On September 26, 2024, the United States Food & Drug Administration (FDA) alerted patients, caregivers, and health care professionals that Pfizer issued a voluntary recall of Oxbryta. This decision was based on postmarketing clinical trial data indicating that the risks of Oxbryta outweigh its benefits for sickle cell patients.
If you took Oxbryta, and you developed vaso-occlusive crisis, you experienced a stroke, organ failure, or a heart attack, or your loved one died after taking the medication, you can still file a lawsuit against Pfizer.
A drug recall does not absolve the manufacturer of liability for victims’ losses.
Big pharma thinks they can get away with putting people’s lives at risk. They’re counting on you to stay quiet and confused about your rights. That’s where Ankin Law comes in. We’ve recovered millions for our clients in pharmaceutical cases, and We’re ready to fight for you too. Contact us online or call 312-600-0000 to schedule a free consultation. Let’s get started with your claim.
Understanding the Oxbryta Recall
If you took Oxbryta and now have questions about your rights, you’re not alone. You trusted Pfizer’s medication. They betrayed that trust. You deserve answers. Your case demands experienced attorneys to help you learn more about the Oxbryta recall and your legal options for seeking compensation.
Oxbryta (voxelotor) is a prescription medication used to treat sickle cell disease by preventing red blood cells from sickling. The medication was initially approved under the FDA’s accelerated approval pathway, but recent safety concerns have led to its voluntary withdrawal from the market.
The FDA’s Accelerated Approval Pathway is essentially a shortcut that allows drug companies like Pfizer to push medications onto the market before they’ve been fully proven safe and effective. Instead of requiring long-term clinical data, the FDA grants approval based on preliminary evidence, like lab results or short-term studies, often relying on surrogate endpoints rather than actual patient outcomes.
This system prioritizes speed over patient safety. These drugs can be widely prescribed before anyone really knows the full risks. While manufacturers are supposed to conduct follow-up studies, many drag their feet or fail to complete them—leaving patients exposed to dangerous side effects for years. In some cases, drugs approved this way have later been recalled or slapped with black box warnings after causing serious harm.
At the end of the day, the Accelerated Approval Pathway is a win for Big Pharma and a gamble for patients, who are often left paying the price—both financially and with their health. That’s what happened with Oxbryta.
Key Reasons for the Oxbryta Recall
- Higher rates of vaso-occlusive crises (VOC) – Clinical trials revealed that patients taking Oxbryta experienced more frequent and severe VOC episodes, which occur when sickled red blood cells block blood flow and oxygen delivery to tissues, causing extreme pain.
- Increased mortality – Studies showed that more deaths occurred among Oxbryta patients compared to those receiving a placebo.
- Postmarketing real-world data – Additional registry studies confirmed higher risks of VOC and adverse events in Oxbryta users.
Pfizer has ceased distribution, discontinued all active clinical trials, and shut down expanded access programs for the drug. The FDA is currently conducting a safety review of the postmarketing clinical trial data, real-world registry studies, and reports from the FDA Adverse Event Reporting System (FAERS). Additional findings may be released after the agency’s review is completed.
What Are the Health Risks Associated With Oxbryta?
Due to the risks identified in clinical trials and real-world studies, patients who took Oxbryta may face severe health complications, including:
- Vaso-occlusive crises (VOC) – Sudden and severe pain episodes due to blocked blood flow.
- Increased risk of death – Higher mortality rates compared to placebo groups.
- Worsening of sickle cell symptoms – Instead of providing relief, some patients experienced an exacerbation of their condition.
- Long-term complications – Unforeseen health effects may arise due to extended use of Oxbryta before its withdrawal.
Legal Options for Victims: Filing a Lawsuit After the Oxbryta Recall
If you suffered harm due to the use of Oxbryta, it’s time to hold Pfizer accountable. You can still file a product liability lawsuit against Pfizer, even though they issued a voluntary recall of the medication. Why? Because they breached their duty to you when they allowed Oxbryta to go on the market before making sure it was safe.
If Oxbryta caused harm to you or your loved one due to its defects, you might be able to pursue compensation under one or more legal theories including negligence, strict liability, breach of implied warranty, and others. Currently, most claims against the pharmaceutical company involve:
Defective design – If the formulation of Oxbryta was inherently dangerous, you can sue Pfizer for the defective design.
Failure to warn – If Pfizer did not adequately warn you of the risks before the Oxbryta recall, and you suffered injuries, you may have a product liability lawsuit.
Negligence – If Pfizer failed to act responsibly in testing Oxbryta, warning the public about the risks, or removing Oxbryta from the market in a timely manner, you may have a negligence claim.
Medical Malpractice – If your healthcare provider continued prescribing Oxbryta when they knew about the safety concerns, or they failed to inform you of the risks, you might have a medical malpractice case.
Who Can File a Lawsuit Against Pfizer for Oxbryta Injuries?
Anyone who suffered harm due to Oxbryta could be eligible to file a lawsuit against Pfizer. This includes patients who experienced severe side effects, such as vaso-occlusive crises (VOC) or worsening sickle cell symptoms instead of the intended improvement, and those who developed life-threatening complications that required hospitalization. Additionally, individuals who faced financial losses due to Oxbryta side effects, such as high medical expenses or lost wages, may have grounds for legal action.
Family members of deceased patients may also pursue compensation through a wrongful death lawsuit if their loved one passed away due to complications linked to Oxbryta. In such cases, compensation may be available for funeral expenses, loss of financial support, and emotional suffering.
Participants in Oxbryta’s clinical trials or expanded access programs who suffered unexpected adverse effects could also be eligible to file a claim. Pfizer’s decision to withdraw Oxbryta suggests that the company may have failed to adequately assess the risks before making the drug widely available.
What Compensation Is Available to Patients Affected By the Oxbryta Recall?
Patients affected by the Oxbryta recall may be entitled to compensation for the harm they suffered due to the drug’s side effects. Depending on the circumstances of the case, financial recovery may include economic damages like medical expenses and lost wages, pain and suffering damages, and, in severe cases, wrongful death damages.
Medical Expenses – Medical expenses are a primary form of compensation, covering costs for hospital visits, treatments, prescription medications, and any long-term care needed due to Oxbryta complications. Patients who experienced severe vaso-occlusive crises or other adverse effects may have required extensive medical intervention, leading to significant financial burdens. A successful claim can provide compensation to help cover past and future medical costs associated with treating these complications.
Lost Income – Lost wages and loss of earning capacity may also be recoverable. Patients who had to miss work due to their injuries or who are now unable to return to their previous employment because of ongoing health issues may seek compensation for the income they lost. This can also apply to individuals whose ability to work in the future has been permanently affected by Oxbryta’s side effects.
Pain and Suffering – Pain and suffering damages may be available for the physical and emotional distress caused by Oxbryta-related health issues. This includes compensation for chronic pain, emotional trauma, and the overall impact on a patient’s quality of life. In cases where a patient’s health significantly deteriorated due to Oxbryta, non-economic damages may play a crucial role in achieving fair compensation.
Wrongful Death Damages – For families who lost a loved one due to complications linked to Oxbryta, wrongful death damages may be available. These damages can include funeral and burial expenses, loss of financial support, and the emotional suffering endured by surviving family members. If Pfizer is found to have acted with gross negligence in failing to warn the public about Oxbryta’s risks, punitive damages may also be pursued to hold the company accountable.
Do You Need to Hire a Lawyer if You Were Impacted By the Oxbryta Recall?
Hiring an experienced mass tort lawyer is crucial if you or a loved one suffered harm due to Oxbryta. You might be thinking that you can take on Pfizer by yourself, just because they did a “voluntary” recall, but that’s not the case. These pharmaceutical giants have armies of lawyers whose only job is to minimize your claim or shut you down completely.
Legally, you don’t “need” a lawyer to sue Pfizer. You also don’t “need” a parachute to skydive – but we wouldn’t recommend trying it without one.
Put decades of experience and a track record of winning against Big Pharma to work for you. These types of cases are Ankin Law’s battlefield. We know the tricks, the loopholes, and the tactics these companies use to dodge responsibility. In fact, they’re already building their defense.
How Will a Lawyer Help?
Your lawyer will evaluate your case by reviewing your medical history, prescription records, and any adverse effects you experienced while taking Oxbryta. They will also establish a link between the medication and your injuries, which is essential for proving liability. Additionally, your attorney will determine the full scope of your damages, including medical expenses, lost wages, pain and suffering, and, in wrongful death cases, compensation for surviving family members.
Your lawyer will level the playing field by negotiating with Pfizer and their legal team or, if necessary, taking the case to court. Experience lawyers will employ the legal strategies needed to hold Pfizer accountable, whether through product liability claims, negligence allegations, or wrongful death lawsuits.
How Long Do You Have to File an Oxbryta Lawsuit?
If you or a loved one suffered injuries due to Oxbryta, it is crucial to act quickly because personal injury and product liability claims are subject to strict legal deadlines known as statutes of limitations.
The time limit to file a lawsuit against Pfizer for injuries caused by Oxbryta depends on the type of claim and the state where you live. In most cases:
- Product Liability & Personal Injury Claims – Many states have a two-year statute of limitations for product liability claims involving personal injuries. If you miss the window to sue Pfizer after discovering the cause of your injuries, you will forfeit your right to recover compensation.
- Wrongful Death Claims – If a family member died due to complications linked to Oxbryta, surviving relatives may have the right to file a wrongful death lawsuit. The deadline for these claims is typically two years from the date of death, but this varies by state.
- Exceptions & Discovery Rule – Some states allow an extended filing deadline under the discovery rule, which applies when an injury is not immediately apparent. If a patient did not realize that Oxbryta caused their health complications until later, the clock may start from the date the injury was discovered.
Because statutes of limitations vary by state and case type, it’s important to consult with an experienced product liability lawyer as soon as possible. Ankin Law in Chicago can help determine the exact deadline for your case.
Getting started with your injury claim is the only way to win. The consultation is free. Legal advice about the Oxbryta case is priceless.