What Is the Tepezza Lawsuit?
The Tepezza lawsuit is a federal multidistrict litigation, MDL No. 3079, over alleged hearing loss and tinnitus after Tepezza infusions. Tepezza (teprotumumab-trbw) is an intravenous drug for thyroid eye disease that the FDA approved in January 2020.
The Judicial Panel on Multidistrict Litigation centralized the federal cases in the Northern District of Illinois on June 2, 2023. Judge Thomas M. Durkin presides over the Tepezza MDL. Horizon Therapeutics USA, Inc. is the defendant named in the Panel's order.
The Tepezza class action question has a direct answer: the litigation is not a class action. An MDL pools individual lawsuits for shared pretrial work, and each plaintiff keeps a separate claim. The sources reviewed describe no certified class.
The Panel found the cases share three questions. They cover general causation, the adequacy of Horizon's testing, and the sufficiency of the label's hearing loss warnings.
“All actions can be expected to share factual questions arising from the alleged propensity of the biologic drug Tepezza, which treats thyroid eye disease, to cause severe or permanent hearing loss and tinnitus.”
Source: U.S. Judicial Panel on Multidistrict Litigation, In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3079, Transfer Order, Document 60 (June 2, 2023)
Why Are People Filing Tepezza Lawsuits?
People are filing Tepezza lawsuits because they allege Horizon failed to warn that Tepezza can cause permanent hearing loss and tinnitus. Plaintiffs say the original label did not convey that the damage could last. Patients and doctors could not weigh the risk before infusions began.
Plaintiffs also challenge how Horizon described how often hearing problems occur. Premarketing trials reported hearing impairment in about 10% of treated patients and none on placebo. The FDA's safety labeling change summaries show postapproval trial rates of 13%, later revised to 19%.
Plaintiff-side summaries add that Horizon did not recommend hearing tests before, during or after treatment. The current label now tells prescribers to assess hearing at each of those points. The label history appears in the defendant section below.
Horizon's June 2023 quarterly report states that hearing impairment was listed as a potential adverse event in the initial label. Plaintiffs counter that the listing did not convey permanence.
What Injuries Are Included in the Tepezza Lawsuit?
The injuries included in the Tepezza lawsuit fall into four hearing-related categories: hearing loss, tinnitus, autophony and hyperacusis. Plaintiffs often allege more than one together, and the Panel's order names hearing loss and tinnitus as the shared signature injuries.
No jury has ruled on whether Tepezza caused any of these injuries. Each item below defines the term and states what plaintiffs allege.
Hearing Loss
Hearing loss is a reduction in the ability to hear sounds. Sensorineural hearing loss involves damage to the inner ear or the nerve that carries sound to the brain.
Plaintiffs allege Tepezza infusions caused hearing loss that did not resolve after treatment ended. The current label states Tepezza may cause severe hearing impairment, which in some cases may be permanent.
A 2023 study by Kay-Rivest and colleagues in Otolaryngology-Head and Neck Surgery followed 35 patients. Among 14 with paired audiograms, 10 (71.4%) showed changes in high-frequency hearing.
Only 5 of the 11 patients with measured changes noticed a decline themselves. The authors described the findings as preliminary because the sample was small.
Tinnitus
Tinnitus is the perception of ringing, buzzing or another sound in the ears when no outside sound is present.
Plaintiffs allege tinnitus that began during or after Tepezza infusions and continued once treatment stopped. Many complaints in the MDL plead tinnitus together with measurable hearing changes.
In the Kay-Rivest cohort, 14.3% of 35 patients reported tinnitus. That ranked third among symptoms, behind hearing decline at 25.7% and aural fullness at 17.1%.
Whether tinnitus is permanent in an individual plaintiff is a medical question that specialist records and testing address.
Autophony
Autophony is the unusually loud or echoing perception of one's own voice, breathing or chewing.
Plaintiffs list autophony among the ear symptoms they attribute to Tepezza. Plaintiff-side summaries describe it alongside a sensation of ear fullness.
Medical references link autophony to eustachian tube problems. The Kay-Rivest authors also flagged those problems as a possible finding in patients treated with teprotumumab.
Hyperacusis
Hyperacusis is an increased sensitivity to everyday sounds that other people find tolerable.
Plaintiffs allege some patients developed hyperacusis after Tepezza, and plaintiff-side summaries list it beyond the core injuries of hearing loss and tinnitus. These summaries describe ordinary noises becoming uncomfortable or painful.
Claims involving hyperacusis generally depend on documentation from an audiologist or ear specialist. An attorney can confirm what a given claim requires.
Who Qualifies for the Tepezza Lawsuit?
You may qualify if:
- You received Tepezza (teprotumumab) infusions, usually for thyroid eye disease, and records confirm the infusion dates.
- You developed hearing loss, tinnitus or related hearing symptoms during or after treatment, ideally documented by an audiologist or doctor.
- Your symptoms are generally not explained by a hearing condition you had before starting Tepezza.
- Your claim falls within your state's statute of limitations, which varies by state.
You may not qualify if:
- You never received Tepezza infusions, since the lawsuit concerns only that drug.
- Your records show significant hearing loss before your first infusion with no documented change afterward.
- Your only symptom was a temporary change that fully resolved, because the claims generally focus on lasting hearing damage.
- Your state's filing deadline has passed, although an attorney can check whether an exception applies.
Eligibility depends on medical records, timing and state law. MDL 3079 consolidates individual lawsuits for pretrial work. Only a qualified attorney reviewing your records can confirm whether you have a claim.
What Is the Current Status of the Tepezza MDL?
The current status of the Tepezza MDL is that it remains in pretrial proceedings. As of the JPML's October 1, 2026 report, no settlement has been announced and no bellwether verdict reported.
Judge Durkin's bellwether trial deadlines were reported struck in October 2025 after an off-the-record conference with the parties. No claims were dismissed, and the sources reviewed confirm no replacement trial dates.
Some law-firm pages still list trial dates in late 2026. Readers should check the MDL 3079 docket for current settings.
In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3079
The Judicial Panel on Multidistrict Litigation centralized federal Tepezza hearing loss cases in the Northern District of Illinois on June 2, 2023. Horizon opposed centralization, and the order counted 37 cases pending in eight districts.
| Court | U.S. District Court, Northern District of Illinois (federal MDL) |
| MDL Number | 3079 |
| Judge | Hon. Thomas M. Durkin |
| MDL Created | June 2, 2023 |
| Cases at Creation | 37 cases pending in eight districts, per the Panel's order |
| Actions Now Pending | 279, per the JPML's October 1, 2026 report |
| Total Actions (Historical) | 289, per the same report |
| Defendant | Horizon Therapeutics USA, Inc. (owned by Amgen Inc. since October 6, 2023) |
| Class Action Status | Not a class action. Individual lawsuits are consolidated for pretrial proceedings. |
| Current Stage | Pretrial. Bellwether trial deadlines reported struck in October 2025. No global settlement announced. |
In the bellwether opinions in Pledger v. Horizon Therapeutics USA, Inc. and Perkett v. Horizon Therapeutics USA, Inc., the court denied Horizon's motions to dismiss the failure-to-warn claims. It granted the motions on the design defect claims.
The docket grew from 42 pending actions in July 2023 to 279 in October 2026. The count has stayed between 272 and 279 since October 2025.
What Is the Tepezza Lawsuit Payout?
The Tepezza lawsuit payout is undetermined, because no settlement or bellwether verdict has set a value for MDL 3079 claims.
Some attorney websites float estimates for hearing loss claims that run from tens of thousands of dollars to more than $1 million. Those figures are projections rather than court-approved amounts, and individual outcomes depend on injury severity, records and state law.
In other pharmaceutical MDLs, settlement programs often score each claim on factors such as injury severity, documentation and treatment history. Any Tepezza program would set its own criteria, and none has been announced.
Bellwether trials usually give both sides a benchmark for settlement values. Because no Tepezza bellwether trial has produced a verdict, no such benchmark exists yet.
Court-ordered settlement conferences have reportedly continued on a quarterly basis. Settlement talks do not guarantee a settlement, and Amgen has not publicly confirmed negotiations.
Tepezza Lawsuit Updates
Here are the latest Tepezza lawsuit updates, covering new court filings, rulings, and case-count reports as they're confirmed. Litigation in the Tepezza hearing loss MDL (MDL 3079) remains active as of October 2026, with no bellwether trial or settlement completed. The timeline below tracks every confirmed development from the first filing forward.
Full Tepezza Lawsuit Timeline
FDA approves Tepezza for thyroid eye disease
The FDA approved Tepezza (teprotumumab-trbw), made by Horizon Therapeutics, in January 2020 as the first treatment aimed at the underlying cause of thyroid eye disease.
Daniel Weibel files the first Tepezza hearing loss lawsuit
Arizona resident Daniel Weibel sued Horizon in the Northern District of Illinois in August 2022, alleging permanent hearing loss after 2020 infusions. Weibel v. Horizon Pharmaceuticals USA, Inc., No. 1:22-cv-04518, became the first-filed action in the later MDL.
JPML hears argument on centralizing Tepezza cases
The Judicial Panel on Multidistrict Litigation heard oral argument on May 25, 2023, on a motion to centralize Tepezza cases. Horizon opposed centralization and suggested the Northern District of Illinois as an alternative.
JPML creates MDL 3079 in the Northern District of Illinois
The Panel centralized the Tepezza cases before Judge Thomas M. Durkin on June 2, 2023. The motion covered 18 actions in five districts, and the order counted 37 pending cases in eight districts.
FDA approves a Tepezza label supplement adding a hearing warning
The FDA's Supplement 23 added Section 5.4 to the Tepezza label in July 2023. It warns of severe hearing impairment that may be permanent and calls for hearing assessments before, during and after treatment.
JPML report counts 42 pending Tepezza actions
The JPML's July 17, 2023 report listed 42 pending actions in MDL 3079, all of them also counted as total actions at that point.
Amgen and the FTC reach a consent order on the Horizon deal
Amgen and the Federal Trade Commission agreed to a consent order in September 2023 that resolved the agency's challenge to the Horizon acquisition. The order bars Amgen from bundling Tepezza with its other products.
Amgen completes its acquisition of Horizon Therapeutics
Amgen Inc. closed its roughly $27.8 billion purchase of Horizon on October 6, 2023, and took ownership of Tepezza four months after the MDL was created.
Pending count in MDL 3079 reaches 54
The JPML's October 16, 2023 report listed 54 pending Tepezza actions, up from 42 in July.
Judge Durkin splits a preemption ruling for an early plaintiff
In November 2023, Judge Durkin reportedly dismissed plaintiff Williams' post-approval design defect claims as preempted while letting her pre-approval design defect claims proceed, according to a plaintiff-side case tracker.
MDL 3079 reaches 71 pending actions
The JPML's December 15, 2023 report showed 71 pending actions in the Tepezza MDL, 17 more than two months earlier.
Tepezza MDL passes 100 pending cases
The JPML counted 101 pending actions in MDL 3079 on April 1, 2024, and every one was still an open case.
Parties finalize a 12-case bellwether pool
The parties reportedly finalized a 12-case bellwether discovery pool in June 2024, made up of four plaintiff picks, four Horizon picks and four random selections.
Horizon moves to dismiss bellwether cases on preemption grounds
Horizon asked the court in July 2024 to dismiss bellwether cases in MDL 3079 on federal preemption grounds. Original bellwether trial dates were set the same month.
Pending count reaches 178 as filings accelerate
The JPML's October 1, 2024 report listed 178 pending actions in MDL 3079 out of 180 total filed.
MDL 3079 holds near 180 pending actions
The Tepezza docket showed 180 pending and 184 total actions on the JPML's November 1, 2024 report.
Tepezza MDL climbs to 191 pending actions
The JPML's December 2, 2024 report counted 191 pending actions and 195 total actions in MDL 3079.
Core fact discovery closes in MDL 3079
Core fact discovery in the Tepezza MDL reportedly closed on December 20, 2024, according to a plaintiff-side case tracker.
MDL 3079 reaches 200 pending actions
The JPML's January 2, 2025 report put the Tepezza MDL at 200 pending actions and 205 total.
Pending count in the Tepezza MDL rises to 203
MDL 3079 listed 203 pending and 209 total actions in the JPML's February 3, 2025 report.
Tepezza MDL records 207 pending actions
The JPML's March 3, 2025 report showed 207 pending actions and 215 total actions in MDL 3079.
Court denies plaintiffs' request to exceed the deposition cap
In April 2025, the court reportedly denied a motion by plaintiffs in MDL 3079 to depose six Patient Access Liaisons and one sales representative beyond the 30-deposition limit, finding no good cause under Rule 30.
MDL 3079 grows to 213 pending actions
The Tepezza MDL counted 213 pending and 221 total actions on the JPML's April 1, 2025 report.
Pending Tepezza actions reach 217
The JPML's May 1, 2025 report listed 217 pending actions in MDL 3079 and 225 total filed since creation.
Fact discovery closes in the Tepezza MDL
Fact discovery in MDL 3079 reportedly closed on May 9, 2025, according to a plaintiff-side case tracker, and expert discovery opened the following month.
MDL 3079 reaches 221 pending actions
The JPML's June 2, 2025 report counted 221 pending and 230 total actions in the Tepezza MDL.
Pending count jumps to 236
MDL 3079 added 15 pending actions in a single month, reaching 236 pending and 245 total on the JPML's July 1, 2025 report.
Judge Durkin resets the bellwether trial schedule
Judge Durkin's July 7, 2025 order moved the first Tepezza bellwether trial to June 8, 2026, after plaintiffs asked for two more months to prepare, and set trials for August 3, September 28 and November 30, 2026, according to HarrisMartin.
Tepezza MDL reaches 260 pending actions
The JPML's August 1, 2025 report listed 260 pending actions, a 24-case increase over July, and 269 total actions in MDL 3079.
First bellwether trial reportedly moved to August 3, 2026
Plaintiff-side trackers reported in August 2025 that the first Tepezza bellwether trial moved to August 3, 2026, with later trials listed for September 28 and November 30, 2026 and February 1, 2027.
MDL 3079 reaches 270 pending actions
The JPML's September 2, 2025 report showed 270 pending and 279 total actions in the Tepezza MDL.
Court extends expert deposition deadlines by 45 days
In September 2025 the court reportedly granted a 45-day extension of expert deposition deadlines in MDL 3079, which pushed back summary judgment and other trial preparation dates.
Bellwether trial deadlines are struck in MDL 3079
The court reportedly struck all bellwether trial deadlines in the Tepezza MDL on or about October 1, 2025, after an off-the-record conference with counsel. No claims were dismissed.
JPML report counts 272 pending Tepezza actions
MDL 3079 listed 272 pending and 281 total actions on the JPML's October 1, 2025 report.
Pending count holds at 272
The JPML's November 3, 2025 report showed no change from the prior month, with 272 pending and 281 total actions in MDL 3079.
Tepezza MDL edges up to 273 pending actions
The JPML's December 2, 2025 report counted 273 pending actions and 282 total actions in MDL 3079.
FDA label update raises the postapproval hearing impairment rate to 19%
FDA safety labeling change summaries show 2025 Tepezza supplements first reporting postapproval trial hearing impairment at 13% and then raising the figure to 19%.
Pending count stays at 273 in January
The JPML's January 5, 2026 report showed 273 pending and 282 total actions in MDL 3079.
Court holds a status conference in MDL 3079
A plaintiff-side tracker reports the court held a status conference in the Tepezza MDL on January 8, 2026.
MDL 3079 rises to 277 pending actions
The JPML's February 2, 2026 report listed 277 pending and 286 total actions in the Tepezza MDL.
Pending count stays flat from March through May
The JPML's March 2, April 1 and May 1, 2026 reports each showed 277 pending and 286 total actions in MDL 3079, a quiet stretch for new filings.
Tepezza MDL ticks up to 278 pending actions
The JPML's June 1, 2026 report counted 278 pending and 287 total actions in MDL 3079.
Pending count returns to 277
MDL 3079 showed 277 pending and 287 total actions on the JPML's July 1, 2026 report. Law-firm trackers said the trial deadlines remained struck and no settlement had been announced.
Pending count holds at 277 through the summer
The JPML's August 3 and September 1, 2026 reports both listed 277 pending and 287 total actions in the Tepezza MDL.
MDL 3079 reaches 279 pending actions
The JPML's October 1, 2026 report counted 279 pending and 289 total actions in MDL 3079, with no global settlement publicly announced.
How to File a Tepezza Lawsuit
To file a Tepezza lawsuit, follow the 5 steps listed below.
- Confirm your Tepezza treatment: Gather infusion records, pharmacy or infusion-center billing and your doctor's notes showing each Tepezza infusion date.
- Document your hearing changes: See an audiologist or ear specialist and keep test results showing hearing loss, tinnitus or related symptoms and when they began.
- Collect earlier hearing records: Find any hearing tests from before Tepezza, since a baseline helps show what changed.
- Check your state deadline: Filing deadlines vary by state, so confirm the statute of limitations that applies to your injury as soon as possible.
- Consult a mass-tort attorney: An attorney experienced with MDL 3079 can review your records, explain your options and file an individual lawsuit if your facts fit.
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What Evidence Do You Need for a Tepezza Lawsuit?
Evidence for a Tepezza lawsuit centers on proof of Tepezza infusions and medical records documenting hearing changes. Infusion dates, the number of infusions and the prescribing doctor's name form the first layer of that proof.
Audiograms from before and after treatment matter most. High-frequency testing detected changes more often than standard audiometry in the Kay-Rivest study, so ask the audiologist whether extended testing is available.
Notes from an ear specialist add support. So do a dated symptom journal and records of out-of-pocket costs, missed work and hearing aids.
Record when your symptoms began relative to your infusions. Filing deadlines may depend on when a patient learned of a possible link. An attorney can explain how your state applies that rule.
What Did Horizon and Amgen Allegedly Know About Tepezza Hearing Risks?
Plaintiffs allege Horizon knew or should have known that Tepezza could cause permanent hearing damage. They say Horizon did not warn patients and doctors adequately.
Tepezza won FDA approval in January 2020. The FDA approved Supplement 23 in July 2023, which added Section 5.4 and its warning that severe hearing impairment may be permanent.
Amgen Inc. completed its roughly $27.8 billion acquisition of Horizon on October 6, 2023, four months after the Panel created MDL 3079. The Panel's order names Horizon Therapeutics USA, Inc. as the defendant.
| Event | Actor | Date | Outcome |
|---|---|---|---|
| Tepezza approved | U.S. Food and Drug Administration | January 2020 | First FDA-approved treatment for thyroid eye disease |
| Label supplement approved | U.S. Food and Drug Administration | July 2023 | Section 5.4 added, warning of severe hearing impairment that may be permanent |
| Horizon acquisition completed | Amgen Inc. | October 6, 2023 | Amgen took ownership of Tepezza and the related litigation |
| Label supplements revised | U.S. Food and Drug Administration | 2025 | Postapproval trial hearing impairment rate raised from 13% to 19% |
These entries are allegations and regulatory records, not findings. Horizon has defended the cases, including through motions to dismiss on federal preemption grounds.
How Does the Tepezza Lawsuit Compare to Related Cases?
The Tepezza lawsuit differs from the FTC's challenge to Amgen's Horizon acquisition, a separate antitrust matter about competition rather than patient injuries.
The FTC sued in May 2023 to block the deal, alleging Amgen could bundle Tepezza and Krystexxa with its other drugs. The agency and Amgen reached a consent order in September 2023 that bars the bundling for 15 years after finalization.
A search for coordinated state-court Tepezza proceedings found none. The sources reviewed describe only the federal MDL.
| Matter | Forum | Subject | Status |
|---|---|---|---|
| Tepezza MDL 3079 | U.S. District Court, N.D. Illinois, Judge Durkin | Alleged hearing loss and tinnitus from Tepezza | Pretrial, no settlement announced |
| FTC challenge to the Horizon acquisition | Federal Trade Commission and federal court | Antitrust concerns about bundling Tepezza and Krystexxa | Resolved by consent order, deal closed October 6, 2023 |
A shared product name does not make two matters the same case. Patients with hearing injuries should not read the FTC order as a ruling on hearing loss.
Frequently Asked Questions
What is the Tepezza lawsuit about?
The Tepezza lawsuit is about allegations that Tepezza infusions for thyroid eye disease caused permanent hearing loss and tinnitus. Plaintiffs say Horizon Therapeutics USA failed to warn patients and doctors. The federal cases are consolidated as MDL 3079 in the Northern District of Illinois.
Is the Tepezza lawsuit a class action or an MDL?
The Tepezza lawsuit is an MDL, not a class action. MDL 3079 consolidates individual lawsuits for shared pretrial work before Judge Thomas M. Durkin, and each plaintiff keeps a separate claim.
Has the Tepezza lawsuit settled?
The Tepezza lawsuit has not settled as of October 2026. No global settlement or payout amount has been publicly announced, and the bellwether trial deadlines were reported struck in October 2025. Payout estimates on attorney websites are unverified projections.
How many cases are in the Tepezza MDL?
The Tepezza MDL had 279 actions pending as of the JPML's October 1, 2026 report, up from 42 in July 2023. The same report lists 289 total actions filed since the MDL began.
Does the Tepezza label warn about hearing loss?
Yes. The current Tepezza label warns that the drug may cause severe hearing impairment, which in some cases may be permanent. The FDA added that warning as Section 5.4 in July 2023 and tells prescribers to assess hearing before, during and after treatment.
Is the FTC case against Amgen the same as the Tepezza lawsuit?
No, the FTC case against Amgen is not the Tepezza lawsuit. The FTC challenged Amgen's acquisition of Horizon on antitrust grounds and reached a consent order in September 2023. MDL 3079 concerns alleged hearing injuries.