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COOK COUNTY RECORD

Monday, September 16, 2024

Patient Sues Pharmaceutical Company Over Alleged Hearing Loss Caused by Thyroid Eye Disease Drug

Federal Court
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A new lawsuit has been filed against a major pharmaceutical company, alleging that their drug caused permanent hearing damage. On August 23, 2024, Linda Bailey filed a complaint in the United States District Court for the Northern District of Illinois against Horizon Therapeutics USA, Inc.

Linda Bailey's complaint details her experience with Tepezza, a prescription drug developed by Horizon Therapeutics to treat thyroid eye disease (TED). Bailey claims that she began receiving Tepezza infusions from October 2020 through June 2021 and subsequently suffered permanent hearing loss and tinnitus. According to the filing, Horizon was aware or should have been aware of these risks but failed to adequately warn patients or healthcare providers. The lawsuit points out that it wasn't until July 2023—nearly three years after Bailey's first infusion—that the drug's label was updated to include warnings about severe hearing impairment and instructions for monitoring patients' hearing before, during, and after treatment.

The complaint provides a detailed account of how Horizon allegedly ignored mounting evidence about Tepezza’s risks. Numerous patient reports and scientific studies reportedly indicated that Tepezza could cause permanent hearing loss and tinnitus. Despite this information, Horizon is accused of failing to inform users, prescribers, or regulators about these dangers. The filing also highlights that Horizon delayed an FDA-required post-marketing study intended to evaluate the safety of Tepezza in a larger patient population until late 2021 while continuing to market the drug aggressively.

Bailey's lawsuit also references internal turmoil within Horizon over the handling of Tepezza’s side effects. It mentions Dr. Wenzhong “Jerry” Liu, a former Executive Medical Director at Horizon who raised concerns internally about the higher-than-reported incidence rates of hearing impairment linked to Tepezza. Dr. Liu suggested disclosing more accurate data showing up to a 40% incidence rate of hearing issues among patients—far higher than the 10% initially reported on the drug’s label. After voicing his concerns and pushing for transparency with regulatory agencies like the FDA, Dr. Liu was allegedly fired by Horizon in retaliation.

In seeking justice, Bailey demands compensatory damages for her injuries along with statutory damages, punitive damages, attorneys’ fees, and costs associated with her case. She argues that her severe injuries were directly caused by her use of Tepezza due to Horizon’s negligent actions and omissions.

The + Case ID: 1:24-cv-07621.

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