Court Identifies 4 Tepezza Lawsuits Over Hearing Loss for Early Bellwether Trials

The U.S. District Judge presiding over all Tepezza lawsuits has identified the four hearing loss claims that will be the first to go before juries, as part of a bellwether process designed to test the strengths and weaknesses of arguments that will be repeated throughout the litigation.

The bellwether trials come as Tepezza’s manufacturer, Horizon Therapeutics, faces more than 200 product liability lawsuits, each raising nearly identical allegations that former users of the thyroid eye disease drug have been left with irreversible hearing damage, including complete hearing loss and a persistent ringing in the ears, known as tinnitus.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment introduced by Horizon Therapeutics in January 2020, as the first medication approved to treat thyroid eye disease or bulging eyes, which is caused by hyperthyroidism and linked to Graves’ disease, resulting in inflammation of eye muscles, eyelids, tear glands and fatty tissues behind the eye.

Although Tepezza infusions were originally intended as a niche treatment, with only a limited market, during the second year the drug was on the market in the United States sales doubled to $1.66 billion, and critics have expressed concern that Tepezza was aggressively marketed without adequately disclosing all of the potential risks.

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.

Faced with a rising number of claims that share common questions of fact and law, the U.S. Judicial Panel on Multidistrict Litigation established a Tepezza MDL (multidistrict litigation) in July 2023, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

Tepezza Lawsuit Bellwether Trial Selections

As part of the management of the litigation, Judge Durkin has established a “bellwether” program, where a group of 12 representative cases were selected by the parties and the court, which have been going through case-specific discovery in preparation for early trial dates, which are currently expected to begin in March 2026.

In a court docket entry (PDF) posted on February 4, Judge Durkin announced the selection of four of those 12 Tepezza lawsuits, which will be the first to go before juries in the federal court system.  However, the exact order of the cases has not yet been finalized.

The selected claims include:

• A Tepezza lawsuit filed by Peter Chryssos, of New York, who indicates he suffered permanent hearing loss due to Tepezza side effects. The complaint (PDF) was originally filed in May 2023.
• A claim filed by Consuelo Egger in October 2023. The California woman suffered both tinnitus and permanent ear damage from her use of Tepezza, according to her lawsuit (PDF).
• A November 22 complaint (PDF) filed by Gloria Pledger of Maryland, who also suffered permanent hearing loss from Tepezza.
• A case brought by Sara Meilleur, who indicates in an October 2023 complaint (PDF) that she was left with permanent hearing damage after Tepezza use.

To determine the order in which the cases will go to trial, Judge Durkin called for the parties to meet and determine if they can reach an agreement, indicating that proposals should be submitted by February 11.

While the outcome of Tepezza bellwether early trial dates will not be binding on other claims in the litigation, they will be closely watched by lawyers involved in the litigation, as the average hearing loss payouts awarded by juries may influence eventual Tepezza settlement negotiations that will be necessary to avoid each individual case being set for trial in the coming years.