AstraZeneca takes a shot at immunity from Covid injury case

(CN) — Pharmaceutical company AstraZeneca is asking the 10th Circuit Court of Appeals to reverse a decision in a lower court that allows a Utah woman who was injured during a clinical trial of the Covid-19 vaccine to sue the company.

A panel of three judges heard oral arguments from both parties via videoconference from Denver on Wednesday. In its opening brief, AstraZeneca asked what it described as a straightforward question to the court: Does a federal statute that protects organizations from lawsuits during times of public health emergencies protect them from all claims or all claims except for breach of contract claims?

According to AstraZeneca, “All means all.”

But Brianne Dressen, the plaintiff, argues in her complaint, filed in U.S. District Court in Utah in May of 2024, that the company failed to uphold its end of a contract that said it would cover the costs if a participant in the vaccine trial suffered a “research injury.” Dressen suffered from numerous symptoms, and in June 2021, a team of neurologists from the National Institute of Health diagnosed Dressen with post-vaccine neuropathy, she says.

Reeves Anderson, a partner with law firm Arnold & Porter representing AstraZeneca, argued that when Congress passed the Public Readiness and Emergency Preparedness Act in 2005, commonly referred to as the PREP Act, it addressed this exact scenario.

“Legislators were forced to make the difficult policy choice that, in an emergency, national interest is best reserved with the rapid deployment of life-saving vaccines without the looming threat of litigation,” Anderson told the judges. “While the uniform rule may seem broad, it is the very breadth that allows the lifesaving countermeasures to exist at all.”

The agreement Dressen signed was subject to the PREP Act, he said.

U.S. District Judge Robert Shelby, a Barack Obama appointee, denied AstraZeneca’s motion to dismiss Dressen’s lawsuit in November 2024, saying the PREP Act does not cover breach of contract claims.

But Anderson argued the court’s decision was incorrect.

“The District Court asked whether the breach of contract was caused by the administration of a vaccine, rather than asking whether the loss was causally related to the administration of a vaccine, which is what the statutory text requires,” he said. “If a covered loss is causally related to a vaccine, then all claims are immunized under the statute.”

Dressen, of Saratoga Springs, Utah, described herself in her complaint as an active, outdoorsy mother who wanted to do her part in the development of the Covid-19 vaccine during the pandemic by participating in a clinical trial.

“I walked into the clinic fine and walked out the beginning of a nightmare I wouldn’t wish on my worst enemy,” Dressen wrote. “There was no break, no reprieve, no escape. No answers, no help, only questions and fear of what was overtaking my body more and more each day as new symptoms piled on.”

According to Dressen, she immediately suffered blurred vision, headache, sound sensitivity, tinnitus, nausea, fever, vomiting and chills. Over the next days and weeks, she says she lost 20 pounds, that her heart would randomly pick up its pace, and that her eyes and ears became more sensitive to light and sound.

Three years later, Dressen remained disabled as a result of the clinical trial.

She said AstraZeneca ignored her complaints until eventually offering her about $1,200 for all past and future medical costs to be released from any financial responsibility. Dressen added that she’s paid hundreds of thousands of dollars since then.

“I did everything they asked of me. I honored my obligations to them,” she said. “They have not honored any. When they needed me, I was there. I cooperated. When I needed them, they were nowhere to be found.”

An attorney representing Dressen, Michael Connett of law firm Siri & Glimstad, described AstraZeneca’s position as inexcusable.

“AstraZeneca’s position is that it can induce prospective trial participants like Mrs. Dressen to take an experimental drug by unequivocally promising that if they get injured, AstraZeneca will cover their costs,” he argued. “And when trusting members of the public act on this cost and get injured, AstraZeneca can turn around and say, ‘Sorry, we don’t owe you a single, solitary cent.’”

Connett argued the PREP Act is not so broad as to exclude civil liability for pharmaceutical companies that lie to clinical participants.

But the appellate judges expressed skepticism over Dressen’s claims. Her claims of medical expenses and emotional distress are losses that are explicitly listed under the PREP Act, U.S. Circuit Judge Robert Bacharach, also an Obama appointee, said.

However, Connett said the statute omits breach of contract and is therefore ambiguous.

Anderson argued the statute also omits other types of statutory claims or constitutional claims.

“All claims means all claims,” he said. “Congress was not interested in legal labels. All claims that could be brought for that kind of loss are immunized.”

The three-judge panel did not make a ruling.

More than 3 billion dosesof the AstraZeneca Covid-19 vaccine were distributed around the world starting in 2021. The vaccine was withdrawn last year due to low demand, according to media reports.

The company, based in the United Kingdom, made $5.7 billion from its sale of Covid vaccines in 2021-2022, according to a report from Amnesty International.