COVID-19 vaccine liability – what are the legal facts and limits

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This article about COVID-19 vaccine liability was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

I have been getting many questions about vaccine manufacturers and liability. Here is a short answer. There are limits to the ability to sue manufacturers for injuries from routine vaccines given to children or pregnant women. They are not absolute and are accompanied by a compensation program that is easier to win in than the regular courts.

There are very strong limits on the ability to sue manufacturers of emergency products – not just vaccines. Those are accompanied by a very hard to use compensation program, that provides limited compensation.

Ideally, I would like to see COVID-19 vaccine liability moved to the routine compensation program.

Liability limits on routine vaccines

Since the 1980s, childhood vaccine manufacturers and providers had limited liability protections under the National Childhood Vaccine Injury Act. This program covers vaccines recommended to children or pregnant women. Note that that is the criteria for including a vaccine in the program – once it is in it, anyone can sue. Right now, most claims brought are for influenza vaccines given to adults (many for shoulder injury from the administration of the vaccine). 

The act says that for a “vaccine-related injury or death”, people have to file a claim with an administrative program – the National Vaccine Injury Compensation Program (NVICP or VICP, sometimes called the Vaccine Court) before they can sue either a manufacturer or a provider. (42 U.S.C. 300aa-11(2)(A)

After such a petition is filed, petitioners (claimants in the program are referred to as “petitioners”) have two ways of getting to regular courts, if that is what they want. First, they can go through the program until there is a judgment, and then reject the judgment and go to court – whether or not they were compensated. 

Petitioners have 90 days from judgment to decide to go to court – if they wait for longer, they are considered to have waived that option. And going to court means that they are rejecting any compensation they have been given through the program – it’s either/or.

Alternatively, petitioners can go to court if the program does not meet its deadlines – 240 days to a decision unless the parties asked to suspend the decision, in which case the judgment needs to be entered within 420 days. If those deadlines are not respected, the petition can be withdrawn and the person can take either a manufacturer or a provider to state (or federal, where they are from different states) court.

There is one set of claims that cannot be taken to state court even after going through the program. Under a 2011 Supreme Court case, Bruesewitz v. Wyeth,  you cannot sue a vaccine manufacturer for design defects – a claim that the design was too dangerous – in state court at all. I analyzed that decision here

However, claimants can still bring other claims against manufacturers – such as manufacturing defect claims or negligence. And they can bring medical malpractice claims against doctors. Often, they wouldn’t be able to prove such claims; but that is part of the reason regular courts are not great for compensating people for vaccine harms.

The logic of requiring people to show fault – to show something wrong – in most cases is that our torts system is based on the idea that others should only pay for your harms if they meet a certain standard of fault, rather than any time they caused you harm.

For example, if another driver crashes into your car, they will have to pay if they did not stop at a stop sign or did not maintain their brakes, but not if their brakes suffered an unexpected and rare mechanical failure. If you take an antibiotic and have a rare allergic reaction that is an inherent risk to the product, you will likely have no claim against the manufacturer unless they did not warn of it. Just the fact that something has risks, or can harm, or harmed you, does not by itself guarantee compensation.

Usually, you use a product for your own benefit and by using it, you take on its inherent risks. But vaccines are different. Vaccines benefit you – but for most vaccines, they confer another benefit on society – if enough people are vaccinated, the disease cannot get a hold in the population. This is what we call herd immunity

Even if there is not enough immunity for herd immunity, when you vaccinate, you reduce or remove the chance that you will infect someone with an infectious disease. So you are not just acting for yourself.

As a matter of fairness, since vaccines confer a public good, it is unfair that the rare cases of serious harm have to cover their costs themselves. That would mean that society benefits, but individuals are left alone to pay any harm. There are strong grounds to say that the costs of serious vaccine harms should be borne by society as a whole – at least, the financial costs.

This means we owe the rare cases of serious harm from vaccines fast and generous compensation. This logic was behind the first no-fault system for vaccines, in Germany. It is why 19 countries have a no-fault system for vaccine injury compensation. 

If you are harmed by a vaccine in one of these systems, you do not have to show someone did something wrong to be compensated. You just have to show the vaccine caused your harm.

The United States’ program did not have a smooth path – it was enacted after lawsuits, most of them, we now know, without a good foundation, made vaccines manufacturers leave the market

Congress, concerned, created the NVICP. But reflecting the issues above, the anti-vaccine organization at the time – Dissatisfied Parents Together, which is now the National Vaccine Information Center – supported the program, which made compensation easier.

Compensation program

I addressed the program in depth elsewhere.  For the purpose of this post, it is important to know that the program provides petitioners important advantages compared to regular courts.

First, unlike regular courts, you do not need to show fault (or other elements) in the program. You only have to show two things:

  1. That the vaccine caused your harm.
  2. Damages.

That is a lot less than required by other courts. 

Second, the standard for showing causation is easier in the program. In a regular court, you would have to provide scientific evidence showing the product can cause this kind of injury. In VICP, if you have a table injury – an injury included in a table that names harms and times – causation is presumed: if the state wants to claim something other than the vaccine caused the harm, it has to prove it. If it’s not on the table, all you have to show is a plausible theory backed by a credible expert – not actual studies or data. That is a big break for the plaintiffs. 

In spite of these lower standards, the rate of compensation is about one per million, most in settlements that do not show causation – reinforcing what science shows: serious harms from routine vaccines are very, very rare

Third, lawyer fees and litigation costs are covered by the NVICP, and there is no contingency fee. Lawyer fees and costs are covered even if you lose, as long as bringing the case was reasonable. 

On the other hand, the program has drawbacks for claimants. First, the statute of limitations period is three years for injury, two years for deaths (so you cannot sue more than three years after the first symptoms of harm). This is comparable to statutes of limitations in states for torts claims, but for children, those statutes are tolled, or put on hold, until the child is 18. That’s not true for NVICP, and that is one thing we may want to reform.

Second, discovery only happens if the special master orders it. But balancing that is the fact that the plaintiff needs to prove less, and most of what they need to prove would not require discovery (causation draws on published scientific studies and case-specific facts, more than company documents), and if needed, discovery can be ordered. Also, the program allows in things that would not be allowed as evidence in regular court.

Third, while economic recovery is unlimited, fees for deaths and pain and suffering are capped, and the caps have not been raised since the 1980s, so are only $250,000. This should be updated.

Finally, you cannot go to state court until going through the program.

So on one hand, the program is easier to win in, on the other, it does come with limits.

COVID-19 vaccine liability

COVID-19 vaccine liability limits under the PREP Act

The situation is very different for emergency vaccines, such as the COVID-19 vaccines. The Public Readiness and Emergency Preparedness Act (PREP) allows the secretary to issue a statement limiting liability for a product during an emergency. The Secretary issued such a declaration for Covid-19 products and vaccines. 

The statement completely isolates “manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States” from liability for harms or deaths from COVID-19 vaccines until October 1, 2024. In other words, you cannot sue these manufacturers at all.

The only exception is “willful misconduct,” which means (42 U.S. Code § 247d–6d (c)(1)(A)):

 …an act or omission that is taken
(i) intentionally to achieve a wrongful purpose;
(ii) knowingly without legal or factual justification; and
(iii) 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.

There are additional requirements that need to be met. This is a very, very high bar. It will be very hard to sue a manufacturer here.

Compensation program

Attached to the act is a government compensation program, the Countermeasures Injury Compensation Program (CICP). This program is much less generous than NVICP.

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.

The program does not cover legal fees. It also serves as the payer of last resort – so if you have another source of funding, like health insurance, workers compensation, etc., the program may not cover your cost even if you are eligible.

Reflecting these harsh terms, only a few claims were ever compensated by CICP. The program site explains

Since the program began in Fiscal Year 2010, the CICP has received 499 claim filings from individuals who alleged they were injured by covered countermeasures and requested compensation. Of the 499 filings, 450 were ineligible for compensation, 10 cases are in the medical review process.

The CICP has compensated 29 claims (also referred to as Request for Benefits) totaling more than $6 million since the program began in Fiscal Year 2010. The CICP determined 39 claims were eligible for compensation; however, 10 claims did not receive compensation because they did not have any compensable expenses or losses.

Conclusion

There are two compensation programs available to those alleging harm from vaccines. One is relatively generous and easy to use and provides only limited liability protections – NVICP.

The other provides extensive liability protections and is very hard to use – CICP.

Note, by the way, that if an employer requires vaccines as an employment condition, workers compensation would likely cover any vaccine harm – which would be a barrier to being compensated under CICP but not NVICP.

Currently, COVID-19 vaccine liability falls under CICP. I think that’s a problem. We want people to get COVID-19 vaccines – it is in the public interest. I expect serious harms to be extremely rare, but if they happen, those rare cases deserve fast and generous compensation – and CICP may meet the “fast” prong, but will not meet the “generous” prong.

COVID-19 vaccine liability should be moved to NVICP. To do so, Congress should pass specific legislation covering them, and add an excise fee.

Dorit Rubinstein Reiss
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy and the law. 

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.