In 2020, COVID-19 was one of the leading causes of death and illness in the United States, with both Pennsylvania and New Jersey reporting significant rates of infections and deaths. Despite efforts to curb the virus, COVID-19 continues to affect many communities. A developing legal question is whether civil tort liability may be imposed against individuals or organizations that allegedly contributed to the pandemic’s spread, by act or omission. Plaintiffs attorneys are advertising for clients affected by the virus, and a number of tort cases already have been filed. As discussed below, a patchwork of state and federal measures provide limited tort immunities.
Pennsylvania’s Tort Immunity
In the early weeks of the pandemic, Pennsylvania sought to bolster its ranks of available medical professionals by loosening certain of its regulations and licensing requirements. Among other things, Pennsylvania suspended certain licensing requirements, permitted out-of-state telemedicine, encouraged retired workers to return, and allowed medical students to begin treating patients. Recognizing that many of these individuals might be providing care outside the scope of their normal practices, Gov. Tom Wolf issued an executive order on May 6, 2020, granting civil immunity to any health care provider engaged in emergency services activities related to COVID-19 in a health care facility, nursing facility, assisted living facility, alternate care facility, community-based testing site or noncongregate care facility. Health care providers shall not be liable for death, injury or loss of property resulting from the emergency services or disaster services activities related to COVID-19. Civil immunity does not apply, however, in the event of willful misconduct or gross negligence. Notably, the executive order explicitly declined to extend the same immunity protections to any health care facility or health system at which these immunized persons are providing care.
The executive order also extends civil immunity from negligence claims to any person, organization or authority that makes all or part of real property for the use of emergency services related to COVID-19, so long as the use of the property is voluntarily and without compensation. The executive order’s protections remain in effect for the duration of the emergency.
In November 2020, Pennsylvania’s legislature passed a broad tort immunity bill that would have extended protections to health care facilities, businesses, schools, and manufacturers of PPE, among others. Wolf vetoed the bill, calling it “broad” and “overreaching.”
New Jersey’s Tort Immunity
New Jersey also has enacted a civil tort immunity act related to the provision of emergency health care that is somewhat broader than Pennsylvania’s executive order. In particular, New Jersey’s law S2333/A3910 provides civil immunity to health care professionals and health care facilities providing essential services in response to the pandemic. Under its terms, a health care professional is not liable for any injury or death resulting from an act or omission occurring in the course of providing medical services, including acts or omissions taken in good faith to treat COVID-19 patients and prevent the spread of the virus. The law expressly excludes from immunity any health care services that are unrelated to COVID-19, such as OB/GYN services and orthopedic procedures. Immunity also shall not apply to any act or omission that constitutes a crime, actual fraud, actual malice, gross negligence, recklessness or willful misconduct. To the extent that a death or injury arises as the consequence of a decision about the allocation or mechanical ventilators or “other scarce medical resources” that are in limited supply and high demand, immunity may also apply, although the facility or system must adopt and adhere to a “scare critical resource allocation policy.” New Jersey’s immunity law applies retroactively to March 9, 2020, and remains in effect for the duration of the emergency.
Since the civil immunity law’s enactment, New Jersey’s Legislature has passed several bills intended to amend it by withdrawing its protections from certain categories of providers, such as for-profit health care facilities and systems and nursing homes and related facilities. Additional proposed bills would immunize businesses and schools that offer good-faith compliance with local, state, and federal guidances to prevent the transmission of COVID-19. To date, these proposed laws have not been enacted.
Federal PREP Act Immunity
Some of the most talked-about protections are those stemming from the federal Public Readiness and Emergency Preparedness Act (PREP Act). On March 17, 2020, the U.S. Department of Health and Human Services (HHS) issued a declaration under the PREP Act that provides “covered persons” with civil immunity for injuries or death arising from the provision of “covered countermeasures,” such as vaccines, FDA-approved medicines and devices, and personal protective equipment (PPE). “Covered persons” include organizations and individuals involved in the manufacture, testing, development, distribution, administration, or use of one or more covered countermeasures. For example, the PREP Act precludes liability against a vaccine manufacturer premised on negligent creation of a vaccine, or against a health care provider for negligently prescribing the wrong dose. In another example, the PREP Act also precludes a liability claim against a distribution program for a slip-and-fall injury or vehicle collision caused by lax security or chaotic crowd control. The PREP Act does not preclude immunity for injuries or losses arising from willful misconduct, however.
Since March 2020, HHS has issued four amendments to the Declaration and four advisory opinions. The Fourth Amendment to the Declaration recognizes that “COVID-19 is an unprecedented global challenge that requires a whole-of-nation response that utilizes federal-, state-, and local-distribution channels as well as private-distribution channels.” It also provides that immunity may apply when a covered countermeasure is withheld from a particular individual due to “prioritization or purposeful allocation of covered countermeasures, particularly if done in accordance with a public health authority’s directive.” An example offered in the Fourth Amended Declaration is when a health care professional administers a COVID-19 vaccine to a person in a vulnerable population but not to another person in a less-vulnerable population. This amendment comes after several district courts ruled that the PREP Act does not apply where allegedly inadequate PPE leads to COVID-19 outbreaks in long-term-care facilities.
The applicable time period for PREP Act protections runs from the Declaration of Emergency on Jan. 31, 2020, until either the final day the Declaration of Emergency or Oct. 1, 2024, whichever occurs first.
In addition, the Fourth Amended Declaration makes explicit that claims implicating the PREP Act should be heard in federal court: “There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the COVID-19 pandemic among federal, state, local and private-sector entities.” An injured person’s exclusive remedy under the PREP Act Declaration is an administrative remedy. To the extent that an injured person claims that an exception to immunity applies as a result of willful misconduct, that claim is exclusively a federal cause of action.
Finally, the PREP Act authorizes a Countermeasures Injury Compensation Program to provide benefits to certain individuals who sustain a covered serious physical injury as a direct result of the administration or use of the covered countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable and valid medical and scientific evidence.
In sum, federal and state civil tort immunities may be available for health care providers and manufacturers of vaccines and PPE; however, many businesses, schools and individuals remain vulnerable to potential civil liability if their actions or omissions result in injuries or deaths from COVID-19.
Molly E. Flynn is a partner and member of Faegre Drinker Biddle & Reath’s products liability and mass torts practice in Philadelphia. She is a trial attorney and litigation strategist for multinational and Fortune 500 companies facing complex litigation, including mass tort, products liability and catastrophic injury claims. Contact her at [email protected].
Rebecca L. Trela is an associate and member of the firm’s products liability and mass torts practice in Philadelphia. She focuses her practice on the defense of major pharmaceutical and medical device companies in complex litigation. Contact her at [email protected].