By Dorit Reiss
COVID-19 vaccines are extremely safe, and serious harms are rare. But rare does not mean the risk is zero; thus, we need a way to determine which people have plausible claims of harm from the vaccines, and we must then compensate them quickly and generously. However, the regular torts system is not a good option for adjudicating these claims. Fortunately, we already have a better system — no-fault compensation — available to address the problem.
No-fault systems provide compensation without having to show fault — all that claimants have to show is causation (that the vaccine caused the damage), and damages. In the United States, no-fault systems usually come with limits on access to the regular tort system — that’s the deal, for example, with workers compensation and the 9/11 compensation fund.
There are two key reasons why this is preferable to the regular torts system for handling claims of vaccine harms. First, because most vaccines are not a large moneymaker, litigation — even unfounded litigation, where most plaintiffs lose — can and will cause manufacturers to leave the market. This is not a hypothetical situation: in the 1980s, manufacturers withdrew from vaccine production due to the threat of litigation. In an emergency, the concern is even higher: COVID-19 came with a large vaccination effort, and however safe the vaccines, claims of harm after them were inevitable. Without protection from liability in the torts system, manufacturers and health facilities may hesitate to produce or give vaccines. Alternative liability arrangements help assure that life-saving vaccines are available.
Second, and just as importantly, compensation in the tort system requires showing some type of fault: for product liability, a defect in the product; for negligence or fraud, unreasonableness or misrepresentation. Fault is often hard to demonstrate, and it could mean that people harmed by vaccines will not be compensated. That’s problematic: people who get vaccinated protect not only themselves, but others, by helping to control infectious diseases and reducing the attendant burden on health care systems. 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.
Thus, a no-fault system provides a better approach to addressing these concerns than relying on courts.
Already, COVID-19 vaccines have liability protections attached to them — the Secretary of Health issued a PREP declaration that limits liability of manufacturers, distributors and administrators of all pandemic products, including vaccines. These protections come with a no-fault system, the Countermeasures Injury Compensation Program (CICP). But the CICP has very real limits as a compensation option. It sets a very high bar for proving causation, requiring “compelling, reliable, valid, medical and scientific evidence,” which, especially in early stages of a new vaccine, may not be available. It also has a very short — one year — statute of limitations. It limits the types of compensation offered, and any alternative source of payment, like workers’ compensation, comes first. It is not a generous program, and would not cover some people with plausible claims of vaccine harm.
The other no-fault compensation program in the United States — the National Vaccine Injury Compensation Program — is not perfect, but is substantially better for the purpose of compensating individuals who are harmed as a result of receiving a COVID-19 vaccine. Its standard of proof is, at most, the civil court’s balance of probabilities (claimants have to show that it’s more likely than not — more than 50% likely — that the vaccine caused their harm); further, it allows claimants to prove their claims with a plausible theory supported by a credible expert, if the data is not yet out there. And the program usually covers a list of injuries that are presumed to be caused by vaccines. It also covers reasonable lawyers’ fees and litigation costs, even if a party loses. It has its problems — it has caps set in the 1980s that have not been raised since, it needs more special masters, and it likely needs to lengthen its statutes of limitations — but it is a reasonably functioning program that can compensate generously. It is a viable option, if Congress acts to include COVID-19 vaccines under its jurisdiction (ideally, with addition of more special masters, to cover the large volume of cases that would add).
Alternatively, a new program modeled after the 9/11 fund, which allows people who show certain medical conditions and meet certain requirements to be compensated through a streamlined, bureaucratic process , or — alternatively — changing CICP to be more generous, could also solve the issues.
The United States has administered hundreds of millions of doses of COVID-19 vaccines, and the vaccines have been subject to unprecedented monitoring. Nevertheless, rare injuries do happen. We need to provide fast, generous compensation to those with plausible claims of vaccine injuries to maintain trust and increase vaccine uptake, because people will be more likely to vaccinate if they can assume that if there is a problem, their costs and expenses would be covered; and higher vaccine rates make all of us better off, reducing disease, deaths, and burden on the health care system. Relying on the existing tort system is not good enough.