A series of lawsuits have been filed against Horizon Pharmaceuticals, the manufacturer of Tepezza, casting a shadow over the company's groundbreaking treatment for thyroid eye disease. These lawsuits, brought by patients who have experienced severe hearing loss and related issues after undergoing Tepezza treatment, allege a serious dereliction of duty on the part of Horizon Pharmaceuticals.
Two such lawsuits were recently filed in the U.S. District Court for the Northern District of Illinois. Both cases involve almost identical allegations. In each case, the plaintiffs had been diagnosed with thyroid eye disease and prescribed a series of Tepezza infusions over a four-month period. Following their treatment, both plaintiffs allege that they experienced significant hearing loss and tinnitus. Crucially, they assert that their doctors were not warned about the potential risk of hearing loss associated with Tepezza.
In response to these allegations, lawyers for Horizon Pharmaceuticals filed a motion to dismiss both cases. This motion is based on the federal preemption doctrine, which argues that the warning labels on Tepezza are governed by federal law and regulations. As such, they contend, these labels preempt any state law tort claims.
However, such federal preemption arguments are not usually successful in drug cases. This is because federal law and FDA regulations permit drug companies to amend their warning labels without FDA approval if new evidence of risk emerges. In the case of Tepezza, this is precisely the allegation: that Horizon Pharmaceuticals failed to update their warning labels despite mounting evidence of the hearing loss risk associated with their drug.
Furthermore, the lawsuits call into question the aggressive marketing of Tepezza by Horizon Pharmaceuticals. Plaintiffs assert that Tepezza was marketed to millions of patients, while only a small number of patients are suitable candidates for treatment with this drug. This aggressive marketing approach, coupled with the alleged failure to adequately warn about potential risks, forms the backbone of the current legal actions.
As these lawsuits move forward, they shine a light on an essential aspect of pharmaceutical law: drug manufacturers' duty to ensure the safety of their products and to provide clear, comprehensive warnings about potential risks. This legal battle is one to watch, as it could set important precedents for future cases involving drug safety and patient rights.
Let's take a closer look at some specific ongoing Tepezza lawsuits, which will provide a clearer picture of the allegations against Horizon Therapeutics.
Doe v. Horizon Therapeutics, PLC: In this case, the plaintiff, identified as John Doe, was diagnosed with thyroid eye disease and started receiving Tepezza infusions in March 2022. Shortly after, he began experiencing hearing loss and tinnitus. Despite stopping the Tepezza treatment, the plaintiff's hearing did not improve. Doe alleges that Horizon failed to provide adequate warnings about the risk of hearing loss from Tepezza.
Smith v. Horizon Therapeutics, PLC: In a similar case, Jane Smith, another thyroid eye disease patient, underwent Tepezza treatment in January 2022. She also started experiencing significant hearing loss and tinnitus shortly after beginning the treatment. Smith accuses Horizon Therapeutics of misrepresenting the safety of Tepezza and failing to warn healthcare providers about its risks.
Roe v. Horizon Therapeutics, PLC: In this case, the plaintiff, identified as Richard Roe, experienced total deafness in one ear after receiving Tepezza treatment. Roe alleges that Horizon Therapeutics was aware of the potential risk of hearing loss associated with Tepezza but failed to provide sufficient warnings to patients and healthcare providers.
These cases highlight the consistent pattern of allegations against Horizon Therapeutics—that the company failed to provide sufficient warning about the potential for severe hearing loss and related issues associated with Tepezza. Each of these cases is now working its way through the court system, and their outcomes could have significant implications for other patients who have suffered similar experiences.