An Illinois man recently filed an Oxbryta lawsuit in the Superior Court for the State of California. He claims that after he used the sickle cell disease (SCD) medication, he suffered from serious injuries.
Manufacturer Pfizer recently announced a global recall of Oxbryta (voxelotor) after two postmarketing clinical trials indicated that the benefits of the drug no longer outweighed the risks.
After Taking Oxbryta for Four Years, Plaintiff Suffers from Stroke
According to his complaint, the plaintiff was diagnosed with SCD as a child. In 2020, he started taking Oxbryta to treat it. While on the drug, he suffered a higher rate of vaso-occlusive crises (VOCs)—blood flow blockages—than he had before starting the medication. He also required more blood transfusions as well, in addition to other debilitating symptoms including pain and swelling.
Then, in 2024, he suffered a stroke which has impaired his vision significantly. He is no longer able to drive or do normal everyday activities. He was not aware at that time that his symptoms may be connected to Oxbryta. It wasn’t until he learned of the recall that he made the connection andstopped taking the drug.
He brings counts of strict liability, defective design, failure to warn, negligence, breach of warranties, unjust enrichment, and false and misleading advertising, and seeks compensatory and punitive damages.
Why Did Pfizer Recall Oxbryta?
SCD is a group of inherited red blood cell disorders. In a person with SCD, the red blood cells become hard and sticky and look like a C-shaped farm tool called a sickle. The cells die early, creating a constant shortage of red blood cells. These abnormal cells can also get stuck in small blood vessels and clog blood flow, resulting in pain and serious complications such as acute chest syndrome and stroke.
Oxbryta is designed to help red blood cells maintain their normal shape and flexibility, improving their lifespan and helping to reduce the symptoms of SCD. The U.S. Food and Drug Administration (FDA) approved Oxbryta in 2019 for the treatment of SCD in adults and children over the age of 12. In 2021, the FDA also approved it for use in children 4 to 11 years old.
In July 2024, the European Medicines Agency (EMA)—a government organization similar to the FDA— initiated a review of Oxbryta after two postmarketing clinical trials raised alarms. The first of these trials looked at the medication’s effects on children with SCD and found 8 deaths in those taking Oxbryta, compared to two in those taking a placebo. The second looked at how the medication affected leg ulcers in patients with SCD and again found that eight deaths occurred.
An investigation is ongoing as to whether Oxbryta caused any of the deaths. But the EMA issued a follow-up notice in which they recommended suspending the use of Oxbryta. They also noted that after analyzing the two studies, results showed that patients had a higher occurrence of VOCs during treatment with Oxbryta than they did before starting the medication.
On September 26, 2024, the FDA alerted patients and healthcare providers to Pfizer’s voluntary withdrawal of Oxbryta. The administration told doctors to stop prescribing it and suggested patients contact their physicians about using another treatment.
Patients Filing Oxbryta Lawsuits
As more people become aware of the potential connection between Oxbryta and blocked blood flow and strokes, more are coming forward to file claims against Pfizer. Patients are understandably upset that the manufacturer failed to do adequate testing before releasing the product on the market, and that they failed to warn about the real risks associated with using it.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
