AstraZeneca can’t be held liable for injuries sustained by a woman who participated in the drugmaker’s COVID-19 vaccine trial, a federal appeals court ruled last week. However, it will be up to a lower court to decide if the company waived its legal immunity by having trial participants sign a consent form promising the drugmaker would pay participants’ medical expenses if the vaccine caused injury or illness.
AstraZeneca can’t be held liable for injuries sustained by a woman who participated in the drugmaker’s COVID-19 vaccine trial, a federal appeals court ruled last week.
However, it will be up to a lower court to decide if the company waived its legal immunity by having trial participants sign a consent form promising the drugmaker would pay participants’ medical expenses if the vaccine caused injury or illness.
In 2024, Brianne Dressen sued AstraZeneca, alleging she was injured and became disabled by the company’s COVID-19 vaccine in 2020, when she participated in the company’s U.S. clinical trial.
According to the complaint, AstraZeneca’s consent form promised trial participants the company would pay for medical treatment if participants were injured or became ill during the study.
Dressen said AstraZeneca offered her $1,243.30 toward her medical expenses — but only if she signed a waiver absolving the company of any further liability.
AstraZeneca asked the court to dismiss the lawsuit, arguing that under the Public Readiness and Emergency Preparedness Act (PREP Act) of 2005, Dressen could not sue the company for her injuries.
The PREP Act grants manufacturers of emergency countermeasures — including treatments, medical devices and vaccines — immunity from legal liability for injuries related to the countermeasure.
In 2024, a federal court agreed with Dressen, finding that the PREP Act’s liability shield doesn’t extend to breach-of-contract claims. But in its ruling last week, the 10th U.S. Circuit Court of Appeals disagreed, finding that the PREP Act’s protections extend to such breach-of-contract claims.
“The PREP Act’s immunity provision says nothing about shielding covered persons from specific causes of action. Instead, the statute protects against particular ‘claims for loss.’ … A suit for breach of contract is as much a ‘claim’ as a suit under tort law,” the ruling states.
Ray Flores, senior outside counsel for Children’s Health Defense and an expert on the PREP Act, called the ruling “an unpleasant surprise.” Flores, who is not involved in this case, said the appeals court should have affirmed the lower court’s ruling in full.
Lower court to consider whether AstraZeneca waived its liability
The appeals court left open the possibility that AstraZeneca waived its PREP Act immunity when Dressen signed an informed consent form, which stated that the company had an insurance policy to cover the costs of injuries caused by the vaccine.
According to the original complaint, the form stated, “If you become ill or are injured while you are in this research study, you must tell your study doctor straight away. The study doctor will provide medical treatment or refer you for treatment.”
Dressen, who was 39 when she was vaccinated, was diagnosed with post-vaccine neuropathy in 2021. She alleged her vaccine-related injuries and disability resulted in prohibitive medical costs, according to Bloomberg. One medication alone costs $432,000 a year.
Dressen, who has since co-founded React19, a nonprofit that helps people injured by COVID-19 vaccines, was previously a preschool teacher. She is now unable to work due to her injuries.
Dressen argued that AstraZeneca breached its contract when it refused to cover the costs of her injuries and subsequent disability. She said she was suing for breach of contract, not vaccine injury. This was not a tort claim — a wrongful injury claim that is barred under the PREP Act.
In its ruling, the 10th Circuit agreed that Dressen’s claim regarding the informed consent waiver she signed was strong enough to send back to the lower court for further consideration.
“We must remand, however, for the district court to now consider whether AstraZeneca waived its immunity” in the informed consent waiver, the ruling states.
Flores said the limited window the 10th Circuit’s ruling left open for Dressen “narrows the battlefield.” He added:
“This case should turn on whether AstraZeneca breached its written agreement to pay her medical bills and whether, in the event of breach, a court should enforce that agreement.
“The contradictory language in AstraZeneca’s ‘informed-consent form’ (both guaranteeing remuneration and precluding an ability to sue) should be stricken since fraud vitiates consent — but under PREP, fraud is encouraged and condoned.”
Legal, congressional challenges against PREP Act immunity continue
In December 2024, shortly before President Joe Biden left office, the U.S. Department of Health and Human Services extended the PREP Act’s liability shield through Dec. 31, 2029. It was the 12th such extension since 2020.
The current administration has not removed the liability shield for the COVID-19 vaccine under the PREP Act.
“If this ruling doesn’t convince the administration that COVID-19 PREP Act protections must end now, then nothing ever will,” Flores said.
Most, but not all, courts have so far sided against vaccine injury lawsuits challenging the PREP Act’s liability shield.
Last year, the Maine Supreme Judicial Court upheld a lower court ruling that school medical staff who gave a COVID-19 vaccine to a minor without obtaining parental consent cannot be held liable under the PREP Act.
The Maine ruling came one week after the U.S. Supreme Court refused to review a lower court’s ruling in a similar lawsuit in Vermont. In that case, a school administered a COVID-19 vaccine to a 6-year-old boy despite his and his parents’ objections.
In 2024, the Vermont Supreme Court ruled that the PREP Act shielded school officials from liability.
However, in March 2025, the Supreme Court of North Carolina ruled that a lawsuit filed by the mother of a 14-year-old boy given a COVID-19 vaccine at school without consent can proceed. The court ruled the PREP Act does not preempt state law requiring parental consent for vaccination. The case is still pending.
The PREP Repeal Act, introduced in Congress last year by Rep. Thomas Massie (R-Ky.), would revoke the PREP Act’s liability shield for vaccine manufacturers. However, the bill has faltered in committee since its introduction.
In 2024, AstraZeneca withdrew its COVID-19 vaccine — which was never approved in the U.S. — from the market, citing commercial reasons, including low demand. However, the company admitted in 2024 U.K. court documents that its shot could, in “very rare cases,” cause blood clots.
This admission forms the basis of a class action lawsuit in the U.K., filed by people who say they or their loved ones suffered significant injuries after receiving the AstraZeneca COVID-19 shot.
In January, newly released U.K. public health data show that in 2021 and 2022, thousands of people filed cardiac-related adverse event reports after receiving the AstraZeneca COVID-19 shot.
Earlier this month, it was revealed that U.S. Health Secretary Robert F. Kennedy Jr. plans to launch a rulemaking process that could make it easier for people injured by COVID-19 vaccines to receive compensation from the federal government, marking one of the most consequential changes yet to the vaccine injury program.
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