Tepezza (generic name Teprotumumab (generic name) is an intravenous medication prescribed by a doctor which was approved by the U.S. Food & Drug Administration (FDA) approval in January 2020 to treat of Thyroid Eye Disease (TED) which is associated with Graves’ disease.

Following its approval and the wider availability there were a few patients who complained of hearing-related side effects which included the tinnitus (ringing in the ear) as well as hearing loss, the eustachian tube dysfunction and in some cases permanent loss of hearing.

Research began to show that hearing loss was much more than that of hearing loss that was reported in the first clinical studies (which revealed around 10 % hearing-related incidents). One study suggested up to 65 percent of patients could have had some hearing issues.

The reports led to litigation on the premise that the company, Horizon Therapeutics, failed to adequately warn physicians and patients about the possibility of permanent hearing loss, or did not design an adequate post-market monitoring system or audiological surveillance.

Status of Class Action vs MDL

The most important distinction in the case will be whether or not the Tepezza cases are being handled in an individual collective action or within the multidistrict litigation (MDL) framework:

• Many law firms’ information pages indicate the fact that there is currently no suit for a class to Tepezza hearing loss claims.
• Instead the claims have been condensed into an MDL within the U.S. District Court for the Northern District of Illinois, under the supervision of Judge Thomas M. Durkin.
• A MDL is when multiple lawsuits that share similar facts or legal concerns are brought together for pre-trial procedures (discovery and expert filings, motions) however, each claimant is able to pursue the right to pursue their own case. This differs from a class action, where the plaintiffs are part of the entire “class” and judgment or settlements are binding on all class members (absent the option to opt out).

Therefore, even though some websites may employ language like “class action lawyers”, the legal meaning is that they are individual claims that are which are consolidated to improve efficiency through MDL rather than the traditional class-action structure.

Key Legal Claims

The most important legal concepts in these cases of Tepezza hearing loss include:

• Inadequate warning Plaintiffs assert that Horizon Therapeutics did not properly inform patients or physicians about the possibility of hearing loss (or the actual extent of risk) or put off updating the label after the release of new data.
• A flawed design or inadequate research Some claims suggest that the mechanism of the drug (inhibition in the pathway for IGF-1R) could pose a danger for auditory hair cells or inner ear function, and Horizon did not anticipate the risk, determine it, or reduce the risk.
• Damages and Causation to recover damages the damages, the claimant must prove that they were injected with Tepezza and then suffered hearing loss (tinnitus or hearing loss etc. ) and prove that the injury was due to the drug, not other factors (age and prior ear problems or exposure to noise, etc.). They are also seeking the reimbursement of medical expenses (audiology as opposed to hearing aids/cochlear implants) as well as loss of wages, pain and suffering, and a diminished the quality of their life.

Procedural Milestones & Litigation Status

• In the early 2025 through mid-2025 there were more than 200 federal lawsuits that were consolidated into the MDL. For instance: “There are now 217 lawsuits pending” at the time of May 2025, according one source.
• The court has set (or declared) bellwether trials (representative trial cases) to begin around 2026 (e.g. June, April, etc.) to determine the response of juries and to give settlement guidelines.
• There was no large settlement that had been announced publicly (as in the middle of 2025) and the jury verdicts do not appear to have been formally negotiated.

Why it is Important

This lawsuit is pertinent to several parties:

• Users who have taken Tepezza and later had hearing issues might be entitled to pursue compensation. They also stress the necessity of monitoring for hearing issues and obtaining informed consent to potential risks.
• Drug makers are advised that adverse event post-market information (especially for serious or rare injuries) should be properly taken action on (labeling updates warnings, labeling updates, monitoring). Failure to follow this procedure could result in the risk of liability.
• The legal precedent: Although not a class action in itself however, the MDL structure permits a variety of similar claims to go forward. The outcome can affect the manner in which “hearing-loss” or “ototoxicity” claims involving drugs will be handled in the future.
• Risk managers and investors for companies that create medications using mechanisms that can affect organs other than the target organs (e.g. the ear/vestibular system, etc.) This lawsuit highlights the potential for latent adverse effects and the possibility of liability for mass torts.

Key Legal Considerations & Challenges

• Causation Plaintiffs must prove the causal connection between Tepezza and the hearing loss. Hearing loss could have multiple causes (aging and noise, as well as ear infections, etc.)) and therefore it is essential to establish that the drug caused or significantly caused the injury will be vital.
• Effectiveness of cautions The FDA label did mention hearing-related incidents (about 10 percent) upon approval The litigation will center on the extent to which Horizon had been aware of a higher risk, and if it was prompt or enough.
• Settlement in contrast to long-running litigation The MDL is still relatively new and is still in the early stages of discovery, parties could decide to settle after bellwether verdicts are made or the data becomes more clear. However, until then, case-by-case outcomes can vary greatly.
• The statute of limitations Every U.S. states has a different time frame (statute of limitation) for filing claims. The affected individuals should consult with counsel immediately.
• There is no classification structure for class actions It is important to remember this absence an official class action implies that every claimant’s situation could differ in terms of the value and result. Although the consolidating MDL offers efficiencies but each claim is still a unique elements.

Settlement Expectations & Case Value

• A number of legal websites estimate settlement amounts (not promises) depending on the degree and extent of injury as well as medical expenses and lost income. One firm estimates that individual settlements could be “between $75,000 and over $200,000” (or greater) dependent on the specifics of the case.
• Another source explains that, while speculation does exist, “no settlement … yet” has been disclosed publicly.
• Aspects that affect value include the severity and length deafness, if hearing aids and cochlear implants will be required and their impact on the communication and working abilities, as well as the the credibility the medical expertise testimony.

Conclusion

Although there is currently any current class action lawsuit involving Tepezza hearing impairment, lawsuit is advancing vigorously through an federal MDL. Plaintiffs claim the defendants Horizon Therapeutics failed to adequately warn of the potential for permanent hearing loss resulting from Tepezza. With more than 200 cases in the midst and bellwether trials scheduled for 2026, and with no major settlements yet to be announced the legal landscape is ever-changing.

For those who have were treated with Tepezza and later experienced auditory or hearing symptoms It is recommended to speak with an attorney with experience in drug mass-tort litigation and defective drugs. The time frame may be restricted by statutes of limitation.