The PREP Act and State Laws: COVID-19 in Long-Term Care Settings

As of June 2021, the Hunton Andrews Kurth COVID-19 Complaint Tracker reported that 255 wrongful death suits have been filed against healthcare providers, with LTC providers accounting for at least 20% of those cases. California, Florida, Texas, New Mexico and Kansas account for over half of these claims. 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.

ACI National Forum - COVID-19 Liability LTC & Senior Care Providers Excelas Medical Legal Solutions

Background of PREP Act

 

The PREP Act was first passed in 2005 in response to the Avian Flu and is meant for public health emergencies.  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 is to encourage expeditious development and deployment of medical countermeasures during a public health emergency, thereby limiting legal liability for losses relating to the administration of medical countermeasures such as diagnostics, treatments, and vaccines.  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 prescribe, dispense, or administer covered countermeasures (including long-term care facilities)
  • The legal claim must be for a “loss” which include: 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 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 does allow for serious physical injury and death claims to be filed with the Countermeasures Injury Compensation Program.

The General Counsel of HHS has issued six advisory opinions since this declaration of the PREP Act, which do not have the force or effect of law but may inform the courts.  The most recent 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.

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.  The PREP Act may protect facilities in states without these immunity provisions.

Examples of Cases

  • 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 doesn’t create liability for willful and wanton misconduct.
  • 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 patient’s death was caused by placement of a COVID-19 positive resident in her room without appropriate interventions.
  • February 2021: Dupervil v. Alliance 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.”
  • November 2020: Robertson v. Big Blue Healthcare, Inc. et al.  The lawsuit alleges negligence by Riverbend Post-Acute Rehabilitation that include lack of adequate staff, allowing infected employees to enter the facility, and failure to adopt social distancing.  The case is currently in federal court under the PREP Act.
  • October 2020: Sherod v. Comprehensive Healthcare Management Services, 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  The case was remanded to the Allegheny Court of Common Pleas.
  • August 2020: Estate of Maglioli v. Andover SubAcute Rehabilitation Center I:  The estates 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 2020: Martin v. Hollywood Premier Healthcare Center.  Case was moved back to federal court a second time and is pending.

Outlook for Long-Term Care Providers

 

According to Dechert LLP, owners and operators of nursing homes and other senior living facilities, who should conservatively expect that claims alleging failure to take appropriate protective action, or non-compliance with alleged standards, will be treated as outside PREP Act protection.  The PREP Act should still preempt claims based solely on the use of covered “countermeasures.”  But in most suits involving personal injury or wrongful death alleging a failure to act appropriately in response to COVID-19, the PREP Act likely will not fully supplant state law or provide for federal jurisdiction.

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.

How Excelas is Supporting Long-Term Care Providers

 

As organizations wait for judges to arbitrate the PREP Act and state immunity provisions, this precious time can be used to continue to prepare.  Excelas’ structured timelines are an excellent way to document, preserve, organize, and present the actions taken to ensure a safe environment during the initial stages of the COVID-19 outbreak in March, up to and including any current changes made by your organization.  We have found that companies who have taken the time to acquire and organize all the relevant documentation are in the strongest position to defend themselves against COVID-related allegations.  Looking at your response retrospectively may seem daunting, but it is absolutely necessary to build a timeline of events and actions (from a risk mitigation perspective).  The more time that passes, the more difficult this essential process will be.

Through our software, all information can be merged into an individual patient or resident’s medical chronology to exhibit a comprehensive, sequential record of all relevant standards and expectations at a specific point in time.

Post Tags: