OAKLAND, Calif. (CN) – A woman demands the right to be artificially inseminated by a willing donor, without paying and “without a medical intermediary, such as a semen bank or medical professional,” in a complaint against the federal government.
Jane Doe sued the U.S. Food and Drug Administration and the Department of Health and Human Services, in Federal Court.
“(T)he FDA prohibits private individuals from donating semen for artificial insemination on an uncompensated basis unless these individuals comply with a panoply of costly and burdensome regulatory requirements,” the complaint states. “These requirements apply even if a man donates semen directly to a woman he considers to be his intimate partner. In doing so, it violates the rights of the plaintiff, other similarly situated women, and men from whom they seek freely donated gametes.
“These FDA regulations are unconstitutional to the extent that they operate to regulate noncommercial, sexually intimate choices and activity protected by the rights to privacy, bodily integrity and autonomy, liberty, life, due process, and equal protection guaranteed by the First, Fifth, Ninth, and Tenth Amendments to the United States Constitution.”
Doe claims she is “a woman in a committed, long-term, monogamous relationship with her female partner. Ms. Doe does not have sexual intercourse with male partners.”
She wants to become pregnant, and “prefers to conceive via intracervical insemination of fresh donor sperm.”
For her own good and that of her child, she “has decided to become pregnant using fresh semen provided by an individual known to her,” so her child can “develop a relationship with [his or her father] if he or she wishes to do so.”
She claims she “extensively reviewed substantial medical information about this individual and his personal and medical history,” and he agree to provide the sperm, “which he did, uncompensated, on a mutually agreed upon date in a mutually agreed upon manner.”
She says she “did in fact inseminate herself with this individual’s donated fresh semen and became pregnant. Unfortunately, the pregnancy was not carried to term.”
She says she was to try it again, “barring doctor’s orders to the contrary.”
But she says the FDA prohibits it, unless she uses “a medical intermediary, such as a medical professional or a semen bank.” She says these methods restrict her choice of donors, who are “of often anonymous,” and the procedures “very expensive.”
Doe says she “does not want to be forced to engage in sexual intercourse with a male partner to conceive a child, even though such a male partner would not be subject to FDA-required screening and testing and other FDA-mandated donor-eligibility requirements.”
Nor does she want to use FDA-approved semen, which “is typically cryogenically quarantined for a six-month period.”
Doe wants to perform the procedure herself, via syringe. She claims FDA regulations restrict the intimate, personal choices available to her and similarly situated women, or “would require Ms. Doe and other similarly situated women to engage in heterosexual intercourse, which would be unconscionable for Ms. Doe on the grounds that she is a lesbian who only engages in sexual intercourse with women.”
She objects, particularly, to the Public Health Service Act, of 1944, and the FDA’s implementing regulations, codified in 21 C.F.R., Part 1271, subparts A, B, C, D and F. Part 1271 regulates “human cells, tissues, and tissue-based products (HCT/P’s),” according to the complaint.
Violation of HCT/P regulations “is a strict-liability crime that is punishable by imprisonment for up to one year and a fine of up to $1,000,” the complaint states.
Doe, of Oakland, calls the FDA’s regulations “unconstitutional,” and says they “directly prohibit her chosen method of procreation.”
“FDA regulations applying to uncompensated donations of semen by private individuals directly to other private individuals deprive Ms. Doe of access to the reproductive method of her choice and burden her procreative liberty,” the complaint states.
Doe also objects to “the sudden enforcement of 21 C.F.R. pt. 1271 against private, uncompensated semen donors,” which she says began in November 2010. On Nov. 1 that year, she says, the FDA’s Center for Biologics Evaluation and Research “issued an Order to Cease Manufacturing (‘Order’) to a California man, Trent C. Arsenault, an individual who donated semen privately and without compensation to women seeking to become pregnant via ICI [intracervical insemination].”
This despite the fact that Arsenault subjects himself to regular medical tests, posts the results on a publicly available website, and “is personally known to all women to whom he donates semen and has entered into agreements with them regarding mutually agreed-upon obligations,” Doe says in her complaint.
The FDA Order to Cease Manufacturing stated: “FDA regulatory requirements do not vary based on whether a sperm donation is free of charge. FDA regulates any establishment that performs any of these manufacturing steps: recovery, processing, storage, labeling, packaging, distribution, or screening of sperm,” according to Doe’s complaint.
Neither Arsenault, apparently, nor Doe’s chosen donor complies with those FDA regulations.
Doe says she has a “fundamental right to procreative choice,” which the defendants are violating. She claims they also violate her, and women’s and donors’, rights to equal protection, and that the rules violate the Commerce Clause. She wants the rules enjoined as unconstitutional. She also seeks attorney’s fees and costs.
Named as defendants are FDA Commissioner Margaret Hamburg and Health and Human Services Secretary Kathleen Sebelius.
Although the complaint mentions similarly situated women several times, it never explicitly states that Doe filed it as a class action.
Doe is represented by Amber Abbasi, with Cause of Action, of Washington, D.C.