By Bob Paterson Patients receiving Tepezza for thyroid eye disease hoped to relieve painful swelling and eye problems. Some instead reported ringing in their ears, changes in hearing and, in certain cases, hearing loss that did not improve after treatment. Those complaints are central to hundreds of lawsuits against Horizon Therapeutics, now owned by Amgen. The dispute is not simply whether Tepezza can affect hearing—its FDA-approved label acknowledges that risk. It is whether the manufacturer provided sufficiently clear and timely warnings about the potential severity and permanence of those injuries.
What Is the Tepezza Lawsuit About?
Tepezza (teprotumumab-trbw) is an intravenous prescription treatment for thyroid eye disease, also called Graves’ eye disease. It was approved by the U.S. Food and Drug Administration in January 2020. Plaintiffs allege that after receiving infusions, they experienced tinnitus, reduced hearing or permanent hearing damage. They claim Horizon knew, or should have known, more about the seriousness of these risks than its earlier product labeling conveyed.
The federal cases were consolidated in June 2023 as In re Tepezza Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3079, in the Northern District of Illinois before Judge Thomas M. Durkin. The named defendant in many individual complaints is Horizon Therapeutics USA, Inc.; Amgen acquired Horizon in October 2023. These are coordinated personal-injury lawsuits, not one certified consumer class action. Each claimant must ultimately establish their own injury and entitlement to relief.
What Did the Tepezza Warning Label Say?
The warning history is important because some accounts incorrectly suggest the initial product label said nothing about hearing problems. When the FDA approved Tepezza in 2020, its clinical-trial section already reported hearing impairment in 10% of patients in two studies. However, that label did not carry the later, explicit warning about severe or potentially permanent hearing loss.
In July 2023, the FDA approved updated wording stating that Tepezza may cause severe hearing impairment, including hearing loss that can sometimes be permanent. The labeling also recommends hearing assessments before, during and after treatment. Patients’ lawyers argue that physicians and patients should have received stronger information sooner; Horizon has contested the legal sufficiency of those allegations.
What Has the Court Ruled?
Horizon has challenged several legal theories, including whether federal drug-labeling requirements bar state-law claims. In a January 10, 2025 order addressing selected bellwether cases, Judge Durkin declined to dismiss the failure-to-warn claims on federal-preemption grounds. He dismissed the design-defect claims then at issue and allowed only portions of the fraudulent-misrepresentation claims to continue, while resolving other procedural matters.
The ruling did not determine that Tepezza caused a particular plaintiff’s hearing loss or that Horizon had been negligent. It determined which claims could proceed beyond that stage. The distinction matters: surviving a motion to dismiss is not a trial victory or a damages award.
Tepezza Lawsuit Status in October 2026
The Judicial Panel on Multidistrict Litigation’s October 1, 2026 figures show 279 pending Tepezza actions, with 289 actions historically included in the MDL. Earlier plans contemplated bellwether trials, in which selected individual cases would test evidence likely to recur in other lawsuits. However, court deadlines for that program were removed following a 2025 conference with counsel, and the previously reported trial dates should not be treated as current.
As of October 15, 2026, the reviewed records do not establish a completed bellwether verdict, an approved global settlement or an official claims-payment deadline. The docket remains the place to confirm any later case-specific ruling or newly scheduled trial.
Can People Receive Compensation?
Plaintiffs may seek damages for documented hearing injuries, related treatment costs, lost income and other legally recoverable harm. The amount, if any, would depend on proof of injury, medical causation, the law governing the individual case and its outcome. There is no verified flat-rate Tepezza payout or court-approved national settlement fund.
Medical records, dates and doses of infusions, hearing tests from before and after treatment, and information about alternative causes of hearing problems can be important evidence. The timing of treatment may also affect the failure-to-warn analysis because Tepezza’s labeling changed in 2023.
Frequently Asked Questions
Q. Is hearing loss from Tepezza always permanent?
No. The FDA warning says hearing impairment can be severe and may be permanent in some cases. It does not say every hearing change is irreversible. An audiologist or treating physician can assess a particular patient’s symptoms.
Q. Does receiving Tepezza before July 2023 automatically qualify someone for a lawsuit?
No. The earlier treatment date may be relevant to what warnings were provided, but a claim also depends on the person’s injury, medical evidence, applicable law and filing deadline.
Q. Is the Tepezza litigation a class action?
No. MDL No. 3079 coordinates pretrial proceedings for separate personal-injury cases. It does not automatically establish one nationwide class or identical compensation for everyone.
Q. What if someone notices ringing or reduced hearing during treatment?
They should contact the prescribing clinician promptly and ask whether hearing testing or changes in treatment are appropriate. Tepezza’s prescribing information recommends monitoring hearing before, during and after infusions.