Annals of Health Law
THE CURIOUS CASE OF TRENT ARSENAULT
News coverage of private sperm donation drew widespread attention to
the issue. After his legal troubles were discussed in a Newsweek cover
story, Arsenault obtained pro bono counsel from a nonprofit that focused on
federal regulatory overreach. 136 This enabled him to file a response in
November of 2011 to CBER’s motion, arguing that his evidence merited a
hearing, and alternatively that the Order was not lawfully issued. 137 Over a
year later, Dr. Jesse Goodman issued a Commissioner’s Decision that
denied Arsenault’s hearing request and deemed “the Cease Manufacture
Order properly issued.” 138 The Order was thus made effective as of
December 7, 2012; Arsenault is barred from donating semen to consenting
women unless he complies with Part 1271’s regulations and he receives
written authorization from the FDA.
IV. ISSUES RAISED BY APPLICATION OF 21 C.F.R. PART 1271 TO PRIVATE,
UNCOMPENSATED SEMEN DONATION
By interpreting its regulations to apply to Arsenault, and potentially
others engaging in similar conduct, the FDA has extended its authority in a
new and troubling manner. The regulations themselves do not appear to
apply to private individuals who give semen directly to recipients for
artificial insemination. 139 Reading them to do so purportedly protects
recipients, but upon examination it may incent riskier, not safer,
conceptions. Barring a man from fathering children with consenting
women by administrative order also raises the question of whether
fundamental rights are being burdened without due process of law. Even if
the FDA had afforded Arsenault more procedural safeguards before issuing
the Order, there remains the substantive question of whether the federal
government has the authority to infringe on the right to procreate in this
manner (which cabins not only Arsenault’s procreative liberty, but that of
136. The author, on behalf of her employer organization Cause of Action, represented
Arsenault for the purpose of filing a brief in opposition to CBER’s motion. See Pls.’ Mot.
Opp. CBER’s Mot. Summ. J. 2, Nov. 7, 2011.
137. See Food Additives Permitted for Direct Addition to Food for Human
Consumption; Bacteriophage Preparation, 76 Fed. Reg. 16285 (March 23, 2011) (to be
codified at 21 C.F.R. § 172), (“In judicial proceedings, a court is authorized to issue
summary judgment without an evidentiary hearing whenever it finds that there are no
genuine issues of material fact in dispute and a party is entitled to judgment as a matter of
law”).
138. Trent Arsenault, Comm’r Decision 12-13 (Food & Drug Admin. Dec. 7, 2012)
(“Mr. Arsenault therefore appears to assert that he has a Constitutional right to transfer his
sperm to others for artificial insemination without adhering to protections against
communicable disease transmission to the recipients. I disagree that he has a right to violate
the applicable FDA regulations.”).
139. See generally 21 C.F.R. § 1271.3. C.F.R. § 1271.3 does not include “sexually
intimate partner” in its defined terms.
