Tepezza is a prescription the U.S. Food and Drug Administration approved to treat thyroid eye disease. Although initial trials showed the effectiveness of the medication, additional studies found a link to hearing loss, tinnitus, and similar medical conditions.
If you experienced hearing-related problems after taking Tepezza, contact TruLaw for an instant case evaluation immediately. You might be entitled to compensation from the manufacturer for the harm you’ve suffered and losses you’ve incurred.
How Tepezza Works
Tepezza is the brand name for teprotumumab-trbw. It’s a prescription medication for treating thyroid eye disease (TED). TED damages tissue around the eye and causes symptoms similar to Graves’ disease, an autoimmune disorder. Progressive swelling, inflammation, and tissue changes lead to various symptoms, including pain, double vision, and watery eyes.
The drug doesn’t only manage TED symptoms. It treats the disease at the source by blocking autoantibodies responsible for activating essential receptors affecting the eyes. It helps to decrease inflammation, prevent tissue expansion behind the eye, and prevent muscle and fat tissue remodeling.
FDA Approval for Tepezza
The FDA granted Tepezza approval to Horizon Therapeutics for thyroid eye disease treatment on January 21, 2020. The drug was one of the first of its kind approved to treat the medical condition.
Tepezza received Orphan Drug designation from the FDA, an incentive to encourage and assist in developing drugs for rare conditions or diseases. The development of the medication also received support from the FDA Orphan Products Grants Program. The program provides grants to companies for clinical studies on the efficacy and safety of products used for rare conditions or diseases.
The most common side effects listed on the original warning labels were:
- Dry skin
- Muscle spasm
- Hair loss
- Change in taste
- High blood sugar
Tepezza labels also included serious side effects, such as:
- Worsening inflammatory bowel disease
- Infusion reactions
- High blood sugar
However, when the drug first hit the market, hearing loss and other hearing-related conditions were not listed on the labels.
Can Tepezza Cause Hearing Loss?
Initial studies showed significant improvement in double vision, proptosis, quality of life, and soft tissue inflammation in patients with moderate to severe TED. Only ten percent of patients reported hearing loss symptoms and were able to reverse the effects after stopping the medication.
However, an Endocrine Society study conducted in March 2021 found a risk of hearing loss as high as 65 percent. During the study, 26 patients received Tepezza four times a day.
After taking the drug, the primary symptoms experienced include:
- Subjective hearing loss – 23 percent of patients
- Ringing in the ears – 27 percent of patients
- A feeling of plugged ears – 12 percent of patients
- Hearing their own voice more loudly than normal – 29 percent of patients
Of the participants in the study, three developed patulous eustachian tube dysfunction, a disorder causing the eustachian tube valve to stay open, distorting the sound of a person’s voice.
Common Complications of Tepezza
TED is a debilitating disease. Adding the component of hearing issues can significantly reduce a person’s quality of life. The most common complications reported after taking Tepezza include:
- Increased sensitivity to sound
- A sensation of the ears feeling full or plugged
- Hearing loss
- Sounds seeming muffled
- Eustachian tube dysfunction, a condition that blocks the tubes connecting the middle ears to the upper throat
Horizon Therapeutics Failed to Warn Consumers of Hearing Loss
Horizon didn’t disclose the risk of hearing loss on Tepezza warning labels. Failure to warn is a type of defect in product liability cases. It occurs when a manufacturer knows about a possible risk of its drug but doesn’t include it on the warning label or packaging.
Your doctor might not be at fault for prescribing the drug to you if they weren’t aware of the dangers. You can hold the manufacturer liable for your hearing loss and related expenses, such as medical treatment and out-of-pocket costs. Two options for pursuing compensation are a product liability claim and a mass tort lawsuit.
You can file a claim with the manufacturer’s liability insurance company in a product liability claim. You don’t assert that the drug has physical flaws in a claim based on failure to warn. Instead, you must establish the manufacturer knew about the adverse effects but didn’t provide adequate warning labels. You must also prove the defect contributed to your injury.
Mass tort cases involve a large group of people harmed by the same defendant’s actions. A mass tort lawsuit combines cases from multiple plaintiffs into a single legal action.
You participate in a mass tort by working with others on similar aspects of the case that apply to everyone. If any element of your case differs from the rest of the group, such as the severity of your injury, you and your lawyer work on that part separately.
Who Is Eligible to File a Tepezza Lawsuit?
You might be eligible for a lawsuit against Horizon Therapeutics if you:
- Received at least one round of Tepezza or teprotumumab injections
- Experienced tinnitus, hearing loss, or another complication of the medication
It’s crucial to remember that taking Tepezza isn’t enough to qualify for a mass tort lawsuit or product liability case. You must have a hearing-related issue that did not develop before taking the drug.
Compensation for Hearing Loss from Tepezza
You can seek compensation pursue compensation in a mass tort case for economic and non-economic losses.
Economic losses are expenses associated with an injury, such as:
- Medical devices, surgery, prescriptions, and other medical treatment
- Lost wages
- Lost earning capacity
- Out-of-pocket expenses
- Costs of paying for daily assistance, such as household work and transportation
Non-economic losses are the intangible effects of an injury, such as:
- Pain and suffering
- Loss of enjoyment of life
- Emotional distress
You might also be able to recover punitive or exemplary damages. This financial award punishes the defendant for their actions. To be awarded these damages, you must show clear and convincing evidence of the manufacturer’s gross negligence or egregious behavior.
Statutes of Limitation on Tepezza Lawsuits
Whether you file a product liability or mass tort lawsuit, you must comply with the laws in your state. Most statutes of limitation allow a one-year to a five-year timeframe to file a lawsuit against a party that injured you. That means you must initiate your lawsuit within the required timeframe to pursue compensation for your injury.
How a Tepezza Hearing Loss Lawyer Can Help
Pursuing legal action without hiring an attorney can decrease your chance of receiving full and fair compensation. Handling a claim or lawsuit is complicated, especially when it involves a large manufacturing company. Horizon Therapeutics has the resources to hire an aggressive and experienced legal team to defend them in a mass tort or product liability case.
You need an experienced defective drug lawyer to guide and support you through every step of the legal process. Your attorney can handle all of the legal legwork of your case, such as:
- Determining the available insurance coverage
- Investigating the circumstances of your case
- Gathering evidence to prove the drug caused your medical condition
- Filing a claim and negotiating a settlement with the insurance company
- Preparing and filing a lawsuit against the manufacturer
- Representing you during legal proceedings, including discovery, medications, and the trial
Speak to a Dedicated Tepezza Lawyer Today
If you suffer from tinnitus, hearing loss, or another adverse effect of Tepezza, find out if you have a case by filling out our Instant Case Evaluation Form right now. Our goal will be to help you get the compensation you need so you can focus on your recovery.