Tepezza Hearing Loss Lawsuits (MDL 3079): What the Record Shows

Tepezza is the brand name of teprotumumab-trbw, a biologic the FDA approved on January 21, 2020 to treat thyroid eye disease. The federal lawsuits collected as MDL No. 3079, In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, allege that the drug causes severe or permanent hearing loss and tinnitus, and that the manufacturer did not warn patients soon enough. The Judicial Panel on Multidistrict Litigation created the proceeding by a transfer order filed June 2, 2023, and assigned it to Judge Thomas M. Durkin in the Northern District of Illinois. The Panel’s statistics report dated October 1, 2026 lists 279 actions pending of 289 filed. The FDA label now carries a Warning and Precaution about hearing impairment, which appears in the label revision dated July 2023 and in every revision since. No court has found that Tepezza caused any individual’s hearing loss, and no approved settlement appears in the documents reviewed for this article.

What is established versus what is alleged

Established by the documents reviewed here: the identity of MDL No. 3079, its transferee district and its judge; the Panel’s transfer order of June 2, 2023 and its own account of the claims before it; the master docket number 1:23-cv-03568; the case management orders the court has posted; the pending-case count of October 1, 2026; and the FDA labeling history set out below, including the addition of a Warning and Precaution for hearing impairment in the July 2023 revision.

Alleged, and not decided: that Tepezza has a propensity to cause severe or permanent hearing loss and tinnitus; that the testing the manufacturer conducted was inadequate; and that the hearing loss warnings on the product label were insufficient. The Panel recorded all of that as the plaintiffs’ allegations, not as findings. No court has determined that the drug caused any particular person’s hearing loss, and no court has held that the label was inadequate.

The Panel’s transfer order describes the litigation as concerning “alleged permanent hearing loss and tinnitus associated with the use of the drug Tepezza.” It identifies the defendant as Horizon Therapeutics USA Inc. and records that Horizon opposed centralization, “arguing that there are not enough actions to justify the creation of an MDL.” The Panel was not persuaded. It wrote that the actions share factual questions about general causation, the biological mechanism of the alleged injury, the adequacy of testing, and “the sufficiency of hearing loss warnings made on the product label.” At the time of the decision the Panel counted 37 cases pending in eight districts.

What the FDA label says about hearing

The hearing warning did not appear on the label at approval. In the original prescribing information, issued with the January 2020 approval, hearing impairment is listed only among the most common adverse reactions, meaning those occurring in more than 5 percent of patients. The adverse reactions table for the two premarketing trials reports hearing impairment in 8 of 84 patients treated with Tepezza (10 percent) and 0 of 86 patients who received placebo. A footnote to that row defines hearing impairment to include deafness, sensorineural deafness, eustachian tube dysfunction, hyperacusis, hypoacusis, autophony and tinnitus. The revisions reviewed for this article that are dated October 2021, December 2022 and April 2023 also listed hearing impairment in the adverse reactions section only.

That changed with a supplement the sponsor submitted on January 20, 2023. The FDA’s approval letter for that supplement, BLA 761143/S-023, records that it provided for additions to the Warnings and Precautions, Adverse Reactions and Patient Counseling Information sections of the prescribing information, and that the agency approved it. The revised label is dated July 2023. It adds section 5.4, “Hearing Impairment Including Hearing Loss,” which states: “TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.”

The current prescribing information, revised September 2026, keeps section 5.4 in the same terms. Its postmarketing experience section lists, under Otologic, “severe hearing impairment including hearing loss, which in some cases may be permanent.” The label also reports that in two postapproval trials hearing impairment occurred in 19 percent of participants treated with Tepezza during the double-masked treatment period.

A label warning is a regulatory action. It records what the agency required the manufacturer to tell prescribers and patients. It is not a finding that the drug caused any person’s hearing loss, and this article draws no such conclusion.

Where the claims stand procedurally

MDL No. 3079 is pending on master docket 1:23-cv-03568 in the Northern District of Illinois before Judge Durkin. The transfer order assigned the actions for coordinated or consolidated pretrial proceedings under 28 U.S.C. § 1407. That centralizes discovery and pretrial motions; it does not merge the individual claims into one lawsuit and it does not decide whether any claim has merit.

Case Management Order No. 1, entered June 13, 2023, consolidated the transferred actions for pretrial purposes and states that the consolidation is not a determination that the actions should be consolidated for trial. Case Management Order No. 2, entered October 3, 2023, governs privileged material and clawback under Federal Rule of Evidence 502(d).

Case Management Order No. 3, entered November 1, 2023, sets up the court’s bellwether process. It provides for twelve cases to be selected as Initial Bellwether Discovery Cases, with case-specific discovery in those cases, and then for four of them to be designated as Initial Bellwether Trial Cases. The same order authorizes the Plaintiff Profile Form that every plaintiff must serve, together with medical records and authorizations.

A minute entry on the docket dated February 4, 2025 records that the court selected four cases as the Initial Bellwether Trial Cases. Bellwether selection is a case-management step: it chooses which claims are prepared for trial first, so that the parties and the court can see how a small number of cases develop. The documents reviewed here contain no trial date, no trial verdict and no fairness hearing on any settlement.

The Panel’s statistics report, as of October 1, 2026, lists 279 actions pending in MDL No. 3079, against 289 actions filed since the proceeding was created. The court’s own page for the litigation records a date closed for a number of individual member cases. A pending count is a count of open dockets, not a measure of whether any claim has merit.

Key dates

• January 21, 2020: the FDA approves Tepezza (teprotumumab-trbw), BLA 761143, for thyroid eye disease; the original label lists hearing impairment among the most common adverse reactions (Drugs@FDA; label revised 1/2020).
• January 20, 2023: the sponsor submits a prior approval supplement, BLA 761143/S-023, providing for additions to the Warnings and Precautions, Adverse Reactions and Patient Counseling Information sections (FDA supplement approval letter).
• June 2, 2023: the Panel files the transfer order creating MDL No. 3079 and assigns it to Judge Thomas M. Durkin in the Northern District of Illinois (JPML transfer order).
• June 13, 2023: the court enters Case Management Order No. 1, consolidating the transferred actions for pretrial purposes and identifying master docket 1:23-cv-03568 (Case Management Order No. 1).
• July 2023: the label revision adding section 5.4, “Hearing Impairment Including Hearing Loss,” takes effect (labels revised 7/2023 and 9/2026).
• October 3, 2023: the court enters Case Management Order No. 2 on privileged material and clawback (Case Management Order No. 2).
• November 1, 2023: the court enters Case Management Order No. 3, creating the bellwether process for twelve discovery cases and four trial cases (Case Management Order No. 3).
• February 4, 2025: a docket minute entry records the court’s selection of four Initial Bellwether Trial Cases (RECAP docket).
• September 2026: the FDA label revision in force at the date of this article keeps section 5.4 (label revised 9/2026).
• October 1, 2026: the Panel’s statistics report lists 279 actions pending of 289 filed in MDL No. 3079 (JPML statistics report).

What this does not establish

Nothing in the documents reviewed here shows a court finding that Tepezza caused any individual’s hearing loss or tinnitus, that the manufacturer’s testing was inadequate, or that the label warnings were legally insufficient. Those remain allegations in the plaintiffs’ complaints, as the Panel itself described them. The FDA’s label change is a regulatory action and not a causation finding, and the figure in the adverse reactions table describes how often hearing impairment was reported in trials, not why any one person’s hearing changed. The record reviewed here contains no trial verdict, no approved settlement, no class certification and no admission of liability by the manufacturer. It also contains no determination about what any individual claim may be worth.

Frequently asked questions

Is there a Tepezza settlement?

No settlement appears in the documents reviewed here. MDL No. 3079 remains in pretrial proceedings, the most recent procedural step in this record is the court’s selection of four bellwether trial cases, and the Panel’s October 1, 2026 report still lists 279 actions pending.

Does the FDA’s hearing warning mean Tepezza caused a particular person’s hearing loss?

No. The warning tells prescribers to assess hearing before, during and after treatment and to consider the benefit and risk with patients. A warning of that kind is the agency’s labeling action. It is not a determination that the drug caused any individual’s injury, and causation is one of the questions the litigation has not resolved.

Who is the defendant in the Tepezza litigation?

The Panel’s transfer order identifies Horizon Therapeutics USA Inc. as the defendant, and the member cases on the court’s page are captioned against Horizon Therapeutics USA, Inc. or closely related Horizon entities.

Is MDL 3079 a class action?

No. MDL No. 3079 is a consolidation of individual federal actions for pretrial proceedings under 28 U.S.C. § 1407. The difference between that procedure and a class action is explained in MDLs compared with class actions.

When did the hearing warning go on the Tepezza label?

The Warning and Precaution for hearing impairment, section 5.4 of the prescribing information, appears in the label revision dated July 2023, following a supplement the sponsor submitted on January 20, 2023. The revisions reviewed for this article that are dated January 2020, October 2021, December 2022 and April 2023 listed hearing impairment in the adverse reactions section only.

Background on how these proceedings fit together appears in the pharmaceutical lawsuits hub and in how mass tort litigation works, alongside the GLP-1 litigation, the Zantac ranitidine litigation and the Depo-Provera meningioma litigation.

Sources

1. U.S. Judicial Panel on Multidistrict Litigation: “In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3079, Transfer Order (June 2, 2023)” (link, accessed 2026-10-16)
2. U.S. Judicial Panel on Multidistrict Litigation: “MDL Statistics Report: Distribution of Pending MDL Dockets by District, Report Date 10/1/2026” (link, accessed 2026-10-16)
3. U.S. District Court for the Northern District of Illinois: “MDL 3079, In Re: Tepezza Marketing, Sales Practices, and Products Liability Litigation (Northern District of Illinois)” (link, accessed 2026-10-16)
4. U.S. District Court for the Northern District of Illinois: “Case Management Order No. 1, In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, No. 1:23-cv-03568 (N.D. Ill. June 13, 2023)” (link, accessed 2026-10-16)
5. U.S. District Court for the Northern District of Illinois: “Case Management Order No. 2, In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, No. 1:23-cv-03568 (N.D. Ill. October 3, 2023)” (link, accessed 2026-10-16)
6. U.S. District Court for the Northern District of Illinois: “Case Management Order No. 3, In re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, No. 1:23-cv-03568 (N.D. Ill. November 1, 2023)” (link, accessed 2026-10-16)
7. U.S. Food and Drug Administration: “TEPEZZA (teprotumumab-trbw) for injection, Prescribing Information (label revised 9/2026)” (link, accessed 2026-10-16)
8. U.S. Food and Drug Administration: “TEPEZZA (teprotumumab-trbw) for injection, Prescribing Information (label revised 7/2023)” (link, accessed 2026-10-16)
9. U.S. Food and Drug Administration: “TEPEZZA (teprotumumab-trbw) for injection, Prescribing Information (label revised 1/2020)” (link, accessed 2026-10-16)
10. U.S. Food and Drug Administration: “BLA 761143/S-023 Supplement Approval Letter, TEPEZZA (teprotumumab-trbw) (2023)” (link, accessed 2026-10-16)
11. U.S. Food and Drug Administration: “Drugs@FDA: TEPEZZA, Biologic License Application 761143, approval history and labeling” (link, accessed 2026-10-16)
12. Free Law Project, RECAP archive: “In Re: Tepezza Marketing, Sales Practices, and Products Liability Litigation, No. 1:23-cv-03568 (N.D. Ill.), docket entries via the RECAP archive” (link, accessed 2026-10-16)

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