefits for patient populations. Earlier in the summer, European regulators had flagged an unusually high number of deaths and pain-related incidents, leading to the suspension of the medication’s approval just one day after Pfizer’s recall announcement.
The recall is a big deal, especially given the high level of marketing investment and patient dependence on the drug.
Oxbryta Lawsuits
The recall of Oxbryta is expect to give rise to a wave of Oxbryta product liability lawsuits against Pfizer. The first Oxbryta lawsuits have already been filed and hundreds more are expected to get filed moving forward. Anyone who took the drug and suffered adverse health consequences, such as increased VOCs or organ failure may be eligible to file a lawsuit and get compensation.
Oxbryta lawsuits allege that the companies failed to adequately warn patients and healthcare providers of the risks of vaso-occlusive crises, death, and other complications associated with the drug. The lawsuits claim that Global Blood Therapeutics and Pfizer knew or should have known about these risks long before the recall and that their failure to disclose the potential harms of Oxbryta to both users and prescribers constituted negligence.
So these lawsuits allege that the defendants knew or should have known of the risks associated with Oxbryta but failed to adequately warn consumers and doctors. Causes of action include strict liability for design defect and failure to warn, negligence, breach of warranties, and violations of California consumer protection laws, including false advertising.
Additionally, claims suggest that the company’s extensive promotional materials misrepresented the drug’s safety profile by minimizing its serious risks, leading many patients to rely on the drug under the assumption it was safer than it was.
Every Oxbryta lawsuit drills down on these facts:
- Increased VOCs and Mortality: Studies indicated an imbalance in VOCs and an increase in mortality for patients on Oxbryta, contrary to its intended purpose of reducing SCD-related complications.
- Accelerated Approval Risks: The drug was approved based on limited, intermediate endpoints under the FDA’s accelerated pathway, which requires post-marketing studies to verify long-term safety and efficacy. Critics argue that the drug’s safety profile was insufficiently established before market entry.
- Inadequate Warnings: Plaintiffs argue that the risks were known or should have been known by Global Blood Therapeutics and that failing to provide adequate warnings constituted a breach of duty toward patients and prescribers.
- Promotional Misrepresentation: The plaintiffs claim that Oxbryta was marketed aggressively with promises of reducing “sickling at its source,” creating a potentially misleading perception of safety that may have influenced patient decisions and treatment protocols.
Plaintiffs’ Oxbryta attorneys will argue that Pfizer and Global Blood Therapeutics should be held accountable for the harm caused by Oxbryta. They will contend that the companies failed in their duty to properly design, manufacture, test, and market the drug, and that they deliberately or negligently misled the public about the risks associated with its use.
In seeking damages, plaintiffs’ lawyers will aim to obtain compensation for the physical, emotional, and financial suffering caused by the medication, as well as punitive damages to punish the companies for their reckless behavior and to deter future misconduct.
Who is Eligible to File an Oxbryta Lawsuit
Our firm is currently seeking and accepting Oxbryta lawsuits across the country from anyone who meets the following eligibility criteria:
- You took Oxbryta for at least 2 months
- After you began taking Oxbryta, you suffered any of the following health problems:
- a vaso-occlusive crisis (VOC)
- Organ damage
- Stroke
- Death
Oxbryta Lawsuit Settlement Amounts
One thing that works in your favor is that there likely won’t be a huge number of lawsuits. Oxbryta hasn’t been on the market for long, so the volume of cases may remain relatively low. This could be a benefit for you. With fewer lawsuits to handle, Pfizer is in a strong position to offer fair settlements breaking the bank.
For the more serious injuries—cases where victims have suffered significant harm—our lawyers believe the potential settlement value could range from $400,000 to $1 million. Of course, if your case involves less severe complications, the payout will likely be lower, but still substantial. Our attorneys are optimistic about this new litigation and believe there’s a good chance that victims like you will receive fair and reasonable compensation.
How long will a Oxbryta settlement take? These cases may not drag on for years, as is often the case in mass torts. Why? Pfizer seems to understand the gravity of its mistake here, and there is a decent chance it want to settle these cases more quickly than you might expect. That means you could see resolution in a much shorter time frame to settlement than is typical in other product liability lawsuits.
Contact Us About an Oxbrtya Lawsuit
If you were injured by Oxbryta, contact our national product liability lawyers today to see if you have a case. Call us at 800-553-8082 or contact us online.