The Tenth Circuit Court of Appeals issued a significant ruling on July 23, 2026, in the case of Dressen v. AstraZeneca AB, No. 24-4114. The court addressed the scope of immunity provided to vaccine manufacturers under the Public Readiness and Emergency Preparedness Act (PREP Act). This ruling impacts individuals who participated in vaccine trials and may seek compensation for injuries.
Brianne Dressen, the plaintiff, participated in a clinical trial for AstraZeneca’s COVID-19 vaccine in 2020. After suffering debilitating injuries, she sought compensation from AstraZeneca, claiming a breach of contract. AstraZeneca argued that it was immune from such claims under the PREP Act, which was designed to protect vaccine developers during public health emergencies. The court's decision clarifies the extent of this immunity and its implications for similar cases.
The PREP Act was enacted in 2005 to encourage the rapid development of medical countermeasures during public health emergencies. It provides broad immunity to manufacturers and distributors of vaccines and other medical products from lawsuits related to their use. The case arose when Dressen filed a breach-of-contract suit after AstraZeneca denied her request for compensation for injuries she sustained during the vaccine trial.
Dressen signed an informed-consent form (ICF) before participating in the trial, which outlined her rights and AstraZeneca’s obligations, including compensation for research injuries. However, the ICF also warned that federal law might limit her right to sue for vaccine-related injuries. After AstraZeneca rejected her claims, Dressen took legal action, arguing that the company breached its contractual obligations.
The district court initially sided with Dressen, ruling that the PREP Act did not provide immunity for contract-based claims. The court stated that the PREP Act’s protections only applied to tort claims, not breaches of contract. AstraZeneca appealed this decision, asserting that the PREP Act should shield it from all claims related to the use of the vaccine.
The Tenth Circuit Court disagreed with the district court's interpretation. In its ruling, the court stated, "The PREP Act confers immunity from this suit," emphasizing that the statute protects against all claims for loss related to the administration of a covered countermeasure, including breach-of-contract claims. The court acknowledged that the PREP Act's definition of loss is broad and includes various types of damages.
The judges on the panel, including Circuit Judges Hartz, Tymkovich, and Bacharach, determined that the PREP Act's immunity extends to all claims arising from the use of covered countermeasures. The court reversed the district court's decision and remanded the case for further proceedings to determine whether AstraZeneca waived its immunity through the language in the informed-consent form.
This ruling has significant implications for individuals who have participated in vaccine trials and may seek compensation for injuries. It clarifies that the PREP Act provides broad immunity to vaccine manufacturers, potentially limiting the avenues available for injured participants to seek redress. The decision reinforces the importance of the PREP Act in protecting vaccine developers during public health emergencies.
Going forward, this ruling may set a precedent for similar cases involving vaccine manufacturers and their liability. Individuals injured during clinical trials may find it more challenging to pursue claims against companies like AstraZeneca. The court's decision underscores the need for clear communication regarding the rights of trial participants and the protections afforded to vaccine developers under federal law.
As for next steps, it remains to be seen whether Dressen will pursue further legal action following the remand. The court did not address whether AstraZeneca waived its immunity in the informed-consent form, leaving that question open for the district court to consider. Additionally, AstraZeneca may seek to appeal this ruling further, although details on any potential appeal were not available in the court filing.