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May 14, 2024 COVID Health Conditions News


Woman Injured by AstraZeneca COVID Vaccine During Clinical Trial Sues for Breach of Contract

Brianne Dressen alleges that under her contract with AstraZeneca, the vaccine maker promised to pay medical expenses for trial participants if the company’s COVID-19 vaccine injured them.

brianne dressen and astrazeneca covid vaccines

A woman injured by the AstraZeneca vaccine she received in 2020 during a U.S. clinical trial is suing the vaccine maker in the first case of its kind challenging the legal liability shield for COVID-19 vaccine makers.

Brianne Dressen, who since 2021 has advocated on behalf of vaccine injury victims, filed suit Monday in the U.S. District Court for the District of Utah seeking compensation for injuries and disability she alleges resulted from the vaccine.

Under the Public Readiness and Emergency Preparedness Act (PREP Act), AstraZeneca and other COVID-19 vaccine manufacturers cannot be held liable for injuries related to the vaccines.

However, Dressen’s lawsuit — which also names the Salt Lake City-based clinical trial site consolidator Velocity Clinical Research — contends AstraZeneca can be sued for breach of contract.

According to the lawsuit, the company agreed to cover the medical costs for any vaccine-related injuries under a contract between AstraZeneca and clinical trial participants.

Dressen alleges that in her case, the cost of her injuries and disability amount to hundreds of thousands of dollars per year. Dressen, who was 39 when she was vaccinated, was previously a preschool teacher but is now unable to work.

Within hours of getting her first dose, Dressen experienced tingling in her right arm — a neurological condition known as paresthesia — and blurred vision and vomiting.

In the weeks that followed, her condition worsened, with the paresthesia spreading to her legs, resulting in disability and a diagnosis in 2021 by the National Institutes of Health (NIH) of post-vaccine neuropathy.

The lawsuit seeks “all available damages, both economic and non-economic.”

Attorney Michael Connett of law firm Siri & Glimstad LLP, who is representing Dressen in her lawsuit, told The Defender, “As far as we know, this is the first case in the U.S. where a pharmaceutical company is being held financially responsible for the harms caused by the COVID vaccine.”

Dressen told The Defender that her breach of contract claim “is another first for the United States, as PREP Act protections have been completely impenetrable.”

Dressen, founder of React19, a nonprofit advocating for vaccine injury victims, said she hopes the lawsuit will provide “accountability for my individual case but also bolsters a pathway forward for my injured colleagues both in the U.S. and abroad — namely, each and every plaintiff in the U.K. seeking restitution from AstraZeneca.”

Dressen cited an ongoing class-action lawsuit in the U.K. against AstraZeneca by people alleging they were injured by the AstraZeneca COVID-19 vaccine and by the relatives of 12 people who died after getting the shot.

In documents AstraZeneca submitted to the U.K. High Court last month as part of that case, the company admitted that its COVID-19 vaccine “can, in very rare cases, cause TTS” — vaccine-induced thrombosis with thrombocytopenia syndrome, which causes the body to produce life-threatening blood clots.

Dressen’s lawsuit comes just days after AstraZeneca announced the withdrawal of its COVID-19 vaccine globally — though the company said it based its decision on the “surplus of available updated vaccines,” leading to reduced demand for its vaccine.

The U.S. never granted emergency use authorization for the AstraZeneca COVID-19 vaccine, citing safety concerns.

However, the vaccine generated over $5.8 billion in sales globally, with the help of the Bill & Melinda Gates Foundation, which funded and promoted the vaccine in other countries. Several countries later stopped administering the AstraZeneca vaccine due to safety concerns.

Connett said AstraZeneca’s decision to withdraw the vaccine “really doesn’t have a bearing” on Dressen’s lawsuit.

Ray Flores, a health freedom rights attorney unconnected to the lawsuit, agreed because “the complaint is not based on product liability.”

Flores said:

“Around the country, COVID-19 vaccine injury cases that alleged negligence, battery of a minor, fraud or emotional distress have all been unsuccessful due to the PREP Act — while cases that allege negligence not involving a countermeasure have generally been successful.

What makes this case unique is that it alleges a breach of a written contract. For a court to allow liability protection here would really stretch the extent of the law. But on the other hand, it would unequivocally etch the stench of the PREP Act in Americans’ minds — but my ‘money’ in this case is on the plaintiff.”

AstraZeneca induced people to join trials by promising to pay for injuries

According to Connett, AstraZeneca induced people to join its clinical trial by promising to pay the medical expenses for any injuries that resulted from its COVID-19 vaccine.

“This inducement, this promise, became a contractual obligation the moment study subjects rolled up their sleeve and let the company inject the experimental vaccine into their arm,” he said.

Just because a company is making the COVID-19 vaccine doesn’t give that company a license “to make false promises to induce people to enter its clinical trial,” he said. “The bonanza of immunity that the PREP Act provides does not go so far as to shield a vaccine maker from its own contractual obligations.”

Flores said that if AstraZeneca “never intended to honor its promise to insure Dressen … it would not only be a breach of contract but would rise to the level of fraud.”

“When a vaccine injury lawsuit highlights a defendant’s inhumanity, it is always highly persuasive,” Flores said. “In this case, an absurd $1,243.30 settlement offer after reneging on its written promise to insure when there are evidently millions of dollars in damages and unspeakable suffering is just that.”

Connett said any other individual injured by the AstraZeneca vaccine “has the legal right to recover the full costs of the injury,” but advised that “The time to take legal action, however, may be limited, so acting expeditiously will be important.”

‘Completely hollowed-out version of who I once was’

The lawsuit described the timeline of Dressen’s symptoms following vaccination, with paresthesia spreading to her right shoulder and left arm and later to her legs. Within weeks, she lost 20 pounds as a result of frequent vomiting, while she also developed light sensitivity and became “acutely sensitive to sound.”

Dressen said her heart rate also would randomly spike, leading to shortness of breath and feelings of fainting. She described her experience in the lawsuit as feeling like a “completely hollowed-out version of who I once was.”

Before her Nov. 4, 2020, vaccination, Dressen filled out consent forms stating the company would “cover the costs” — including, but not limited to, medical bills — if she experienced a “research injury.”

Those forms, Dressen said, claimed the study doctor would provide treatment or referral in the event of injury, noting that the study sponsor had the necessary insurance.

“Sponsor will pay the costs of medical treatment for research injuries, provided that the costs are reasonable, and you did not cause the injury yourself,” the contract stated, according to the lawsuit.

The lawsuit notes that two days after Dressen signed the consent form, AstraZeneca amended the form to state that its vaccine may cause “neurological disorders” such as “demyelinating disease,” which could “cause substantial disability” or death “if not treated promptly.”

Dressen received multiple diagnoses indicating her symptoms were related to her vaccination. Her husband eventually reached out to the NIH, which invited her to visit its Bethesda, Maryland, campus “for extensive testing and treatment,” as part of a study the agency was conducting at the time involving people injured by COVID-19 vaccines.

As a result of those tests, NIH neurologists concluded that Dressen had sustained post-vaccine neuropathy, which had caused “dysautonomia” and “chronic inflammatory demyelinating polyneuropathy.”

“The limited safety data that AstraZeneca has released to the public shows that other clinical trial participants who received the company’s COVID vaccine suffered a higher incidence of nervous system disorders, including various types of demyelinating diseases, where the myelin sheaths that protect the nerve cells are stripped away,” Connett said.

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AstraZeneca ‘were nowhere to be found’

According to the lawsuit, Dressen’s medical costs are prohibitive. One medication alone costs $432,000 a year, “although her insurance company has been able to negotiate this down (at least for now) to $119,000 per year,” she said.

But despite these high costs and Dressen’s ongoing disability, which makes her “unable to drive more than a few blocks at a time” and limits her parenting ability, the lawsuit states that AstraZeneca offered her only $1,243.30 in total compensation.

“When they needed me, I was there, I cooperated. When I needed them, they were nowhere to be found,” Dressen said in the lawsuit. “I called the test clinic early on with tears running down my face, begging them to help me. They said the drug company would call back any day now. Nightmarish days turned into weeks, and those nightmarish weeks turned into months, and now years. That call never came.”

In July 2021, Dressen’s injuries led her to contact Dr. Anthony Fauci directly to request help, according to documents recently obtained by Children’s Health Defense in a lawsuit against the NIH.

In that email, Dressen said she had been contacting federal health agencies for months with “No substantiative [sic] response.”

Dressen said Fauci never responded to her message.

Calling her lawsuit a “David v. Goliath type case,” Dressen told The Defender her “heart has and always will be with the injured community.” She said, “Every single American injured by a pharmaceutical product deserves their day in court.”

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