Horizon Therapeutics Files Motion To Dismiss Tepezza Hearing Loss Bellwether Claims

Manufacturer argues that nearly all claims presented in the Tepezza hearing loss lawsuits selected for bellwether trials should be dismissed based on federal preemption

Following the selection of 12 Tepezza hearing loss lawsuits in the federal MDL, which were intended to serve as bellwether claims during the coordinated pre-trial proceedings and be prepared for a series of early trial dates, Horizon Therapeutics has filed motions to dismiss many of the claims presented in the complaints.

The drug manufacturer currently faces about 140 product liability lawsuits over Tepezza, each raising similar allegations that users and the medical community were not adequately about the risk that the thyroid eye disease treatment may leave users with permanent and irreversible hearing damage.

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. Howver, concerns have emerged that the drug maker placed a desire for profits before consumer safety, but aggressively marketing the treatment without disclosing that some users may experience hearing loss from Tepezza side effects.

Given common questions of fact and law raised in complaints brought throughout the federal court system, a Tepezza MDL (multidistrict litigation) was established last year, centralizing the lawsuits before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated discovery and a series of early trial dates, which are intended to help the parties gauge how juries may respond to certain evidence and testimony that will be repeated throughout large numbers of other claims.

Early in the MDL proceedings, Judge Durkin established a Tepezza “bellwether” program, where a group of 12 representative cases were selected to go through case-specific discovery and preparations for early trial dates, which are currently scheduled to begin in March 2026.

Plaintiffs selected four of the bellwether lawsuits over Tepezza and hearing loss, with Horizon Therapeutics selecting another four and the Court randomly selecting the final four last month.

Horizon Seeks Dismissal of Tepezza Hearing Loss Claims

On July 19, Horizon filed several motions calling for all of the selected cases to be dismissed based on a variety of grounds.

One motion to dismiss (PDF) names 11 of the claims, alleging that plaintiffs failed to argue plausible strict liability or negligent design defect claims. Another motion (PDF), names nine of the bellwether selections, that the manufacturer says should be dismissed due to federal preemption laws.

In addition, another motion (PDF) calls for the court to dismiss fraudulent misrepresentation claims asserted in five of the selected lawsuits. And yet a fourth memorandum (PDF) singles out a Michigan claim which it says fails to state a claim based upon that state’s laws.

For the preemption claims, Horizon argues that the FDA deemed its label warnings sufficient at the time the medication was first approved, which should shield the company from liability.

“The FDA approved Tepezza, including its label, in January 2020 knowing that hearing impairment was an adverse reaction observed in Horizon’s pivotal clinical trials,” Horizon’s attorneys argue. “To plausibly state a non-preempted claim, plaintiffs must offer specific allegations of ‘newly acquired information’ that Horizon obtained after FDA approved Tepezza® and before plaintiffs’ last use.”

August 2024 Tepezza Lawsuit Update

Plaintiffs have not yet responded to the motions. However, unless the court agrees to dismiss all of the bellwether claims, it is expected that discovery will move forward, and the 12 initial claims will later be narrowed down to a group of four that will go before juries on March 9, 2026, May 4, 2026, June 29, 2026 and August 24, 2026.

While the outcome of these early bellwether trials will not have any binding impact on other claims presented in the litigation, the average Tepezza lawsuit payouts awarded by juries are likely to have a large impact on settlement negotiations between the parties.

The bellwether selections are intended to involve claims will be representative of the larger litigation, helping the parties weigh the relative strengths and weaknesses of the 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.

Following the early trial dates in the MDL, if the parties fail to reach Tepezza hearing loss settlements or another resolution for the litigation, Judge Durkin may begin remanding individual cases to U.S. District Courts nationwide for separate trial dates in the coming years.