Gilead Falsely Advertised Remdesivir as Safe and Effective, Lawsuit Alleges
A lawsuit filed last week alleges Gilead knew remdesivir, prescribed for people hospitalized with COVID-19, could cause kidney damage, but failed to disclose that and other risks.
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The widow of a man who died after being treated for COVID-19 with remdesivir, and a man who alleges he was injured by the drug, last week sued the drug’s manufacturer, Gilead Sciences.
The plaintiffs allege Giliead engaged in false advertising and deceptive promotion and failed to warn about the possible side effects.
The complaint cited a myriad of documents, public statements and press releases, as evidence that Gilead demonstrated “a pattern of downplaying or omitting altogether the clinical dangers experienced by patients from remdesivir use, instead emphasizing its supposed benefits, safety, and efficacy.”
Gilead’s marketing of remdesivir “misrepresented and/or omitted the true content and nature of the drug,” the lawsuit states, adding:
“Defendant’s advertising that remdesivir is a safe and effective treatment for COVID-19 is false and misleading to a reasonable consumer, including plaintiffs, because 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.”
The lawsuit also alleges Gilead did not disclose the risk of kidney injuries posed by the drug. According to The Epoch Times, “a website for the drug, also known as Veklury, makes no mention of kidney problems. A handout given to patients also does not mention the issues.”
By not disclosing this risk, Gilead may have violated California laws against using deceptive practices and making untrue or misleading statements, The Epoch Times reported. One such law is the California Legal Remedies Act (CLRA).
Attorney Bradford Geyer, who works for the FormerFedsGroup Freedom Foundation (FFFF), which advocates on behalf of COVID-19 hospital protocol victims, told The Defender the lawsuit is “very significant” because the victims, “one egregiously injured and one widow of someone who was killed,” proactively reached out to the organization.
“As a rule, those who have been egregiously injured or have lost loved ones want their oppressors to be exposed,” he said.
Remdesivir is “a terrible drug,” Geyer told The Epoch Times, adding that FFFF “has thousands of members who have the hospital records, and you can see there’s a big difference in the creatinine levels” in blood and kidney readings after patients receive remdesivir.
Lawsuit ‘appears to skillfully skirt the boundaries of the PREP Act’
In an interview with The Defender last month, FFFF Media Director and Task Force Coordinator Carolyn “CC” Blakeman said they were working on a class action suit that the attorneys believed “found a way around the PREP Act” using a false advertisement claim because Gilead was advertising that “remdesivir did something that it didn’t.”
The PREP Act — the Public Readiness and Emergency Preparedness Act — shields manufacturers, distributors and others from any liability for injuries caused by a covered countermeasure, except in cases of “willful misconduct.” For COVID-19 countermeasures, PREP Act protections are in place until at least Dec. 31, 2024.
Blakeman told The Defender that the plaintiffs filed the suit in California because the state has strict product protection statutes and because Gilead, and the plaintiffs, are based there.
Geyer said, “We view the PREP Act as unconstitutional and violative of international law as well, as it’s applied to COVID-19 hospital protocols.”
Ray Flores, senior counsel to Children’s Health Defense, said, “This case is well thought out and appears to skillfully skirt the boundaries of the PREP Act, since 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.”
Also, “Although the defendant may be classified as a ‘covered person,’ it is likely that, as the 9th Circuit [U.S. Court of Appeals] ruled in Saldana v. Glenhaven Healthcare, the PREP Act does not completely preempt when ‘claims in the complaint are raised under California law and do not raise questions of federal law on the face of the complaint,’” Flores said.
However, plaintiffs’ failure to demand rectification [damages] under the CLRA’s 30-day safe harbor provision may keep this vital portion of the suit from moving forward,” Flores explained.
Lawsuit seeks class certification, return of profits, withdrawal of drug
The two plaintiffs are seeking class status, which would enable others who were injured after receiving remdesivir while hospitalized with COVID-19, and relatives of individuals who died after being administered remdesivir following hospitalization for COVID-19, to join the suit.
The lawsuit seeks to prevent Gilead from engaging in “unfair, unlawful, and deceptive business practices, and false advertising.”
Geyer said the lawsuit is asking for disgorgement — a return of all profits made from remdesivir — plus the withdrawal of the drug and all marketing materials that are being used to “push it on unsuspecting victims that include not only recipients, but the physicians using it who, as a general rule, are also deceived by the Gilead marketing materials.”
Blakeman, who interviewed several remdesivir-injured individuals on behalf of the FFFF, said, “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 effective and safe.”
“This was misleading to the public and caused many to take it without knowing that it affected the kidneys and other organs,” she added, noting that many patients also were not asked for their consent before remdesivir was administered.
The plaintiffs are also seeking payment of damages, restitution and interest.
Michigan court rules PREP Act doesn’t apply in case involving remdesivir injury
According to The Epoch Times, the new lawsuit comes after a Michigan court ruled in August that remdesivir does not enjoy protection from the PREP Act’s liability shield.
Daniel Nowacki’s family sued Gilead as a result of injuries — including two strokes and the eventual amputation of his leg — he sustained after receiving remdesivir allegedly contaminated with glass particles. Nowacki suffered his first stroke within days of receiving remdesivir in November 2021. He is now bedridden and in need of 24/7 care.
In a potential precursor to the California lawsuit against Gilead, the company argued in Michigan that it could not be sued due to the liability shield afforded by the PREP Act. However, the court rejected the company’s argument, ruling that the PREP Act did not cover Gilead for its “negligent manufacture of the product.”
Discovery and a trial are set to follow in that case.
Ven Johnson, one of Nowacki’s lawyers, told The Epoch Times “One of the things that we’re going to figure out is exactly what Gilead, the FDA [U.S. Food and Drug Administration], and the hospital knew and when.”
Called COVID ‘standard of care’ by Fauci, remdesivir blamed for organ damage
The FDA granted Emergency Use Authorization (EUA) to Gilead for remdesivir in May 2020. According to The Epoch Times, the EUA was granted “primarily based on results from a government-sponsored trial in which researchers changed the endpoint midway” and which some alleged “was done in order to garner positive results.”
The FDA granted the EUA “without consulting its advisory committee on antimicrobial drugs,” and in October 2020, the FDA granted full approval to remdesivir and expanded its use to children, The Epoch Times reported.
One month earlier, then-director of the National Institute of Allergy and Infectious Diseases (NIAID) Dr. Anthony Fauci said remdesivir would become the “standard of care” for treating COVID-19.
However, according to investigative journalist Jordan Schachtel, studies “show that there are zero clinical benefits to injecting patients with remdesivir. Many studies show that remdesivir can severely injure vital organs such as the heart and kidneys.”
A World Health Organization (WHO) study published in the New England Journal of Medicine found that remdesivir did not reduce mortality or speed up recovery time, leading the WHO to recommend against using the drug in hospitalized patients — contrary to the advice given by public health authorities in the U.S.
Data from a WHO database subsequently showed a significantly higher rate of kidney injuries in COVID-19 patients who received remdesivir as opposed to other treatments.
Fauci’s replacement at the helm of NIAID, Dr. Jeanne Marrazzo, supervised clinical trials for remdesivir at the University of Alabama at Birmingham when she was director of the institution’s Division of Infectious Diseases.
She has also previously received seven payments from Gilead, totaling $2,474.93.
Numerous COVID patients injured after remdesivir administered without consent
Patients in U.S. hospitals are advised by the FDA to disclose all of their medical conditions — including kidney problems — to hospitals prior to receiving remdesivir.
However, many individuals have publicly shared stories about injuries they or their loved ones sustained after receiving remdesivir. In many instances, these individuals claim that remdesivir was administered without their or their loved ones’ knowledge.
In a June interview with The Defender, Denise Fritter said that her 36-year-old daughter Jamie Kay Wylie died within two weeks of being hospitalized for COVID-19. During her hospital stay, Wylie was administered remdesivir without consent.
“She had received two doses of remdesivir,” Fritter said at the time. “When she started the remdesivir, she started to go down. I could just tell she was down. I could tell in her voice when I spoke to her and in the last pictures I ever received of her,” adding that she “didn’t know anything about it” until after remdesivir had been given to her mother.
Similarly, 70-year-old Ralph Marxen received remdesivir while in the hospital, and ultimately died from a host of conditions, including multiple organ system failure including renal failure, endocarditis, hyperkalemia, MRSA (methicillin-resistant Staphylococcus aureus) pneumonia, MRSA bacteremia and sepsis.
In a May interview with The Defender, Nicole Riggs said that her father had been pressured to take remdesivir even before he had been tested for COVID-19. His family’s requests for safer alternative treatments were denied.
In an August interview with The Defender, Andy Kotsanis shared the story of his father, Dr. Constantine “Gus” Kotsanis, who tested positive for COVID-19 and was subsequently administered four rounds of remdesivir daily while in the hospital. He and his family had not authorized remdesivir to be given.
“All over his chart, it [said] he didn’t want to be intubated. No ventilator, no remdesivir,” Kotsanis said. His father ultimately died in the hospital.
In a July interview, Gail Seiler told The Defender that soon after testing positive for COVID-19 and being hospitalized, she was told “you are going to die” and that her only options were to receive remdesivir and be placed on a ventilator.
Seiler was also told that she would be permitted visitation from her priest only on the condition that she agreed to take remdesivir. When, however, her priest could not make it to a scheduled visit, the hospital administered remdesivir to Seiler anyway.
In August, Scott Schara shared the story of his daughter, Grace Schara, who died in the hospital at age 19, soon after testing positive for COVID-19. While in the hospital, she was administered a series of drugs and treatments, including remdesivir, without her or her parents’ permission.
In an interview soon to be published in The Defender, New Jersey native Charlene Delfico shared the story of her father, Otto Moring, who was admitted to a hospital with COVID-19 and later administered remdesivir — despite having a documented history of acute kidney disease that the hospital was aware of. Moring died in the hospital.
In her interview with The Defender, Blakeman said that hospitals “get a lot of money from the CARES Act if they give you remdesivir and more if they ventilate you,” referring to the Coronavirus Aid, Relief, and Economic Security Act.
According to Blakeman, these practices are the result of COVID-19 hospital protocols prescribed by the Centers for Disease Control and Prevention and which are the subject of a report, “Follow the Money: Blood Money in U.S. Healthcare,” that the FFFF commissioned.
“They get money if they have a COVID-19 admission, then they get money if they use remdesivir, they get a 20% bonus on the entire hospital bill,” Blakeman said. “If they put them on a ventilator, they get an extra $39,000. And if they put COVID-19 on the death certificate, they get another bonus.”
‘People want to be part of something that takes on Big Pharma’
Blakeman said that the FFFF and its associated COVID-19 Humanity Betrayal Memory Project (CHBMP), which describes itself as an effort to build “a living archive of ongoing crimes against humanity,” has compiled and documented stories of COVID-19 hospital protocol victims, many of whom received remdesivir.
Geyer said that FFFF and CHBMP volunteers, aside from documenting these stories, are “assisting victims and next of kin in obtaining hospital records and reviewing them to prepare them for enforcement agency interest that they see as inevitable.”
Blakeman told The Defender last month that FFFF was fundraising to cover the legal costs of the planned class-action lawsuit against Gilead, which “is going to cost millions of dollars.” She said that the independent attorneys working on the case “have a great complaint … but they can’t go against Gilead without a war chest.”
Blakeman added that the FFFF plans to use a similar fundraising strategy for future legal cases against Pfizer and other Big Pharma firms.
Blakeman said, “I think people want to be part of something that takes on Big Pharma and a drug that’s killed so many.”
“Our collective mission transcends legalities; it embodies a moral obligation to seek truth and justice. We stand with the victims, whose voices, often suppressed, have now found an unwavering echo through this lawsuit,” Geyer said.
Geyer added:
“We call upon the public, organizations, and legal entities to support our cause. Every voice and signature matter in this collective pursuit of justice and transparency. Together, we will champion truth, justice, and accountability.
“The fight begins now, and it will not waver until justice is served.”
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