Tepezza Manufacturer Seeks Delay in Selecting Hearing Loss Lawsuits For Bellwether Discovery

Horizon Therapeutics has asked a federal judge for an additional two months before they are required to select four Tepezza hearing loss lawsuits to go through early bellwether discovery and prepare for potential trial dates, indicating that it has not yet finished reviewing medical records to select the most representative claims in the litigation.

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.

The manufacturer now faces nearly 100 product liability lawsuits brought by individuals experiencing 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 has established a “bellwether” program, where a group of 12 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.

Judge Durkin ordered plaintiffs and defendants to each select four cases to be part of the initial Tepezza lawsuit bellwether discovery pool. Then the parties were to confer on a list of eligible remaining Tepezza lawsuits, from which the Court will choose four at random.

Manufacturer Seeks Tepezza Bellwether Selection Delay

Although plaintiffs turned in their list of Tepezza lawsuit bellwether selections by the court-established deadline of March 1, the drug makers are asking for an extension of their deadline, which requires they select another four cases by April 1.

In a motion (PDF) filed on March 5, lawyers for Horizon Therapeutics asked the Court to delay the Tepezza bellwether case selections by 60 days, requesting that their deadline be extended until May 30.

Horizon Therapeutics indicates the extension is necessary due to the number of medical records involved, and an on-going effort to find the most representative claims to be included in the bellwether discovery process.

“Horizon requires an additional 60 days to complete the process of medical records collection from almost 700 identified providers for the 69 bellwether-eligible plaintiffs in order to select truly representative cases for bellwether treatment, a subset of which will become the bellwether trial cases,” the manufacturer argues in a memorandum in support of the motion (PDF). “At the current pace of collection, Horizon still will not have sufficient data to make informed selections by the current deadline of April 1, 2024. Forcing it to do so in the absence of these data would violate principles of due process and the goals of the bellwether process.”

The manufacturer notes that it conferred with plaintiffs before they submitted their bellwether selections, but plaintiffs indicated they intend to object to the extension.

As a result, the Court has established a briefing scheduling, calling for plaintiffs to file a response to the motion this week; and Horizon will enter a reply to the plaintiffs’ response by March 15. Judge Durkin has set oral arguments over the request for March 20.

March 2024 Tepezza Lawsuit Update

The bellwether selections are intended to prepare a group of representative cases for early trials, which the parties can use to gauge how juries are likely to respond to certain evidence that will be presented throughout the litigation, including 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.

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.

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