Tepezza, scientifically known as Teprotumumab-trbw, is a crucial medication in the treatment of Thyroid Eye Disease (TED). Acknowledged for its efficacy in managing this condition, Tepezza has gained prominence in medical circles.
However, recent developments have marked a significant shift in its narrative. A surge in lawsuits directed at Horizon Therapeutics, the manufacturer of Tepezza, has emerged, alleging a serious side effect – hearing loss. This legal turmoil adds a layer of complexity to the drug’s reputation. It prompts scrutiny not only from affected patients but also within the pharmaceutical industry and regulatory frameworks.
In this article, we will examine the legal standing of these lawsuits and their impact on individuals and the healthcare landscape.
Allegations Against Tepezza
A growing number of patients who sought relief from TED through Tepezza have reported serious hearing issues, including tinnitus and hearing impairment.
Forbes reports that these complications have prompted a surge in lawsuits against Horizon Therapeutics. The lawsuit claims that Tepezza’s use may lead to severe and potentially permanent hearing complications.
Tepezza’s mechanism of action, inhibiting the insulin-like growth factor one receptor (IGF-IR), is integral in safeguarding the inner ear against various forms of damage. This inhibition, unfortunately, has been linked to significant consequences, particularly in terms of hearing loss.
Patients affected by this issue argue that Horizon Therapeutics failed to adequately warn them about the likelihood of these hearing-related complications. Allegations also assert a lack of information on the severity and permanence of potential issues.
Clinical trials initially indicated that around 10% of patients experienced hearing problems. However, a 2021 study suggested a much higher risk – up to 65% of Tepezza users might face such complications.
Responding to mounting concerns, the drug manufacturer added a warning label in 2023. It advises healthcare providers to assess patients’ hearing before, during, and after treatment, acknowledging the potential for severe and permanent hearing impairment.
Unfortunately, many patients had already used Tepezza before this warning, as the drug gained FDA approval in January 2020. Reports of hearing problems surfaced shortly after the medication’s approval, prompting the initiation of the Tepezza lawsuit. Plaintiffs claim varying degrees of hearing loss, ranging from tinnitus to complete deafness, attributing these issues directly to Tepezza’s use.
According to TorHoerman Law, the lack of initial warnings regarding hearing loss as a potential side effect raises concerns. Evidence suggests that the drug label and early drug information failed to mention the risk of hearing impairment associated with Tepezza.
Furthermore, allegations against the manufacturers include claims that the company may have been aware of the hearing loss risk but failed to disclose it. According to Lawsuit Information Center, a recent case involves a Florida woman who underwent Tepezza infusions from August 2022 to April 2023.
Her lawsuit contends that Horizon Therapeutics negligently failed to warn her and her doctor about the risk of hearing damage associated with Tepezza. This resulted in permanent hearing loss and tinnitus after her last infusion. This case exemplifies the personal impact and underscores the urgency of addressing the allegations surrounding Tepezza and hearing loss.
Legal Standing of the Plaintiffs
To establish a strong legal standing, Tepezza plaintiffs face the challenging task of demonstrating causation. They need to provide concrete evidence that their hearing loss directly results from Tepezza usage, not pre-existing conditions or concurrent medications. This critical element will play a pivotal role in the success of their claims.
Plaintiffs are seeking compensation for a range of damages, including medical expenses, lost wages, pain and suffering, and emotional distress. The multifaceted nature of these damages reflects the diverse ways in which individuals have allegedly suffered due to Tepezza-induced hearing loss.
According to Drugwatch, as of January 2024, 74 Tepezza cases are pending in multidistrict litigation (MDL). Despite being in the early stages, the sheer number of cases underscores the magnitude and complexity of the legal challenge.
In March 2023, plaintiffs filed a motion to consolidate the cases. This led to the establishment of an MDL in the Northern District of Illinois in June 2023. This centralized approach streamlines legal proceedings, ensuring efficiency in handling the growing number of Tepezza lawsuits.
Upcoming Bellwether Selections in Hearing Loss Litigation
As the Tepezza hearing loss lawsuits progress, an important phase is the selection of bellwether cases, which serve as indicators for the broader litigation.
According to AboutLawsuits.com, the process, originally set to conclude in November, experienced an extension. In November, Judge Durkin mandated that plaintiffs and defendants select four cases each for the initial bellwether discovery pool. This was to conclude within 60 and 90 days, respectively.
Subsequently, the Court would randomly choose four additional cases from a list of eligible lawsuits, totaling 12 bellwether cases. However, a joint stipulation issued on January 2 revealed that both parties agreed to an additional 60 days for bellwether case selections. The extension provides the defendants more time to acquire plaintiffs’ medical records and allows addressing any concerns with Plaintiff Profile Forms. The deadline for filing Amended Complaints has been extended to March 1.
This delay signifies the complexity of gathering evidence in these cases, particularly concerning plaintiffs’ medical records. The outcome of the Tepezza bellwether trials won’t bind other claims in the litigation. However, it may influence the average lawsuit payout settlement negotiations. As the legal landscape unfolds in the early months of 2024, these bellwether cases will shape the trajectory of the Tepezza hearing loss litigation.
In conclusion, the unfolding saga of Tepezza hearing loss lawsuits is rife with complexities, legal intricacies, and profound implications. The surge in litigation underscores the gravity of the allegations, as patients contend with severe hearing complications allegedly linked to Tepezza.
For Horizon Therapeutics, the stakes are high. This is because the outcome will impact the company financially and shape the pharmaceutical industry’s approach to disclosure and safety. The repercussions from these lawsuits may extend beyond individual cases, influencing the regulatory environment and drug safety protocols.
Patients, especially those dealing with TED, find themselves in a delicate balance. They are in pursuit of effective treatments while grappling with potential unforeseen consequences.
As we navigate the evolving landscape of Tepezza litigation, one thing remains certain: transparency, thorough investigation, and ongoing research are paramount. The outcomes of these legal battles will not only determine the fate of individual cases but may reverberate throughout the pharmaceutical realm.
