Doe v. Hamburg: Are FDA Regulations to Protect Sperm Donor Recipients and Their Offspring from Disease Unfairly Burdensome?

Laurie Rosenowby Laurie Rosenow

A woman residing in Oakland, CA recently filed a lawsuit against the Food and Drug Administration and Health and Human Services claiming the FDA regulations established to prevent the spread of communicable diseases create an unfair barrier to women who wish to use donor sperm of a known donor of her choice.

The six count lawsuit filed in the U.S. District Court for the Northern District of California alleges that the regulations contained in 21 C.F.R. 2171 infringe on Jane Doe’s, other similarly situated women’s, and individual male donors’ rights to privacy, bodily integrity and autonomy, procreative liberty, and due process.  These regulations require “directed” semen donors (a donor known by the recipient prior to donation) to undergo testing at the time of donation for various communicable disease such as HIV, hepatitis B and C, Creutzfeld-Jacob disease, human t-lymphotropic virus type I and II, chlamydia, and gonorrhea.  However, screening is not required for “sexually intimate partners” of a recipient.  Doe, who is in a same-sex relationship, does not wish to conceive “naturally” and prefers to use an uncompensated known donor outside of a medical setting.

The complaint further claims that treating sperm donors who help women become pregnant via artificial insemination differently from men who impregnate women using “natural” insemination (i.e. sexual intercourse) violates the Equal Protection Clause and creates undue burden and expense by requiring private, individual, uncompensated donors to comply with registration, screening, testing, and record-keeping under the FDA Regulations.

While the complaint does not provide any specifics as to whom Doe wishes to use as a sperm donor, it states that Doe fears prosecution in light of the FDA investigation of sperm donor Trent Arsenault.

Mr. Arsenault, also a California resident, operates his own website to provide sperm at no fee to women.  In November 2010, the Center for Biologics Evaluation and Research (CBER) issued an order to “Cease Manufacturing” to Arsenault claiming that he did not comply with 21 CFR 1271 for failure to test for all required communicable diseases and for other infractions.

The FDA inspection found that Arsenault had distributed 328 donations of semen intended for artificial insemination to 46 different women from December 2006 until November 2010.  With such high frequency, it may be difficult for Arsenault to prove he was not operating an “establishment” under the FDA regulations.   Perhaps in light of this, Doe claims that sperm donors, like Arsenault, should be exempt from the FDA regulations as a “sexually intimate partner” of the recipients.  She claims that the process of identifying a donor, meeting in person, creating an agreement, and coordinating fertility cycles constitutes a “sexually intimate partnership” between the parties.  This may be an uphill battle as the CBER denied this characterization in Arsenault’s hearing related to his Cease Manufacturing notice.

Though not at issue in the complaint, Arsenault has also come under scrutiny for allegedly misleading visitors to his website about his U.S. Naval Academy service and his pornographic web appearances.

Additionally, the Doe complaint includes claims that application of the FDA regulations exceeds Congress’s Commerce Clause powers under Article I of the Constitution, and that the FDA’s actions to investigate and punish sperm donors violates the 9th and 10th Amendments as applied to Doe.  Doe seeks preliminary injunctive and declaratory relief as well as attorneys’ fees and costs.

The suit was filed by a Washington D.C.-based organization, Cause of Action, who also represents Trent Arsenault.

1 thought on “Doe v. Hamburg: Are FDA Regulations to Protect Sperm Donor Recipients and Their Offspring from Disease Unfairly Burdensome?

  1. This is an interesting topic that I would not have thought about as a sperm donor myself. I think it brings up several valid points, and points that I would even not consider myself.

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