Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
question of fact existed: namely, whether he was a directed donor subject to
21 C.F.R. Part 1271 or an exempt SIP. 159 Arsenault was only able to
present his legal arguments on why the order should not be issued after he
received the order. The Court made it clear in Stanley v. Illinois that in
matters regarding fundamental rights the individual must be provided a
hearing before action is taken, not after. 160 The FDA cannot simply
determine that Arsenault, or any donor, is subject to their regulatory regime
and then require him to prove that he is not. The burden of proof is on the
State to prove the matter asserted. 161
The FDA’s investigatory procedures and process for issuing cease-manufacture orders are not legally sufficient where, as in the Arsenault
matter, an individual’s fundamental rights are at stake. Although they
might be adequate where a regulated commercial enterprise is the target, a
corporation’s right to do business in the health care industry, or even an
individual medical professional’s right to practice his or her occupation,
differs in kind from an individual’s right to make intimate decisions about
procreation. As discussed below, a long line of cases recognize this right as
fundamental. 162 By failing to provide a hearing prior to issuance of an order
that infringes a fundamental constitutional right and by placing the burden
on Arsenault to prove to the government why he should be allowed to father
additional children, the FDA comprehensively failed in its due process
obligations to Mr. Arsenault.
VI. APPLYING 21 C.F.R. PART 1271 TO THE EXERCISE OF FUNDAMENTAL
RIGHTS PROTECTED BY SUBSTANTIVE DUE PROCESS VIOLATES THE
Perhaps the most troubling aspect of the FDA’s targeting of private,
uncompensated semen donation and Trent Arsenault is the implication that
two adults may be prevented from conceiving a child together if the
government disapproves. 163 CBER’s cease-manufacture order and the
related Commissioner’s Decision signify that if your sexual relationship
does not fall within certain privileged categories, or if you wish to conceive
without medical intervention but also without sexual intercourse between
159. Id. at 4-5.
160. Stanley v. Illinois, 405 U.S. 645, 649 (1972).
161. Loudermill, 470 U.S. at 658.
162. See infra notes 165-70 and accompanying text.
163. The FDA’s decision to interpret its regulations to constrain and potentially
criminalize certain private procreative decisions stands in tension with a long line of
Supreme Court cases striking down state criminal statutes that criminalized both
contraception and conception-related procreative choices. See supra note 151 and