A month ago we thought our country had turned the corner on Covid-19. Not so. The plague continues. Bad show, America. We’re sick of Covid, sick of reading about Covid, sick of the controversies, sick of the deprivations, and, most of all, sick of all the disease and death. We won’t say we’re sick of writing about COVID, because we’ve mostly left that to others. When the tongue of history tells the final tale of Covid, we suspect it will be a catalogue of human errors, with occasional hiccups of heroism and ingenuity.
Covid implicates science more than law, but we are lawyers and we know how to stick to our lane. (That is an out and out lie, of course. At the drop of a hat or mask we are happy to bloviate ignorantly and loudly about Covid lockdowns and anti-vaxxers.) Just as with public health measures, legal responses to Covid have had a mixed, perhaps mostly bad, track record in contending with Covid. Depressingly stupid laws have been passed and predictably silly lawsuits have been filed.
But the Public Readiness and Emergency Preparedness (PREP) Act was a singularly sensible response to Covid. We have written about the PREP Act before, but for a quick refresher, recall that the PREP Act provides that “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, related to or resulting from the administration to or the use by an individual of a covered countermeasure if the [Secretary of Health and Human Services has issued a declaration permitting the administration of that covered countermeasure.]”. In a major health emergency, you don’t want hesitancy based on fears of liability. Ah, but how will the PREP Act be enforced in cases where things go wrong and all the sympathy goes to the injured party?
Cannon v. Watermark Retirement Communities, Inc., 2021 U.S. Dist. LEXIS 133613, 2021 WL 3033762 (E.D. Pa. July 19, 2021), is an interesting PREP Act decision from the Eastern District of Pennsylvania. It is also another example of the courts letting plaintiffs chip away at the ostensibly broad preemption that the Act and the HHS directives created.
Instead of suing over a nursing home patient catching COVID, the decedent here had COVID and was treated for it with an “experimental” drug combination, hydroxychloroquine and doxycycline. The estate alleged that the family was concerned about the experimental treatment because it was not FDA approved and had a history of causing heart problems, and that the decedent’s son explicitly declined to consent to the experimental treatment. The estate also contended that the treatment was not permitted to be used either outside of a hospital or on asymptomatic patients. But it was administered here just the same. Following this treatment the decedent allegedly “deteriorated” and died. The estate of the decedent brought a wrongful death and survival action against the senior community for negligence, negligence per se, and reckless and outrageous conduct.
The defendant senior community filed a Rule 12(b)(6) motion to dismiss based on PREP Act immunity. The court denied the motion to dismiss, reasoning that the treatment was not a “covered countermeasure” under the PREP Act because FDA’s emergency authorization was limited to persons who were hospitalized with COVID, and the decedent was never hospitalized. Thus, according to the court, the experimental treatment did not “fall within the clear, explicit, and limited scope of the drug’s FDA emergency use authorization.” That sounds almost like a presumption of non-immunity.
The defendant argued that PREP Act immunity also applies to the “misuse” of a covered countermeasure. The court disagreed because it interpreted “misuse” to be limited to nonuse or omission. What happened in Cannon was an affirmative misuse, not a nonuse or omission. We’re not sure this distinction makes sense either in terms of statutory interpretation or underlying policy, but there it is.
The defendant’s final defense was invocation of the PREP Act’s safe harbor provision, which extends immunity to circumstances in which a covered countermeasure was administered by someone who reasonably could have believed that the countermeasure was being used appropriately. The court held that on a motion to dismiss, where all inferences must be drawn in favor of the plaintiff, the court could not conclude that the defendants reasonably believed it was administering a covered countermeasure because the PREP Act’s definition of the “population” was unambiguous and the decedent fell outside it – she was neither hospitalized nor determined to be eligible for clinical trials.
It will be interesting to see whether the defendant in Cannon can make out facts supporting a reasonable belief that the countermeasures were appropriate. We wouldn’t be surprised if they ultimately do so. But in the meantime, the case goes on, with discovery and all the other expensive machinery of civil litigation. It is possible that the aims of the PREP Act are not being well served.