Plaintiffs Propose Tepezza Bellwether Schedule Leading Up To First Trial Over Hearing Loss in Jan 2026

Plaintiffs' proposed Tepezza bellwether schedule would see the first cases go before juries in early 2026, while defendants' plan would not result in a trial until mid-2027

Plaintiffs and defendants have presented the U.S. District Judge overseeing Tepezza hearing loss lawsuits with dueling bellwether schedules that could make over a year’s difference in when the first bellwether lawsuits go before juries.

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.

Horizon Therapeutics, the manufacturer, now faces nearly 100 complaints from individuals that 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.

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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.

Proposed Tepezza Bellwether Schedules Vastly Different

Plaintiffs identified their four Tepezza bellwether lawsuit picks on March 1, and the drug manufacturer was expected to select another four cases by April 1, after which the court will randomly select the final four cases that will go through cases-specific discovery in preparation for early trial dates. However, Horizon Therapeutics requested an extension, so that it could review additional medical records before selecting what they believe are the most representative claims for trial.

That extension was granted by Judge Durkin in late March, giving defendants until May 1 to make their bellwether selections. However, in competing schedules submitted by both parties on April 26, plaintiffs’ proposed schedule (PDF) seek for the cases to begin much earlier than defendants’ plan (PDF).

While the plaintiffs’ proposal calls for the first trials to begin in early 2026, defendants’ plan would not see bellwether cases go before a jury until 2027, which plaintiffs say is a stalling tactic and unnecessary waste of time.

“The PLC’s proposed schedule is consistent with MDL best practices, and the approach commonly taken by MDL courts in this District. The schedule anticipates deadlines that can be met with the reasonable diligence of all parties while also ensuring the litigation proceeds at a reasonable clip,” the plaintiffs’ leadership committee’s proposal states. “Defendant’s proposed schedule, however, unnecessarily prolongs all phases of litigation, and particularly bogs down discovery with bifurcated briefing on general and specific causation—a common defense proposal that MDL courts in this District routinely reject for its glaring inefficiencies.”

The PLC notes that their plan calls for 13 months to close fact discovery, setting a May 30, 2025, deadline for both general-liability witnesses and bellwether trial selections. By comparison, the defendants’ plan would not close supplemental fact discovery until March 2, 2026.

“Worse, its proposal contemplates the first trial in mid-2027—four years after the JPML centralized this MDL,” plaintiffs wrote. “These differences demonstrate that the extra months baked into Defendant’s schedule serve no purpose other than increasing costs and delaying resolution.”

Horizon has requested that Judge Durkin hear oral arguments over the dispute when the parties meet for a status conference scheduled for Wednesday.

May 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.

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