Ex-Weil Lawyer Takes Lead in Legal Fight Spawned by One-Man ...
December 21, 2011 5:45 PM
Ex-Weil Lawyer Takes Lead in Legal Fight Spawned by One-Man Sperm Bank
Posted by Tom Huddleston Jr.
Trent Arsenault's Web site?says the Fremont, California, resident studied engineering and computer science at the United States Naval Academy, has a technology job in Silicon Valley, and counts hiking and bird watching among his hobbies. Arsenault's site also lists his blood type, information about his latest physical exam, and the results of his most recent sexually transmitted disease tests.
The reason Arsenault, 36, makes all that information available online is that he provides his sperm to infertile married couples and female domestic partners. Here's the twist: He gives his sperm away for free. He does so, he says, because he wants to spare those trying to conceive the high prices typically charged by traditional sperm banks.
Since undertaking his unconventional mission in 2006, Arsenault?who executes written donor agreements with his recipients and delivers his sperm in what he says are sterile storage cups?claims to have sired 14 children, with four more on the way.
If the U.S. Food and Drug Administration gets its way, his one-man sperm bank won't be in business much longer.
Accusing Arsenault of breaking the law by ignoring agency regulations covering those who "manufacture" human cells or tissues, the FDA served him with an "order to cease manufacturing" in November 2010. Specifically, the FDA claims, Arsenault has failed to adequately meet its requirements related to testing donors for communicable diseases.
Arsenault is challenging the order and has filed with the agency seeking a hearing on the matter. He argues that his relationship to those to whom he gives his sperm is that of a "sexually intimate partner" and that his donations are therefore not subject to FDA regulations. He is being represented pro bono in his petition, which the FDA is still considering?by lawyers from Washington, D.C.?based nonprofit public interest group Cause of Action.
Amber Taylor, who joined Cause of Action as a senior attorney in June after three years as an associate at Weil, Gotshal & Manges, authored the group's November 7 brief backing Arsenault's petition seeking a hearing.
Cause of Action's brief also seeks to counter a motion to deny Arsenault's bid for a hearing that FDA staffers filed in February. The agency argues in the order that his sexually intimate partnership claim is merely "an attempt to skirt the law." Taylor says an evidentiary hearing is necessary to determine whether or not Arsenault's claim holds water.
Taylor, who spent two years as an associate at O'Melveny & Myers before joining Weil in 2008, says Cause of Action contacted Arsenault in October to offer its assistance.
"We took up the Arsenault case because we saw it as an instance where the government was improperly applying some regulations, and stepping between two individuals who were trying to have a child," she says.
Taylor says the group's role in the matter extends only to Arsenault's petition. Should he be granted a hearing, she says, he will have to make his own case. A key element of that case, as laid out in the Cause of Action brief, is that by moving to bar Arsenault from making future sperm donations, the FDA is invading both his and his would-be recipients' privacy rights.?
"Mr. Arsenault wants to present testimony at the hearing?from himself and from some of the recipients [who are] willing to testify?that they believe that their agreement that they entered into . . . does constitute a sexually intimate partnership, such that the government doesn't need to be stepping between them," Taylor says.
(The Huffington Post spoke with a woman who is currently pregnant after receiving Arsenault's sperm. She says that their relationship is intimate and should not be subject to federal regulation.)
FDA guidelines, she says, do not actually define sexually intimate partnerships. That, the Cause of Action brief notes, is evidence that such relationships are defined on an individual basis. "We're a little concerned when the government is telling people what kind of relationships they have," she says.
Arsenault is allowed to continue making donations as long as his hearing request is pending.
Contacted by The Am Law Daily, an FDA spokeswoman said the agency does not comment on active investigations. Speaking generally, she said the FDA regulates sperm donations whether they are made freely or for pay, adding that the agency's donor eligibility rules are designed to protect sperm recipients against the transmission of communicable diseases.
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Source: http://amlawdaily.typepad.com/amlawdaily/2011/12/sperm-donor-fda-lawsuit.html
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