Tepezza Litigation Updates
Teprotumumab has been linked to irreversible hearing damage, yet Horizon Therapeutics PLC, the drug’s producer, neglected to alert both physicians and patients about the potential for enduring hearing impairment. Furthermore, Horizon did not supply doctors with official protocols for audiometric surveillance. The initial legal action has been initiated in the Northern District of Illinois, with anticipation of thousands more to follow.
The inaugural lawsuit against Tepezza was initiated on August 25, 2022, by Daniel Weibel, a patient who suffered irreversible total hearing loss after using the medication. Teprotumumab, marketed under the brand name Tepezza, was greenlit by the FDA in January 2020, marking it as the first-ever treatment for thyroid eye disease. This condition, which is highly debilitating, triggers eye inflammation, resulting in symptoms like redness, discomfort, and protrusion. The drug was granted Fast Track and Breakthrough Therapy status, expediting its approval process. Despite its effectiveness in managing thyroid eye disease, the medication has been linked to unforeseen auditory side effects, some of which have proven to be permanent.
Teprotumumab is administered as an IV infusion every three weeks for eight doses. According to Horizon Therapeutics PLC, the side effects include:
- Muscle spasms
- Nausea
- Hair loss
- Diarrhea
- Fatigue
- Hyperglycemia
- Hearing problems
- Headache
- Dry skin
- Menstrual changes
The pharmaceutical company reports that auditory issues were observed in 10 percent of the patients examined, which could range from deafness and fluid blockage in the ears to difficulties in discerning sound volumes. The company asserted that these side effects were generally mild or moderate and typically resolved during or post-treatment. However, Horizon has not indicated in any of its provided materials that these auditory complications could potentially be enduring.
Tepezza / Teprotumumab Studies
Horizon Therapeutics PLC secured FDA endorsement for teprotumumab following two placebo-controlled trials involving 170 patients. The pharmaceutical company disclosed that around 10 percent of patients treated with teprotumumab encountered transient, mild to moderate auditory issues. Nonetheless, independent research has revealed a higher incidence of auditory symptoms, along with indications of permanent hearing damage.
Hearing Symptoms in 65 Percent of Subjects
A study reported by the Endocrine Society on May 3, 2021, showed that 65 percent of subjects experienced hearing symptoms after an average of 3.6 infusions. The symptoms included:
- Autophony
- Tinnitus
- An ear-plugging sensation
- Hearing loss
- Muffled hearing
Examinations indicated that certain patients suffering from hearing loss had developed sensorineural hearing loss, a condition resulting from damaged hair cells within the inner ear. Only half of these patients with sensorineural hearing loss saw any improvements. Those suffering from patulous eustachian tube dysfunction, the condition that causes the sensation of ear plugging and autophony, saw some improvements, but not a complete resolution of their symptoms.
Hearing Symptoms in 81.5 Percent of Subjects
A separate research report, featured in the February 2022 edition of the American Journal of Ophthalmology, revealed that a substantial 81.5 percent of individuals encountered auditory issues following an average of 3.8 infusion sessions. Subsequent observations conducted about 9 months after the final infusion pointed out that only 45.5 percent of those affected by these symptoms experienced some degree of resolution in sensorineural hearing impairment.
How Tepezza Causes Hearing Loss
Present within the body, insulin-like growth factor-1 (IGF-1) is a molecule pervasive across multiple bodily systems, exerting diverse functions. It assumes a significant responsibility in the inner workings of cellular metabolism and the upkeep of the inner ear. Of particular note is its role in safeguarding the vitality of hair cells situated within the inner ear, which are pivotal for auditory function.
Teprotumumab, on the other hand, operates through the inhibition of the IGF-1 signaling pathway, with its sights set on the IGF-1 receptor. This action induces a deficiency in IGF-1, a scenario that has the potential to trigger the demise of those crucial hair cells in the inner ear. The culmination of this process could manifest as sensorineural hearing loss.
Current Tepezza Litigation
The inaugural lawsuit directed at Tepezza involves Daniel Weibel vs. Horizon Pharmaceuticals Inc., designated as case number 22-cv-4518, officially lodged on August 25, 2022, within the jurisdiction of the Northern District of Illinois. The party on the receiving end is identified as Horizon Therapeutics PLC, albeit misidentified as Horizon Pharmaceuticals Inc. Anticipated are the forthcoming initiation of a multitude of analogous legal proceedings.
At the core of this legal dispute lies the assertion that Horizon was duty-bound to ensure the well-being of the general public through the following avenues:
- Provision of a comprehensively informative label, with apt advisories
- Execution of post-market oversight and exhaustive safety assessments
- Timely amendment of the label when substantial evidence pointing toward irreversible hearing impairment surfaced
Within the plaintiff’s claims, a narrative unfolds wherein Horizon flouted its duty of care by engaging in the ensuing actions and omissions:
- Manipulation and suppression of pertinent information from both the FDA and the wider public
- Disregard of the apparent correlation between Tepezza and auditory loss
- Neglect to apprise the plaintiff and the plaintiff’s healthcare providers of the substantial jeopardy linked to auditory damage
- Failure to impart directives to healthcare providers regarding the vigilant monitoring of potential hearing-related complications
For the purpose of securing punitive reparations, the plaintiff seeks restitution grounded in the ensuing rationale:
- Demonstrable reckless indifference toward human life and the welfare of individuals subjected to Tepezza
- Exhibition of recklessness, audacity, and an egregiously negligent disregard for the overall safety and welfare of the public.
Preapproval Errors
According to the plaintiff’s assertions, Horizon’s preliminary research efforts fall short of adequacy, encompassing a mere 84 test subjects who were administered the drug. The legal proceedings further contend that Horizon possessed or should have possessed the awareness that IGF-1 disruptors bore a connection to hearing impairment.
In the pursuit of securing FDA endorsement, the lawsuit claims that Horizon deliberately downplayed the extent and duration of hearing loss, characterizing it as mild and temporary.
Post-Approval Investigation Errors
Subsequent to the drug’s regulatory clearance, Horizon opted against delving into accounts indicating that patients were grappling with irreversible hearing deterioration, even though a plethora of studies had already cast a spotlight on this concern. In addition, both medical professionals and patients swiftly communicated significant auditory side effects right after the approval, yet the company persisted in depicting the hearing impairment as transient and inconsequential.
Failure to Warn and Instruct
The company’s oversight extended to neglecting the imperative of guiding doctors to administer audiometric monitoring throughout the course of treatment. This type of monitoring could have empowered patients to make informed decisions regarding the continuation of their treatment. It is a customary procedure for ototoxic medications to advocate for this form of monitoring.
Upon the emergence of studies and patient accounts that unveiled the actual jeopardy of enduring hearing impairment, the company possessed the option to amend the label using the FDA’s “Changes Being Effected” supplement, thereby furnishing the updated and accurate information.
Aggressive Marketing
The company embarked on an aggressive campaign to promote a hazardous product, all the while refraining from alerting the public about the inherent risks it carried. In the span of the year 2021 alone, Tepezza’s sales soared to a staggering $1.66 billion.
Horizon’s Response
Horizon Therapeutics PLC asserts the sufficiency of its provided warnings, countering the argument that the newly acquired information warranted substantial modification to the label.
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