Claims arising from receiving contaminated remdesivir (an FDA-approved medication); Immunity for manufacturing defects under the federal Public Readiness & Preparedness (PREP) Act; 42 USC §§ 247d-6d(a)(1) & (2)(B); Hudak v Elmcroft of Sagamore Hills (6th Cir); “Loss”; “Covered person”; “Covered countermeasure”; Effect of the fact the product allegedly contained microscopic glass particles; Willful misconduct exception to immunity; § 247d-6d(d)(1)

The court held that the PREP Act’s plain language clearly granted defendants-Gilead “and St. Joseph immunity from all liability for injuries that were not caused by willful misconduct.” As plaintiffs did not allege that either defendant “engaged in willful misconduct by manufacturing or administering remdesivir to” plaintiff-DN, plaintiffs’ claims failed. The then-83-year-old DN allegedly received two contaminated doses of the FDA-approved medication remdesivir in 2021 after being diagnosed with COVID-19. He then suffered two strokes. St. Joseph later informed DN’s guardian that the two doses “involved recalled lot numbers of the drug.” The recall was due to “the presence of glass particulates.” Plaintiffs subsequently filed this suit. Defendants argued that the trial court erred in denying their summary disposition motions “because the PREP Act’s plain language grants immunity from manufacturing defect claims.” The court agreed. Plaintiffs argued that “the remdesivir administered to DN should not be considered a ‘covered countermeasure’ because Gilead manufactured, and St. Joseph administered, a product containing microscopic glass particles. Plaintiffs maintain that it is the glass particles, and not the remdesivir itself, that caused DN’s lasting injuries.” The court understood their argument but concluded that “Congress acted to prevent suits like this in the face of a serious public health emergency. Gilead and St. Joseph are ultimately correct: under the PREP Act, no liability can attach here.” Under the Act’s plain language, defendants “cannot be held liable for any alleged wrongdoing short of ‘willful misconduct.’ . . . Plaintiffs did not plead in avoidance of the PREP Act by alleging that Gilead or St. Joseph engaged in willful misconduct in this case, nor does it appear that an unintentional error allegedly causing contamination of the remdesivir during the manufacturing process rises to the level of willful misconduct for which [they] can be held liable.” The court found that to “conclude that manufacturing defects prevent products from being considered ‘covered countermeasures’ under the PREP Act, we would necessarily have to render some of the language of the PREP Act nugatory[.]” Reversed and remanded for entry of an order granting defendants summary disposition.