Malpractice Lawsuit Alleges Side Effects of Oxbryta Caused Untimely Death

Widow accuses hospital of failing to diagnose husband’s fatal vaso-occlusive crisis, which resulted from side effects of the recalled sickle cell disease drug, Oxbryta.

A California woman has brought a wrongful death lawsuit against the makers of Oxbryta, as well as medical malpractice claims against the medical staff who gave her husband the sickle cell drug before his death.

The complaint (PDF) was filed by Laura Christine Matteliano Madu in California Superior Court in Alameda County on April 3, presenting claims on behalf of herself and her late husband, Nbubuishi Madu. 

Unlike other Oxbryta lawsuits filed in recent months against Pfizer and Global Blood Therapeutics, which manufactured and sold the recently recalled drug, the lawsuit filed by Madu also names Children’s Hospital and Research Center at Oakland, the Regents of the University of California and Sutter Health Alliance as defendants.

Oxbryta Recall Issued Amid Reports of Side Effects Among Users

Oxbryta (voxelotor) was introduced in 2019, as the first medication to treat the root cause of sickle cell disease, which it was supposed to do by improving hemoglobin levels in the body and helping the blood cells retain more oxygen. 

After numerous reports of painful sickle cell complications and deaths reported among users, Pfizer announced a global Oxbryta recall in September 2024, determining that the risks associated with the drug outweighed the potential benefits only five years after it was introduced.

Over the past six months, a steadily growing number of lawsuits have been filed, alleging that painful and life-threatening side effects of Oxbryta may have been avoided if Pfizer and Global Blood Therapeutics had adequately researched the medication or issued an earlier recall. However, unlike other Oxbryta recall lawsuits filed in recent months, Madu’s complaint also includes claims of medical malpractice by hospital staff.

According to the product liability aspect of the complaint, leveled against Prizer and Global Blood Therapeutics, the use of Oxbryta led to a sickle cell crisis, vaso-occlusive crisis (VOC), veno-occlusive disease and acute chest syndrome with hypoxia, which took her husband’s life.

The lawsuit also contends that the hospitals failed to diagnose his problems in a timely fashion, and negligently treated his complications, which also contributed to his death on March 28, 2024. 

Madu was 45 at the time of his death, and had been diagnosed with Sickle Cell Disease (SCD) as a child. The lawsuit indicates hospital staff were familiar enough with his case that they should have foreseen problems and monitored him more closely.

In 2021, Madu participated in a Pfizer clinical trial for Oxbryta and was prescribed to take 1,500 mg of Oxbryta daily. The lawsuit indicates Madu suffered a vaso-occlusive crisis days before his death.

Vaso-occlusive crises occur when the red blood cells block blood flow, and the tissues become deprived of oxygen. This can cause an inflammatory response, which can lead to symptoms like pain in the chest, back and limbs, as well as fever. Patients often have to be hospitalized and can suffer kidney failure and stroke. Additionally, many patients can die following a vaso-occlusive event.

”On March 28, 2024, Plaintiffs Decedent Nbubuisi Madu tragically lost his life, after succumbing to the injuries he 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,” the lawsuit states.

His wife presents claims of medical malpractice, design defect, failure to warn, negligence, breach of warranty, false and misleading advertising, violation of California consumer protection laws and wrongful death.