Tepezza, a medication approved by the FDA in 2020 for the treatment of Thyroid Eye Disease (TED), has recently come under scrutiny due to reports linking it to hearing-related side effects, including hearing loss and tinnitus. These developments have led to a series of lawsuits against the manufacturer, Horizon Therapeutics, alleging failure to adequately warn patients and healthcare providers about these potential risks.

Background on Tepezza

Tepezza (teprotumumab-trbw) is an intravenous infusion therapy designed to address symptoms of TED, such as eye bulging, double vision, and pain. Since its introduction, it has been administered to thousands of patients seeking relief from this debilitating condition. However, emerging evidence suggests that the drug may have unintended ototoxic effects.

Emergence of Hearing Loss Reports

Clinical observations and patient reports have raised concerns about Tepezza’s safety profile concerning auditory health. In a study involving 26 patients who received at least four infusions of Tepezza, approximately 23% reported new or worsening hearing loss. These findings have been corroborated by other studies and case reports, indicating a potential link between Tepezza and hearing impairments. 

FDA Label Update

In response to these reports, the FDA updated Tepezza’s warning label in July 2023 to include information about the risk of severe hearing impairment, including hearing loss, which in some cases may be permanent. This update underscores the importance of monitoring auditory function in patients undergoing Tepezza treatment. 

Legal Actions and Multidistrict Litigation (MDL)

The alleged failure of Horizon Therapeutics to provide timely and adequate warnings has led to a series of lawsuits filed across the United States. As of February 2025, there are over 200 pending cases consolidated in a multidistrict litigation (MDL) in the Northern District of Illinois. This consolidation aims to streamline pretrial proceedings and promote efficient resolution of common issues. 

Bellwether Trials

To facilitate the litigation process, the court has selected four bellwether cases from the MDL to proceed to early trials. These cases are intended to provide insight into how juries might respond to evidence and arguments, potentially guiding future settlements or verdicts. 

Implications for Affected Patients

Individuals who have experienced hearing loss or related symptoms following Tepezza treatment may be entitled to compensation for medical expenses, lost wages, pain and suffering, and other damages. Potential claimants are advised to consult with legal professionals experienced in pharmaceutical litigation to explore their options.

Conclusion

The ongoing Tepezza litigation highlights the critical need for comprehensive drug safety evaluations and transparent communication of potential risks. As these lawsuits progress, they will not only impact the parties involved but also influence future practices in drug approval, labeling, and monitoring to ensure patient safety.