A Michigan judge ruled for the first time that Gilead Sciences, Inc. is not protected under the PREP Act after a man experienced severe injuries from taking two doses of a COVID-19 drug contaminated with glass particles.
In a groundbreaking decision, a Michigan judge ruled on Aug. 8 that a drug manufacturer and hospital are not protected by the Public Readiness and Emergency Preparedness (PREP) Act in the case of a man who experienced two strokes and a leg amputation after receiving the COVID-19 medication remdesivir that was contaminated with glass particles.
This is the first time a judge has ruled a drug manufacturer and hospital are not protected under the PREP Act, which provides immunity from lawsuits and liability protections under state and federal law concerning all claims for loss resulting from the administration of the covered countermeasure, except in the case of willful misconduct. Although the ruling is not a binding precedent, this case sets the tone for future lawsuits against the company for injuries potentially incurred by those given the drug.
Detroit-based attorney Ven Johnson filed a lawsuit on behalf of Dan Nowacki, his wife, and son against Gilead Sciences, Inc. (Gilead), the manufacturer of remdesivir—marketed under the brand name Veklury—and St. Joseph Mercy Chelsea Hospital that administered the drug, alleging breach of warranty, negligence, gross negligence, and loss of consortium—as Ms. Nowacki has lost her husband’s “society, companionship, and household services.”
The hospital and pharmaceutical company claimed they could not be sued because they had immunity under the PREP Act.
“Their argument has been, ‘Yeah, we know we voluntarily recalled. Yeah, we know there are glass particulates in it, and we know that two doses were given to Dan, and we know he had a stroke. But since we followed the FDA guidelines and were approved, we have drug immunity. You can’t sue us because it was approved by the FDA,'” Mr. Johnson told The Epoch Times.
“We obviously knew when we filed this case that challenging the immunity given by the PREP Act would be an uphill battle,” Mr. Johnson said. “But we could not be more proud that both judges [in state and federal court] saw through the charade—that Gilead Sciences Inc. got approval for the drug, but not glass particles.”
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