Tepezza Lawsuit: A Comprehensive Guide (2024)

What is the Tepezza Lawsuit? (2024)

Tepezza, also called teprotumumab, fights a rare autoimmune disorder called thyroid eye disease. This condition causes eye inflammation and bulging, leading to discomfort and vision problems. If not treated, it can even cause blindness.

Horizon Therapeutics, PLC makes and sells Tepezza. It's a special medicine infused into the body. This drug, made from living things, targets and blocks parts of the immune system causing thyroid eye disease.

Tepezza blocks insulin-like growth factor-1 receptors (IGF-1R). In thyroid eye disease, these receptors are too active, causing too many fibroblasts. This leads to the disease's symptoms.

Patients get Tepezza through IV infusions every three weeks for about five months. A nurse usually gives the treatment in a clinic.

At present, Tepezza is the sole FDA-approved remedy for thyroid eye disease, a noteworthy achievement in medicine. Of course, that means you had no other options when seeking treatment for thyroid eye disease.

Despite its success for many, Tepezza has associated risks, notably alleged permanent hearing loss and ringing in the ears. These side effects have led to lawsuits against Horizon Therapeutics.

The Tepezza Warning Label

Following growing concerns, the manufacturer of Tepezza included a warning label on the medication in 2023, stating the following:

“Hearing Impairment Including 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.”

Despite this warning, many patients had already taken the medication since its FDA approval in January 2020.

Patients started experiencing hearing problems shortly after the FDA approval, leading to Tempezza lawsuits.

Does Tepezza Cause Hearing Loss?

According to the FDA, the answer is yes — Tepezza can cause hearing loss.

The FDA now warns that Tepezza (teprotumumab) could cause severe hearing problems, possibly leading to permanent loss. And it’s not just straight hearing loss; the drug may lead to other hearing-related problems, such as the following:

• Muffled hearing

• Feeling like ears are blocked

• Heightened sensitivity to sound

• Hearing your own voice and breath loudly

This isn’t a new warning from the FDA. But now, it seems that the initial warning might not have captured the full severity of the hearing loss risks. A recent study suggested that more patients might face hearing symptoms from Tepezza than initially thought.

How a Tempezaa Might Proceed

Due to the high number of Tepezza users experiencing hearing issues, they may combine their cases.

This can happen in a few ways. One way is through a class action, grouping many cases together. Alternatively, cases can be consolidated in multidistrict litigation (MDL), where several cases are overseen by one judge.

Tepezza plaintiffs have already moved for MDL consolidation, and the U.S. Judicial Panel on Multidistrict Litigation issued a transfer order in June 2023, merging pending lawsuits in the Northern District of Illinois.

Once combined, pretrial proceedings occur, where the judge addresses common issues. As the MDL is relatively new for Tepezza, not many pretrial actions have happened yet.

There are currently over 59 pending cases in the consolidated MDL as of December 2023. More plaintiffs may join in federal court filings, while some may pursue claims in state court.

During MDL, bellwether trials are scheduled with representative plaintiffs to gauge case outcomes. This informs settlement talks, where defendants may offer a settlement split among all plaintiffs involved in the mass tort case, depending on trial results.

Tepezza Side Effects: Hearing Loss

The auditory complications associated with Tepezza use are concerning, particularly because of their potentially permanent nature. It's important to understand these symptoms, as early detection could be key in preventing further damage.

Subjective Hearing Loss

This is one of the most commonly reported side effects. Patients perceive a decrease in their hearing ability, which can range from slight muffled sounds to a significant reduction in auditory perception. The distress caused by this loss can be immense, impacting daily routines and quality of life.

Tinnitus

This symptom is characterized by a persistent ringing, buzzing, or hissing sound in one or both ears, even in the absence of external sound. Tinnitus can be extremely distressing, affecting concentration, sleep, and mental health. In some cases, tinnitus can be a precursor to more severe hearing loss.

Ear-Plugging Sensation

Many patients report a sensation akin to their ears being blocked or plugged. This can cause discomfort and a feeling of pressure, as well as contributing to the perception of hearing loss.

Autophony

This is the perception of one's own voice being unusually loud or echoing in their ears. This can be a symptom of a patulous Eustachian tube, a condition in which the Eustachian tube remains open, causing sounds to be transmitted directly into the ear canal.

Total Deafness

In severe cases, patients have reported total deafness in one or both ears. This is the most devastating potential consequence of the hearing loss associated with Tepezza. The inability to hear properly can lead to isolation, anxiety, and depression. It can also interfere with a person's ability to work, enjoy social interactions, and carry out everyday activities.

Given the severity of these potential symptoms, it's essential that anyone experiencing them after undergoing treatment with Tepezza seek medical advice immediately. Moreover, if you or a loved one has experienced these symptoms following Tepezza treatment, you should file a claim with the help of ConsumerShield.

Other Tepezza Side Effects

Tepezza, while hailed as a groundbreaking treatment for thyroid eye disease, is also associated with a range of side effects. These side effects range from relatively minor to severe, and have been reported in varying degrees by those undergoing treatment.

Minor side effects may include muscle cramps, nausea, hair loss, or changes in taste. However, it's the severe side effects that have raised significant concerns and are at the heart of the ongoing Tepezza lawsuits. The most alarming of these side effects is the potential for permanent hearing loss and associated auditory complications.

A study reported by the Endocrine Society suggested that up to 65% of patients receiving Tepezza infusions experienced hearing-related side effects. These included subjective hearing loss, where the patient perceives a decrease in their hearing ability. Tinnitus, a persistent ringing or buzzing in the ears, was also reported by many patients. Other auditory disturbances included an ear-plugging sensation and autophony, where the patient's own voice sounds unusually loud to them.

These hearing-related side effects can be indicative of underlying damage to the inner ear labyrinth. This damage can lead to conditions such as sensorineural hearing loss, where the hair cells in the inner ear, responsible for transmitting sound to the brain, are damaged. Another potential consequence is patulous Eustachian tube, a condition where the Eustachian tube, which links the middle ear to the back of the nose and throat, stays open. This can result in symptoms like autophony.

What's particularly concerning is that these side effects aren't always temporary. There are reports of patients who have experienced ongoing or permanent hearing loss, tinnitus, and related issues following Tepezza treatment.

This connection between Tepezza and permanent hearing loss is the central focus of the ongoing lawsuits against Horizon Therapeutics, the manufacturer of Tepezza. As these legal actions unfold, a vital question remains: Were patients and healthcare professionals adequately warned about these potential risks before starting treatment with Tepezza? This question is at the heart of the current legal action, as we will discuss further in this article.