Tepezza, a medication used to treat thyroid eye disease, has come under scrutiny due to reports of unexpected and severe side effects. Patients who have experienced hearing loss or other auditory problems after using Tepezza are now seeking justice through legal action.
A Tepezza lawsuit aims to hold the drug manufacturer accountable for potential negligence in warning patients about these serious risks. If you or a loved one has been affected by Tepezza-related hearing issues, you're not alone, and we can help you explore your legal options.
Living with unexpected hearing loss can be devastating, impacting your quality of life and daily activities. A Tepezza lawsuit lawyer can help you navigate the complex legal landscape surrounding Tepezza claims, fighting for 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 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.
The legal process is set to continue, with the first Tepezza bellwether trials scheduled for 2026. These initial trials will likely play a crucial role in shaping the trajectory of the ongoing litigation and potential settlements.
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.
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 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.
What types of compensation might be available in a Tepezza lawsuit?
Potential compensation may include medical expenses, lost wages or income, pain and suffering, and other damages related to hearing loss or auditory problems. The exact amount would depend on the specifics of each case.
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.