Tepezza, also known as teprotumumab-trbw, is the first and only prescription drug approved by the FDA to treat thyroid eye disease (TED). While offering a much-needed treatment for patients with this vision-threatening autoimmune condition, concerns have arisen due to the drug’s connection to hearing damage.
Patients who experienced permanent hearing loss or tinnitus after taking Tepezza have started filing lawsuits against the drug manufacturer Horizon Therapeutics PLC (NASDAQ: HZNP), alleging negligence and failure to warn patients of these severe and potentially debilitating side effects.
The plaintiffs in the Tepezza lawsuits seek compensation for medical expenses, lost wages, pain and suffering, and the diminished quality of life resulting from the drug’s adverse effects. The legal proceedings also aim to raise awareness of the risks associated with Tepezza and ensure that the manufacturer takes necessary precautions to protect the well-being of patients relying on this medication to manage their condition.
Key Takeaways
- Tepezza is the only FDA-approved drug for treating thyroid eye disease but has been linked to hearing loss.
- Lawsuits have been filed against Horizon Therapeutics for alleged negligence and failure to warn patients about hearing damage risks.
- The plaintiffs seek compensation and aim to raise awareness about the potential side effects of Tepezza.
Tepezza and Thyroid Eye Disease
Thyroid eye disease, also known as Graves’ orbitopathy or ophthalmopathy, is an autoimmune condition that affects the eyes. It occurs when the body’s immune system attacks the tissues surrounding the eyes, resulting in inflammation and swelling. Common symptoms of thyroid eye disease include eye pain, redness, double vision, and bulging eyes.
Tepezza, with the generic name teprotumumab-trbw, is a medication specifically developed for treating thyroid eye disease. In January 2020, the Food and Drug Administration (FDA) approved Tepezza as the first and only drug for this condition. Teprotumumab is a monoclonal antibody that inhibits the insulin-like growth factor-1 receptor (IGF-1R), which plays a crucial role in developing thyroid eye disease.
Significant clinical trials have demonstrated the efficacy and safety of Tepezza in treating thyroid eye disease. The FDA’s approval is based on positive results from these trials, showing significant improvements in symptoms and quality of life for patients treated with the drug. As with any medication, there are potential side effects associated with Tepezza use, and patients and healthcare providers need to be aware of these risks to make appropriate treatment decisions.
However, recent developments have raised concerns about potential hearing loss and tinnitus associated with the use of Tepezza. Patients who experienced these permanent side effects have initiated lawsuits against the manufacturer, claiming that the drug’s label did not warn them or their doctors about these potential risks. As of August 2023, the Tepezza lawsuits are in the early stages, and no trials or court-approved settlements have occurred.
The Lawsuit Against Tepezza
Tepezza is a medication manufactured by Horizon Therapeutics designed to treat thyroid eye disease. However, lawsuits have been filed against the company, claiming that the drug has caused permanent hearing loss and tinnitus in some users. These lawsuits allege that Horizon Therapeutics failed to warn doctors and patients about potential health risks associated with Tepezza.
One of the first cases against Horizon Therapeutics was filed in August 2022 by Daniel Weibel, a patient who experienced permanent hearing loss after undergoing Tepezza treatment for his thyroid eye disease. This case was filed in the U.S. District Court for the Northern District of Illinois. Since then, several other Tepezza lawsuits have emerged as more patients come forward with similar claims.
Attorneys representing clients in these lawsuits seek cases in all 50 states for individuals who have experienced hearing damage after receiving Tepezza infusions. These lawyers specialize in product liability litigation and assist their clients in seeking financial compensation through settlements or jury payouts.
The plaintiffs in the Tepezza lawsuits argue that Horizon Therapeutics used deceptive marketing practices concerning their thyroid eye disease drug. As a result of these alleged practices, doctors and patients were not adequately informed of the risks associated with Tepezza use, leading to avoidable hearing damage.
In light of the ongoing litigation, attorneys offer case reviews for patients who received Tepezza infusions and subsequently suffered hearing loss or other related issues. These legal professionals evaluate the potential for additional legal action against Horizon Therapeutics on a case-by-case basis.
As the Tepezza lawsuits progress, it remains to be seen how the court will determine liability and, ultimately, the extent of compensation awarded to plaintiffs who have experienced hearing loss due to Tepezza.
Medical Complications Associated With Tepezza
Tepezza, or teprotumumab-trbw, is a medication used to treat thyroid eye disease. While it has successfully treated this condition, it has also been linked to several serious side effects. Some of these complications have led patients to file lawsuits against the drug manufacturer Horizon Therapeutics.
One of the most concerning side effects reported by some Tepezza patients is permanent hearing loss. This form of sensorineural hearing loss can significantly impact a person’s quality of life, as it may not be reversible. Another related issue is tinnitus, which manifests as a persistent ringing or buzzing sound in the ears. These hearing problems can be debilitating and affect various aspects of a person’s life, such as work, social interactions, and overall mental well-being.
Other notable side effects associated with Tepezza include autophony, where a person can hear their voice echoing inside their head, and eustachian tube dysfunction, which can cause issues with balance, dizziness, and a feeling of fullness in the ears. Additionally, patients may experience increased sensitivity to sound, known as hyperacusis, or a decreased ability to hear, known as hyperacusis. In severe cases, individuals may even experience complete deafness.
While the drug’s label contains warnings for infusion reactions, exacerbation of preexisting inflammatory bowel disease, and hyperglycemia, it does not specifically address the aforementioned hearing-related complications. Lawsuits filed against Horizon Therapeutics argue that the company failed to adequately test Tepezza, investigate the risks associated with the drug, and that they aggressively marketed the product without warning of these potential risks.
In summary, Tepezza has been linked to numerous medical complications, primarily focused on hearing problems such as permanent hearing loss, tinnitus, and other debilitating issues. Patients and healthcare professionals need to be aware of these potential side effects when considering Tepezza as a treatment option for thyroid eye disease.
Clinical Trials and Studies
Tepezza, a medication used to treat thyroid eye disease, has faced lawsuits alleging it causes hearing loss or tinnitus in patients. The drug’s clinical trials and studies are crucial in understanding these claims and their overall efficacy.
The manufacturer of Tepezza, Horizon Therapeutics, conducted pre-market and post-market clinical trials that suggested approximately 10% of patients receiving the medication reported hearing complications. However, it’s worth noting that these trials were limited in their scope and sample size. Horizon’s single clinical trial for FDA approval of Tepezza involved less than 100 patients, leading to concerns about the robustness of the study’s findings.
Despite the limited testing, Tepezza received FDA approval based on its efficacy in managing thyroid eye disease symptoms. However, the exact mechanism of action of the drug remains unclear. This lack of understanding adds uncertainty to potential side effects and contraindications arising from its use.
Critics of Horizon’s clinical testing process have pointed out that the company did not adequately warn patients about the potential hearing loss and tinnitus associated with Tepezza. These concerns have led to numerous lawsuits in their early stages. As of August 2023, the cases have been consolidated and will be heard in a court in Chicago, overseen by Judge Thomas M. Durkin.
As the legal proceedings unfold, the importance of thoroughly analyzing Tepezza’s clinical trials and studies cannot be understated. Evaluating the drug’s safety and efficacy based on solid scientific evidence is essential for protecting patients’ health and ultimately determining the validity of hearing loss claims. As more information emerges from the ongoing litigation process, healthcare professionals and patients should stay informed on the latest updates and research findings related to Tepezza and its potential side effects.
Horizon Therapeutics
Horizon Therapeutics is an Ireland-based biopharmaceutical company that specializes in developing and manufacturing drugs for rare rheumatoid and autoimmune diseases. One of their most notable products is Tepezza, a medication approved by the Food and Drug Administration (FDA) in January 2020 for treating thyroid eye disease (TED).
Horizon Therapeutics USA Inc., a subsidiary of the parent company, is currently facing multiple lawsuits in the United States. The plaintiffs in these cases claim that the company did not adequately warn about the potential risks of hearing loss and tinnitus associated with using Tepezza. As a result, patients who took the medication and subsequently experienced permanent hearing loss or tinnitus are filing lawsuits against the company.
Recently, the MDL Panel agreed to consolidate federal lawsuits involving the Tepezza product. The consolidated cases will be heard in a court in Chicago under the supervision of Judge Thomas M. Durkin. This decision aims to streamline the legal process for the numerous cases filed against Horizon and effectively address the plaintiffs’ claims.
Despite the ongoing litigation, Tepezza remains patent-protected and available for prescription. Current and future patients must know this medication’s potential side effects and legal developments. As the litigation unfolds, Horizon Therapeutics may release additional information addressing the concerns raised by the plaintiffs and potentially updating the warning labels or prescribing information for Tepezza.
In conclusion, Horizon Therapeutics is a prominent drug manufacturer that faces several lawsuits alleging inadequate warnings about possible hearing loss and tinnitus caused by their thyroid eye disease medication, Tepezza. The litigation against the company is ongoing, and further updates regarding the case will be crucial in understanding potential risks and outcomes for Tepezza users.
Patient Compensation and Settlements
Individuals affected by Tepezza may be eligible for financial compensation through a lawsuit against the drug’s manufacturer. This compensation aims to cover various damages experienced by the patient, such as medical bills, pain and suffering, lost wages, and decreased quality of life.
Financial compensation can be obtained through settlements or jury payouts. Settlement amounts typically vary based on the specific circumstances of each case. Factors that can influence settlement amounts include the severity of hearing loss, the extent of medical treatment required, and the impact of the injury on the patient’s livelihood.
In some instances, settlements are reached outside of court to resolve the case more efficiently and to avoid the potential costs of a lengthy trial. However, if a settlement cannot be reached, the case may proceed to trial, wherein a jury will determine the appropriate compensation for the plaintiff. It is essential to note that potential settlement amounts are difficult to predict as they depend on the specifics of each case.
When pursuing a Tepezza lawsuit, seeking legal assistance is crucial for navigating the complexities of the legal process and ensuring a compelling case. Skilled attorneys can help patients obtain the financial compensation they need and deserve for their injuries. Moreover, filing a lawsuit puts other patients on notice about the risks of taking Tepezza, which can help prevent further harm.
Multidistrict Litigation and Legal Proceedings
The Tepezza lawsuit involves multiple complainants who have alleged that Horizon Therapeutics USA Inc. did not adequately warn about potential hearing loss and tinnitus caused by its thyroid eye disease medication, Tepezza. In response to these allegations, the Judicial Panel on Multidistrict Litigation consolidated the federal lawsuits into a single multidistrict litigation (MDL) for increased efficiency and fairness.
This decision to create the Tepezza MDL, MDL No. 3079, was made in June 2023. The cases within this MDL will be heard in a federal court in the Northern District of Illinois, overseen by Judge Thomas M. Durkin. As of July 2023, 42 Tepezza cases are pending in this newly formed MDL.
The multidistrict litigation aims to address the common legal and factual questions arising from the alleged permanent hearing loss and tinnitus associated with Tepezza use. By combining the lawsuits, the court can streamline the discovery process, avoid duplicate rulings, and ultimately work to resolve the cases more efficiently.
The individual plaintiff cases within the MDL will be handled under federal law and managed by various federal districts involved in the litigation process. As these legal proceedings continue, both the Tepezza users and Horizon Therapeutics will have the opportunity to present their arguments and opposition to the claims in the consolidated setting of the Northern District of Illinois federal court.
In summary, the Tepezza lawsuit has progressed to a multidistrict litigation stage to address the numerous complaints of hearing loss and tinnitus related to the medication. This consolidated legal approach will allow for a more efficient resolution of the cases under the federal court’s jurisdiction in the Northern District of Illinois.
FDA, FTC, and Regulatory Matters
The U.S. Food and Drug Administration (FDA) has approved Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease, a rare condition affecting the muscles and fatty tissues around the eyes. This approval signifies that the FDA has reviewed the safety and efficacy of the drug for this indication.
Recently, lawsuits related to Tepezza have emerged, claiming that the drug causes hearing loss and tinnitus in some patients. These lawsuits allege that the manufacturer, Horizon Therapeutics, failed to warn adequately about potential side effects, including hearing damage. As part of the legal process, the manufacturer has filed a motion to dismiss one such lawsuit, arguing that the plaintiff failed to establish that the company could have changed the drug’s label without FDA approval. Moreover, the manufacturer contends that federal regulations preempt the plaintiff’s failure-to-warn claims.
While the FDA is responsible for drug approvals and safety, the Federal Trade Commission (FTC) protects consumers from unfair or deceptive marketing practices. To ensure compliance with FTC regulations, pharmaceutical companies like Horizon Therapeutics must ensure that their advertising and promotional materials do not contain misleading or unsubstantiated claims about their products. In the case of Tepezza, the relevant information and risks associated with the drug should be communicated clearly to both healthcare providers and patients.
Drug manufacturers must comply with FDA and FTC regulations for drug safety, efficacy, and marketing practices. In the context of Tepezza, both regulatory agencies will continue to monitor the drug’s performance and the legal proceedings to ensure that patient safety remains the top priority.
Other Potential Tepezza Side Effects
While the primary concern regarding Tepezza is its potential to cause hearing loss and tinnitus (ringing in the ear), there are other potential side effects that users should be aware of.
One common side effect of Tepezza is muscle pain and inflammation. This can manifest as general discomfort in various muscle groups, potentially impacting a person’s quality of life. Sometimes, the pain can be severe and may require medical intervention.
Blurred vision and double vision are also reported side effects of Tepezza. These issues may arise due to the impact of the medication on the ocular tissue or the surrounding eye muscles involved with eye movement. Patients experiencing these vision problems should discuss them with their healthcare provider to determine if adjustments in treatment are necessary.
Eye disorders involving the eyelids are another potential concern, as Tepezza has been linked to issues like eyelid swelling and retraction. If not addressed, these side effects can lead to discomfort, dryness, and the potential for further complications, such as corneal damage.
In addition to these side effects, patients receiving Tepezza infusions may experience infusion reactions. These can range from mild symptoms, such as shortness of breath or dizziness, to severe reactions that require immediate medical attention. Patients should be closely monitored during the infusion process for any signs of adverse reactions.
Overall, these safety concerns highlight the need for patients and healthcare providers to weigh the benefits of Tepezza against the potential risks. Monitoring their responses to the medication and reporting any concerning side effects is essential to ensure the most appropriate and effective treatment.
Failure to Warn and Product Liability
Tepezza lawsuits involve the negligence of Horizon Therapeutics in failing to adequately warn patients and healthcare providers about the potential risks associated with the drug. Tepezza, a treatment for thyroid eye disease, has been linked to serious side effects, including permanent hearing loss and tinnitus. Many patients who experienced these side effects have filed product liability lawsuits against the manufacturer, claiming negligent failure to warn.
In a product liability lawsuit, the plaintiff must establish that the manufacturer or seller had a duty to warn about the potential risks involved in using the product and that they failed to meet this obligation. The warning label is crucial in ensuring that consumers are fully informed about the potential dangers of using a product. In the case of Tepezza, plaintiffs argue that Horizon Therapeutics did not provide sufficient warnings about the possibility of severe auditory side effects.
Design defects can also be part of a product liability lawsuit. The manufacturer may be liable if the plaintiff can demonstrate that a defect in the product’s design caused the injury. However, in the case of Tepezza, the primary basis for the lawsuits is the lack of adequate warnings rather than a specific design defect.
When a company is found to have acted negligently in the failure to warn or provide insufficient information about the risks associated with their product, they may be liable for any resulting injuries. In these cases, the manufacturer or seller may be required to compensate the victims for medical expenses, pain and suffering, lost wages, and other damages related to the injury.
In conclusion, the Tepezza hearing loss lawsuits focus on Horizon Therapeutics’ alleged negligent failure to adequately warn patients and doctors about the true risk of hearing damage from the drug. The plaintiffs in these cases aim to hold the manufacturer responsible for their injuries and seek financial compensation for their losses.
Monopoly Concerns and Amgen
The Federal Trade Commission (FTC) has raised monopoly concerns with Amgen and its proposed acquisition of Horizon Therapeutics, valued at more than $26 billion. The central issue lies in how the deal could potentially strengthen the monopoly of two Horizon drugs, Tepezza and Krystexxa. Both are critical treatments for rare diseases, with Tepezza addressing thyroid eye disease and Krystexxa focusing on chronic refractory gout.
According to the FTC lawsuit, the acquisition may allow Amgen to leverage rebates on its existing blockbuster drugs to coerce insurance companies and pharmacy benefit managers (PBMs) into favoring Horizon’s two monopoly products. This could potentially stifle competition and negatively impact consumers regarding treatment costs and access to alternative medications.
A biotech drug developer, Amgen initially pursued the acquisition to expand its presence in the rare disease treatment market. Tepezza, Horizon’s bestseller, is presently only approved for use in the United States and caters to patients suffering from eye bulging and double vision caused by thyroid eye disease.
Standing in opposition to the deal, the FTC’s primary goal is to ensure that the market remains competitive, offering patients a healthy variety of treatment options. While the outcome of the lawsuit remains uncertain, it demonstrates the importance of regulatory scrutiny in preventing potential monopolies in the pharmaceutical industry and safeguarding consumer interests.
Tepezza Treatments and Application
Tepezza is a groundbreaking drug approved by the FDA to treat thyroid eye disease (TED). This condition can cause vision problems and discomfort for patients affected. The drug is administered through infusions to deliver effective results for the recipient.
Tepezza infusions are typically given in a healthcare setting under the supervision of trained professionals. Each infusion session lasts 60 to 90 minutes, and the entire treatment process usually consists of a series of infusions at regular intervals. The doses are determined by the patient’s body weight and are given every three weeks for eight infusions.
The drug works by targeting and interfering with the cause of inflammation in TED, relieving swelling, redness, and pain. This innovative approach helps alleviate symptoms and prevents further damage to delicate eye structures, ensuring patients can maintain their vision and quality of life.
Notably, Tepezza has shown a high success rate in clinical trials, with most patients experiencing significant improvements in their TED symptoms. Moreover, the drug has been praised for addressing active inflammation and long-term TED-related issues.
However, it is important to note that Tepezza treatments are not without risks. Some patients have reported side effects such as headache, muscle pain, diarrhea, and, in rare cases, permanent hearing loss or tinnitus. This has led to lawsuits against the drug’s maker, Horizon Therapeutics USA Inc., with claimants seeking compensation for damages incurred.
In conclusion, Tepezza represents a pioneering approach to treating thyroid eye disease, offering promising results for needy patients. The infusions provide an effective means of delivering the drug, and the treatment process has been designed to minimize potential risks. While the drug is groundbreaking and beneficial for many patients, it is essential to weigh its advantages against the potential side effects and stay informed about ongoing legal proceedings.
Autoimmune Condition and Tepezza
Thyroid eye disease (TED) affects approximately 50% of people with the autoimmune disorder Graves disease. Graves’ disease causes the immune system to attack healthy tissues in the thyroid gland, leading to hyperthyroidism. In the case of TED, the immune system targets the tissues around the eyes, resulting in inflammation and other eye-related issues.
Horizon Therapeutics, a biopharma company specializing in rare rheumatoid and autoimmune diseases, developed Tepezza to address this eye condition. The treatment is administered through intravenous injections, typically in a healthcare setting such as a doctor’s office. Patients receive eight Tepezza infusions, with one session every three weeks. It is essential to note that Tepezza is not intended for long-term use.
Despite its usefulness in managing TED, some individuals who have taken Tepezza have experienced adverse side effects, including permanent hearing loss or tinnitus. As a result, several Tepezza lawsuits have been filed, with plaintiffs seeking compensation for medical expenses, pain and suffering, lost wages, and decreased quality of life. These lawsuits also warn other patients about the potential risks associated with the medication.
If you or someone you know has suffered hearing loss or other hearing-related issues after receiving Tepezza infusions, there may be an opportunity to file a product liability lawsuit. Attorneys are currently looking into Tepezza hearing damage cases in all 50 states, with the prospect of obtaining financial compensation through a settlement or jury payout.
Statute of Limitations
When considering the Tepezza lawsuit, knowing the statute of limitations is important. This is the legal time limit within which a claim must be filed. The statute of limitations varies from state to state, and filing a claim after the time limit can result in losing legal rights to pursue compensation.
The Tepezza lawsuit involves claims against Horizon Therapeutics for not adequately warning consumers about the risk of hearing damage associated with using Tepezza. As cases are still in the early stages, individuals who have experienced hearing loss or other related side effects after using Tepezza should be aware of the statute of limitations in their respective states.
Potential plaintiffs should consult with an attorney as soon as possible to better understand the specific statute of limitations that applies to their case. This will help ensure their claim is timely, and they can seek compensation for any harm they’ve experienced.
Understanding the statute of limitations is crucial for those considering participating in the Tepezza lawsuit. Consulting with an attorney to determine the applicable time limit for filing a claim can help protect their legal rights and enhance their chances of successfully pursuing compensation for related injuries.
Medical Devices and Dangerous Drugs
Dangerous drugs and medical devices can not only disrupt the human body’s normal functioning but also potentially cause significant and long-lasting harm. The Food and Drug Administration (FDA) is responsible for approving and regulating medical devices and pharmaceuticals to ensure they are safe and effective. However, despite the rigorous approval process, some products may still pose risks to patients.
In the case of Tepezza, the lawsuits claim that Horizon Therapeutics did not provide sufficient warnings about the potential side effects of the drug. People who developed hearing loss or tinnitus after taking Tepezza are now filing lawsuits for compensation. Recently, federal lawsuits related to Tepezza have been consolidated and are set to be heard in a court in Chicago, overseen by Judge Thomas M. Durkin.
Patients and medical professionals must be aware of the risks and complications that can arise from dangerous drugs and medical devices. This awareness can lead to better-informed decisions regarding treatment options and potential adverse effects. If a patient experiences problems or side effects from a medication or medical device, they need to seek medical assistance promptly.
Finally, people impacted by dangerous drugs or medical devices may consider legal action to obtain compensation for the harm they have suffered. Collaborating with experienced attorneys specializing in medical device and drug-related litigation can be beneficial in navigating the complex legal process. In doing so, they can help safeguard the rights of those affected by these products and hold the responsible parties accountable.
Medical Expenses and Lost Wages
Patients who have experienced these adverse effects may face significant medical costs related to their hearing loss or tinnitus. This can include expenses for audiology appointments, hearing aids, and ongoing therapy or treatment. In some cases, the severity of the hearing loss may require a cochlear implant, which can also be expensive.
In addition to medical expenses, plaintiffs in these Tepezza lawsuits may also seek compensation for lost wages. Hearing loss or tinnitus can impact a person’s ability to work and sometimes lead to long-term disability. This can result in the loss of potential earnings, further exacerbating the financial toll the side effects have on these individuals and their families.
Economic damages in a Tepezza lawsuit may encompass various costs, including medical bills and lost income. These damages can be estimated by considering the amount of lost wages, medical bills, and other related expenses. Moreover, some plaintiffs may also pursue compensation for pain and suffering, which can be difficult to quantify but is intended to address their injuries’ emotional and psychological impact.
In summary, lawsuits involving Tepezza and its associated hearing loss or tinnitus primarily seek compensation for medical expenses and lost wages. By holding the drug’s manufacturer accountable, these lawsuits aim to provide financial relief to affected individuals and their families while also potentially raising awareness about the risks associated with Tepezza.
Quality of Life and Physical Pain
Tepezza’s side effects can be permanent and significantly impact a person’s quality of life. Lawsuits are claiming that Tepezza caused hearing-related issues, including permanent hearing loss.
Individuals affected by these side effects often suffer physical pain, mental anguish, and a diminished quality of life. Chronic tinnitus and hearing loss can lead to difficulties in communication, social isolation, and increased stress levels. Mental anguish is a common consequence of these challenges, affecting the individual’s overall well-being.
Furthermore, the impact on a person’s quality of life also extends to their employment and financial stability. Medical expenses and lost wages can compound the difficulties faced by those experiencing Tepezza-related side effects, adding to the emotional strain and the hardships they must endure.
Compensation for these suffering parties can alleviate the financial burden they have to bear. Tepezza lawsuit participants may seek damages for medical bills, pain and suffering, and lost wages related to their decreased quality of life. By filing a lawsuit, individuals can seek monetary compensation for their losses and hardships and help raise awareness and warn other patients about the potential risks of taking Tepezza.
In summary, Tepezza-related side effects can significantly impact the affected individual’s quality of life, causing physical pain and mental anguish. Lawsuits filed against the manufacturer aim to compensate those affected for their medical expenses, pain and suffering, and lost wages and raise awareness about the risks of using the medication.
Medical Findings and Journals
The association between Tepezza and hearing loss has been a growing concern in the medical community. In the American Journal of Ophthalmology, a 2021 study found that the risk of hearing impairment due to Tepezza could be as high as 65%. This alarming research prompted further investigations into the link between medication and hearing problems.
Following the study, in July 2023, Horizon Therapeutics, the drug manufacturer, updated the medication’s label to include a warning about potential hearing impairment associated with Tepezza. The warning states, “Hearing Impairment Including Hearing Loss: Tepezza may cause severe hearing impairment including hearing loss, which in some cases may be permanent.”
These medical findings have led to lawsuits against Horizon Therapeutics by patients who claim they developed permanent hearing loss or tinnitus due to using the medication. The plaintiffs allege that Horizon Pharmaceuticals failed to adequately research and warn patients about the risk of irreversible hearing loss, tinnitus, and other hearing-related problems associated with using Tepezza.
In light of the medical findings and available research, the ongoing litigation against Horizon Therapeutics seeks to hold the manufacturer accountable for the potential adverse effects suffered by the patients. With the cases now consolidated and being heard in a court in Chicago under Judge Thomas M. Durkin, the outcome of this litigation will further shape the understanding of the risks associated with Tepezza and the obligations of drug manufacturers to inform patients about potential side effects adequately.
