Products Liability
Tepezza® is a fairly new prescription drug developed to treat thyroid eye disease (TED). Tepezza can cause a serious adverse reaction in some patients resulting permanent hearing damage and/or tinnitus (ringing in the ears). Patients who suffered hearing loss from Tepezza are now able to file product liability lawsuits and get compensation for their injury.
In this post, our defective drug lawyers analyze the basics of the Tepezza hearing loss lawsuits and provide our best estimate as to what the potential settlement value of these cases might be. We also offer some insight into how the Tepezza litigation is taking shape and how that might impact the timing of Tepezza settlement payouts.
Our lawyers are currently seeking Tepezza hearing damage cases in all 50 states. If your hearing was damaged after taking Tepeza, contact us today at 800-553-8082 to see if you have a case.
Tepezza
Tepezza is the brand name for teprotumumab, a prescription drug that was recently developed and approved for the treatment of thyroid eye disease (TED) and a related condition known as Graves’ eye disease. TED is a condition in which the fatty tissue behind the eyes and other parts of the eye are plagued by chronic inflammation. The inflammation in the eye tissue is caused by an abnormal autoimmune response in which the body’s immune system targets the eye tissue. This inflammatory reaction causes the eyes to swell which can significantly obstruct vision. The condition is usually associated with hyperthyroidism and is most commonly caused by Graves’ disease, an autoimmune disorder that affects the thyroid gland.
Tepezza was developed Horizon Therapeutics, a biopharma company that specializes in developing drugs for rare rheumatoid and autoimmune diseases. Tepezza received approval from the Food and Drug Administration (FDA) in January 2020 and it is currently still under patent protection.
Tepezza was the first drug approved for the treatment of thyroid eye disease. Tepezza works by blocking a specific protein that is believed to trigger the immune reaction that causes TED. Tepezza is administered by injection about every 3 weeks for around 5 months.
Like so many new drugs released on the market today, FDA approval for Tepezza was obtained based on very limited testing and without determining the exact mechanism of action of the drug. The single clinical trial which Horizon used for the FDA approval of Tepezza included less than 100 patients.
Tepezza Causes Serious Hearing Loss
Immediately after Tepezza was released on the U.S. market, reports of serious hearing damage from patients and doctors began coming in. A new post market study on Tepezza was published in 2021 and it showed that not only did Horizon grossly understated the risk of hearing damage associated with Tepezza during the FDA approval process.
Another major study linking Tepezza to serious hearing loss was published in the Endocrine Society journal. The study reported 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.
Tepezza Lawsuits
Individuals who received Tepezza injections and subsequently suffered an abnormal reaction resulting in hearing damage, and/or tinnitus are now bringing product liability lawsuits against Horizon. The lawsuits allege that Horizon negligently failed to adequately warn patients and doctors about the true risk of hearing damage from Tepezza.
Deceptive Practices
Every Tepezza lawsuit we have seen alleges that Horizon Therapeutics engaged in deceptive marketing practices regarding their thyroid eye disease drug. Horizon marketed Tepezza as a treatment for anyone diagnosed with TED, including patients with mild forms of the condition who would not be expected to experience vision impairment. But Tepezza lawsuits claim that only a small percentage of TED patients, about 3-5%, experience vision impairment as a result of the condition. Despite being aware of this fact, Horizon allegedly promoted Tepezza as a treatment for early intervention in TED.
Testing and Warnings
The lawsuit also claims that Horizon failed to adequately test Tepezza and investigate the risks associated with the drug. The Tepezza label reportedly contains warnings for infusion reactions, exacerbation of preexisting inflammatory bowel disease, and hyperglycemia, but the label only lists hearing impairment as an adverse reaction, with no mention of the possibility of extended duration or permanent injury. The lawsuit claims that Horizon failed to warn patients of the risk of ear injury and permanent or extended hearing impairment.
Delaying Post Marketing Study
The lawsuit further alleges that Horizon delayed the start of an FDA-required post-marketing study to evaluate the safety of Tepezza in a larger patient population and retreatment rates relative to how long patients receive the medicine. The post-marketing analysis of the drug reportedly demonstrated that approximately 10% of all cases reported to the safety database have included a hearing-related event, with hypoacusis (reduction in hearing) and tinnitus (ringing in the ears) being the most frequently reported hearing events.
Damages Sought
The lawsuit seeks compensation for damages and for Horizon to be held accountable for their marketing practices and failure to adequately test and investigate the risks of Tepezza.
To date, the number of Tepezza lawsuits filed across the country by hearing loss lawyers has been relatively limited. But many more are expected moving forward. There is currently no motion seeking to consolidate the Tepezza lawsuits into a class action MDL, and there are not enough cases pending to warrant MDL consolidation anyway.
For settlement, given the size of the pool of plaintiffs, this might be a good thing for victims.
Estimated Settlement Payouts for a Tepezza Lawsuit
Anyone who is considering filing a Tepezza lawsuit will naturally wonder how much money they might get if the case succeeds. At this point, we can’t say for certain exactly how much Tepezza hearing damage lawsuits could potentially be worth in settlement or at trial. It’s simply too early to know how much these cases might be worth.
The first Tepezza lawsuits were only recently filed, and there are too many variables that could impact the viability and valuation. The best our attorneys can do is provide a reasonable settlement estimate of what a successful Tepezza settlement would be.
Based on our analysis of the Tepezza hearing loss lawsuits, our lawyers estimate that a successful Tepezza settlement could be between $140,000 to $250,000. A Tepezza settlement payout of a specific case will depend on various factors, including the age of the plaintiff and whether they had any preexisting hearing issues.
Suits involving a major, permanent hearing loss in relatively young plaintiffs with no preexisting conditions will be worth more. A number? We are guessing that an average Tepezza payout would be between $250,000 and $500,000.
What would the average jury payout be in a Tepezza lawsuit? That is even more speculative. But it is not hard to see an award in the millions when you look at the multimillion-dollar verdicts in the 3M earplug litigation.
When Will Tepezza Lawsuits Settle?
In most mass tort litigation involving a defective drug, thousands of cases get filed and consolidated into a class action MDL. The cases then go through a long period of consolidated discovery, after which a handful of representative cases are selected out. These cases are then sent for bellwether trials, which are basically test trials to give the parties a small sample of what to expect if all of the cases went to trial.
After the bellwether trials, both sides usually negotiate a global settlement. This process generally takes several years to evolve. We think the Tepezza hearing loss plaintiffs can expect a much faster settlement process. Why?
The first reason why the Tepezza settlement process could be faster is that the litigation will be relatively small. We will probably see a few hundred rather than a few thousand Tepezza cases get filed. This means there will be not consolidation into an MDL, which slows things down. A class action lawsuit can take over five years to resolve. Individual claim rarely last more than a few years.
The second reason to expect a streamlined settlement process is that Horizon has extra incentive to get these cases resolved quickly and quietly … the type of “incentive” that comes in a 10 figure dollar amounts. In December 2022, Amgen, one of the biggest biopharmaceutical companies in the world, announced that it had a deal to acquire Horizon for $27.5 billion (around $115 dollars per share). The current executives and other major shareholders at Horizon stand to pocket millions if the deal goes through.
What makes things interesting is that Amgen’s primary reason for acquiring Horizon is to capture the patent-protected sales for Tepezza. Tepezza is the only approved drug for TED and it is generating billions in revenue. This means that Horizon may be hard pressed to get the Tepezza lawsuits resolved quickly to avoid generating concerns about liabilities that could threaten the acquisition deal.
Example Tepezza Lawsuit (Diaz v. Horizon)
This is a lawsuit brought by a woman against Horizon Therapeutics. The lawsuit alleges that Tepezza caused permanent hearing damage to Diaz and that Horizon knew or should have known that the drug could cause hearing loss, but did not warn Diaz or her doctors. The lawsuit claims that numerous studies and reports have shown that Tepezza can cause hearing loss and tinnitus (ringing in the ears), but the drug label did not include any warning about these risks.
The lawsuit also alleges that Horizon promoted Tepezza as a treatment for thyroid eye disease to anyone diagnosed with the condition, despite the fact that only a small percentage of patients with the disease actually experience vision impairment. The lawsuit claims that Horizon failed to conduct sufficient testing of Tepezza to determine its mechanism of action, and submitted the drug for FDA approval with less than 100 patients enrolled in clinical trials actually receiving the drug.
The lawsuit further alleges that Horizon failed to investigate the risks posed by Tepezza, and delayed starting an FDA-required post-marketing study to evaluate the drug’s safety in a larger patient population. The lawsuit seeks damages for the injuries suffered by Diaz as a result of her Tepezza infusions.
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 reach out to us online.