Tepezza (teprotumumab-trbw) is a breakthrough medication used to treat thyroid eye disease (TED), a rare condition that causes inflammation and bulging of the eyes. Tepezza was approved by the U.S. Food and Drug Administration (FDA) in January 2020 and has been celebrated for providing relief to many patients suffering from the debilitating effects of TED. However, despite its effectiveness in treating this condition, some patients have reported experiencing hearing complications following Tepezza infusions.
Hearing-related side effects have raised serious concerns, and patients must understand their options if they experience these complications. In this blog, the product liability attorneys at Kherkher Garcia will discuss what Tepezza is, the reported hearing complications, the legal implications, and what steps you should take if you or a loved one has been affected.
What Is Tepezza?
Tepezza is a monoclonal antibody designed to inhibit the insulin-like growth factor 1 receptor (IGF-1R), which plays a critical role in the development and progression of TED. By blocking IGF-1R, Tepezza reduces inflammation and alleviates symptoms like eye bulging, double vision, and discomfort, offering a treatment option for those suffering from this rare condition.
Although Tepezza has proven to be effective in reducing TED symptoms, its use has not been without concerns. Shortly after its release, reports began emerging of patients developing hearing complications, prompting closer scrutiny of the drug’s potential side effects.
Hearing Complications Linked to Tepezza
Several studies and patient reports have documented various hearing-related side effects following Tepezza infusions. The most common hearing complications include:
- Hearing Loss: Some patients have experienced partial or total hearing loss, often affecting one or both ears. In some cases, this loss may be temporary, but for others, it has been permanent.
- Tinnitus: Many patients have reported ringing or buzzing in the ears, a condition known as tinnitus. This symptom can range from mild to severe and can significantly impact a person’s quality of life.
- Autophony: Autophony is the perception of one’s own voice or other internal sounds as abnormally loud. This condition can make normal speech uncomfortable and may be associated with Eustachian tube dysfunction.
- Hyperacusis: This is an increased sensitivity to everyday sounds, which can make normal noise levels unbearable for some individuals.
- Ear Pain and Discomfort: Some patients have reported a sense of fullness or pressure in the ears, as well as pain and discomfort following infusions.
These complications vary in severity, and while some patients have experienced temporary relief after discontinuing Tepezza treatment, others have been left with lasting damage.
Why Are Hearing Complications Occurring?
The exact cause of hearing complications related to Tepezza is still under investigation. However, researchers have suggested that the drug’s effect on IGF-1R, a receptor that is also present in the ear’s auditory system, could potentially interfere with normal hearing functions. This interference may result in damage to the cochlea or other auditory structures, leading to hearing loss and other complications.
While the FDA did approve Tepezza for treating TED, the hearing complications associated with its use have raised questions about the adequacy of pre-approval testing and the sufficiency of warnings provided to patients and healthcare providers.
Your Legal Rights If You Experience Hearing Complications Due to Tepezza
If you have experienced hearing complications as a result of Tepezza infusions, you may have grounds to pursue legal action. Drug manufacturers have a responsibility to ensure that their products are safe for use and to provide adequate warnings about potential side effects. If it is determined that Horizon Therapeutics, the manufacturer of Tepezza, failed to properly warn patients or healthcare providers about the risk of hearing complications, they may be held liable for damages.
A lawsuit may be based on several legal theories, including:
- Failure to Warn: Drug manufacturers are required to provide adequate warnings about potential risks and side effects. If Horizon Therapeutics did not sufficiently disclose the risks of hearing complications associated with Tepezza, you may have a failure-to-warn claim.
- Product Liability: If it is found that Tepezza was defective or unreasonably dangerous when used as directed, you may be able to pursue a product liability claim. This can include issues with the drug’s design, manufacturing, or marketing.
- Negligence: If Horizon Therapeutics failed to conduct proper testing or did not take reasonable steps to ensure the safety of its product, you may be able to file a negligence claim.
Steps to Take if You Experience Hearing Complications from Tepezza
If you or a loved one has experienced hearing complications after receiving Tepezza infusions, it is essential to take immediate action to protect your health and legal rights. Below are the steps you should consider:
Seek Medical Attention
Your health should be your top priority. If you experience hearing loss, tinnitus, or any other ear-related symptoms, contact your healthcare provider immediately. They may refer you to an audiologist or an ear, nose, and throat (ENT) specialist for further evaluation.
Early intervention may improve your chances of recovery, and a thorough medical evaluation will also document your condition, which can be critical evidence in a potential legal case.
Document Your Symptoms
Keep a detailed record of your symptoms, including when they began, how they have progressed, and how they affect your daily life. This documentation will be valuable when discussing your condition with healthcare providers and attorneys.
Additionally, if you have any communication from your doctor or the drug manufacturer about the risks of hearing complications, save these records. They could be used as evidence in a legal claim.
Contact an Experienced Attorney
If you suspect that Tepezza is responsible for your hearing complications, it is essential to consult with a skilled attorney who specializes in product liability and dangerous drug claims. An experienced attorney can help you understand your legal options and guide you through the process of pursuing compensation for your injuries.
Your attorney will review your medical records, gather evidence, and consult with experts to build a strong case against the manufacturer. They will also handle negotiations with the drug company and its insurance representatives to ensure that you receive fair compensation for your damages.
Understand Your Potential Compensation
If you pursue legal action against Horizon Therapeutics, you may be entitled to compensation for various damages, including:
- Medical Expenses: This includes the cost of treating your hearing complications, including doctor visits, hearing aids, medications, surgeries, and other treatments.
- Lost Wages: If your hearing complications have affected your ability to work, you may be able to recover compensation for lost wages and diminished earning capacity.
- Pain and Suffering: Hearing complications can significantly impact your quality of life. You may be able to recover compensation for the physical pain, emotional distress, and reduced enjoyment of life caused by your condition.
- Punitive Damages: In cases where the drug manufacturer’s conduct is deemed especially reckless, the court may award punitive damages to punish the company and deter future misconduct.
Keep Track of Legal Deadlines
It is important to be aware of the statute of limitations in your state, which is the legal deadline for filing a lawsuit. Missing this deadline could prevent you from pursuing compensation, so it is crucial to act quickly.
Your attorney will help you determine the applicable deadlines and ensure that all necessary paperwork is filed in a timely manner.
Getting Help after Tepezza Hearing Loss
While Tepezza has provided relief to many individuals suffering from thyroid eye disease, its potential to cause hearing complications is a serious concern. If you or a loved one has experienced hearing loss, tinnitus, or other hearing issues after receiving Tepezza infusions, you have legal options. Consulting with an experienced product liability attorney can help you protect your rights and pursue the compensation you deserve.
If you believe that Horizon Therapeutics may be liable for your hearing complications, do not hesitate to reach out to Kherkher Garcia for help. Our skilled team will help you navigate the legal process and hold the responsible parties accountable.
To find out more about your legal rights and potential claims, call Kherkher Garcia at 713-333-1030. You can also reach out to us online via our website contact form. Our consultations are completely free. Don’t wait to get the help you need.
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