Oxbryta Lawsuit

Oxbryta (voxelotor) was a medication used to treat sickle cell disease. It was a daily pill that helped the blood carry more oxygen by making hemoglobin — the protein in red blood cells — work better. It also prevented the sickle-shaped deformities in those cells.

However, after 16 people taking Oxbryta died in two clinical trials, Pfizer issued a worldwide Oxbryta recall and took the drug off the market in September 2024.

“Oxbryta was advertised as a drug that would ‘reduce sickling and help red blood cells deliver oxygen throughout your body,’” Laura Baughman, a drug and medical device attorney with Weitz & Luxenberg, told Drugwatch. “Sadly, for individuals suffering from sickle cell disease, the drug does the opposite — it reduces the delivery of oxygen throughout the body and causes pain.”

The clinical trials found that patients who took Oxbryta experienced higher rates of death and severe pain episodes known as vaso-occlusive crises (VOCs) than those who received a placebo. Pfizer deemed these risks more significant than any benefits the drug could provide.

The FDA approved Oxbryta in 2019 for treating sickle cell disease in adults and children aged 12 and older, and in 2021, the agency expanded approval to those aged 4 to 11.

The FDA granted these approvals through its “accelerated approval” process due to the drug’s potential benefits for serious health issues. However, the process requires further studies to confirm a drug’s safety and effectiveness, and those aftermarket studies revealed serious problems with Oxbryta.

In 2024, the FDA announced that Pfizer withdrew Oxbryta from the market because data from postmarketing clinical trials showed there were more deaths in people who took Oxbryta versus those who received a placebo. There was also a higher rate of VOCs in people who took Oxbryta versus placebo in real-world registry studies.

FDA advised health care professionals to stop prescribing the drug. The agency also advised patients to contact their medical provider about stopping Oxbryta and asking for an alternative treatment.

Clinical Trial Fatalities Led to Oxbryta Recall

Pfizer noted that two clinical studies showed worrying findings connecting Oxbryta to an increase in pain and deaths among patients. “Their studies found that Oxbryta more than doubled the rate of VOCs and deaths in people taking the drug,” Baughman said.

There is no evidence that Oxbryta directly caused the deaths in this study, as most of the fatal cases were due to infections like malaria or sepsis. However, researchers suspended both studies, and Pfizer ordered a worldwide market withdrawal of the drug.

Oxbryta lawsuits seek compensation from manufacturer Pfizer and its subsidiary Global Blood Therapeutics, which Pfizer acquired in 2022. The lawsuits claim that the companies acted improperly while creating and selling Oxbryta. This includes how the drug was developed, tested, labeled, marketed and distributed.

People filing Oxbryta lawsuits want compensation to cover past, present and future losses, with the amounts to be determined at trial. They also seek money for damages related to lost earnings, wrongful death, pain and suffering and other financial issues. In addition, the lawsuits ask for punitive damages — intended to punish the manufacturers — and reimbursement for case-related costs and attorney’s fees.

As of October 2025, Oxbryta lawsuits are still in the early stages. There have been no trials, verdicts or publicly announced settlements. Lawyers have accepted and filed lawsuits in state and federal courts for clients from various states, including Illinois and California. In June 2025, a federal court in California set a trial date for September 2027 for an Oxbryta lawsuit. This may be the first case to go before a jury.

It’s unclear how widely used Oxbryta was while the drug was on the market from 2019 to 2024. However, it was the first medicine to target the cause of sickle cell disease — which affects roughly 8 million people — so it’s likely many people may have used it. Therefore, there is potential for a large number of lawsuits.

According to legal industry estimates, the payout for an Oxbryta settlement could range from $20,000 to over $1 million depending on the specific details of your case. It’s important to remember that these figures are speculative and that every lawsuit is different.

Because attorneys are filing these initial lawsuits in both state and federal courts, the Judicial Panel on Multidistrict Litigation could eventually combine these actions into multidistrict litigation if there are many lawsuits.

Is There an Oxbryta MDL or Class Action?

So far, there isn’t an Oxbryta MDL, but there has been an Oxbryta class action complaint filed in California by plaintiffs Rick Jolly, Amanda Winbush, Darryl Weekly and Antonio Johnson.

A class action lawsuit is made up of a lead plaintiff who files the lawsuit and opens the case for others to also be a part of the lawsuit so the case can proceed. A class action is one lawsuit with many plaintiffs.

An MDL, or multidistrict litigation, takes several individual cases from many courts across the country and consolidates these cases into a single court. Class actions can also be included in a multidistrict litigation. While there isn’t an Oxbryta MDL yet, it may be possible in the future depending on how many more lawsuits are filed.

If a loved one passed away or you’ve experienced serious health problems — such as VOCs worsening or happening more often after taking Oxbryta — you might be eligible to file an Oxbryta lawsuit.

Make sure you have medical records, prescription receipts and information, and a death certificate if your loved one passed away. This will be important evidence in your case.

Even if you don’t think you qualify for an Oxbryta lawsuit, speak to an attorney. Only they can tell you if you qualify.

If you have suffered injuries after taking Oxbryta, you should talk to an experienced attorney who specializes in prescription drug lawsuits. These cases are complicated and involve large pharmaceutical companies with their own lawyers.

Remember that you have limited time to file an Oxbryta lawsuit. This is due to the statute of limitations, which varies by state. In some states, it may be as little as one year from the time of your injury.

Choosing the Right Oxbryta Attorney

When it comes to choosing the right Oxbryta attorney, make sure to find an attorney who has experience with mass torts and drug litigation. You should also discuss what the fee will be to file your case. Typically, product liability lawsuits work on a contingency fee basis. This means lawyers don’t collect fees unless they win your case.

Drugwatch makes it easy to find an experienced lawyer. All you have to do is fill out a form on our site, and we’ll connect you with one of our legal partners. Drugwatch works with firms that have years of experience handling cases against big drug and devices companies. These firms also have a proven track record in court and negotiating settlements for their clients.

In addition to an increased risk of death, the clinical trials found a higher rate of vaso-occlusive crises (VOCs) — a common type of sickle cell crisis. VOCs happen when the sickle-shaped red blood cells block small blood vessels in your body, cutting off blood flow to critical organs and tissues. This can cause severe pain and complications.
By increasing the risk of VOCs, Oxbryta may trigger several conditions typically associated with these crises.

Before the market withdrawal, many common side effects were relatively minor. The Oxbryta label listed headache, diarrhea, abdominal pain, rash, nausea and fever as the most common side effects.

Editor Lindsay Donaldson contributed to this article.