In a groundbreaking legal decision, a U.S. District Court judge has ruled that AstraZeneca cannot use the Public Readiness and Emergency Preparedness (PREP) Act to dismiss a breach of contract lawsuit filed by Brianne Dressen, a Utah woman who suffered severe injuries during the company’s COVID-19 vaccine trial.
Dressen, a preschool teacher and mother of two, volunteered in November 2020 for AstraZeneca’s COVID-19 vaccine trial. Shortly after receiving her first dose, she began experiencing severe neurological symptoms, including numbness and tingling that spread throughout her body, blurred vision, and extreme sensitivity to light and sound.
These symptoms escalated and left her unable to resume her normal life. Dressen reported sensations of electric shocks, muscle weakness, tremors, and debilitating pain. She also suffered from brain fog, confusion, and memory issues, which significantly impaired her ability to perform daily tasks and care for her children. Her condition was so severe that she became unable to work and was often confined to a dark, quiet room due to her extreme sensitivity to light and sound. Despite her efforts to report these issues, AstraZeneca neglected to investigate her injuries or acknowledge them as a potential consequence of participating in the trial.
Dressen, who co-founded the COVID-19 vaccine-injured group React19, filed a lawsuit against AstraZeneca and trial site consolidator Velocity Clinical Research for breach of contract.
Central to Dressen’s lawsuit is the informed consent agreement she signed before participating in the trial. The agreement stated that AstraZeneca would cover “reasonable” medical costs associated with injuries sustained during the trial, provided the injuries were not self-inflicted. However, when Dressen sought reimbursement for her mounting medical expenses, the company allegedly denied her claims and instead offered a one-time payment of $1,243.30—a fraction of her actual costs.
Dressen incurred substantial medical expenses for diagnostic tests, treatments, and therapies to manage her debilitating symptoms. She claims that AstraZeneca’s response left her financially burdened and abandoned.
In response to the lawsuit, AstraZeneca sought to invoke the PREP Act, a federal law enacted to provide immunity to vaccine manufacturers and others involved in developing and distributing medical countermeasures during public health emergencies. The law has been widely criticized for granting pharmaceutical companies near-total protection from lawsuits related to their products, leaving injured individuals with limited legal recourse. However, U.S. District Judge Robert J. Shelby ruled that the PREP Act does not apply in this case because Dressen’s claims are rooted in a breach of contract rather than allegations of vaccine-related harm.
This ruling allows Dressen’s case to proceed, opening the door for similar lawsuits against vaccine manufacturers that fail to uphold their contractual obligations to clinical trial participants.
Judge Shelby’s decision highlights the distinction between claims involving vaccine administration, which are generally protected under the PREP Act, and those based on contractual promises. This distinction is likely to have far-reaching implications, particularly for individuals who have been harmed during clinical trials and feel abandoned by the companies they trusted.
While the PREP Act was designed to encourage rapid innovation and deployment of countermeasures during emergencies, critics argue that it has enabled vaccine makers to sidestep their ethical and legal responsibilities.
As Dressen’s lawsuit moves forward, it may set a legal precedent for others seeking justice for injuries sustained in COVID-19 vaccine trials. The case also puts renewed focus on the need for greater oversight and accountability in vaccine clinical trials, particularly in ensuring that participants are not left to bear the physical, emotional, and financial consequences of injuries incurred during these experiments.
