As of August 2021, the Hunton Andrews Kurth COVID-19 Complaint Tracker reported 302 wrongful death suits have been filed against healthcare providers, with LTC providers accounting for at least 20% of those cases.  Over half of these claims have been filed in California, Florida, and Texas.  Many states have implemented immunity provisions for healthcare facilities, including senior living, as a result of the pandemic.  In addition, the Public Readiness and Emergency Preparedness Act (PREP Act) provides some immunity to facilities on the federal level.  However, the PREP Act and state immunity provision have not preempted state tort claims in all cases to date.  Most recently, a federal judge in Brooklyn, NY rejected the defendant’s argument that federal law preempts or exempts nursing homes from state negligence suits.

Background of the PREP Act

The PREP Act was first passed in 2005 in response to the Avian Flu and is meant for use in public health emergencies.  As a result of the COVID-19 pandemic, the Secretary of Health and Human Services (HHS) declared the PREP Act effective as of February 4, 2020, and ending as late as October 1, 2025.  The intent of the Act is to encourage expeditious development and deployment of diagnostics, treatments, and vaccines during a public health emergency while limiting legal liability for losses relating to the administration of these medical countermeasures.  Under this Declaration, “covered persons” are generally immune from legal liability, with the exception of death or serious injury caused by “willful misconduct.”

In March 2021, the Congressional Research Service explained that in “the PREP Act, Congress made the judgment that, in the context of a public health emergency, immunizing certain persons and entities from liability was necessary to ensure that potentially life-saving countermeasures will be efficiently developed, deployed, and administered.”  The requirements for PREP Act immunity include:

• The individual or entity must be a “covered person” who prescribes, dispenses, or administers covered countermeasures (including long-term care facilities).
• The legal claim must be for a “loss” which includes death; physical, mental or emotional injury; illness; disability or condition; fear of such injury including medical monitoring costs; and loss of or damage to property, including business interruption loss.
• The loss must have a “causal relationship” with the administration of a covered countermeasure.
• The medical product that caused the loss must be a “covered countermeasure” including vaccines, drugs, biological products, therapeutics, and devices (including masks and respirators) approved or otherwise authorized by the FDA.

The language in all of these elements is broad and may be subject to interpretation by the courts.  The PREP Act allows for injured persons alleging serious physical injury and death to submit a claim within one year to the Countermeasures Injury Compensation Program, which is a federal cause of action in the U.S. District Court for the District of Columbia.

The General Counsel of HHS has issued eight advisory opinions since this current declaration of the PREP Act, which do not have the force or effect of law but may be used to inform the courts.  The Advisory Opinion issued on January 8, 2021, discussed the PREP Act as a “Complete Preemption” Statute.  It further defined non-use of covered countermeasures as triggering the PREP Act immunity.  Examples of “non-use” of a countermeasure include failure to administer the vaccine to a person in a less vulnerable population when vaccines were prioritized due to scarcity.  Another example of “non-use” could relate to lack of PPE at a facility as provided by the federal government.  However, the court in Lutz v. Big Blue Healthcare did not agree with this view of non-use.

On August 4, 2021, the eighth amendment to the PREP Act clarified that pharmacy technicians are “covered persons” and expanded the scope of authority for qualified pharmacy technicians to administer seasonal influenza vaccines and for interns to administer seasonal influenza vaccines to adults.  The Federal Register states, “…if boosters become necessary, allowing pharmacy interns and technicians to administer both COVID-19 vaccines and influenza vaccines would allow states maximum flexibility in limiting potential impacts of both illnesses.”  These qualified pharmacy technicians and interns will be afforded liability protections in accordance with the PREP Act and any state law that would otherwise prohibit these healthcare professionals who are a “qualified person” from prescribing, dispensing, or administering COVID-19 vaccines or other covered countermeasures is preempted.  The document indicates “…preemption of state law is justified to respond to the nation-wide public health emergency caused by COVID-19 as it will enable states to quickly expand the vaccination workforce with additional qualified healthcare professionals where state or local requirements might otherwise inhibit or delay allowing these healthcare professionals to participate in the COVID-19 countermeasure program.”

Overview of State Immunity Laws/Regulations

Seyfarth Shaw LLP provides a survey of executive and legislative actions in each state that protect healthcare providers from liability arising from the COVID-19 pandemic.  26 states have implemented immunity provisions for senior living and other healthcare providers for acts or omissions during the pandemic.

Examples of Cases

• August 2021: Rivera-Zayas v. Our Lady of Consolation Geriatric Care Center et al A federal judge found in favor of plaintiff Vivian Zayas and sent her case against Our Lady of Consolation of Long Island back to state court in Brooklyn, New York. The case includes making the repeal of the state law, the Emergency or Disaster Treatment Protection Act, retroactive to the beginning of the pandemic.  Statistics indicate about 16,000 NY nursing home/long-term care facility residents have died of COVID.  The outcome of this suit could flood the court with these additional cases.
• June 2021: Estate of Maglioli v. Andover SubAcute Rehab Ctr. I: a Third Circuit panel heard oral arguments on Andover’s appeal of the district court sending the matter back to state court.  In August 2020, the estate sued for negligence, wrongful death, and medical malpractice due to the nursing homes’ failure to take precautions against COVID-19.  The court disagreed that the PREP act displaced the state law causes of action.  The court stated the Act “does not, by its plain terms, cover more generally the care received by patients in healthcare facilities,” to include the facility’s decision to do nothing in the face of a COVID-19 outbreak.
• May 2021: Jackie Saldana et al. v. Glenhaven Healthcare LLC et al., the Ninth Circuit court is considering the case for oral arguments based on Glenhaven’s brief that the family’s claims are preempted by the PREP Act. In October 2020 a California federal judge had rejected the facility’s bid to keep the case in federal court.
• April 2021: S. District Court for the Northern District of Illinois decided a case of neglect and misconduct can move forward against Westchester Health nursing home (operated by Aperion Care) despite Illinois’ immunity laws.  The judge said the immunity order does create liability for nursing homes accused of intentional or negligent conduct, although Westchester argued the state’s executive order granted immunity to long-term care facilities from neglect claims and does not create liability for willful and wanton misconduct.  The allegations are that the facility failed to implement proper infection control protocols and negligently allowed symptomatic workers to treat patients with wearing PPE.
• March 2021: Holman v. Knollwood Nursing Home, LLC et al.  The nursing home is arguing the case should be referred to federal court under the PREP Act.  The family claims the Alabama patient’s death was caused by placement of a COVID-19 positive resident in her room without appropriate interventions.
• February 2021: Dupervil v. All. Health Operations: New York District court found the PREP Act does not preempt state law tort claims.  This court did not agree with the January 8, 2021, HHS advisory opinion of “complete preemption” and remanded to the Supreme Court of New York, Kings County.
• February 2021: Gilbert Garcia et al v. Welltower OpCo Group LLC, Sunrise Senior Living Management, Inc. et al. The defendants were accused of failing to take adequate measures to prevent the spread of COVID-19.  The court ruled the assisted living facility was deemed a “Covered Person” under the PREP Act and was afforded immunity.  The plaintiff is appealing in the U.S. Court of Appeals, Ninth Circuit.
• February 2021: Robertson v. Big Blue Healthcare, Inc. et al. The lawsuit alleges negligence by Riverbend Post-Acute Rehabilitation that included lack of adequate staff, allowing infected employees to enter the facility, and failure to adopt social distancing.  Defendants argued the case should fall under the PREP Act.  The judge determined, citing 12 other cases which were substantively identical, the plaintiff’s claims do not fall under the PREP Act but rather under state law, and the case was remanded to the District Court of Wyandotte County, Kansas.
• January 2021: Roberta Anson v. HCP Prairie Village KS OPCO LLC, et al: The daughter of a resident of an assisted living facility sued for wrongful death, lost chance of survival, and negligence with multiple allegations of failure to follow COVID-19 protocols.  The U.S. District Judge concluded that the doctrine of “complete preemption” does not apply; therefore, plaintiff’s claims do not fall under federal law.  The case was remanded to state court.
• October 2020: Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC: A Pennsylvania federal judge ruled the plaintiff’s allegations of negligence, misrepresentation, and wrongful death fell outside the PREP Act because they related the facility’s alleged failure to use countermeasures.  The case was remanded to the Allegheny Court of Common Pleas.

Outlook for Long-Term Care Providers

The rulings in the above personal injury and wrongful death cases, alleging failure to act appropriately in response to COVID-19, will set a precedent as to whether the PREP Act will supplant state law or provide for federal jurisdiction.  According to Dechert LLP, owners and operators of nursing homes and other senior living facilities should conservatively expect that claims alleging failure to take appropriate protective action, or non-compliance with alleged standards, will be treated outside PREP Act protection.

Documentation of compliance with federal, state, and local guidelines is critical in managing these lawsuits.  As emphasized in McKnight’s Long-Term Care News, documentation should be digitized and include a chronology of actions taken to prevent or minimize the spread of the virus.  Excelas’ COVID-19 Comprehensive Database integrates federal and state guidance with a healthcare organization’s protocols along with a patient’s medical records allowing for a clear chronology of events to assist in the defense of COVID-19 claims.