Authored by Zachary Stieber via The Epoch Times (emphasis ours),
A federal law that grants broad legal immunity to vaccine manufacturers does not protect AstraZeneca against a breach of contract claim brought by a woman who was injured by the company’s vaccine, a U.S. judge ruled on Nov. 4.
The Public Readiness and Emergency Preparedness (PREP) Act protects manufacturers of vaccines during times of emergency, such as the COVID-19 pandemic.
Brianne Dressen sued AstraZeneca for neglecting to, as promised in a contract, cover the costs of injuries she suffered after participating in the company’s clinical trial in 2020. The pharmaceutical company said it was immune from the lawsuit under the PREP Act.
U.S. District Judge Robert J. Shelby disagreed, ruling on Monday in favor of Dressen and denying AstraZeneca’s motion to dismiss.
While Dressen can’t sue over the injuries, she can over the breach of contract because the legal immunity granted by the law does not cover at least some contractual claims, Shelby said.
“The basis of Dressen’s claim is a broken promise, not a countermeasure,” he said, adding later: “Dressen was administered a covered countermeasure, and she was warned that she may suffer from an adverse reaction, but the fact that she suffered from such reaction was not sufficient to ripen her claim. Rather, she only has a claim because AstraZeneca made a contractual promise to her that happened to involve the effects of a covered countermeasure.”
AstraZeneca put forth a theory in legal filings that immunity from breach of contract claims helps encourage the quick development and deployment of countermeasures during health emergencies, which is the purpose of the PREP Act. Dressen’s lawyers argued enforcing contracts achieves the same result. The judge sided with the latter.
“If the PREP Act immunized deceptive contractual inducement and sanctioned illusory promises, then no one would agree to undertake the high-risk activities that are critical during public health emergency responses,” Shelby said. “The PREP Act drafters could not have intended to allow pharmaceutical companies to make illusory promises to clinical trial participants because doing so would erode public trust and undermine the ability to recruit willing participants, which in turn would erode and undermine pandemic preparedness.”
The judge used the example of AstraZeneca agreeing to pay $125 for time and travel reimbursements to Dressen per study visit during the clinical trial. “AstraZeneca’s theory of immunity would allow it to shirk this and any other promise made to trial participants merely because the promise ultimately relates to the administration or use of a vaccine,” he said.
Dressen, a preschool teacher in Utah, volunteered for the 2020 clinical trial. The consent form she signed said AstraZeneca would “cover the costs of research injuries” and “pay the costs of medical treatment.” After receiving the company’s shot, she suffered from a variety of injuries. U.S. National Institutes of Health doctors diagnosed her with vaccine side effects.
AstraZeneca largely declined to offer payment for treatment, beyond a final offer of $1,243, according to court documents.
AstraZeneca’s vaccine was administered widely in some other countries but U.S. authorities never authorized its use beyond clinical trials.
Shelby’s ruling means Dressen’s case will move forward.
Dressen wrote on the social media platform X that the judge “handed down a thoughtful and timely decision.”
“My deepest gratitude to the court for respectfully reviewing this important case and allowing it to move forward,” she said.
An AstraZeneca spokesperson told The Epoch Times in an email that the company cannot comment on ongoing litigation.
“Patient safety is our highest priority,” the spokesperson said. “From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”
Authored by Zachary Stieber via The Epoch Times (emphasis ours),
A federal law that grants broad legal immunity to vaccine manufacturers does not protect AstraZeneca against a breach of contract claim brought by a woman who was injured by the company’s vaccine, a U.S. judge ruled on Nov. 4.
The Public Readiness and Emergency Preparedness (PREP) Act protects manufacturers of vaccines during times of emergency, such as the COVID-19 pandemic.
Brianne Dressen sued AstraZeneca for neglecting to, as promised in a contract, cover the costs of injuries she suffered after participating in the company’s clinical trial in 2020. The pharmaceutical company said it was immune from the lawsuit under the PREP Act.
U.S. District Judge Robert J. Shelby disagreed, ruling on Monday in favor of Dressen and denying AstraZeneca’s motion to dismiss.
While Dressen can’t sue over the injuries, she can over the breach of contract because the legal immunity granted by the law does not cover at least some contractual claims, Shelby said.
“The basis of Dressen’s claim is a broken promise, not a countermeasure,” he said, adding later: “Dressen was administered a covered countermeasure, and she was warned that she may suffer from an adverse reaction, but the fact that she suffered from such reaction was not sufficient to ripen her claim. Rather, she only has a claim because AstraZeneca made a contractual promise to her that happened to involve the effects of a covered countermeasure.”
AstraZeneca put forth a theory in legal filings that immunity from breach of contract claims helps encourage the quick development and deployment of countermeasures during health emergencies, which is the purpose of the PREP Act. Dressen’s lawyers argued enforcing contracts achieves the same result. The judge sided with the latter.
“If the PREP Act immunized deceptive contractual inducement and sanctioned illusory promises, then no one would agree to undertake the high-risk activities that are critical during public health emergency responses,” Shelby said. “The PREP Act drafters could not have intended to allow pharmaceutical companies to make illusory promises to clinical trial participants because doing so would erode public trust and undermine the ability to recruit willing participants, which in turn would erode and undermine pandemic preparedness.”
The judge used the example of AstraZeneca agreeing to pay $125 for time and travel reimbursements to Dressen per study visit during the clinical trial. “AstraZeneca’s theory of immunity would allow it to shirk this and any other promise made to trial participants merely because the promise ultimately relates to the administration or use of a vaccine,” he said.
Dressen, a preschool teacher in Utah, volunteered for the 2020 clinical trial. The consent form she signed said AstraZeneca would “cover the costs of research injuries” and “pay the costs of medical treatment.” After receiving the company’s shot, she suffered from a variety of injuries. U.S. National Institutes of Health doctors diagnosed her with vaccine side effects.
AstraZeneca largely declined to offer payment for treatment, beyond a final offer of $1,243, according to court documents.
AstraZeneca’s vaccine was administered widely in some other countries but U.S. authorities never authorized its use beyond clinical trials.
Shelby’s ruling means Dressen’s case will move forward.
Dressen wrote on the social media platform X that the judge “handed down a thoughtful and timely decision.”
“My deepest gratitude to the court for respectfully reviewing this important case and allowing it to move forward,” she said.
An AstraZeneca spokesperson told The Epoch Times in an email that the company cannot comment on ongoing litigation.
“Patient safety is our highest priority,” the spokesperson said. “From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”
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