Covid-19 Vaccine Liability - The PREP Act – How broad are the protections?

Recent litigation involving COVID-19 related deaths in nursing homes and other care facilities has brought attention to the federal law known as the Public Readiness and Emergency Preparedness (PREP) Act. Many nursing homes in the United States who are defending lawsuits for COVID-19 related deaths are seeking immunity from liability using a very broad interpretation of the liability protections provided by the PREP Act.

The PREP Act was originally signed in 2005 and has been somewhat controversial since its inception, as it protects drug makers and vaccine manufacturers from legal actions related to manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics if there was a declared public health emergency. PREP Act immunity applies to any “covered person” with respect to all “claims for loss” caused by, arising out of, relating to, or resulting from the “administration” or the “use” of a “covered countermeasure” if a declaration has been issued with respect to that countermeasure. 42 U.S.C. § 247d-6d(a)(1).

The PREP Act was meant to provide U.S. defenses against the avian flu epidemic or bioterrorist attacks and to persuade drug developers to produce emergency vaccines during an epidemic. Vaccine manufacturers had lobbied for the legislation, which effectively preempts state vaccine safety laws in the case of an emergency declaration by the Department of Health and Human Services (HHS), by making clear they would not produce new vaccines unless the legislation was enacted. Developers of recent COVID-19 vaccines and therapies like Pfizer Inc, BioNTech, and Moderna Inc., are covered under the PREP Act as countermeasures.

The legal protections afforded by the PREP Act are quite broad. The HHS Secretary is given wide discretion on whether to declare an emergency through what is known as an “Emergency Declaration.” These Declarations essentially justify removing financial risk barriers that would otherwise cause manufacturers and others to exercise caution. The PREP Act removes the right to a jury trial for persons injured by a covered vaccine or other countermeasure used in response to a declared emergency, unless a plaintiff can provide clear evidence of “willful misconduct” that resulted in death or serious physical injury. An example of “willful misconduct” would be if a doctor or nurse purposely gave a shot or vaccine incorrectly to cause harm to the patient. For questions or more information about the PREP Act, you can visit https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx.

In March 2020, the Secretary issued a declaration in response to the COVID-19 pandemic to provide liability immunity to certain individuals and entities (covered persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (covered countermeasures). Under the March 10, 2020 declaration, covered countermeasures are 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. (85 Fed. Reg. 15,198, 15,202 (March 17, 2020)).

HHS issued an advisory opinion on the PREP Act’s March 10, 2020 Declaration. According to HHS, any drug, device, or biological product that is approved, cleared, or licensed by the FDA and is used to diagnose, mitigate, prevent, treat, cure, or limit the harm of COVID-19 is a covered countermeasure. (https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-hhs-ogc.pdf)

HHS’s advisory opinion further advised that an entity or individual who complies with all other requirements of the PREP Act and the conditions of the Secretary’s declaration will not lose PREP Act immunity—even if the medical product at issue is not a covered countermeasure—if that entity or individual reasonably could have believed that the product was a covered countermeasure.

The advisory opinion explained that given the broad scope of PREP Act immunity, Congress did not intend to impose a strict liability standard on covered persons for determining whether a product is a covered countermeasure. Instead, HHS believes that a person or entity that otherwise meets the requirements for PREP Act immunity will not lose that immunity—even if the product is not a covered countermeasure—if that person or entity reasonably could have believed that the product was a covered countermeasure. See, e.g., 42 U.S.C. § 247d-6d(a)(4)(B) (applying the “reasonably-could-have-believed” standard to predicate requirements for PREP Act immunity not involving the actual use and administration of covered countermeasures).

HHS’s advisory opinion also advised that a person who complies with all other requirements of the PREP Act and the conditions of the Secretary’s Declaration will not lose PREP Act immunity—even if the person at issue is not a covered person—if the entity or individual reasonably could have believed that the person was a covered person.

Many nursing homes across the U.S. have cited the PREP Act as a defense in recent wrongful death actions related to COVID-19 deaths. There have been over 100,000 residents of nursing homes and senior living facilities known to have died from COVID-19. Although no judge has yet taken on the nursing homes’ interpretations of the law, it has led to significant procedural delays. Plaintiffs’ counsel have complained of gamesmanship by the defendants who have raised the PREP Act in order to introduce delays into the litigative process by intentionally making the cases more complex by having cases moved back and forth between state and federal courts.

Several federal judges have issued preliminary rulings all in favor with the plaintiffs and ordered the cases to return to state court. It remains to be seen whether the nursing home defendants will be successful in relying on the PREP Act’s emergency declarations’ broad protections.

References

https://www.reuters.com/article/us-health-coronavirus-usa-liability-insi-idUSKBN29X1DG

https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx

https://www.hhs.gov/about/news/2020/12/03/hhs-amends-prep-act-declaration-including-expand-access-covid-19-countermeasures-telehealth.html

https://www.astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Public-Readiness-and-Emergency-Preparedness-Act-Fact-Sheet/