Tepezza Lawsuit Lawyers | Tepezza Lawsuit Attorneys

A lawsuit, Perez Diaz v. Horizon Therapeutics USA, Inc., has been filed against Horizon Therapeutics, aiming to secure compensation for damages and hold Horizon accountable for their marketing practices and failure to sufficiently test, investigate, and disclose the health risks associated with Tepezza.

So far, the number of Tepezza lawsuits filed nationwide has been relatively small, but many more are anticipated to emerge. Currently, there is no motion to consolidate the Tepezza lawsuits into a class action MDL (Multidistrict Litigation), and the number of pending cases does not yet warrant such consolidation.

The claims against Horizon Therapeutics include:

• Misleading Actions. In every Tepezza lawsuit brought to light, Horizon Therapeutics is accused of engaging in deceptive tactics regarding their thyroid eye disease drug. Allegedly, Horizon marketed Tepezza as a treatment for all diagnosed cases of TED, including patients with mild forms of the condition who wouldn't typically experience vision impairment. However, Tepezza lawsuits argue that only a small percentage of TED patients, around 3-5%, experience vision impairment due to the condition. Despite being aware of this, Horizon allegedly promoted Tepezza as a remedy for early intervention in TED.
• Testing and Warnings Negligence. The lawsuit further claims that Horizon failed to conduct adequate testing and investigate the potential risks associated with Tepezza. While the Tepezza label does contain warnings about infusion reactions, exacerbation of preexisting inflammatory bowel disease, and hyperglycemia, it reportedly lacks any mention of the possibility of extended duration or permanent injury, particularly regarding hearing impairment. According to the lawsuit, Horizon did not adequately warn patients about the risks of ear injury and the potential for permanent or extended hearing impairment.
• Post-Marketing Study Delay. The lawsuit also alleges that Horizon purposely delayed the commencement of an FDA-required post-marketing study to assess Tepezza's safety in a larger patient population and the frequency of retreatment rates. According to the post-marketing analysis, approximately 10% of all cases reported to the safety database included hearing-related events, with hyperacusis (hearing reduction) and tinnitus (ringing in the ears) being the most commonly reported hearing issues.

According to a Endocrine Society Journal study, approximately 65 percent of Tepezza patients reported experiencing otologic (or hearing) symptoms, including hearing loss or muffled hearing. This is over six times higher than the estimated risk of hearing loss disclosed by Horizon during the FDA approval process.

The researchers evaluated 26 patients treated with Tepezza, and 17 (65 percent) reported otologic symptoms. The most common symptoms included subjective hearing loss, ear ringing (tinnitus), a sensation of ear plugging, and autophony (unusually loud hearing of one's own voice). The onset of these symptoms occurred after an average of 3.6 infusions of the drug.

Four patients with new hearing symptoms experienced new or worsening sensorineural hearing loss, a type of hearing loss caused by damage to the hair cells in the inner ear. Additionally, three patients had patulous eustachian tube. In this condition, the channel between the middle ear and the back of the nose and throat remains open, affecting air pressure regulation around the ear drum. While some symptoms of patulous eustachian tube improved after three months, they did not completely disappear.

The authors, including Dr. Andrea Lora Kossler from Stanford University School of Medicine, acknowledge that Tepezza is effective for thyroid eye disease but emphasize the importance of understanding its potential risks, including hearing impairment. They recommend implementing screening precautions, such as baseline audiogram testing, to monitor and reduce the risk of hearing loss in patients undergoing Tepezza treatment.

To gain a deeper understanding of this potential side effect, further research will focus on evaluating risk factors for hearing loss and the reversibility of symptoms. It should be noted that the follow-up period of three months after stopping the drug might be too short to assess the reported reversibility of otologic symptoms fully. As the medical community becomes more aware of otologic symptoms associated with Tepezza, measures can be taken to mitigate potential risks and ensure patient safety during treatment for thyroid eye disease.