Oxbryta Lawsuits: Issues After Voluntary Recall (2025)
Contributor
Reviewed By Adam Ramirez, J.D.
Editor
Summary
- Oxbryta was approved to treat sickle cell anemia
- Pfizer, the drug’s manufacturer, voluntarily recalled it after user deaths
- An Oxbryta lawsuit could compensate injured patients and their families
Oxbryta was supposed to be a revolutionary treatment for sickle cell anemia — the FDA even granted accelerated approval to the medication in 2019 based on its likely effectiveness. However, Pfizer voluntarily recalled it in 2024 after studies revealed that patients taking the medication were more likely to die than those taking a placebo.
This situation has just come to light. As a result, patients and their lawyers are in the earliest stages of determining whether to take legal action. If you can establish a causal link between your injuries and Pfizer’s drug, you’re eligible to file an Oxbryta lawsuit.
ConsumerShield helps injured consumers find lawyers for product liability cases. Contact us for a free case review and lawyer referral.
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Sickle Cell Anemia and Oxbryta
Sickle cell anemia is a genetic disease that affects the blood.
Normally, red blood cells are disc-shaped. However, those with sickle cell anemia have crescent-shaped red blood cells. This physical difference has profound effects. The cells can get stuck in blood vessels, causing a vaso-occlusive crisis (VOC). These episodes can cause the following injuries:
- Stroke
- Kidney damage
- Chronic pain
- Lung problems
- Eye problems
Oxbryta changes the chemistry of blood cells to make them less likely to stick together. The idea is that if blood cells were better bonded to the oxygen they carried, they would be less likely to clump.
Since VOCs produce many of the harmful effects of sickle cell anemia, this reduction was supposed to reduce symptoms, as well as the organ damage and deaths that could result from them.
Grounds for the Oxbryta Recall
Neither Pfizer nor independent researchers have identified what went wrong with Oxbryta. Instead, the company voluntarily recalled the medication after internal studies revealed troubling data. The grounds for recalling the drug included the following:
First, a study of children taking the drug reported eight deaths in the Oxbryta group and two in the control group. Second, a study of adolescents and adults taking the drug reported eight deaths. Finally, monitoring reports of users outside the study found that patients using Oxbryta had an increased risk of stroke and chronic pain.
Pfizer voluntarily recalled Oxbryta on the strength of this evidence. It notified the FDA, which advised doctors to stop prescribing the medication. It also informed the European Medicines Agency, which recommended suspending the medication’s approval.
Pfizer recommended that patients consult their doctors about alternative treatments. However, it did not explicitly advise them to stop taking any Oxbryta they had already received.
Will There Be an Oxbryta Class Action Lawsuit?
There is currently no class action lawsuit against Pfizer for injuries caused by Oxbryta. A class action lawsuit allows multiple people with similar injuries to form a single group (a “class”) to sue the entity that caused them.
However, class actions aren’t as popular as they used to be. Instead, many product liability claims are brought in individual federal lawsuits that are transferred to a single federal court. This process, which is known as multidistrict litigation (MDL), provides many of the benefits of a class action lawsuit while avoiding its drawbacks.
One distinct downside of a class action lawsuit is that the settlement or damage award is shared across the entire class.
In an MDL, cases remain separate and are settled individually. However, plaintiffs can work together on discovery and motions. Moreover, the manufacturer can offer a global settlement, but each plaintiff can choose whether to accept it or continue their case.
Pfizer could face product liability litigation because of the serious health problems patients allegedly suffered. These lawsuits will claim product liability. The law of most states makes manufacturers strictly liable for injuries their defective products cause. This liability applies regardless of the manufacturer’s intent or knowledge of the defect.
In this case, plaintiffs could allege that Oxbryta had a defective design or inadequate warnings. A faulty design claim would assert that the medication failed to suppress symptoms and, in fact, worsened them in many cases. Thus, there was no safe way to use the drug to perform its intended function.
A failure-to-warn claim would assert that Pfizer didn’t warn doctors or patients of the risks involved. The merit of such a claim would likely rely on the accelerated approval obtained in the U.S., which suggests that Pfizer rushed the testing process and couldn’t adequately advise users of the medication’s risks.
Possible Oxbryta Settlement Amounts
Pfizer and its patients are still learning about the scope of the risk posed by Oxbryta. As such, there currently isn’t enough information to predict possible settlement amounts. That said, if a few lawsuits succeed, Pfizer may find the motivation to offer a global settlement to users who meet certain criteria.
The settlement will likely set up tiers based on consumers’ ages, earnings, and injuries.
Patients with permanent organ damage will likely qualify for higher settlements than those who experienced chronic pain until they stopped taking Oxbryta. Younger patients might be entitled to larger settlements when their injuries affect their earning capacities. The families of patients who died would probably receive the highest settlements.
Contact ConsumerShield to Learn More About Product Liability
Pfizer’s Oxbryta medication was recalled because it failed to treat sickle cell anemia and may have exacerbated some patients’ symptoms. However, more legal investigation and analysis are needed to determine the manufacturer’s liability.
ConsumerShield can educate you about your legal rights after suffering an injury due to defective products. Contact us today to learn more about product liability and get help finding a lawyer.
Frequently Asked Questions
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Oxbryta allegedly fails to reduce sickle cell anemia symptoms and may cause strokes and kidney damage. Consider talking to a product liability attorney if you’ve suffered permanent injuries to your brain or kidneys while taking Oxbryta or if one of your loved ones has died while using the medication.
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Pfizer has identified at least 16 deaths in medication users. It hasn’t yet been determined whether Oxbryta caused those deaths. However, one study saw eight deaths in the Oxbryta group and only two in the control group. Based on these results, injured users and their families are filing lawsuits.
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Since the drug was recalled in 2024 and lawsuits are just starting, no one can predict when or whether Pfizer will settle them. If the settlements come to fruition, patients with permanent injuries, such as kidney damage, and families who have lost loved ones will likely receive the greatest awards.
