Because No One is Immune to the Law
September 18, 2020 - United States, FDA, COVID-19, Product Liability + Class Action, Healthcare

First Decisions Limit PREP Act Immunity in Coronavirus Context

Using Waivers to Curb COVID-19 Legal Exposure

When we discussed the Public Readiness and Emergency Preparedness (PREP) Act earlier this year, we predicted that its tort liability protections would reassure manufacturers and distributors of novel COVID-19 drugs and medical products. So far, so good: the first court decisions interpreting PREP Act immunity in the COVID-19 setting have emphasized that the protection applies to those who actually use medical countermeasures, not where injuries arise from parties not using countermeasures. By extension, these cases establish that certain negligence claims may escape the scope of PREP Act immunity and can be properly heard in state court—even if those claims are related to COVID-19.

Each of the cases described below was brought against healthcare facilities that allegedly failed to take appropriate COVID-19 prevention measures like social distancing, disinfecting, and using adequate personal protective equipment. The actions were originally filed in state court and the defendants removed them to federal court, claiming that the PREP Act preempts state law claims and presents a federal question. The district courts weighed in to determine whether the PREP Act applied and preempted the state law claims.

Estate of Maglioli

In Estate of Maglioli, plaintiffs brought wrongful death and medical malpractice claims based on the defendants’ failure to implement proper COVID-19 prevention measures. Estate of Maglioli v. Andover Subacute Rehab. Center, 2020 WL 4671091 (D.N.J. 2020). No product liability claims were asserted. The issue before the court was plaintiffs’ motion to remand the case back to a New Jersey state court after defendants removed it to federal court.

The defendants argued that the PREP Act preempted this action because the claims originated and arose from the allocation, use, distribution, procurement, and administration of various covered countermeasures in responding to COVID-19: namely, the decision not to use those countermeasures. But plaintiffs asserted that the claims did not fall within the scope of the Act because they simply related to medical negligence, and were not directed to the defendants’ role in manufacturing, distributing, administering, or using the covered countermeasures.

The court remanded the case, holding that the PREP Act was “designed to protect those who employ countermeasures, not those who decline to employ them.” Id. at *9. In addition, many of the allegedly negligent acts related to measures like social distancing, quarantining, and lockdowns, which are not covered countermeasures at all. Id. at *10. The court clarified that it was not deciding whether or not the defendants were entitled to a PREP Act defense. Instead, the ruling was limited to the narrow issue that the Act “does not so occupy the field as to squeeze out state court jurisdiction over what are state-law claims of negligence and require an exclusive federal forum.” Id. at *11. “[T]he Act still leaves room for ordinary claims of negligent or substandard care.” Id. at *9.

Big Blue Healthcare

Twelve similar lawsuits alleging negligence claims were filed against defendant care facilities Big Blue Healthcare, Inc. et al. in Kansas. See, e.g., Lutz v. Big Blue Healthcare, Inc., 2020 WL 4815100 (D. Kansas 2020). Just as in Estate of Maglioli, the plaintiffs alleged that the defendant care centers negligently failed to provide COVID-19 protections, and the issue before the court was whether to remand the cases back to state court after defendants removed them to a federal forum.

The court declined to apply the PREP Act to plaintiffs’ claims because they were not causally connected or related to the administration or use of a covered countermeasure. Id. at *5. Defendants argued that the PREP Act applied to plaintiffs’ claims because the Act applied to the use of covered countermeasures for other individuals elsewhere in the facilities. But these arguments were rejected because the Act requires a causal connection: the PREP Act “addresses the administration or use of covered countermeasures. There is simply no room to read it as equally applicable to the non-administration or non-use of covered countermeasures.” Id. at *8.


These cases should not be interpreted as significantly limiting the scope of PREP Act protection. The findings are consistent with the policy rationale behind the PREP Act, which is to protect entities that affirmatively distribute and manufacture products to treat and prevent COVID‑19, not to protect those that fail to do so. Courts have reached similar conclusions applying the PREP Act in other settings. See, e.g., Casabianca v. Mt. Sinai Med. Ctr., 2014 WL 10413521 (N.Y. Sup. 2014) (holding that the PREP Act does not apply to defendant hospital’s failure to administer the H1N1 vaccine to a patient).

Although these cases affirm the ability of plaintiffs to sue healthcare facilities in state courts over ordinary negligence claims, they do not present new liability exposure for manufacturers or distributors of covered countermeasure products or erode any of the PREP Act immunity protections we have previously written about. For more updates on the PREP Act and COVID‑19 legal issues, visit MoFo’s Class Dismissed and Life Sciences blogs.