Tepezza Class Action Lawsuit

Tepezza (generic name teprotumumab) is a prescription intravenous drug that received U.S. Food & Drug Administration (FDA) approval in January 2020 for the treatment of Thyroid Eye Disease (TED) associated with Graves’ disease.

Shortly after its approval and wider use, a number of patients reported hearing-related adverse effects, including tinnitus (ringing in the ears), muffled hearing, eustachian‐tube dysfunction, and in some cases permanent hearing loss.

Studies began to suggest the incidence of hearing damage was significantly higher than the rate reported in the original clinical trials (which had disclosed around 10 % hearing-related events). For example, one study suggested as many as 65 % of patients may have experienced some hearing symptoms.

These reports triggered litigation under the theory that the manufacturer, Horizon Therapeutics, failed to adequately warn patients and physicians about the risk of permanent hearing damage and/or failed to design adequate post-market monitoring or audiological surveillance.

Status of Class Action vs MDL

A key distinction in the litigation is whether the Tepezza cases are proceeding as a class action or under a multidistrict litigation (MDL) framework:

• Several law-firm information pages state that there is currently no class action lawsuit for Tepezza hearing-loss claims.
• Instead, the claims have been consolidated into an MDL in the U.S. District Court for the Northern District of Illinois, under Judge Thomas M. Durkin.
• An MDL means multiple individual lawsuits with similar factual and legal issues are centralized for pre-trial proceedings (discovery, expert filings, motions) but each claimant retains an individual case. This differs from a true class action, in which one or more plaintiffs represent a large “class” and judgment or settlement binds all class members (absent opt-out).

Thus, while some websites may use language such as “class action lawyers”, the correct legal status is that these are individual claims, consolidated for efficiency via MDL, not a classic class-action structure.

Key Legal Claims

The key legal theories in these Tepezza-hearing-loss cases include:

• Failure to warn: Plaintiffs allege Horizon Therapeutics did not properly warn patients/physicians about the risk of hearing damage (or the true magnitude of the risk) and/or delayed updating the label even after emerging data.
• Defective design or inadequate study: Some claims assert that the drug’s mechanism (inhibition of the IGF-1R pathway) may pose a known risk to auditory hair cells or inner ear function, and that Horizon failed to anticipate, test for, or mitigate that risk.
• Causation and damages: To recover, claimants must show they received Tepezza, subsequently experienced hearing injury (tinnitus, hearing loss, etc.), and that the injury is linked to the drug rather than other causes (age, prior ear disease, noise exposure, etc.). They also seek compensation for medical costs (audiology vs hearing aids/cochlear implants), lost wages, pain & suffering, diminished quality of life.

Procedural Milestones & Litigation Status

• As of early to mid-2025, there were over 200 federal lawsuits consolidated in the MDL. For example: “There are now 217 lawsuits pending” as of May 2025, according to one source.
• The court has scheduled (or announced) bellwether trials (representative test cases) beginning in 2026 (e.g., April, June, etc) to gauge how juries respond and provide settlement guidance.
• No large global settlement had been publicly announced (as of mid-2025) and no jury verdicts appear to have been finalized.

Why this Matters

This litigation is relevant for a number of stakeholders:

• Patients who took Tepezza and later developed hearing problems may have legal recourse to seek compensation. They also highlight the importance of monitoring for hearing issues and informed consent regarding risks.
• Drug manufacturers are reminded that post-market adverse event data (especially for rare or serious injuries) must be appropriately acted upon (labeling updates, warnings, monitoring). Failure to do so may lead to liability.
• Legal precedent: While not a class action per se, the MDL structure allows many similar claims to proceed efficiently. The outcome may influence how “hearing-loss” or “ototoxicity” claims associated with drugs are handled in future.
• Investors and risk managers: For companies that develop medications with mechanisms that may affect non-target organs (e.g., ear/vestibular systems), this litigation underscores the risk of latent side-effects and potential mass tort exposure.

Key Legal Considerations & Challenges

• Causation: Plaintiffs must establish a causal link between Tepezza and the hearing injury. Hearing loss can have many causes (aging, noise, ear infections), so the ability to show the drug caused or substantially contributed to the injury will be crucial.
• Adequacy of warnings: Because the FDA label did list hearing-related events (about 10%) at approval, the litigation will focus on whether Horizon knew or should have known about a greater risk, and whether the warning was timely or sufficient.
• Settlement vs protracted litigation: Since the MDL is relatively new and only in early discovery, parties may decide to settle once bellwether verdicts emerge or when data is clearer. But until then, case‐by‐case outcomes may vary widely.
• Statute of limitations: Each U.S. state has its own time limit (statute of limitations) for filing such claims. Affected individuals should consult counsel promptly.
• No class action structure: It’s important to note that the absence of a formal class action means each claimant’s case may differ significantly in value and outcome. While the consolidated MDL provides efficiencies, each claim retains individual elements.

Settlement Expectations & Case Value

• Several legal websites estimate settlement values (not guarantees) based on the severity of the injury, medical cost, lost income, etc. One firm estimates individual settlements could range “between $75,000 and over $200,000” (or more) depending on case specifics.
• Another source notes that while speculation exists, “no settlement … yet” has been publicly disclosed.
• Factors influencing value include: degree and permanence of hearing loss, whether hearing aids or cochlear implants are needed, impact on ability to work/communicate, and strength of medical expert testimony.

Conclusion

While there is not currently a traditional class action lawsuit for Tepezza hearing loss, the litigation is proceeding robustly via a federal MDL. Plaintiffs allege that Horizon Therapeutics failed to adequately warn about the risk of permanent hearing damage associated with Tepezza. With over 200 cases pending, bellwether trials upcoming in 2026, and no major settlement yet announced, the legal landscape remains dynamic.

For individuals who received Tepezza and later developed hearing or auditory symptoms, it is wise to talk with an attorney experienced in pharmaceutical mass-tort/defective drug litigation. Time may be limited due to statutes of limitation.