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 thousand 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.
