Tepezza Settlement Talks For Hearing Loss Claims Will Commence Next Month

As a series of Tepezza hearing loss lawsuits are being prepared for early trial dates set to begin next year, parties have been ordered to hold quarterly mediation talks starting next month, to discuss whether settlements can be reached to avoid dozens of individual cases going before juries in the coming years.

Horizon Therapeutics currently faces nearly 140 product liability claims brought throughout the federal court system, each alleging the drug manufacturer failed to adequately warn users about the link between hearing loss and Tepezza (teprotonumab-trbw), which is a new generation biologic treatment marketed for thyroid eye disease. However, the number of claims is expected to continue to grow, and will likely include several hundred hearing loss lawsuits before the first jury trials begin in March 2026.

In July 2023, the U.S. Food and Drug Administration (FDA) released a new version of the Tepezza prescribing information guide, which now adds many of the same hearing loss warnings plaintiffs indicate should have been included when the drug was first introduced.

The new Tepezza label update now discloses that users have been left with severe and permanent hearing loss. It also indicates doctors should assess patients’ hearing before, during, and after Tepezza infusions, to avoid users experiencing permanent ear damage. However, plaintiffs now pursuing lawsuits allege that they may have avoided permanent hearing loss if earlier warnings and information had been provided.

Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established last year, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

As part of the coordinated management of the litigation, Judge Durkin has established a “bellwether” program, where a group of 12 representative cases have been selected to go through case-specific discovery in preparation for early trial dates, which will help the parties gauge how juries are likely to respond to certain evidence and testimony that will be repeated throughout various cases in the litigation.

Tepezza Settlement Talks Ordered

As part of the discovery process in preparing the first Tepezza hearing loss lawsuits for trial, Magistrate Judge M. David Weisman issued a case management order (PDF) on July 2, indicating that the court has adopted a discovery schedule proposed last month by both plaintiffs and defendants.

As part of that schedule, the parties have been ordered to commence quarterly Tepezza settlement talks, starting on or about August 1. Such mediation sessions could help the parties reach a global Tepezza settlement agreement to resolve all or many claims. However, such talks are expected to take time.

Judge Weisman’s order indicates the parties will continue to meet at least once every 90 days to try and hammer out a deal.

The order also sets the close of core fact discovery for December 20, 2024, and recommendations for the parties to submit a list of four cases they propose for the first four bellwether trials by January 17, 2025.

Last month, Judge Durkin issued an order indicating the first Tepezza bellwether trial will begin on March 9, 2026, with additional claims expected to go before juries about every two months: on May 4, 2026; 6/29/2026; and 8/24/2026.

July 2024 Tepezza Settlement Update

While the outcome of these early bellwether trials will not have any binding impact on other hearing loss claims presented in the litigation, the average jury payouts are likely to have a large impact on Tepezza settlement negotiations between the parties, and the amount Horizon may need to pay to avoid each individual claim going to trial in the future.

The bellwether selections are intended to involve claims representative of the larger litigation, helping the parties weigh the relative strengths and weaknesses of the allegations that users may have avoided Tepezza hearing problems if the drug maker had disclosed information about the risk, and instructed doctors to obtain hearing tests before and during treatments.

Following the bellwether trials and MDL mediation talks, if the parties fail to reach Tepezza hearing loss settlements or another resolution for the litigation, Judge Durkin may begin remanding individual cases to U.S. District Courts nationwide for separate trial dates in the coming years.