In January 2020, the U.S. Food and Drug Administration (FDA) approved the first and only therapy for treating thyroid eye disease. Teprotumumab, known by the brand name Tepezza, is a type of infusion therapy in which the treatment is delivered to the patient every three weeks for a total of eight infusions.
Unfortunately, just over a year after the approval of this treatment, a study revealed that many patients undergoing the treatment suffered hearing complications. Here is a look at the complications associated with Tepezza and your legal options if you experience hearing complications after taking the medication.
What Is Tepezza?
Teprotumumab (Tepezza) is a drug used to treat thyroid eye disease, which is an autoimmune disease that causes the eye muscles and the fatty tissue behind the eye to become inflamed. The condition is generally associated with an overactive thyroid gland due to Graves’ disease. Symptoms of thyroid eye disease include dry, watery, red, or bulging eyes, vision problems, and difficulty closing the eyes. Ireland-based Horizon Therapeutics USA Inc. manufactures tepezza.
Tepezza is administered to patients intravenously as an infusion. A Tepezza treatment involves eight infusions, each taking about 60-90 minutes, with around three weeks between infusions. According to the FDA, after six months of treatment, 71-85 percent of patients participating in clinical trials involving Tepezza experienced a demonstrated reduction in the symptoms of thyroid eye disease.
From these trials, possible side effects included infusion reactions, worsening of inflammatory bowel disease, and high blood sugar. Other, more-common side effects included muscle spasms, hair loss, nausea, diarrhea, fatigue, dry skin, change in taste, and headache. The trials also reported hearing complications in 10 percent of the patients who received the treatment. However, new studies show hearing complications in as much as 65 percent of patients.
The Hearing Complications Tepezza May Cause
To explore the hearing complications associated with Tepezza, researchers from Stanford University School of Medicine evaluated 26 patients who had received at least four infusions. Seventeen of those patients (65 percent of the patients studied) complained of hearing issues. The types of hearing complications experienced included:
Hearing Loss
Of the 17 patients who had experienced hearing symptoms after taking the medication, four had new or worsened sensorineural hearing loss, a type of hearing loss associated with damaged hair cells in the inner ear. Two patients experiencing sensorineural hearing loss experienced improvements in the condition within six months after treatments ended.
Three patients suffered from a patulous eustachian tube, a disorder in which the channel between the middle ear and the back of the nose and throat remains open. This channel typically only opens when needed to regulate air pressure around the ear drum. While the symptoms of the patulous eustachian tube lessened within three months after patients stopped Tepezza treatments, they did not disappear.
Ringing in the Ears (Tinnitus)
Seven patients in the study experienced ringing in the ears, known as tinnitus. While sufferers with tinnitus most commonly hear ringing, some people suffer from hearing buzzing, chirping, hissing, humming, roaring, or even shrieking as a result of the condition. It is considered chronic tinnitus when the condition lasts longer than six months.
While tinnitus can occur anywhere on the auditory pathway, from the outer ear to the middle and inner ear and even the brain’s auditory cortex, the condition most commonly occurs due to damage to the hair cells in the cochlea. Aspirin, other anti-inflammatories, anticonvulsants, antimalarials, and some antibiotics can also cause tinnitus.
Ear Plugging Sensation
Six of the patients involved in the study reported muffled hearing and feeling like their ears were plugged. Muffled hearing is most commonly a result of sinus issues or earwax buildup. However, certain medications can also cause the sensation.
Autophony
For most people, the sound of their own voice sounds different to them than it does to other people. When someone speaks, their voice travels out their mouth, up the sides of their face, and into their ears, causing vocal vibrations to be felt in their ears and head. Autophony refers to a condition in which the sufferer’s own voice—and other bodily sounds such as breathing or the blood moving through arteries—sounds abnormally loud to them.
This condition often results from significant infections in the middle ear. However, it is also a common effect of a patulous eustachian tube, which has also been linked to Tepezza. Three individuals included in the research experienced autophony.
Additional Research Yields Similar Results
The study conducted by Stanford University researchers was just one that linked Tepezza infusions to hearing loss. Other studies have revealed similar results. A study published in February 2022 revealed that 81.5 percent of patients—22 out of 27 evaluated—suffered hearing complications after using the drug. Like the Stanford research, this study showed that otologic symptoms most commonly occurred between the third and fourth infusion treatments.
Both studies encouraged the use of screening to develop baseline hearing information about patients before they begin treatment so that they can monitor for new hearing loss during their treatment.
Is Tepezza Hearing Loss Permanent?
While it is not yet clear whether the hearing loss associated with Tepezza is permanent, several patients studied continued to experience hearing loss six months after treatment stopped. Several patients obtained treatment for hearing loss, and some showed improvement. The researchers who performed studies on the matter have stated that additional studies are needed to determine whether the condition can be reversed.
Does the Manufacturer of Tepezza Know It Can Cause Hearing Loss?
In February 2022, Tepezza manufacturer, Horizon Therapeutics USA Inc, issued a press release in which they noted that approximately 10 percent of the thousands of patients who participated in clinical trials before the drug’s approval “included a hearing-related event.” However, the company also stated that the adverse experiences reported by patients “were manageable, with few discontinuations or therapy disruptions.”
In August 2022, the first lawsuit was filed against the company by a patient who had used the drug. The lawsuit states that the company knew or should have known the medication, when used as prescribed, causes hearing loss and other hearing complications such as tinnitus. The complaint also notes that while Tepezza’s label contains warnings about potential side effects such as reactions to the infusions, worsening of irritable bowel disease, and an increase in blood sugar, it does not specifically address risks of hearing loss or tinnitus.
Seeking Compensation After Suffering Tepezza Hearing Loss
A lawsuit filed against the maker of Tepezza due to hearing loss is a type of personal injury claim known as product liability.
Product liability involves manufactured products, including drugs and food, that are unsafe due to:
- A design flaw that causes all lots of the medication to be unsafe as a result of an improper design.
- A manufacturing flaw that causes a product to become unsafe during the manufacturing process, such as introducing broken glass into the product or the presence of bacteria or foreign material in the product.
- A packaging flaw, such as failing to warn users of the product of all potential risks or failing to provide instructions on how to use the product safely.
Lawsuits filed against Horizon Therapeutics thus far have involved design flaws, as the company’s own clinical trials and studies about hearing loss associated with Tepezza have revealed a significant risk of hearing complications. These legal claims also suggest a packaging flaw, as the company has not mentioned that hearing complications are a known risk of using the medication.
What Should You Do If You Sufferer Hearing Complications After Tepezza Infusions?
Individuals who have suffered hearing complications after receiving Tepezza infusions should speak with an experienced product liability lawyer to learn more about the available legal options. While individuals injured by a defective product are not required to hire an attorney, these cases are often complex and place the claimant against a large pharmaceutical company with high-powered insurers and lawyers.
In other words, an attorney is crucial in obtaining the compensation you need in your Tepezza hearing loss case.
Is There a Class Action or Multi-District Litigation Associated with Tepezza Claims?
Product liability matters often involve hundreds or even thousands of claimants impacted by the same hazard.
Because of this, it is not unusual for the claims to be joined at least for part of the court process to relieve the burden on the court system hearing all of the cases individually and providing claimants with a standard resolution method.
- Multi-District Litigation (MDL) occurs when lawsuits containing similar claims against the same defendant in federal courts around the country are consolidated for the early part of the court process, known as discovery. While the claims are consolidated, each claimant has the same access to the evidence obtained through discovery and can use the same expert witnesses. After the discovery phase of the trial is complete, the judge may select a few individual cases to send to trial, known as “bellwether trials.” These trials are a test run to determine how juries are likely to decide the cases. For the defendant, this is a time to determine whether they wish to settle the remaining claims or feel they can fight each claim in court.
- Class actions involve many similar claims combined into one lawsuit in which a group of people (known as a “class”) seek compensation together. Just a few of the claimant’s testimony is presented as a representation of the injuries all class members incurred.
To date, no MDLs or class actions involve Tepezza claims. However, plaintiffs will likely file hundreds or even thousands of new claims in the coming months as more people suffer hearing complications related to Tepezza use. A product liability lawyer can file your Tepezza claim and keep you informed as the case—and others like it—progress.
Compensation You Can Seek
If you experienced hearing complications due to Tepezza use, you can seek compensation for the expenses and impacts of the injury.
Expenses include:
- The medical treatments and tests provided to reverse the condition.
- The wage loss associated with frequent treatments or the inability to work due to symptoms of the complication.
- Even loss of future earning capacity for permanent hearing loss that impairs the sufferer’s ability to work.
The types of impacts you can seek compensation for include:
- The physical pain and suffering associated with the complication,
- The mental distress from permanent hearing loss and
- The loss of the enjoyment of hobbies and activities you previously enjoyed, such as musical or theatrical performances or simple conversations with family and friends.
Contact an experienced product liability attorney for your free case evaluation and learn how you can pursue compensation for your losses due to Tepezza.