Tepezza Lawsuit | Tepezza Hearing Loss Lawsuit

Tepezza Hearing Loss Lawsuit Overview

Tepezza is a prescription the U.S. Food and Drug Administration approved to treat thyroid eye disease.

Although initial trials showed the effectiveness of the medication, additional studies found a link to hearing loss, tinnitus, and similar medical conditions.

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You may qualify to file a Tepezza Lawsuit if you experienced hearing-related problems after taking Tepezza.

Contact TruLaw for an instant case evaluation immediately to see if you qualify for a Tepezza Hearing Loss Lawsuit in as little as 60 seconds!

You might be entitled to compensation from the manufacturer for the harm you’ve suffered and losses you’ve incurred.

Table of Contents

Lawsuit Updates

  • February 2024 Updates:

    February 2nd, 2024:

    The Tepezza hearing loss class action MDL has maintained its sluggish pace since its inception six months ago.

    Within this timeframe, only 33 new cases have been added to the Tepezza MDL. Notably, in the past month, no new cases have been introduced into the MDL, further highlighting the ongoing slow start of the litigation.

  • January 2024 Updates:

    January 31st, 2024:

    The next status hearing for the MDL is scheduled for March 6, 2024. This hearing will likely play a crucial role in determining the future direction and pace of the litigation.

    January 15th, 2024:

    Over the past month, three additional cases alleging hearing loss related to Tepezza have been added to the ongoing class action MDL. This brings the total number of cases within the Tepezza MDL to 74, with one additional case, Ingram v. Horizon, filed in 2024, which makes the true count 75. Despite the growing number of cases, legal experts suggest that this MDL might not balloon into massive litigation, potentially expediting settlements and offering better outcomes for affected individuals.

    January 9th, 2024:

    Attorneys involved in the Tepezza hearing loss litigation have jointly requested a 60-day extension from the presiding U.S. District Judge. This extension is sought to allow for a thorough review of medical records and critical documents, crucial for selecting cases for the Initial Bellwether Discovery Pool. The outcomes of these test trials will significantly impact settlement amounts, underscoring the importance of accurate case selection.

    January 8th, 2024:

    Despite the six-month consolidation of litigation before Judge Thomas Durkin, progress within the MDL has been notably slow. Plaintiffs’ attorneys are actively pushing for advancement, opposing Horizon’s attempts to delay case management conferences. These conferences serve as vital platforms for resolving disputes and advancing litigation. Plaintiffs argue that any delay only prolongs the already sluggish pace of the MDL, urging for continued momentum and judicial intervention.

    January 1st, 2024:

    The last week of 2023 saw no activity within the Tepezza hearing loss class action MDL, signaling a period of relative inactivity in the legal proceedings.

  • December 2023 Updates:

    December 18th, 2023:

    Over the past month, 12 new cases have been added to the Tepezza hearing loss class action MDL, increasing the total number of cases to 71. This represents a significant surge compared to the previous month and signaling a rise in case filings.

    December 1st, 2023:

    A new plaintiff in the Tepezza MDL from Florida recently emerged. According to the complaint, she underwent Tepezza infusions for thyroid eye disease spanning from August 2022 to April 2023.

    Following her final Tepezza infusion, she contends that she experienced permanent hearing loss and tinnitus (ringing in the ears), as outlined in her Complaint. Alleging negligence on the part of Horizon Therapeutics, the lawsuit claims the company failed to adequately warn both the plaintiff and her doctor about the potential risk of hearing damage associated with Tepezza.

  • November 2023 Updates:

    November 8th, 2023:

    Defendant Horizon Therapeutics USA, Inc. sought to dismiss Cynthia Williams’s complaint, arguing preemption under Federal Rule of Civil Procedure 12(b)(6).

    The central question revolved around whether federal law preempts pre-approval design defect claims.

    Williams alleged that her hearing loss and tinnitus were a result of the drug’s design.

    The Court’s verdict stated that Williams’s pre-approval design defect claims are not preempted. 

    The reasoning was that Horizon had the ability to create a safer product before seeking FDA approval without conflicting with federal requirements. 

    It was determined that Horizon had control over the drug’s design prior to FDA approval, thus indicating no conflict between federal and state laws.

    However, the Court did grant the dismissal of Williams’s post-approval design defect claims on preemption grounds.

    The question of whether her design defect claims should be dismissed on other grounds was left unaddressed in this opinion.

    The Court emphasized that the debate over the application of Virginia or Illinois law was irrelevant to the preemption argument since federal law did not dictate the drug’s design prior to seeking FDA approval.

    The decision referred to similar cases where pre-approval design defect claims were not preempted and contrasted them with a Sixth Circuit decision that reached different conclusions, explaining why it found the latter unpersuasive.

    The Court also underscored that Horizon’s argument, suggesting that the biologic drug Tepezza was incapable of redesign, required further examination through discovery and was distinct from the preemption question.

    The Court allowed the pre-approval design defect claims to proceed, reasoning that the defendant had control over the drug’s design before seeking FDA approval and could have designed a safer product without violating federal regulations. 

    This ruling favored Williams by permitting her pre-approval design defect claims to continue while dismissing the post-approval claims.

    November 3rd, 2023:

    In the Tepezza hearing loss class action MDL, the judge has issued a Case Management Order outlining rules for selecting bellwether cases and conducting trials. A total of 12 bellwether candidates will be chosen in 60 days. Each side will pick 4 cases, and the remaining 4 will be randomly selected. These 12 cases will then proceed to a fact-discovery process.

  • October 2023 Updates:

    October 27th, 2023:

    An important status conference within the Tepezza MDL, initially set for October 12th, 2023, has been rescheduled to October 19th, 2023.

    During this conference, Judge Durkin is expected to offer guidance on electronic discovery procedures and address initial disputes between the involved parties regarding discovery regulations.

    It’s worth noting that all legal representatives are required to attend this hearing in person.

    October 2nd, 2023:

    An important status conference in the Tepezza MDL is scheduled for October 25, 2023. During this conference, Judge Durkin will address electronic discovery protocols and address initial disputes between the parties concerning discovery rules.

    Notably, all counsel are mandated to attend the hearing in person, indicating its importance in shaping the course of the lawsuit.

  • September 2023 Updates:

    September 18, 2023:

    This week, the number o pending cases has increased from 41 in June to 54, marking a relatively modest rise.

    September 11th, 2023:

    Amgen Inc., a prominent global biopharmaceutical firm, has successfully brokered an agreement with the FTC, allowing it to proceed with its $27 billion acquisition of Horizon Therapeutics, the producer of Tepezza.

    September 8th, 2023: 

    A status hearing took place in the class action lawsuit today wherein Tepezza’s legal team received instructions to submit a proposed agreed order addressing matters related to 502(d) and privileged materials.

    They were also instructed to submit a protective order to the Court, with the intention of enabling Horizon’s attorneys to share documents and information during the discovery process while preserving their attorney-client privilege and work-product protection.

    September 1st, 2023: 

    Plaintiffs in the class-action MDL are pressing for a speedy schedule to reach the initial round of bellwether trials. According to the proposed bellwether schedule put forth by plaintiffs’ lawyers and discussed at a recent status conference, each side would pick three potential bellwether cases, subjecting them to a brief, 150-day case-specific discovery phase.

    Following this, three out of the six lawsuits would be chosen for the first set of test trials. In contrast, Horizon Therapeutics’ defense counsel has proposed a larger pool of 10 cases for bellwether discovery.

  • August 2023 Updates:

    August 18th, 2023:

    A new Tepezza lawsuit, Mhamdi v. Horizon Therapeutics USA, Inc., was recently filed in MDL by a Florida woman who claims to have suffered severe injuries, including permanent hearing loss and tinnitus, due to Tepezza infusions.

    The plaintiff, who was diagnosed with thyroid eye disease and/or Graves’ Disease, received these infusions from August 2020 to February 2023. The lawsuit alleges that neither the plaintiff nor her physicians were provided with any warnings or knowledge about the potential serious risks of permanent hearing loss or tinnitus associated with Tepezza.

    August 15th, 2023:

    In the past month, five additional hearing loss cases related to Tepezza have been moved into the recently established Tepezza class action MDL. This development has increased the total number of pending cases to 46 in an MDL that has been in existence for only three months.

  • July 2023 Updates:

    July 1st, 2023:

    Judge Durkin held the first class action MDL status conference on June 28th.

    The meeting brought together all parties and their attorneys to allow the judge to outline his strategy for effectively managing the lawsuits.

    Moreover, Judge Dirken clarified the process for selecting lawyers to serve on the plaintiffs’ steering or executive committee.

  • June 2023 Updates:

    June 16th, 2023:

    U.S. District Judge Thomas Durkin recently issued a case management order in the Tepezza hearing damage MDL, scheduling the first status conference for June 28.

    The conference will address the allowance of consolidated complaints involving multiple plaintiffs, potential evidence preservation orders, and the appointment of Tepezza lawyers to leadership positions.

    Although Judge Durkin stated the final appointment of attorneys won’t take place until after the conference, he assured a decision can be expected promptly afterward.

    June 12th, 2023:

    A group of Tepezza attorneys filed a motion suggesting a list of attorneys including three co-lead counsel, one liaison counsel, and an executive committee comprising eight individuals, to take on leadership roles in the MDL case.

  • May 2023 Updates:

    May 8th, 2023:

    The number of Tepezza hearing loss lawsuits being filed nationwide has significantly risen in the past six weeks.

    Initially, there were only 18 pending cases across five federal districts when a motion for MDL consolidation was filed in March.

    However, since then, seven additional Tepezza hearing loss lawsuits have been filed in federal courts across the country.

    The Judicial Panel on Multidistrict Litigation (JPML) is scheduled to review the possibility of creating a new class action MDL at the end of this month.

    May 11th, 2023:

    Horizon Therapeutics, the manufacturer of Tepezza, has filed a motion opposing the consolidation of Tepezza cases into an MDL.

    Horizon argues that an MDL is unnecessary due to the limited number of pending cases and optimistically suggests that future Tepezza lawsuits will be few.

    The JPML is set to hold a hearing on May 25, 2023, to determine whether the Tepezza cases in federal courts should be consolidated into a class action MDL.

  • April 2023 Updates:

    A new case study from Stanford University found that hearing loss is linked to dosage levels of Tepezza injections.

    The study focused on a 64-year-old woman who experienced hearing loss in both ears after a full round of Tepezza injections.

    However, when she was taken off the injections, her hearing problems went away.

    When she tried a lower dose a year later, she did not experience the same hearing loss.

    This case study strengthens the evidence of a direct connection between Tepezza and hearing loss.

  • March 2023 Updates:

    There have been four new lawsuits filed alleging the permanent hearing damage caused by Tepezza injections.

    Out of the 34 cases filed in federal courts, there have been 13 voluntary dismissals.

    These dismissals indicate that there may have been settlements.

  • February 2023 Updates:

    February 14th, 2023:

    Horizon Therapeutics filed a motion to dismiss the Tepezza hearing loss claims against it under the doctrine of federal preemption, arguing that the tort claims asserted by the Tepezza plaintiffs are preempted by federal law because the FDA regulated Horizon’s ability to change the warning label for Tepezza.

    February 16th, 2023:

    Nine Tepezza product liability lawsuits have been filed in federal courts, with the most recent being Diaz v. Horizon Therapeutics USA Inc. filed on February 14, 2023.

    The plaintiff suffered permanent hearing loss and tinnitus after receiving Tepezza infusions and the complaint alleges that Horizon was aware of the drug’s potential for hearing loss.

  • January 2023 Updates:

    A motion to consolidate Tepezza Lawsuits into multidistrict litigation (MDL) has been filed on behalf of ten individuals who have suffered from hearing loss after taking Tepezza.

    Attorneys representing the claimants have requested that all Tepezza Hearing Loss claims be consolidated before one judge in the U.S. District Court for the Northern District of Illinois.

    Tepezza lawsuits allege that Horizon Therapeutics knew or should have known about the risk of hearing loss from Tepezza, but failed to fully test the treatment and provide adequate warnings to users and the medical community.

    Horizon has objected to the consolidation request, stating that the cases involve different facts and defenses that would not benefit from coordinated pretrial proceedings.

    The number of Tepezza hearing loss lawsuits is expected to grow in the coming months as more patients discover that their hearing damage was caused by the drug.

    Contact us for a free consultation, or use the chatbot on this page to see if you qualify for a Tepezza Lawsuit instantly.

How Tepezza Works

Tepezza is the brand name for teprotumumab-trbw.

It’s a prescription medication for treating thyroid eye disease (TED).

TED damages tissue around the eye and causes symptoms similar to Graves’ disease, an autoimmune disorder.

Progressive swelling, inflammation, and tissue changes lead to various symptoms, including pain, double vision, and watery eyes.

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The drug doesn’t only manage TED symptoms.

It treats the disease at the source by blocking autoantibodies responsible for activating essential receptors affecting the eyes.

It helps to decrease inflammation, prevent tissue expansion behind the eye, and prevent muscle and fat tissue remodeling.

FDA Approval for Tepezza

The FDA granted Tepezza approval to Horizon Therapeutics for thyroid eye disease treatment on January 21, 2020.

The drug was one of the first of its kind approved to treat the medical condition.

Tepezza received Orphan Drug designation from the FDA, an incentive to encourage and assist in developing drugs for rare conditions or diseases.

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The development of the medication also received support from the FDA Orphan Products Grants Program.

The program provides grants to companies for clinical studies on the efficacy and safety of products used for rare conditions or diseases.

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The most common side effects listed on the original warning labels were:

  • Dry skin
  • Diarrhea
  • Muscle spasm
  • Hair loss
  • Change in taste
  • Nausea
  • Headache
  • Fatigue
  • High blood sugar

Tepezza labels also included serious side effects, such as:

  • Worsening inflammatory bowel disease
  • Infusion reactions
  • High blood sugar

However, when the drug first hit the market, hearing loss and other hearing-related conditions were not listed on the labels.

Can Tepezza Cause Hearing Loss?

Initial studies showed significant improvement in double vision, proptosis, quality of life, and soft tissue inflammation in patients with moderate to severe TED.

Only ten percent of patients reported hearing loss symptoms and were able to reverse the effects after stopping the medication.

However, an Endocrine Society study conducted in March 2021 found a risk of hearing loss as high as 65 percent.

During the study, 26 patients received Tepezza four times a day.

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After taking the drug, the primary symptoms experienced include:

  • Subjective hearing loss – 23 percent of patients
  • Ringing in the ears – 27 percent of patients
  • A feeling of plugged ears – 12 percent of patients
  • Hearing their own voice more loudly than normal – 29 percent of patients

Of the participants in the study, three developed patulous eustachian tube dysfunction, a disorder causing the eustachian tube valve to stay open, distorting the sound of a person’s voice.

Common Complications of Tepezza

TED is a debilitating disease.

Adding the component of hearing issues can significantly reduce a person’s quality of life.

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The most common complications reported after taking Tepezza include:

  • Increased sensitivity to sound
  • A sensation of the ears feeling full or plugged
  • Hearing loss
  • Sounds seeming muffled
  • Tinnitus
  • Eustachian tube dysfunction, a condition that blocks the tubes connecting the middle ears to the upper throat

Horizon Therapeutics Failed to Warn Consumers of Hearing Loss

Horizon didn’t disclose the risk of hearing loss on Tepezza warning labels.

Failure to warn is a type of defect in product liability cases.

It occurs when a manufacturer knows about a possible risk of its drug but doesn’t include it on the warning label or packaging.

Your doctor might not be at fault for prescribing the drug to you if they weren’t aware of the dangers.

You can hold the manufacturer liable for your hearing loss and related expenses, such as medical treatment and out-of-pocket costs.

Two options for pursuing compensation are a product liability claim and a mass tort lawsuit.

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You can file a claim with the manufacturer’s liability insurance company in a product liability claim.

You don’t assert that the drug has physical flaws in a claim based on failure to warn.

Instead, you must establish the manufacturer knew about the adverse effects but didn’t provide adequate warning labels.

You must also prove the defect contributed to your injury.

Mass tort cases involve a large group of people harmed by the same defendant’s actions.

A mass tort lawsuit combines cases from multiple plaintiffs into a single legal action.

You participate in a mass tort by working with others on similar aspects of the case that apply to everyone.

If any element of your case differs from the rest of the group, such as the severity of your injury, you and your lawyer work on that part separately.

Who Is Eligible to File a Tepezza Lawsuit?

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You might be eligible for a lawsuit against Horizon Therapeutics if you:

  • Received at least one round of Tepezza or teprotumumab injections
  • Experienced tinnitus, hearing loss, or another complication of the medication

It’s crucial to remember that taking Tepezza isn’t enough to qualify for a mass tort lawsuit or product liability case.

You must have a hearing-related issue that did not develop before taking the drug.

Compensation for Hearing Loss from Tepezza

You can seek compensation pursue compensation in a mass tort case for economic and non-economic losses.

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Economic losses are expenses associated with an injury, such as:

  • Medical devices, surgery, prescriptions, and other medical treatment
  • Lost wages
  • Lost earning capacity
  • Out-of-pocket expenses
  • Costs of paying for daily assistance, such as household work and transportation

Non-economic losses are the intangible effects of an injury, such as:

  • Pain and suffering
  • Loss of enjoyment of life
  • Emotional distress
  • Inconvenience

You might also be able to recover punitive or exemplary damages.

This financial award punishes the defendant for their actions.

To be awarded these damages, you must show clear and convincing evidence of the manufacturer’s gross negligence or egregious behavior.

Statutes of Limitation on Tepezza Lawsuits

Whether you file a product liability or mass tort lawsuit, you must comply with the laws in your state.

Most statutes of limitation allow a one-year to a five-year timeframe to file a lawsuit against a party that injured you.

That means you must initiate your lawsuit within the required timeframe to pursue compensation for your injury.

How a Tepezza Hearing Loss Lawyer Can Help

Pursuing legal action without hiring an attorney can decrease your chance of receiving full and fair compensation.

Handling a claim or lawsuit is complicated, especially when it involves a large manufacturing company.

Horizon Therapeutics has the resources to hire an aggressive and experienced legal team to defend them in a mass tort or product liability case.

You need an experienced defective drug lawyer to guide and support you through every step of the legal process.

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Your attorney can handle all of the legal legwork of your case, such as:

  • Determining the available insurance coverage
  • Investigating the circumstances of your case
  • Gathering evidence to prove the drug caused your medical condition
  • Filing a claim and negotiating a settlement with the insurance company
  • Preparing and filing a lawsuit against the manufacturer
  • Representing you during legal proceedings, including discovery, medications, and the trial

Speak to a Dedicated Tepezza Lawyer Today

If you suffer from tinnitus, hearing loss, or another adverse effect of Tepezza, find out if you have a case by filling out our Instant Case Evaluation Form right now.

Our goal will be to help you get the compensation you need so you can focus on your recovery.

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Written By:
Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

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