Pre-Approval Design Defect Claims Not Preempted, Tepezza MDL Judge Rules
November 6, 2023
CHICAGO — The judge overseeing the federal Tepezza hearing loss MDL docket has rejected Horizon Therapeutics USA Inc.’s argument that pre-approval design defect claims are preempted, finding the defendant did not cite any federal law that would have prohibited it from making changes to the drug’s design before it sought FDA approval.
In a Nov. 3 order, Judge Thomas M. Durkin of the U.S. District Court for the Northern District of Illinois noted that as alleged, Horizon had “complete and independent control” over the thyroid eye disease drug’s design before it sought FDA approval.
Plaintiffs in the MDL allege Tepezza …