Compilation PDFs with footnotes

Also I added a few paragraphs to the previous post.

Jun 14, 2022

Footnoted PDF compilations of posts published this year. I started focusing on Covid-19 legal issues at the end of January.

Also, I added a couple of paragraphs to the prior post about the Project Bioshield Act hearings and informed consent.

See 21 USC 360bbb-3(e)(1)(A)(ii) waiving informed consent for unapproved products (2004); 21 USC 360bbb-3(e)(2)(A) waiving informed consent for unapproved use of an approved product (2004). See also 21 USC 355(i)(4) waiving informed consent for experimental products classified by HHS as ‘minimal risk’ drugs (2016); 21 USC 360j(g)(3) waiving informed consent for experimental ‘minimal risk’ devices (2016).
The statutes include language that HHS Secretary may set conditions on EUAs that recipients be informed “of the option to accept or refuse administration of the product, [and] of the consequences, if any, of refusing administration of the product,” which appears to protect a meaningful option to refuse, thus upholding the principle of informed consent as framed by the Nuremberg Code.
However, the Department of Justice and at least one federal judge have interpreted the “consequences of refusal” to mean that recipients may be told by the person demanding that they accept the product, that if they refuse, they will be disciplined, fired or lose their place at school, thus legalizing coercive medical treatment in violation of the Nuremberg Code.