Tepezza Hearing Loss Lawsuit

Tepezza is a prescription intravenous medication approved by the U.S. Food & Drug Administration (FDA) in January 2020 for the treatment of Thyroid Eye Disease (TED), a condition associated with Graves’ disease in which the eyeballs may bulge, double-vision may occur, and the tissues behind the eye become inflamed.

Shortly after its approval and uptake, users began reporting hearing-related side effects (including tinnitus, muffled hearing, partial or total hearing loss). The manufacturer is Horizon Therapeutics (and its U.S. affiliates).

In response to emerging data, the FDA updated Tepezza’s label to add a specific warning:

“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.”

Legal Claims & Allegations

In litigation now pending, plaintiffs raise several claims against Horizon Therapeutics (and related entities). The core allegations include:

1. Failure to warn / inadequate labeling
   Plaintiffs allege that Horizon knew (or should have known) of a substantial risk of hearing injury from Tepezza, but did not sufficiently warn doctors or patients, nor did it update the label in a timely fashion, thereby exposing patients to a risk of permanent hearing damage without adequate notice.
2. Defective design / inadequate testing
   Some claims assert that the drug’s design (mechanism of action) carries inherent risk of auditory injury and that Horizon failed to conduct adequate long-term studies of hearing outcomes. The plaintiffs contend this amounts to a defect in the product.
3. Causation of hearing damage
   The complaints allege that users who received Tepezza infusions and subsequently suffered hearing loss, tinnitus or other auditory impairment were injured by the drug, and that the manufacturer should be liable for those injuries. Several studies indicate a higher incidence of hearing-related side effects than initially disclosed. For example, one study found up to 65% of patients experienced hearing issues versus the ~10% rate stated in early trials.
4. Compensation for damages
   Plaintiffs seek to recover for medical expenses (hearing aids, cochlear implants, audiology monitoring), lost wages (if hearing loss impairs ability to work), pain and suffering, decreased quality of life, and other related harms.

Litigation Status & Procedural Developments

Here’s where things currently stand (in 2025) with the Tepezza hearing-loss litigation:

• The cases have been consolidated into a federal multidistrict litigation (MDL) before the United States Judicial Panel on Multidistrict Litigation in the Northern District of Illinois (Judge Thomas M. Durkin).
• As of April 2025, there were over 200 individual lawsuits filed.
• Early bellwether trials (representative cases selected to test the legal issues) are scheduled; originally set for mid-2026, some deadlines have been pushed back.
• No major global settlement has been publicly announced (as of late 2025). Legal commentary suggests the litigation is still in discovery, and outcomes will depend on proof of causation, severity of injuries, and defendant’s knowledge/warning record.

Why This Case Matters

For Patients

Hearing is a vital sense; when it is compromised—especially permanently—it has profound consequences. For patients treated for TED with Tepezza, the risk of hearing loss or tinnitus (ringing in the ears) is not just inconvenient—it may be life-altering. The lawsuits highlight that patients (and their physicians) must weigh benefits of treatment against potential irreversible side-effects, and, critically, rely on accurate warnings.

For Drug Manufacturers

This litigation emphasizes the obligation of pharmaceutical companies to:

• Adequately test for long-term and less-common side-effects (including auditory injuries)
• Monitor and report post-market adverse events
• Update labeling promptly when new risks become evident
  Failing to do so can trigger liability for product-defect, failure-to-warn, and consumer-injury claims.

For The Legal System

The Tepezza litigation is an example of mass tort/regulatory interplay: a drug approved with known side-effects, emerging clinical data showing greater risk, a regulatory label update, and now litigation over whether the manufacturer acted appropriately. It raises issues of causation (did the drug cause the hearing loss?), apportionment (how much was due to the drug-versus patient’s underlying condition?), and damages quantification.

Key Legal Considerations & Challenges

• Causation: Plaintiffs must show that Tepezza caused the hearing loss (rather than other conditions, age-related decline, pre-existing ear problems). Medical records and expert testimony will matter.
• Warning Adequacy: Did Horizon provide sufficient warnings? Was the label timely updated? Did physicians understand the risk? The July 2023 FDA label change (adding “hearing impairment including hearing loss”) is significant.
• Extent and permanence of injury: Is the hearing loss temporary or permanent? Courts will evaluate severity of injury, length of impairment, and whether recovery is possible. Some research shows persistent hearing problems in many patients.
• Statutes of limitation and eligibility: Filing deadlines vary by state; timely legal action matters. Some lawsuits require that the hearing loss extends for a certain duration (e.g., >6 months) and occurred after using the drug.
• Settlement vs trial: With mass-tort litigation, settlement is often a possibility once bellwether verdicts give parties insight into risk. Until then, outcome uncertainty remains.

What Could Plaintiffs Recover?

While no definitive settlement figures exist yet for Tepezza-hearing-loss claims, legal commentary gives some benchmarks:

• Some law-firms estimate individual case values might range from $50,000 to $1 million+ depending on severity, lost income, medical costs and impact.
• Because hearing-loss cases vary widely (from mild tinnitus to total deafness), compensation will depend on degree of injury, whether treatment is ongoing, and personal circumstances.
• For serious, irreversible hearing loss (e.g., total loss) in other contexts, median awards have exceeded $1 million. While this does not mean Tepezza cases will reach those levels, the magnitude of hearing loss is a key factor.

Conclusion

The Tepezza hearing-loss litigation is a meaningful case at the interface of pharmaceuticals, patient safety, regulatory oversight, and mass-tort law. For individuals who took Tepezza and later suffered hearing damage (or tinnitus), the case offers a potential avenue for accountability and compensation. For the manufacturer, it signals that risks—especially severe and irreversible ones—must be transparently disclosed and monitored.

If you or someone you know took Tepezza and suffered hearing loss or tinnitus, it is prudent to consult with an attorney experienced in dangerous-drug litigation to evaluate possible legal options. Given the evolving nature of the MDL and litigation schedule, acting sooner rather than later may be beneficial.