Tepezza Lawsuit | 2024 Latest Updates

If you or a loved one experienced hearing loss, tinnitus, or other auditory issues following Tepezza treatment for Thyroid Eye Disease, you may be entitled to pursue compensation. At Schmidt&Clark, we are dedicated to helping individuals who have suffered due to undisclosed side effects of this medication. Our experienced legal team is here to guide you through the process and fight for the compensation you deserve. Contact Schmidt&Clark today for a free, no-obligation consultation.

Tepezza Lawsuit Overview

Tepezza lawsuits focus on allegations that Horizon Pharmaceuticals failed to adequately warn patients and healthcare providers about serious side effects, particularly permanent hearing loss and tinnitus. The first lawsuit was filed in the U.S. District Court for the Northern District of Illinois, with the plaintiff claiming the manufacturer withheld crucial data about hearing risks during the FDA approval process. Multiple patients are reporting severe and potentially irreversible hearing issues after Tepezza treatment, with studies showing up to 65% of users experiencing auditory problems.

Latest Tepezza Lawsuit Updates

2022 – Daniel Weibel filed the first Tepezza lawsuit against Horizon Pharmaceuticals Inc. in the U.S. District Court for the Northern District of Illinois (case number 1:22-cv-04518), alleging the company failed to warn about risks of permanent hearing loss and tinnitus associated with the thyroid eye disease medication [1].

FDA Reports and Statistics

According to FDA reports, approximately 10% of patients included in a 19-month analysis (January 2020 – August 2021) reported hearing-related events after Tepezza treatment [2]. The most frequently reported hearing event was hypoacusis (reduction in hearing), followed by tinnitus (ringing in the ears). The mean age of affected patients was 59.3 years.

Alarming Tepezza Hearing Loss Statistics

• 65% of Tepezza users develop hearing problems
• 27% experience tinnitus
• 23% suffer from hearing loss
• 29% report developing autophony
• Average Onset: Symptoms typically manifest after an average of 3.6 infusions.

These findings come from a comprehensive Stanford University study and highlight the significant risks associated with Tepezza treatment for Thyroid Eye Disease (TED).

What is Tepezza?

According to the U.S. Food and Drug Administration notice published in 2022, Tepezza (generic: teprotumumab) is used to treat thyroid eye disease, which can cause eyes to be dry, watery, or red, and can cause eyes to bulge and cause double vision, as well as other vision problems [3].

The drug is injected once every 3 weeks until patients have received 8 infusions total. Tepezza was approved by the FDA in January 2020 and is made by Horizon Pharmaceuticals.

Tepezza Injuries & Side Effects

Tepezza (teprotumumab) has been linked to a range of side effects, from mild discomfort to severe and potentially permanent complications affecting the auditory system.

Severe Side Effects:

• Hearing Loss: 23% of patients in studies reported permanent hearing loss, with some diagnosed with sensorineural hearing loss caused by damage to hair cells in the inner ear
• Tinnitus: 27% of patients experience persistent ringing or buzzing in the ears
• Autophony: 29% of patients reported their voices sounding unusually loud to themselves
• Plugged Ear Sensation: 12% of patients experienced this condition

Moderate Side Effects:

• Hyperacusis: Reduction in hearing sensitivity resulting in difficulty understanding conversations
• Worsening of Inflammatory Bowel Disease
• Infusion Reactions
• High Blood Sugar

Mild Side Effects:

• Muscle spasms
• Nausea
• Fatigue
• Hair loss
• Diarrhea
• Dry skin
• Change in taste
• Headache

Among the thousands of patients included in this 19-month analysis (Jan. 2020 – Aug. 2021), approximately 10% of all cases reported to the safety database have included a hearing-related event. The most frequently reported hearing event was hypoacusis (reduction in hearing), followed by tinnitus (ringing in the ears). The mean age of the patient, where known, was 59.3 years. FDA stated.

Do You Qualify for a Tepezza Lawsuit?

You may qualify for a Tepezza lawsuit if:

• You received Tepezza infusions for the treatment of Thyroid Eye Disease
• You experienced hearing-related side effects including hearing loss, tinnitus, autophony, or plugged ear sensation
• Your symptoms appeared during or after Tepezza treatment
• You can provide medical documentation linking your injuries to Tepezza use

Evidence Required for a Tepezza Lawsuit

To strengthen your Tepezza lawsuit, you should gather:

• Medical records confirming your Tepezza treatment
• Documentation of hearing tests before and after Tepezza treatment (if available)
• Medical diagnosis of hearing loss, tinnitus, or other auditory issues
• Records of ongoing treatment for hearing problems

Damages You Can Recover

Potential compensation in a Tepezza lawsuit may include:

• Medical expenses for hearing treatment, devices, and ongoing care
• Lost wages and reduced earning capacity
• Pain and suffering related to hearing loss and its impact on quality of life
• Punitive damages against the manufacturer (if applicable)

Statute of Limitations for Tepezza Lawsuits

The statute of limitations for filing a Tepezza lawsuit varies by state. These time limits determine how long you have to file a claim after discovering your injury. While specific timeframes differ across jurisdictions, most product liability and personal injury claims must be filed within:

• 1-2 years in states with shorter limitations periods
• 2-3 years in states with standard limitations periods
• Up to 6 years in states with more extended deadlines

It’s crucial to understand that the “discovery rule” may apply in some jurisdictions, meaning the statute of limitations clock starts when you discovered (or reasonably should have discovered) that Tepezza caused your hearing problems.

Frequently Asked Questions

What is the basis for the Tepezza lawsuits?

The basis for Tepezza lawsuits typically includes failure to warn about serious side effects, such as hearing loss and tinnitus, inadequate testing before release, and the impact of these side effects on patients’ quality of life and ability to work.

Can I still file a lawsuit if I stopped using Tepezza?

Yes, you can still file a lawsuit if you have stopped using Tepezza, provided you have experienced severe side effects linked to the medication. Consulting with a lawyer can help determine your eligibility based on your circumstances.

Are there any ongoing class action lawsuits for Tepezza?

Yes, there are ongoing class action lawsuits for Tepezza, where multiple plaintiffs with similar claims against the manufacturer can join together. Participating in a class action can streamline the legal process and potentially increase the chances of a successful outcome.

What research supports the connection between Tepezza and hearing loss?

A 2021 study by the Endocrine Society found that 65% of Tepezza patients developed hearing problems, with symptoms typically appearing after an average of 3.6 infusions [4].

How does Tepezza cause hearing loss?

Research suggests that Tepezza’s inhibition of the insulin-like growth factor-1 (IGF-1) pathway, which plays a critical role in auditory function, may be responsible for the hearing damage experienced by patients.

Is there a hearing loss warning on the Tepezza label?

According to the Ophthalmology Times, the original Tepezza warning label indicates in Section 6 that temporary hearing loss occurred in patients during clinical trials [5]. However, the label did not adequately warn that hearing loss might be irreversible.

What is thyroid eye disease?

According to Penn Medicine, thyroid eye disease – also known as Graves’ Orbitopathy, Ophthalmopathy, or simply ‘TED’ – is an autoimmune condition in which the eye muscles, eyelids, tear glands, and fatty tissues behind the eye become inflamed [6]. This can cause the eyes and eyelids to become red, swollen, and uncomfortable, with the eyes potentially pushed forward (‘staring’ or ‘bulging’ eyes).

See all related dangerous drug lawsuits our attorneys covered so far.

Take Action Now: Time-Sensitive Legal Claims

Time is limited to pursue legal action for Tepezza-related hearing damage. Waiting too long to file your claim could permanently bar you from seeking compensation, regardless of how severe your injuries may be.

The Pharmaceutical Litigation Group at Schmidt and Clark, LLP offers:

• Free, confidential consultations for Tepezza victims
• No upfront costs or fees
• Payment only if we win your case

References

1. https://www.ilnd.uscourts.gov/mdl-details.aspx?fnu/YDnD0O7Y8SjpUhHmZA==
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761143s023lbl.pdf
3. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-tepezza
4. https://www.endocrine.org/news-and-advocacy/news-room/featured-science-from-endo-2021/increased-risk-of-hearing-impairment-with-new-thyroid-eye-disease-treatment
5. https://www.ophthalmologytimes.com/view/fda-adds-hearing-loss-and-impairment-warnings-to-tepezza-label
6. https://www.pennmedicine.org/for-patients-and-visitors/find-a-program-or-service/ophthalmology/thyroid-eye-disease-graves-disease