Molly Flynn (left) and Rebecca Trela (right) from Fagre Drinker Biddle & Reath. Photos with kind permission
In 2020, COVID-19 was one of the leading causes of death and illness in the United States. Both Pennsylvania and New Jersey reported significant infection and death rates. Despite efforts to contain the virus, COVID-19 continues to affect many communities. An evolving legal question is whether civil liability can be imposed on individuals or organizations who allegedly contributed to the spread of the pandemic by act or omission. Plaintiffs’ attorneys are soliciting clients affected by the virus and a number of criminal cases have already been filed. As discussed below, a patchwork of state and federal measures offers limited immunity from tort.
Pennsylvania Tort Immunity
During the first few weeks of the pandemic, Pennsylvania attempted to strengthen its ranks of available health care professionals by relaxing certain regulations and licensing requirements. Among other things, Pennsylvania suspended certain licensing requirements, allowed telemedicine outside of the state, encouraged retired workers to return, and allowed medical students to begin treating patients. Recognizing that many of these individuals may provide care outside of their usual practices, Governor Tom Wolf issued an executive order on May 6, 2020 granting civil immunity to any healthcare provider engaged in emergency service activities related to COVID-19 in a healthcare facility Care facility, assisted living facility, an alternative care facility, a community-based test site, or a non-congregated care facility. Healthcare providers are not liable for death, injury, or loss of property resulting from emergency services or disaster prevention activities associated with COVID-19. However, immunity under civil law does not apply in the event of willful intent or gross negligence. In particular, the Executive Ordinance specifically refused to extend the same immunity protection to any health facility or health system in which these vaccinated individuals provide care.
The Implementing Ordinance also extends the civil law immunity from claims for negligence to persons, organizations or authorities who manufacture real estate in whole or in part for the use of emergency services in connection with COVID-19, provided that the property is used voluntarily and without compensation. The protection provided by the Executive Ordinance remains in effect for the duration of the emergency.
In November 2020, Pennsylvania lawmakers passed comprehensive tort immunity law that would have expanded protection to include healthcare facilities, businesses, schools, and PPE manufacturers, among others. Wolf vetoed the bill, calling it “broad” and “exaggerated”.
New Jersey’s Tort immunity
New Jersey also enacted a Tort Immunity Act that relates to the provision of emergency medical care and is somewhat broader than the Pennsylvania Order. In particular, New Jersey Law S2333 / A3910 provides civil immunity for health professionals and health care facilities providing essential services in response to the pandemic. As per its policy, a health care professional is not responsible for any injury or death resulting from acts or omissions in the provision of medical services, including acts or omissions carried out in good faith to treat COVID-19 patients and prevent the spread from patients were made the virus. The law specifically excludes health services unrelated to COVID-19, such as OB / GYN services and orthopedic procedures, from immunity. Immunity also does not apply to acts or omissions that constitute a criminal offense, actual fraud, actual malice, gross negligence, recklessness or willful misconduct. To the extent that death or injury occurs as a result of a decision to allocate or use mechanical ventilators or “other scarce medical resources” with limited supply and high demand, immunity may also apply despite the facility or the system and must take over Follow a “Critical Resource Allocation Policy”. New Jersey’s Immunity Act will apply retrospectively March 9, 2020 and will remain in effect for the duration of the emergency.
Since the Civil Immunity Act went into effect, the New Jersey legislature has passed several laws aimed at changing it by adding protection to certain categories of providers such as: B. Withdraw from for-profit healthcare facilities and systems, as well as nursing homes and related facilities. Additional legislative proposals would immunize businesses and schools that act in good faith with local, state, and federal guidelines to prevent the transmission of COVID-19. So far, these legislative proposals have not been passed.
Federal PREP Act Immunity
Some of the most talked about safeguards are those resulting from the Federal Public Preparedness and Emergency Preparedness Act (PREP Act). On March 17, 2020, the US Department of Health (HHS) issued a statement under the PREP Act that provides “insured persons” with civil immunity from injury or death resulting from the provision of “covered countermeasures” such as vaccines, By FDA-approved drugs and devices and personal protective equipment (PPE). “Insured Persons” includes organizations and individuals who are involved in the manufacture, testing, development, distribution, administration or application of one or more covered countermeasures. For example, the PREP Act excludes liability to a vaccine manufacturer who relies on the negligent manufacture of a vaccine, or to a healthcare provider who negligently prescribed the wrong dose. In another example, the PREP Act also excludes liability against a distribution program for a slip, fall, or vehicle collision caused by lax security or chaotic crowd control. However, the PREP Act does not preclude immunity from injury or loss from willful misconduct.
As of March 2020, HHS has issued four amendments to the declaration and four expert opinions. The fourth amendment to the statement recognizes that “COVID-19 is an unprecedented global challenge that requires a nationwide response using both federal, state and local sales channels as well as private sales channels.” It also sees stipulates that immunity can apply if a certain person is withheld a covered countermeasure because “the covered countermeasures are prioritized or specifically allocated, in particular if they are carried out in accordance with the guidelines of a health authority”. An example in the fourth amended statement is when a healthcare professional is administering a COVID-19 vaccine to one person in a population at risk but not to another person in a less at risk population. This change came after multiple district courts ruled that the PREP law was not applicable when allegedly inadequate PPE leads to COVID-19 outbreaks in long-term care facilities.
The applicable period of time for the protection of the PREP Law is from the declaration of emergency on January 31, 2020 to the last day of the declaration of emergency or October 1, 2024, whichever comes first.
In addition, the fourth amended declaration expressly points out that claims relating to the PREP Act should be heard in a federal court: Grable & Sons Metal Products v. Darue Engineering & Manufacturing, 545, US 308 (2005), with a unified, state-wide response to the COVID-19 pandemic between companies at the federal, state, local and private levels. “An injured person’s exclusive remedy under the PREP Act Statement is an administrative remedy. If an injured person claims that there is an exception to immunity due to willful misconduct, this claim is solely a federal cause of action.
Finally, the PREP Act approves a Countermeasure Injury Compensation Program to provide benefits to certain individuals who suffer direct grievous bodily harm as a direct result of the administration or use of the covered countermeasures. The causal link between the countermeasure and the grievous bodily harm must be supported by convincing, reliable and valid medical and scientific evidence.
Overall, health care providers and manufacturers of vaccines and PPE can have federal and state immunities against unauthorized acts. However, many companies, schools, and individuals continue to face potential civil liability if their acts or omissions result in injury or death from COVID-19.
Molly E. Flynn is a partner and member of the product liability and mass practice of Faegre Drinker Biddle & Reath in Philadelphia. She is a litigation attorney and litigation strategist for multinational and Fortune 500 companies facing complex litigation, including mass killings, product liability, and catastrophic injury claims. Contact them at [email protected].
Rebecca L. Trela is an associate and member of the Philadelphia Company’s Product Liability and Mass Destruction Practice. Her practice focuses on defending large pharmaceutical and medical device manufacturers in complex litigation. Contact them at [email protected].