The PREP Act is having a moment. Congress enacted the Public Readiness & Emergency Preparedness Act (“PREP Act”) in 2005 to ensure the availability of effective countermeasures in the event of public health emergencies. The declaration of COVID-19 as an “emergency” has thus thrust the PREP Act into the limelight. Heck, when you’re a federal statute and Bexis has started a scorecard to track your progress, you know you’ve arrived!
Despite the PREP Act’s remarkably straightforward rules, some courts insist on getting it wrong. That is what happened recently in Coleman v. Sharp Memorial Hospital, No. 37-2023-00033307-CU-PO-CTL, 2024 Cal. Super. LEXIS 10893 (Cal. Sup. Ct. Mar. 29, 2024), where a California trial court refused to apply the PREP Act to claims arising from the use the antiviral medication Remdesivir to treat COVID-19.
To review, when the Secretary of the Department of Health and Human Services declares a public health emergency (such as COVID-19), the Act provides that a “covered person” shall be immune from liability under state and federal law with respect to all claims relating to “covered countermeasures.” Rather than allowing such claims, the Act establishes a fund to compensate “eligible individuals for covered injuries” through an administrative remedy. There is only one exception: The PREP Act provides “an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct.” See 42 U.S.C. § 247d-6d(d)(1)) (emphasis added). The Act also expressly preempts contrary state law, so long as the Secretary’s emergency declaration is in place. See 42 U.S.C. § 247d-6d(b)(8).
The Prep Act should have shut down the state-court claims in Coleman. The hospital and physician defendants were covered persons under the Act, and Remdesivir is a covered countermeasure. The plaintiff therefore had two options: File an administrative claim for compensation, or file a lawsuit for willful misconduct under federal law in federal court.
This plaintiff chose neither, and instead pressed a state-law fraud claim in California state court. To avoid the PREP Act, the plaintiff argued that her claims did not pertain to a covered countermeasure, but instead alleged that the defendants fraudulently concealed “other treatments that could have been available.” Coleman, at *3.
The order does not disclose what those “other treatments” would have been, but it doesn’t matter. The plaintiff was claiming compensation for harm (death) caused by administration of a covered countermeasure (Remdesivir) prescribed by a covered person (a physician in a hospital). That is the exact scenario that the PREP Act was enacted to address, no matter how many alternate treatments “could have been available.” The exclusive civil action under the Act is a federal action for willful misconduct, and the Act expressly preempts contrary state law. This action therefore was boxed out, without regard to how many other ways the defendants “could have” treated this plaintiff’s decedent.
The trial court, however, bought the plaintiff’s argument and allowed the claim, reasoning that “[t]he complaint may reasonably be read to allege a claim not based on the countermeasure, but rather on the alleged concealment of facts.” Id. at *4. This outcome might reflect more on California’s liberal pleading standards than on the underlying substantive law, but that does not make it any more palatable.