Tepezza Lawsuits: Patients Seek Justice for Permanent Hearing Loss

In the realm of rare disease treatments, Tepezza (teprotumumab-trbw) emerged as a significant development for patients suffering from thyroid eye disease (TED). Developed by Horizon Therapeutics and approved by the FDA in January 2020, Tepezza became the first and only medication specifically designed to treat this uncommon autoimmune condition that can cause bulging eyes, double vision, and potential vision loss.

However, what began as a promising treatment for TED patients has become a source of concern for a growing number of individuals. An increasing number of patients who underwent Tepezza treatment are reporting an unexpected and troubling side effect: hearing loss. Reports of hearing impairment, tinnitus, and other auditory complications have raised serious questions about the drug’s safety profile within the medical community treating TED.

 

Tepezza: A Promising Treatment with Hidden Dangers

Tepezza (teprotumumab-trbw) was hailed as a groundbreaking therapy for thyroid eye disease (TED), offering hope to patients suffering from this rare and debilitating condition. Its approval by the FDA marked a significant step forward for individuals grappling with the symptoms of TED, such as eye-bulging, double vision, and potential vision loss. However, as more information has come to light, concerns have arisen about potential risks that may have been overlooked during its development and approval process.

 

Initial Purpose: Treatment for Thyroid Eye Disease

Tepezza was developed to address a significant unmet medical need for patients with TED. This innovative treatment offered several groundbreaking benefits:

• It was the first and only FDA-approved treatment for TED.
• Designed to reduce eye bulging, double vision, and other symptoms associated with TED.
• Provided a non-surgical alternative for patients.

During clinical trials, Tepezza showed promising results, with 71% to 83% of patients demonstrating a significant reduction in eye protrusion compared to placebo groups. These outcomes generated widespread enthusiasm among healthcare providers and patients alike.

 

FDA Approval Process: Were There Overlooked Red Flags?

Tepezza’s approval by the FDA in January 2020 was based on two clinical trials involving a total of 170 patients. While the initial warnings focused on infusion reactions, inflammatory bowel disease exacerbation, and hyperglycemia, the risk of hearing impairment, including permanent hearing loss, was not prominently featured. It wasn’t until July 2023 that the FDA updated Tepezza’s label to include a specific warning about severe hearing impairment, raising questions about the thoroughness of the initial approval process.

 

Horizon Therapeutics’ Marketing vs. Reality

Horizon Therapeutics embarked on an aggressive marketing campaign to promote Tepezza. This campaign played a pivotal role in the drug’s financial success, yet it may have downplayed potential risks. Key elements of the marketing strategy included:

• Generating $820 million in first-year sales, far exceeding analyst projections.
• Launching a pre-approval disease awareness campaign six months before FDA approval.
• Achieving 95% brand awareness among target physicians within three months of launch.

Despite the impressive marketing, post-market data began to reveal a starkly different reality for some patients. Studies have indicated that up to 65% of patients reported hearing problems after receiving Tepezza treatment. Additionally, lawsuits allege that Horizon Therapeutics failed to adequately warn patients and healthcare providers about the risks of permanent hearing loss, only updating the label years after its initial approval.

Uncovering the Link: The Long-Term Side Effects of Tepezza 

Tepezza (teprotumumab) has been a groundbreaking medication for treating Thyroid Eye Disease (TED), offering hope to many suffering from this debilitating autoimmune condition. However, as its use has become more widespread, a concerning pattern of hearing-related complications has begun to emerge. 

What was once considered a rare side effect is now understood to be a much more common and significant issue, impacting a substantial number of patients. Researchers and medical professionals have been actively working to uncover the precise link between Tepezza and these auditory issues, leading to a growing body of compelling scientific evidence that sheds light on the prevalence, types, and severity of these complications.

This increased awareness underscores the importance of both healthcare providers and patients being fully informed about the potential risks. Early detection and management of hearing changes are crucial for mitigating long-term impacts and ensuring the best possible quality of life for individuals undergoing Tepezza treatment. The journey to understanding this link has involved dedicated research and a re-evaluation of initial clinical trial data in light of real-world patient experiences.

Compelling Scientific Evidence

The initial clinical trials for Tepezza reported a relatively low incidence of hearing-related side effects, around 10%. However, as more patients received the drug in a real-world setting, anecdotal reports and subsequent studies have painted a different picture, revealing a significantly higher prevalence of auditory complications. Two key studies, in particular, have been instrumental in highlighting the true scope and nature of these issues:

Stanford Study Published in the American Journal of Ophthalmology (February 2022)

One pivotal study, conducted by Stanford University researchers and published in the American Journal of Ophthalmology in February 2022, raised significant concerns about the frequency of hearing-related side effects from Tepezza (teprotumumab). This study specifically evaluated 27 patients who had received at least four infusions of the medication. Strikingly, 81.5% of these patients (22 out of 27) reported experiencing new otologic symptoms following treatment—including hearing loss, tinnitus (persistent ringing or buzzing in the ears), and a sensation of ear plugging or fullness.

These findings revealed that hearing issues were far more common than initially reported in Tepezza’s clinical trials, where only about 10% of patients were documented to have hearing-related side effects. The discrepancy highlighted the need for more rigorous pre-treatment hearing assessments and ongoing monitoring during and after therapy. The critical data from this single influential study have helped reshape the understanding of Tepezza’s side effect profile, emphasizing the importance of post-marketing surveillance and appropriate patient care practices.

Types and Severity of Hearing Complications

Patients treated with Tepezza have reported a diverse range of auditory issues, which can vary considerably in their specific presentation and severity. Understanding these different manifestations is crucial for both diagnosis and management. The commonly reported symptoms include:

• Sensorineural hearing loss (SNHL): This is a type of hearing loss that results from damage to the inner ear (cochlea) or the nerve pathways from the inner ear to the brain. It can range from mild to profound and may affect one or both ears. SNHL is often irreversible, which makes its occurrence a significant concern for Tepezza patients.
• Tinnitus: Described as a phantom sound, tinnitus can manifest as ringing, buzzing, hissing, clicking, or roaring in the ears. Its intensity can range from a minor annoyance to a debilitating condition that significantly impacts a patient’s quality of life, interfering with concentration, sleep, and overall well-being.
• Ear plugging or fullness sensation: Many patients describe a feeling of pressure or blockage in their ears, as if their ears are “plugged.” This sensation can be uncomfortable and may or may not be accompanied by actual hearing loss.
• Autophony: This is an unusual and often disturbing symptom where a person perceives their own voice or other internal bodily sounds (like breathing or chewing) as unusually loud or resonant in their ears. It can be quite disorienting and can make conversations difficult.
• Hypoacusis: Characterized by a decreased sensitivity to sound, meaning sounds are perceived as quieter than they actually are. This is essentially another term for hearing loss, but it specifically emphasizes the reduced perception of volume.
• Hyperacusis: The opposite of hypoacusis, hyperacusis is an increased sensitivity to everyday sounds, which are perceived as uncomfortably or painfully loud. Sounds that most people tolerate easily, like running water or normal conversation, can become overwhelming.

The onset of these symptoms typically occurs after three to four infusions of Tepezza, suggesting a cumulative effect of the medication on the auditory system. This pattern allows for a window of opportunity for early detection and intervention if regular monitoring is in place.

While some patients have reported improvements in their hearing symptoms over time after discontinuing Tepezza, a significant number have experienced persistent or long-term issues. This highlights the potential for permanent damage and underscores the seriousness of these side effects.

Risk Factors and Monitoring

An important finding in the research is the identification of a history of prior hearing loss as a potential risk factor. This emphasizes the critical need for comprehensive pre-treatment evaluations for all patients being considered for Tepezza therapy. 

Such evaluations should include a detailed audiological assessment, including pure-tone audiometry and possibly other tests, to establish a baseline hearing status. Knowing a patient’s pre-existing hearing condition allows clinicians to identify individuals who might be at higher risk and to monitor them even more closely throughout their treatment course.

Furthermore, ongoing monitoring during therapy is paramount. Regular audiological assessments should be incorporated into the treatment protocol for all patients receiving Tepezza. 

This allows for the early detection of any changes in hearing function, enabling clinicians to intervene promptly. Early intervention could involve adjusting the treatment plan, managing symptoms, or referring the patient to an audiologist or ENT specialist for further evaluation and support.

The long-term implications of these hearing complications, especially sensorineural hearing loss, can significantly impact a patient’s quality of life, affecting communication, social interaction, and overall well-being. 

Therefore, a proactive and vigilant approach to monitoring and managing hearing health is an indispensable component of Tepezza treatment. The evolving understanding of this link between Tepezza and hearing loss empowers both healthcare providers to offer better care and patients to make more informed decisions about their treatment journey.

Types and Severity of Hearing Complications

Patients treated with Tepezza have reported a range of auditory issues, which can vary in severity. Commonly reported symptoms include:

• Sensorineural hearing loss (SNHL)
• Tinnitus (ringing in the ears)
• Ear plugging or fullness sensation
• Autophony (unusually loud perception of one’s own voice)
• Hypoacusis (decreased sound sensitivity)
• Hyperacusis (increased sound sensitivity)

The onset of symptoms typically occurs after three to four infusions. While some patients experienced improvements over time, others reported persistent or long-term issues. Importantly, a history of prior hearing loss has been identified as a potential risk factor, emphasizing the need for comprehensive pre-treatment evaluations and ongoing monitoring during therapy.

The Legal Battle: Holding Horizon Therapeutics Accountable

The growing number of lawsuits against Horizon Therapeutics has shed light on the company’s alleged negligence in addressing Tepezza’s risks. This litigation highlights key issues that patients and healthcare providers must consider when weighing the benefits and risks of this medication.

To address these claims, the formation of multidistrict litigation (MDL) was a pivotal step in consolidating and managing the increasing number of cases.

 

Formation and Growth of the Tepezza MDL

The MDL aimed to consolidate pretrial proceedings and ensure consistent rulings across similar cases. Key milestones include:

• August 2023: MDL formed with 41 cases.
• November 2024: MDL expanded to 180 pending cases.

 

Key Allegations Demonstrating Manufacturer Negligence

Plaintiffs have raised several allegations of negligence against Horizon Therapeutics, including:

• Failure to warn patients and providers despite early indications of hearing loss risks.
• Insufficient pre-market testing, with approval based on limited clinical trials.
• Delay in updating the product label to reflect known risks of hearing impairment.

These allegations underscore the importance of transparency and rigorous testing in ensuring patient safety.

 

The Human Cost: Patients’ Struggles

The impact of hearing loss extends far beyond physical symptoms, profoundly affecting the lives of patients and their families. This human toll underscores the importance of addressing Tepezza’s risks.

 

Life-Altering Impacts of Permanent Hearing Loss

Hearing loss can have profound effects on a patient’s quality of life. Common challenges reported by Tepezza patients include:

• Communication difficulties leading to social isolation.
• Increased risk of cognitive decline and dementia.
• Challenges in professional settings, affecting career prospects.
• Loss of enjoyment in daily activities, such as listening to music or attending social gatherings.

 

Emotional and Financial Burdens

Beyond physical symptoms, hearing loss imposes significant emotional and financial burdens on patients and their families. These include:

• Mental health struggles, including depression and anxiety.
• Strained relationships due to communication barriers.
• Financial costs for hearing aids, treatments, and potential loss of income.

For many patients, these challenges represent not only the physical consequences of hearing loss but also the emotional toll of adapting to an unexpected and often debilitating condition.

 

Horizon Therapeutics’ Negligence: A Closer Look

Critics have scrutinized Horizon’s actions surrounding Tepezza, suggesting lapses in addressing known risks and ensuring patient safety. These criticisms form a central theme in ongoing litigation.

Timeline of Knowledge vs. Action

The timeline of Horizon’s actions suggests a delay in addressing known risks. Early patient reports and studies indicated potential hearing issues, yet the label was not updated until July 2023. This delay is a central issue in the ongoing litigation.

Critique of Post-Market Surveillance Efforts

Critics argue that Horizon’s post-market monitoring efforts fell short. Delayed responses to safety signals and insufficient proactive monitoring have drawn scrutiny, highlighting the need for robust post-market surveillance systems.

 

The Ongoing Fight for Justice in Tepezza Litigation

The litigation surrounding Tepezza continues to evolve as more patients come forward, seeking accountability for the drug’s alleged risks.

As of December 2024, there are 191 pending cases in the Tepezza MDL. Bellwether trials are expected to begin in 2026, offering plaintiffs an opportunity to test the strength of their claims in court. These trials are likely to set the tone for future settlements and may provide valuable insights into how juries perceive the allegations against Horizon Therapeutics.

Legal experts estimate settlement amounts ranging from $75,000 to over $200,000, depending on the strength and circumstances of individual cases. These settlements could provide much-needed relief for affected patients, helping them cover medical expenses, lost wages, and other costs associated with their hearing loss.

Powell & Majestro, experienced leaders in pharmaceutical mass tort litigation, are dedicated to advocating for individuals who have suffered hearing loss or other auditory complications after Tepezza treatment. If you or a loved one has experienced hearing problems following Tepezza infusions, we encourage you to reach out to our firm. Our team of skilled attorneys is prepared to evaluate your case as part of the ongoing Tepezza multidistrict litigation (MDL).

Contact us today for a free, confidential consultation to discuss your legal options and potential inclusion in this important MDL. Let us help you seek the justice and compensation you deserve.