Alabama Oxbryta Lawsuits Lawyer
Did you lose your loved one, or do you currently suffer from severe health complications that arose after taking Oxbryta for sickle cell disease treatment, such as more frequent and severe vaso-occlusive crises (VOCs), chest issues, organ damage, or blood clots? If so, you need to protect your health and your legal rights.
In September 2024, the U.S. Food and Drug Administration (FDA) warned doctors to discontinue prescribing Oxbryta and urged patients to consult their doctors immediately about starting a different sickle cell disease treatment. The warning came after patients suffered severe health complications in active clinical trials, and the drug’s manufacturers subsequently pulled it from the market.
An Experienced Product Liability Attorney Can Help You
If you are a patient who has suffered severe complications after taking Oxbryta, or if your loved one died after using the sickle cell disease medication and suffering severe adverse effects, you should consult an experienced product liability attorney as soon as possible. You may be entitled to compensation for your medical expenses, lost wages, pain, emotional distress, and other losses and harm.
Attorney Aaron Gartlan — a member of the Million Dollar and Multi-Million Dollar Advocates forums who has dedicated his career to protecting the rights of patients, consumers, and their families throughout Alabama — is here to help. Contact us today to learn more about Gartlan Injury Law in a free consultation and review your rights and options.
Why Did Doctors Prescribe Oxbryta as a Treatment for Sickle Cell Disease?
For blood vessels to carry oxygen through the body, red blood cells need a protein called hemoglobin. When hemoglobin fails to function properly in red blood cells, a genetic blood disorder called sickle cell disease (SCD) develops. The cells bear a sickle shape, leading to disrupted blood flow, severe pain, vaso-occlusive crises (VOC), and many other serious health risks and life-threatening complications.
By addressing the cause of sickle cell disease and improving the function of hemoglobin in red blood cells, Oxbryta (voxelotor) was once considered a significant medical advance. The FDA granted “accelerated” approval for Oxbryta in 2019 for treating patients with sickle cell disease aged 12 and older. In 2021, the agency expanded its approval to patients between the ages of 4 and 11. However, due to its “accelerated” status, the drug’s manufacturers — Pfizer, Inc., and Global Blood Therapeutics, Inc. — still needed to conduct clinical studies to confirm its safety and effectiveness.
Did Pfizer Voluntarily Withdraw Oxbryta from the Market?
The Oxbryta clinical studies produced alarming results. Patients who took Oxbryta suffered more frequent and more severe VOCs, other life-threatening complications, and even deaths than patients in a placebo group. In two separate clinical studies, sickle cell patients died from potentially Oxbryta-related complications, including children.
On September 25, 2024, Pfizer, Inc., announced a voluntary global withdrawal of Oxbryta due to concerns that its health risks outweighed its benefits. To protect patients, the pharmaceutical company also halted all clinical trials involving Oxbryta.
Did the FDA Issue a Recall of Oxbrytra?
The FDA did not issue an Oxbrytra recall. Instead, on September 26, 2024, after Pfizer pulled Oxbryta, the FDA issued a warning to doctors and patients with sickle cell disease about the voluntary, global withdrawal of the medication. The warning echoed serious safety concerns that agencies dedicated to health and care excellence and monitoring of dangerous drugs had voiced in Europe. In addition to warning healthcare professionals to stop prescribing Oxbryta and advising patients to discuss alternative treatments, the FDA encouraged patients experiencing serious Oxbryta to report them to the FDA’s Adverse Event Reporting System (FAERS).
What Are Potential Health Risks and Injuries Caused by Oxbryta?
Headaches, diarrhea, and fatigue were among the only side effects listed when Oxbryta was first approved by the FDA in 2019 for sickle cell treatment. The labeling noted no other severe risks or serious concerns about the drug’s safety. However, based on post marketing clinical trials, many more serious health complications have been linked to sickle cell disease patients’ use of Oxbryta (voxelotor), including the following:
- Vaso-occlusive crises (more frequent and severe)
- Acute chest syndrome
- Organ damage and organ failure (mainly in the liver and kidneys)
- Blood clots
- Pulmonary hypertension
- Heart attacks
- Strokes
- Death
If you have experienced any of these symptoms while using Oxbryta for treating sickle cell disease or sickle cell anemia, you should consult your doctor immediately, in addition to consulting with an experienced attorney to protect your legal rights.
Who May Be Eligible to File an Oxbryta Injury Lawsuit?
Sickle cell disease patients, and those who have lost their loved ones after they used Oxbryta, have filed product liability and wrongful death lawsuits in state and federal courts across the country against Pfizer and Global Blood Therapeutics, including in Alabama. Patients seek compensation based on claims that include:
- The drug’s defective design
- Negligence in developing, testing, marketing, and distributing it
- Failure to warn doctors and patients about the risks of using Oxbryta
- Misleading advertising that suggested the medication would be safe and effective when sickle cell disease patients used it as intended.
You may be eligible to pursue an Oxbryta claim if you:
- Suffer from sickle cell disease, or your loved one suffered from it
- Used Oxbryta, or your loved one did, after being prescribed the drug
- Subsequently, you suffered adverse side effects or lost your loved one
As federal agency health figures show, SCD affects about 100,000 people in the U.S., including patients throughout Alabama. So, a large number of patients may have been given Oxbryta prescriptions without fully knowing its risks after the FDA’s first approval of the drug in November 2019 and before the manufacturers’ voluntary withdrawal of the medication in September 2024.
If you believe you have a potential Oxbryta claim, you should do your best to compile any medical records you may have about your sickle cell disease, prescribed use of Oxbryta, and any health problems you may have suffered after using the medication.
What Compensation Could I Potentially Recover in an Oxbryta Lawsuit?
If you file an Oxbryta lawsuit, you can seek full and fair compensation in a settlement or judgment for the physical, emotional, and financial harm you have suffered, including the following:
- Past medical costs and future medical expenses
- Lost wages and diminishment of future earnings
- Pain and suffering
- Emotional anguish
You may also be eligible to recover punitive damages. Those damages would not compensate you, but instead serve to punish and deter the manufacturers of the medication.
Is There a Deadline for Filing an Oxbryta Claim?
You do not have unlimited time to take legal action if you have experienced severe complications after using a defective medication. In Alabama, you must file a product liability claim within two years from the date you suffered your injury, or within two years from the date when you could have reasonably discovered it. The deadline to file a wrongful death claim in Alabama is two years from the date of the death.
Get Help from an Experienced Alabama Personal Injury Attorney
At Gartlan Injury Law, we stand up for individuals and families when they suffer harm from using dangerous medications or other types of defective products. Attorney Aaron Gartlan is an experienced Alabama personal injury lawyer who puts his clients first and is willing to take on pharmaceutical companies and insurance companies to protect their rights.
If you believe that you have suffered harm from using Oxbryta, or if your loved one died after being prescribed the medication for sickle cell disease treatment, contact us today to learn more about your rights and options. We can provide a free consultation and answer your questions.
