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Tepezza Hearing Loss MDL: Bellwether Trials Set for 2026

Tepezza Hearing Loss MDL: Bellwether Trials Set for 2026

Tepezza Hearing Loss MDL: Bellwether Trials Set for 2026

Introduction

A U.S. District Judge overseeing Tepezza hearing damage lawsuits nationwide has scheduled four bellwether trials for 2026. These trials are intended to help both parties assess how juries may respond to the evidence and testimonies that could be repeated in hundreds of other cases.

Tepezza: A Biologic Treatment for Thyroid Eye Disease

Tepezza (teprotumumab-trbw) is a biologic medication introduced by Horizon Therapeutics in January 2020. It was the first FDA-approved treatment for thyroid eye disease (TED), a condition linked to Graves’ disease that causes inflammation of the eye muscles, eyelids, tear glands, and fatty tissues, leading to bulging eyes.

Market Expansion and Concerns Over Risks

Initially expected to serve a limited patient population, Tepezza saw rapid market growth. By its second year in the U.S., sales doubled to $1.66 billion. However, critics argue that Horizon Therapeutics aggressively marketed the drug without adequately disclosing its potential risks, particularly concerning hearing damage.

FDA Warning and Creation of the MDL

In July 2023, the FDA updated Tepezza’s prescribing information to include hearing damage warnings. More than 200 product liability lawsuits claim that this warning should have been present when the drug was first introduced. That same month, a Tepezza multidistrict litigation (MDL) was established in the Northern District of Illinois, consolidating cases for coordinated discovery and pretrial proceedings.

Establishment of the Bellwether Trial Program

As part of the MDL, the judge set up a bellwether trial program to test representative cases before juries. Originally, the first trial was set for March 2026, but a recent docket entry on March 11, 2025, moved the start date to April 6, 2026. The remaining trials are scheduled for June 1, July 27, and September 21, 2026.

Discovery and Pretrial Schedule

To ensure proper case preparation, the court issued an amended discovery schedule:
·    Fact discovery closes by May 9, 2025
·    Summary judgment motions are due by December 5, 2025
·    Final pretrial case management conference set for early March 2026
The four bellwether cases were selected from 12 representative claims, with final selections made in February 2024.

Potential Impact of the Bellwether Trials

While these trials are not legally binding on other cases, they will significantly influence the litigation’s direction. The jury’s verdicts will likely play a crucial role in settlement negotiations, potentially setting a precedent for Tepezza lawsuit payouts.

Possible Settlements or Further Litigation

If a settlement is not reached after the bellwether trials, the judge may remand individual lawsuits to U.S. District Courts nationwide, leading to numerous trials in the coming years. To avoid prolonged litigation, the parties have been directed to engage in quarterly settlement discussions to explore possible resolutions without requiring extensive federal trials.

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