Oxbryta Lawsuit

People taking Oxbryta (voxelotor) to manage sickle cell disease may be at risk of serious and potentially life-threatening health complications.

Several studies have linked this medication, once seen as a major breakthrough treatment, to vaso-occlusive crises, organ damage, stroke, kidney failure, or other severe injuries. In September 2024, Oxbryta was pulled from the market after new safety concerns came to light.

Many trusted Oxbryta to improve their health. However, patients and their families have been left devastated by injuries that have only worsened their condition. People are now filing lawsuits following the Oxbryta recall to recover compensation for their injuries and to hold Pfizer accountable to stop similar tragedies.

At Osborne, Francis & Pettis, we've been standing up for individuals harmed by dangerous drugs for nearly a decade. We’ve earned a strong reputation for courageously taking on large pharmaceutical companies with deep pockets. If you or a loved one took Oxbryta and later developed health complications, contact our team online or by calling (561) 293-2600 today.

“With Osborne, Francis & Pettis, their team has been there with me every step of the way. They are very informative and are easy to get in touch with whenever I have questions or need help with anything. They were very thorough and understanding when it came to handling my case. I highly recommend this firm! Thanks for all you do!”

- Brandi H. | Client

About Oxbryta

Oxbryta, also known as voxelotor, is a prescription drug developed to treat sickle cell disease (SCD), a serious condition that affects how red blood cells carry oxygen throughout the body. This condition primarily impacts people of African, Mediterranean, Middle Eastern, and South Asian backgrounds.

For people suffering from SCD, their red blood cells become stiff and become crescent-shaped, which can block blood flow to the rest of the body. Oxbryta, available in tablet or liquid form, is a hemoglobin S polymerization inhibitor and targets the underlying cause of SCD, preventing the blood cells from deforming into the rigid sickle shape.

By helping blood cells remain disc-shaped and flexible, Oxbryta was intended to stop dangerous episodes called vaso-occlusive crises (VOCs), which are not only extremely painful but can also cause organ damage.

Pfizer marketed Oxbryta as an innovative drug since this drug marked the first time people living with sickle cell had a treatment that focused on fixing the root cause of their condition, not just treating the symptoms.

The FDA’s Fast-Track Approval of Oxbryta

In 2019, the U.S. Food and Drug Administration (FDA) approved Oxbryta to treat sickle cell disease in adults and children aged 12 and older. The drug was fast-tracked for approval because of the urgent need for better treatments for sickle cell disease.

The FDA even expanded its approval in 2021 to include children as young as 4, offering new hope for families who have been struggling with this lifelong disease.

Oxbryta is used globally; in fact, between 2019 and 2024, Oxbryta received approval in 35 different countries.

Understanding the Oxbryta Recall

In September 2024, Pfizer, the company that manufactures Oxbryta, announced a voluntary recall of the drug. This recall came after several studies indicated the benefit of Oxbryta does not outweigh the risks for sickle cell patients.

In studies after Oxbryta was approved, Pfizer found that patients taking Oxbryta had more severe pain episodes, known as vaso-occlusive crises, compared to those taking a placebo (a treatment with no active drug). These pain episodes happen when sickled red blood cells block blood flow and oxygen to tissues.

There were also more deaths in the group of patients using Oxbryta than in the group using the placebo. Pfizer saw the same results in two other studies that looked at how Oxbryta worked in real-world settings. After reviewing all the data, Pfizer decided that the risks of Oxbryta were too high compared to the benefits it provided.

In light of the Oxbryta recall, the FDA issued a safety alert and encouraged patients to stop using Oxbryta right away. They advised people to speak with their doctors to figure out the best alternative treatment for their sickle cell disease.

The FDA is also continuing to review the safety data and is asking for more reports on any side effects that patients may have experienced while using the drug.

The FDA is not the only regulatory agency that has cautioned the public against Oxbryta. Given the drug’s widespread reach and use, the European Medicines Agency also recommended the suspension of Oxbryta in September 2024.

Oxbryta Linked to Vaso-Occlusive Crises and Death

Patients who had hoped Oxbryta would help manage their condition allegedly found that it sometimes caused even more problems.

One of the most concerning issues linked to Oxbryta is increased occurrences of vaso-occlusive crises (VOCs). VOCs inhibit blood flow and prevent oxygen from reaching critical parts of the body, which could result in organ damage. Although Oxbryta was intended to reduce the frequency of VOC events, studies found that it may actually cause patients to experience them more often.

Additional injuries reported by patients who took Oxbryta include:

• Irreversible organ damage
• Strokes
• Kidney failure

Alarmingly, clinical trials have also uncovered higher death rates among Oxbryta patients compared to placebo patients. For example, in the “Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease” (HOPE Kids 2) study, which focused on children with sickle cell disease, 8 children taking Oxbryta died, while only 2 children in the placebo group passed away.

Additionally, in the “Resolution of Sickle Cell Leg Ulcers With Voxelotor” (RESOLVE) study, which looked at adults with sickle cell disease and leg ulcers, 8 out of 88 patients taking Oxbryta died.

Drug labels must clearly and thoroughly list potential side effects. Without these critical warnings, healthcare providers and patients are left in the dark, and innocent lives can be tragically impacted.

It can feel devastating to be betrayed by a drug you thought was safe and could trust. If you experienced severe health complications after taking Oxbryta, there is a path forward. Find out more about your rights by filling out our online form or calling (561) 293-2600 today.

Do I Qualify for an Oxbryta Lawsuit?

While Pfizer did warn of certain side effects of Oxbryta on the drug’s label, such as headaches, diarrhea, abdominal pain, nausea, fatigue, rash, and fever, the company made no mention of the other health complications from the postmarket studies.

Vaso-occlusive crises (VOCs) are extremely painful and, in some cases, can be life-threatening. While these crises are a difficult reality for people living with sickle cell disease, Oxbryta was specifically designed to reduce or prevent them. Yet, surprisingly, studies have shown that Oxbryta may actually make these painful episodes more frequent, rather than easing them.

If you or a loved one took Oxbryta to treat sickle cell disease and suffered severe health complications, such as a vaso-occlusive crisis, organ damage, strokes, kidney failure, or death, you may be eligible for an Oxbryta lawsuit.

Contact the trusted lawyers at Osborne, Francis & Pettis today online or by calling (561) 293-2600 to learn more about whether you have an Oxbryta case and what your legal rights are going forward.

How Can an Oxbryta Lawyer Help Me?

Living with sickle cell disease is already incredibly challenging. Now, imagine getting your hopes up for some much-needed relief and comfort through a medication that promises to help, only to have it worsen your condition. Unfortunately, this may have been the frustrating reality for some Oxbryta patients, who trusted the drug to improve their lives but endured more frequent and intense complications instead.

When dealing with the aftermath of a harmful drug, an experienced legal team can be an invaluable support system in seeking compensation and justice. Here’s how an Oxbryta lawyer can fight for you:

• Investigate Oxbryta Risks: A lawyer will thoroughly investigate the truth behind Oxbryta, including premarket and postmarket clinical trial data to determine whether Pfizer failed to adequately warn the public about the drug’s risks.
• Gathering Crucial Evidence: An attorney can collect medical records, prescription history, and medical professional testimony to demonstrate how Oxbryta directly caused health complications, such as VOCs, organ damage, or fatalities.
• Managing Pesky Legal Deadlines: A lawyer will remove all of the guesswork by making sure all legal papers are filed correctly and on time, avoiding any delays or pitfalls that could hurt your case.
• Handling All Negotiations: Through their experience and resources, a lawyer will challenge Pfizer on the safety of Oxbryta and the potential negligence in its approval and distribution. From there, they will take care of the negotiations with Pfizer and its legal time.
• Defend You in Court: If the other side won’t agree to a fair settlement, your lawyer will be ready and able to fight for maximum compensation in court.

At Osborne, Francis & Pettis, we know that a relentless and debilitating illness like sickle cell disease can drain you in more ways than one. If Oxbryta has caused you suffering, expensive medical complications, or even the heartbreaking loss of a loved one, we know you may feel financially and mentally overwhelmed. The weight of it all might leave you wondering how you could ever afford legal help in the first place.

That’s why our team works on a contingency fee basis, meaning you won’t pay us a single dime unless we win your case. No more worrying about upfront legal costs that will leave you high and dry or financially in the hole. If you want to learn more about our fee structure, call Osborne, Francis & Pettis today at (561) 293-2600 or by filling out our quick online form.

What Types of Compensation Can I Get in an Oxbryta Lawsuit?

Pharmaceutical giants like Pfizer have enormous resources, with billions in revenue and legal teams ready to fight back against claims. It’s understandable that many might feel intimidated about taking legal action against large drug companies. But here, at Osborne, Francis & Pettis, we don’t let companies off the hook so easily.

When it comes to patients allegedly harmed by Oxbryta, we are committed to ensuring that every possible type of compensation is pursued. Here's what we’ll fight for:

• Past and Future Medical Expenses: This includes all hospital bills, doctor visits, treatments, surgeries, and any long-term care required due to the complications caused by Oxbryta.
• Lost Wages and Future Earnings: If your condition due to Oxbryta has affected your ability to work or has led to job loss, we’ll fight for compensation to cover lost wages and future earnings.
• Pain and Suffering: The emotional toll and physical pain caused by Oxbryta’s side effects will be accounted for to ensure you are compensated for everything you’ve been through.
• Punitive Damages: If the company’s actions were particularly reckless or egregious, we may be able to pursue punitive damages, which are intended to punish the company and deter future misconduct.
• Wrongful Death: For the families who tragically lost a loved one due to the complications from Oxbryta, we will pursue wrongful death claims to hold Pfizer accountable and provide the family with the financial support they need during this difficult time.

A lawyer will leave no stone unturned when calculating the full extent of damages you may be entitled to. Plus, having a lawyer on your side is crucial because negotiating with a large company can be daunting, and settling for the first offer could mean leaving money on the table.

Studies show that patients who held out for a better deal received settlements that were, on average, $30,700 higher than those who accepted the first offer. With a skilled attorney, you can ensure that you’re not just accepting what's offered, but fighting for the compensation you truly deserve.