(LifeSiteNews) – One of the world’s largest “Big Pharma” companies is denying blame while pointing a finger at a manufacturing company based in the United Kingdom after its product, Remdesivir, was found to have been contaminated with glass particles that risked serious adverse events such as stroke and death.
This is a classic case of David v. Goliath: An elderly man who suffered two strokes and a leg amputation after receiving the contaminated drug is challenging one of the world’s largest corporations that claims it did no wrong.
The finger pointing began after a Michigan Circuit Court judge ruled that Gilead Sciences Inc. is not shielded by the Public Readiness and Emergency Preparedness (PREP) Act, which was intended to legally protect drug manufacturers from liability if individuals experience physical harm from its products.
The PREP Act of 2005 “authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines,” according to the Congressional Research Service (CRS). Near the beginning of the pandemic, the Trump administration’s HHS invoked the Act in declaring the virus a “public health emergency.”
The PREP Act has made it difficult for injured individuals and their families to have legal recourse against doctors, hospitals, and pharmaceutical companies for deaths and other harms attributable to the COVID vaccines, lockdowns, ventilators, and other measures.
Gilead has filed a Notice of Nonparty at Fault, meaning that it is now accusing British manufacturer Hikma for the presence of the glass particles in the liquid form of the medicine.
The precise relationship between Gilead and Hikma remains unclear. All that’s known at this point is that Gilead is trying to deflect blame away from itself.
In a perhaps unsurprising development, the U.S. Chamber of Commerce has come to Gilead’s defense, filing an amicus brief claiming that if the injured man prevails in court against Gilead, harm would be caused to the pharmaceutical industry.
Gilead is one of the U.S. Chamber’s largest clients.
According to his lawyers, Dan Nowacki of metro Detroit suffered two strokes and had his leg amputated in 2021, days after receiving multiple doses of Remdesivir that were produced by Gilead Sciences.
The judge’s decision, which was handed down in August, ruled that Gilead is not shielded by the PREP Act, a move that is likely to increase the possibility of future class-action lawsuits against pharmaceutical companies.
Nowacki, who is in his 80s, lived an active life with his wife before being administered Remdesivir at St. Joseph Mercy Chelsea Hospital. He is now confined to a wheelchair.
Nowacki’s attorney, Ven Johnson of Johnson Law, said during a press conference at the time that the hospital took several months to confirm Nowacki was given two doses of Remdesivir that contained microscopic glass shards.
Gilead Sciences produced the drug, which is known as Veklury in its intravenous form. In December 2021, Gilead issued a voluntary recall of reportedly 55,000 vials of Veklury after admitting they had glass particulates in them.
Both St. Joseph Hospital and Gilead argued in court that they were protected by the PREP Act, but the judge rejected their arguments.
“You didn’t get FDA approval to put glass particulates in this medication,” Johnson said. “You had the medication that was approved, never the glass particulates. So, you do not have drug immunity.”
Johnson specified that Nowacki’s lawsuit seeks to find out why patients at St. Joseph were not informed about the glass in Gilead’s vaccine.
“It took the hospital nearly five months after they knew, or should have known, that the Remdesivir was contaminated with glass particulates and never contacted our clients,” Johnson said.
“They know they screwed up somewhere. That’s why they took it off the market,” he remarked. “You would think that Gilead would step up and do the right thing, and come to this family and help this family as opposed to simply playing the lawsuit game.”
The Michigan lawsuit follows a similarly successful legal challenge to the PREP Act last spring in California.
“Doctors have a duty to review the literature, especially in an emerging crisis, and to stay abreast of these developing guidelines,” the attorneys argued in a press release. “Safety and avoiding harm should always come first in a clinical environment. COVID-19 has a 99.97% survival rate. Remdesivir decreases this survival rate exponentially. This protocol is cruel, deadly, unnecessary and also, as it turns out, highly financially incentivized.”
Additionally, attorney Matthew P. Tyson said he found the drug carries a 3,000% higher risk of death than other medications.
Remdesivir received Emergency Use Authorization in or around May 2020 after being recommended by a [National Institutes of Health] panel that contained nine individuals with financial ties to its creator, Gilead Sciences.”
Writing for the Brownstone Institute, Liam Cosgrove added that the NIH “funded trials for remdesivir, still under patent with Gilead, despite being less effective and having more severe side effects than ivermectin,” and that the U.S. Food & Drug Administration “approved remdesivir under EUA despite published trials later stating ‘remdesivir was not associated with statistically significant clinical benefits.’”