MDL 3079 · U.S. District Court for the Northern District of Illinois

Tepezza use and a claim for hearing loss

Hearing changes after Tepezza? Contact your care team.

See If You Qualify

Free · No obligation · About 2 minutes

Updated 12 sources

This may apply to you if

  • For a review, gather records of Tepezza infusions and the hearing harm you report.
  • Include tests and symptoms from before treatment as well as later changes.
  • Ask a lawyer to assess the claim and time limit from your records.

The process

What happens next

  1. 01

    You answer a few questions

    About two minutes. Nothing is sent until you agree on the last step and press submit.

  2. 02

    A lawyer looks at it

    A lawyer at the firm reads your answers and checks them against the current case criteria.

  3. 03

    The firm decides and gets in touch

    If the firm takes your case, you get the terms in writing to read before you sign. You can always say no.

An IV infusion bag beside an empty infusion chair (photo illustration)
Photo illustration

At a glance

Pending cases
279JPML pending actions report, October 1, 2026 · OCT 1, 2026
MDL
3079JPML transfer order, June 2, 2023 · OCT 3, 2026
Court
U.S. District Court for the Northern District of IllinoisJPML transfer order, June 2, 2023 · OCT 3, 2026
Judge
Thomas M. DurkinJPML transfer order, June 2, 2023 · OCT 3, 2026

The short answer

Could I qualify?
A lawyer must check your drug use, hearing harm and records. This page cannot promise that you qualify. [12]
What is the case status?
The cases were grouped in one court. Ask for the latest order that applies to your claim. [6]
How much could I receive?
No payout range is verified here. A court case count is not an award. [8]
What might it cost?
Ask for written fee terms. Check who pays costs if there is no recovery. [9]

Who qualifies

Do you qualify?

  • For a review, gather records of Tepezza infusions and the hearing harm you report.
  • Include tests and symptoms from before treatment as well as later changes.
  • Ask a lawyer to assess the claim and time limit from your records.

What the public record says

These are cited sources. Their inclusion does not imply that they endorse People’s Justice or reviewed this page.

Thomas M. Durkin · U.S. District Court for the Northern District of Illinois · United States District Judge

Finding: The first case management order groups the cases for pretrial work and does not itself decide that they will have a consolidated trial.

Tepezza Case Management Order 1, June 13, 2023 (opens in a new tab) · Jun 13, 2023 · Checked Oct 3, 2026

The evidence and its limits

Single care setting, Department of Orbital and Oculoplastic Surgery, Beverly Hills · Thyroid · 2024

A Prospective Study Examining Audiometry Outcomes Following Teprotumumab Treatment for Thyroid Eye Disease

Design:
Cohort
Participants:
52 people who completed eight infusions and at least six months of follow-up
Finding:
At six months, five had mild new or worse changes on hearing tests: one with normal starting hearing and four with abnormal starting hearing.
Main limitation
No untreated randomized group; six-month follow-up and limited types of hearing testing. Does not predict personal cause, recovery or lifelong loss.

Read the source: A Prospective Study Examining Audiometry Outcomes Following Teprotumumab Treatment for Thyroid Eye Disease (opens in a new tab) · Checked Oct 3, 2026

Texas Tech University Health Sciences Center, Lubbock · Endocrine · 2026

Audiometric changes during teprotumumab therapy for thyroid eye disease: a prospective pilot study

Design:
Cohort
Participants:
16 completers in one care setting; initial enrollment count not specified in the abstract
Finding:
The abstract reports hearing test changes during treatment and some recovery afterward.
Main limitation
Multiple comparisons were not formally adjusted; exploratory results. Author abstract and metadata read, full paper not read.

Read the source: Audiometric changes during teprotumumab therapy for thyroid eye disease: a prospective pilot study (opens in a new tab) · Checked Oct 3, 2026

Multicenter trial; first author at Cedars-Sinai Medical Center · New England Journal of Medicine · 2020

Teprotumumab for the Treatment of Active Thyroid Eye Disease

Design:
Randomized controlled trial
Participants:
83 randomized, calculated from 41 assigned to Tepezza and 42 to placebo
Finding:
The author abstract reports better eye-bulging and other eye measures at 24 weeks with the drug versus placebo in active thyroid eye disease.
Main limitation
Not the hearing follow-up study; does not establish an individual cause of hearing loss. Horizon Therapeutics funded the trial. Author abstract and metadata read, full paper not read.

Read the source: Teprotumumab for the Treatment of Active Thyroid Eye Disease (opens in a new tab) · Checked Oct 3, 2026

What rules a case out

Not covered by this case

  • A hearing warning alone does not prove your claim.
  • A pending court count is not a list of people approved for payment.
  • This page does not confirm that a firm accepts your case or keeps an intake form private.

What it costs

Lawyer fee
Ask for written terms

Check the fee method and costs owed if there is no win.

Source: ABA Model Rule 1.5 fees · as of Oct 3, 2026

Case expenses
Ask who pays

Ask how costs are deducted and what you may owe without a recovery.

Source: ABA Model Rule 1.5 fees · as of Oct 3, 2026

Health record copies
Check provider charges

Certain copying and mailing charges may apply.

Source: HHS medical records access · as of Oct 3, 2026

What happens step by step

  1. Gather your records

    Keep infusion dates, hearing tests and care notes. Ask the provider for copies.

    Source: HHS medical records access · as of Oct 3, 2026

  2. Ask for a review

    Ask a lawyer to check your records, the time limit and written fee terms.

    Source: SDNY filing-time FAQ · as of Oct 3, 2026

  3. Confirm the next step

    Ask who will handle the case and whether a complaint will be filed. An intake form is not a court filing.

    Source: U.S. Courts civil cases process · as of Oct 3, 2026

Public agency records

FDA recalls

Ingredient-level FDA records for teprotumumab, including other brands and formulations. Recalls only: no reaction term was selected for this hub, so FAERS counts are not shown.

FDA data updates: Unavailable. Queries refresh about once a day. Source data may lag reporting by three months or more. These records do not determine whether an individual has a legal claim.

Recall events

Latest matching enforcement records, up to ten; recall dates are initiation dates. A match does not establish that a particular unit or lot was recalled. Check the product details in the FDA source.

No matching recall records were found. This does not establish that the product has never been recalled.

Could I qualify for a Tepezza hearing loss claim?

A lawyer must review your use of Tepezza and the hearing harm you report. The label warns of hearing loss, but it does not prove the cause for one person. A review is a way to check the facts, not a promise that you qualify.

Start with your infusion dates, the name of your care team and the hearing changes you noticed. Include ringing in the ears if that was part of your experience. The transfer order describes claims of hearing loss and ringing, also called tinnitus. Keep your own account separate from a diagnosis you have not received.

If you had hearing loss before treatment, tell the lawyer and your care team. The 2024 hearing study included people with abnormal hearing at the start. That fact calls for a careful comparison of records; it does not set a legal rule that all such people qualify or are excluded.

For a family member, ask what permission is needed to obtain records and seek a review. The federal records guide covers access by patients and their personal representatives, with limits. Do not assume a family link alone lets you share all of another adult's health information.

What is the status of the Tepezza cases?

A June 2023 order placed the federal Tepezza cases in a shared pretrial proceeding in Illinois. The October 1, 2026 court report lists 279 pending actions in that group. These records do not tell us the result of your case or the full current trial schedule.

The group is MDL 3079 in the Northern District of Illinois, assigned to Judge Thomas M. Durkin. MDL is a way to handle shared pretrial issues across separate cases. The first case management order says this grouping does not itself decide that the cases will have one trial.

The report lists pending actions, not people approved for money. Its count is dated, and it does not show that every person with a hearing concern has a filed case. Ask a lawyer for the latest order and how it applies to a case already filed for you.

An old hearing or proposed trial date does not establish that a trial took place or that a jury reached a verdict. This source check did not establish the full current docket, payment terms or trial results. Request the actual order or result before relying on a status claim.

How much money could a Tepezza claim bring?

This page cannot give you a supported payout range. A pending case count is not an award or an offer. Any money claim needs a review of the harm, proof and terms that apply to the case.

In a civil case, a person seeks relief for harm and must support the claim. Records of hearing care, bills and changes in daily life can give a lawyer facts to assess. A large number of cases does not establish what any one person will receive.

Do not treat a dollar amount on another page as your offer. Ask for the source, the case or group it concerns, and any terms that must be met. This source check did not verify current settlement terms; that limit is not a claim that no settlement exists.

What could a Tepezza case review cost?

Ask for the fee terms before you agree to hire a lawyer. A fee based on a result still needs clear written terms. This page has not verified a firm's free review offer or who pays case costs.

The ABA model fee rule describes a signed written agreement for fees tied to a result. It calls for the method used to set the fee and how costs are taken out. It also calls for a clear statement about costs the client may owe without a win. This is a model rule, not a verified promise from an intake partner.

Ask whether record fees, expert work and court costs are part of the fee or separate charges. Ask what you would owe if there were no recovery. A provider may charge certain copying and mailing costs for health records; access does not mean every copy is free.

What deadline could apply to my Tepezza claim?

There is no single filing deadline verified for every reader here. The law, the claim and your own dates matter. Ask a lawyer to check the time limit that applies to you.

Keep the dates of each infusion, first hearing change, hearing tests and discussions with your care team. Give the lawyer any prior case, release or lawyer agreement as well. These are facts to review, not a formula on this page for when a legal clock starts.

The FDA label date and the date of an MDL order are dates for those records. They do not establish your personal filing deadline. If someone gives you a deadline, ask for the law and the facts used to work it out. Do not assume time remains just because other cases are pending.

What should I do today about hearing changes after Tepezza?

Tell your care team about hearing changes. The label calls for hearing checks before, during and after treatment and a discussion of benefits and risks. This page cannot decide your treatment plan or diagnose the cause of a symptom.

Ask which hearing tests and follow-up are right for you. Keep any test results and visit notes you receive. For a legal review, make a short list of the infusion dates, changes you noticed and care you sought. You do not need to turn that list into a diagnosis.

Use the provider's records process to request copies. Keep the dates and the original files when you can. Ask where to send sensitive records and who will see them before using a web intake form. A right to obtain records does not establish that a separate intake site keeps them private.

What happens when I check a Tepezza claim?

First, gather the dates and records you have. Next, ask a lawyer to check the possible claim, time limit and fee terms. A contact form is not the same as filing a court case.

A useful packet can include infusion records, hearing tests from before and after treatment, visit notes and bills. Mark gaps rather than filling them with guesses. Keep a copy of what you share so you can answer later questions from the same records.

Ask who is reviewing the packet and what happens next. If a lawyer takes the case, ask for the written agreement and the plan for a filing. A federal civil case starts with a complaint; sharing your story alone does not start one. Do not assume a web form means a firm has accepted you as a client.

What does the evidence say about Tepezza and hearing loss?

The label warns that hearing loss can be severe and, in some cases, permanent. A small follow-up study found hearing changes that improved for some people and persisted for others at six months. Neither record can predict the course or cause of hearing loss for one reader.

The 2024 study followed 52 people who completed eight infusions and at least six months of follow-up. At six months, five had mild new or worse hearing changes on testing. One had normal hearing at the start; four had abnormal hearing at the start. This is not a report that five people lost all hearing.

Among the 20 people with abnormal starting tests, ten had a decline during treatment. Six of those ten had test changes that resolved by six months. The study used one care setting, lacked an untreated random group and did not include every type of hearing test. Its six-month results do not promise either lifelong loss or recovery.

A separate 2026 pilot study reports 16 people who finished follow-up. It found changes on hearing tests during treatment, with some recovery afterward. The authors did not formally adjust for multiple comparisons, so the findings are exploratory. Only the author abstract and source record were read for that study here.

Benefits also matter to care decisions. In a 2020 trial, 41 people were assigned to Tepezza and 42 to placebo. The author abstract reports better eye-bulging and other eye measures with Tepezza at 24 weeks in active thyroid eye disease. That trial does not replace the hearing follow-up studies or prove the drug caused an individual's hearing loss.

What other questions do people ask about Tepezza hearing claims?

The questions below focus on hearing tests, follow-up and how to read the evidence. They do not supply a diagnosis or a firm's intake rules. A lawyer and your care team can address the parts that depend on your own records.

Ask about tests from before treatment, even if you do not have a copy yet. Ask what a six-month hearing result does and does not show. If eye symptoms improved while hearing changed, describe both rather than leaving one out. The benefit trial and hearing studies look at different outcomes.

A label warning, a count of court cases and a missing hearing test each mean different things. None alone resolves a person's claim. Ask for the source behind an answer and the part that still needs a review.

Which sources support this Tepezza hearing loss guide?

This guide uses drug labels, original study records and dated court records. The hearing study was read in full; the pilot and eye-benefit trial were read as author abstracts. The source list states those limits so a summary does not stand in for a full clinical review.

The available FDA label is dated September 2025. The manufacturer's label, revised September 2026, was also read and keeps the hearing warning and testing advice. The current FDA-hosted label link could not be opened in this check, so the available older FDA copy is not presented as the latest complete label.

The court sources include the 2023 transfer and first case management orders, plus the October 2026 pending-actions report. Fees, record access and filing-time guidance have separate primary sources. Check each record's date and scope before using it to make a claim about current treatment, your case or an intake service.

How Tepezza Causes Hearing Loss and Tinnitus

Tepezza (teprotumumab-trbw) is a monoclonal antibody approved in January 2020 for thyroid eye disease (TED). It works by blocking the insulin-like growth factor 1 receptor (IGF-1R), which plays a central role in the inflammatory orbital tissue expansion that characterizes TED. However, IGF-1R is also critically expressed in the inner ear — specifically in cochlear hair cells, the stria vascularis, and the spiral ganglion neurons that transmit auditory signals to the brain. By inhibiting IGF-1R throughout the body, Tepezza disrupts the maintenance and survival signaling these inner ear structures depend on, leading to sensorineural hearing loss, tinnitus, and autophony (hearing one's own voice or body sounds abnormally loudly). Clinical trial data showed hearing adverse events in approximately 10% of Tepezza patients compared to 0% in the placebo group — a signal that was inadequately disclosed in the original labeling. Post-market studies have since reported hearing changes in up to 65% of patients receiving the standard eight-infusion course.

IGF-1R Inhibition in Cochlear Hair Cells

The inner ear's outer hair cells — responsible for amplifying sound vibrations and enabling frequency discrimination — express high levels of IGF-1R. These cells rely on IGF-1 signaling for survival, metabolic support, and resistance to oxidative stress. When teprotumumab blocks IGF-1R systemically, cochlear hair cells lose this protective signaling. Unlike most cells in the body, cochlear hair cells in humans do not regenerate. Once damaged or lost, the hearing deficit is permanent. This mechanism explains why Tepezza-induced hearing loss is predominantly sensorineural (nerve-based) rather than conductive, and why it can persist long after the drug is discontinued.

Disruption of the Stria Vascularis and Endocochlear Potential

The stria vascularis is a highly vascularized tissue in the cochlea that generates the endocochlear potential — the electrochemical gradient essential for sound transduction. IGF-1R signaling is critical for maintaining the ion transport channels and cellular integrity of the stria vascularis. Tepezza's systemic IGF-1R blockade impairs strial function, reducing the endocochlear potential and diminishing the cochlea's ability to convert mechanical sound waves into electrical nerve impulses. This disruption manifests as a broad decline in hearing sensitivity across multiple frequencies and contributes to the tinnitus reported by many patients.

Spiral Ganglion Neuron Degeneration

Spiral ganglion neurons are the primary afferent neurons that carry auditory information from the cochlea to the brainstem. These neurons depend on neurotrophic support mediated in part through the IGF-1/IGF-1R signaling axis. Animal models have demonstrated that IGF-1 deficiency leads to progressive spiral ganglion neuron loss, reduced auditory nerve conduction, and elevated hearing thresholds. Tepezza's blockade of this pathway in humans is consistent with the pattern of progressive sensorineural hearing decline observed in treated patients, particularly those receiving the full eight-infusion protocol.

Eustachian Tube Dysfunction and Autophony

A distinctive feature of Tepezza-related otologic complaints is autophony — a condition in which patients hear their own voice, breathing, or heartbeat at abnormally high volume. This symptom is associated with eustachian tube dysfunction and patulous eustachian tube, both of which have been reported in Tepezza patients. The mechanism likely involves IGF-1R-mediated changes in the mucosal and cartilaginous tissues of the eustachian tube, leading to abnormal tube patency. While autophony is not hearing loss per se, it is a debilitating auditory disturbance that significantly impairs quality of life and is characteristic of Tepezza ototoxicity.

  • No Regeneration of Human Cochlear Hair Cells: Unlike birds and some fish, mammals cannot regenerate cochlear hair cells. Once Tepezza damages or destroys these cells through IGF-1R blockade, the hearing loss is irreversible. This biological reality makes Tepezza ototoxicity fundamentally different from many other drug side effects that resolve when the drug is stopped.
  • Cumulative Dose-Dependent Toxicity: Tepezza is administered as eight intravenous infusions over approximately 21 weeks. Clinical and post-market data indicate that otologic adverse events increase with cumulative dosing, with many patients experiencing hearing changes only after the fourth or fifth infusion — by which point significant cochlear damage may have already occurred.
  • Patients who reported hearing changes mid-course were not consistently advised to discontinue treatment.
  • Delayed Onset Masking Early Detection: Some patients do not experience noticeable hearing changes until weeks or months after completing Tepezza treatment, when irreversible cochlear damage has already been established. The delayed onset of symptoms complicates early detection and intervention.
  • The American Academy of Otolaryngology has acknowledged Tepezza-associated hearing loss and recommends baseline and serial audiometric monitoring for all patients receiving the drug
  • Post-market studies published in peer-reviewed otolaryngology journals report hearing changes in 65% or more of Tepezza patients — far exceeding the 10% rate reported in clinical trials
  • The FDA required a label update in 2023 to strengthen warnings about hearing impairment, including the potential for permanent hearing loss, tinnitus, and autophony
  • IGF-1R is well-established in the otologic literature as essential for inner ear development and maintenance, with animal knockout models demonstrating profound hearing loss in the absence of IGF-1 signaling
  • Multiple ENT specialists have published case series documenting severe, bilateral sensorineural hearing loss in Tepezza patients that persisted more than one year after drug discontinuation

The Tepezza hearing loss litigation centers on the manufacturer's failure to adequately warn prescribing physicians and patients about the risk of permanent sensorineural hearing loss. The clinical trial data showed a clear 10% vs. 0% hearing adverse event signal, yet the original label characterized hearing events as generally reversible and did not recommend audiometric monitoring. Post-market evidence showing 65% hearing change rates has strengthened plaintiffs' claims that the risk was significantly understated. For affected patients — many of whom are women with thyroid eye disease who were promised a life-changing treatment — the permanent loss of hearing represents a devastating and undisclosed trade-off.

Throughout this period, Horizon's public communications emphasized Tepezza's efficacy and commercial potential while minimizing the emerging hearing safety signal that post-market studies would eventually reveal affected a majority of treated patients.

Regulatory History of Tepezza: From Accelerated Approval to Hearing Loss Warnings

Tepezza received FDA approval in January 2020 as the first and only drug approved for thyroid eye disease (TED). The approval was based on two clinical trials totaling 170 patients. While hearing adverse events were observed in the Tepezza arm and not in the placebo arm, the original prescribing information did not include a boxed warning, did not recommend audiometric monitoring, and characterized otologic events as generally reversible. As post-market reports of permanent hearing loss, tinnitus, and autophony accumulated through the FDA Adverse Event Reporting System (FAERS), the agency required label revisions strengthening the hearing warnings — but critics argue these changes came years too late for thousands of patients already treated.

The regulatory history of Tepezza reveals a pattern in which a clear clinical trial safety signal — 10% hearing adverse events vs. 0% placebo — was inadequately communicated in the original label, post-market evidence of much higher rates and permanent injury accumulated rapidly, and label corrections came years after thousands of patients had already been treated without appropriate audiometric monitoring or informed consent regarding the risk of permanent hearing loss.

Your state

Deadlines and venues by state

Deadlines vary by state and by case. A lawyer can confirm yours.

Questions people ask

Why do hearing tests from before Tepezza matter?

Tests from before treatment help compare starting hearing with later changes. The 2024 study separated normal and abnormal starting tests and found different follow-up patterns. Ask your care team which comparisons are useful; the test alone does not decide a legal claim.

Source: Douglas et al., prospective hearing follow-up study, Thyroid 2024 · as of Oct 7, 2026

Did the six-month Tepezza study show that hearing loss always lasts?

No. Some hearing test changes resolved by six months, while five of 52 people still had mild new or worse changes. Six months of follow-up does not show every person's lifelong course or promise recovery.

Source: Douglas et al., prospective hearing follow-up study, Thyroid 2024 · as of Oct 7, 2026

Can improved eye symptoms settle whether Tepezza caused hearing harm?

No. The Tepezza label describes the drug’s use for thyroid eye disease and separately warns that it may cause severe hearing impairment, including hearing loss that can sometimes be permanent. Tell your care team and lawyer about both eye improvement and hearing changes so each can be reviewed from the records.

Source: DailyMed: Tepezza prescribing information · as of Oct 7, 2026

Does the Tepezza hearing warning prove the cause of my hearing loss?

No, the Tepezza hearing warning does not prove the cause of your hearing loss. The warning says hearing loss can be severe and sometimes permanent. A clinician and lawyer still need to review timing, tests, and other possible causes.

Source: DailyMed: Tepezza prescribing information · as of Oct 7, 2026

Does the Tepezza court count show how many people will be paid?

No, the Tepezza court count does not show how many people will be paid. JPML reports list pending court actions, not people approved under any program. A court count does not decide your individual claim.

Source: JPML actions pending report, October 1, 2026 · as of Oct 7, 2026

What Tepezza records help with a hearing-loss review?

Gather infusion dates, dose records, thyroid eye disease notes, hearing tests, ear symptoms, and later hearing treatment. The Tepezza label and studies are background sources. Your own timing and test records still matter.

Source: HHS medical records access · as of Oct 7, 2026

Is the Tepezza MDL count my deadline?

No, the Tepezza MDL count is not your deadline. JPML reports list pending actions, not personal filing limits. A lawyer can check your treatment dates, hearing records, and state deadline.

Source: JPML Tepezza MDL 3079 transfer order, June 2, 2023 · as of Oct 7, 2026

Can a Tepezza study prove my hearing loss claim?

No, a Tepezza hearing study does not prove your individual claim. Studies can support general medical questions, but your records must show timing, symptoms, tests, and other possible causes. A lawyer can compare the study with your facts.

Source: Douglas et al., prospective hearing follow-up study, Thyroid 2024 · as of Oct 7, 2026

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Sources

  1. FDA-hosted Tepezza prescribing information, September 2025FDA-hosted Tepezza prescribing information, September 2025 · regulator
  2. Amgen Tepezza prescribing information, revised September 2026Amgen Tepezza prescribing information, revised September 2026
  3. Douglas et al., prospective hearing follow-up study, Thyroid 2024Douglas et al., prospective hearing follow-up study, Thyroid 2024 · study
  4. Van Swol et al., prospective hearing pilot, Endocrine July 15, 2026Van Swol et al., prospective hearing pilot, Endocrine July 15, 2026 · study
  5. Douglas et al., active thyroid-eye-disease trial, NEJM January 23, 2020Douglas et al., active thyroid-eye-disease trial, NEJM January 23, 2020 · study
  6. JPML Tepezza MDL 3079 transfer order, June 2, 2023JPML Tepezza MDL 3079 transfer order, June 2, 2023 · court
  7. Tepezza Case Management Order 1, June 13, 2023Tepezza Case Management Order 1, June 13, 2023 · court
  8. JPML actions pending report, October 1, 2026JPML actions pending report, October 1, 2026 · court
  9. ABA Model Rule 1.5 feesABA Model Rule 1.5 fees
  10. HHS medical records accessHHS medical records access · regulator
  11. SDNY filing-time FAQSDNY filing-time FAQ · court
  12. U.S. Courts civil cases processU.S. Courts civil cases process · court

Checked against 11 primary sources by People's Justice editors · Updated

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