Pfizer Inc. has announced a global recall of Oxbryta® (voxelotor), an FDA-approved medication for treating sickle cell disease (SCD). The decision comes after clinical data revealed that the risks associated with the drug outweigh its potential benefits. Patients taking Oxbryta have experienced serious side effects, including life-threatening vaso-occlusive crises and fatal events.
Meyers & Flowers: Compassionate Legal Support for Victims of Oxbryta
If you or a loved one has been adversely affected by a dangerous medication, such as Oxbryta, it’s essential to understand your legal rights and take proactive steps to seek the compensation you deserve. Meyers & Flowers is committed to providing compassionate and expert legal support to those impacted by harmful drugs, guiding you through every step of the legal process. Book a consultation with us today to learn how we can help you secure the justice and compensation you are entitled to.
What Is Oxbryta?
Oxbryta (voxelotor) is an oral medication designed to treat sickle cell disease (SCD) by increasing hemoglobin’s affinity for oxygen. Developed by Global Blood Therapeutics (GBT), Oxbryta works by inhibiting the polymerization of sickle hemoglobin (HbS), which is the primary cause of red blood cell sickling and destruction in SCD. By preventing HbS polymerization, Oxbryta aims to reduce the sickling and destruction of red blood cells, addressing the fundamental pathologies of the disease.
How Oxbryta Works
Oxybryta binds to the hemoglobin molecule and stabilizes it in the oxygenated state. This action increases hemoglobin’s affinity for oxygen, which inhibits the formation of deoxygenated HbS polymers that cause red blood cells to deform into a sickle shape.
By maintaining red blood cells’ normal, flexible shape, Oxbryta improves their lifespan and functionality, leading to better oxygen delivery throughout the body. In 2022, Pfizer acquired Global Blood Therapeutics (GBT), the original developer of Oxbryta, in a $5.4 billion deal—the acquisition aimed to expand Pfizer’s portfolio in rare disease treatments. However, safety concerns have led to the global recall of Oxbryta just two years after its approval.
Why Is Oxbryta Being Recalled?
After thoroughly reviewing clinical data, Pfizer determined that Oxbryta poses significant patient risks. The data indicated an imbalance in serious side effects among those using the medication, notably:
- Vaso-occlusive crises: Blockages in blood vessels caused by sickled red blood cells, leading to severe pain, organ damage, and increased risk of stroke.
- Fatal events: Reports of deaths among Oxbryta users have raised serious safety concerns.
A clinical trial involving 236 patients revealed at least eight deaths among those taking Oxbryta, prompting a global safety review and the subsequent recall.
About Sickle Cell Disease
Sickle cell disease (SCD) is a hereditary blood disorder caused by a mutation in the gene that instructs the body to produce hemoglobin—the protein in red blood cells responsible for carrying oxygen. This mutation leads to the production of abnormal hemoglobin called hemoglobin S (HbS). When oxygen levels are low, HbS causes red blood cells to become rigid and deform into a sickle (crescent) shape. These sickled cells are less flexible and can stick to the walls of blood vessels, blocking blood flow and leading to various complications, including:
Severe pain crises
Also known as vaso-occlusive crises, these episodes occur when sickled cells block blood flow to bones, organs, and tissues, causing intense pain lasting from hours to days.
Anemia
Sickled cells break down prematurely, leading to a shortage of red blood cells (anemia). This can cause fatigue, weakness, and delayed growth in children.
Organ damage
Repeated blockages can deprive organs of oxygen-rich blood, leading to damage in organs such as the spleen, liver, kidneys, and lungs.
Increased risk of infections and stroke
Damage to the spleen impairs the body’s ability to fight infections. Blocked blood flow to the brain increases the risk of stroke, particularly in children.
Acute chest syndrome
A life-threatening complication resembling pneumonia is caused by sickled cells blocking blood vessels in the lungs.
Vision problems
Blocked vessels in the eyes can damage the retina, leading to vision impairment.
SCD affects millions worldwide, with a high prevalence among people of African descent. It is also found in individuals from Mediterranean countries, the Middle East, and South Asia. The disease poses significant public health challenges due to its impact on quality of life and healthcare systems.
EMA Recommends Suspension of Oxbryta in the European Union
Adding to the global concern, the European Medicines Agency (EMA) has recommended suspending Oxbryta’s marketing authorization across all European Union member states. This precautionary measure is based on emerging safety data indicating an increased occurrence of vaso-occlusive crises among patients treated with Oxbryta compared to before they started the medication. The EMA’s human medicines committee (CHMP) initiated a review after registry-based studies showed a higher incidence of vaso-occlusive crises during Oxbryta treatment.
Additionally, clinical trials revealed a higher number of deaths among Oxbryta users than anticipated. While the EMA’s review is ongoing, they have advised healthcare providers not to start new patients on Oxbryta and to contact current patients to discuss alternative treatments. They also advise patients to consult their doctors before discontinuing the medication.
What Should Patients Do Next?
If you or a loved one are currently taking Oxbryta, it is crucial to:
- Contact Your Healthcare Provider Immediately: Avoid taking the medication without consulting your doctor. Your physician can discuss alternative treatments to manage your sickle cell disease.
- Report Any Adverse Effects: If you’ve experienced severe side effects, inform your healthcare provider and consider reporting them to the FDA at 1-800-FDA-1088.
Legal Framework Surrounding Dangerous Drugs
When people experience harmful side effects from medications that are considered dangerous, there are legal options available to seek compensation and justice. The legal process for addressing issues related to dangerous drugs mainly involves product liability law, consumer protection laws, and regulatory compliance. Having an understanding of these areas can assist victims in navigating the complexities of holding pharmaceutical companies accountable.
Product Liability Law
Product liability law holds manufacturers, distributors, suppliers, and retailers accountable for any injuries caused by defective or harmful products. In the context of dangerous drugs, this typically involves three main types of claims:
- Negligence: Plaintiffs must prove that the pharmaceutical company failed to exercise reasonable care in designing, manufacturing, or warning about the drug’s risks. This includes inadequate testing, poor quality control, or insufficient labeling.
- Strict Liability: Under strict liability, the focus is on the product itself rather than the manufacturer’s conduct. If a drug is found to be inherently dangerous or defective, the manufacturer can be held liable regardless of whether they were negligent.
- Breach of Warranty: This involves violations of the promises or assurances made regarding the product’s safety and effectiveness. It includes both express warranties (explicit statements) and implied warranties (unstated assurances of safety and functionality).
Consumer Protection Laws
Consumer protection laws are designed to safeguard consumers from fraudulent, deceptive, or unfair business practices. These laws can be invoked in pharmaceutical cases if a drug is marketed with false claims about its safety or efficacy. Key aspects include:
- False Advertising: Misleading advertisements that downplay risks or exaggerate benefits can lead to legal action under consumer protection statutes.
- Unfair Business Practices: Actions that harm consumers, such as concealing known side effects or manipulating clinical trial data, can result in penalties and lawsuits.
Potential Compensation for Victims
Victims of dangerous drugs may be entitled to various forms of compensation, depending on the nature and extent of their injuries. Common types of compensation include:
- Current Medical Bills: Coverage for hospital stays, surgeries, medications, and ongoing treatments related to the adverse effects.
- Future Medical Costs: Anticipated long-term care, rehabilitation, or additional surgery expenses.
- Physical Pain: Compensation for chronic pain and discomfort resulting from the drug.
- Emotional Distress: Damages for anxiety, depression, and other psychological impacts caused by the injury.
- Lost Income: Reimbursement for time off work due to medical treatments and recovery.
Future Earnings: Compensation for reduced ability to work or earn income in the future due to the injury. - Disability: Compensation for permanent or temporary disabilities that affect daily living and quality of life.
- Loss of Consortium: Damages awarded to spouses or family members for the impact of the victim’s injury on the relationship.
- Punitive Damages: In cases of gross negligence or intentional wrongdoing, courts may award punitive damages intended to punish the defendant and deter similar conduct in the future.
Legal Process for Those Harmed by Oxbryta
The first step is to consult with an attorney specializing in pharmaceutical litigation. During this meeting, the attorney will review all relevant evidence, including medical records, prescription history, and potential regulatory violations, to assess the strength of your case and determine the best legal strategies. Once a viable case is established, the attorney will file a lawsuit by submitting a legal complaint outlining the specific allegations against the pharmaceutical company. Both parties then enter the discovery phase, exchanging important information and evidence related to the case to build their arguments. Many cases are resolved before reaching the trial stage through settlement negotiations. In these negotiations, the defendant may agree to compensate the plaintiff without the need for a prolonged court battle.
If a settlement cannot be achieved, the case proceeds to trial. During court proceedings, both the plaintiff and the defendant present their arguments, evidence, and witness testimonies. The judge or jury then determines liability and the appropriate amount of damages based on the evidence presented. The judgment will specify the compensation awarded to the victim for their injuries and losses. After a judgment is rendered, either party may choose to appeal the decision if they believe legal errors affected the outcome. The appeals process involves a higher court reviewing the case for any mistakes in applying the law or procedural issues that may have occurred during the trial. This step ensures that the legal process is fair and just.
Meyers & Flowers is Here to Help Patients Affected by the Oxbryta Recall
At Meyers & Flowers, we advocate for individuals harmed by dangerous or defective medications. Pharmaceutical companies are responsible for ensuring their drugs’ safety and warning the public of potential risks. When they fail to do so, patients suffer.
Why choose Meyers & Flowers?
- Extensive Experience: Our team has successfully represented clients in high-profile cases involving recalled and dangerous medications.
- Dedicated Advocacy: We are committed to securing the compensation and care our clients deserve.
- No Fees Unless We Win: We operate on a contingency basis, meaning you pay nothing unless we recover damages for you.
Don’t navigate this challenging time alone. Our experienced Chicago dangerous drugs attorneys are here to help you understand your legal options and fight for justice on your behalf. Call Meyers & Flowers today for a free, no-obligation case evaluation.
References
- Pfizer Press Release: Pfizer Voluntarily Withdraws Oxbryta
- European Medicines Agency: EMA Recommends Suspension of Oxbryta