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.
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.
“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 for glass particles.”
Based on the complaint (read below) acquired by The Epoch Times, as of Nov. 10, 2021, Mr. Nowacki was admitted to St. Joseph Mercy Chelsea Hospital due to a COVID-19 diagnosis. During his hospitalization, he was administered five doses of remdesivir, with at least two doses originating from batches contaminated with glass particles.
Within a few days, Mr. Nowacki encountered his initial severe stroke. Subsequently, on Nov. 24, he was discharged to a skilled nursing facility, where he started exhibiting hematomas and swelling in his hands, face, and arms. His condition led to readmission to Henry Ford Hospital, where his “symptoms continued to baffle medical professionals.”
A second stroke struck Mr. Nowacki on Dec. 16, rendering him immobile and dependent on constant care for the remainder of his life.
Authorized by the FDA in May 2020, remdesivir is an antiviral medication designed to target SARS-CoV-2’s RNA in order to inhibit replication and alleviate COVID-19 symptoms. Over time, its usage has gained approval for both adults and children as young as 28 days, provided they weigh at least 6.6 pounds.
A company announcement published on the FDA’s website on December 3, 2021, stated that Gilead issued a voluntary recall for two batches of Veklury, also recognized as remdesivir. This action followed a customer complaint about the presence of glass particulates in the drug. Subsequent investigation verified the validity of the complaint.
In a risk assessment statement, the company acknowledged that the presence of “glass particulates” could potentially result in strokes or even fatality if these particles were to enter the bloodstream, travel to various organs, or obstruct blood vessels within the heart, lungs, or brain. Despite this, Gilead pointed out that up to that point, no adverse events related to the recall had been reported. The company began notifying its distributors and customers through expedited delivery using UPS next-day air services, facilitating the return of any remaining vials from the affected lots.
Around 55,000 doses of remdesivir were affected by the recall, according to a press release (pdf) issued by the Ven Johnson Law.
However, it wasn’t until April 2022, four months later, that Mr. Nowacki and his family received notification about the recall. St. Joseph Mercy Hospital sent a letter (pdf) confirming that Mr. Nowacki had been administered at least two doses of remdesivir from batches potentially tainted with glass particles. Interestingly, Mr. Johnson, the attorney, revealed that his clients were the ones who initiated contact with Gilead and the hospital to inquire about whether Mr. Nowacki had received remdesivir from the affected lots. Gilead’s response was that they needed to establish communication with the hospital.
“One of the things that we’re going to figure out is exactly what Gilead, the FDA, and the hospital knew and when,” Mr. Johnson stated. “How did glass particles that could cause strokes and death in people get into this medication? Why aren’t these people approaching us to get our client’s medical records to understand what happened?”
According to Mr. Johnson, he expressed his perplexity at Gilead’s lack of proactive measures to reach out to individuals who might have been exposed to the tainted batches or to extend assistance to those who could have been adversely affected. Instead, the company seems to be using technicalities as a shield.
“Dan Nowacki’s case is a tragic example of the devastating consequences that can arise from sheer negligence and greed from pharmaceutical companies and the incompetence of St. Joseph Mercy Chelsea in not giving timely notice of a recalled drug,” said Mr. Johnson, in a press release. “Drug manufacturers and medical institutions need to prioritize patient safety above all else. The four-month delay of alerting Nowacki of the recalled remdesivir prevented Mr. Nowacki’s subsequent treaters from administering necessary treatment, which compromised Nowacki’s recovery.”
In conversation with The Epoch Times, Mr. Johnson conveyed that it is atypical for a company to initiate a voluntary product recall.
“They had to have had contact with the FDA,” he said. “They claim in their December press release they had evidence of a customer who had some type of reaction, and they confirmed it was accurate—but when was it, where did it happen, and when did they first learn about it, because this process didn’t happen in two to three weeks.”
Now that a judge has ruled out Gilead and the hospital’s immunity under the PREP Act, the subsequent stages entail the discovery process followed by a trial.
Mr. Johnson is actively urging Michigan’s Attorney General, Dana Nessel, to initiate an investigation into the marketing of the drug within their state. He is also encouraging individuals possessing any information about the presence of glass particles in the medication or anyone who may have likewise received tainted doses to reach out to his law firm.
The Midazolam + Morphine protocol, combined with false diagnosis of C19 could also be responsible for half of the deaths ascribed to C19 in the UK in 2020. Just how many people were actually killed by Remdesivir?
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