Introduction To The Tepezza Litigation – MDL 3079

by Robert Wilson | Last updated Jun-26-23

Understanding the Tepezza Litigation: Hearing Loss Claims and Lawsuit

Tepezza has generated attention by mass tort attorneys for alleged failure to warn about permanent hearing loss and Tinnitus.

“We have hope.”

Have you heard that before? Well, in the realm of medical advancements, the introduction of new drugs often brings a wave of hope for patients suffering from various health complications.

One such drug that provided hope is Tepezza, developed by Horizon Therapeutics.

Tepezza, known generically as teprotumumab-trbw, is an FDA-approved medication designed to alleviate the symptoms of Thyroid Eye Diseas (TED). This ailment is often associated with Graves’s disease and can cause a range of distressing symptoms, including eye pain, double vision, light sensitivity, and even vision loss.

Tepezza is administered intravenously and works by reducing inflammation and expansion of muscle and fat tissue behind the eye, which are characteristic of TED.

However, hope for patients suffering from TED and its effects has been dimmed by a series of alarming reports linking the drug to permanent hearing loss, partial hearing loss, and related side effects. This revelation has led to a surge of legal actions against the manufacturer.

In fact, on June 2, 2023, the Judicial Panel on Multidistrict Litigation (JPML) consolidated cases against Horizon to the Northern District of Illinois and will be presided by Judge Thomas M. Durkin.

II. What is the Basis for Tepezza Lawsuits?

Plaintiffs from the Tepezza lawsuit contend that Horizon Therapeutics failed to fully disclose these possible hazards to patients and medical professionals.

Litigation against Horizon Therapeutics primarily revolves around the company’s alleged failure to provide sufficient warning about the potential side effects of Tepezza.

The drug has been linked to hearing complications, the most serious being permanent hearing loss and Tinnitus. Plaintiffs argue that Horizon Therapeutics did not adequately inform patients and healthcare providers about these potential risks.

Plaintiffs’ claims are ground in principles of product liability law, which holds manufacturers responsible for the safety of their products. The plaintiffs also argue that the company was negligent in its testing and research procedures, which should have identified these risks.

The severity of the alleged side effects further strengthens the basis for litigation.

These side effects have profoundly impacted patient’s quality of life leading to the following

• Emotional distress
• Loss of enjoyment of life
• Financial burdens due to medical expenses

Plaintiffs argue that had they been appropriately informed about these risks, they could have made an informed decision about whether to use Tepezza or seek alternative treatments.

III. What are the injuries related to this claim?

Medically speaking, the primary injury associated with Tepezza is called ototoxicity, a condition characterized by damage to the inner ear or auditory nerve, leading to temporary or permanent hearing loss. This can manifest as Tinnitus (ringing in the ears), vertigo (a sense of spinning), or balance issues. The severity of these symptoms can vary widely among patients, from mild discomfort to debilitating conditions that significantly impair daily functioning. Ototoxicity is particularly concerning because it can occur even at therapeutic doses of Tepezza. Here is the kicker: once the damage is done, it is often irreversible.

In addition to ototoxicity, patients may also experience hyperacusis, an increased sensitivity to particular frequency and volume ranges of sound, which can lead to pain or discomfort. This can make everyday sounds, such as the hum of a refrigerator or the sound of a conversation, unbearably loud or even painful. Hyperacusis can be particularly distressing, as it can limit a person’s ability to participate in normal social activities and lead to social isolation. Furthermore, the psychological impact of these auditory injuries should not be underestimated, as they can lead to anxiety, depression, and a decreased quality of life.

Below is a look at categorical injury types law firms may focus when pursuing these claims.

Patients using Tepezza have experienced reduced hearing ability, ranging from partial to permanent hearing loss.

A. Partial or Permanent Hearing Loss:

Many patients have reported a noticeable decrease in their ability to hear after using Tepezza. For some, this reduction in hearing ability is partial, affecting only certain frequencies or volumes. However, hearing loss may be more severe for others, leading to a complete inability to perceive sound. This permanent hearing loss can drastically alter a patient’s life, impeding their ability to communicate effectively, engage in social activities, and navigate their environment safely and independently.

b. Tinnitus:

Tinnitus occurs when a person hears persistent ringing, buzzing, or hissing sounds in the ears. This phantom noise can be incredibly distressing for patients, ranging from a low roar to a high squeal. It can disrupt sleep, concentration, and overall peace of mind, leading to significant distress and decreased quality of life.

c. Sensorineural Hearing Loss:

Sensorineural hearing loss involves damage to the inner ear or the nerve pathways that carry sound from the ear to the brain. This hearing loss is particularly concerning because it is often irreversible. Patients with this condition may struggle with understanding speech, particularly in noisy environments, and may find that sounds are muffled or distorted.

d. Patulous Eustachian Tube Dysfunction:

Patulous Eustachian Tube Dysfunction is characterized by abnormal patency of the Eustachian tubes, which are responsible for equalizing pressure in the middle ear. Symptoms can include a sensation of echoing, fullness, or other auditory disturbances, which can be highly uncomfortable and disorienting. Patients may also experience autophony, where they hear their voice or breathing sounds amplified, which can be particularly distressing.

e. Hyperacusis (Increased Sensitivity to Sound):

Some patients have reported a heightened sensitivity to sound, a condition known as hyperacusis. This can make everyday environments, such as busy streets or crowded restaurants, unbearable. Even moderate or low-level sounds can be perceived as excessively loud or painful, leading to social isolation and significantly reduced quality of life.

f. Aural Fullness (Sensation of the Ears Feeling Full or Plugged):

Aural Fullness can lead to discomfort and difficulties with balance and spatial orientation. Patients may describe a sensation of pressure or fullness in the ear, similar to the feeling experienced during changes in altitude. This can be particularly problematic and interfere with daily activities and overall comfort.

g. Other Auditory Complications:

In addition to the above ailments, patients may experience various auditory symptoms. These can include difficulty understanding speech, especially in noisy environments; a decreased ability to hear high-frequency sounds and; auditory processing disorders. These issues can make it challenging for patients to engage in conversations, enjoy music or other auditory experiences, and lead to frustration and social isolation.

IV. Who is Horizon Therapeutics?

Horizon Therapeutics is a biopharmaceutical firm dedicated to discovering, creating, and marketing drugs for patients suffering from rare and rheumatic diseases. However, the issue over Tepezza is currently obscuring the company’s reputation for innovation.

Horizon Therapeutics considers itself to be a globally recognized biopharmaceutical company that has made significant strides in the medical field. The company primarily focuses on researching, developing, and commercializing innovative medicines aimed at transforming and improving lives. Their portfolio is diverse, particularly emphasizing rare diseases, rheumatology, and primary care.

The company claims to be instrumental in developing groundbreaking treatments for previously underserved or overlooked conditions. Their commitment to addressing unmet medical needs has led to the creation of several novel therapies that reportedly has changed the treatment landscape in their respective fields. According to Horizon Therapeutics, this dedication to innovation and patient care has positioned the company as a leader in the biopharmaceutical industry.

However, the company’s reputation for innovation is currently overshadowed by the controversy surrounding Tepezza, one of its most notable products. This has led to a wave of legal claims against the company, casting a shadow over their previous accomplishments and raising questions about their commitment to patient safety.

V. What types of damages may be included?

Patients who have suffered the adverse effects of these auditory complications, ranging from mild hearing loss to profound deafness, may be eligible to claim a broad spectrum of damages. These damages, often a critical component of legal proceedings, are designed to provide financial relief for the hardships that have emerged as a direct result of patients hearing impairments.

These hardships are not limited to the physical realm, such as the discomfort and inconvenience of hearing loss or the side effects of treatments. They also extend to the emotional sphere, where patients may grapple with frustration, anxiety, and depression due to their altered sensory experience and its impact on their daily lives. The psychological toll can significantly affect personal relationships, self-esteem, and overall mental well-being.

A. Past and Future Medical Expenses:

Hearing complications causes financial burden of past and future medical treatments, therapies, and essential assistive devices for managing hearing issues.

This category of damages covers the financial strain of medical treatments and therapies that the patient has already received and those that will be necessitated in the future due to the progression or persistence of the hearing issues. It also incorporates the cost of essential assistive devices, such as hearing aids or cochlear implants, required to manage hearing complications. The financial implications can be substantial, especially if the auditory difficulties are severe or require long-term management.

B. Pain and Suffering, Mental Health Effects:

Hearing complications, along with the resulting emotional turmoil and mental health repercussions, significantly impact a patient’s quality of life.

The emotional turmoil induced by these hearing complications can be substantial. This turmoil, coupled with the associated mental health repercussions such as anxiety and depression, can drastically affect a patient’s quality of life. This category of damages is intended to compensate for the emotional and psychological suffering endured by the patient.

C. Lost Wages:

Auditory complications can hinder a patient’s work ability, requiring time off for medical appointments and impacting job performance, leading to lost wages.

Auditory complications can impede a patient’s ability to work by necessitating time off for medical appointments and recovery. Plus, it can impair job performance. In these cases, prospective claimants may be eligible for compensation for lost income. This can encompass both past and future earnings, if the patient’s capacity to work continues to be affected.

D. Loss of Enjoyment of Life:

Hearing complications affect a patient’s ability to engage in and enjoy their regular activities.

The impact of these hearing complications on a patient’s ability to engage in and enjoy their usual activities and hobbies can be profound. This category of damages is intended to compensate for the diminished quality of life that results from a person being unable to participate in activities that were once a source of pleasure and fulfillment.

E. Permanent Disability:

Permanent hearing loss and other complications causes loss of future opportunities resulting from permanent disability.

In severe cases where permanent hearing loss has occurred, patients may be eligible for compensation for the life-altering impact of this disability. This can include the costs of long-term care and support for the profound changes to the patient’s lifestyle. This category of damages also aims to provide financial relief for the loss of future opportunities resulting from the permanent disability.

Final Words

In conclusion, the introduction of Tepezza by Horizon Therapeutics, initially hailed as a significant advancement in treating Thyroid Eye Disease (TED), has been marred by reports of severe auditory side effects.

The company’s alleged failure to adequately warn patients and healthcare providers about these potential risks has led to a surge of legal actions. The plaintiffs, who have experienced a range of auditory complications, argue that this lack of information prevented them from making an informed decision about their treatment.

The failure of Horizon Therapeutics to adequately warn patients and healthcare providers of these potential side effects has led to unexpected and often severe complications. As a result, numerous patients are now seeking legal recourse to obtain compensation for the physical, emotional, and financial hardships they have endured.

The litigation against Horizon Therapeutics is grounded in product liability law, with the plaintiffs claiming that the company breached its duty of care. The severity of the alleged side effects, which have profoundly impacted the patient’s quality of life, strengthens the basis for these legal actions. The controversy surrounding Tepezza has cast a shadow over Horizon Therapeutics’ regarding its supposed commitment to patient safety.

The goal of mass tort attorneys is to ensure that these patients receive the justice they deserve. They must continue to scrutinize the actions of pharmaceutical companies like Horizon Therapeutics and hold them accountable for any negligence and lack of transparency. When Big Pharma puts profits over lives, mass torts like the Tepezza Litigation are selected as MDLs to provide justice to large numbers patient-victims whose claims are grounded in the same questions of fact.