Tepezza Hearing Loss Lawsuit

What Is the Tepezza Hearing Loss Lawsuit?

The Tepezza hearing loss lawsuit involves allegations that the drug manufacturer Horizon Therapeutics failed to adequately warn about the risk of permanent hearing loss or tinnitus side effects caused by the Thyroid Eye Disease (TED) drug, Tepezza.

While the manufacturer disclosed a 10% risk of hearing problems discovered during clinical trials, studies have found that up to 65% of patients have developed new, worsening or permanent hearing problems.

Tepezza is an injection used to treat individuals with thyroid eye disease (TED) caused by hyperthyroidism and Grave’s disease. With no other available treatment on the market for the conditions, Tepezza was fast tracked through the FDA approval process in January 2020, without extensive research from large clinical trial groups to determine all of the potential side effects and their severity among diverse groups.

Since the drug’s release, individuals have reported suffering hearing problems after Tepezza infusions, including ringing of the ears, autophony, a sensation that their ears were plugged, or total hearing loss.

As a result of the growing evidence establishing that the drug makers knew or should have known about the risk of permanent hearing loss after infusions, individuals are now pursuing settlement benefits through a Tepezza lawsuit, alleging that permanent hearing damage could have been avoided if adequate warnings had been provided to users, regulators and the medical community.

Who is Eligible for a Tepezza Hearing Loss Lawsuit?

Financial benefits may be available through a Tepezza settlement or lawsuit payout for individuals who received multiple Tepezza infusions, and were diagnosed with any of the following conditions;

• Permanent or partial hearing loss
• Tinnitus (ringing of the ears)
• Autophony
• Ear plugging sensation
• Eustachian tube dysfunction
• Hyperacusis
• Hypoacusis
• Other permanent hearing problems

2025 Tepezza Lawsuit Updates

• January 21, 2025 Update: As the Tepezza hearing loss litigation progresses, Judge Durkin is moving forward with the Tepezza bellwether trial process, with the first trials scheduled to begin in March 2026. Following the close of fact discovery last month, both plaintiffs and defendants submitted their proposed selections for the initial four cases, each arguing why their choices best represent the broader litigation. The court will now review the submissions and select the final four bellwether cases, which will help gauge how juries may respond to key evidence and testimony in the upcoming trials.
• December 2, 2024 Update: The U.S. JPML has released its latest docket report indicating another 11 Tepezza hearing loss lawsuits were added to the litigation over the month of November, bringing the total number of claims pending claims filed to 191.
• November 11, 2024 Update: During Tepezza hearing loss lawsuits, plaintiffs’ attorneys have accused Horizon Therapeutics’ lawyers of disruptive deposition conduct meant to hinder testimony, prompting a motion for stricter oversight. On November 1, U.S. Magistrate Judge M. David Weisman ruled that Horizon’s attorneys’ behavior was improper, supporting the call for stricter deposition rules. While the Court did not impose any specific sanctions, the parties were encouraged to work together to reschedule remaining depositions and maintain a tighter discovery timeline in preparing the claims for trial.
• November 1, 2024 Update: The Tepezza MDL has seen minimal growth, adding only seven cases to the docket since September, for a total of 180 pending cases. Meanwhile, Horizon utilized a recently amended but non-retroactive Michigan law to dismiss one of the twelve bellwether cases in the MDL, as Judge Durkin ruled Michigan law applied because the plaintiff experienced side effects there, although the lawsuit was filed in Illinois where Horizon is based.
• October 14, 2024 Update: In a recent ruling by United States Magistrate Judge, M. David Weisman ordered how confidential documents will be managed during the Tepezza litigation. Weisman dismissed both the plaintiffs’ and Horizon’s requests for additional protections on these documents during witness depositions, pointing out that existing protective orders already provide clear guidelines. According to these rules, confidential documents may be disclosed to relevant individuals if necessary for the case’s progression. This decision allows the litigation to continue smoothly, ensuring that witness questioning proceeds without delays, while maintaining strict confidentiality protocols.
• September 12, 2024 Update: According to the latest JPML docket report, over 30 new Tepezza hearing lawsuits were filed throughout the month of August, marking one of the largest increases in recent months, and bringing the total number of lawsuits filed in the MDL to 173.
• July 26, 2024: Horizon has filed several motions to dismiss, calling for 12 Tepezza hearing loss lawsuits that were selected for bellwether trials to be dismissed on the ground of preemption. 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.
• July 3, 2024 Update: In one of the most recently filed Tepezza lawsuits, Michael Wuss of Illinois, claims that Horizon withheld Tepezza hearing loss side effects information for three years before updating the warning label. Wuss claims that Horizon knew, or should have known, about Tepezza hearing impairment risks shortly after the drug hit the market in 2020, yet placed a desire for profits before the health and safety of users.
• June 17, 2024 Update: The Judicial Panel on Multidistrict Litigation (JPML) has issued the latest update on the Tepezza MDL docket, indicating there are now 120 Tepezza hearing loss lawsuits currently pending in the multidistrict litigation.
• May 6, 2024 Update: The parties have submitted proposed schedules for the first round of Tepezza hearing loss bellwether trials, with plaintiffs’ counsel proposing the first trials to begin in early 2026, while 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.
• April 8, 2024 Update: Horizon Therapeutics has been granted an extension until May 30 to select Tepezza bellwether lawsuits, citing the extensive medical records review and the search for the most representative claims for the bellwether discovery process. This decision came despite opposition from plaintiffs in a brief on March 12. Following a hearing on March 20, Judge Durkin allowed the deadline extension but emphasized in a recent Docket Entry that no further delays would be permitted.
• March 1, 2024 Update: Plaintiffs submitted a list of bellwether selections on March 1 to be prepared for a series of early Tepezza hearing loss trials. Two of the four claims selected involve individuals diagnosed with permanent hearing loss, while the remaining two involve individuals diagnosed with both permanent hearing loss and tinnitus allegedly caused by Tepezza injections.
• November 1, 2023 Update: Judge Durkin ordered parties to select 12 cases to form an initial Tepezza bellwether lawsuit pool to be prepared for early trial dates.
• July 20, 2023 Update: The FDA issued an updated Tepezza prescribing information guide on July 20, 2023, adding new warnings about the potential risk of permanent hearing loss from Tepezza. In the guideline, the FDA instructs doctors to evaluate patients’ hearing before, during, and after the use of Tepezza, and emphasizes that Tepezza can cause severe hearing impairment.
• June 2, 2023 Update: The U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order on June 2, directing the growing number of Tepezza hearing loss lawsuits to be consolidated into a Tepezza hearing loss multidistrict litigation (MDL) before U.S. District Judge Thomas Durkin in the Northern District of Illinois for coordinated pretrial proceedings. Later that month, Judge Durkin appointed several Tepezza plaintiffs’ attorneys to key leadership positions in the litigation.
• May 26, 2023 Update: Despite Horizon Therapeutics motion in opposition to the creation of the Tepezza multidistrict litigation, the U.S. JPML heard oral arguments on the centralization of the Tepezza hearing loss lawsuits on May 25, 2023, at the James A. Byrne U.S. Courthouse in Philadelphia.
• March 22, 2023 Update: With at least 18 Tepezza hearing loss lawsuits now filed in five different U.S. District Courts, a second motion to transfer has been filed with the U.S. JPML, requesting the claims to be centralized for pretrial proceedings in a Tepezza hearing loss multidistrict litigation in the U.S. District Court for the Northern District of California.
• January 5, 2023 Update: A group of plaintiffs filed a petition with the Judicial Panel on Multidistrict Litigation, calling for consolidation of all Tepezza lawsuits into a multidistrict litigation (MDL) for consolidated pretrial proceedings before one federal judge.

How Does Tepezza Cause Hearing Loss?

Tepezza can cause hearing loss by blocking a protein called IGF-1R, which plays a crucial role in the growth and maintenance of the cells responsible for transmitting sound waves in the inner ear. By blocking this protein it dulls the sensory cells that are essential for hearing, which can lead to permanent cell damage and the onset of hearing problems.

Tepezza works by targeting and inhibiting the Insulin-like Growth Factor-1 Receptor (IGF-1R) to reduce inflammation and swelling in the cells of patients with Thyroid Eye Disease (TED). However, the Tepezza warning label states that no formal studies evaluating the drug’s molecular, biochemical, and physiologic effects or actions have been conducted.

What are the hearing loss side effects of Tepezza?

A wide range of hearing loss side effects after Tepezza infusions have been reported by individuals, including;

• • • Sensorineural Hearing loss
    • Tinnitus (ringing in the ears)
    • Patulous Eustachian tube
    • Clicking and popping sounds
    • Deafness
    • Difficulty hearing
    • Dizziness and balance problems
    • Ear plugging sensation
    • Muffled sounds
    • Sensitivity to certain sounds
    • Problems hearing words in noisy environments
    • Pain mimicking an ear infection
    • Voice sounding abnormally loud and low-pitched

Is Tepezza Hearing Loss Permanent?

Multiple reports of permanent hearing loss after Tepezza infusions have been reported. While Horizon claims that Tepezza side effects typically resolve within three months of stopping infusions, a study published in the American Journal of Ophthalmology in 2022 found that 55% of Tepezza patients continued to suffer earing loss after eight months of stopping Tepezza infusions

Due to the lack of clinical data provided by the manufacturer, the percentage of individuals who will be left with potentially permanent hearing loss from Tepezza is still largely unknown at this time due to the novelty of the drug.

Lawsuits are being filed by individuals claiming that if Horizon had warned doctors and patients about the risk of permanent hearing loss, healthcare professionals could have performed before and after Tepezza hearing testing on patients for early signs of hearing loss and stopped treatment before permanent damage to the sensory cells in the inner ear occurred.

Horizon Acknowledges Tepezza Permanent Hearing Loss Risks

In July 2023, the U.S. Food and Drug Administration (FDA) approved an updated Tepezza drug warning label. The update includes crucial information in the “Warnings and Precautions” section, highlighting that Tepezza may cause serious and irreversible hearing loss, stating;

“Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with Tepezza and consider the benefit-risk of treatment with patients.”

However, this updated warning has come too late for many previous Tepezza users who are now coping with permanent hearing loss as a result of the manufacturers failure to disclose auditory damage risks.

Case Reports and Studies Linking Tepezza to Hearing Loss

Tepezza’s link to hearing problems and other side effects were seen by the manufacturer in the early stages of the drug’s development, with two separate clinical studies finding that about 10% of users experienced hearing loss or other hearing-related problems.

Since the clinical trials, several peer reviewed medical journals have published studies and articles warning about the risk of hearing loss from Tepezza. Some of the studies and evidence suggesting that side effects of Tepezza cause hearing loss include:

Horizon Failed to Update Tepezza’s Safety Label

Allegations raised in Tepezza lawsuits claim that Horizon had the opportunity to update Tepezza’s drug safety label to warn patients and the medical community about the increasing number of individuals reporting hearing loss and ringing of the ears, but chose not to in an effort to maximize sales.

When a new drug is approved, the FDA allows manufacturers to submit changes to the safety labeling if new or increasing rates of side effects are identified, which is called a Changes Being Effected, or CBE supplement.

However, Horizon failed to file a CBE supplement despite a growing number of Tepezza hearing loss reports being submitted by patients immediately following the drug’s approval. According to reports submitted to the FDA by the end of 2021, at least 135 patients had suffered hearing complications after receiving Tepezza, which included tinnitus, hypoacusis, and deafness.

Tepezza lawsuits claim that rather than taking the corrective action to warn the medical community, Horizon placed its efforts into an aggressive marketing strategy, which helped the manufacturer earn more than $3.2 billion in net sales for 2021.

Is there a Tepezza Class Action Lawsuit?

The U.S. Judicial Panel on Multidistrict Litigation has ordered all Tepezza hearing loss lawsuits filed throughout the federal court system to be centralized in the Northern District of Illinois before U.S. District Judge Thomas Durkin, where the cases will undergo coordinated discovery and pretrial proceedings under a single Tepezza Product Liability multidistrict litigation.

In response to two motions filed by plaintiff’s earlier this year, the JPML held oral arguments at the James A. Byrne U.S. Courthouse in Philadelphia on May 25, 2023, where both plaintiff’s and Horizon presented arguments to support or rebuke the consolidation of the claims into an MDL.

Tepezza Hearing Loss MDL 3079

Within three weeks of the arguments and evidence provided at the hearing, the JPML voted in favor of the plaintiffs to consolidate the claims before one judge for coordinated pretrial proceedings. It is common in large product liability lawsuits alleging similar injuries caused by a common problem to be centralized into a multidistrict litigation to avoid duplicate discovery and conflicting rulings.

Now that the Tepezza Product Liability multidistrict litigation (MDL 3079) has been formed, U.S. District Judge Thomas Durkin will be tasked with overseeing pretrial proceedings. It is expected that as the litigation develops a small group of representative claims involving similar allegations will be prepared for early trial dates, to help gauge how juries are likely to respond to certain evidence and testimony.

Following the outcomes of any potential future Tepezza bellwether trials, if settlements are not reached by manufacturers and plaintiffs, each individual case would later be remanded to U.S. District Courts nationwide for separate trial dates to determine the amount of each Tepezza lawsuit payout.

Examples of Tepezza Lawsuits

The amount of lawsuits over hearing loss from Tepezza are expected to grow significantly in the coming months and years as individuals learn about the emerging medical evidence linking the drug to hearing problems.

What is the Average Tepezza Settlement Amount?

With the first Tepezza hearing loss lawsuits being filed in late 2022, there have not yet been any settlements or Tepezza lawsuit payouts by the manufacturer, so the average settlement amount has not been determined. However, as cases go to trial or Tepezza settlements are reported, we will track the average payouts here.

It is likely that there will be a very wide range of Tepezza settlement amounts, given the different types and severity of injuries. In some cases, Tepezza users may make a full recovery from their hearing injuries after stopping infusion treatments. However, those who suffer total hearing loss or permanent Tinnitus may be offered much larger Tepezza settlement amounts.

In determining the amount of any individual Tepezza lawsuit payouts, the following are some of the common factors that will be taken into consideration when lawyers negotiate offers:

• The extent and duration of Tepezza infusions;
• Permanency of the hearing problems caused by Tepezza;
• The amount of any past or future medical expenses incurred as a result of Tepezza injuries;
• The amount of any lost wages or loss of earning capacity;
• The effect of the Tepezza on the individual’s overall physical and mental health or well-being;
• The pain and mental anguish suffered in the past and that may likely be suffered in the future;
• Additional damages individuals may be entitled to receive to settle their case.

Have a Tepezza Lawyer Review Your Hearing Loss Case

It is important to obtain experienced legal representation before you file a Tepezza lawsuit. A Tepezza hearing loss lawyer can make sure you receive the financial compensation you deserve.

A Tepezza lawyer will help protect your legal interests, and they provide free consultations to help determine if you or a loved one may be eligible for financial compensation from a Tepezza lawsuit settlement. There are no fees or expenses unless a recovery is obtained in your case.