DETROIT — A Michigan judge ruled a drug manufacturer and hospital can be held financially liable in a case where a man was permanently disabled after being administered a COVID-19 medication.
The drug, Remdesivir, which is designed to combat COVID-19 symptoms, was discovered to be contaminated with glass particles.
This is the first time a judge has ruled a drug manufacturer and hospital are not protected by the Public Readiness and Emergency Preparedness Act or PREP. The act was declared by the U.S. Department of Health and Human Services for emergency use, and shields manufacturers, administrators and distributors of vaccines from liability claims of loss caused by the drug.
Detroit-based attorney Ven Johnson, who is representing Dan Nowacki, says this case will hopefully hold "Big Pharma" accountable.
Johnson filed a lawsuit on behalf of Nowacki against the drug's manufacturer, Gilead Services Inc and St. Joseph Mercy Chelsea Hospital that administered the drug citing greed, incompetence and negligence.
According to the complaint, in Nov. 2021, Nowacki was admitted to the hospital after being diagnosed with COVID-19. He was administered five doses of Remdesivir and at least two of those doses belonged to the contaminated lot. He suffered two strokes and an amputated leg.
A once very independent man, his family now says they have to care for him 24/7.
"I just can't do the things I used to do before," said Nowacki's wife. "I used to be so independent myself and now I have to take care of him."
On Dec. 2021, Gilead issued a voluntary recall highlighting the contamination of glass particles and the risks of stroke and death.
"Dan's second stroke occurred two weeks or so after Gilead voluntarily recalled their product. Did they go and tell his treating physicians about that? The answer is no, they didn't. Could that second stroke have been avoided had they known he was not prone to that?" said Johnson.
On April 2022, the hospital sent Nowacki's family a letter confirming at least two doses of Remdesivir were part of Gilead's nationwide recall.
"I would expect they would've figured out who they gave this medication to and who they didn't and make sure there's not a problem. But that's not what they did here," said Johnson.
Johnson says the manufacturer and hospital's argument against being sued was they had drug immunity, however, a judge denied that argument so now the case can proceed to trial.
"...Judge Carol Kuhnke concluded Congress did not plan to extend the PREP Act immunity to a drug that substantially deviated from FDA approval, and included glass particles..."
Johnson adds these rulings in state and federal court could set a precedent for future cases.
"It's not what we call binding precedent. In other words, it's not automatic but it would certainly be very important for a judge somewhere else in the country to see that and it would be very important for the victim."
The lawsuit was filed in Washtenaw County Circuit Court. Depositions and discovery can proceed so Johnson says so more information about the case can be uncovered.
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