Tepezza Hearing Loss Lawsuits: What Patients Need to Know About Thyroid Eye Disease Drug Litigation

Tepezza Hearing Loss Lawsuits

Patients who received Tepezza (teprotumumab-trbw) for thyroid eye disease are coming forward in growing numbers with a similar story: their eyes improved, but their hearing did not recover. Reports of permanent hearing loss, tinnitus, autophony, and a persistent muffled sensation in the ears have prompted a wave of pharmaceutical injury litigation against the drug’s manufacturer, Horizon Therapeutics — now part of Amgen following the 2023 acquisition. At the center of these claims is a question regulators and researchers have been studying for several years: did the company adequately warn patients and physicians about the risk of irreversible auditory damage before the FDA required a label update in July 2023?

Today, hundreds of federal Tepezza hearing loss lawsuits are consolidated in multidistrict litigation (MDL) before a single judge in the Northern District of Illinois. This guide explains how the litigation reached this point, the medical evidence linking Tepezza to hearing impairment, who may qualify to file a claim, what compensation could be available, and what patients should do if they suspect their hearing damage is connected to treatment. The information here is educational, not legal advice — but it should help you understand the landscape before you speak with a qualified mass tort attorney.

What Is Tepezza?

Tepezza is the brand name for teprotumumab-trbw, a fully human monoclonal antibody developed by Horizon Therapeutics. In January 2020, the U.S. Food and Drug Administration approved Tepezza as the first — and to date only — drug specifically indicated for the treatment of thyroid eye disease (TED), a serious autoimmune condition most often associated with Graves’ disease. TED can cause bulging eyes (proptosis), double vision, eyelid retraction, and in severe cases, optic nerve compression that threatens vision.

Tepezza works by blocking the insulin-like growth factor-1 receptor (IGF-1R), a signaling pathway that contributes to the inflammation and tissue expansion behind the eye that drives TED symptoms. The standard treatment course consists of eight intravenous infusions, given once every three weeks over approximately six months. Clinical trials demonstrated meaningful reductions in proptosis and double vision compared with placebo, and for many patients the drug has been life-changing for their vision and appearance.

But IGF-1R is not unique to the eye. Receptors for IGF-1 are present throughout the body, including in the cochlea and auditory pathways — and that biological reality is now central to the litigation now unfolding in federal court.

Why Are Patients Filing Tepezza Hearing Loss Lawsuits?

The lawsuits filed against Horizon Therapeutics (and now Amgen, as the successor in interest) center on a familiar set of pharmaceutical product liability allegations. Plaintiffs argue the company:

• Failed to adequately warn patients and prescribing physicians about the risk of permanent hearing loss and tinnitus associated with Tepezza infusions.
• Marketed the drug with safety labeling that downplayed or omitted the auditory risks suggested by post-approval research and adverse event reports.
• Knew, or reasonably should have known, of the ototoxic potential of IGF-1R inhibition based on internal data, the FDA Adverse Event Reporting System (FAERS), and emerging peer-reviewed literature.
• Delayed updating the drug’s label until the FDA required a hearing impairment warning in July 2023 — years after patients began reporting symptoms.

These are not abstract complaints. Plaintiffs describe receiving Tepezza for thyroid eye disease, then experiencing muffled hearing, ringing in the ears, ear fullness, or sudden hearing loss — sometimes during the infusion course, sometimes weeks afterward. In many cases, the auditory symptoms have not resolved after treatment ended. The legal theory is straightforward: had patients and their doctors been properly informed of the risk, many would have weighed the trade-off differently or chosen a different treatment path.

Scientific Evidence Linking Tepezza to Hearing Loss

The medical case for a connection between Tepezza and ototoxicity has strengthened considerably since the drug’s 2020 approval. The original Phase 2 and Phase 3 clinical trials reported hearing-related symptoms in roughly 10% of patients, and described those symptoms as generally reversible. Subsequent real-world research has painted a more concerning picture.

A 2021 single-center prospective study presented at ENDO 2021 followed patients undergoing Tepezza infusions and found otologic symptoms in approximately 65% of those who received at least four infusions — a rate roughly six times higher than what the pivotal trials had suggested. A separate audiometric study published in peer-reviewed literature reported that nearly half of patients met formal criteria for ototoxicity in at least one ear when audiograms were performed before and after treatment, with high-frequency hearing the most affected.

A propensity score-matched cohort study using the TriNetX database compared more than 500 Tepezza-treated patients with matched controls and identified a roughly threefold increase in the relative risk of sensorineural hearing loss over a five-year window. A 2024 meta-analysis pooling randomized and observational evidence reached a similar conclusion: a statistically significant increase in hearing impairment risk under both broad and strict definitions, consistent across study designs.

The reported auditory symptoms include:

• Sensorineural hearing loss (often at high frequencies first)
• Tinnitus — ringing, buzzing, or hissing in the ears
• Autophony — hearing one’s own voice or breathing unusually loudly
• Patulous eustachian tube and ear-fullness or pressure sensations
• Muffled hearing or hyperacusis
• Balance disturbances in some patients

The proposed mechanism involves IGF-1R signaling in the inner ear and auditory nerve pathways, although the precise pathway by which teprotumumab disrupts hearing is still being investigated. The FDA’s July 2023 label change formally acknowledged hearing impairment as a known adverse effect — a regulatory milestone that has become a central exhibit in the litigation.

Who May Qualify for a Tepezza Hearing Loss Lawsuit?

Eligibility for a Tepezza hearing loss claim is fact-specific and ultimately depends on the laws of the state where treatment occurred and where the patient resides. That said, plaintiffs’ attorneys are generally evaluating individuals who can demonstrate the following core elements:

• Documented Tepezza exposure — typically at least one full infusion, often the complete course of eight infusions for thyroid eye disease.
• Onset of hearing-related injury — hearing loss, tinnitus, autophony, or related auditory symptoms that began during or after Tepezza treatment.
• Medical records connecting the two — pharmacy or infusion center records confirming Tepezza administration, audiology reports, ENT evaluations, and clinical notes describing the timeline of symptoms.
• Persistence or severity of injury — claims involving permanent sensorineural hearing loss, chronic tinnitus, or significant impairment in daily function generally carry the strongest evidentiary profile.
• A timely filing — every state imposes a statute of limitations on product liability claims, generally two to four years from the date of injury or its discovery. Some patients treated between 2020 and 2022 are approaching deadlines now.

Documentation typically requested by attorneys includes infusion records, audiograms (ideally before and after treatment), tympanometry results, ENT specialist notes, and any FDA MedWatch reports the patient or treating physician may have submitted. A free legal consultation is the standard entry point for evaluating whether a specific case fits the criteria.

What Injuries Are Being Reported in Tepezza Lawsuits?

The injuries described in Tepezza complaints filed in the MDL share a recognizable pattern. Plaintiffs report a mix of permanent and persistent auditory and quality-of-life harms, including:

• Permanent sensorineural hearing loss — irreversible damage to the inner ear or auditory nerve, often beginning in the high-frequency range and progressing into the speech range.
• Chronic tinnitus — persistent ringing, buzzing, or hissing that interferes with sleep, concentration, and emotional well-being.
• Partial hearing impairment — reduced clarity that requires hearing aids, assistive listening devices, or accommodation in noisy environments.
• Auditory nerve damage — neurological injury that may not respond to hearing aids and that complicates speech recognition.
• Long-term neurological symptoms — including dizziness, balance issues, and a sense of ear fullness that does not resolve.

The downstream impact on daily life is significant. Patients describe difficulty following conversations at work, in restaurants, or with family members; withdrawal from social settings; the need for career changes when phone-based or auditory-intensive work becomes untenable; and the emotional weight of a permanent injury that arose from a treatment they pursued in good faith. These quality-of-life harms are recognized in tort law as compensable non-economic damages, and they form a substantial component of many Tepezza claims.

Tepezza Lawsuits and Mass Tort Litigation

It is important to understand a distinction that often confuses patients researching their options: the Tepezza litigation is a mass tort, not a class action. The two structures sound similar but operate very differently.

In a class action, a single representative plaintiff sues on behalf of a large class of similarly situated individuals, and any settlement or judgment is divided across the class according to a court-approved formula. In a mass tort, by contrast, each plaintiff files an individual lawsuit, and each case retains its own facts, damages, and ultimate value — even when many cases are coordinated for pretrial efficiency. Pharmaceutical injury cases overwhelmingly proceed as mass torts because each patient’s medical history, exposure, and injury severity is unique and not easily averaged across a class.

To learn more about how these cases work and the broader landscape of pharmaceutical and product injury litigation, see CredibleLaw’s overview of mass tort lawsuits, the general mass torts hub, currently active mass tort cases, emerging mass tort investigations, and ongoing mass tort investigations. These resources provide context for how Tepezza fits within the larger pharmaceutical accountability ecosystem.

How Mass Tort Drug Litigation Works

When dozens or hundreds of similar pharmaceutical injury lawsuits are filed in different federal courts, the Judicial Panel on Multidistrict Litigation (JPML) typically consolidates them into a single MDL before one federal judge. That is exactly what happened with Tepezza. In June 2023, the JPML created MDL No. 3079, In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, and assigned all federal Tepezza cases to U.S. District Judge Thomas M. Durkin in the Northern District of Illinois.

From there, the MDL follows a relatively predictable arc:

• Case investigation and filing — attorneys evaluate individual claims, gather medical records, and file complaints directly into the MDL or transfer existing cases.
• Coordinated discovery — the parties exchange documents, depose corporate witnesses (including pharmacovigilance and regulatory affairs personnel), and develop expert reports on causation and damages.
• Bellwether selection — a small group of representative cases is chosen to be tried first, providing both sides with data on how juries are likely to respond.
• Bellwether trials — the early jury verdicts (or lack of trials, if cases settle) shape the framework for resolving the remaining inventory.
• Global settlement negotiations — when both sides have enough information to value the claims, a settlement matrix can be negotiated. Each plaintiff’s individual recovery still depends on their specific facts.

Crucially, an MDL is a procedural tool — not a verdict on the merits. Each plaintiff’s case is decided on its own evidence even after years of coordinated proceedings.

Potential Compensation in Tepezza Hearing Loss Lawsuits

As of this writing, no global settlement has been finalized in the Tepezza MDL, and any specific dollar figures circulating online should be treated as educated estimates rather than guarantees. With that caution stated, compensation in pharmaceutical injury cases generally falls into two broad categories.

Economic Damages

• Medical costs already incurred for ENT evaluations, audiograms, and treatment of hearing complications
• Future medical expenses, including hearing aids, cochlear implants where appropriate, and ongoing audiology care
• Speech therapy and aural rehabilitation
• Lost wages and reduced earning capacity, particularly for individuals whose work depends on auditory function

Non-Economic Damages

• Pain and suffering tied to chronic tinnitus and hearing loss
• Emotional distress, including anxiety, depression, and social withdrawal
• Loss of enjoyment of life and impacts on personal relationships
• Permanent disability and the cost of adapting to a new sensory baseline

The ultimate value of any individual claim depends on the severity and permanence of the injury, the strength of the medical documentation, the patient’s age and earning trajectory, and the trajectory of the broader litigation. Some plaintiffs’ attorneys have publicly estimated potential settlement ranges between $140,000 and $500,000 for cases with strong supporting facts, but those figures are projections — not court-approved values. A qualified mass tort attorney can give a more grounded assessment based on the specifics of a case.

Tepezza Litigation Timeline

The Tepezza MDL has moved through the standard phases of pharmaceutical mass tort litigation:

• January 2020 — FDA approves Tepezza for thyroid eye disease.
• 2021–2022 — Independent studies begin reporting otologic symptom rates well above what was disclosed in the pivotal trials.
• Early 2023 — The first wave of individual Tepezza hearing loss lawsuits is filed in federal courts across the country.
• June 2023 — JPML consolidates the cases into MDL No. 3079 before Judge Thomas M. Durkin in the Northern District of Illinois.
• July 2023 — FDA requires Horizon Therapeutics to add a hearing impairment warning to the Tepezza label.
• Late 2023 — Amgen completes its acquisition of Horizon Therapeutics, becoming the defendant of record in the litigation.
• 2024 — A bellwether pool of twelve representative cases is selected; coordinated discovery proceeds.
• 2025 — Court orders quarterly settlement conferences; bellwether trial dates set and then adjusted multiple times.
• October 2025 — The court vacates all bellwether deadlines, signaling intensified settlement negotiations.
• 2026 and beyond — Status conferences continue as the parties work toward potential global resolution; new individual claims continue to be filed where statutes of limitations remain open.

What to Do If You Experienced Hearing Loss After Tepezza

If you or a family member received Tepezza for thyroid eye disease and have since noticed hearing changes, tinnitus, or other auditory symptoms, the following steps can protect both your health and your potential legal claim.

• Seek a medical evaluation — schedule an appointment with an audiologist or ENT specialist for formal hearing testing. An audiogram is essential, both for clinical care and for any future legal claim.
• Document your symptoms — keep a written log of when symptoms began, how they have progressed, and how they affect your daily life.
• Preserve your medical records — request a complete copy of your Tepezza infusion records, including dates, dosages, and the prescribing facility, along with any pre- and post-treatment audiology results.
• Report adverse events to the FDA — patients and physicians can submit reports to the FDA’s MedWatch program, which contributes to ongoing post-market surveillance.
• Consult a mass tort attorney — an initial consultation is typically free and can clarify whether your situation fits the eligibility profile and whether the statute of limitations remains open in your state.

Acting sooner rather than later matters. Statutes of limitations for product liability claims are unforgiving, and patients treated several years ago may have less time than they realize.

Why Pharmaceutical Mass Tort Cases Matter

Pharmaceutical mass tort litigation does more than compensate individual plaintiffs. It serves several broader functions in the public health and consumer protection ecosystem:

• Corporate accountability — civil litigation creates financial consequences for manufacturers that cut corners on safety testing, post-market surveillance, or warning labels.
• Improved drug warnings — pressure from litigation, FDA action, and adverse event reporting often work in tandem to update labels and inform future patients and prescribers.
• Patient safety improvements — the discovery process can surface internal documents that inform regulators, researchers, and the medical community.
• Compensation for victims — when serious injury occurs, the civil justice system provides a structured path to medical care, lost income, and acknowledgment of harm.

The Tepezza litigation reflects all four of these dynamics. Whether or not it ends in a global settlement, it has already contributed to a stronger label, a more informed prescribing environment, and a more cautious approach to monitoring auditory function in TED patients.

Frequently Asked Questions About Tepezza Hearing Loss Lawsuits

Can Tepezza cause permanent hearing loss?

Yes. Independent peer-reviewed studies and a 2024 meta-analysis have linked Tepezza (teprotumumab-trbw) to a statistically significant increase in sensorineural hearing loss, tinnitus, autophony, and other ototoxic effects. While some symptoms resolve after treatment ends, a substantial subset of patients report permanent auditory injury. The FDA acknowledged this risk in July 2023 by requiring a hearing impairment warning on the drug’s label. The proposed mechanism involves the IGF-1 receptor pathway, which is present not only in the eye but throughout the auditory system. If you experienced hearing changes during or after Tepezza treatment, an audiogram and ENT evaluation are essential first steps.

Who qualifies for a Tepezza hearing loss lawsuit?

Generally, you may qualify if you received Tepezza infusions for thyroid eye disease, subsequently developed hearing loss, tinnitus, autophony, ear fullness, or related auditory injuries, and can document the connection through medical records. Strong claims typically include audiology testing, ENT evaluations, and a clear timeline showing symptoms began during or after treatment. Statutes of limitations vary by state, generally between two and four years from the date of injury or its discovery. A free consultation with a qualified mass tort attorney is the most reliable way to determine whether your specific facts meet eligibility criteria in your jurisdiction.

Is there a Tepezza class action lawsuit?

No. Despite some informal references to a ‘class action,’ the Tepezza litigation is structured as a multidistrict litigation, or MDL — specifically MDL No. 3079, pending in the Northern District of Illinois before U.S. District Judge Thomas M. Durkin. In an MDL, individual lawsuits are coordinated for pretrial efficiency, but each plaintiff’s case retains its own facts, damages, and ultimate value. This structure typically produces higher individual recoveries than a class action would, because each claim is evaluated on its own merits rather than averaged across a class. The distinction matters when evaluating attorney fee structures and expected outcomes.

What symptoms have patients reported after Tepezza treatment?

The most commonly reported auditory symptoms include sensorineural hearing loss (often beginning at high frequencies), tinnitus, autophony (hearing one’s own voice or breathing unusually loudly), ear fullness or pressure, patulous eustachian tube, muffled hearing, hyperacusis, and in some cases balance disturbances. Symptoms may begin during the infusion course or appear weeks to months later. Studies have reported otologic symptoms in anywhere from 10% (in pivotal trials) to 65% (in independent prospective research) of treated patients, with permanent injury most likely to involve sensorineural hearing loss in the higher frequency ranges.

How long do pharmaceutical mass tort lawsuits typically take?

Mass tort drug litigation generally unfolds over several years. After consolidation into an MDL, coordinated discovery typically takes 18 to 36 months, followed by bellwether trials and settlement negotiations. The Tepezza MDL was established in June 2023, bellwether trial dates were initially set for 2026, and the court vacated those deadlines in October 2025 to focus on settlement. Many plaintiffs’ attorneys have suggested the Tepezza litigation may resolve faster than typical pharmaceutical MDLs because the inventory is smaller. Still, individual case resolution often takes two to four years from the date of filing.

What compensation may be available in a Tepezza lawsuit?

Compensation generally falls into economic damages (past and future medical costs, hearing aids, audiology care, lost wages, reduced earning capacity) and non-economic damages (pain and suffering, emotional distress, loss of enjoyment of life, permanent disability). No global settlement has been finalized as of this writing, so any specific dollar figures should be considered estimates. Some plaintiffs’ attorneys have projected potential settlement ranges of $140,000 to $500,000 for cases with strong supporting facts, but actual recovery depends on injury severity, medical documentation, jurisdiction, and the trajectory of the broader litigation.

How do mass tort drug lawsuits work?

Mass tort drug litigation begins when individual plaintiffs file lawsuits alleging similar injuries from the same product. When enough cases accumulate across multiple federal courts, the Judicial Panel on Multidistrict Litigation can consolidate them into a single MDL before one federal judge. Coordinated discovery, expert testimony, and bellwether trials proceed in that forum, but each plaintiff’s case retains its own identity. Settlements are typically negotiated globally but valued individually based on injury severity and supporting evidence. This structure differs sharply from a class action, where one outcome applies to the entire class.

What evidence is needed for a Tepezza hearing loss claim?

The strongest claims rest on documentary evidence connecting Tepezza exposure to auditory injury. Key documents include pharmacy or infusion center records confirming the dates and doses of Tepezza administration; pre- and post-treatment audiograms; ENT and audiology specialist evaluations; clinical notes describing the timeline of symptoms; and any FDA MedWatch reports submitted by the patient or treating physician. In many cases, attorneys also gather employment and earnings records to support damages calculations. Plaintiffs do not need to prove how the drug caused their injury at the case-evaluation stage; they need to demonstrate exposure, injury, and a plausible temporal connection.

Can tinnitus alone be part of a Tepezza lawsuit?

Yes. Tinnitus is one of the recognized auditory injuries reported in the Tepezza MDL and appears in many active complaints. Chronic tinnitus can be debilitating — interfering with sleep, concentration, and emotional well-being — and is treated as a compensable injury under product liability law. Claims involving tinnitus alone are generally evaluated alongside the same documentation as hearing loss claims: confirmed Tepezza exposure, audiology evaluation, ENT records, and a clear timeline. Cases combining permanent sensorineural hearing loss with chronic tinnitus typically carry a stronger evidentiary profile than tinnitus alone, but isolated tinnitus claims are still actively being filed.

What should patients do if they suspect Tepezza caused hearing damage?

Take five practical steps. First, schedule an audiology evaluation and an ENT consultation to formally document hearing status. Second, keep a written log of when symptoms began and how they have progressed. Third, request complete medical records from every facility involved in your Tepezza treatment, including infusion records and any pre- and post-treatment hearing tests. Fourth, consider submitting an adverse event report to the FDA’s MedWatch program. Fifth, schedule a free consultation with a qualified mass tort attorney to evaluate whether your case meets eligibility criteria and whether the statute of limitations remains open in your state. Acting promptly preserves both clinical and legal options.

The Bottom Line on Tepezza Hearing Loss Litigation

Tepezza was approved as a breakthrough treatment for thyroid eye disease, and for many patients it has delivered exactly what was promised. But mounting medical evidence — and hundreds of federal lawsuits — point to a meaningful risk of permanent hearing loss, tinnitus, and related auditory injuries that was not adequately disclosed before the FDA required a label update in mid-2023. Patients who developed hearing damage during this window deserve a clear understanding of their legal options.

If you or a loved one received Tepezza for thyroid eye disease and have experienced hearing loss, tinnitus, or other auditory symptoms, the most important next steps are clinical: get evaluated by an audiologist and an ENT, document your symptoms, and preserve your medical records. From there, a qualified mass tort attorney can help you understand whether a Tepezza hearing loss lawsuit fits your circumstances and how the broader MDL may shape the value and timing of your claim. The information in this article is educational, not legal advice — but it should help you ask better questions when you’re ready to pursue them.

Authoritative Sources and Further Reading

• FDA Drug Safety Information — Tepezza (teprotumumab-trbw)
• National Library of Medicine — PubMed (search ‘teprotumumab hearing loss’ for current peer-reviewed research)
• FDA MedWatch Adverse Event Reporting
• Endocrine Society — Thyroid Eye Disease Resources
• U.S. Judicial Panel on Multidistrict Litigation (MDL No. 3079, In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation)

Disclaimer: This article is intended for educational purposes only and does not constitute legal or medical advice. Reading this content does not create an attorney-client relationship. Statutes of limitations, eligibility criteria, and case values vary by jurisdiction and individual circumstances. If you believe you have been injured by Tepezza, consult a qualified attorney and a licensed medical professional for guidance on your specific situation.