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Michigan judge denies immunity in contaminated drug case

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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.

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