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Tepezza Lawsuit Guide (January 2024 Update)
Since there are many potential plaintiffs due to the number of people who used Tepezza and who were struck with hearing loss or tinnitus, it makes sense to consolidate these cases.
This could happen in a few ways. One option is a class action, which would mean many plaintiffs' cases are grouped together in one big case. Cases can also be consolidated in a multidistrict litigation (MDL), which means many independent cases are moved before one judge to simplify the management of those cases.
Tepezza plaintiffs have already moved to consolidate independent claims in a multi-district litigation, and the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order in June of 2023, consolidating pending Tepezza lawsuits in the Northern District of Illinois.
After cases are combined, coordinated pretrial proceedings take place. This means the judge rules on issues that relate to all cases. Since the MDL is relatively new in Tepezza cases, not many pre-trial actions have taken place yet, though.
There are more than 59 pending cases that are part of the consolidated MDL as of December 2023. More plaintiffs may join as cases are filed in federal court. And some plaintiffs may opt to pursue their own claims in state court as well.
When MDL takes place, something called bellwether trials are scheduled. These are trials with representative plaintiffs, and the goal is to see how the case plays out in court. This can help inform settlement negotiations. Based on how the cases go, the defendant may decide to offer a settlement that, if accepted, could be split with all of the plaintiffs who are part of the mass tort case.
Tepezza Bellwether CasesInitially, 12 candidate cases will be selected as bellwether cases among the pending Tepezza claims. The plaintiffs and defendants will each select four, and four will be chosen at random. However, many steps have to happen before then, and the Tepezza case is still in the very early phases.
The most recent action involved a narrative submission submitted by the plaintiffs' attorneys, which includes allegations that the defendant has not complied properly with initial requests for information during the discovery process. That's the process by which information is exchanged so both sides can build their cases.
The court will be making many more rulings on procedural issues in the coming months before bellwether cases will move forward. And plaintiffs can continue to join the MDL or pursue other means to file claims against Horizon if they suffered consequences due to this allegedly dangerous drug.
Did you experience hearing loss and tinnitus after using Tepezza? You may be eligible for significant compensation. Find out if you qualify.
Could A Drug Prevent Hearing Loss From Loud Music And Aging?
Researchers have found a gene that links deafness to cell death in the inner ear in humans -- creating new opportunities for averting hearing loss.
A person's hearing can be damaged by loud noise, aging and even certain medications, with little recourse beyond a hearing aid or cochlear implant.
But now, UCSF scientists have achieved a breakthrough in understanding what is happening in the inner ear during hearing loss, laying the groundwork for preventing deafness.
The research, published on Dec. 22, 2023, in the Journal of Clinical Investigation Insight, links animal studies on hearing loss with a rare type of inherited deafness in humans. In both cases, mutations to the TMTC4 gene trigger a molecular domino effect known as the unfolded protein response (UPR), leading to the death of hair cells in the inner ear.
Intriguingly, hearing loss from loud noise exposure or drugs such as cisplatin, a common form of chemotherapy, also stems from activation of the UPR in hair cells, suggesting that the UPR may underly several different forms of deafness.
There are several drugs that block the UPR -- and stop hearing loss -- in laboratory animals. The new findings make a stronger case for testing these drugs in people who are at risk of losing their hearing, according to the researchers.
"Millions of American adults lose their hearing due to noise exposure or aging each year, but it's been a mystery what was going wrong," said Dylan Chan, MD, PhD, co-senior author on the paper and director of the Children's Communication Center (CCC) in the UCSF Department of Otolaryngology. "We now have solid evidence that TMTC4 is a human deafness gene and that the UPR is a genuine target for preventing deafness."
How hair cells in the ear self-destruct
In 2014, Elliott Sherr, MD, PhD, director of the UCSF Brain Development Research Program and co-senior author of the paper, noticed that several of his young patients with brain malformations all had mutations to TMTC4. But laboratory studies of this gene soon presented a conundrum.
"We expected mice with TMTC4 mutations to have severe brain defects early on, like those pediatric patients, yet to our surprise, they seemed normal at first," Sherr said. "But as those animals grew, we saw that they didn't startle in response to loud noise. They had gone deaf after they had matured."
Sherr partnered with Chan, an expert on the inner ear, to look into what was happening to the mice, which looked like an accelerated version of age-related hearing loss in humans. They showed that mutations to TMTC4 primed hair cells in the ear to self-destruct, and loud noise did the same thing. In both cases, hair cells were flooded with excess calcium, throwing off the balance of other cellular signals, including the UPR.
But they found there was a way to stop this. ISRIB, a drug developed at UCSF to block the UPR's self-destruct mechanism in traumatic brain injury, prevented animals who were exposed to noise from going deaf.
The first adult human deafness gene
In 2020, scientists from South Korea, led by Bong Jik Kim, MD, PhD, connected Chan and Sherr's 2018 findings with genetic mutations they found in two siblings who were losing their hearing in their mid-20s. The mutations were in TMTC4 and matched what Chan and Sherr had seen in animals, although they were distinct from those in Sherr's pediatric neurology patients.
"It's rare to so quickly connect mouse studies with humans," Sherr said. "Thanks to our Korean collaborators, we could more easily prove the relevance of our work for the many people who go deaf over time."
Kim, an otolaryngologist at the Chungnam National University College of Medicine (Korea), facilitated the shipping of cells from those patients to UCSF. Sherr and Chan tested those cells for UPR activity and found that, indeed, this flavor of TMTC4 mutation turned on the destructive UPR pathway in a human context.
When Chan and Sherr mutated TMTC4 only in hair cells in mice, the mice went deaf. When they mutated TMTC4 in cells from individuals in the Korean family who hadn't gone deaf, and in laboratory human cell lines, the UPR drove the cells to self-destruct. TMTC4 was more than a deafness gene in mice -- it was a deafness gene in humans, too.
Translating a discovery to prevent deafness
Understanding TMTC4 mutations gives researchers a new way of studying progressive deafness, since it is critical for maintaining the health of the adult inner ear. The mutations mimic damage from noise, aging or drugs like cisplatin.
The researchers envision a future where people who must take cisplatin, or who have to be exposed to loud noises for their jobs, take a drug that dampens the UPR and keeps hair cells from withering away, preserving their hearing.
The science also suggests that the UPR could be targeted in other contexts where nerve cells become overwhelmed and die, including diseases long thought to be incurable, like Alzheimer's or Lou Gehrig's disease.
"If there's any way that we can get in the way of the hair cells dying, that's how we're going to be able to prevent hearing loss," Chan said.
Hearing Loss Increases The Risk Of Dementia
People who are hard of hearing spend more energy listening. That energy comes at the expense of other cognitive functions. Cognitive functions are the mental processes in the brain that enable us to think and solve problems, among other things.
In a new study featuring data from 573,088 people, researchers from the Department of Clinical Research at the University of Southern Denmark have found a link between hearing loss and the development of dementia. The study is the largest of its kind to date.
There is already an increase in the number of people with dementia. This is mainly due to the ageing of the population as a whole, but there are also other risk factors, such as lifestyle and hearing.
- Previous studies have suggested that there could be a link between hearing loss and dementia. Our study is larger than the previous studies, and we have demonstrated a link between hearing loss and dementia, says Assistant Professor Manuella Lech Cantuaria from the Department of Clinical Research at the University of Southern Denmark.
The results of the study show that people affected by hearing loss have up to a 13% higher risk of developing dementia compared to people with normal hearing. The high risk is especially seen in people with severe hearing loss.
The researchers also studied whether there was a difference in the risk depending on whether or not people wear hearing aids.
- We found that the risk of developing dementia was 20% higher for people who didn't wear hearing aids compared to people with normal hearing. People who used hearing aids had a 6% increased risk of developing dementia. This suggests that wearing a hearing aid can prevent or delay the development of dementia, explains Manuella Lech Cantuaria.
About the studyThe study is a so-called cohort study that follows a group of people with common characteristics over a longer period of time. In this study, all of the people were above 50 years of age and from the Region of Southern Denmark between 2003–2017. People diagnosed with dementia before the commencement of the study were excluded. The researchers compared data on people's hearing with data on the development of dementia during the period. The researchers have found a significant – that is, clear – correlation between hearing loss and the development of dementia.
Hearing loss – a national scourgeAround 800,000 Danes suffer from hearing loss. And that number is only likely to get higher in the future because we are getting older in general, and we are exposed to more and more noise. Hearing loss is measured in decibels (dB). There are different degrees of hearing loss. For example, hearing loss above 60–70 dB means you can't hear normal speech. Above 90–100 dB means you can't hear shouting.
DementiaDementia is a term used to describe the weakening of mental abilities due to illness in the brain. Dementia is characterised by an impairment of cognitive functions such as: Impaired memory and concentration, impaired orientation, language disorders, personality and behavioural changes. Alzheimer's, for example, is a type of dementia.
JournalJAMA Otolaryngology–Head & Neck Surgery
Method of ResearchData/statistical analysis
Subject of ResearchPeople
Article TitleHearing Loss, Hearing Aid Use, and Risk of Dementia in Older Adults
Article Publication Date4-Jan-2024
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