Thyroid eye disease (TED), also known as Graves’ orbitopathy, is a serious autoimmune condition that affects the eye. It causes pain, redness, swollen eyelids, double vision, and even vision loss in severe cases.
Tepezza (teprotumumab-trbw), approved by the U.S. Food and Drug Administration (FDA) in 2020, was hailed as a groundbreaking treatment for TED. However, recent developments have led to a surge in Tepezza lawsuits, with patients claiming severe and permanent hearing impairment. This has raised complex legal questions regarding medical product liability and patient safety.
In this article, we will delve into the growing legal complexities surrounding Tepezza.
Tepezza: A Double-Edged Sword
Tepezza’s introduction in 2020 was met with anticipation and optimism, as it addressed the root cause of TED rather than merely alleviating its symptoms. According to Drugs.com, it is an insulin-like growth factor-1 receptor (IGF-1R) targeted biologic inhibitor used to treat TED. It is a human monoclonal antibody that inhibits IGF-1R activity and signals.
To put it simply, it targeted the receptors on the cells behind the eye that caused inflammation. By binding to these receptors, Tepezza effectively blocks the inflammatory response, providing relief from symptoms such as eye pain, inflammation, and bulging eyes. It even helps people suffering from TED’s double vision symptoms.
However, recent developments have uncovered a darker side of Tepezza’s impact.
The Unfolding Legal Battle
The legal battle surrounding Tepezza has evolved into a complex and multifaceted issue. Affected individuals across the nation continue to file lawsuits. These lawsuits allege that the manufacturer, Horizon Therapeutics, failed to warn about the potential risks associated with Tepezza.
The Tepezza lawsuit has set the stage for a high-stakes battle at the intersection of pharmaceutical product liability and patient safety. Patients who have experienced hearing impairments, particularly tinnitus, after undergoing Tepezza treatment are at the forefront of this legal confrontation.
These legal actions underscore the fundamental responsibility of pharmaceutical companies to thoroughly assess and communicate the potential risks of their products. Patients place their trust in these medications in the hope of finding relief from their debilitating symptoms. As such, transparency and disclosure of possible side effects are essential.
Recent Regulatory Actions
In response to mounting concerns and legal claims regarding Tepezza’s side effects, the FDA took regulatory action in July 2023. There has been a significant update to Tepezza’s label that acknowledges the possibility of permanent hearing impairment associated with the drug.
As noted by Ophthalmology Times, the label now contains a warning for “hearing impairment including hearing loss” as one of the “major recent changes.” Hyperglycemia, inflammatory bowel disease aggravation, and infusion reactions are three other warnings listed on the label. The updated label also urges doctors to monitor patient health before, during, and after the treatment.
Legal Criteria for Tepezza Lawsuits
The eligibility for filing a Tepezza lawsuit hinges on a range of factors. These include the nature and diagnosis of hearing problems, the number of Tepezza treatments received, and the medical response from healthcare providers.
According to TruLaw, individuals contemplating legal action must consult with an experienced attorney for assistance with navigating this complex legal terrain. Legal professionals can offer guidance, evaluate the merits of each case, and ensure that all necessary criteria for filing a lawsuit are met.
Potential Legal Outcomes
As the Tepezza lawsuits continue to progress, interest grows regarding potential outcomes for plaintiffs and Horizon Therapeutics. As noted by Drugwatch, there are 54 Tepezza cases pending in the MDL as of October. The post also notes that there have been no settlements in this case till now. New claims continue to be filed.
A variety of potential scenarios could emerge in the near future. Below we have listed some of the possible outcomes:
- Individual Settlements: Some Tepezza lawsuits may lead to individual settlements. In such cases, the plaintiff and the defendant, in this instance, Horizon Therapeutics, might reach an agreement outside of a courtroom. These settlements could involve financial compensation for the affected individuals.
- Multidistrict Litigation (MDL): The establishment of MDLs indicates a consolidation of similar cases for more efficient handling. This approach streamlines pre-trial proceedings and, depending on its outcome, could lead to mass settlements.
- Jury Trials: If individual cases proceed to trial, they will be presented before a jury. The jury’s decisions will play a critical role in determining liability and compensation. The results of these trials will set legal precedents and serve as indicators for subsequent cases.
It’s important to note that each Tepezza lawsuit is unique, and the legal process can be complex and time-consuming. As the legal battle unfolds, it will continue to evolve, and additional factors and developments may impact the potential outcomes.
The legal complexities surrounding Tepezza lawsuits underscore the critical importance of pharmaceutical companies’ responsibilities. With the FDA’s recent label update, the issue of hearing impairment and patient safety has gained significant attention.
The evolving legal landscape offers a range of potential outcomes, from individual settlements to multidistrict litigation and jury trials. Each outcome has its unique implications. These cases shed light on the necessity of a rigorous and comprehensive evaluation of medical products and the imperative for patients to be fully informed.
As the legal battle unfolds, it serves as a reminder to preserve the balance between innovation and safeguarding public health.