Gamete Donation – Buyer Beware

Gamete Donation – Buyer Beware

Protecting Donors as to the Sperm They Donate and Protecting Recipients of the Sperm Used to Create: The Unfortunate Story of a “Sperm Warranty” Gone Afoul

- By Colleen M. Quinn, Esq., Fellow of AAARTA and AAAA

The recent lawsuit out of North Texas underscores the need for donors and recipients of gametes (sperm or egg) to seek out legal counsel as well as other means of protective action. If you have not heard the story – (which can be found at http://dfw.cbslocal.com/2012/02/16/parents-sue-cryogenic-center-over-childs-cystic-fibrosis/), Sharine and Brian Kretchmar purchased sperm from the New England Cryogenic Center (“NECC”), near Boston, which they needed to help them conceive a child. The sperm bank’s website talks about having a “healthy baby.” It states: “No specimens are released until it has been tested” for a list of diseases including cystic fibrosis. Yet their son Jaxon, now 22 months old, was born with debilitating cystic fibrosis.

Turns out that NECC evidently purchased the sperm from a bank in Wyoming called Rocky Mountain Cryogenics in 1993. Notably, in April of 2008, the New York Department of Health evidently inspected NECC and cited that some “donors are not appropriately screened and tested.” And, some vials of semen are “not tested” for infectious diseases including syphilis and gonorrhea. The sample vials it referenced were from the Rocky Mountain Cryogenic inventory purchased by NECC. In response to its findings, the New York Department of Health sent NECC a letter stating that it could not “distribute” sperm received from Rocky Mountain Cryogenic to the state of New York. However, that did not prevent the sperm from being shipped elsewhere.

NECC has since updated its website. It now states: “Cystic fibrosis (please note that not all donors have been tested for the same number of CF mutations. Please call and speak with an NECC customer representative to find out the specific number of mutations tested on your donor of choice).”

Effective on May 25, 2005, the FDA commenced its regulation of reproductive tissue banks (21 CFR Part 1271). The FDA’s regulatory focus includes standards for the screening and testing of donors and proper record keeping procedures. Since these regulations became effective, all major sperm banks are to be audited for compliance by the FDA through on-site inspections. However, while the FDA is the regulatory agency for reproductive tissue banking and mandates testing for infectious diseases, the FDA audits and inspections are limited and tissue banking remains a not very tightly regulated industry. Certain industry standards require genetic testing and most banks claim to test for genetic disorders; however, such testing for genetic disorders is not legally mandated by the FDA. So what lessons can be learned from this tragic situation other than “buyer beware”?

All parties involved: donors, recipients, gestational carriers and donor banks should consult with qualified legal counsel (specifically Fellows in the American Academy of Assisted Reproductive Technology Attorneys “AAARTA”) to ensure the best and most up to date advice.

Donors and recipients should only use a qualified cryogenic bank – that includes ensuring that the bank is registered with the Food and Drug Administration (“FDA”) and doing an accredited bank search with the American Association of Tissue Banks (the “AATB”). It also includes making sure that the cryogenic bank meets all regulatory requirements of the American Society of Reproductive Medicine (“ASRM”) and the AATB. The 12th Edition of the AATB Standards for Tissue Banking can be ordered through the AATB Markeplace. More standards, protocols and practice standards can be found through the ASRM.

Ask for specific documentation that establishes that screening has occurred and specifically lists the exact genetic screening done with the actual results (donor identity redacted for the recipients). Donors should be concerned about seeing the test results as well for their own protection.

The specific tests and results should be shared with the involved fertility specialists who can assist in determining if the most technologically advanced testing was performed.

Recipients as well as donors should be tested (note that the CF gene must be carried in both the sperm and the egg).

The “age” of the sperm should be assessed and “older” stored sperm (anything more than six months old, possibly less than that per the advice of the fertility specialist) should be re-tested using the most technologically advanced protocols.

Cryogenic banks and fertility clinics should consult qualified legal counsel with regard to the nature of any warranties or representations made. Appropriate disclaimers and releases of liability should be signed by donors, recipients and carriers.

Hopefully with sound advice and counsel, situations such as the one encountered by the Kretchmars with their son Jaxon can be avoided in the future.