A federal judge ruled that a lawsuit filed by a woman injured by AstraZeneca’s COVID-19 vaccine during a clinical trial can proceed.
Brianne Dressen sued the company in May, alleging she suffered an injury after participating in a 2020 clinical trial.
According to the complaint, the consent form “promised that AstraZeneca would ‘cover the costs’ if a participant suffered a ‘research injury,’ including but not limited to medical bills.”
Following the trial, “Bri’s right arm began tingling and prickling within an hour of the shot. It was a condition called paresthesia, as Bri would soon learn. Bri figured the paresthesia was temporary. But it did not go away. Instead, it spread over the next few hours: first to her right shoulder, then to her left arm,” the complaint says. She then experienced blurred vision, tinnitus, fever, vomiting, and other symptoms.
The woman’s condition left her disabled, the document explains.
In an effort to dismiss the complaint, AstraZeneca said that it was immune from legal liability under the Public Readiness and Emergency Preparedness Act (PREP Act) of 2005.
Chief Judge Robert J. Shelby of the U.S. District Court in Utah allowed Dressen’s lawsuit to continue, writing that her allegations center around a “broken promise, not a countermeasure.”
“The court finds the text of the PREP Act exempts contractual violations from its scope of immunity,” the ruling says. “PREP Act immunity requires a causal link between the claim and a tangible medical countermeasure, and breach of contract claims arise from one party’s failure to perform a legal obligation without regard to any countermeasure.”
Protecting drug manufacturers is not the intent of the PREP Act, the judge added.
“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,” he wrote. “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.”
Dressen wrote on social media following the ruling, “The judge handed down a thoughtful and timely decision November 4, 2024, the fourth anniversary of when [the] nightmare began.”
“My deepest gratitude to the court for respectfully reviewing this important case and allowing it to move forward. Also to my stellar legal team @AaronSiriSG @michaelpconnett and Elizabeth Brehm. Here is one for the underdogs.”
