The U.S. District Judge overseeing Tepezza lawsuits has outlined criteria for selecting 12 cases for early "bellwether" test trials.
Simultaneously, the judge rejected the drug maker's attempt to dismiss the litigation regarding the alleged failure to warn about the risk of hearing problems.
Tepezza (teprotumumab-trbw), introduced by Horizon Therapeutics in January 2020, is a novel biologic treatment for thyroid eye disease or bulging eyes associated with hyperthyroidism and Graves’ disease. The drug's sales surged to $1.66 billion in the second year on the U.S. market, raising concerns about aggressive marketing without full disclosure of potential risks.
Numerous former users are now stepping forward, reporting various hearing problems linked to Tepezza, such as persistent ringing in the ears (tinnitus) and complete hearing loss. In many instances, hearing issues endure long after the thyroid eye disease treatment, resulting in irreversible damage.
Due to common questions of fact and law across federal court complaints, a Tepezza MDL (multidistrict litigation) was established in July 2023. This centralizes lawsuits before a U.S. District Judge in the Northern District of Illinois for coordinated discovery and pretrial proceedings.
Plaintiffs in the Tepezza lawsuits share common arguments, contending that the disclosure of information about the risk of hearing problems by the drug maker, along with instructions for doctors to conduct hearing tests before and during treatments, could have potentially prevented their issues.
In July, the U.S. Food and Drug Administration (FDA) updated the Tepezza prescribing information guide, incorporating many of the hearing loss warnings that plaintiffs claim should have been present from the drug's initial introduction.
The revised Tepezza label now acknowledges instances of severe and permanent hearing loss among users. It advises doctors to assess patients' hearing both before and after Tepezza infusions to mitigate the risk of permanent ear damage.
Although the outcomes of the early trial dates for Tepezza bellwether cases won't be legally binding on other claims in the litigation, the average payouts in these lawsuits may influence settlement negotiations. These negotiations become crucial to avoid setting each individual case for trial in the upcoming years.