Judge Rosenbaum responded to plaintiffs’ claim that MDH failed to comply with the GPA by ruling that the GPA does not even apply to MDH’s actions because:
- NBS samples do not constitute genetic information; and
- The statute contains reference that it will not apply if an express provision in the law exists.
The GPA clearly defines genetic information as:
- “Information about an identifiable individual derived from the presence, absence, alternation, or mutation of a gene… which has been obtained from an analysis of the individual’s biological information or specimen” and
- “Medical and biological information about a particular genetic condition that is or might be used to provide medical care to that individual.”
Judge Rosenbaum’s finding that NBS are not classified as genetic information ignores the plain language of the statute. NBS are collected to analyze the presence, absence, or mutation of a disease during the newborn screening process and used to obtain medical and biological information about a particular genetic condition so parents of newborns can make medical decisions accordingly. Thus, logic compels classifying NBS as genetic information.
Defendants argued that the newborn screening statute which states that the NBS and results of the screening tests “may be retained by the [MDH]” amounts to an express provision authorizing exemption from the GPA. Judge Rosenbaum’s agreement disregards the meaning of “express provision” and the substantive fact that the collection and temporary retention for screening purposes is distinct from the collection, retention, and use for additional research reasons. Accounting for this important division, the statute would have explicitly and distinctly contained a section authorizing additional retention and research use beyond the collection and retention for detection, treatment, and follow up of heritable and congenital disorders if the legislature intended.
Additionally, this interpretation ignores the purpose of the GPA as a means to limit collection of genetic information by a government entity.
The finding that this section of the newborn screening statute (“may be retained by the [MDH]”) constitutes an express provision allowing retention and research beyond the initial screening poses two additional dilemmas. First, it problematically ratifies blurring screening with additional retention and research. Second, Judge Rosenbaum’s finding ignores that the retention and research is not limited to the MDH but extends to its research partners such as the University of Minnesota, the Mayo Clinic, and the CDC.
Randall Knutson, attorney for the plaintiffs, responded:
“It is our hope to bring some legal guidance and common sense to DNA issues, including the storage and dissemination of genetic information by our government agencies. As it now stands, the State of Minnesota appears free to use and sell our genetic information, without us having any say in the matter. That is simply unacceptable, and we intend to continue to fight on to change this situation.”
Knutson plans to appeal Judge Rosenbaum’s decision.
--Katherine Drabiak-Syed
