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By: Jake Daly
Now that COVID-19 vaccines are being administered to millions of people across the country, it is worth asking whether the manufacturers of these vaccines (and others) can be liable for injuries they cause to recipients. This question is particularly interesting to many people because they are suspicious of the safety of these vaccines based on the speed with which the manufacturers developed them and the FDA approved them. For most people who sustain a vaccine-related injury, the answer should be no.
The applicable law is the Public Readiness and Emergency Preparedness Act, which Congress enacted in 2005 to encourage the rapid production of vaccines and other medical countermeasures to be used in response to public health emergencies. The PREP Act provides immunity from claims for personal injuries for (1) manufacturers and distributors of a covered countermeasure, (2) state and local governments and their employees who supervise or administer a program relating to the administration, dispensing, distribution, provision, or use of a covered countermeasure, and (3) licensed health professionals and other people who are authorized to prescribe, administer, or dispense a covered countermeasure, provided that the Secretary of the Department of Health and Human Services must first issue a declaration finding there to be a public health emergency with respect to the particular disease, condition, or threat at issue and defining the medical countermeasures to be covered.
On March 10, 2020, HHS Secretary Alex Azar issued a declaration extending the PREP Act to medical countermeasures to be used against COVID-19. Under this declaration, which expires on October 1, 2024, a “covered countermeasure” is “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.”
The PREP Act does not provide immunity from claims for death or serious physical injuries caused by willful misconduct. For such claims, compensation is available through the Countermeasures Injury Compensation Program. Some people regard the CICP as inadequate because (1) a claim must be filed within one year of the use or administration of the countermeasure (regardless of when the death occurs or the injury manifests), (2) death benefits are capped at $370,376, (3) benefits for unreimbursed lost wages and out-of-pocket medical expenses are capped at $50,000, and (4) benefits are reduced by amounts received from collateral sources. Moreover, the CICP rarely awards benefits to claimants. According to data published on its website, it has awarded benefits to only 29 of 499 claimants since its inception in 2010, and it awarded only about $6,000,000 in total benefits to those 29 claimants (an average of a little more than $200,000 per claimant).
In addition to these structural barriers, claims under the PREP Act must comply with any conditions imposed in the applicable declaration(s). For example, Secretary Azar’s March 10, 2020 declaration provides that a claimant may receive benefits only upon proof by “compelling, reliable, valid, medical and scientific evidence” that the countermeasure caused the death or serious physical injury. The “compelling” part of this standard suggests that something more than the traditional tort standard of a preponderance of the evidence is required.
Because of the limitations on claims under the PREP Act, claimants will avoid seeking benefits from the CICP if there are any other options available. Unfortunately for them, but fortunately for entities and people who are covered by the PREP Act, there appears to be no other recourse for a person killed or injured by a COVID-19 vaccine (or other COVID-19 countermeasure). Most importantly, the PREP Act expressly preempts conflicting state laws, and so a claimant generally cannot file a traditional state-law tort claim. Further, the doctrine of sovereign immunity likely forecloses any claim against the FDA based on its approval of a COVID-19 vaccine or other countermeasure. Finally, the more familiar (and more friendly to claimants) National Vaccine Injury Compensation Program does not apply to COVID-19 vaccines because they are not included on that program’s Vaccine Injury Table.
Thus, most people who sustain an injury caused by a COVID-19 vaccine or other countermeasures will likely be limited to an administrative remedy, if any. Manufacturers and other covered persons face minimal exposure. Fair or not, this was the goal of the PREP Act.
If you have questions or would like more information, please contact Jake Daly at [email protected].
FMG has formed a Coronavirus Task Force to provide up-to-the-minute information, strategic advice, and practical solutions for our clients. Our group is an interdisciplinary team of attorneys who can address the multitude of legal issues arising out of the coronavirus pandemic, including issues related to Healthcare, Product Liability, Tort Liability, Data Privacy, and Cyber and Local Governments. For more information about the Task Force, click here.
You can also contact your FMG relationship partner or email the team with any questions at [email protected].
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