Tepezza, a drug prescribed for thyroid eye disease, has recently come under legal scrutiny following reports of severe and unexpected side effects. Many individuals who have suffered permanent hearing loss or other auditory complications after using Tepezza are now pursuing legal action to seek justice.
Filing a Tepezza hearing loss claim is a way for affected patients to hold the manufacturer responsible for failing to adequately warn about these risks. If you or a loved one has been impacted by hearing-related side effects after taking Tepezza, experienced Tepezza lawyers can guide you through your legal options.
Hearing loss can have a profound effect on your daily life, making even simple tasks challenging. A dedicated Tepezza lawsuit lawyer can assist you in navigating the complexities of pursuing Tepezza hearing loss litigation. Our network of attorneys will work to secure a fair Tepezza settlement and ensure you receive the compensation you deserve.
What is Tepezza?
Tepezza (teprotumumab-trbw) is a prescription medication specifically designed to treat thyroid eye disease (TED), a rare autoimmune disorder. TED causes inflammation and swelling of the tissues surrounding the eyes, leading to uncomfortable and often distressing symptoms. Tepezza is the first and only FDA-approved medication for this condition.
Developed by Horizon Therapeutics, Tepezza targets and blocks the activity of the insulin-like growth factor 1 receptor (IGF-1R). This protein is believed to play a crucial role in the development and progression of TED. By inhibiting IGF-1R, Tepezza aims to reduce the inflammation and tissue changes associated with the disease.
Tepezza is administered intravenously (IV) over three to six months. Clinical studies have shown promising results, with many patients experiencing improvements in symptoms such as eye-bulging, double vision, and eye pain.
The FDA approved Tepezza in January 2020, marking a significant milestone in treating thyroid eye disease. This approval offered new hope to patients with limited treatment options for managing their condition.
Tepezza is still under its original patent protection, and as such, it remains the primary pharmaceutical intervention for TED. While the medication has shown effectiveness in treating the condition, patients and healthcare providers should be aware of potential side effects and discuss the benefits and risks before starting treatment.
Do I Have Grounds for a Tepezza Lawsuit?
While Tepezza has shown effectiveness in treating certain symptoms of thyroid eye disease, such as protruding eyes, double vision, and tissue inflammation, some users have reported experiencing serious hearing-related side effects.
Hearing loss and other auditory issues can significantly affect a person's life, potentially leading to substantial medical expenses, lifestyle changes, emotional distress, and other challenges. When pharmaceutical companies fail to provide adequate warnings about potential side effects, they may be held legally responsible for harm caused by their products.
Individuals who have suffered adverse effects from medications that lacked proper warnings about potential risks may have grounds to seek compensation from manufacturers and, in some cases, distributors and retailers. In the case of Tepezza, some users claim they were not adequately informed about the possibility of developing hearing problems due to their treatment for eye conditions.
Common hearing-related issues reported by some Tepezza patients include:
- Eustachian tube dysfunction (abnormal pressure, pain, or stuffiness in the middle ear)
- Hyperacusis (increased sensitivity to everyday sounds)
- Partial or complete hearing loss
- Autophony (perception of one's own voice as unusually loud or echoing)
- Tinnitus (ringing in the ears)
If you have undergone Tepezza treatment and are experiencing severe hearing impairment or any of these symptoms, you may be eligible to seek compensation for your losses. It's advisable to consult a qualified attorney experienced in mass tort litigation to understand your legal rights and options.
Studies Link Tepezza to Severe Hearing Loss
Recent research has uncovered concerning connections between Tepezza use and various hearing-related issues. A study presented at the ENDO 2021 conference revealed that 65% of Tepezza patients reported otologic symptoms, including hearing loss, tinnitus, ear plugging sensation, and autophony. This rate significantly exceeds the 10% Horizon Therapeutics reported in earlier clinical trials.
These symptoms typically emerged after an average of 3.6 infusions. Some patients developed new or worsening sensorineural hearing loss, which involves damage to the inner ear's hair cells.
A case study in The Annals of Otology, Rhinology, and Laryngology detailed a patient experiencing significant hearing loss after Tepezza treatments. Notably, the patient's symptoms persisted even after discontinuing the drug and receiving oral corticosteroid treatment.
The American Journal of Ophthalmology published findings on Tepezza's long-term impact on hearing function. The study showed that only a small portion of patients who experienced subjective hearing loss or decreased word comprehension fully recovered eight months after stopping Tepezza infusions.
A separate case series documented four instances of Tepezza-associated hearing loss among 28 patients treated by three doctors. The authors proposed a potential mechanism for how Tepezza might cause hearing damage.
Contrary to initial public statements, patients and healthcare providers began reporting severe ear and hearing complications shortly after the FDA approved Tepezza. Subsequent research suggested that Horizon Therapeutics may have understated the risk and severity of hearing damage associated with the drug.
Former Horizon Therapeutics Employee Raises Concerns About Hearing Loss
Within Horizon Therapeutics, employees raised significant concerns about Tepezza's potential link to hearing loss. Dr. Wenzhong "Jerry" Liu, a professional with extensive experience in clinical development and medical affairs, was particularly vocal about these issues.
Dr. Liu questioned the accuracy of the initially reported 10% incidence rate of hearing impairment. He pointed to findings from later studies, including Study 401 (EAP), which suggested a much higher rate of 40%. Despite this alarming discrepancy, Horizon continued to downplay these risks publicly.
The company's official position maintained that most hearing-related adverse events observed in pivotal trials and post-approval were minor to moderate and reversible. However, Dr. Liu advocated for fully disclosing the updated data to regulatory agencies, healthcare professionals, and the public. He emphasized that the true frequency of serious hearing impairment was significantly higher than what the drug's label suggested.
Dr. Liu persistently recommended sharing the findings from Study 401 and expressed ongoing concerns about the accuracy of public disclosures regarding hearing impairment risks. Despite his efforts to ensure transparency and patient safety, Dr. Liu was eventually dismissed from his position at Horizon.
Dr. Liu filed a wrongful termination lawsuit against the company, bringing these internal conflicts and potential safety concerns into the public eye. This situation highlights the complex issues surrounding drug safety reporting and corporate responsibility in the pharmaceutical industry.
Tepezza Litigation
In 2022, a wave of product liability lawsuits emerged against Horizon Therapeutics from individuals who experienced hearing loss or tinnitus following Tepezza treatments. These legal actions allege that Horizon was negligent in failing to adequately warn both patients and healthcare providers about the significant risks of hearing damage associated with the medication.
The plaintiffs in these Tepezza lawsuits claim that the absence of sufficient warning about potential hearing complications left them and their doctors unaware of the drug's possible harmful effects. They argue that had Horizon provided accurate and comprehensive information about these risks they would have opted against using Tepezza to treat their thyroid eye disease.
Recognizing the growing number of similar cases, the federal court system took action in June 2023. Tepezza hearing loss lawsuits from various federal courts nationwide were consolidated into a multidistrict litigation (MDL) under the supervision of Judge Thomas M. Durkin in the U.S. District Court for the Northern District of Illinois. As of now, over 145 lawsuits are pending within this MDL.
In July 2023, the FDA also took action, requiring Horizon Therapeutics to update Tepezza's label to include a warning about the drug's risk of hearing problems.
Tepezza Hearing Loss Lawsuit Updates - May 2025
May 1, 2025: In the Tepezza multidistrict litigation (MDL No. 3079), the presiding judge rejected a motion from plaintiffs seeking to compel Horizon Therapeutics to make six Patient Access Liaisons (PALs) and one sales representative available for depositions.
Plaintiffs maintained that these PALs—who had direct communication with them regarding their Tepezza treatments—possessed pertinent, individualized knowledge that should not be counted toward the 30-deposition cap outlined in Case Management Order No. 5. They further contended that they were not fully aware of the PALs' importance at the time deposition limits were set, as significant document disclosures had yet to occur.
The judge disagreed, citing several reasons for denying the request:
- Horizon had identified PALs as custodians as early as August 2023.
- Plaintiffs did not begin pursuing PAL-related information until more than a year later.
- The 30-deposition limit was meant to apply universally to all plaintiffs, regardless of which attorneys originally agreed to the stipulation.
- The cited language concerning PAL documents did not transform those materials into justification for unlimited case-specific depositions.
- Adding seven additional depositions so late in the discovery phase would place an unreasonable burden on Horizon.
Ultimately, the Court concluded that the plaintiffs failed to demonstrate “good cause” under Rule 30 to go beyond the established deposition limits and thus denied their motion.
April 1, 2025: The Tepezza hearing loss MDL has grown to include 207 lawsuits, a modest increase from 203 the previous month. Although the pace of filings remains gradual, attention is now turning to the bellwether trials scheduled for 2026, which may become a turning point for potential settlements. The first of four bellwether trials is expected to begin in March 2026, with both parties currently narrowing down their selections from the initial trial pool.
March 25, 2025: The opening bellwether trials in the Tepezza MDL are scheduled to begin in 2026, spanning from April through September. These early trials are intended to act as test cases, offering insight into how juries may respond and what outcomes could be expected in future proceedings. While not binding on other cases, the verdicts are likely to heavily influence settlement discussions and shape the strategic direction of the litigation.
October 2023: Amgen completes its acquisition of Horizon Therapeutics, paying $27.8 billion.
If you or someone you know took Tepezza and experienced hearing issues, it's important to consult with a healthcare provider. Additionally, seeking legal advice can help you understand your options for potential compensation.
What Should I Do if I Have Hearing Loss After Using Tepezza?
If you've experienced hearing loss or other auditory issues after using Tepezza, it's crucial to take prompt action to protect your health and legal rights. Here are the steps you should consider:
- Seek medical attention immediately: Consult an audiologist or an ear, nose, and throat (ENT) specialist. They can assess the extent of your hearing loss and recommend appropriate treatments.
- Document your symptoms: Keep a detailed record of when you started noticing hearing problems and how they've progressed. Include any impact on your daily life, work, or relationships.
- Gather your medical records: Collect all records related to your Tepezza treatment and subsequent hearing issues. This includes prescription information, treatment dates, and any relevant test results.
- Report the side effect: Inform your prescribing doctor about your hearing problems. They should report this to the FDA's MedWatch program.
- Don't stop treatment without medical advice: While it's natural to be concerned, never discontinue any medication without consulting your healthcare provider first.
- Consult a legal professional: Given the ongoing litigation surrounding Tepezza, speak with an attorney experienced in pharmaceutical litigation. They can evaluate your case and advise you on potential legal options.
Remember, every case is unique, and you need a lawyer to tailor your legal strategy to your specific situation. A qualified medical professional can guide your health decisions, while an experienced attorney can help you understand and protect your legal rights.
Legal Process Overview: Filing a Tepezza Lawsuit
If you or a loved one has suffered permanent hearing loss or other auditory issues after receiving Tepezza treatment, pursuing legal action can help you seek compensation for your damages. Below is a step-by-step breakdown of the legal process involved in filing a Tepezza hearing loss claim:
Initial Case Evaluation
The first step in the legal process is to consult with the experienced Tepezza lawyers in our network who handle pharmaceutical litigation. During this consultation, the attorney will review your case by examining:
- Your medical history before and after taking Tepezza.
- Documentation of hearing loss symptoms and their impact on your daily life.
- Any medical records, including audiology tests, doctor’s reports, and treatment details.
- Proof of Tepezza prescriptions and treatment dates.
Determining Eligibility & Case Viability
Your attorney will assess whether you meet the criteria for a Tepezza lawsuit based on:
- The severity of your hearing loss and related symptoms.
- Whether the manufacturer, Horizon Therapeutics, failed to provide adequate warnings.
- The timeline of your symptoms relative to your Tepezza treatment.
- Whether your case aligns with multidistrict litigation (MDL) requirements.
Gathering Evidence
To strengthen your case, your attorney will collect and organize crucial evidence, including:
- Medical evaluations confirming hearing loss or tinnitus.
- Expert testimony from healthcare professionals about Tepezza's risks.
- Scientific studies linking Tepezza to severe hearing loss.
- Internal company communications or whistleblower reports, if applicable.
Filing the Lawsuit
Once the evidence is compiled, your attorney will officially file a lawsuit against Horizon Therapeutics. This claim may be filed:
- As an individual lawsuit, where you sue the manufacturer separately.
- As part of a mass tort or multidistrict litigation (MDL), where multiple similar cases are consolidated under one court.
Pre-Trial Proceedings & Settlement Negotiations
After filing, both sides will engage in a discovery phase, where they exchange evidence and testimonies. During this period:
- Your legal team will negotiate a potential Tepezza settlement.
- Horizon Therapeutics may offer compensation to resolve the case before trial.
- If a settlement is not reached, your case will proceed to trial preparation.
Resolution: Settlement or Verdict
At this stage, there are two possible outcomes:
- Settlement Agreement: If Horizon Therapeutics agrees to compensate affected patients, your attorney will work to ensure you receive a fair Tepezza settlement.
- Court Verdict: If the case goes to trial, a judge or jury will decide whether Horizon is liable and determine compensation amounts for victims.
Appeals (If Necessary)
In some cases, the losing party may file an appeal to challenge the verdict. Your legal team will continue to advocate on your behalf throughout this process.
What Compensation Can I Receive from a Tepezza Hearing Loss Claim?
If you or a loved one has suffered permanent hearing loss or other auditory complications due to Tepezza, you may seek financial compensation through a Tepezza hearing loss claim. The compensation you receive will depend on the specific damages you have experienced. Below are the key categories of compensation that may be available.
Medical Expenses
Hearing loss often requires extensive medical treatment, including:
- Audiology tests and diagnostic evaluations
- Hearing aids or cochlear implants
- Ongoing medical treatments and therapies
- Surgery (if required for severe cases)
- Future medical care related to hearing loss
A Tepezza lawsuit lawyer will help ensure that your past, present, and anticipated future medical costs are factored into your claim.
Lost Wages & Reduced Earning Capacity
Hearing impairment can significantly impact your ability to work, especially if your job relies on communication, customer interactions, or sound perception. Compensation may cover:
- Lost wages due to missed workdays or job loss
- Reduced earning potential if your hearing loss limits your ability to perform job duties
- Loss of career opportunities or forced early retirement
If your hearing impairment has affected your employment, your Tepezza lawyers can help calculate and pursue the appropriate compensation.
Pain and Suffering
Hearing loss can have a profound emotional and psychological impact, affecting your:
- Ability to engage in conversations and social activities
- Overall mental well-being (e.g., depression, anxiety, and frustration)
- Quality of life, as hearing impairment can lead to isolation and difficulty performing daily tasks
Compensation for pain and suffering seeks to acknowledge and address these emotional and lifestyle challenges.
Loss of Enjoyment of Life
Permanent hearing loss can affect your ability to:
- Enjoy music, television, or other forms of entertainment
- Participate in social gatherings or communicate effectively with loved ones
- Safely navigate the environment (e.g., difficulty hearing alarms, traffic, or emergency signals)
A Tepezza settlement may include damages for the loss of these essential life experiences.
Punitive Damages (If Applicable)
If the court determines that Horizon Therapeutics acted with gross negligence or deliberately withheld information about the risks of Tepezza, you may be awarded punitive damages. These damages are meant to punish the company and prevent similar misconduct in the future.
Out-of-Pocket Expenses
Many people facing hearing loss incur additional costs, such as:
- Transportation to medical appointments
- Home modifications (e.g., specialized devices to assist with hearing loss)
- Hiring assistance for daily activities affected by hearing impairment
How Much Compensation Can I Expect?
The exact amount you may receive depends on several factors, including:
- The severity and permanence of your hearing loss
- The financial and emotional toll of your condition
- Whether your case is resolved through a settlement or trial verdict
- The strength of your legal representation and evidence
While there is no fixed amount for Tepezza settlements, similar pharmaceutical lawsuits have resulted in compensation ranging from tens of thousands to millions of dollars, depending on individual circumstances.
Related article: How to File a Lawsuit For Tepezza Injuries
Tepezza Lawsuit FAQs
What is the main issue in the Tepezza lawsuit?
The main issue is that Tepezza, a medication used to treat thyroid eye disease, has been linked to unexpected hearing loss, permanent hearing impairment, and other auditory problems in some patients. Lawsuits claim the manufacturer, Horizon Therapeutics, failed to adequately warn patients and healthcare providers about these risks.
How common is hearing loss among Tepezza users?
While initial clinical trials reported a 10% incidence rate of hearing impairment, later studies suggest the rate could be as high as 65%. However, the exact frequency is still being investigated through ongoing research and legal proceedings.
How long do I have to file a Tepezza lawsuit?
The time limit, or statute of limitations, for filing a Tepezza lawsuit varies by state. It's important to consult an attorney as soon as possible to ensure you don't miss any important deadlines.
Will participating in a Tepezza lawsuit affect my medical care?
Participating in a lawsuit should not affect your medical care. You have the right to seek legal recourse without it impacting your treatment. However, always consult your healthcare provider before changing your medication regimen.
Discuss Your Tepezza Case with an Experienced Lawyer
The ongoing Tepezza litigation highlights the complex interplay between medical advancements and patient safety. While Tepezza has offered hope to many individuals suffering from thyroid eye disease, the reports of hearing loss and other auditory issues underscore the importance of comprehensive drug testing and transparent communication of potential risks.
If you or a loved one has experienced hearing problems after using Tepezza, you don't have to navigate this challenging situation alone. An experienced attorney can provide invaluable assistance in several ways:
- Evaluate your case: Determine if you have grounds for a legal claim
- Gather evidence: Collect and organize medical records and other crucial documentation
- Handle communications: Interact with drug manufacturers and insurance companies on your behalf
- Negotiate settlements: Seek fair compensation for your medical expenses, lost wages, and pain and suffering
- Represent you in court: If necessary, present your case before a judge and jury
- Stay informed: Keep you updated on the progress of the Tepezza multidistrict litigation
Don't let the complexities of pharmaceutical litigation deter you from seeking justice. Contact a qualified attorney today at 888-984-6195 or through the online form to discuss your case and explore your legal options. Act now to protect your rights and join the effort to ensure safer medications for all patients in the future.