Products Liability
Our lawyers are handling Tepezza lawsuits throughout the country.
Tepezza is a drug used to treat the symptoms of thyroid eye disease (TED). Soon after Tepezza was released on the market, it was discovered that Tepezza can cause permanent hearing damage and/or tinnitus (ringing in the ears) in some patients. Patients who received Tepezza and suffered hearing damage are now filing Tepezza lawsuits.
If you received Tepezza infusions and subsequently suffered a loss of hearing or other hearing issues, you may be able to file a product liability lawsuit and get financial compensation by a settlement or jury payout.
This page will provide the latest news and updates on the Tepezza litigation, as well as our predictions about the potential settlement value of these cases.
Our attorneys are currently seeking Tepezza hearing damage cases in all 50 states. Contact us today at 800-553-8082 or reach out to us online.
Tepazza Lawsuit Update
Our law firm is committed to keeping victims updated on the latest news and information in the Tepezza litigation.
November 1, 2024: Just two new cases were added to the Tepezza hearing loss MDL last month. The total number of pending cases in the MDL is now 180. We are still quite a while from trial in this litigation, with the first trial in 2026. So there is a chance of adding many more plaintiffs. But this will never be a large mass tort.
October 18, 2024: In a new lawsuit filed yesterday, a resident of Logan County, Oklahoma, brought claims against Horizon. The lawsuit, filed directly in the MDL, alleges that Tepezza caused the plaintiff to suffer permanent hearing loss and tinnitus.
The complaint claims that Horizon knew or should have known about the risks of hearing damage associated with Tepezza but failed to properly warn doctors, patients, and regulators. Despite numerous reports and studies suggesting a link between the drug and permanent hearing impairment, the lawsuit argues that Horizon delayed updating the drug’s label to include a warning until July 2023—months after the plaintiff began treatment in November 2022. The plaintiff seeks compensatory and punitive damages, citing Horizon’s alleged failure to act promptly despite evidence of the drug’s risks.
October 16, 2024: Horizon is arguing that that nine out of twelve selected bellwether cases should be dismissed due to federal preemption. The argument is that these nine cases should be tossed because the FDA had approved the Tepezza label, which included known risks of hearing issues, and no new information had surfaced that would justify a label change.
This argument seems extremely unlikely to succeed.
October 1, 2024: In September, five new Tepezza lawsuits were filed in the Tepezza hearing loss MDL, bringing the total number of pending cases to 178. Our lawyers believe there will be over 500 lawsuits that are viable for settlement before it is over.
September 3, 2024: In August, 33 new cases were added to the Tepezza hearing loss MDL, which is significantly higher than the usual volume of new cases we’ve seen in this MDL. This brings the total number of pending cases to 173.
July 30, 2024: Attorneys for both parties in the Tepezza MDL were scheduled to meet to discuss and resolve issues concerning the scope and number of corporate and expert witness depositions allowed. The defendants aim to limit the number of corporate depositions, while the plaintiffs advocate for allowing as many as possible. The parties are expected to report back to the MDL judge later this week.
July 1, 2024: Nineteen new Tepezza lawsuits were filed last month, bumping up the total number of lawsuits to 138. One of those cases was a Nevada resident who filed a lawsuit alleging severe injuries from the infusion of Tepezza, a biological product produced by the defendant.
The plaintiff, who was diagnosed with thyroid eye disease and/or Graves’ disease, received Tepezza infusions from June to November 2021.
She says that neither she nor her physicians were warned about the risk of permanent hearing loss and/or tinnitus associated with Tepezza until July 2023.
As a result, the plaintiff now suffers from permanent hearing damage and is seeking damages for her injuries, citing the defendant’s failure to provide adequate warnings and guidance on monitoring hearing during treatment.
June 20, 2024: A Magistrate Status hearing was conducted to address ongoing matters in the case. The following key dates and requirements were established:
- July 19, 2024: The parties are required to submit a joint status report. This report should include:
- The number of anticipated corporate depositions.
- The parties’ positions on the number of depositions.
- The number of lingering corporate depositions expected to occur after February 14, 2025.
- Any issues with the production of documents.
- Any other issues the parties wish to raise.
- June 21, 2024: The parties must submit agreed-upon Case Management Orders consistent with the court’s instructions.
- June 27, 2024: A status hearing is scheduled for 9:15 a.m. for docket management purposes. This hearing will ensure the entry of appropriate case management orders. Notably, no appearance is necessary for this hearing.
- July 24, 2024: Another status hearing is set for 12:00 p.m. to further discuss the case’s progress and any outstanding issues.
June 3, 2024: The Tepezza hearing loss class action MDL continues to grow slowly. Only 7 new cases were added over the last month, fewer than in April. The MDL now has a total of 120 cases.
May 30, 2024: The parties disagree over what the rules for depositions in the Tepezza class action lawsuit should be. There needs to be a protocol that outlines rules for deposition conduct, including the order of questioning, which remains disputed between the parties.
Three primary points of contention exist between the parties. First, the plaintiffs propose that the party who picks the deposition goes first, while the defendants suggest that the party who notices the deposition should begin. For depositions of the defendant’s employees and corporate representatives, the number and duration of depositions is also contested. The plaintiffs’ counsel argues for flexibility, given the early stages of discovery, while the defendants seek to limit the depositions to twenty.
The duration of depositions for healthcare providers is also disputed, with varying proposals on the time allocated for questioning.
This is the usual wrangling you see in mass tort pre-trial discovery that usually does not have a huge impact on the outcome of the litigation. But as they should be, Tepezza lawyers on both sides are trying to secure every advantage that they can.
May 20, 2024: The first bellwether trial in the Tepezza hearing loss class action MDL has been set for March 2026. Now the MDL Judge has tasked lawyers for both sides with coming up with a joint schedule for how to get through discovery and bellwether case selection during the intervening time.
May 1, 2024: The Tepezza hearing loss litigation maintains its sluggish pace of growth. Merely 13 additional cases were incorporated into the Tepezza hearing loss MDL throughout April. Presently, there are only 113 cases awaiting resolution in the MDL.
April 4, 2024: The expansion of the Tepezza hearing loss class action MDL remains sluggish, with just eight new cases added over the last month. This brings the total number of pending cases to 101. Notably, there were 54 pending cases at the inception of the Tepezza MDL back in August 2023.
March 28, 2024: Unfortunately, the MDL judge managing the federal Tepezza hearing loss litigation has granted defendants an extension until the end of the following month to submit their selection of bellwether cases. This pushes things back a bit. This extension was granted because Horizon sought, over plaintiffs’ lawyers objection – additional time to examine more medical records before deciding on the claims they consider most indicative for trial.
postpones the initial deadline for choosing potential trial claims by two months.
On March 1, plaintiffs announced their selection of four Tepezza bellwether lawsuits (none of which were ours, unfortunately), with the pharmaceutical manufacturer scheduled to choose another four cases by April 1. Subsequently, the court would randomly choose the final four cases for case-specific discovery ahead of the preliminary trial dates.
March 19, 2024: Tepezza lawyers have agreed to a joint stipulation to modify the deadlines outlined in Case Management Order No. 3 . Key modifications include:
The random selection of four initial bellwether discovery cases from the MDL case list, with a joint proposal to identify a total of twelve initial bellwether discovery cases. This includes provisions for replacing any plaintiffs removed due to Lexecon objections.
Clarifications on Lexecon waivers, with parties indicating within specific time frames whether they will waive their rights under Lexecon. If a party chooses not to waive these rights and a plaintiff is removed from the initial bellwether discovery cases as a result, the selecting party must choose a replacement from the MDL list of filed and served cases. Again, a Lexecon waiver refers to a party’s decision to waive their right under the Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach Supreme Court ruling, which allows a case transferred to a MDL for pretrial proceedings to be returned to the original court for trial. By waiving this right, the party agrees to allow the trial to proceed in the MDL court rather than insisting on returning to the original venue for trial.
For motion practices related to the initial bellwether discovery cases, if Horizon opts to seek dismissal under Federal Civil Procedure Rule 12(b)(6) for any of the cases, such motions must be filed within a specified period following the selection of all twelve initial bellwether discovery cases.
Plaintiff Fact Sheets (PFS) deadlines are established for the four plaintiffs identified as initial bellwether discovery cases by the PLC, with specific deadlines for submission. Additionally, any replacements for initial bellwether discovery cases must submit their PFS within a set timeframe after being identified.
March 1, 2024: During the previous month, the Tepezza class action MDL saw the addition of 19 new hearing loss cases, raising the total number of pending cases in the MDL to 93. This marks the highest monthly influx of new claims since the inception of the MDL last year.
February 2, 2024: The Tepezza hearing loss class action MDL has grown very slowly since its establishment six months ago, with the addition of only 33 new cases so far. Notably, there were no new cases added to the MDL in the last month.
January 15, 2024: There are now 74 pending cases in the Tepezza hearing loss class action MDL. That is an increase of 3 new cases since mid-December. Next month we will see a big jump as new cases have been filed in the last week.
January 9, 2024: In the Tepezza hearing loss litigation, both plaintiffs and defendants have requested a 60-day extension from the judge for selecting cases for the initial bellwether. This extension is to allow more time for a thorough review of medical records and documents. Lawyers know how important it is to pick the best bellwethers so everyone wants to take one long look at the inventory of cases before committing.
January 8, 2024: Despite an initial Case Management Conference (CMC) on June 28, 2023, no significant discovery against the Defendant in the Tepezza class action has occurred in over six months. This is maddening and plaintiffs’ Tepezza lawsuits are trying to do something about it. The defendants sought to push back a status conference set for tomorrow claiming there’s nothing for the Court to resolve. But the reality is deadlines and court appearances advance litigation… and this litigation needs to advance.
Plaintiffs’ lawyers argue exactly this in a new motion that court hearings resolve outstanding issues or guide the Court’s recommendations. Delay will only perpetuate the existing slow pace of the MDL. Compared to other MDLs in the same district, this case lags significantly behind in procedural orders, agreed-upon terms, and discovery progress. So plaintiffs urge the Court to maintain the scheduled CMC to expedite resolutions, set firm deadlines, and start discovery.
December 18, 2023: There are now 71 cases pending in the Tepezza hearing damage class action MDL. That is an increase of 12 cases over last month, which is actually a significant increase in new case volume.
December 1, 2023: Discovery in the Tepezza hearing loss class action MDL is just getting started, but we already have a potential battle developing. In a recently filed narrative submission, the lawyers for the Tepezza plaintiffs set forth a number of complaints to the court about the way in which Horizon has handled initial discovery inquiries. This could eventually lead to a showdown.
November 20, 2023: One of the most recent Tepezza hearing loss cases filed in the MDL was brought by a middle-aged woman from Florida who received Tepezza for treatment of her thyroid eye disease. The woman’s doctor gave her Tepezza infusions from August 2022 to April 2023 and she subsequently suffered permanent hearing loss and ringing in her ears. She filed her case directly in the MDL alleging that the manufacturer of Tepezza was negligent for failing to warn about the hearing loss risk associated with the drug.
November 17, 2023: The Tepezza class action MDL has grown very slowly since it was established 3 months ago. Only 5 new cases have been added to the MDL since it was created, for a total pending case count of 59.
November 6, 2023: As expected, Judge Durkin ruled that Horizon Therapeutics can be sued for allegedly failing to design a safer version of its drug Tepezza before seeking FDA approval, as federal law does not block such pre-approval design defect claims. The court dismissed the defense’s argument of impossibility preemption post-approval, as it doesn’t apply to the pre-approval phase when Horizon had the opportunity to meet both federal and state safety requirements. The decision opens the door for the litigation to explore whether a safer alternative was feasible and whether the FDA would have approved such an alternative.
Horizon path to ending this litigation involves offering reasonable Tepezza settlement compensation to victims. Moving past these lawsuits from a motion to dismiss is a pipe dream and Horizon’s lawyers knew that when they filed this motion.
November 2, 2023: The Tepezza MDL Judge issued a Case Management Order today establishing how the bellwether trial candidate cases will be selected. A pool of 12 cases will be selected as bellwether candidates. The plaintiffs will pick 4 and the defense will pick 4. The remaining 4 will be randomly selected. This group of 12 cases will then go through fact discovery to learn more about the cases. After that, some of them will be picked for trial.
October 26, 2023: A telephone status meeting is scheduled for November 1, 2023, at 9:00 a.m. to discuss the bellwether protocol in the Tepezza class action.
Every MDL class action moves slowly from the victims’ perspective. But the Tepezza lawsuits are moving as quickly as we could hope for, at least so far.
October 21, 2023: The Tepezza status conference was not a huge event. Both sides are in discussions over a bellwether protocol, and that will get flushed out shortly, which is great because this is fairly early in the litigation to get into trial dates. Trial dates lead to settlements in class action lawsuits.
The defendant has supplied the plaintiffs with a list of custodians of documents, but there are no date ranges or search terms agreed upon for electronic discovery.
October 17, 2023: No new cases were transferred into the Tepezza hearing loss class action MDL over the last month. The Tepezza MDL was just created two months ago, and it is very typical of brand-new MDLs to have very slow new case volume in the first few months.
The size of the potential plaintiff field in this litigation is not overwhelmingly large, so this is never going to be an MDL that posts 1,000 new cases per month.
October 12, 2023: The status conference that was set for tomorrow, and which Judge Durkin required all counsel to attend in person, has been pushed back to next week. The new conference will be held on October 19, 2023, all appearances must be in person.
October 2, 2023: In the new Tepezza class action MDL, Judge Durkin has scheduled the first major status hearing for October 12, 2023. At that conference, Judge Durkin is expected to rule on an earlier dispute between the parties regarding electronic discovery materials and protocol. The hearing is set for 10:30 a.m., and Judge Durkin is requiring all counsel to attend in person.
September 18, 2023: The Tepezza class action MDL now has a total of 54 pending cases. That is only a small increase from the 41 cases that were pending in the MDL back in June, but the litigation is relatively new. Most MDLs don’t start growing until 5-7 months after the cases are initially consolidated.
September 11, 2023: The acquisition of Horizon Therapeutics by biopharma giant Amgen Inc. is now back on following a deal reached with the FTC. Amgen acquire Horizon for $27.8 billion and assume all liability for the Tepezza hear loss claims. This is a good thing for Tepezza plaintiffs because the Amgen acquisition will mean more money and deeper pockets to cover any eventual settlement in the Tepezza class action.
August 30, 2023: Both sides recently submitted their bellwether proposals in the Tepezza class action MDL. The proposal submitted by the plaintiffs suggests that 6 cases be picked (3 by each side) for an initial pool of bellwether candidates. These cases would go through a short case-specific discovery process, after which 3 of the 6 would be picked for the opening bellwether trials. Defense counsel submitted a very similar proposal, except that it called for a larger initial pool of 10 cases instead of 6. Both proposals call for a comparatively short process.
August 25, 2023: The parties submitted this week their joint statements on the ESI (Electronically Stored Information) protocol and the bellwether/briefing plan. The sooner we get trial dates in the Tepezza lawsuits, the better.
The ESI protocol outlines the procedures for handling digital or electronic data during the litigation process. The bellwether/briefing plan refers to a strategy where a few representative cases (bellwether cases) are tried first to test the waters and gauge potential outcomes in other similar cases, helping both parties in decision-making and potential settlement discussions.
August 18, 2023: A new Tepezza lawsuit – Zafar v. Horizon Therapeutics USA, Inc – was directly filed this week in the Tepezza MDL by a Florida man who claims that he suffered serious injuries as the result of the plaintiff’s infusion teprotumumab, the prescription drug marketed as Tepezza.
This plaintiff was diagnosed with thyroid eye disease and/or Graves’ Disease and received Tepezza infusions from Plaintiff’s physician from July 2012 through November 2021. Her suit alleges that as a result of her Tepezza infusions, he now has permanent tinnitus and/or hearing loss.
The central allegation of her lawsuit – and of all of these legal actions involving teprotumumab – is that Horizon did not give him or his doctors any warning about the serious risk of permanent hearing loss or tinnitus posed by Tepezza infusions.
August 15, 2023: There are now a total of 46 cases pending the Tepezza class action MDL. When the MDL was formed earlier this summer, there were 41 cases, so the growth rate has not exactly been significant so far. We don’t expect that this will ever turn into a mass tort with thousands of plaintiffs, but we do think things will pick up before the end of the year.
August 2, 2023: The pace of new Tepezza hearing damage lawsuits has been somewhat sporadic recently. 16 new cases were filed in June, which was the highest monthly volume since the litigation began last year. In July, however, only 3 additional Tepezza product liability lawsuits were filed in federal courts. It will be interesting to see whether things pick back up again in August. Meanwhile, an initial scheduling order should be coming out fairly soon in the newly formed Tepezza MDL.
July 25, 2023: Federal authorities have updated the warning label of Tepezza to reflect the potential for severe and possibly irreversible hearing impairment. The FDA unveiled a revised version of the Tepezza prescribing information guide, incorporating a section that underscores the potential for severe and even permanent hearing loss. The revamped guide also recommends medical practitioners to monitor patients’ hearing before, during, and following Tepezza infusions.
July 18, 2023: In the first month since the Tepezza hearing damage lawsuits were consolidated into a new class action MDL, only 1 new case was added. That brings the total number of pending cases up to 42. This sort of slow start is very typical for new class action MDLs in the first few months after they are created. By the end of this year the monthly volume of new Tepezza cases will likely increase significantly.
July 1, 2023: The first Tepessa class action lawsuit status conference was held this week.
This will not be a huge class action. This is good for victims. Our lawyers expect the settlement amounts will be higher – and much quicker – than in litigation for similar injuries like the 3M earplug lawsuits.
June 19, 2023: The MDL judge in the newly created Tepezzza hearing loss class action MDL has set an initial status conference with all parties for June 28th. The conference will give Judge Durkin his first opportunity to set protocols and rules for the management of the litigation moving forward. He will also lay out his process for the appointment of attorneys to the plaintiffs’ leadership committee that will make collective decisions on behalf of all plaintiffs.
June 5, 2023: We now have a Tepezza class action lawsuit. The MDL Panel agreed that federal lawsuits alleging Horizon Therapeutics USA Inc. did not adequately warn about potential hearing loss and tinnitus caused by their thyroid eye disease medication, Tepezza, have been consolidated and will be heard in a court in Chicago and overseen by Judge Thomas M. Durkin.
The Panel said that holding a single proceeding will streamline the process and make the litigation more equitable. It also noted that the Northern District of Illinois has more pending suits than any other district.
There are currently 37 cases related to this matter in eight different districts. All these cases share common factual questions, including whether the drug causes the claimed issues, whether adequate testing was conducted, and whether the warnings given were sufficient, as stated by the panel.
This is all good news. The plaintiffs’ lawyers wanted the Northern District of California. Horizon opposed the class action but wanted it in Illinois if the Panel decided to form one. But this is a fair judge in a good jurisdiction and the changes of an eventual global settlement have now increased exponentially. Our lawyers believe these are strong lawsuits and the plaintiffs will get fair compensation.
May 22, 2023: It looks like Amgen will no longer acquire Horizon Therapeutics for $27 billion. The FTC is seeking an injunction to block the deal because it would result in an improper monopoly over the market for certain drugs. Meanwhile, with the JPML hearing later this week on whether to create a new Tepezza class action, the rate of new cases continues to climb. Ten new Tepezza lawsuits were filed over the last seven days. Still, the pace of Tepezza lawsuits is slower than we expected when this litigation took off.
May 11, 2023: As we reported in a previous update, a group of plaintiffs with pending Tepezza hearing loss lawsuits filed a motion in March asking the JPML to consolidate all Tepezza cases in federal courts into a new class action MDL.
Horizon Therapeutics, the company that makes Tepezza, has recently filed a response in opposition to that motion. Horizon’s position is that there are not enough pending cases to justify MDL consolidation. Horizon also claims that the number of new Tepezza lawsuits will be limited. Our take is that this prediction is based on nothing but misguided optimism. The JPML is set to hear arguments from both sides later this month and rule in early June.
May 8, 2023: With the JPML set to hear arguments on whether to create a new class action MDL for the Tepezza hearing loss cases, the volume of new Tepezza lawsuits continues to increase. The MDL motion filed six weeks ago listed 18 pending Tepezza cases across five federal districts. Since then, seven more cases have been filed. This increase in volume makes it more likely that the JPML will grant the motion and consolidate the Tepezza cases into a new class action.
April 25, 2023:A panel of federal judges is set to hear oral arguments in late May 25, 2023, to decide whether to create an MDL Tepezza class action lawsuit for all Tepezza hearing loss claims filed in federal courts in the U.S.
April 14, 2023: It might just be Horizon pays a fortune in Tepezza settlement amounts and jury payouts to victims and still makes a bigger fortune from the drug. Horizon Therapeutics has announced today FDA approval for an updated indication language for TEPEZZA, specifying its use in treating Thyroid Eye Disease (TED) patients, irrespective of disease activity or duration.
This update follows positive results from a Phase 4 clinical trial, demonstrating a significant reduction in proptosis at Week 24 for patients receiving TEPEZZA compared to those receiving a placebo. The updated indication aims to provide unrestricted access to all eligible patients across the full spectrum of TED, potentially easing the access burden for patients and physicians and reducing the time to therapy. The company plans to present data from the Phase 4 trial at a future medical congress and publish the data in a peer-reviewed medical journal.
April 4, 2023: A newly published case study from Stanford University has found that the risk of hearing loss as a side effect of Tepezza injections can be significantly reduced when the injection dose is lowered. The case study looked at the experience of a 64-year-old woman who received two rounds of Tepezza infusions about 12 months apart. The first round of Tepezza injections were at a full dosage, and the woman suffered numerous side effects, including bilateral hearing damage. When the same woman received another full round of injections the following year, however, her doctors reduced the dose level, and the woman did not experience any hearing loss. The case study offers further evidence of the causal link between Tepezza injections and hearing loss.
March 25, 2023: A motion has been filed asking the Judicial Panel on Multidistrict Litigation (JPML) to consolidate the Tepezza hearing loss cases into a new class action MDL. The motion seeking MDL consolidation cites at least 18 Tepezza cases pending across five different federal districts. The motion names the Northern District of California as the preferred venue for the MDL. A Tepezza class action lawsuit would change the dynamics of this litigation.
March 24, 2023: Four more Tepezza hearing loss lawsuits have been filed in federal courts nationwide since the start of March. To date, 34 lawsuits have been filed alleging that Tepezza injections caused patients to suffer permanent hearing loss. Thirteen of those lawsuits were voluntarily dismissed, suggesting they may have been settled.
February 16, 2023: Nine Tepezza product liability lawsuits alleging that the drug caused hearing damage have been filed in federal courts since the start of 2023.
One of the most recently filed Tepezza cases is Diaz v. Horizon Therapeutics USA Inc. (1:23-cv-00896), filed on February 14, 2023, in the Northern District of Illinois. The plaintiff, Norma Diaz, is a resident of California who suffered from thyroid eye disease and Grave’s disease. Diaz received a series of Tepezza infusions between November 2021 and April 2022. Diaz experienced a severe adverse reaction to the Tepezza infusions, which caused permanent hearing loss and tinnitus.
The Complaint underscores that Horizon was aware that Tepezza was causing hearing loss. In fact, the Complaint devotes ten pages to listing every adverse event report to the FDA involving Tepezza and hearing loss. The Complaint asserts four separate causes of action, with the primary theory of liability being failure to warn.
February 14, 2023: Horizon Therapeutics is moving to dismiss the Tepezza hearing loss lawsuits filed against it based on the federal preemption doctrine. In a motion to dismiss filed last week in one of the pending Tepezza lawsuits, Horizon argued that the plaintiff’s product liability claims are preempted by federal law because the contents of the warning label for Tepezza were regulated by the FDA. We see similar preemption motions in nearly all product liability mass torts involving failure to warn claims, and the argument is rarely successful.
January 19, 2023: A group of Tepezza plaintiffs have filed a motion seeking consolidation of ten Tepezza hearing loss lawsuits pending in the Northern District of Illinois.
So we now have a Tepezza class action lawsuit? Yes and no. If granted, the motion would result in sort of a mini-MDL within the district in which the cases proceed before a single judge and discovery is consolidated.
Horizon filed a response last week stating that it is opposed to the consolidation request on the grounds that the cases involve substantially different facts. There are a handful of Tepezza cases pending in other federal districts.
January 18, 2023: Lawyers began looking to file Tepezza hearing loss lawsuits in earnest about four months ago. What have we learned?
We have learned that there are not many Tepezza lawsuits out there. We have a strong position in developing these cases, and we have not had even 100 potential leads. No lawyer we have spoken to has a significant volume of Tepezza lawsuits to file. This tells us the Tepezza litigation will be small.
But those same lawyers we have talked to universally agree these are strong claims that will have a high settlement value. Smaller litigation is bad for lawyers but good for victims. Horizon or Amgen will be able to pay the high settlement amounts a Tepezza claim should garner without
January 17, 2023: Many victims are interested in knowing what a Tepazza settlement might look like. We have written a new page projecting Tepazza settlement amounts we anticipate at the conclusion of this litigation.
January 9, 2023: Last month, biopharmaceutical giant Amgen announced a deal to acquire Horizon Therapeutics for $116.50 per share. One of the main goals of the acquisition was to increase Amgen’s rare disease drug portfolio, which includes Tepezza.
Now, however, Amgen investors have filed suit seeking to block the acquisition due to concerns about the Tepezza litigation liabilities.
From a plaintiff’s perspective, the Amgen acquisition would be a good thing because it would mean more resources available to make fair settlement payouts to victims.
Brief History of Tepezza
Tepezza (teprotumumab) is a new prescription drug that is used for the treatment of thyroid eye disease (TED) and a condition known as Graves’ eye disease. TED is a condition in which the eye muscles, eyelids, tear glands, and fatty tissue behind the eyes become inflamed. An abnormal autoimmune response triggers the inflammation, and it can cause the eyes to swell and obstruct vision.
Tepezza was developed by Horizon Therapeutics, and it is still under its original patent protection. Tepezza was formally approved by the Food and Drug Administration (FDA) in January 2020. It was the first medication approved for the treatment of thyroid eye disease. Tepezza blocks a specific protein that is believed to be responsible for the development of TED. Tepezza is administered by injection about every three weeks for around five months.
Horizon obtained FDA approval for Tepezza based on very limited testing and without determining the exact mechanism of action of the drug. The clinical trial that Horizon used for the FDA approval of Tepezza included less than 100 patients. Critics argue that the drug was aggressively marketed without adequately disclosing all potential risks.
Initially intended as a niche treatment with a limited market, Tepezza saw its U.S. sales double quickly to a stunning $1.7 billion in just its second year on the market. Now, hundreds of former users report experiencing various forms of hearing issues after using Tepezza, including persistent tinnitus and complete hearing loss. In many cases, the problems persist long after thyroid eye disease treatments, leaving users with permanent hearing damage.
How Tepezza Works
Tepezza works by targeting and inhibiting the insulin-like growth factor-1 receptor (IGF-1R) pathway, which plays a critical role in the development of thyroid eye disease (TED). In patients with TED, an abnormal autoimmune response leads to inflammation of the tissues around the eyes, causing symptoms like swelling, bulging eyes, and vision impairment. By blocking the IGF-1R pathway, Tepezza reduces this inflammation, alleviating the symptoms and helping to improve both eye appearance and function. This mechanism is what makes Tepezza effective in treating the underlying cause of TED, rather than just managing its symptoms.
Study Links Tepezza to Serious Hearing Loss
During the FDA review and approval process for Tepezza, Horizon acknowledged that the drug presented some risk of hearing damage as a potential side effect. However, Horizon represented to the FDA that the hearing loss was “temporary and generally of limited duration,” and claimed that this side effect occurred in less than 10% of patients. But adverse event reports, the medical literature, and even Horizon’s post-marketing studies suggested that Tepezza causes permanent hearing loss.
Soon after Tepezza was released on the U.S. market, reports of serious hearing damage from patients and doctors began coming in. In early 2021, the results of new research studies on Tepezza showed that not only did Horizon grossly understated the risk of hearing damage associated with Tepezza, it also undersold how serious that hearing damage could be.
In March 2021 the results of a major study were published in the Endocrine Society journal which found that 65% of patients who received Tepezza reported some level of hearing damage or ringing in the ears. This is over 6 times higher than the estimated risk of hearing loss disclosed by Horizon during the FDA approval process. Additional case reports about the risk of hearing loss associated with Tepezza followed.
Summary of Studies on Tepezza and Hearing Loss
| Hearing Loss and Teprotumumab ,Journal of the Endocrine Society, Volume 5 Issue 1 – April-May 2021
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This study was done to evaluate the incidence rate of hearing loss related to Tepezza. 46% of the study participants experienced hearing loss symptoms and sensorineural hearing loss. This was more than 4 times the incident rate reported by Horizon Therapeutics during clinical trials. The study concluded that hearing loss caused by Tepezza is a serious concern that providers should take into consideration before prescribing.
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| Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease, American Journal of Ophthalmology, Volume 240, August 2022 | Study examined outcomes of 27 individuals who experienced hearing loss or tinnitus after received Tepezza. The study found that 45% of the participants who reported hearing loss after the infusions had no resolution or improvement 39 weeks later. The study concluded that hearing loss was a concerning side effect of the drug and further study was warranted.
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| Sensorineural Hearing Loss After Teprotumumab Therapy for Thyroid Eye Disease: A Case Report., Otology & Neurotology, Volume 43(2), February 2022
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Case study report of a 77-year-old female who reported suffering hearing loss after Tepezza infusions. Hearing testing showed moderate to moderate-severe loss of hearing with word recognition scores of 64% in the right ear and 68% in the left ear. The authors strongly encouraged audiometric monitoring for patients undergoing treatment with Tepezza.
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| Teprotumumab and Hearing Loss: Case Series and Proposal for Audiologic Monitoring.
Ophthalmic Plastic and Reconstructive Surgery, Volume 38(1), January/February 2022 |
Study reported that Tepezza “may cause a spectrum of potentially irreversible hearing loss ranging from mild to severe, likely resulting from the inhibition of the insulin-like growth factor-1 and the insulin-like growth factor-1 receptor pathway.” The authors recommended further investigations and studies on the connection between hearing loss and Tepezza.
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Horizon’s Failure to Warn About Tepezza and Hearing Loss
Horizon acknowledged to a limited extent in its warnings that hearing damage was a potential side effect of Tepezza infusions. However, the warning was grossly inadequate because it understated the level of risk and did not advise doctors (or patients) about the risk of permanent hearing damage or the need for monitoring. Horizon knew or should have reasonably known about this potential risk associated with Tepezza and warned doctors and patients accordingly.
Tepezza Hearing Loss Lawsuits
In the summer of 2022, patients who received Tepezza and subsequently suffered hearing damage or tinnitus began filing product liability lawsuits against Horizon. The Tepezza lawsuits allege that Horizon negligently failed to properly warn doctors and patients about the true level of hearing loss risk presented by Tepezza.
At least two Tepezza hearing damage lawsuits have been filed against Horizon in federal court so far. The cases were filed in August and September in the Northern District of Illinois, which is where Horizon has its corporate headquarters.
The plaintiffs in these Tepezza lawsuits claim that they suffered hearing damage as a result of receiving Tepezza infusions for the treatment of their TED. The lawsuits claim that the lack of an adequate warning about the risk of hearing damage from Tepezza left the plaintiffs and their doctors unaware of the potential harm that the drug could cause. The lawsuits bring claims based on negligent failure to warn and defective design.
Many more Tepezza hearing loss lawsuits are expected to be filed as more Tepezza patients suffer damage to their hearing. Now, the Tepezza lawsuits have been consolidated into a class action MDL.
So far, Horizon’s defense strategy to every Tepezza lawsuit has been to seek dismissal because the plaintiffs’ state law tort claims are preempted by federal law. The argument (which we see all the time in pharmaceutical tort cases and will see in the Tepezza litigation) is that the warning labels on Tepezza are governed by federal law and regulations that preempt the state law tort claims. But this defense is unlikely to be successful in the Tepezza MDL class action.
Estimated Settlement Payout Value of Tepezza Hearing Lawsuits
There is no way of knowing for certain how much Tepezza hearing damage lawsuits could potentially be worth in settlement or at trial. The Tepezza MDL has not completed pre-trial discovery. So there are too many variables at this stage to know for certain whether these cases will be viable or not. But confidence from paintiffs’ lawyers is extremely high. What we can do is provide a reasonable estimate of what a successful Tepezza hearing loss lawsuit could be worth in a settlement.
Our attorneys predict that the average Tepezza hearing loss lawsuit with favorable facts may have a payout value for a settlement of $160,000 to $350,000 (we increased this projection in October 2024). The precise Tepezza compensation amount for 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.
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 at 800-553-8082 or contact our team online. We want to help you.