Tepezza Hearing Loss Lawsuit

Updates and Settlement Information

LAWSUIT STATUS: New Cases Being Accepted

Lawsuits are being pursued over Horizon Therapeutics failure to warn about the risk of permanent hearing loss side effects caused by Tepezza.

Individuals are claiming that the manufacturer knew or should have known that Tepezza may cause permanent hearing loss, yet failed to disclose the risks or recommend monitoring programs.

Tepezza hearing loss settlements may be available for individuals who received Tepezza infusions and developed any of the following hearing problems:

  • Permanent hearing loss
  • Partial hearing loss
  • Tinnitus (ringing of the ears)
  • Autophony
  • Ear plugging sensation
  • Eustachian tube dysfunction
  • Hyperacusis
  • Hypoacusis

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

Tepezza Lawsuits

Did You or a Loved One Receive a Tepezza Injection?

Side effects of Tepezza may cause permanent hearing problems. Lawsuits are being pursued over the drug maker's failure to warn about the risk. Find out if qualify for a settlement.

SEE IF YOU QUALIFY FOR COMPENSATION

2024 Tepezza Lawsuit Updates

  • 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.
Show More Tepezza Lawsuit Updates

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:

May 2021Tepezza Increases Hearing Problem Risks by 65%: A study by Stanford University researchers was published in the Journal of the Endocrine Society, finding 65% of patients who took Tepezza reported hearing problems, such as ringing of the ears, autophony, a sensation that their ears were plugged, or total hearing loss.

Researchers evaluated the side effects of Tepezza in 26 patients who were given at least four infusions. Of those, 17 patients, or 65%, reported developing hearing problems. Of those, six, or 23%, reported suffering hearing loss; seven, or 27% developed tinnitus, a ringing in the ears; and three, or 12%, reported feeling an ear plugging sensation. In addition, 29% said they developed autophony, where their own voices sounded unusually loud to themselves.

The researchers recommended doctors to caution patients about the potential hearing issues they may experience after receiving Tepezza infusions and further recommended that patients be screened for hearing issues and receive baseline audiogram testing.

August 2021Permanent Hearing Loss After Tepezza Use Case Study: A report published in The Annals of Otology, Rhinology, and Laryngology identified an instance of a 61 year old female with Grave’s disease who suffered significant hearing loss following Tepezza treatments.

The case report indicates the Grave’s disease patient suffered bilateral hearing loss, sound distortion, and tinnitus (ringing of the ears) following treatment with teprotumumab (Tepezza). The patient’s Tepezza treatment was stopped and she was treated with oral corticosteroids. However, after 4 months post Tepezza infusion, her hearing loss symptoms remained unchanged. Researchers stated “This is one of the first descriptive cases of ototoxicity resulting in irreversible sensorineural hearing loss in the setting of treatment with teprotumumab.”

January 2022Tepezza Hearing Loss Case Report: A case report study published in the medical journal Ophthalmic Plastic and Reconstructive Surgery evaluated four cases of patients receiving Tepezza infusions and experiencing significant hearing loss side effects.

The case report warned that Teprotumumab (Tepezza) may cause a variety of irreversible hearing loss symptoms that can range from mild to severe. Specifically, researchers stated the cause of the hearing loss from Tepezza was likely due to the inhibition of the insulin-like growth factor-1 and the insulin-like growth factor-1 receptor pathway.

Authors of the case report warned that the lack of a comprehensive understanding of Tepezza’s effect on hearing should be considered when prescribing treatments to patients.

February 2022Tepezza Post-Marketing Safety Analysis: Prior to receiving FDA Orphan Drug designation, Horizon Therapeutics conducted two clinical trials, which involved less than 100 patients.

In Horizon’s own clinical trials, the manufacturer reported that 10% of individuals treated with Tepezza suffered new hearing problems that included deafness, eustachian tube dysfunction, hyperacusis, hypoacusis, and autophony, which is the perception that your voice is too loud or echoing in your ears.

Horizon reported to the FDA that the hearing loss side effects of Tepezza were only temporary, claiming they would resolve after months of stopping infusion treatments. However, published case studies have found the contrary, documenting hearing loss injuries remaining for more than four months after stopping Tepezza infusions.

February 2022Long Term Tepezza Hearing Loss Study:  While the data on long-term hearing loss side effects from Tepezza is lacking, a study was published in the American Journal of Ophthalmology, finding that only 45.5% of patients who developed subjective hearing loss/decreased word comprehension made a full recovery after eight months of stopping Tepezza infusions.

At the same follow up period, almost 20% of patients still suffered from autophony and nearly 10% of patients still suffered earplugging sensation symptoms.

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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.

Tapezza Hearing Loss Lawsuit: The first Tepezza hearing loss lawsuit was filed by Daniel Weibel in the U.S. District Court for the Northern District of Illinois in August 2022, indicating he developed permanent hearing loss after receiving intravenous Tepezza infusions from June 2020 through September 2020 for the treatment of thyroid eye disease.

Weibel raises allegations that Horizon Therapeutics misrepresented the Tepezza hearing problems recorded in its clinical trials as temporary or of a limited duration. The lawsuit claims the manufacturer failed to adequately research the permanency of many hearing loss reports recorded during its clinical trials, and failed to warn users or regulators that Tepezza can cause serious and irreversible hearing loss and/or tinnitus.

The lawsuit presents claims of failure to warn, design defect, negligent failure to warn, and negligent design. Weibel seeks both compensatory and punitive damages.

Tepezza Hearing Damage Lawsuit: Norma Perez Diaz filed a Tepezza hearing damage lawsuit in the U.S. District Court for the Northern District of Illinois on February 14, claiming she nor her doctor were ever provided any warnings from the manufacturer about the risk of Tepezza side effects. Diaz claims she now suffers from permanent and irreversible hearing loss and ringing of the ears after receiving Tepezza infusions.

Tepezza Tinnitus and Hearing Loss Lawsuit: Angela Simpson filed a lawsuit in the U.S. District Court for the Middle District of Georgia on March 21, 2023, claiming she developed hearing loss and ringing of the ears after only a few shorts months of receiving Tepezza infusions to treat her thyroid eye disease. Simpson claims Horizon failed to adequately test Tepezza for side effects before aggressively marketing the drug as the first medication approved to treat Grave’s disease or bulging eyes.


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.

FIND OUT IF YOU QUALIFY FOR A TEPEZZA LAWSUIT

If you or a loved one were diagnosed with tinnitus or hearing loss from Tepezza, lawyers provide free consultations and claim evaluations to help determine if settlement benefits may be available. There are no fees or expenses unless you win.

CONTACT A LAWYER

1 Comments

  • barbaraJuly 30, 2023 at 10:45 pm

    I have tetinus and severe hives from trapezza

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