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: Tepezza and Hearing Loss
As more patients received Tepezza treatment, a concerning pattern of hearing-related complications began to emerge. Researchers and medical professionals have sought to uncover the link between Tepezza and these auditory issues, leading to compelling scientific evidence.
Compelling Scientific Evidence
Key studies have highlighted the prevalence and nature of hearing complications associated with Tepezza:
- Stanford University Study: This study evaluated 26 patients who received at least four infusions of Tepezza. Of these, 65% reported experiencing hearing problems, including hearing loss, tinnitus, and a sensation of ear plugging.
- February 2022 Study: Published in the American Journal of Ophthalmology, this study analyzed 27 patients and found that 81.5% reported hearing complications, a figure that is higher than the Stanford study and significantly higher than the 10% rate initially reported in clinical trials.
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.