Parties Seek More Time to Make Tepezza Lawsuit Bellwether Selections in Hearing Loss Litigation

A status report on Tepezza lawsuits is due on January 5, and will update the judge on the continuing preparations for early hearing loss litigation test trials.

Lawyers involved in the federal Tepezza hearing loss litigation have asked the U.S. District Judge presiding over the claims to provide another 60 days before a group of lawsuits are selected to serve as the Initial Bellwether Discovery Pool, allowing them more time to go through medical records and other detailed documents to determine which cases are best suited to serve as test trial cases.

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.

Hundreds of former users are now coming forward to report that they experienced various forms of hearing damage from Tepezza, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the hearing loss persists long after the thyroid eye disease treatments, leaving users with irreversible hearing damage.

Given common questions of fact and law raised in complaints filed in federal courts nationwide, a Tepezza MDL (multidistrict litigation) was established 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.

As part of the coordinated management of the litigation, Judge Durkin is establishing a “bellwether” program, where a small group of representative cases will be 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 Lawsuit Bellwether Selection Deadline Extended

On November 1, Judge Durkin told the plaintiffs they had 60 days to select four cases to be a part of the Initial Tepezza Lawsuit Bellwether Discovery Pool, and the defendants were given 90 days to select four cases. The parties were then to confer on a list of eligible remaining Tepezza lawsuits, from which the Court would choose four at random, for a total of 12.

However, in a joint stipulation (PDF) issued on January 2, the parties told the court that they had mutually agreed that they both need an additional 60 days to make the bellwether case selections.

The proposal indicates that this will allow the Defendants more time to secure plaintiffs’ medical records, and will also allow the parties to address any problems with Plaintiff Profile Forms. It also indicates that the parties have also agreed to an extension of the deadline for filing Amended Complaints to March 1.

January 2024 Tepezza Lawsuit Update

Plaintiffs each raise similar arguments that they 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.

In July, 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.

While the outcome of Tepezza bellwether early trial dates will not be binding on other claims in the litigation, the average lawsuit payouts may influence eventual Tepezza settlement negotiations that will be necessary to avoid each individual case being set for trial in the coming years.