Tepezza, also known as Teprotumumab, is a prescription drug that received FDA approval for thyroid eye disease (TED) treatment. This condition is a part of Graves’ disease, albeit affecting the eyes.
Painful as it is, TED can lead to chronic inflammation of the eye tissue. Patients were glad at the discovery of a drug that showed treatment promise. Manufactured by Horizon Therapeutics, Tepezza works by blocking a specific protein that is believed to cause an abnormal immune response.
Patients are administered the drug through three-week infusions for a period of five months. Just like any other drug on the market, Tepezza’s FDA approval was granted after limited clinical trials (only 100 patients).
Over time, people came forward, complaining that Tepezza treatments led to auditory issues. Today, multidistrict litigation (MDL) exists in the Federal courts, with victims seeking justice for their injuries. In this article, we will discuss the litigation’s progression to understand how soon plaintiffs may expect settlements.
Tepezza Causes Serious Hearing Loss
The first-ever Tepezza lawsuit was filed back on August 25th, 2022 – Weibel vs. Horizon Therapeutics. The plaintiff complained that the drug caused permanent hearing loss issues.
Soon after the first case, several others were filed with related injuries, including partial or permanent hearing loss, tinnitus (ringing sensation in the ears), and increased sensitivity to sound.
In a post-marketing study (2021), it was found that Horizon grossly understated Tepezza’s side effects during the FDA approval process. In the same year, the Endocrine Society published a study in which 65% of the patients developed otologic symptoms (post Tepezza infusions).
This figure was six times higher when compared to the hearing-related risks originally disclosed by the drug’s manufacturer. Despite these studies validating the lawsuits, the FDA added the hearing impairment warnings to Tepezza’s labels only from July 2023.
Moreover, the Endocrine Practice journal published a study where 16% of the 121 patients developed Tepezza-related auditory adverse events. Out of the 20 cases, at least 12 reported suffering from tinnitus, eustachian tube dysfunction, and autophony.
Horizon’s Deceptive Marketing Practices
In every Tepezza hearing loss lawsuit, the plaintiff has alleged that the drug manufacturer was fully aware of its serious side effects. Even then, Horizon Therapeutics engaged in deceptive marketing tactics for profits.
Tepezza was marketed as a drug that anyone with thyroid eye disease could benefit from (even those with a milder form of the condition). It was later discovered that Tepezza was unsuitable for early intervention (since most patients do not experience vision impairment at this stage).
Despite this knowledge, Horizon continued to market the drug as safe and effective for mild TED as well. At the time of drug approval, nearly 77% of ophthalmologic offices had shut down. The drug manufacturer adopted innovative strategies to market it directly to consumers.
It developed a network of over 1000 infusion centers and reached out to physicians through digital channels. Gradually, the digital marketing practices turned into regional TV advertisements, and ultimately into national ads. The ads included eye-popping, animated images to attract the audience.
Litigation Progression and Estimated Settlement Amounts
Tepezza’s hearing loss lawsuit is still awaiting its Bellwether trials, and plaintiffs have proposed some cases to prevent further delay. According to TruLaw, the case numbers stood at a modest 54 by the end of September 2023.
On the other hand, Amgen, the biopharmaceutical giant, announced its plans to acquire Horizon Therapeutics. The Federal Trade Commission (FTC) has tried to block this move through a separate lawsuit. It is believed that the acquisition involved the danger of favoring Horizon’s monopoly products, including Tepezza.
Apart from some litigation delays, the first meaningful status conference is expected to take place on October 25, 2023. At this conference, the presiding Judge Durkin will look closely into the electronic discovery protocols for the chosen cases.
Besides, he will also weigh in on some preliminary disagreements regarding the discovery process. Both sides of the counsel will need to attend this hearing in person. As for the settlement amounts, lawyers cannot offer a definite sum as it may vary from case to case.
The reasonable settlement estimate is that a successful lawsuit holding up in court could be settled between $140,000 and $250,000. The exact amount will vary based on the plaintiff’s age and the presence or lack of preexisting hearing issues.
The relatively younger plaintiffs with permanent hearing loss and no pre-existing issues can expect a payout between $250,000 and $500,000.
The plaintiffs are waiting with bated breath for the Tepezza MDL to progress in the courts. Usually, product liability lawsuits involve thousands of plaintiffs, tedious discovery periods, and multiple Bellwether trials before settlements are made.
This is why they generally take several years to resolve. Though the Tepezza hearing loss lawsuit has also moved through Federal courts for over a year, it is expected to be settled soon due to less number of cases (a few hundred).
Moreover, if the FTC’s move to block Amgen’s acquisition does not work, Horizon gets another incentive to resolve Tepezza MDL quickly. However, will it be permitted to market the drug in the future? Perhaps yes, given that it is the only FDA-approved treatment for TED, but certainly not without the correct warning labels.