Oxbryta Litigation Deep Dive

The pharmaceutical industry is currently facing significant legal scrutiny following the recall of Oxbryta, a medication developed to treat sickle cell disease (SCD).

Manufactured by Pfizer, Oxbryta was intended to alleviate the symptoms of SCD but has been linked to severe health complications, including increased risks of vaso-occlusive crises and death.

This article from Legalcalls.com by Attorney Jeff Keiser delves into the background of Oxbryta, the ensuing litigation, the challenges faced by law firms, and the potential implications for the pharmaceutical industry.

Background: Oxbryta and Its Intended Use

Oxbryta (voxelotor) received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2019 for patients aged 12 and older, with approval extending to children aged 4 to 11 in 2021.

The drug was designed to inhibit hemoglobin polymerization, thereby preventing the sickling of red blood cells—a hallmark of sickle cell disease. By increasing hemoglobin’s affinity for oxygen, Oxbryta aimed to reduce hemolytic anemia and improve patients’ quality of life.

However, post-marketing studies and real-world data began to reveal concerning side effects. Patients reported an increased incidence of vaso-occlusive crises (VOCs), which are painful episodes caused by the obstruction of blood flow due to sickled red blood cells.

More alarmingly, some cases resulted in fatalities. In September 2024, Pfizer issued a global recall of Oxbryta, citing emerging data that suggested the risks outweighed the benefits of the medication.

The Litigation Landscape: Claims and Allegations

Following the recall, numerous lawsuits have been filed against Pfizer, alleging that the company failed to adequately warn patients and healthcare providers about the potential risks associated with Oxbryta.

Plaintiffs claim that Pfizer was negligent in its duty to ensure the safety of the drug and that the company continued to market Oxbryta despite evidence of serious side effects.

The lawsuits seek compensation for medical expenses, pain and suffering, and, in cases involving fatalities, wrongful death.

The legal actions are grounded in several key allegations:

• Failure to Warn: Plaintiffs argue that Pfizer did not provide sufficient warnings about the potential for VOCs and death, depriving patients and doctors of the information needed to make informed decisions.
• Negligence: It is alleged that Pfizer failed to conduct adequate testing and monitoring of Oxbryta, leading to the distribution of a drug with undisclosed risks.
• Breach of Warranty: Claims suggest that Pfizer breached express and implied warranties by promoting Oxbryta as safe and effective when it was not.

These allegations form the basis of the litigation, with plaintiffs seeking accountability and compensation for the harm suffered.

Challenges Faced by Law Firms in Oxbryta Cases

The litigation surrounding Oxbryta, a medication developed for sickle cell disease (SCD), presents several intricate business and legal challenges for Pfizer, the pharmaceutical industry, and affected patients. As is typical, causation is likely to be a central focus of the litigation, especially in these early stages.

• Establishing Causation: A central legal challenge is demonstrating a definitive causal link between Oxbryta and adverse health outcomes, such as increased vaso-occlusive crises (VOCs) and mortality. Plaintiffs must provide robust scientific evidence to substantiate their claims, while Pfizer may contest these findings by highlighting the complexities of SCD and potential alternative causes for the observed adverse events.
• Liability Theories: Plaintiffs are likely to pursue claims based on negligence, strict liability, failure to warn, and breach of warranty. Pfizer’s defense may involve asserting compliance with regulatory standards and arguing that the benefits of Oxbryta outweighed the risks at the time of approval.

Potential Payout Estimates

As of November 2024, no settlements or verdicts have been finalized in the Oxbryta litigation. However, based on similar pharmaceutical cases, potential payouts could be substantial.

While specific figures are speculative, settlements in pharmaceutical litigation often range from hundreds of thousands to several million dollars, depending on individual case circumstances..

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Potential Timeline

The litigation concerning Oxbryta (voxelotor) has evolved rapidly following its market withdrawal due to safety concerns. Below is an overview of the history of the drug, and the litigation:

• FDA Approval and Market Introduction. On November 25, 2019, the FDA granted accelerated approval for Oxbryta to treat SCD in patients aged 12 and older, later expanding use to children over 4. Pfizer acquired Global Blood Therapeutics in 2022, the original developer of Oxbryta, for $5.4 billion, integrating Oxbryta into its pharmaceutical portfolio.
• In July 2024, the European Medicines Agency (EMA) initiated a review of Oxbryta following concerns from two ongoing placebo-controlled clinical trials indicating a higher rate of vaso-occlusive crises (VOCs) and fatalities among patients taking the drug compared to those on a placebo.
• In September 2024, Pfizer announced a voluntary global withdrawal of Oxbryta from all markets, citing safety concerns, including an increased risk of VOCs and deaths among patients. The EMA recommended the suspension of Oxbryta’s marketing authorization as a precautionary measure while the review of emerging data continued.
• A lawsuit was filed in the Superior Court of California for the County of San Francisco by a patient alleging that Oxbryta caused significant injuries, including a stroke leading to vision loss. The litigation is in its early stages, with additional lawsuits anticipated as more patients come forward. The cases are expected to be consolidated into an MDL to streamline pretrial proceedings, though formal consolidation has not yet occurred.
• As of November 7, 2024, no bellwether trials have been scheduled in the Oxbryta litigation. The legal proceedings are in the early stages. The consolidation of these cases into a multidistrict litigation (MDL) is anticipated but has not yet been formalized. Once an MDL is established, the court will likely set a schedule for bellwether trials to assess the merits of representative cases and guide potential settlements.
• This procedural history underscores the swift progression from Oxbryta’s approval and market presence to its withdrawal and the onset of legal challenges, highlighting the complexities inherent in pharmaceutical litigation.

Broader Implications for the Pharmaceutical Industry

The Oxbryta litigation underscores the critical importance of post-marketing surveillance and transparent communication between pharmaceutical companies, healthcare providers, and patients. The case may lead to:

• Stricter Regulatory Oversight: Regulatory agencies may implement more rigorous monitoring of drugs approved through accelerated pathways.
• Enhanced Patient Education: Pharmaceutical companies might be required to provide more comprehensive information about potential risks to ensure informed consent.
• Reevaluation of Risk-Benefit Analysis: The industry may need to reassess how it evaluates the risks and benefits of medications, particularly for vulnerable populations.

These potential changes aim to enhance patient safety and restore public trust in pharmaceutical products.

These cases provide a framework for estimating potential settlement amounts in the hair straightener litigation, considering factors such as the number of claimants, severity of alleged injuries, and strength of scientific evidence linking product use to health risks. Of course, these estimates are just that – estimates – and it will take time to determine any actual settlement amounts. No two cases are the same, and facts and the law will determine how the hair straightener cases play out.

Conclusion

The Oxbryta litigation represents a pivotal moment in pharmaceutical law, highlighting the delicate balance between innovation and patient safety.

As these cases progress, they may set significant precedents for how pharmaceutical companies approach drug development, marketing, and post-market surveillance. Law firms engaged in this litigation play a crucial role in advocating for affected individuals and driving systemic change within the industry.

For those impacted by Oxbryta, seeking legal counsel can provide guidance on potential claims and help navigate the complexities of pharmaceutical litigation. The outcome of this case could drive stricter regulatory oversight and improve patient protections, ensuring that companies prioritize patient health as much as they do innovation.

Ultimately, this litigation underscores the need for transparency, safety, and accountability in pharmaceuticals—a goal that will benefit not only patients affected by sickle cell disease but also the broader public relying on safe and effective medications.

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