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People can sue manufacturers for injury following routine childhood vaccines, contrary to a claim by Robert F. Kennedy Jr.

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CLAIM

“As long as you take an Emergency Use [vaccine], you can’t sue them. Once they get approved, now you can sue them—unless they can get it recommended for children”

DETAILS

Misleading: People can sue vaccine manufacturers for alleged vaccine injury following the administration of childhood vaccines, but they must first go through the Vaccine Injury Compensation Program. Contrary to Kennedy’s implication that people can sue for any approved vaccine, approved COVID-19 vaccines are also practically immune to lawsuits like their authorized counterparts, due to the PREP Act declaration.
Accurate: Because authorized COVID-19 vaccines are considered pandemic countermeasures under the PREP Act declaration, they are virtually immune to lawsuits.

KEY TAKE AWAY

In the U.S., the National Vaccine Injury Compensation Program (VICP) is a no-fault program that compensates people who are found to have been injured by certain vaccinations. It doesn’t prohibit people from suing vaccine manufacturers, but people can only pursue legal action against manufacturers after exhausting their options through the VICP. Both authorized and approved COVID-19 vaccines are pandemic countermeasures under the PREP Act declaration. Therefore, they aren’t covered by the VICP, but by another program known as the Countermeasures Injury Compensation Program.

FULL CLAIM: “As long as you take an Emergency Use [vaccine], you can’t sue them. Once they get approved, now you can sue them—unless they can get it recommended for children”; “Under the Vaccine Act, you cannot sue a vaccine company for injuring you, no matter how negligent they were, no matter how reckless they were, no matter how grievous your injury, you cannot sue them.”

REVIEW

In December 2021, lawyer and founder of the anti-vaccine organization Children’s Health Defense, Robert F. Kennedy Jr., was interviewed on The Mikhaila Peterson Podcast on the subject of legal immunity for COVID-19 vaccine manufacturers. Clips of the interview were uploaded on social media; an excerpt uploaded by Mikhaila Peterson to Instagram received more than 130,000 views to date. 

Peterson is better known as the daughter of prominent clinical psychologist and author Jordan Peterson. She has affirmed that her adherence to a “carnivore diet”, also called the “lion diet”, helped cure her depression and arthritis. However, there is a lack of scientific evidence to support this claim and there are health risks to a carnivore diet. Consisting primarily of red meat and little to no fiber, this diet may contribute to a higher risk of heart disease and diabetes.

During the interview on the podcast, Kennedy claimed that “As long as you take an Emergency Use [vaccine], you can’t sue them. Once they get approved, now you can sue them—unless they can get it recommended for children”.

Emergency Use Authorizations (EUAs) for COVID-19 vaccines in children began to roll in as the year 2021 unfolded. In May that year, an EUA was granted for the Pfizer-BioNTech COVID-19 vaccine for use in adolescents aged 12 to 15. In October, the EUA extended to children aged five to 11. The Moderna and Novavax vaccines were authorized for children and adolescents in 2022. At the moment, these three vaccines are the only ones that are available for use in children in the U.S. At the time of writing, only the Pfizer-BioNTech COVID-19 vaccine has been approved for adolescents in the U.S.

Vaccine misinformation that hinges on the legal protection that manufacturers receive aren’t new, as Vaxopedia documented in various articles. This type of misinformation tends to frame the legal protection in a manner that falsely implies that there are serious safety issues with vaccines. 

Kennedy’s claim during the Peterson interview runs in the same vein, as we will see, reinforced by his claim that the COVID-19 vaccines will “kill and injure a huge number of children”. Despite the magnitude of this claim, he produced no evidence to support it, nor did Peterson request any. 

In fact, studies have shown that there are no safety issues with COVID-19 vaccines in children and adolescents and that the vaccines’ benefits outweigh their risks[1-5]. The American Academy of Pediatricians has recommended that children aged six months and older with no contraindications to COVID-19 vaccines who are eligible be vaccinated against COVID-19.

As we will explain below, Kennedy’s claim contains a mix of accurate and inaccurate information about the legal immunity of COVID-19 vaccines and vaccines in general.

The PREP Act currently provides almost complete legal immunity for COVID-19 vaccine manufacturers

To address the credibility of the claims made by Kennedy, Health Feedback reached out to Dorit Reiss, a professor at the University of California, Hastings College of the Law, who specializes in legal and policy issues related to vaccines.

Speaking of the liability protection for COVID-19 vaccines specifically—both authorized and approved vaccines—Reiss said that, practically speaking, vaccine manufacturers are “almost completely immune from lawsuits”.

This is because of the PREP Act declaration by the Secretary of Health and Human Services, in response to the COVID-19 public health emergency. The declaration has been in effect since 4 February 2020 and limits “legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines”.

Now, the PREP Act does contain an exception for legal immunity when it comes to “willful misconduct”, as the Office of the Assistant Secretary for Preparedness and Response stated on its website:

‘Immunity from liability under the PREP Act is not available for death or serious physical injury caused by willful misconduct.  A “serious physical injury” is one that is life-threatening, or results in or requires medical or surgical intervention to preclude permanent impairment of a body function or results in permanent damage to a body structure.  Willful misconduct is misconduct that is greater than any form of recklessness or negligence. It is defined in the PREP Act as an act or failure to act that is taken:

  • intentionally to achieve a wrongful purpose;
  • knowingly without legal or factual justification; and
  • in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit. All three of these conditions must be proven with clear and convincing evidence.’

Actions that constitute willful misconduct could be something like “hiding evidence that the vaccine causes heart attacks or intentionally putting a harmful ingredient into the vaccine”, said Reiss. However, she also pointed out that this exception is “very narrow” and would require evidence of “intentional wrongdoing”. 

“This is simply unlikely to be shown, so in practice, lawsuits are unlikely,” concluded Reiss.

Therefore, it’s true that people cannot sue manufacturers for authorized COVID-19 vaccines, as Kennedy claimed. However, the PREP Act declaration at the moment covers both authorized and approved COVID-19 vaccines. Therefore, Kennedy’s assertion that getting vaccines approved means people can sue vaccine manufacturers is inaccurate.

People can sue vaccine manufacturers for alleged vaccine injury, even if the vaccine is recommended for children, but COVID-19 vaccines are an exception

Kennedy’s claim that vaccine manufacturers cannot be sued for vaccine injuries following childhood vaccination provides an inaccurate picture of how the U.S. vaccine injury compensation program work.

“You can go to court for all routine vaccines,” said Reiss, but for childhood vaccines, individuals must first go through the National Vaccine Injury Compensation Program (VICP).

This program was created thanks to the National Childhood Vaccine Injury Act, passed by the U.S. Congress in 1986. The VICP is a no-fault program that compensates people who are found to have been injured by vaccination using certain vaccines. Despite the name of the Act, adults can also receive compensation through the VICP.

According to the Health Resources and Service Administration (HRSA), for a vaccine to be covered by the VICP, “the category of the vaccine must be recommended for routine administration to children and/or pregnant women by the Centers for Disease Control and Prevention and subject to an excise tax”. The excise tax, set at $0.75 per dose, goes towards funding the Vaccine Injury Compensation Fund.

Contrary to a common misconception about the National Childhood Vaccine Injury Act, previously addressed by Health Feedback here, the Act doesn’t prevent people from suing vaccine manufacturers. But people need to seek recourse through the VICP first.

If a petitioner isn’t satisfied with the outcome through the VICP, also known informally as the vaccine court, they “can appeal the result to the federal courts or choose to go to state courts for a variety of claims”, Reiss explained. However, the exception is a claim of design defect, following a Supreme Court case Bruesewitz v. Wyeth in 2011. This means that people cannot sue by claiming a vaccine design is too dangerous.

The HRSA website provides examples of other situations which permit someone to file suit against a vaccine manufacturer:

To exhaust the remedies available under the VICP and pursue a legal action against a vaccine manufacturer or administrator outside of the VICP, a VICP petitioner must either withdraw his or her petition (if the special master of the U. S. Court of Federal Claims (Court) has failed to issue a decision or the Court has failed to enter judgment within the time provided by the Act) or reject the judgment under the VICP.

Although the Act provides liability protections to vaccine manufacturers and vaccine administrators who administer covered vaccines in many circumstances, these protections are not absolute.

There are instances when a vaccine manufacturer or administrator who gives a covered vaccine is not protected from liability by the Act, such as when an individual files a petition and is requesting damages of $1,000 or less. In this case, a civil suit against a vaccine manufacturer or an administrator may be permitted to be filed in state or federal court without first filing a petition in the VICP.

It’s not the first time Kennedy alleged that vaccine manufacturers cannot be sued in the case of childhood vaccines. His claim is all the more inexplicable given his record of filing multiple lawsuits for alleged vaccine injury by the HPV vaccine Gardasil against its manufacturer Merck. Gardasil is a recommended vaccine for children and is listed in the U.S. Centers for Disease Control and Prevention’s childhood immunization schedule. That he did file lawsuits against a vaccine manufacturer for a vaccine recommended for children contradicts his assertion that this cannot be done.

COVID-19 vaccines specifically aren’t covered under the VICP, but in a separate compensation program

Vaccine injury compensation programs like the VICP are essential to vaccination programs from both a practical and ethical perspective.

From a practical point of view, they help to ensure a steady supply of vaccines by limiting the costs of potential litigation that vaccine manufacturers face. In an article for the Bill of Health, the blog of the Petrie-Flom Center at Harvard Law School, Reiss explained that since most vaccines don’t generate much profit, even unfounded lawsuits can lead vaccine manufacturers to leave the market, limiting vaccine supply and threatening public health.

This did happen in the 1980s, as people filed a growing number of lawsuits against vaccine manufacturers, particularly for the diphtheria-polio-tetanus vaccine. The website History of Vaccines reported

“In this environment of increasing litigation, mounting legal fees, and large jury rewards, many pharmaceutical companies left the vaccine business. By the end of 1984, only one U.S. company still manufactured the DPT vaccine, and other vaccines were also losing manufacturers.

This occurred even though many of these lawsuits turned out to be frivolous. The National Childhood Vaccine Injury Act, discussed above, was passed precisely in response to this situation.

And from an ethical standpoint, since people who get vaccinated protect not only themselves but also society in general, those who suffer from rare side effects of vaccination should be compensated by society, as a matter of fairness. “People who suffer a rare side effect while contributing to the common good should not have to bear this burden by themselves: the public should compensate them,” Reiss wrote.

Indeed, the U.S. isn’t the only country to have vaccine injury compensation programs; Denmark, Germany, and the United Kingdom are among the countries with such programs.

However, COVID-19 vaccines specifically aren’t covered by the VICP, regardless of whether they’re under EUA or have been approved, even though the U.S. Centers for Disease Control and Prevention (CDC) have since recommended COVID-19 vaccines for children. This is because of their status as pandemic countermeasures under the PREP Act declaration. And under the PREP Act declaration, individuals who suffer serious injury from COVID-19 vaccines must seek compensation through another program, known as the Countermeasures Injury Compensation Program, or CICP.

In an article for Skeptical Raptor, Reiss highlighted that this program is more difficult to use compared to the VICP and isn’t as generous:

First, to be compensated, a serious injury or death needs to be shown to have been caused by the vaccine (or other covered product) by ‘compelling, reliable, valid, medical and scientific evidence.’ That is a very, very high bar, too, and for a new product, simply won’t always be achievable.

Second, the request needs to be filed within a year from the administration of the product – not a year from symptoms.  This is a shorter statute of limitations and does not cover delayed injuries at all. I will add that to my knowledge, we have never had an injury from a vaccine that occurred a long time after the vaccine – issues usually arise within a few weeks at most – but the theoretical possibility exists.

And unlike the VICP, CICP doesn’t cover a petitioner’s legal fees.

Reiss and other legal experts called for COVID-19 vaccines to be added to the VICP, but it remains to be seen if and when this will happen.

Conclusion

In summary, Kennedy’s claim that people cannot sue for authorized vaccines, but can sue for approved vaccines unless the vaccine is recommended for children, contains a mix of accurate and inaccurate information.

Firstly, Kennedy’s claim that people cannot sue for authorized vaccines—in the context of a discussion about COVID-19 vaccines—is true. However, where the claim goes wrong is in implying that people can sue for any vaccine once it’s approved. Approved COVID-19 vaccines are also virtually immune to lawsuits as a result of the PREP Act declaration, like their authorized counterparts.

Secondly, it’s not true that people cannot file lawsuits for alleged vaccine injury following vaccines that are recommended for children. People can do so, but must first go through the VICP. Only when they have exhausted their options through the VICP can they pursue legal action against manufacturers.

However, COVID-19 vaccines are in a separate category from routine childhood vaccines, They aren’t covered by the VICP despite having been recommended for children by the CDC. Because of COVID-19 vaccines’ current status as pandemic countermeasures under the PREP Act declaration, individuals who suffer serious injury after COVID-19 vaccination must seek compensation through the CICP, but this program is difficult to use and is less generous compared to the VICP.

SCIENTISTS’ FEEDBACK

Dorit Reiss, Professor, University of California, Hastings College of the Law:
Practically speaking, vaccine manufacturers are almost completely immune from lawsuits for COVID-19 pandemic countermeasures’ harms, and this includes COVID-19 vaccines, both vaccines under an EUA and vaccines licensed for COVID-19. This is because of the PREP Act declaration that covers pandemic countermeasures. So they cannot be sued for COVID-19 vaccine injuries. While there is an exception for willful misconduct, that is a very narrow exception that will require showing intentional wrongdoing. For example, fraudulently hiding evidence that the vaccine causes heart attacks, or intentionally putting a harmful ingredient into the vaccine. This is simply unlikely to be shown, so in practice, lawsuits are unlikely.

Vaccines recommended for children (even if they’re also given to adults) are covered under  the National Vaccine Injury Compensation Act from 1985 (NVICA). Under that Act, harms blamed on covered vaccines need to first go through a government compensation program before you can go to state court. The compensation program involves an adjudication under requirements that are easier to meet than those you would need to show in a civil court case, and then you can appeal the result to the federal courts—or choose to go to state court for a variety of claims, the exception being design defect claim: the Supreme Court interpreted the Act to meant that you cannot go to state court and claim the design of the vaccine is flawed.

So you can go to court for all routine vaccines, but for childhood vaccines you would have to go through the program first.

REFERENCES

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