The company that manufactures remdesivir, used across the United States to treat COVID-19, has been hit with a class-action lawsuit over allegations it deceptively promoted the drug without disclosing possible side effects.
Deborah Fust, the surviving spouse of Michael Fust, and Edward Pimentel, who says he was injured after receiving remdesivir, are accusing California-based Gilead of failing to mention documented side effects in its promotion of remdesivir.
"It's a terrible drug. 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," Bradford Geyer, an attorney with Former Feds Group who is representing the plaintiffs, told The Epoch Times.
The suit says that Gilead's press releases and statements to consumers and investigators from Gilead show "a pattern of downplaying or omitting altogether the clinical dangers experienced by patients from remdesivir use, instead emphasizing its supposed benefits, safety, and efficacy."
"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 suit states.
The advertising "misrepresented and/or omitted the true content and nature of the drug," it also says.
Gilead did not respond to a request for comment.
Early FDA Authorization
The agency made the move without consulting its advisory committee on antimicrobial drugs.
The FDA approved remdesivir in October 2020 and expanded its allowable use to outpatient settings and children.
Animal studies found indications that remdesivir injured the kidney. The U.S. trial found kidney injuries among remdesivir recipients, including in three patients who were forced to stop taking the drug.
Other studies, as well as post-approval data, have also raised safety and effectiveness concerns.
Gilead, while promoting remdesivir, needed to disclose the risk of kidney injuries, according to the new suit.
By not doing so, the company allegedly violated California laws against using deceptive practices and making untrue or misleading statements.
Gilead also made negligent misrepresentations, resulting in unjust enrichment, the suit says.
Plaintiffs are seeking an order establishing a class, an order preventing Gilead from engaging in "unfair, unlawful, and deceptive business practices, and false advertising," an order forcing Gilead to correct its previous advertisements, an order ordering Gilead to recall and destroy misleading and deceptive advertising materials, an order requiring Gilead to pay back money obtained by the allegedly violative actions, and an order compelling Gilead to pay restitution and interest.
Follows Michigan RulingThe new suit comes after a court in Michigan ruled that remdesivir was not protected under federal law against an action brought by a man who needed his leg amputated after receiving remdesivir.
The man, Don Nowacki, also suffered two strokes.
The remdesivir he received was said to be contaminated with glass particles.
Gilead argued that it could not be sued because of immunity granted by the Public Readiness and Emergency Preparedness Act, which was triggered by the Trump administration during the COVID-19 pandemic.
The judge rejected that argument, finding the act did not cover the manufacturer in the situation.
Mr. Nowacki and his lawyers are now poised to receive discovery, with a trial coming later.