Oxbryta Lawsuit Settlement

Oxbryta Lawsuits: Potential Settlement Value

This page examines Oxbryta lawsuits and their potential settlement value. Oxbryta, a prescription drug by Pfizer, was recalled in September 2024 due to evidence linking it to serious health problems, including vaso-occlusive crisis and organ damage.

Our firm is currently accepting Oxbryta recall 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

April 16, 2025: New Lawsuit
In a new Oxbryta lawsuit in California, a woman brought claims for her husband’s death, alleging medical malpractice by hospital systems and defective design/marketing of Oxbryta by pharmaceutical corporations. The suit claims delays in treating his vaso-occlusive crisis and acute chest syndrome led to multi-organ failure and death. It also alleges Oxbryta, which he took in a 2021 clinical trial, was defectively designed and its risks inadequately disclosed, referencing Pfizer’s September 2024 recall due to increased VOCs and fatalities. The lawsuit includes twelve causes of action, seeking compensatory and punitive damages.

March 1, 2025: Trial Date Set…for 2027
A federal judge set a trial date of June 7, 2027, for the first Oxbryta lawsuit against Pfizer and Global Blood Therapeutics, expected to last 12-15 days. The central issue will be whether the companies downplayed the risk of vaso-occlusive crises (VOCs) for sickle cell patients taking Oxbryta.

February 3, 2025: New Study Inconclusive
A recent study on Oxbryta in “Blood” had over half of its 60 patients not complete all trial steps, limiting the reliability of its findings. There are rumors Pfizer may try to reverse the recall based on this limited study.

January 8, 2025: Fraudulent Concealment
Oxbryta plaintiffs argue that the statute of limitations should be tolled due to fraudulent concealment and delayed discovery by Pfizer and Global Blood Therapeutics regarding the drug’s risks.

December 30, 2024: Many Saw This Coming
Pfizer’s global withdrawal of Oxbryta followed years of concerns from regulatory agencies like NICE in England, which rejected the drug due to insufficient evidence of cost-effectiveness. The withdrawal in September 2024 highlighted long-standing doubts about Oxbryta’s real-world benefits over existing therapies, providing strong support for compensation claims from affected victims.

November 19, 2024: European Ban
The EMA’s Committee for Medicinal Products for Human Use recommended halting the marketing authorization for Oxbryta in Europe.

November 9, 2024: New Oxbryta Lawsuit Filed in California
A new Oxbryta lawsuit in California alleges the drug caused a worsening of vaso-occlusive crises (VOCs) and a stroke in a patient who began taking it in August 2024. The lawsuit claims Pfizer and Global Blood Therapeutics knew or should have known about these risks but failed to adequately warn the public, seeking damages for strict liability, negligence, breach of warranty, unjust enrichment, and consumer protection violations.

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 global recall of Oxbryta due to emerging data indicating increased risks of vaso-occlusive crises (VOCs) and fatal events in sickle cell disease patients.

Oxbryta

Oxbryta (voxelotor) is a prescription medication for sickle cell disease (SCD), designed to prevent red blood cells from sickling. Approved by the FDA in 2019 (adults/children 12+) and 2021 (children 4-11) under accelerated approval, it was seen as a significant innovation. In 2022, its developer, Global Blood Therapeutics (GBT), was acquired by Pfizer. Oxbryta aimed to improve quality of life by reducing painful episodes and complications like blood clots and organ damage by targeting hemoglobin polymerization.

Sickle Cell Disease

Sickle cell disease (SCD) is a hereditary blood disorder causing red blood cells to become rigid and sickle-shaped due to abnormal hemoglobin S. This leads to blockages in blood vessels, reducing oxygen flow and causing pain crises (VOCs), strokes, organ damage, chronic anemia, and potentially premature death. Traditional treatment focuses on managing symptoms, but Oxbryta was developed to target the underlying sickling process.

Oxbryta Was Thought to Be A Huge Innovation

Oxbryta was developed to manage SCD complications by preventing hemoglobin polymerization, aiming to improve red blood cell flexibility and reduce blockages. Often used with hydroxycarbamide, it was marketed as a first-of-its-kind oral medication to reduce sickling and improve oxygen transport, with the potential to transform SCD management.

Oxbryta’s FDA Approval Process

Oxbryta received accelerated FDA approval in November 2019 based on the GBT-HOPE trial showing improved hemoglobin levels. This was expanded to children aged 4 and older in 2021 after the HOPE-KIDS study. The accelerated pathway allowed quicker market access but potentially meant less scrutiny of long-term safety and efficacy data.

Evidence Links Oxbryta to Serious Health Problems

Post-market studies and lawsuits suggest Oxbryta was riskier than initially presented:

  • GBT440-032 Study (Stroke Risk in Children): Showed an unexpected increase in deaths in the Oxbryta treatment group.
  • GBT440-042 Study (Leg Ulcer Trial): Reported eight patient deaths, raising concerns about increased fatal complications.
  • European Investigation: The EMA flagged an alarming increase in mortality rates among Oxbryta users, leading to a marketing ban.
  • Lawsuit Allegations of Concealment: Plaintiffs claim Pfizer and GBT concealed internal safety data showing higher rates of VOCs, strokes, and deaths.

Lawsuits allege Pfizer’s internal analysis showed higher VOC and stroke rates but this risk was not disclosed, leading to patients taking the drug without proper warning.

Oxbryta Recall

Concerns from post-release studies and patient data led Pfizer to a voluntary global recall of all Oxbryta lots in September 2024, citing an imbalance of VOCs and “fatal events.” European regulators had also flagged safety concerns, suspending approval just after Pfizer’s announcement. The recall is significant due to the drug’s high marketing investment and patient reliance.

Oxbryta Lawsuits

The Oxbryta recall is leading to product liability lawsuits against Pfizer, alleging the company knowingly concealed the drug’s risks, particularly regarding vaso-occlusive events. Plaintiffs claim they would not have taken Oxbryta with proper warnings. Lawsuits include claims of failure to warn, negligence, and product liability, seeking damages for physical and emotional suffering, medical expenses, lost wages, and punitive damages. Allegations focus on:

  • Increased VOCs and Mortality in studies.
  • Risks associated with the Accelerated Approval pathway.
  • Inadequate Warnings to patients and prescribers.
  • Promotional Misrepresentation of the drug’s safety.

Plaintiffs’ attorneys aim to hold Pfizer and Global Blood Therapeutics accountable for the harm caused by Oxbryta, alleging failures in design, manufacturing, testing, and marketing, as well as deliberate or negligent misleading of the public about the drug’s risks.

Who is Eligible to File an Oxbryta Lawsuit

Our firm is accepting Oxbryta lawsuits nationwide for individuals who:

  • Took Oxbryta for at least 2 months.
  • After starting Oxbryta, suffered a vaso-occlusive crisis (VOC), organ damage, stroke, or death.

Where Is the Oxbryta Litigation Going and What Is The Path to Settlement?

The Oxbryta litigation may evolve into a multidistrict litigation (MDL) to consolidate cases for coordinated pretrial proceedings. While not a class action for injury claims, an MDL would streamline discovery and potentially lead to bellwether trials and a global settlement. However, the variability of individual cases and a potentially small number of lawsuits might make an MDL less effective. If not pursued as an MDL, cases may resolve more quickly but on a smaller scale. Regardless, these lawsuits highlight serious allegations against Pfizer and GBT regarding their handling of Oxbryta.

Oxbryta Lawsuit Settlement Amounts

It is very early in the Oxbryta litigation, making settlement amount predictions difficult. However, the potentially low volume of lawsuits may incentivize Pfizer to offer fair settlements. For serious injuries, potential settlement values could range from $400,000 to $1 million, with lower but still substantial payouts for less severe complications. Our attorneys are optimistic for fair and reasonable compensation for victims. These cases may also resolve more quickly than typical mass torts, as Pfizer may want to address these issues promptly.

Contact Us About an Oxbryta Lawsuit

If Oxbryta injured you, contact our national product liability lawyers today to see if you have a case. Contact us online.

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Please be advised that submitting this form to Class Action Law does not establish an attorney-client relationship. I further understand that Class Action Law collaborates with various law firms on these matters and that an affiliated law firm working with Class Action Law may contact me regarding these lawsuits.

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