Judge Tosses Demand for FDA-Barred Sperm

     (CN) – A woman failed to persuade a federal judge to let a willing donor artificially inseminate her for free after the Food and Drug Administration shut down his “service.”
     Jane Doe, as she is identified in the complaint, sued the FDA and the Department of Health and Human Services, in Oakland, Calif., last year.
     Doe said she was “in a committed, long-term, monogamous relationship with her female partner” and did “not have sexual intercourse with male partners.”
     She wanted to become pregnant and preferred “to conceive via intracervical insemination of fresh donor sperm,” according to the complaint.
     Federal regulations, however, would allegedly require Doe to use a medical intermediary – such as a medical professional or a semen bank – for insemination, restricting her to “often anonymous” donors and “very expensive” procedures.
     “The 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,” Doe said. “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.”
     Doe added that the “unconstitutional” regulations “directly prohibit her chosen method of procreation.”
     FDA-approved semen does not interest Doe since it “is typically cryogenically quarantined for a six-month period,” according to the complaint.
     Doe said she preferred to perform the insemination herself, via syringe. Indeed, Doe had allegedly attempted self-insemination once before, using from sperm from self-described virgin Trent Arsenault.
     Doe said the 2010 pregnancy was not carried to term.
     Before the Food and Drug Administration shut him down, Arsenault advertised himself as a free sperm donor on his website trentdonor.org. His site attributes 18 births and 25 reported pregnancies to the rogue donor.
     The FDA’s Center for Biologics Evaluation and Research (CBER) issued a cease manufacturing order against Arsenault in 2010 after investigating his donations.
     U.S. District Judge Edward Chen concluded Tuesday that Doe lacks prudential standing to bring claims on behalf of Arsenault.
     “According to the government, Ms. Doe and her donor [Arsenault] do not have the necessary closeness because her interests and his are not parallel and are potentially in conflict,” Chen wrote.
     “Both in her papers and at the hearing, Ms. Doe failed to identify any obstacles that prevent Mr. Arsenault from bringing suit on his own behalf. Moreover, any obstacles are not otherwise facially apparent.
     “Accordingly, to the extent Ms. Doe brings claims solely on behalf of Mr. Arsenault, those claims are dismissed for lack of prudential standing,” the 14-page ruling states.
     Chen said FDA regulations “indirectly affected” Doe, and that third-party standing analysis was not permissible in her case.
     “Ms. Doe is not a direct target of the FDA regulations and the CBER order, and her alleged constitutional rights are derived entirely from Mr. Arsenault’s alleged constitutional rights,” the ruling states.
     “While there are situations where third-party standing is permissible, this is not one of them,” Chen added. “Accordingly, the court concludes that Ms. Doe lacks prudential standing to proceed with this litigation.”
     Doe is not barred from procreating via artificial insemination or doing so at home without a medical intermediary, as she claimed, given a donor complies with FDA regulations, Chen added.
     “She can obtain semen from a donor who is not an establishment,” the ruling states. “She can also obtain semen from a directed reproductive donor, who like Mr. Arsenault, is an establishment, so long as the donor complies with the FDA regulations regarding, e.g., testing. Thus, Ms. Doe is not impeded from exercising any general constitutional right to procreate or even a more specific right (if it exists) to procreate via artificial insemination. The only thing Ms. Doe is deprived of is the right to have Mr. Arsenault’s child specifically through a ‘commercial’ (i.e., nonintimate) relationship.”

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