Tepezza Infusions Caused Permanent Hearing Loss, Lawsuit Alleges

Lawsuit indicates that neither the plaintiff nor her doctors were warned that Tepezza infusions could cause hearing loss and tinnitus, which persists long after the thyroid eye disease treatments

A Pennsylvania woman indicates she was left with permanent hearing loss caused by Tepezza infusions administered to treat thyroid eye disease, according to a product liability lawsuit recently filed against the drug maker.

The complaint (PDF) was brought last week by Deborah Welch Klostermann in the U.S. District Court for the Northern District of Illinois, pursuing damages against Horizon Therapeutics USA, Inc., for failing to adequately warn about the potential side effects following Tepezza infusions.

Tepezza (teprotumumab-trbw) is a new-generation biologic treatment, which was introduced 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 was 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 Tepezza infusions caused hearing loss or ringing in the ears, known as tinnitus, with many of the problems persisting long after last use of the medication.

In her lawsuit, Klostermann indicates she was diagnosed with thyroid eye disease and received Tepezza infusions from July through December of 2021. The lawsuit indicates neither she nor her physician were warned by the defendants about the potential hearing side effects, or the importance of audiological monitoring during treatments.

Klosterman indicates the drug makers knew or should have known about the link between Tepezza and hearing loss, but placed the desire for profits before the safety of consumers.

“Numerous patient reports, including significant newly acquired reports immediately following Defendant’s launch of Tepezza, scientific studies, and even Defendant’s post-marketing studies establish that Tepezza causes hearing loss and tinnitus,” the lawsuit states. “Nevertheless, Defendant failed to warn, instruct, advise, educate, or otherwise inform Tepezza users, Tepezza prescribers, or United States governmental regulators about the risk of hearing loss, or the need for medical and/or audiological monitoring.”

Klostermann indicates her hearing problems are permanent, and joins a growing number of plaintiffs now pursuing a Tepezza lawsuit to obtain financial compensation and settlement benefits.

 April 2023 Tepezza Lawsuit Update

Given similar questions of fact and law raised in complaints filed throughout the federal court system, the U.S. Judicial Panel on Multidistrict Litigation (JPML) is currently considering a motion filed to consolidate all Tepezza lawsuits over hearing problems.

A group of plaintiffs filed a request last month to centralize claims filed in U.S. District Courts nationwide before one judge to reduce duplicative discovery into common issues about the link between Tepezza infusions and hearing loss, and to avoid conflicting pretrial schedules and rulings.

The U.S. JPML is expected to hear oral arguments on the motion at an upcoming hearing session in Philadelphia, which is scheduled for May 25, 2023.

If the cases are centralized as part of a Tepezza MDL (multidistrict litigation), the lawsuit filed by Klostermann will be consolidated with the other claims. However, if the parties fail to reach Tepezza hearing loss settlements following discovery and any early bellwether trials, each lawsuit may later be remanded back to the U.S. District Court where it was originally filed for a separate trial date in the future.