A recently filed California medical malpractice lawsuit alleges that on March 28, 2024, Nbubuisi Madu tragically lost his life, after succumbing to the injuries suffered due to all Defendants’ negligence, which included sickle cell crisis, vaso occlusive crisis, veno-occlusive disease, acute chest syndrome with hypoxia, fever, pain, suffering, emotional anguish, and untimely death.
At the time of his death, decedent Nbubuisi Madu was a 45-year-old male who was diagnosed with Sickle Cell Disease (SCD) as a child. Nbubuisi Madu was approximately seven years old when his parents brought him to UCSF Benioff Children’s Hospital in Oakland for the treatment of SCD. In approximately 2021 and on the recommendation of his doctor, Mr. Madu began participating in a Pfizer clinical trial of Oxbryta. Mr. Madu was receiving the active medication during the trial, not the placebo. In approximately September of 2021, Mr. Madu was prescribed 1,500 mg Oxbryta daily.
From March 25, 2024 through March 28, 2024, while still on Oxbryta, Mr. Madu suffered a vaso-occlusive crisis (“VOC”) and suffered injuries, which included sickle cell crisis, acute chest syndrome with hypoxia, fever, pain, suffering, emotional anguish, and untimely death.
Oxbryta
Oxbryta is manufactured as an oral, once-daily therapy for patients with SCD. On September 25, 2024, Pfizer announced their voluntary withdrawal of all lots of Oxbryta from all markets where it is approved. The decision came after “data showed an imbalance in Vaso-occlusive crises, a complication of the disease and ‘fatal events’ that required further assessment.”
The active substance in Oxbryta was supposed to work by improving the ability of the hemoglobin to hold on to oxygen, and preventing it from forming chains. In theory, this would help the red blood cells to maintain normal shape and flexibility, reducing their excess breakdown and improving their lifespan. Defendants marketed Oxbryta through various forms of media and promised its purchasers would “experience less sickling.”
The Plaintiff alleges that Pfizer knew or should have known for decades that Oxbryta, when administered and prescribed as intended, can cause or substantially contribute to VOCs and even death. Nevertheless, prior to the Decedent’s death, Pfizer failed to warn, instruct, advise, educate, or otherwise inform Oxbryta users and prescribers, including the Plaintiff’s Decedent, about the risk of VOCs and/or death.
The Plaintiff alleges Mr. Madu and his physicians foreseeably used Oxbryta, and did not misuse or alter Oxbryta in an unforeseeable manner. At the time of his death, Decedent Nbubuisi Madu was unaware that Oxbryta had a higher rate of vaso-occlusive crisis. As a direct result of being prescribed and consuming Oxbryta, Mr. Madu experienced severe injuries, including sickle cell crisis, vaso-occlusive crisis, acute chest syndrome, physical pain, emotional distress, and death. Mr. Madu was also unaware that there were more deaths in the Oxbryta treatment group as compared to the placebo group in post-marketing studies or that there were higher rates of vaso-occlusive crises in patients with sickle cell disease receiving Oxbryta in two real-world registry studies.
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