United States: Early Cases Find PREP Act May Not Shield Employers From Claims They Failed To Provide PPE And Other Precautions, But Recent HHS Advisory Opinion Suggests Otherwise

Two recent court decisions have suggested that the federal Public Readiness and Emergency Preparedness (PREP) Act, codified at 42 U.S.C. § 247d-6d, may not protect employers who are facing lawsuits alleging a failure to supply personal protective equipment ("PPE") to employees. In particular, two recent opinions by the Courts in Sherod v. Comprehensive Healthcare Management Services, LLC et al, Case No. 2:20-cv-01198 (W.D. Pa.) and the consolidated cases of Estate of Joseph Maglioli, et al. v. Andover Subacute Rehabilitation Center I, et al. and Estate of Wanda Kaegi, et al. v. Andover Subacute Rehabilitation Center I, et al., Civ. No. 20-6605 and 20-6985 respectively, have held that federal jurisdiction related to the PREP Act may be more limited than employers and health care providers had initially suspected. However, an advisory opinion issued by HHS on October 23, 2020 calls these decisions into question.

Sherod v. Comprehensive Healthcare Management Services, LLC et al.

In Sherod, surviving family members sued a nursing facility for the death of an employee who contracted COVID-19 while working at the facility. The plaintiffs sued the facility in Pennsylvania state court claiming the nursing facility failed to provide PPE to its employees and otherwise take precautions to protect its staff from COVID-19, despite knowing that PPE would be required to keep its employees safe. The defendants attempted to remove the case to federal court asserting that the PREP Act provides for federal immunity against claims based upon how countermeasures are used.

The Sherod court granted the plaintiffs' motion to remand on the basis that the PREP Act only provides immunity for claims relating to countermeasures that are "actually utilized," as opposed to claims alleging that the facility failed to provide the decedent plaintiff with any protection/countermeasures. Simply put, the court wrote, negligence and wrongful death claims based upon an alleged failure to use face masks and other PPE are not connected to a nursing facility's use of protective equipment, because they demonstrate the lack of any such use. Accordingly, the court found that there was no federal jurisdiction associated with the case and remanded it to state court for continued litigation.

Estate of Joseph Maglioli, et al. v. Andover Subacute Rehabilitation Center I, et al. and Estate of Wanda Kaegi, et al. v. Andover Subacute Rehabilitation Center I, et al.

The claims in these two consolidated cases are similar to the claims presented in Sherod. In Maglioli and Kaegi, the estates of deceased employees and residents sued a group of nursing facilities asserting claims of negligence, wrongful death and medical malpractice related to the facilities' care of residents and patients with respect to COVID-19 infections. The plaintiffs alleged the facilities were negligent in a variety of ways, including failing to provide PPE. Like in Sherod, the defendants in Maglioli and Kaegi removed the case to federal court on the basis that plaintiffs' claims were preempted by the PREP Act.

On August 12, 2020, the court found that the PREP Act was designed to encourage caregivers to administer certain forms of care, without the need to face liability for doing so. The plaintiffs, however, were alleging that defendants failed to provide the proper care, and the court reasoned that such claims concerning the quality of care do not fall within the scope of the PREP Act. The Court thus found that removal was improper and remanded the cases back to the state court. The court did, however, leave open the possibility that the PREP Act could be used as a defense at a later stage in the litigation.

HHS October 23, 2020 Advisory Opinion 20-04

Following these recent decisions, on October 23, 2020, the general counsel's office of the U.S. Department of Health and Human Services issued a new advisory opinion concerning the PREP Act. The advisory opinion focuses primarily on two frequently asked questions—who is a "program planner" under the PREP Act and what is the scope of the declaration provision limiting PREP Act coverage to activities authorized by an "authority having jurisdiction."  However, the advisory opinion also specifically addresses the question of whether PREP Act immunity is limited to "provision of a countermeasure to a recipient" or if it can also apply to decisions not to provide medical countermeasures. In the advisory opinion, HHS indicates that PREP Act coverage can encompass "[a]ctivities relating to management and operation of a vaccination program pursuant to an Authority Having Jurisdiction," which would "include following CDC directions on who to vaccinate when there are limited doses."

In this regard, the HHS's recent advisory opinion is contrary to the courts' recent decisions in Sherod, Maglioli and Kaegi and may call their future relevance into question. However, as these cases and others work their way through the trial courts, and eventually appellate courts, we can expect to see more case law addressing the issues discussed above.

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