from Great Game India:
In a historic ruling, a judge in Michigan decided on August 8th that the Public Readiness and Emergency Preparedness (PREP) Act does not shield a drug manufacturer and a hospital in the case of a man who suffered two strokes and had to undergo a leg amputation due to receiving remdesivir, a COVID-19 medication that was contaminated with glass particles.
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This marks the inaugural instance where a judge has determined that the PREP Act does not provide protection to a drug manufacturer or a hospital. The PREP Act typically grants immunity from legal actions and liability safeguards under both state and federal regulations for all claims related to losses arising from the use of the covered countermeasure. However, exceptions are made in cases of intentional misconduct. While this ruling is not a legally binding precedent, it establishes a precedent for potential future lawsuits against the company concerning injuries that could be sustained by individuals who were administered the drug.
Dan Nowacki, along with his wife and son, brought forth a lawsuit through Detroit-based attorney Ven Johnson against Gilead Sciences, Inc. (Gilead), the producer of remdesivir (marketed as Veklury), and St. Joseph Mercy Chelsea Hospital, the facility that administered the medication. The lawsuit alleges various claims, including breach of warranty, negligence, gross negligence, and loss of consortium. Loss of consortium pertains to the deprivation experienced by Ms. Nowacki due to the absence of her husband’s “society, companionship, and household services.”
The hospital and the pharmaceutical firm contended that they were immune to legal action based on their assertion of protection 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 stated.
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