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Understanding the Tepezza Hearing Loss Case

Introduction to the Tepezza Hearing Loss Case

Person using ear thermometer to check ear temperature.

Tepezza, a drug used to treat Thyroid Eye Disease (TED), has recently come under scrutiny due to allegations of causing permanent hearing loss. The drug’s manufacturer, Horizon Therapeutics, is facing lawsuits for failing to adequately warn about the risk of these severe side effects.

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. This has led to a growing number of lawsuits against Horizon Therapeutics.

The FDA’s Role and Response

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.

“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 manufacturer’s failure to disclose auditory damage risks.

Eligibility for a Tepezza Hearing Loss Lawsuit

Individuals who received multiple Tepezza infusions and were diagnosed with conditions such as permanent or partial hearing loss, tinnitus (ringing of the ears), autophony, ear plugging sensation, Eustachian tube dysfunction, hyperacusis, hypoacusis, or other permanent hearing problems may be eligible for a Tepezza hearing loss lawsuit.

Several of the potential side-effects of the prescription drug include:

  • Permanent hearing loss caused by Tepezza
  • Difficulty in discerning words in loud surroundings
  • Sensitivity to specific sounds
  • Experiencing muffled sounds
  • Sensation of the ears being plugged
  • Balance issues and dizziness
  • Problems related to hearing
  • Complete deafness
  • Sounds that resemble clicks and pops
  • Condition of the Eustachian tube becoming patulous
  • Tinnitus, characterized by a ringing sound in the ears
  • Sensorineural loss of hearing
  • Pain that resembles that of an ear infection
  • Voice appearing unusually loud and of a low pitch

These lawsuits allege that permanent hearing damage could have been avoided if adequate warnings had been provided to users, regulators, and the medical community.

Tepezza Lawsuits and Settlements

As of now, there have been no 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, if this case settles, 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.

Current State of Litigation in Connection with Tepezza Injuries

The following timeline highlights key developments such as the filing of the first lawsuit, the petition for consolidation of cases into a multidistrict litigation (MDL), and the FDA’s updated prescribing guidelines. It offers a comprehensive view of the unfolding legal landscape surrounding Tepezza and its alleged side effects.

  • In May 2021, the Journal of the Endocrine Society released a study revealing that up to 65% of Tepezza users reported new hearing loss side effects after receiving infusion treatments for Grave’s disease and thyroid eye disease (TED).
  • The first lawsuit related to Tepezza-induced hearing loss was filed in August 2022. The lawsuit claimed that the manufacturer failed to disclose known hearing loss side effects from Tepezza infusions.
  • In January 2023, a group of plaintiffs submitted a petition to the Judicial Panel on Multidistrict Litigation, advocating for the creation of a multidistrict litigation (MDL) for streamlined pretrial proceedings related to injuries from Tepeeza. This would allow this to be heard under a single federal judge, consolidating and streamlining claims.
  • By March 2023, at least 18 Tepezza hearing loss lawsuits had been filed in connection with these injuries. A second motion to transfer was submitted to the U.S. JPML.
  • In May 2023, the U.S. JPML in Philadelphia heard oral arguments regarding the centralization of the Tepezza hearing loss lawsuits. Horizon Therapeutics opposed the creation of the MDL.
  • In June 2023, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order on June 2. This order directed the increasing number of Tepezza hearing loss lawsuits to be consolidated into a Tepezza hearing loss multidistrict litigation (MDL). This matter is being heard in the Northern District of Illinois before U.S. District Judge Thomas Durkin. Judge Durkin appointed several Tepezza plaintiffs’ attorneys to leadership roles in the MDL.
  • In July 2023, the FDA released an updated Tepezza prescribing information guide. This was released on July 20, 2023. This guide included new warnings about the potential risk of permanent hearing loss from the use of Tepezza. Additionally, the FDA has advised doctors to assess patients’ hearing, including before, during, and after the use of Tepezza, looking for signs of hearing impairment.

Contact Alonso Krangle LLP Today to Discuss Your Injuries

The Tepezza hearing loss case is a stark reminder of the importance of thorough clinical trials and transparent communication from drug manufacturers. As the case unfolds, it will be crucial to monitor the outcomes of the lawsuits and the potential impact on future pharmaceutical practices.

If you have been injured by Tepezza, it is important you act quickly to protect and preserve your rights. You may be entitled to significant compensation. Contact our firm today at (800) 403-6191 or complete the form on this page to learn more.

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