A judge in Michigan has denied a drug manufacturer’s immunity in a case regarding contaminated COVID-19 medication.
The judge has ruled that the manufacturer is not protected by the Public Readiness and Emergency Preparedness Act in the case, where a man received multiple doses of Remdesivir that were contaminated with glass particles. That patient suffered two strokes and a leg amputation, leading to two lots of the drug — 55,000 vials — being recalled for similar glass particles in 2021.
The judge ruled that Congress did not plan to extend the PREP Act immunity to a drug that substantially deviated from FDA approval and included glass particles.