Health and Beauty

You possibly can’t sue Pfizer or Moderna for uncomfortable side effects

If you’ve had serious side effects after taking a Covid vaccine, attorneys tell CNBC that there is basically no one to blame in a U.S. court.

The federal government has granted companies like Pfizer and Moderna liability immunity if something goes wrong with their vaccines.

“It is very rare for a blanket immunity bill to be passed,” said Rogge Dunn, a Dallas work and employment attorney. “As a rule, pharmaceutical companies do not receive high statutory liability protection.”

Neither can you sue the Food and Drug Administration for approving an emergency vaccine, nor can you hold your employer accountable for making vaccination a condition of employment.

Congress created a fund specifically to cover lost wages and medical expenses for people who have been irreparably harmed by a “covered countermeasure” such as a vaccine. But it’s hard to use and rarely pays off. Lawyers say it has compensated less than 6% of claims filed over the past decade.

Immune to lawsuits

In February, the Secretary for Health and Human Services, Alex Azar, invoked the Public Preparedness and Emergency Preparedness Act. The 2005 Act empowers the HHS Secretary to provide legal protection to companies that manufacture or sell critical medical supplies such as vaccines and treatments unless the company has “willful misconduct”. The protection lasts until 2024.

This means these companies “cannot be sued in court for monetary damages” for violations related to the administration or use of products to treat or protect against Covid for the next four years.

HHS declined CNBC’s request for an interview.

Dunn believes a big reason for the unprecedented protection has to do with the accelerated timeline.

“When the government said, ‘We want you to develop this four or five times faster than normal,’ the manufacturers most likely said to the government, ‘We want you, the government, to protect us from multi-million dollar lawsuits. “” said Dunn.

It is very rare for a blanket immunity law to be passed. … Pharmaceutical companies are usually not afforded much liability protection by law.

Rogge Dunn

Dallas work and employment attorney

The fastest vaccine ever developed was for mumps. It took four years and was approved in 1967. Pfizer’s Covid-19 vaccine was developed and approved for emergency use within eight months – a fact that has fueled public distrust of coronavirus vaccination in the United States

About 4 in 10 Americans say they “definitely” or “probably” wouldn’t get the vaccine, according to a recent poll from the Pew Research Center. While this is lower than two months ago, it still indicates a large trust gap.

But drug manufacturers like Pfizer continue to reassure the public that no shortcuts have been taken. “This is a vaccine that has been developed without compromising,” said CEO Dr. Albert Bourla in an interview with CNBC’s “Squawk Box” on Monday. “This is a vaccine that is approved by all government agencies in the world. That should say something.”

The immunity granted to pharmaceutical companies not only protects them from lawsuits. Dunn said it helps lower the cost of vaccinations.

“The government doesn’t want people to sue the companies that make the Covid vaccine, because then the manufacturers would likely charge the government a higher price per person per dose,” said Dunn.

Pfizer and Moderna have not returned CNBC’s request for comment on their legal protection.

Is anyone liable?

Remember, vaccine manufacturers are not the ones to approve their product for mass distribution. That is the job of the FDA.

Which begs the question, if you react extremely poorly to a vaccine, can you sue the US government?

Again the answer is no.

“You can’t sue the FDA for approving or rejecting a drug,” said Dorit Reiss, professor at the University of California’s Hastings College of Law. “That’s part of his sovereign immunity.”

The sovereign immunity came from the king, explains Dunn, referring to British law before the American Revolution. “You couldn’t sue the king. So America has sovereign immunity, and even every state has sovereign immunity.”

There are limited exceptions, but Dunn said he doesn’t think they are a viable legal avenue to hold the federal government responsible for a Covid vaccination violation.

Bringing workers back to a post-Covid world also brings with it an increased fear of employer liability. Lawyers across the country say their corporate clients are reaching out to them to ask if they can require employees to be vaccinated.

India Medley, Chief Nurse Officer at Howard University Hospital, receives the Covid-19 vaccine at Howard University Hospital in Washington, DC on December 15, 2020.

Nicholas Comb | AFP | Getty Images

Dunn’s customers, who run businesses that serve customers in person or on-site, are most interested in getting a Covid vaccine for employees.

“They see it as a selling point,” said Dunn. “It is particularly important for restaurants, bars, gyms and salons. My customers in this segment of the service industry are very keen to make this a binding selling point for their customers.”

While this is in part a PR tactic, it is legally the right of an employer to impose such a requirement.

“Requiring a vaccine is a health and safety work rule, and employers can do it,” Reiss said.

There are a few notable exceptions. If a workforce is unionized, the collective agreement may need to require negotiation with the union before a vaccine is made mandatory.

Anti-discrimination laws also offer protection. The American with Disabilities Act allows workers who do not wish to be vaccinated for medical reasons to apply for an exemption. If ingestion of the vaccine is a violation of a “righteous” religious belief, Title VII of the Civil Rights Act of 1964 would possibly provide a route sign out.

If none of these exceptions apply, employees can appeal if they suffer from debilitating side effects after a work-related Covid vaccination.

Lawyers say claims would most likely be passed through employee compensation programs and treated as workplace injury.

“However, there are significant limits or caps on the damage an employee can claim,” Dunn said. He added that it would likely be difficult to prove.

However, mandatory vaccination protocols may not be created until the FDA officially approves the vaccines and licenses Pfizer and BioNTech or Moderna for sale. This will take several months for data to show their safety and effectiveness.

“An emergency permit is not a license,” said Reiss. “There is a legal issue as to whether you can mandate an emergency observation. The language, in fact, is somewhat unclear on this.”

$ 50,000 per year

The government has created a way to compensate people in case something goes wrong after vaccination.

In addition to Due to legal immunity, the PREP Act introduced the Countermeasures Injury Compensation Program (CICP), which provides benefits to eligible individuals who have been seriously injured by one of the protected companies.

The little-known government program has been around for a decade and is administered by an agency under HHS. This fund usually only deals with vaccines that you would probably never get, like the H1N1 and Anthrax vaccines.

If a case is successful for compensation from the CICP, the program allows up to $ 50,000 per year in non-reimbursed lost wages and medical expenses. No legal fees or other services to compensate for pain and suffering are covered.

It is also limited to the $ 370,376 death benefit amount. This is the maximum amount a surviving family member will receive if a Covid vaccine turns out to be fatal.

However, experts who specialize in vaccination law say it is difficult to navigate. “This state compensation program is very difficult to apply,” said Reiss. “The bar for compensation is very high.”

Also of concern to some vaccination injury attorneys is the fact that the CICP has turned down a large portion of the claims for compensation it has made since the program began 10 years ago. Of the 499 claims filed, The CICP has settled only 29 claims totaling more than $ 6 million.

People harmed by a Covid vaccine deserve to be compensated quickly and generously. The PREP law doesn’t do that.

Dorit Reiss

Professor at the University of California Hastings College of Law

David Carney, vice president of the Vaccine Bar Association, said the CICP could deny a claim for a variety of reasons. “One reason could be that the medical records do not support an allegation,” said Carney, who regularly deals with vaccination injury cases. “We have to process a lot of really complex questions … and provide a medical basis for why the injury occurred.”

Evidence of injury as a direct result of the Covid vaccine could be difficult, Carney said. “It’s not as easy as saying, ‘Hey, I got Covid treatment and now I have an injury.’ There’s a lot of evidence there. “

There is also a strict one year law, which means that all claims must be made within 12 months of receiving the vaccine.

“People who are harmed by a Covid vaccine deserve to be compensated quickly and generously,” said Reiss. “The PREP Act doesn’t do that.”

Lawyers tell CNBC that it would make more sense to channel Covid vaccination violations through another program under the HHS called the National Vaccine Injury Compensation Program, which processes applications for 16 routine vaccines instead. The program, known colloquially as the “vaccination court”, paid for about 70% of the petitions ruled by the court from 2006 to 2018.

And since reviewing claims in 1988, the VICP has paid total compensation of approximately $ 4.4 billion. This dwarfs the approximately $ 6 million in paid services of the CICP during the life of the program.

The VICP also gives you more time to file your claim. You have three years from the date of the first symptom to apply for compensation.

“The VICP provides recovery from pain and suffering, legal fees, and any medical expenses and lost wages,” said Michael Maxwell, an attorney specializing in litigation and personal injury. “Under the CICP, it’s just lost wages and medical expenses. That’s it, unless there’s a death.”

However, the Covid-19 vaccines are not on the list of eligible vaccines.

Reiss said the best solution would be to change VICP’s rulebook to include Covid vaccines in the vaccination coverage list. “That requires a change in the law. I hope that there will be a change in the law.”

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