Provider giving a patient a vaccination

01.05.21

COVID-19 Vaccine Liability Protections

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Drummond Jane   Source

Jane Drummond

General Counsel and Vice President of Legal Affairs

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Fact Sheets

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  • COVID-19
  • Disease Management
  • Legal

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coronavirus COVID-19 fact sheet legal

Operation Warp Speed brought COVID-19 vaccines to the public in record time. Federal and state health officials tout the safety and effectiveness of the currently available vaccines, despite the extremely condensed clinical trials. As hospitals begin to administer vaccines to staff, patients and eventually the general public, they may be concerned about potential liability in the event an individual has an adverse reaction or contracts the virus after vaccination. The Public Readiness and Emergency Preparedness Act, 42 U.S.C. § 247d-6d, provides substantial protections to vaccinators, but hospitals should be aware of what is and what is not covered by the Act.

 

Who is Covered?

The PREP Act provides immunity to “covered persons” who manufacture, distribute, formulate, dispense, prescribe, administer or use “covered countermeasures” during a public health emergency declaration by the Secretary of Health and Human Services. A specific declaration must be issued in reference to the PREP Act. Covered persons include individuals who prescribe, administer or dispense vaccines, so long as they are authorized to do so under state law. Covered countermeasures are drugs, such as vaccines, authorized for use during a PHE by the U.S. Food and Drug Administration.

Secretary Alex Azar issued a declaration under the PREP Act, effective Feb. 4, 2020, which was amended April 15, June 8 and Aug. 24, 2020.

 

What Liability Protections Exist?

The PREP Act provides broad liability protections for personal injury and property damage claims related to the use of a covered countermeasure during the effective period of and in accordance with the requisite declaration. This means that hospitals distributing, dispensing, formulating or administering approved COVID-19 vaccines generally are free from suit or liability grounded in general negligence so long as they do so in accordance with the applicable FDA emergency use authorization or approvals. The statute does not protect a covered person from liability for death or serious physical injury proximately caused by willful misconduct, defined as acts or omissions intended to achieve a wrongful purpose; knowingly without legal or factual justification; and in disregard of a known or obvious risk so great that it was highly probably the harm would outweigh the benefit. A plaintiff must prove by clear and convincing evidence a covered person acted with willful misconduct.

The Pfizer vaccine is more challenging to handle and administer than Moderna, given its ultra-cold storage and reconstitution requirements. PREP Act protections should apply to hospitals’ handling of Pfizer, unless there is a willful disregard for the manufacturer’s instructions or the FDA’s EUA. For example, if hospital personnel knew that the vaccine had not been stored at the proper temperature for an extended period but decided to administer it anyway, the PREP Act likely would not shield them from suit if an individual suffered an adverse reaction to the vaccine. Conversely, good faith attempts to store, distribute and administer the vaccine in accordance with all applicable guidance and instructions likely will bring the PREP Act’s protections into play.

The PREP Act expressly preempts conflicting state laws that otherwise would impose liability for activities protected by the statute. While the PREP Act provides liability protection, it does not prevent an individual from suing a hospital for personal injury associated with the administration of a COVID-19 vaccine. If a hospital were sued for personal injury associated with a COVID-19 vaccine, it would need to seek dismissal under the PREP Act’s preemption clause.

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