Remdesivir lawsuits are personal injury and wrongful death claims filed by patients and families who say the antiviral Veklury, made by Gilead Sciences, caused kidney failure, organ damage, or death during COVID-19 treatment. Cases have been brought against Gilead and the hospitals that gave the drug, but almost every one that has reached a ruling has been dismissed under a federal law called the Public Readiness and Emergency Preparedness Act (PREP Act), which grants broad immunity to companies and providers who administer covered countermeasures during a declared public health emergency.1Public Readiness and Emergency Preparedness Act
What People Are Suing Over
The claims fall into a few groups. Some are medical negligence and wrongful death suits against hospitals, alleging that staff gave remdesivir without proper informed consent, kept infusing it after lab work showed kidneys were failing, or never disclosed known risks. Others target Gilead directly on product liability theories, arguing the company failed to warn about acute kidney injury or, in a smaller set of cases, that specific vials were contaminated with glass particles. A third strand focuses on informed consent, alleging patients were never told the drug was initially authorized under an Emergency Use Authorization rather than fully FDA-approved, or that they could refuse it.
In the wrongful death cases, plaintiffs typically say remdesivir triggered kidney failure that cascaded into multi-organ failure. Proving that is the hard part. Expert witnesses have to work through a differential diagnosis, tracking creatinine levels, kidney filtration rates, and the timing of infusions to separate drug-related harm from damage caused by COVID-19 itself.
The PREP Act Is the Wall
Anyone considering a remdesivir suit runs into the PREP Act first. Courts have consistently held that remdesivir is a “covered countermeasure,” and that Gilead and treating hospitals are “covered persons” protected by the statute. The immunity reaches claims about design, manufacture, labeling, distribution, marketing, prescribing, and administration of the drug. It covers state law claims and federal claims alike.
The shield is not going away soon. In December 2024, the Department of Health and Human Services amended its PREP Act declaration to extend immunity for COVID-19 vaccines and treatments through December 31, 2029. That means the defense remains fully available in ongoing and future cases.
The Willful Misconduct Exception
The statute allows one narrow way through: claims for death or serious physical injury caused by “willful misconduct.” That means an intentional act taken to achieve a wrongful purpose, knowingly without legal or factual justification, and in disregard of a known or obvious risk. It is a much higher standard than ordinary negligence or even recklessness.
The procedural hurdles are separate and stacked on top. A plaintiff must first exhaust administrative remedies through the federal Countermeasures Injury Compensation Program, file the eventual lawsuit exclusively in the U.S. District Court for the District of Columbia, and support the complaint with a verification under oath, a physician’s affidavit, and certified medical records.
No plaintiff has cleared that bar in a reported remdesivir case. In Baghikian v. Providence Health & Services, a California federal court rejected a willful misconduct argument outright, finding the allegations amounted to “strict liability or, at most, recklessness,” and noting the plaintiffs had not met the procedural prerequisites either.
How the Cases Have Actually Turned Out
Fust v. Gilead Sciences
Two plaintiffs filed a putative nationwide class action in the Eastern District of California, alleging Gilead exaggerated the benefits and concealed the dangers of remdesivir. They brought six claims under California law, including consumer protection violations, false advertising, negligent misrepresentation, and unjust enrichment. On February 21, 2024, Senior Judge William B. Shubb dismissed the case with prejudice on PREP Act grounds, finding the marketing and informed consent allegations were causally connected to the use of a covered countermeasure. Leave to amend was denied as futile.
Nowacki v. Gilead Sciences
Dan Nowacki alleged he suffered two massive strokes after receiving remdesivir from a contaminated batch at St. Joseph Mercy Hospital in Chelsea, Michigan, in November 2021. Gilead voluntarily recalled two lots the following month, but Nowacki said the hospital did not notify him until April 2022.
The family filed in state court on theories including breach of warranty, negligence, gross negligence, and intentional misrepresentation. After removal to federal court and dismissal of the misrepresentation claim for failure to exhaust administrative remedies, the remaining claims went back to state court. In April 2025, the Michigan Court of Appeals reversed the trial court and ordered all claims dismissed, holding that PREP Act immunity reaches manufacturing defects too. Reading the statute otherwise, the court said, would make its explicit coverage of “manufacture” meaningless. The Michigan Supreme Court declined to hear the appeal on October 29, 2025.
Wrongful Death Suits in California and Minnesota
In September 2022, Christina Briones sued Kaiser Permanente Riverside Medical Center over the death of her 50-year-old husband Rodney, and Evangeline Ortega sued Redlands Community Hospital over the death of her 65-year-old husband Armando. Both complaints alleged fraud and that remdesivir caused kidney and organ failure leading to death. The hospitals declined to comment on the pending litigation.
In Minnesota, a wrongful death suit was filed in Ramsey County District Court against HealthPartners and Regions Hospital. Attorney Andrew Barnhart, representing plaintiffs through an organization called Medical Justice MN, said in late 2023 that his group was in contact with families regarding roughly 75 hospital deaths and expected more filings. One plaintiff in the Minnesota case was dismissed without prejudice. No final outcomes in either group of cases have been publicly reported.
If You Received a Recalled Vial
Gilead has issued two voluntary recalls of Veklury for glass particulate contamination. The first, announced December 3, 2021, covered lots 2141001-1A and 2141002-1A, distributed in late October and early November 2021. The second, announced September 20, 2024, covered lot 47035CFA, distributed between July and August 2024. The FDA has noted that glass particles in injectable drugs can cause local irritation, blood vessel blockage, stroke, or death. Gilead said it had received no adverse event reports tied to either recall, though the Nowacki suit alleged injuries from the 2021 lots.
The Michigan appellate ruling in Nowacki is the practical answer for anyone considering a contamination-based claim: the court held that PREP Act immunity applies to manufacturing defects, which sharply narrows the room for product liability suits tied to the recalled lots.
The Medical Evidence Plaintiffs Use
Causation cases lean on a body of pharmacovigilance data and clinical literature. A study in Frontiers in Pharmacology reviewed nearly 13,000 COVID-19 cases in the FDA’s adverse event reporting system and found a statistically significant association between remdesivir and acute kidney injury, with a reporting odds ratio of 2.81 that rose to 3.85 after statistical adjustment. More than 77% of the kidney injury events occurred within five days of starting treatment, and the fatality rate among those patients was over 36%.
The World Health Organization flagged a “disproportionately high number” of kidney and liver problems in remdesivir-treated patients as early as August 2020, and the European Medicines Agency opened a safety review around the same time. A Cochrane systematic review of studies covering more than 7,000 participants concluded that remdesivir “probably has little or no effect on all-cause mortality” in hospitalized adults within 28 days, and that its effect on clinical improvement, worsening, and time on mechanical ventilation was uncertain. Plaintiffs use that review to argue the drug’s risk-benefit profile fell outside the evidence-based standard of care.
Informed Consent Under the EUA
The FDA first authorized remdesivir under an Emergency Use Authorization on May 1, 2020, expanded that EUA on August 28, 2020, and granted full approval on October 22, 2020 for adults and pediatric patients 12 and older weighing at least 40 kg who required hospitalization. Under the EUA, providers were required to tell patients the drug was unapproved and authorized for emergency use, disclose that alternatives existed, and obtain consent before starting treatment. Several lawsuits allege none of that happened.
Financial Incentive Claims
A recurring allegation is that hospitals had a financial motive to push remdesivir. The CARES Act added a 20% Medicare payment for inpatient COVID-19 cases, and CMS created a separate New COVID-19 Treatments Add-On Payment for FDA-authorized treatments including remdesivir, in effect from November 2020 through September 2023. The Minnesota lawsuit alleged hospitals could bill a base of $3,200 per remdesivir treatment and potentially up to $20,000 per patient. A 2023 HHS Inspector General audit of $2.7 billion in Medicare COVID-19 payments found hospitals “generally paid” in accordance with federal requirements, flagging only three noncompliant claims totaling $18,911 out of a sample of 150. Courts have not treated the payment structure as a basis for overcoming PREP Act immunity.
Where Things Stand
Remdesivir litigation is active, but no plaintiff has won. Every case that has produced a substantive ruling has been dismissed under the PREP Act. The willful misconduct exception has not been successfully used in any reported decision. The Michigan Supreme Court’s October 2025 refusal to take up Nowacki left standing an appellate ruling that immunity extends even to manufacturing defects, and the HHS declaration keeps that immunity in place through 2029. New wrongful death cases are still being filed in California and Minnesota, and plaintiffs’ attorneys have signaled more to come. Whether any of them can clear the willful misconduct standard, after exhausting administrative remedies and filing in the required D.C. federal court, is the open question.