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Case Overview
Sickle cell disease (SCD) is a lifelong, devastating disease affecting millions worldwide. Oxbryta®, a first of its kind medication, was granted accelerated approval by the U.S. Food & Drug Administration (FDA) for SCD treatment in 2019. However, less than five years after its approval for sale on the U.S. market, Oxbryta has been recalled.
Pfizer Inc. issued a voluntary recall of Oxbryta after serious adverse events, including death, were reported. Motley Rice is currently investigating claims of alleged harm resulting from use of Oxbryta.
Background on SCD and Oxbryta
SCD is an inherited disorder that affects hemoglobin, the protein in red blood cells responsible for carrying oxygen throughout the body. In individuals with SCD, red blood cells are misshapen, impacting the cell’s ability to move in the human body. Oxbryta (voxelotor) is a prescription medication intended to treat SCD by improving hemoglobin’s ability to carry oxygen.
However, after Oxbryta’s release, studies revealed significant, increased risks. Pfizer not only reported a higher than anticipated number of deaths in clinical trials for those in the group prescribed Oxbryta, but also an unexpected increase in vaso-occlusive crisis. Vaso-occlusive crises are acute pain events caused by blocked blood flow in the body. Vaso-occlusive crises can lead to serious complications, including stroke, kidney disease, and arthritis.
Risks associated with Oxbryta
Oxbryta has been linked to an increased risk of:
- Death– Studies showed a higher rate of mortality among Oxbryta patients when compared to a placebo group.
- Vaso-occlusive crises (VOCs) – VOCs are a dangerous, painful complication of sickle cell disease that occur when sickled red blood cells block blood flow to tissues. This can result in severe pain and lead to potential organ damage. Oxbryta patients experienced VOCs more frequently compared to patients not using the drug, resulting in greater risk of long-term health issues such as stroke and kidney failure.
Our history with medical drug litigation
Our medical attorneys have extensive experience with prescription and over-the-counter drugs and have held many leadership roles in these types of cases. We understand the complex legal and scientific aspects of medical litigation, and work to uncover aggressive product development and marketing practices that may have caused you or a loved one harm. Our attorneys handle all aspects of discovery and trial in medical lawsuits, including product identification, medical causation, compliance with FDA regulations, adequacy of warnings, allegations of product defects, and coordination of witnesses and experts.
Our attorneys have represented victims of medications including:
Recall
Background on SCD and Oxbryta
Risks associated with Oxbryta
Our history with medical drug litigation
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