Tepezza Hearing Loss Lawsuit

Our lawyers are investigating Tepezza hearing loss lawsuits in all 50 states. This page examines Tepezza class action lawsuits, discusses when they might settle, and describes possible settlement amounts (or jury payouts).

People who had Tepezza injections for TED and subsequently suffered hearing loss or tinnitus may be eligible to bring a product liability lawsuit and get financial compensation. Our lawyers are currently accepting Tepezza hearing damage cases.

Our attorneys believe in these lawsuits. While there are no guarantees, we are optimistic that high settlement amounts will be offered, maybe even before a single Tepezza lawsuit goes to trial. This page provides the latest news and updates on the Tepezza litigation, as well as our estimated settlement value of these cases.

Tepezza Lawsuit Update

Our lawyers will keep you abreast of what is happening with our Tepezza lawsuit updates as news develops:

November 13, 2024: The court addressed the plaintiffs’ motion we discussed in our last update and we got a good ruling. The court found the defense counsel’s objections were obstructive and unnecessary. The court noted that the defendant’s repeated objections over document foundations were largely misplaced, as documents produced during discovery imply authentication. It also found that another defense attorney could have used a “running objection” rather than repeatedly objecting.

None of this really matters but it is good for the judge to get an idea of who the good guys and the bad guys are in the litigation.

November 4, 2024: In mass tort cases, defense lawyers are expected to limit their objections in depositions to issues of form and foundation. But they cannot help themselves. The temptation to influence the witness’s testimony, subtly or otherwise, lead to speaking objections, witness coaching, or repetitive interruptions.

During a recent deposition of Horizon’s Director of Regulatory Affairs, plaintiffs’ counsel alleges that defense attorneys repeatedly crossed the line with speaking objections and witness coaching. Plaintiffs’ attorneys observed that each time they tried to question the witness about key regulatory documents, Horizon’s counsel interjected with extended objections, calling into question whether the documents were relevant or if the witness was even familiar with them.

At one point, before plaintiffs’ counsel could complete a question, defense counsel interrupted to state that the documents at hand were only “draft exchanges” not directly connected to defense lawyer. This line of objection, plaintiffs argue, was clearly aimed at shaping the witness’s answers by pre-emptively suggesting that her knowledge of the documents was limited.

When plaintiffs’ counsel tried to proceed, defense counsel maintained a constant flow of “foundation” objections, arguing the documents had not been properly authenticated or confirmed. Of course, this is nonsense. If the witness held a central role in Horizon’s regulatory affairs during Tepezza’s FDA approval process, she should have insight into these documents.

Plaintiffs’ lawyers have filed a motion in an effort to make sure this does not continue to happen.

November 1, 2024: The Tepezza MDL continues to experience gradual growth, with only two new cases added in October, bringing the total to 180 pending cases.

This slow increase underscores the slow pace at which plaintiffs are joining the litigation. There are many more victims out there. But despite steady efforts from plaintiffs’ attorneys to build awareness, the MDL’s modest growth tells us the message has not gotten through. This litigation probably will not grow all that much.

As we discuss below, we think there is more upside than downside for existing plaintiffs with the litigation so small in terms of how quickly the litigation progresses and the settlement amounts victims will ultimately receive.

October 29, 2024: Taking advantage of a now-fixed Michigan law, Horizon was able to dismiss one of the 12 bellwether cases in the MDL. Judge Durkin ruled that Michigan law applied to the plaintiff’s claim since she took the drug and experienced alleged side effects in Michigan, despite the suit being filed in Illinois where Horizon is based.

Horizon relied on a now-repealed Michigan law that barred product liability claims against FDA-approved drugs. The law has since been fixed but it is not retroactive.

October 18, 2024: In a newly filed lawsuit, an Oklahoma resident has taken legal action against Horizon Therapeutics claiming that Tepezz caused irreversible hearing damage. The plaintiff, who was treated for thyroid eye disease between November 2022 and February 2023, asserts that Horizon failed to provide adequate warnings about the risk of permanent hearing loss, despite evidence of the drug’s potential side effects.

This appears to be a strong case. The lawsuit highlights that Horizon only updated the Tepezza label to include a warning about severe hearing impairment in July 2023—not long after the plaintiff had already undergone several infusions. It further alleges that Horizon was aware of reports and clinical studies indicating the risk of hearing-related issues well before the warning change.

The plaintiff argues that Horizon’s failure to act on this information earlier directly resulted in significant harm and seeks both compensatory and punitive damages for the company’s alleged negligence in addressing known risks.

October 1, 2024: Only five new cases were added to the Tepezza hearing loss class action MDL during September. There are now 178 pending cases in the MDL. Again, this is not going to be a huge MDL, but our lawyers think these lawsuits have high settlement values.

September 17, 2024: A Florida woman has filed a new lawsuit against Horizon Therapeutics USA, Inc., alleging that the company’s drug, Tepezza, caused her permanent hearing loss. The plaintiff received Tepezza infusions from October 2020 to June 2021 to treat thyroid eye disease.

She claims that Horizon Therapeutics failed to provide adequate warnings about the risks of hearing damage, despite numerous reports and studies linking the drug to permanent hearing impairment and tinnitus. The lawsuit highlights that the Tepezza label did not include warnings about these risks until July 2023, several years after her treatment began.

The plaintiff seeks damages for the injuries she suffered as a result of the company’s alleged failure to properly inform patients and healthcare providers about the potential side effects of Tepezza.

Horizon Therapeutics, which as we discuss below was acquired by Amgen Inc. in 2023, is accused of failing to conduct adequate safety studies and delaying necessary label changes that would have warned of these severe risks. The plaintiff is requesting compensatory and punitive damages for her injuries.

September 3, 2024: In August, 33 new cases were added to the Tepezza hearing loss MDL. That is significantly higher than the normal volume of new cases that we have seen so far in the MDL. There are now 173 total cases pending.

August 27, 2024: The next status conference in the MDL has been set for September 5, 2024. Earlier this summer the defense filed a motion to dismiss one of the bellwether discovery cases for failure to state a claim. Oral arguments on that motion have been set for October 16, 2024, although the outcome of that will only impact 1 specific case. Otherwise August has been a very slow month in the Tepezza MDL.

August 18, 2024: The parties have successfully negotiated an agreement regarding the number and scheduling of depositions. According to the Joint Status Report, they have settled on the total number of depositions and divided them into two phases: those to be completed before February 14, 2025, and those to be conducted between this date and April 10, 2025. Additionally, they have reached consensus on various aspects of the deposition process.

Our take continues to be these cases will likely settle much quicker than you usually see in an MDL and long before the first bellwether trial in 2026.

August 1, 2024: Growth in the Tepezza MDL continues to be slow. Only 10 new cases were added to the MDL in July, bringing the total number of pending cases up to 148.

I’m surprised at how few Tepezza leads we get in 2024, honestly. There are more victims out there on the sidelines. If you have a case, you should call a Tepezza lawyer – preferably us – sooner rather than later.

July 30, 2024: Horizon filed a motion to dismiss that will surely fail. Meanwhile, lawyers for both sides in the Tepezza MDL were scheduled to meet and work out issues regarding the scope and number of corporate and expert witness depositions that would be permitted. The defendants are seeking to limit the number of corporate depositions while the plaintiffs are pushing for as many as possible. The parties are supposed to report back to the MDL judge sometime this week.

July 18, 2024: There will be a Tepezza settlement mediation this month. It is hard to be optimistic these settlement talks will yield a resolution but hopefully some progress can be made.

July 14, 2024: There is good news and bad news in the Tepezza litigation. The good news the court has set bellwether trial dates:

Bellwether	Date
First Bellwether Plaintiff Trial (3-4 weeks)	March 9, 2026
Second Bellwether Plaintiff Trial (3-4 weeks)	May 4, 2026
Third Bellwether Plaintiff Trial (3-4 weeks)	June 29, 2026
Fourth Bellwether Plaintiff Trial (3-4 weeks)	August 24, 2026

The bad news is obvious – the first trial is still 20 months away. There is talk of an early Tepezza settlement long before we get to 2026. It is rare have an MDL settlement until a trial date gets closer. But the small size of this litigation makes an early settlement possible.

July 1, 2024: The Tepezza MDL continues to grow at a steady rate. Nineteen new lawsuits were added last month. One of those lawsuits, filed last Thursday, was on behalf of a plaintiff from Arvada, Colorado who received three infusions of Tepezza from May 20, 2022, to June 30, 2022, and claims that the drug led to severe and potentially permanent hearing loss.

The plaintiff argues that the manufacturer of Tepezza was aware or should have been aware of the risks associated with the drug. Scientific studies, patient reports, and post-marketing data have indicated that Tepezza can cause significant hearing impairments. Despite this knowledge, the defendant allegedly failed to provide adequate warnings or instructions about the need for audiologic monitoring before, during, and after treatment. It wasn’t until July 17, 2023, that the drug’s label was updated to include warnings about the risk of severe hearing impairments and the necessity of hearing assessments.

June 5, 2024: The first bellwether trial for the Tepezza MDL is set for March 9, 2026. Following this, three additional trials are scheduled, with the second starting on May 4, 2026, the third on June 29 of the same year, and the fourth slated to begin on August 24, 2026.

Is that a long time from now? It is. Unfortunately, this is how mass torts work. I do think there will be a Tepezza settlement before one of these lawsuits goes to trial. Plaintiffs’ lawyers really like these cases, and there is not the volume of cases we thought we would see when this whole thing got started. That will make settlement much easier for Horizon.

June 3, 2024: More slow growth in the Tepezza hearing loss class action MDL. Just 7 new cases were added to the MDL over the last month, which is even less than what we saw in April. There are now 120 total cases in the MDL.

June 2, 2024: Horizon has picked four women as its bellwether selections.

May 20, 2024: The judge in the Tepezza hearing loss MDL recently set a date of March 9, 2026, for the first bellwether trial to begin. Judge Durkin has instructed both sides to collaborate and submit a proposed schedule for how discovery and bellwether case selection should proceed leading up to the bellwether trial.

May 1, 2024: We continue to see very slow growth in the Tepezza hearing loss litigation. Only 13 new cases were added to the Tepezza hearing loss MDL over the month of April. There are now just 113 total cases pending in the MDL.

April 13, 2024: The status hearing originally scheduled for April 22, 2024, before the magistrate judge, has been canceled. The joint status report, previously due on April 18, 2024, is now required to be submitted by April 24, 2024.

Additionally, an in-person status hearing before the Honorable Thomas M. Durkin is scheduled for May 1, 2024, at 1:30 p.m.

April 9, 2024: In a new Tepezza lawsuit, a Florida man alleges he sustained severe injuries due to the infusions of Tepezza.

Diagnosed with eye disease, the man underwent a series of Tepezza infusions from February 25, 2022, to July 29, 2022 in Ohio. Throughout the treatment period, neither he nor his doctors were warned or had any knowledge of Tepezza’s serious risk of causing permanent hearing loss and/or tinnitus. It was not until July 2023 that information about Tepezza’s potential to cause permanent hearing damage became known, with no prior directives for baseline audiology testing or hearing acuity monitoring during treatment. As a result, the plaintiff now suffers from permanent hearing loss and tinnitus due to the Tepezza infusions. Consequently, he is seeking compensation for the permanent injuries sustained from these infusions.

April 1, 2024: The growth in the Tepezza hearing loss class action MDL continues to be very slow. Only 8 new cases were added to the MDL over the last month. That brings the current total of pending cases up to 101. There were 54 pending cases when the Tepezza MDL was created back in August 2023.

March 19, 2024: Oral arguments are tomorrow on the defendants’ effort to slow down the process of getting to bellwether trials. It is hard to imagine the MDL judge will not want to push this litigation forward, but we should know soon enough.

March 13, 2024: Lawyers defending Tepezza for Horizon want to slow things down. They have submitted a request to the MDL judge to postpone for two months the deadline for choosing four lawsuits related to Tepezza hearing loss for early bellwether discovery and potential trial preparation. The company cites the ongoing review of medical records to identify the most suitable cases for this process as the reason for needing more time.

It is all the same; only the names change. Defendants want to slow the pace of litigation any way they can. What we need to do is push forward to get these lawsuits to trial because that is how we get to a Tepezza settlement.

March 10, 2024: Last month, 19 new cases were transferred into the Tepezza hearing loss class action MDL, bringing the total number of pending cases in the Tepezza MDL to 93. This is also the largest monthly volume of new cases since the MDL was created seven months ago.

March 1, 2024: Good news for patients looking for an alternative to Tepezza. Innovent Biologics’ thyroid eye disease (TED) treatment, a direct competitor to Amgen’s Tepezza, is on the verge of approval in China following a successful phase 3 trial.

The trial showcased the treatment’s ability to significantly reduce eyeball protrusion compared to a placebo, with 85.8% of participants treated with Innovent’s candidate, IBI311, showing a marked improvement. This promising result, along with no serious adverse events reported, positions Innovent to swiftly pursue a new drug application in China and perhaps here soon.

February 15, 2024: Tepezza lawyers reported yesterday that there is still disagreement over a protocol for handling data from non-custodial sources. Should unresolved issues remain, both parties will present their arguments through simultaneous submissions to the Court by 5:00 p.m. CST on February 28, 2024. Presumably, the court would resolve this difference at the status conference on March 6th.

February 8, 2024: The parties have agreed to a plan for how Horizon will produce documents in the Tepezza hearing loss lawsuits. For those of you hoping for a Tepezza settlement in 2024, this agreement is a dose of cold water. Horizon will not complete the full production until the end of the year.

Gaining access to Horizon’s internal documents is key to this litigation. Tepezzaa lawsuits think these documents will fully reveal what Horizon knew about the risks associated with Tepezza and when they knew it. Effective discovery strategies will be essential to unearth emails, meeting minutes, and internal studies that could prove critical in establishing knowledge and liability.

There is talk that this will be the MDL that settles earlier than you think. That would be great, but we need to keep pressure on Horizon.

January 15, 2024: Since mid-December, three new cases alleging hearing loss have been added to the Tepezza class action MDL. That brings the total number of cases in the Tepezza MDL up to 74. (There was a case – Ingram v. Horizon – filed in 2024 that is not in that count, so the actual number is 75.)

Again, as our lawyers have said, this will not be huge litigation. This is bad news for Tepezza lawsuits but, by and large, probably good news for victims. It will make it easier to settle this litigation faster with a higher average settlement amount than if there were many thousands of plaintiffs.

January 9, 2024: Attorneys engaged in the Tepezza hearing loss litigation have jointly requested an extension from the presiding U.S. District Judge. They seek 60 days beyond the original deadlines to review medical records and other critical documents. This extension is needed to more effectively identify which cases should be included in the Initial Bellwether Discovery Pool for test trials. These test trials are key to determining settlement amounts in the litigation. So lawyers on both sides are pressed to get it right.Originally, on November 1, Judge Durkin had allocated 60 days for the plaintiffs to choose four cases for this initial pool, while the defendants were given 90 days to select their four cases. Following these selections, the parties were to collaborate on finalizing a list of remaining eligible Tepezza lawsuits. The Court would randomly pick four additional cases from this list, bringing the total to 12. However, in a joint agreement submitted on January 2, 2024, lawyers on both sides indicated to the court that they require more time, agreeing on the necessity of a 60-day extension for selecting the bellwether cases.

January 8, 2024: On June 25, 2023, the JPML centralized litigation before Judge Thomas Durkin. That was six months ago. Where are we now? The answer is not far. The slow progress of this MDL, noted in the latest CMC, must end.

Tepezza plaintiffs’ attorneys are on it. They filed a motion opposing Horizon’s request to postpone tomorrow’s case management conference. Why do they want to postpone? They claim there’s nothing for the Court to resolve. But that is not the only reason for a status conference.

The Tepezza plaintiffs’ attorneys argue that disputes, like the unresolved Production Protocol, need the Court’s intervention. But, more to the point, these get-togethers with the lawyers and judge advance the litigation. Defendants love to stall. Delaying the CMC would only perpetuate the MDL’s slow pace.

Hopefully, the status conference goes off as planned tomorrow. The judge will have to rule today at some point.

January 1, 2024: The last week of 2023 was extremely slow for the Tepezza hearing loss class action MDL. No entry was made on the MDL over the last week of the year.

December 18, 2023: Twelve new cases were transferred into the Tepezza hearing loss class action MDL over the last month, bringing the current case total up to 71. That may seem insignificant, but it is double the volume of new cases we saw last month and could be the start of a growth trend as we head into 2024.

December 1, 2023: We already have an early discovery battle taking shape in the newly created Tepezza hearing loss MDL. Plaintiffs’ lawyers recently filed a “Narrative Submission” before an upcoming conference. The narrative outlines a number of complaints about the way Horizon and its defense team have complied (or failed to comply) with initial discovery issues and requests.

November 20, 2023: A Florida woman became one of the most recent plaintiffs in the Tepezza hearing loss class action litigation. According to the Complaint in her case, the woman received Tepezza infusions for thyroid eye disease from August 2022 to April 2023. After her last Tepezza infusion, the woman alleges that she suffered permanent hearing loss and tinnitus (ringing in the ears). Her lawsuit alleges that Horizon Therapeutics negligently failed to warn her and her doctor about the risk of hearing damage associated with Tepezza.

November 19, 2023: Only five new cases were transferred into the Tepezza hearing loss class action MDL over the last month. There are now 59 pending cases in the MDL, which has grown very slowly in the first three months of its existence.

This is a good thing for victims in many ways. A smaller pool of plaintiffs in an MDL makes settlement easier and faster to effectuate.

November 6, 2023: Lawyers for Tepezza victims knocked by a motion to dismiss, allowing claims alleging Horizon should have developed a safer version of its thyroid eye disease drug, Tepezza, before seeking FDA approval. The plaintiffs contend that the drug is linked to hearing loss. The court ruled that federal law does not preempt these “pre-approval” design defect claims.

The plaintiffs’ willing argument was that Horizon had a duty under state law to propose a formulation that did not lead to permanent hearing damage. According to the court, at this point in the process, federal law doesn’t dictate Horizon’s design choices, allowing the state-law claim to stand.

November 3, 2023: Yesterday, the judge in the Tepezza hearing loss class action MDL issued a new Case Management Order laying out the rules and procedures for the bellwether case selection process and the bellwether trials. An initial pool of 12 bellwether candidate cases will be selected in 60 days. Each side will select 4 cases, and the remaining four will be randomly selected. These 12 cases will then go through a fact-discovery process.

September 18, 2023: In June, 41 cases were pending in the Tepezza class action MDL. As of this week, there are not 54, a comparatively small increase. As we move forward, the volume of new cases will likely start to pick up considerably.

September 14, 2023: The Tepezza class action is now being overseen by Magistrate Judge M. David Weisman to manage the discovery process, including the authority to modify the discovery deadline and oversee the settlement conference.

The preliminary status hearing is set for September 19, 2023, at 9:15 a.m. Plaintiffs can listen in if they like. The conference call-in number is 1-877-411-9748, and the passcode is 1814539. (The big thing is just do not record anything because that is against court rules.)

September 11, 2023: Amgen Inc., one of the biggest biopharma companies in the world, has reached a deal with the FTC that will enable it to move forward with its $27 billion acquisition of Horizon Therapeutics, the manufacturer of Tepezza. Amgen’s acquisition was halted when the FTC obtained an injunction to stop the deal based on concerns that it would violate anti-trust laws. Now that the deal is back on, Amgen will assume liability for the Tepezza hearing loss claims. This is a positive development for plaintiffs because Amgen is a bigger company with more financial resources to cover any eventual settlement.

September 10, 2023: There was a status hearing in the Tepezza class action lawsuit on Friday, September 8, 2023.

During this hearing, Tepezza lawyers were directed to submit a proposed agreed order concerning matters related to 502(d) and privileged materials and a protective order to the Court. This would allow Horizon’s lawyers to share documents or information during the discovery process without necessarily giving up their attorney-client privilege or work-product protection.

The Honorable M. David Weisman will assist the MDL judge in handling various aspects of this lawsuit, including overseeing the discovery process and facilitating potential settlements.

September 1, 2023: Plaintiffs in the Tepezza class action MDL are pushing for a fast schedule to get to the first round of bellwether trials as soon as possible.

In the proposed bellwether schedule submitted by the plaintiffs’ lawyers and discussed yesterday at a status conference, each side would select three bellwether candidate cases for a short case-specific discovery phase of 150 days.

After that brief discovery period, three of the six lawsuits will be picked for the first test trials. Defense counsel for Horizon Therapeutics submitted its proposal, which called for a slightly larger pool of 10 cases to go through bellwether discovery.

August 18, 2023: A new Tepezza lawsuit – Mhamdi v. Horizon Therapeutics USA, Inc. – was directly filed this week in the MDL 3568 by a Florida woman who claims that she suffered severe injuries as a direct result of the plaintiff’s infusion of the biological product Tepezza.

This plaintiff was diagnosed with thyroid eye disease and/or Graves’ Disease and received Tepezza infusions from Plaintiff’s physician from August 2020 through February 2023. She now has permanent hearing loss and/or tinnitus.

Her Tepezza suit alleges that she and her physicians were given no warning and they had no knowledge of the severe risk of permanent hearing loss or tinnitus posed by Tepezza.

August 15, 2023: Five new Tepezza hearing loss cases were transferred into the new Tepezzza class action MDL over the last month. That brings the current number of pending cases up to 46 for an MDL only three months old. This will probably never be a huge class action, but we could quickly get to 100 by the end of the year… and every lawyer you talk to is very high on these cases. (Update: we got to 73 in 2023.)

August 2, 2023: We are still waiting for the first major scheduling order to be issued in the new Tepezza class action MDL. In the meantime, the stream of new incoming Tepezza hearing loss lawsuits has been intermittent. Only three new Tepezza cases were filed in July, but June was the highest-volume month to date, with 16 new cases filed.

July 25, 2023: Amid mounting lawsuits against Horizon Pharmaceuticals over allegations of Tepezza-induced hearing loss, the company is under scrutiny for purportedly failing to sufficiently warn consumers and the medical fraternity about the associated risks of their thyroid eye disease medication.

The government is stepping deeper to protect patients. The FDA has updated Tepezza’s warning to include strong language that Tepezza might inflict severe and irreversible auditory damage.

What we saw in the Elmiron litigation was lower settlement amounts if the patient continued to use the drug after the new warning. So, should you stop taking the drug to protect your future Tepezza lawsuit? Your health is more important than your lawsuit. You should talk to your doctor about the best course of action.

June 19, 2023: On June 28, 2023, the new Tepezza class action MDL judge will hold the first status conference with all parties and their attorneys. The meeting will be Judge Durkin’s first opportunity to become familiar with the litigation and develop his plan for collectively managing the Tepezza hearing loss lawsuits. Judge Durkin will also explain how he will select individual lawyers to serve on the plaintiffs’ steering or executive committee for the litigation.

June 5, 2023: It is official. There is now a new Tepezza class action lawsuit against Horizon Therapeutics USA Inc. The lawsuit alleges that the company failed to warn about potential hearing loss and tinnitus caused by their thyroid eye disease drug, Tepezza. The MDL Panel has consolidated the cases, and Judge Thomas M. Durkin of Chicago will preside over this class action (technically not a class action but an MDL).

Our legal team is confident in the strength of these lawsuits. We expect that victims will receive just settlement compensation, particularly now that plaintiffs will have a jointly organized plan to pursue discovery and put these Tepezza lawsuits together.

May 31, 2023: A new Tepezza lawsuit was filed in Ohio last week. The plaintiff was diagnosed with thyroid eye disease (or Graves’ disease) and underwent a course of Tepezza infusions from April 2021 through October 2021. During these critical times, her Tepezza lawsuit alleges neither the plaintiff nor their physicians were provided any warnings or made aware of the severe risk of permanent hearing loss and/or tinnitus associated with Tepezza. The plaintiff now suffers from permanent hearing loss (and/or tinnitus – the complaint was short on nailing down the details).

May 22, 2023: With the JPML set to hear oral arguments on whether to create a new class action MDL, the pace of new Tepezza hearing loss cases continues to accelerate. Ten new Tepezza lawsuits were filed in federal courts over the last week. Meanwhile, Amgen’s acquisition of Horizon Therapeutics may be off after the Federal Trade Commission sought an injunction to block the $27 billion deal.

May 11, 2023: As we previously reported, With the number of Tepezza hearing loss lawsuits continuing to rise, the Judicial Panel on Multidistrict Litigation (JPML) is set to hold a hearing on May 25, 2023, to determine whether the Tepezza cases in federal courts should be consolidated into a class action MDL.

Horizon Therapeutics, the manufacturer of Tepezza, has now filed a motion opposing MDL consolidation. In their opposition motion, Horizon argues that an MDL is not warranted because there are not enough pending cases. In a bit of wishful thinking, Horizon also suggests that the number of Tepezza lawsuits filed in the future will be limited.

May 8, 2023: The pace of new Tepezza hearing loss lawsuits being filed around the country has increased dramatically over the last six weeks. When a motion seeking MDL consolidation was filed back in March, it listed just 18 Tepezza cases pending in 5 different federal districts. Since that motion was filed, however, seven more Tepezza hearing loss lawsuits have been filed in federal courts across the country. The JPML is set to consider whether to create a new class action MDL at the end of this month.

April 26, 2023: The Multidistrict Litigation (MDL) panel, also known as the U.S. Judicial Panel on Multidistrict Litigation (JPML), is a group of federal judges responsible for determining whether to consolidate and centralize civil cases that involve similar questions of fact and are filed across multiple federal courts.

The panel’s purpose is to streamline and coordinate pretrial proceedings, promoting efficiency, avoiding duplicate discovery, and preventing inconsistent rulings. On May 25, 2023, this panel of judges will decide whether a Tepezza class action lawsuit should be created to consolidate all federal court cases under one judge.

April 14, 2023: As more Tepezza lawsuits are filed and we await a ruling on whether there will be a class action lawsuit, Horizon keeps looking to make more money from Tepezza. Today, Horizon Therapeutics announced new FDA approval for an amendment to the indication language for Tepezza, broadening when the drug should be used in treating Thyroid Eye Disease (TED) patients.

This change comes after a Phase 4 clinical trial showed positive results, with patients receiving Tepezza experiencing a significant reduction in proptosis at Week 24 compared to those given a placebo. The revised indication aims to offer unrestricted access to all eligible patients throughout the entire range of TED, potentially alleviating the access burden for both patients and doctors and shortening the time to treatment. The company intends to present the Phase Four trial data at an upcoming medical congress and publish the findings in a peer-reviewed medical journal.

The reality is that for drug companies, what seems to us like a King’s ransom in settlement payouts and jury awards is a drop in the bucket to the billions these companies can make. Horizon could weather a successful Tepezza class action lawsuit and still make a huge profit for the drug.

April 13, 2023: Recently, a motion was filed seeking consolidation of the hearing damage lawsuits into a single Tepezza class action lawsuit for federal court claims. The motion was filed with the Judicial Panel on Multidistrict Litigation (JPML), and it lists 18 pending Tepezza product liability cases across five different federal districts. If the MDL is granted, the movants request that the venue be the Northern District of California.

April 4, 2023: A research team from Stanford University recently published a new case study report that indicates that hearing loss is directly connected to dosage levels of Tepezza injections. The case study looked at a 64-year-old woman who received a full round of Tepezza injections in 2021. She immediately suffered significant side effects from injections, including hearing loss in both ears. When she was taken off the injections, her hearing problems went away. A year later, her doctors tried another round of Tepezza injections, this time at a much lower dose, and the woman did not experience the same hearing loss issues as with the first round. The case study provides further evidence that there is a clear and direct link between Tepezza and hearing loss.

March 24, 2023: Since the start of March, four new lawsuits have been filed in federal courts alleging that Tepezza injections caused permanent hearing damage. A total of 34 Tepezza hearing loss lawsuits have been filed in the federal courts to date. Voluntary dismissals were filed in 13 of those cases, indicating that they might have been settled.

February 28, 2023: What a Tepezza hearing loss suit looks like.

February 14, 2023: The maker of Tepezza, Horizon Therapeutics, is seeking to have the Tepezza hearing loss claims against it dismissed under the doctrine of federal preemption. Preemption motions are very common in product liability cases, especially those involving claims of failure to warn about prescription drug risks. Horizon’s motion to dismiss argues that the tort claims asserted by the Tepezza plaintiffs are preempted by federal law because the FDA regulated Horizon’s ability to change the warning label for Tepezza.

January 20, 2023: Lawyers for Tepezza plaintiffs have filed a motion to consolidate 10 Tepezza hearing loss cases currently pending in the Northern District of Illinois. The request seeks to consolidate these 10 cases before a single judge.

The result would be similar to a “local MDL class action lawsuit” within the federal district and apply only to these ten Tepezza hearing lost suits (and perhaps more in the future).

Horizon has filed an opposition. It argues each Tepezza lawsuit involves significantly different factual allegations. Fewer than 20 Tepezza product liability claims are pending in federal courts, including ten in Illinois.

January 18, 2023: It was announced that Amgen, a massive biopharmaceutical company, had a deal to acquire Horizon Therapeutics (the maker of Tepezza) for $116.50 per share. Recently, however, a group of Amgen investors has filed suit to block to sale, citing concerns about claims that Horizon withheld information about the risk of hearing damage associated with Tepezza.

This is a positive development if you consider bringing a Tepezza lawsuit.

Tepezza

Tepezza (teprotumumab-trbw) is a prescription medication used to treat thyroid eye disease (TED), a rare autoimmune disorder that causes inflammation and swelling of the tissues around the eyes. Tepezza is the first and only FDA-approved medication for this condition. It works by blocking the activity of the insulin-like growth factor 1 receptor (IGF-1R), which is believed to play a role in the development of TED. Tepezza is administered intravenously (IV) over three to six months, and it has been shown to improve symptoms such as eye bulging, double vision, and eye pain in patients with active TED.

Tepezza inhibits (or blocks) the activity of the protein insulin-like growth factor-1, which is believed to play a significant role in the development of the disorder. Horizon Therapeutics developed TepezzaHorizon Therapeutics, and it is still under its original patent protection. Tepezza is administered by injections.

In January 2020, the U.S. Food and Drug Administration (FDA) approved Tepezza. This was the first approved drug indicated to treat thyroid eye disease.

In addition to the serious risk of hearing loss which is the subject of this litigation, Tepezza is associated with several other side effects that patients keep in mind. The most commonly reported side effects include muscle spasms, nausea, diarrhea, fatigue, dry skin, and headaches. Some patients also experience an altered sense of taste, making certain foods taste metallic or different than usual.

Tepezza is also known to cause an increase in blood sugar levels, which may be problematic for patients with diabetes or those at risk for developing high blood sugar. Swelling, particularly in the hands and feet, is another commonly reported side effect. Additionally, some patients may experience high blood pressure during the course of their treatment.

While most of these side effects are mild and temporary, they can still affect a patient’s quality of life during treatment. Patients should, of course, discuss any side effects with their healthcare provider, as some may need extra management or monitoring while on Tepezza. Being aware of the full range of potential risks enables patients to make well-informed choices about their treatment options. That is where the hearing loss and tinnitus issue comes into play which we will get to in a moment.

Graves Disease

Thyroid Eye Disease (TED) is characterized by the progressive inflammation of the tissues surrounding the eyes, leading to symptoms such as red, swollen eyelids and discomfort, with the eyes sometimes bulging outwards (proptosis). Despite Horizon Therapeutics’ promotional materials suggesting a commonality of vision impairment among those with TED, such severe outcomes are actually quite rare, affecting only 3–5% of those with the condition. Despite this knowledge, Horizon pushed Tepezza for use in anyone diagnosed with TED, advocating for its early treatment.

TED is an autoimmune condition frequently linked to hyperthyroidism, with its precise disease mechanism still not fully understood. Symptoms can greatly vary among individuals, ranging from mild to severe, and can include redness, irritation, discomfort of the eyes and eyelids, dry eyes, pain upon eye movement, and eyelid retraction.

The most noticeable symptom, and it can be pretty awful for some, is exophthalmos or proptosis, which occurs when the eyes bulge outwards. Other symptoms may include blurred vision, double vision (diplopia), eye misalignment (strabismus), chronic bloody eyes, swelling near the eyelids, light sensitivity, and difficulty moving the eyes.

TED progresses through two stages: an “active phase” marked by worsening symptoms and visible inflammation, followed by an “inactive phase” with no further deterioration. The active phase typically spans six months to two years.

TED is most commonly associated with Graves’ disease, an autoimmune disorder affecting the thyroid, skin, and eyes, but it can also occur in individuals with an overactive or underactive thyroid. For those with mild TED, treatments may include supportive measures like dark sunglasses, ointments, artificial tears, or prism glasses. Corticosteroids may reduce inflammation in moderate-to-severe cases. Surgery might be considered for individuals with moderate-to-severe TED but is usually recommended after the active phase.

The 2008 Consensus Statement of the European Group on Graves’ Orbitopathy (EUGOGO) on the Management of Graves’ Orbitopathy suggests that the condition is often mild, self-limiting, and potentially decreasing in frequency, with a small percentage of cases threatening eyesight. So taking mediation for Graves’ disease requires careful balancing of the risks and benefits of the drug. This requires knowing all of the risks associated with the drug, right?

Studies Link Tepezza to Serious Hearing Loss

Several studies and reports have linked the use of Tepezza to hearing loss and other hearing-related issues.

A small study presented at the ENDO 2021 conference found that 65% of patients taking Tepezza reported otologic symptoms such as hearing loss, tinnitus, ear plugging sensation, and autophony (hearing one’s own voice unusually loud). This rate is so much higher than the 10% reported in earlier clinical trials. These symptoms often developed after an average of 3.6 infusions, and among the patients with new hearing symptoms, some showed new or worsening sensorineural hearing loss, which is a type of hearing loss resulting from damaged hair cells in the inner ear.

Furthermore, a report published in The Annals of Otology, Rhinology, and Laryngology described a case of significant hearing loss in a patient after receiving Tepezza treatments, with the patient’s symptoms not improving even after the discontinuation of the drug and treatment with oral corticosteroids.

The American Journal of Ophthalmology highlighted the long-term impact of Tepezza on hearing function, revealing that only a fraction of patients who experienced subjective hearing loss or decreased word comprehension made a full recovery after eight months of discontinuing Tepezza infusions.

A case series of four cases of Tepezza-associated hearing loss was reported based upon patients of three doctors who treated 28 patients. The authors proposed a mechanism for how Tepezza was causing hearing damage.

In contrast to the public statements, almost immediately after the FDA approved Tepezza, patients and doctors began reporting severe complications relating to ear and permanent hearing problems in patients taking Tepezza. New research soon began to emerge to show that not only did Horizon grossly understate the risk of hearing damage associated with Tepezza, but it also undersold how severe that hearing damage could be.

Dr. Liu

If you are wondering why many Tepezza lawyers think settlement amounts could be offered early in this litigation, you can start with plaintiffs’ allegations with respect to Dr. Lu. According to reports and plaintiffs’ lawsuits, concerns were raised internally at Horizon by employees, including Dr. Wenzhong “Jerry” Liu, regarding hearing loss linked to the use of Tepezza.

Despite clinical trial data and further analysis indicating a higher rate of hearing impairment than initially reported, Horizon continued to downplay these risks. The company’s official stance suggested that most hearing-related adverse events observed in pivotal trials and after approval were minor to moderate and reversible.

Dr. Liu, with extensive experience in clinical development and medical affairs, questioned the accuracy of the reported 10% incidence rate of hearing impairment, suggesting that findings from later studies, including Study 401 (EAP), indicated a much higher rate. He advocated for the disclosure of this updated data to regulatory agencies, healthcare professionals, and the public, emphasizing that the true frequency of serious hearing impairment was significantly higher than the label suggested.

Despite Dr. Liu’s suggestions to share the findings from Study 401, which showed a 40% incidence rate of hearing impairment, and his ongoing concerns about the accuracy of public disclosures on hearing impairment risks, he was eventually dismissed from his position. Dr. Liu subsequently filed a wrongful-termination lawsuit against Horizon.

Horizon Failed to Adequately Warn About the Risk of Hearing Loss from Tepezza

Although Horizon acknowledged hearing loss as a potential side effect of Tepezza, every Tepezza lawsuit will allege this warning was inadequate because it grossly understated the level of risk. A warning that does not meaningfully convey the risk is no warning at all.

Horizon knew or should have reasonably known that Tepezza presented a much higher risk of hearing loss and that this hearing loss could be permanent. There was ample medical literature suggesting that IGF-I plays a central role in hearing and that low levels of IGF-I are associated with hearing loss. Horizon arguably should have known this when Tepezza was submitted for FDA approval. At the very least, however, Horizon became of the issues with Tepezza at some point soon after the drug was approved, and reports and studies linking it to hearing damage started to emerge.

Tepezza Hearing Loss Lawsuits

In 2022, individuals who suffered hearing loss or tinnitus after receiving Tepezza injections began filing product liability lawsuits against Horizon. The Tepezza hearing loss lawsuits allege that Horizon negligently failed to adequately warn patients and doctors about the real risks of hearing damage associated with Tepezza.

The plaintiffs in every Tepezza lawsuit in the MDL claim that the lack of an adequate warning about the risk of hearing damage from Tepezza left them and their doctors unaware of the potential harm that the drug could cause. These plaintiffs allege that they would never have to take Tepezza for treatment of their TED had Horizon provided an adequate and accurate warning about this risk.

Over 175 Tepezza lawsuits have been filed in the MDL. We expect more. There is now, was we discuss above, a class action MDL.

Potential Settlement Payouts for Tepezza Hearing Loss Lawsuits

It is very premature to say how much a Tepezza lawsuit could be worth in settlement. There are too many variables at this point to determine whether these cases will be viable. But I can tell you… mass tort lawyers really believe the future settlement amounts these lawsuits could be high. So we can offer a reasonable estimate of what a successful Tepezza hearing loss lawsuit could be worth in a settlement based on the facts that are on the ground right now.

Our lawyers estimate that a Tepezza hearing loss case with favorable facts could have an average settlement compensation in the range of $140,000 to $350,000. The exact value of a specific case will depend on various factors, including the age of the plaintiff and whether they had any preexisting hearing issues. Cases involving a major, permanent hearing loss in relatively young plaintiffs could be worth much more.

Hearing Loss Settlements and Verdicts

One of the best ways to accurately predict the potential settlement value of tort cases is to look at prior settlements and trial verdicts in cases involving the same type of injury. Below are summaries of prior verdicts and reported settlements in cases in which the plaintiff’s primary injury was hearing loss or tinnitus. Most of these are verdicts from the recent bellwether trials in the 3M earplugs class action. For these verdicts, we are excluding the amount of punitive damages awarded and only listing the amount of compensatory damages.

Beal v 3M Co. (Florida 2022) $72,500,000: the last of 16 bellwether test trials in the 3M earplugs class action resulted in a verdict of $72.5 million in punitive damages and $5 million in compensatory damages for hearing loss suffered by an Army veteran. These 3M verdicts are telling because they are hearing loss lawsuits against a big company for failure to warn–a good comparable.
Vaughn v 3M Co. (Florida 2022) $2,200,000: 3M earplug bellwether verdict from April 2022 in which veteran was awarded $2.2 million in compensatory damages for hearing loss allegedly caused by defective earplugs.
M. v Viola (New York 2020) $250,000: A 2-year-old suffered permanent hearing loss from injuries in a car accident. The case settled for $250,000, but this was likely the available insurance limit and would have been worth more otherwise.
Luoma v State Farm (Washington 2020) $126,025:60-year-old plaintiff injured in an auto accident alleged permanent hearing loss. The jury awarded $101,025, and he received another $25,000 in a settlement payout before trial.

Recent Tepezza Lawsuits

A pair of Tepezza hearing loss lawsuits were recently filed in the U.S. District Court for the Northern District of Illinois (Chicago). The first case, Weibel v. Horizon Pharmaceuticals, Inc. (1:22-cv-4518), followed by a second case, Nethery v. Horizon Pharmaceuticals Inc. (1:22-cv-5005) two weeks later.

Both cases involve nearly identical factual allegations. Both plaintiffs were diagnosed with TED and prescribed a full series of Tepezza infusions by their doctor over four months. Both plaintiffs further allege that shortly after the Tepezza infusions they suffered major hearing loss and tinnitus. The Complaints alleged that the doctors were given no warning about the risk of hearing loss.

Lawyers for Horizon filed an identical Motion to Dismiss in both of these Tepezza hearing loss cases. The motion to dismiss is a simple two page document that argues that the plaintiffs’ claims based on failure to warn should be dismissed based on the federal preemption doctrine. The argument (which we see all the time in pharmaceutical tort cases) is that the warning labels on Tepezza are governed by federal law and regulations that preempt the state law tort claims.

This argument failed. Federal preemption arguments in drug cases are usually not successful because federal law and FDA regulations permit drug companies to amend their warning labels without FDA approval if new evidence of risk emerges. That is exactly what is being alleged in the Tepezza cases.

In these cases and all Tepezza lawsuits, lawyers need to establish a direct link between Tepezza and hearing loss. Plaintiffs’ Tepezza lawyer will rely on the strong scientific evidence and expert testimony to demonstrate that Tepezza directly caused their hearing impairments. This requires gathering detailed medical records, expert analyses, and possibly conducting independent studies that corroborate claims of hearing damage due to Tepezza.

How Does Tepezza Cause Hearing- Related Complications?

The exact mechanism through which Tepezza might cause these hearing issues is not fully understood. But some of the experts believe it related to its immunomodulatory effects, which might inadvertently affect the inner ear or auditory pathways.

Tepezza works by inhibiting the insulin-like growth factor-1 receptor (IGF-1R), which plays a role in the inflammatory processes of TED. This inhibition modulates the immune response, potentially impacting various body systems, including the auditory system. Experts believe that these immunomodulatory effects could inadvertently affect the inner ear or auditory pathways, leading to hearing issues.

So the could involve an inflammatory response within the ear. By altering the immune system’s function, Tepezza could potentially trigger inflammation that impacts hearing structures, such as the cochlea, auditory nerve, or Eustachian tube.

Contact Us About a Tepezza Hearing Damage Lawsuit

Our firm is currently seeking Tepezza hearing damage lawsuits across the country. If you took Tepezza for treatment of TED and you subsequently suffered hearing damage, hearing loss, or permanent ringing in the ears (tinnitus) contact our office today for a free consultation. Call us today at 800-553-8082 or contact us online for a free consultation.