Oxbryta Lawsuits: Sickle Cell Drug Injuries

Oxbryta (voxelotor) was created to treat sickle cell disease in adults and children four years and older. Early studies of Oxbryta showed that it bonded well to hemoglobin, improving hemoglobin’s ability to absorb oxygen. One study also indicated that Oxbryta reduced the sickling of red blood cells.

Since Oxbryta’s release in 2019, however, evidence is mounting that its risks may outweigh its benefits. In September 2024, Pfizer announced a voluntary withdrawal of Oxbryta from markets worldwide.

The Recall: What Went Wrong?

In its voluntary withdrawal, Pfizer cited “safety concerns” regarding Oxbryta. Specifically, the company noted that “the data suggest an imbalance in vaso-occlusive crises and fatal events which require further assessment.”

Pfizer identified two primary problems with Oxbryta:

• Vaso-occlusive crises (VOCs): Vascular events involving blocked blood flow, which cause severe pain. VOCs are a common, severe complication of sickle cell disease. Depending on the location and severity, a VOC can result in organ damage and other serious health issues.
• Fatalities: Studies showed a higher rate of fatalities from VOCs and other causes in Oxbryta patients, compared to patients taking a placebo.

Preliminary data from post-marketing studies also indicates that Oxbryta may be linked to a higher risk of cerebrovascular occlusive events – blocked blood flow occurring in the brain. More research is needed to fully understand these events’ link to Oxbryta use.

The US Food and Drug Administration (FDA) also issued a news release providing information to patients, caregivers, and health professionals, stating “Pfizer has determined the benefit of Oxbryta does not outweigh the risk.”

Legal Implications

For many patients, Pfizer’s withdrawal and warnings come too late. These patients must now seek compensation for serious injuries through the courts.

Grounds for Oxbryta-related lawsuits may include:

• Failure to warn: Patients may argue that Pfizer failed to adequately warn them or their healthcare providers of the risks of taking Oxbryta. Many such cases will depend on the research timeline: What Pfizer knew and when.
• Defective drug design and testing gaps in accelerated approval: Oxbryta followed an accelerated approval path to market. Along the way, the drug may have missed several key steps in safety and efficacy testing. Unraveling Oxbryta’s path to market may reveal grounds for legal action.

The most common claim types likely to arise include strict liability for product defects, breach of warranty, and negligence. Both personal injury and wrongful death lawsuits are likely to result. Efforts to file one or more class actions on behalf of Oxbryta patients are already underway.

Key Issues for Attorneys

Attorneys handling Oxbryta claims will likely face several key issues. These will include gathering key medical evidence, addressing common challenges, and proving compensation in key categories.

Evidence collection will likely focus on medical records, prescription details, and adverse event reports. Handling this evidence in a privacy-forward manner will be essential, as will connecting individual patients’ details to the broader picture.

Potential challenges include proving causation and evaluating pre-existing conditions. Understanding Oxbryta’s journey to market will be essential in illuminating causation issues. For some patients, expert witnesses will need to explain the impact, if any, of the patient’s pre-existing medical conditions.

Compensation-related challenges will include establishing medical expenses and evaluating patients’ pain and suffering. Attorneys may also need to determine whether punitive damages are appropriate.

Lessons for Legal Professionals

Oxbryta litigation could have a significant impact on future pharmaceutical liability cases. The timeline of Oxbryta’s approval and its associated risks emphasizes both the risk of disclosure failures associated with accelerated paths to market and the importance of post-marketing surveillance in drug litigation. Expert witnesses will likely play a significant role in substantiating patients’ claims.

The Oxbryta case highlights the risk of accelerated paths to market for new medications. It underscores the importance of thorough testing and study before a drug is placed on the market. The results of this case could have a significant impact on the expectations placed on drugmakers in the future.

Attorneys working with affected clients will benefit from early communication with experts. Experts can explain the timeline and risks associated with Oxbryta, highlighting potential defects, breaches of warranty, failures to warn, and possible negligence. A qualified expert can also substantiate clients’ individual claims and contextualize these cases within the broader scope of pharmaceutical liability claims.