PREP Act immunity does not apply to unauthorized hydroxychloroquine administration

Abstract

Under the Public Readiness and Emergency Preparedness (PREP) Act, there is legal protection from liability for those who perform specially authorized emergency activities during a pandemic. The PREP Act states “a covered person shall be immune from suit and liability under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to an individual of a covered countermeasure.” A recent case illustrates that there can be limits on the applicability of PREP Act immunity. A patient resided in a “senior living community.” On April 20, 2020, the patient tested positive for COVID-19, although she was “completely asymptomatic.” Two days later, a nurse assistant called the patient's son, who served as the patient's medical power of attorney. The nurse assistant wanted to “commence treating the patient with hydroxychloroquine for five days.” The son did not consent to this plan due to his mother's history of heart issues. Nevertheless, the mother was allegedly administered hydroxychloroquine for 5 days without consent. The patient “fell ill and her condition deteriorated.” On May 4, 2020, the patient died, reportedly due to “a cardiac event and COVID-19.” The patient's family sued the senior living facility. The plaintiffs asserted various legal claims, including negligence, reckless and outrageous conduct, and wrongful death. The defendant facility filed a motion to dismiss the case based on PREP Act immunity. The court considered whether the administration of hydroxychloroquine in this manner qualified as a “covered countermeasure” for purposes of PREP Act immunity. The defendant contended that on March 28, 2020, FDA issued an emergency use authorization (EUA) for hydroxychloroquine. Based on this EUA, the defendant argued that the hydroxychloroquine administered to the patient was a “covered countermeasure,” and that PREP Act immunity should apply. The plaintiffs directed the court's attention to the “fine print” of the March 28 EUA. The EUA stated that “the hydroxychloroquine sulfate may only be used to treat adult and adolescent patients who weigh 50 kg or more, hospitalized with COVID-19, for whom a clinical trial is not available, or participation is not feasible.” The court acknowledged the plaintiffs' contention that the patient was not in a hospital, was never hospitalized for her asymptomatic COVID-19, and that it had never been determined that the patient was ineligible for a clinical trial or that her participation was not feasible. In ruling on the defendant's motion to dismiss, the court concluded that the “Defendants' administration of hydroxychloroquine sulfate does not fall within the clear, explicit, and limited scope of the drug's FDA emergency use authorization. Therefore, based on these allegations, the administration of the treatment as defendants used it cannot be considered a covered countermeasure because it was not ‘authorized for investigational or emergency use, as those terms are defined in the [FDCA Food, Drug, & Cosmetic Act],' as required by the PREP Act.” The motion to dismiss was denied. This case teaches one of many lessons to be learned from the COVID-19 pandemic. If there is any silver lining to the dark cloud of a global pandemic, it is that improvements can be made to the way things were done, and the next epidemic or pandemic can be managed more efficiently and productively. An EUA is not an open invitation to use a drug in any way that a health care institution chooses to use it. PREP Act immunity only extends to the use of a drug consistent with the guidelines and limitations specified in an EUA. Read the EUA to learn those guidelines and limitations. The hydroxychloroquine EUA was revoked 6 weeks after this patient died. The important lesson of this case is that administration of a drug contrary to EUA guidance, and without patient consent, exposes an institution to a risk of legal liability. There is no PREP Act immunity.