The Tepezza class action lawsuit refers to the growing litigation against Horizon Therapeutics, the manufacturer of Tepezza, a drug approved for thyroid eye disease. Plaintiffs allege that Tepezza causes severe and potentially permanent hearing loss and tinnitus, claims that were not adequately disclosed to patients and healthcare professionals in a timely manner.
Background of the Tepezza Class Action Lawsuit
Tepezza was approved by the FDA in 2020 to treat thyroid eye disease, but multiple patients reported experiencing hearing-related side effects, including hearing loss, during and after treatment. Despite early clinical data showing significant incidence of auditory side effects, the company delayed updating its label and warnings until 2023.
In response, hundreds of lawsuits have been filed in state and federal courts. Many of these cases were consolidated into a multidistrict litigation (MDL) in the Northern District of Illinois to streamline pretrial proceedings and discovery.
Details of the Lawsuit Claims and Allegations
- Failure to warn patients and doctors about the risk of severe hearing damage linked to Tepezza use.
- Negligence in conducting comprehensive safety testing and post-market surveillance.
- Delaying label changes and safety disclosures despite internal knowledge of hearing loss reports.
- Breach of warranty and product liability for damages suffered by plaintiffs.
Legal Framework and Progress
The litigation cites product liability laws, negligence, failure to warn, and breach of warranty claims. As of August 2025, roughly 260 lawsuits are active within the MDL. While no formal class action settlement has been announced yet, bellwether trials—test cases to gauge outcomes—are scheduled to begin in 2026.
Experts from both sides will present scientific and medical evidence to determine causation and liability, a crucial phase before potential settlements or trials.
Health and Legal Implications
Health implications center on the prevalence and severity of hearing loss and tinnitus as serious adverse effects impacting patients’ quality of life. The lawsuit highlights the critical need for early warning and transparency in pharmaceutical safety.
Legally, this case may set important precedents for post-market drug monitoring and manufacturer responsibilities regarding adverse event disclosures.
Current Status and Next Steps
The MDL is progressing with scheduled expert disclosures, depositions, and discovery deadlines. Plaintiffs’ attorneys are actively preparing bellwether trial candidates to be heard beginning in early to mid-2026. Meanwhile, no settlement has been reached, but ongoing negotiations are expected.
Advice for Patients and Healthcare Providers
Patients who have taken Tepezza and experienced hearing loss or related symptoms are encouraged to seek medical evaluation and legal consultation. Documenting medical history and hearing changes is essential for potential claims.
Healthcare providers should remain vigilant in monitoring hearing health in patients prescribed Tepezza and promptly report adverse events to improve drug safety protocols.
Conclusion: The Outlook of the Tepezza Class Action Lawsuit
The Tepezza class action lawsuit embodies the complex interplay between drug innovation, safety monitoring, and patient rights. Its developments over the coming years will influence pharmaceutical accountability, drug labeling standards, and patients’ legal protections in the healthcare industry.
