Eliding Consent in the Case of Pandemic Countermeasures Authorized Only for Emergency Use

Abstract

Four months after the first vaccines against Covid-19 became available to the public, and just as some universities announced plans to require inoculations, the Boston Globe quoted me as (alone) suggesting that mandates would conflict with federal law. When Congress created a special mechanism for the emergency use of still investigational products, it directed providers to reveal, among other things, that individuals remained free to decline such an intervention; only after full FDA approval of a medical countermeasure would this disclosure obligation become inapplicable. I have watched with dismay over the last three years as nearly everyone—including Executive branch officials, federal and state judges, and various academic commentators— cavalierly dismissed an entirely valid statutory objection. This Article probes what accounts for the universal rejection of an argument that, on further reflection, continues to strike me as far from frivolous.