Lawyers in Tepezza Hearing Loss Litigation Will Meet for MDL Status Conference Next Week

The conference comes as a growing number of former users continue to file lawsuits over Tepezza hearing loss, alleging that the manufacturer failed to adequately warn about risks associated with the thyroid eye disease treatment.

The U.S. District Judge recently appointed to preside over the federal Tepezza litigation will meet with lawyers involved in the cases next week, to discuss early progress in a growing number of lawsuits being brought by former users of the thyroid eye disease, who have been left with permanent hearing damage.

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 hearing loss side effects from Tepezza, including persistent ringing in the ears known as tinnitus, and complete hearing loss. In many cases, the problems persist 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 last month, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and pretrial proceedings.

Status Conference Agenda for Tepezza Hearing Loss Litigation

During an initial status conference held on June 28, Judge Durkin established a schedule for a series of meetings with the lawyers in the Tepezza hearing loss litigation to review how the coordinated pretrial proceedings are progressing.

On Monday, the parties submitted a joint status report and proposed agenda (PDF) for an upcoming conference that will be held on July 31, which calls for the court to review plans for protective orders, identification of individuals in charge of key documents needed during the discovery process and other preliminary proceedings that will help keep the cases moving forward.

As part of the coordinated management of the litigation, it is expected that Judge Durkin will establish 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.

The proposed agenda calls for the parties to meet and confer over the coming weeks to work on a proposed bellwether plan, which would ideally result in a process to select the first candidates for early trial dates.

While the outcome of these 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.

July 2023 Tepezza Lawsuit Update

The upcoming status conference comes days after the U.S. Food and Drug Administration (FDA) released a new version of the Tepezza prescribing information guide, which added many of the hearing loss warnings that 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 that doctors should assess patients’ hearing before, during, and after Tepezza infusions, to avoid users experiencing permanent ear damage.