Key Takeaways
- Tepezza lawsuits allege that Horizon Therapeutics failed to adequately warn patients and healthcare providers about the risk of hearing loss and related side effects.
- Over 200 cases have been consolidated in federal multidistrict litigation (MDL) as of April 2025, reflecting the widespread nature of the claims.
- Plaintiffs seek compensation for hearing loss, tinnitus, and related injuries, with some settlements potentially reaching substantial amounts.
Introduction
The Tepezza hearing loss lawsuit is a major legal development in the pharmaceutical industry. It centers on claims that Horizon Therapeutics, the manufacturer of Tepezza, did not provide sufficient warnings about the risk of hearing-related side effects. Tepezza is an FDA-approved drug used to treat thyroid eye disease (TED). Since its approval, reports have surfaced linking the drug to hearing loss, tinnitus, and other auditory issues. These reports have led to a surge in lawsuits across the United States.
Background on Tepezza
What Is Tepezza?
Tepezza (teprotumumab-trbw) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) in January 2020 for the treatment of thyroid eye disease, a rare autoimmune condition. The drug is administered through intravenous infusions and was considered a breakthrough for patients with TED, offering a non-surgical treatment option. For more information, see the FDA’s approval announcement.
Reported Side Effects
Shortly after its release, patients and healthcare providers began reporting hearing-related side effects. These included tinnitus (ringing in the ears), hypoacusis (reduced hearing), and in some cases, complete hearing loss. According to Horizon’s own reports to the FDA, at least three patients experienced hearing-related adverse events by July 2020 (source). However, lawsuits allege that the true scope of the risk was not adequately communicated to the public or the medical community.
Allegations in the Lawsuits
Failure to Warn
The central allegation in the Tepezza lawsuits is that Horizon Therapeutics failed to provide adequate warnings about the potential for permanent hearing loss and other auditory side effects. Plaintiffs claim that Horizon knew, or should have known, about these risks based on clinical trial data and post-market reports. Despite this, the company allegedly did not update its labeling or issue sufficient warnings to patients and healthcare providers.
Lack of Medical Protocols
Another key argument is that Horizon did not instruct physicians to conduct baseline audiology testing or monitor patients’ hearing during treatment. Such protocols are standard when a drug is known to carry a risk of hearing loss. The absence of these recommendations is cited as evidence of negligence (source).
Impact on Patients
Many plaintiffs report experiencing tinnitus, partial hearing loss, or total hearing loss after receiving Tepezza infusions. Some claim that the hearing loss is permanent and has significantly affected their quality of life. The lawsuits seek compensation for medical expenses, lost wages, pain and suffering, and other damages.
Status of the Litigation
Multidistrict Litigation (MDL)
As of April 2025, there are 213 Tepezza hearing loss cases pending in federal multidistrict litigation (MDL) in the Northern District of Illinois (source). MDL is a legal process that consolidates similar cases to streamline pretrial proceedings and address common issues efficiently. This approach is often used in complex pharmaceutical litigation.
Recent Developments
The MDL is still in the early stages, with discovery and pretrial motions ongoing. No cases have gone to trial as of this writing. The outcome of bellwether trials—test cases selected to represent the broader group—will likely influence settlement negotiations and the direction of the litigation.
Potential Settlements
Plaintiffs are seeking compensation for a range of injuries. According to some estimates, settlements for cases involving permanent hearing loss could reach up to $1.1 million (source). The actual value of each case will depend on the severity of the injury, the impact on the plaintiff’s life, and other factors.
Legal Arguments and Evidence
What Plaintiffs Must Prove
To succeed in a Tepezza hearing loss lawsuit, plaintiffs generally need to prove:
- They received Tepezza as prescribed.
- They suffered hearing loss, tinnitus, or related injuries after treatment.
- Horizon Therapeutics failed to provide adequate warnings about these risks.
- The lack of warning was a direct cause of their injuries.
Evidence Cited
Plaintiffs often rely on:
- Medical records documenting hearing loss after Tepezza treatment.
- Expert testimony linking the drug to auditory side effects.
- Internal company documents and FDA reports showing Horizon’s knowledge of the risks.
Horizon’s Defense
Horizon Therapeutics has denied wrongdoing. The company argues that it complied with all FDA requirements and that the risk of hearing loss is rare and was disclosed in the drug’s labeling. The outcome of the litigation will depend on how courts interpret the evidence and the adequacy of Horizon’s warnings.
Regulatory and Industry Implications
FDA Involvement
The FDA monitors adverse event reports for all approved drugs. In the case of Tepezza, the agency has received reports of hearing-related side effects but has not issued a recall or additional warnings as of April 2025. For updates, see the FDA’s MedWatch Safety Information.
Impact on Pharmaceutical Companies
The Tepezza litigation highlights the importance of post-market surveillance and transparent communication of drug risks. Pharmaceutical companies are required to update labeling and issue warnings when new risks are identified. Failure to do so can result in significant legal liability.
What Patients and Attorneys Should Know
For Patients
If you have experienced hearing loss or tinnitus after receiving Tepezza, it is important to consult with a healthcare provider and document your symptoms. You may also wish to speak with an attorney to discuss your legal options. The outcome of the MDL could affect your ability to recover compensation.
For Attorneys
Attorneys representing clients in Tepezza lawsuits should stay informed about developments in the MDL and monitor new scientific studies on the drug’s safety profile. Access to comprehensive legal research tools, such as those offered by Counsel Stack, can be valuable in building a strong case.
How to File a Tepezza Hearing Loss Lawsuit
Steps to Take
- Consult a Medical Professional: Obtain a diagnosis and document any hearing-related symptoms.
- Gather Medical Records: Collect records showing Tepezza treatment and subsequent hearing issues.
- Contact an Attorney: Seek legal advice from a lawyer experienced in pharmaceutical litigation.
- File a Claim: Your attorney can help you file a lawsuit, which may be consolidated into the MDL.
Statute of Limitations
The time limit for filing a lawsuit varies by state. It is important to act promptly to preserve your legal rights. For more information, consult your state’s laws or speak with an attorney.
Conclusion
The Tepezza hearing loss lawsuits represent a significant challenge for Horizon Therapeutics and raise important questions about drug safety and corporate responsibility. With over 200 cases consolidated in federal court, the outcome of this litigation could have lasting effects on the pharmaceutical industry. Patients and attorneys should monitor developments closely and seek reliable legal research to inform their decisions.
Disclaimer:
This guide provides a general overview of the Tepezza hearing loss lawsuits. The litigation is ongoing, and the information presented is based on current allegations and available data as of April 2025. Outcomes may change as new evidence emerges. This is not legal advice. For specific guidance, consult a qualified attorney.
