Thyroid Eye Disease (TED), also known as Graves’ orbitopathy, can be a distressing autoimmune condition. It is characterized by eye pain, inflammation, and double vision. In 2020, hope emerged in the form of Tepezza (teprotumumab-trbw), the first FDA-approved medication to address the underlying cause of TED.
However, as promising as this treatment seemed, it has been reported that the treatment can lead to irreversible hearing loss. According to studies shared by Stanford University researchers, around 65% of patients receiving Tepezza experienced hearing loss. This has sparked a wave of lawsuits that are being filed by patients who have experienced hearing loss following Tepezza’s treatment.
This has raised questions about its safety and the responsibilities of its manufacturer, Horizon Therapeutics. In this article, we will thoroughly examine the legal intricacies surrounding the Tepezza lawsuits. We will explore the current legal proceedings, label updates, and potential avenues for compensation.
Understanding Thyroid Eye Disease and Tepezza
Thyroid Eye Disease is a condition where the immune system attacks the tissues around the eye socket. This leads to a range of painful symptoms, including eye bulging and double vision. Tepezza, with its active ingredient teprotumumab-trbw, emerged as a groundbreaking treatment for TED.
It targets the root cause of the condition, addressing the immune system’s attack on the eye socket tissues. While Tepezza has shown promising results in relieving TED symptoms, it has also raised concerns due to reports of severe hearing impairment.
The Role of Patient Advocacy
Patient advocacy plays a crucial role in ensuring that individuals have access to accurate information about their treatments and medications. In the case of Tepezza, advocates have raised important questions about whether patients and healthcare providers were adequately informed about the potential risks.
Advocates argue that informed consent is a fundamental right for patients, and any potential risks associated with a medication should be transparently communicated. Patient advocacy in Tepezza lawsuits continues to emphasize the importance of ensuring patients have all the information they need to make informed decisions.
Legal Actions and Lawsuits
A significant development in the aftermath of Tepezza’s approval has been the emergence of lawsuits against Horizon Therapeutics, the drug’s manufacturer. According to TruLaw, plaintiffs in these lawsuits claim that the company did not provide sufficient warnings about the risk of hearing impairment.
These lawsuits have been consolidated into multidistrict litigation (MDL), a legal process designed to efficiently handle cases with similar claims. MDLs can help streamline proceedings, ensuring that cases move forward consistently and efficiently. As the Tepezza hearing loss lawsuit progresses through MDL, it aims to hold the manufacturer accountable for the alleged failures in warning patients.
Warnings and Label Updates
Regulatory agencies, such as the FDA, play a central role in evaluating and approving medications. As new information emerges about a drug’s safety profile, these agencies can require updates to labeling.
This helps ensure that healthcare providers and patients are well-informed about potential risks. In July 2023, Horizon updated Tepezza’s label to include a warning about severe hearing impairment.
According to Medtruth, both the manufacturer and the FDA have added hearing-loss-related warnings to their packaging label and their website, respectively. The updated label emphasizes the importance of assessing patients’ hearing before, during, and after treatment.
This update raises questions about the adequacy of initial labeling and the role of regulatory agencies.
Potential Compensation and Patient Support
For individuals who have experienced permanent hearing loss as a result of Tepezza treatment, seeking compensation can be essential for covering medical expenses. The lawsuit also seeks to address lost wages and mitigate the impact on their quality of life.
These cases seek to offer a legal channel for impacted patients to obtain the financial assistance they require. According to an October 2023 update from Drugwatch, 54 Tepezza cases are pending in the MDL. Tepezza claims are in their early stages, with no planned trials or court-approved settlements.
These legal actions serve as a form of patient advocacy, raising awareness about the potential risks of Tepezza. These lawsuits contribute to patient safety by ensuring that others are informed about the risks and holding the manufacturer accountable.
The Tepezza lawsuits and the subsequent patient advocacy efforts shed light on the complexities surrounding medication safety, informed consent, and manufacturer accountability. As these legal actions progress through multidistrict litigation, they highlight the necessity of transparent communication of potential risks associated with medications.
The updated labeling and regulatory agency involvement underscore the ongoing responsibility to ensure patient safety. These legal proceedings provide a means for affected individuals to seek compensation and justice. They also serve as a powerful mechanism for raising awareness about medication risks and holding manufacturers accountable for their products.