Laura Baughman

Just months after being pulled from the market, Oxbryta is the center of lawsuits filed over its impact. The drug, which was used to treat sickle cell disease (SCD), was pulled by Pfizer in September after new data revealed that its benefits do not outweigh its risks.

Now, plaintiffs have filed lawsuits over claims that Pfizer and Global Blood Therapeutics (GBT) failed to warn that Oxbryta can cause many serious and painful health issues.

Laura Baughman is an attorney with Weitz & Luxenberg. She has decades of litigation experience and focuses on defective drugs and devices. In a recent interview with Drugwatch, she discusses the emerging Oxbryta litigation and how users of the drug have been impacted.

Q: Why are people filing Oxbryta lawsuits?

Oxbryta was advertised as a drug that would “reduce sickling and help red blood cells deliver oxygen throughout your body,” as stated, for example, in GBT’s TV commercial “It’s My Time.” 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. This pain includes an increase in vaso-occlusive crises (episodes of serious pain), referred to as VOCs.

In September 2024, Pfizer withdrew Oxbryta from the global market, discontinued all studies of the drug and advised doctors to stop prescribing it. The drug was discontinued because clinical trials and registry-based studies conducted by Pfizer and GBT found that the risks of Oxbryta exceed the benefits. Their studies found that Oxbryta more than doubled the rate of VOCs and deaths in people taking the drug.

Q: How have these issues impacted plaintiffs’ lives?

The symptoms and complications of SCD include anemia, acute chest syndrome, stroke, multi-organ damage (including kidney and liver damage) and VOCs. Oxbryta increases the frequency and severity of symptoms of SCD. It makes the disease it is supposed to be curing worse.

Q: What are some of the claims plaintiffs are bringing against Oxbryta’s manufacturers?

We allege that GBT and Pfizer failed to warn patients and their doctors that Oxbryta reduces the delivery of oxygen and increases the risk of VOCs, pain, anemia, acute chest syndrome, stroke and organ failure. We also allege that a defect in the drug’s design caused it to deliver less oxygen to the body and that GBT and Pfizer were negligent in how they tested, designed and marketed Oxbryta. They were also negligent in their representations about the drug. We allege that they made numerous misleading assurances in their marketing that Oxbryta is safe, effective, prevents sickling, reduces sickling, increases oxygen delivery and helps red blood cells deliver oxygen throughout the body.

Q: Who may be eligible to file an Oxbryta lawsuit?

Anyone who took Oxbryta for at least one month at the age of 12 or older from Nov. 2019 to Sept. 2024 or at the age of 4 or older from Dec. 2021 through Sept. 2024 and suffered an increase in SCD-related symptoms or death.

Q: What is the status of the Oxbryta litigation? Are things still in the early stages?

Yes, the litigation is in the very early stages. Only six cases have been filed so far, and discovery has not started.