Gongwer News Service
The Public Readiness and Emergency Preparedness Act gives drug companies and hospitals liability immunity in drug manufacturing defect lawsuits if the injuries were not caused by willful misconduct, a Court of Appeals ruled Tuesday in a unanimous decision.
In a published opinion released Wednesday written by Judge Michelle Rick, the panel in DN v. Gilead Sciences Inc. (COA Docket Nos. 367271; 368026) reversed two Washtenaw Circuit Court opinions that sided with the DN, a legally incapacitated person represented by their guardians, Mark and Kathleen Nowacki. The appellate panel remanded the cases for additional proceedings.
Judge Mark Boonstra and Judge Anica Letica joined the opinion.
The lawsuit involved the 83-year-old, identified in the case with he initials “DN,” who contracted COVID-19 in 2021. He was sent to St. Joseph Hospital and was given monoclonal antibodies and discharged. DN was admitted to the emergency department the following day because his symptoms worsened.
DN was then given two doses of remdesivir, an anti-viral medication that emerged as a means to fight COVID-19 infections during the early days of the pandemic. Within a week, DN had a stroke, suffered from large bruises and swelling of his face and arms and had a second stroke one month later.
DN’s guardians in April 2022 received a letter from the hospital noting DN had received remdesivir, and that the lot containing two of the five doses he received were recalled because they contained glass particles.
By way of his guardians, DN sued the remdesivir manufacturer and the hospital on claims for breaching an implied warranty, negligence and intentional misrepresentation. The lawsuit was filed in federal court but it was removed to the circuit court. Gilead argued the PREP Act preempted the state law claims.
The federal district court agreed and dismissed the lawsuit because DN’s guardians had not exhausted all their available remedies outside of court. The federal district court also said the tainted remdesivir doses were drugs covered by the PREP Act’s liability protections.
Before the Washtenaw Circuit Court, Gilead asked the court to dispose the case in its favor. The company argued the PREP Act provided immunity for the same reasons it presented to the federal district court. The hospital also asked the court to dismiss the case.
A Washtenaw Circuit Court judge denied both motions, orders that Gilead and St. Joseph Hospital appealed.
The company and the hospital argued that the circuit court wrongly decided its motions because the PREP Act’s plain language granted immunity from manufacturing defect lawsuits.
Rick and her colleagues agreed with the company and the hospital’s argument on Tuesday, and noted that the federal PREP Act only allows manufacturing defect injury claims if those defects arose from willful misconduct.
“Congress has unequivocally extended immunity to scientists, pharmaceutical companies, and other health care providers who grappled with the unprecedented nature of the COVID-19 pandemic,” Rick wrote. “Gilead and St. Joseph are ultimately correct: under the PREP Act, no liability can attach here.”
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