Written By Kristen Dianne
Remdesivir Producer “Gilead Sciences” Facing Class-Action Lawsuit for Alleged Deceptive Practice.
Gilead Sciences Inc. is accused of “promoting Remdesivir’s safety and efficacy without revealing it’s potential risks”.
Gilead Sciences, the pharmaceutical company that manufactures remdesivir which has been used extensively across Canada, Australia, The European Union, and the United States to treat Covid-19 has been hit with a class action lawsuit over allegations that they deceivingly advocated for the drug without revealing potential side effects. The plaintiffs are claiming false advertising, deceptive promotion, personal injuries, and wrongful death in their class action lawsuit against the California based drug company.
This new class action lawsuit was filed on September 27, 2023, in Shasta County by two residents of California, one of whom is a relative of a person who died after receiving remdesivir and another who suffered complications from the drug.
Edward Pimentel claims that he suffered severe physical injuries after receiving remdesivir and Deborah Fust whose husband Michael Fust died after receiving the drug, are accusing the drug manufacturer of failing to provide critical information regarding documented risks and known side effects in its promotion of the drug.
Pimental and Faust are seeking class status which would allow for two distinct groups of individuals to also join the lawsuit. This will include those whose hospitalized family members passed away after receiving remdesivir to treat Covid-19 and those who suffered injury from remdesivir but survived.
Run death is near
Remdesivir, otherwise known as veklury and often referred to as “run death is near” is one of the most litigious drugs in recent history. It was first introduced in 2009, by Gilead Sciences as a Hepatitis C and RSV drug, then was studied for use against Ebola, Zika virus. During the Ebola study the drug was removed and found to be fatally toxic to the kidneys.
Early in the pandemic, it was given emergency use authorization against the treatment of severe Covid-19. Within a few months and after one controversial trial, it became the drug of choice for use against Covid-19, despite research showing that it lacks effectiveness and can cause organ failure.
According to their statement of facts, the plaintiff’s claim that Remdesivir is an “investigational antiviral drug that the Food and Drug Administration hastily authorized on March 20, 2020, for emergency use for hospitalized patients with severed Covid-19 during the first year of the pandemic. The emergency use was authorized based predominantly on one study by the NAIAID (ACTT-1) where the endpoint was changed midstream to ensure a positive result.” Many researchers point to the study as questionable and possibly flawed based on how it was performed.
A very very bad look for remdesivir
In November 2020, the drug was given full FDA approval, later expanded to include pediatrics and outpatient use. All this, despite many studies proving that it was of little value against Covid-19. According to “Science Magazine” in their article titled “A Very Very Bad Look for Remdesivir” people were also concerned that the FDA passed the controversial drug under what many called “unusual circumstances”.
In fact, the FDA would normally consult the Antimicrobial Drugs Advisory Committee (AMDAC) to review the data on experimental treatments. This committee would then make recommendations about drug approvals especially complicated antiviral drugs like remdesivir. Surprisingly the FDA did not seek the committee’s advice on this drug, right as the manufacturer had just made a deal with the European Union-a deal that would bring them at least one billion dollars. This was followed with deals for use in many other countries including the United States of America, Canada, Australia, and New Zealand.
This decision concerned many doctors, scientists and researchers who carefully watched the clinical trials unfold-leaving them with many questions about remdesivir’s efficacy against Covid-19, a virus with a 99% survival rate.
Meanwhile the World Health Organization (WHO) disagreed with the FDA’s opinion about the efficacy of the drug and did not recommend it for the treatment of Covid-19. According to the New England Journal of Medicine, the WHO confirmed that remdesivir had “little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and of hospital stay” based on their own studies.
A plethora of other studies by countries around the world showed alarming results with many stopped or discontinued altogether. A 2020 study in Hubei China was stopped early for 12% of the participants due to immediate and serious “adverse events.” China later suggested that “Gilead should ditch remdesivir and focus on its simpler and safer ancestor.”
Italy reported that it had to discontinue the 10-day treatment regimen after only 5 doses for 23% of the patients due to “toxicities”. According to the Italian authors, 42.8% of the adverse events were severe liver damage while 22.8% comprised of acute kidney injury.
France reported in June 2020, on the first five patients to be treated with remdesivir. According to their report, four out of five of the patients had their course of treatments “interrupted.” They claimed this was due to critically high “aminotransferase elevations” (showing liver damage) in two of the patients and the other two were stopped because of renal failure “requiring kidney replacement”. The authors recommended that, “particular attention should be paid to hepatic and kidney function when administering this treatment.”
Despite numerous documented serious adverse reactions including many fatalities from remdesivir worldwide, Gilead Sciences continued to falsely advertise the controversial treatment as “safe and effective” for use against Covid-19. This highly controversial claim continues to be parroted by corporate media throughout the United States of America and Canada by these heavily sponsored media outlets.
“6% of these children died, 72% had an adverse event and 21% had a serious adverse event”
In April 2022, the FDA expanded its approval to babies older than 28 days. Gilead exclaimed that the approval is an “indication for veklury for the treatment of children is a testament to the safety, tolerability and efficacy profile of this therapy, which has remained the foundational antiviral for Covid-19 treatment.”
Many clinicians expressed concern about the FDA’s approval after such a short trial that produced questionable results. According to Dr. Meryl Nass, “the FDA just licensed remdesivir for children as young as one month old. Both hospitalized children and outpatients may receive it. The drug might work in outpatients, but the vast majority of children have a very low risk of dying from COVID. If 7 deaths per 1,000 result from the drug, as … European investigators thought … it is possible it will harm or kill more children than it saves.”
Dr. Nass continues, “Shouldn’t the FDA have waited longer to see what early outpatient treatment did for older ages? Or studied a much larger group of children? Very little has been published on children and remdesivir. When we look at the press release issued by Gilead, we learn the approval was based on an open label, single arm trial in 53 children, 3 of whom died (6% of these children died); 72% had an adverse event and 21% had a serious adverse event.”
Pattern of “downplaying or omitting altogether the clinical dangers experienced by patients from remdesivir”
Former Feds Group Freedom Foundation, a non-profit organization based in the United States has been providing support for its members to push back against what many people believe to be “unlawful pandemic policies of all stripes”. They now advocate on behalf of victims of the Covid-19 hospital protocols which many members believe have led to serious injury and even death.
The site lists thousands of victims of all ages, whose testimonials, along with medical records appear to show severe injuries and death resulting from the use of remdesivir. These are all documented on the foundation’s website formerfedsgroup.org. Lawyers for this group who filed this suit claim that Gilead Sciences press releases to the public show a pattern of “downplaying or omitting altogether the clinical dangers experienced by patients from remdesivir use, instead emphasizing it’s supposed benefits, safety and efficacy.”
The lawsuit claims the “Defendant’s advertising that remdesivir is a safe and effective treatment for Covid-19 is false and misleading to a reasonable consumer, including the plaintiffs, because the defendant in fact knew or should have known, based upon prior studies and data on remdesivir, that it was unsafe and posed a high risk of severe adverse effects and death to plaintiffs and the class”. Then goes on to say that the advertising “misrepresented and/or omitted the true content and nature of the drug.”
The claim includes numerous documents, statements, press releases and studies that indicate the pharmaceutical giant’s deliberate and methodical omission of facts necessary for a patient and their families to make an educated decision based on “informed consent.”
“It’s a terrible drug,” Bradford Geyer, the attorney with Former Feds Group who is representing the plaintiffs in the case told the Epoch Times. “The nonprofit has thousands of members who have the hospital records, and you can see there’s a big difference in the creatinine levels and the blood levels, kidney readings after they get the remdesivir.”
“Misleading to the public and caused many to take it without knowing that it affected the kidneys and other organs”
Carolyn “CC” Blakeman, Media Director and Taskforce Coordinator with the Former Feds Group interviewed many of the remdesivir victims and their loved ones as she was collecting their information on behalf of the foundation. According to Blakeman, “those side effects were stated in the fact sheet that was mandated to be shown to the patients, except no patient/victim that I know of saw that fact sheet and all the American public saw was their ads/press releases that it was safe and effective.”
“This was misleading to the public and caused many to take it without knowing that it affected the kidneys and other organs,” Blakeman continued. Then added that many patients were not asked for their consent before being administered this drug.
The FDA advised that patients who receive remdesivir should disclose their medical conditions, including kidney issues, before receiving the drug. However, many victims claim that they were given remdesivir without their knowledge or consent.
The veklury website provides general information about the safety and use of the drug yet fails to mention concerns around kidney issues or other severe events that continue to be reported. While thousands of patients have experienced severe side effects and even death, the site only mentions “allergic reactions” as the most serious complication of the drug.
Found a way around the PREP ACT
One of the primary challenges facing the thousands of victims of these pharmaceutical giants is the Public Readiness and Emergency Preparedness Act or “PREP Act” which is a tort liability shield intended to protect manufacturers and distributers from financial risk in the event of a declared pandemic. It was signed into law in the United States by George W. Bush in December 2005, affording pharmaceutical companies immunity from such lawsuits.
While this law has effectively protected the drug manufactures from the multiple lawsuits that have risen during the Covid-19 pandemic, many feel that it is an unjust, unconstitutional violation of international law. It provides absolute and unfettered protection for the drug companies, while leaving the consumer without a means of recourse against what many feel is “unfair, unlawful and deceptive business practices”.
According to Blakeman, in a statement to “The Defender,” the attorneys in this case have “found a way around the PREP Act,” with a false advertising claim. She believes this approach will be effective because Gilead clearly advertised that “remdesivir did something that it didn’t”.
Blakeman goes on to explain that the plaintiff’s filed the claim in California, which is known to have strict product protection laws, because they are residents of the state and Gilead is also based there.
Ray Flores, senior counsel to The Children’s Health Defense, believes that the case is “well thought out” and that it appears to “skillfully skirt the boundaries of the PREP Act”. This is because the suit doesn’t claim loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure such as remdesivir.”
The lawsuit seeks class certification, return of profits, withdrawal of the drug, and to prevent Gilead from engaging in “unfair, unlawful and deceptive business practices.”
It is also seeking “disgorgement” or “a return of all profits made from remdesivir,” according to Geyer, plus the withdrawal of the drug and all marketing materials that are being used to push it on unsuspecting victims that include not only the recipients, but the physicians using it who, as a general rule, are also deceived by the Gilead marketing materials.”
Gilead did not return a request for comment on the lawsuit.
More lawsuits pile up around remdesivir
Christina Briones, 52, is one of two widows suing Kaiser Permanente and Redlands Community Hospital for administering remdesivir to treat their husbands for Covid-19. She claims that her husband Rodney was in good health and at low risk of dying from Covid-19 prior to his death on September 12, 2021.
Briones said her 50-year-old husband’s death just doesn’t “add up,” so she pulled his medical records a few months after he passed to see if she could make sense of it.
In her interview with CBS, the widow said, “the day he was admitted on Aug. 12 they started the remdesivir and on Aug. 17 is when they were done. Five doses. On the 17th his kidneys started to fail.”
Briones claimed in her interview that the doctors did not advise her or her husband about the dangerous side effects of remdesivir. She also pointed out that they were not informed that he had been given the questionable treatment protocol claiming that they would have “refused” had they been aware, noting that many people treated for Covid-19 with remdesivir experienced sudden kidney failure.
3 California Hospitals face lawsuits for using the “remdesivir protocol”
California News reported on 3 California hospitals faced lawsuits for using the “Remdesivir Protocol” that attorneys Daniel Watkins with Watkins & Letofsky and Michael Hamilton with Hamilton & Associates filed three complaints against three different California Hospitals on September 7th, 2022.
These lawsuits were filed on behalf of fourteen families of the Fresno California area who purported that medical centres engaged in deceptive practices and failed to provide patients and their families with informed consent regarding the potential risks and side effects of remdesivir use.
“Full informed consent means that the patients must be provided with full information about the deadly harm that this dangerous experimental drug causes on its own,” the suit claims. “They must be told that the only time it was ever tested, it was pulled because it killed so many people.”
Approved for the drug but not the “glass particles”
In a surprise decision, a Michigan judge ruled on Aug. 8 that Gilead would not be protected under the PREP act after a patient received remdesivir that was contaminated with glass particles. This is the first time that a judge has ruled that a drug manufacturer and hospital were not protected under the PREP Act.
Dan Nowacki was administered the tainted drug as part of his Covid-19 treatment protocol and immediately suffered strokes and had to have one of his legs amputated.
While St. Joseph Mercy Chelsea Hospital and Gilead Sciences argued that they had immunity under the PREP Act, the judge made a surprise ruling, the first of its kind, asserting the drug manufacturer was approved for the drug but, “not the glass particles” contained in the drug.
According to Detroit-based attorney Ven Johnson, Gilead and St. Joseph Hospital had argued, “Yeah, we know we voluntarily recalled. Yeah, we know that there are glass particulates in it, and we know 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 immunity. You can’t sue us because it was approved by the FDA.”
Then Johnson goes on to say, “we obviously knew when we filed this case that challenging the immunity given by the PREP Act would be an uphill battle. But we could not be more proud that both judges in the state and federal court saw through the charade…”
The ruling is not a binding precedent but the case opens the possibility for future lawsuits against the drug giant for injuries sustained by those treated with remdesivir.
Wrongful death case beats the PREP Act immunity challenge
Attorney Matthew P. Tyson of La Jolla California filed his first remdesivir “wrongful death suit” last year. The lawsuit alleges “fraud neglect and denial of a patient’s sacred and constitutional right to chose or deny any treatment.”
According to the claim, “49-year-old Donna Bustra, faced extremely low risk of death and would have realized full recovery if legally required fiduciary disclosures had been provided. Instead, Donna received treatment other than what she would have chosen, without consent, and she suffered and died.”
“Yes, we filed the first remdesivir wrongful death case back in June 2022, and it has beaten the PREP Act immunity challenge and is moving forward,” Johnson told the Winnipeg Alternative Media. “We have a dozen more similar cases proceeding across California, each on behalf of a victim’s family.”
While the victims and families of the victims do not have trial dates at this time, many people will be watching to see potential outcomes as these cases move forward through the courts.
Approved in Canada despite many countries reporting toxicity and serious adverse event
Remdesivir, was authorized for use in Canada on July 20, 2020, under emergency use authorization for the treatment of severe Covid-19 in adults and youth (aged 12 years and over and weighing at least 40 kg with pneumonia requiring supplemental oxygen). After “limited clinical testing in humans”, the drug became fully approved by health Canada in October 2020 despite many countries reporting toxicity and serious adverse events.
Health Canada published an update on November 26, 2020, after the WHO recommended against the use of remdesivir in the treatment of Covid-19. The agency acknowledged the WHO’s own widely published statements that the drug had “little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and of hospital stay.” However, they go on to claim that their authorization for the use of remdesivir in the treatment of Covid-19 was “based on the ACTT-1 trial,” the above-mentioned questionable trial.
The Government Health agency then says, “the WHO’s analysis of the combined clinical trial data on remdesivir does not prove that remdesivir has no benefits for some patients. In developing its guidelines, the WHO also looked at the cost of remdesivir and its need to be administered intravenously.”
There is no mention of potential side effects on the Health Canada website, nor does it indicate how the drug is being monitored for safety in Canada.