Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
recipients—a serious infringement of a core liberty153—its issuance was the
result of an administrative process lacking in safeguards required to protect
such rights.
Prior to taking an action that deprives an individual of his rights, the
government must conduct a searching inquiry on how such a deprivation
can be accomplished. In Mathews v. Eldridge, the Supreme Court
described the balancing test that should be used to determine the amount of
process that must be provided before the government may deprive an
individual of their rights:
First, the private interest that will be affected by the official action;
second, the risk of an erroneous deprivation of such interest
through the procedures used. . . and finally, the Government’s
interest, including the function involved and the fiscal and
administrative burdens that the additional or substitute procedural
requirement would entail. 154
The effective consequence of this balancing test is that the amount of
process due is directly proportional to the right being deprived. 155 With
respect to the right to reproduce, the Court has determined the right is
fundamental, which requires the utmost procedural due process. 156 While
the Court does not generally provide detailed guidance on procedure, in this
instance it has explicitly held that “[t]he opportunity to present reasons,
either in person or in writing, why proposed action should not be taken is a
fundamental due process requirement.” 157
The decision to issue an order to Mr. Arsenault before granting even a
simple hearing to present his evidence clearly falls short of what the
Constitution requires. Arsenault was not afforded a hearing prior to
issuance of the order, and the existing regulatory framework, as the FDA
itself affirmed, permits the agency to decline his request for one if it
determines that no questions of fact remain. 158
The FDA also incorrectly imposed the burden of proof on Arsenault
when he attempted to challenge the cease-manufacturing order. According
to CBER, the burden of proof rested on Arsenault to prove that a genuine
153. See Carey v. Population Servs. Int’l, 431 U.S. 678, 685 (1977).
154. Mathews v. Eldridge, 424 U.S. 319, 335 (1976).
155. Clark v. Jeter, 486 U.S. 456, 461 (1988).
156. Skinner, 316 U.S. at 538.
157. Cleveland Bd. of Educ. v. Loudermill, 470 U.S. 532, 546 (1985).
158. Motion to Deny Trent Arsenault’s Request for a Hearing at 4, Center for Biologics
Evaluation and Research (CBER), (Feb. 7, 2011), available at http://trentdonor.org/
sites/g2sites/trentdonor/d/21703-2/trentdonor-fda-motion-to-deny-hearing-07feb2010.pdf
(last visited Aug. 3, 2012).
