The Minnesota Supreme Court issued a decision on November 16, 2011 holding that the state’s Genetic Privacy Act, Minn. Stat. Section 13.386 (2010) restricts the collection and use of blood samples taken from newborns pursuant to the state’s Newborn Screening Statutes, Minn. Stat. Section 144.125-128. The litigation, captioned Bearder et al v. State of Minnesota, was initiated by a group of families with children born between 1998 and 2008 who challenged the newborn screening program run by the Minnesota Department of Health ("DOH"). The DOH’s program requires the collection of blood samples from newborn children within the fifth day of birth. The DOH analyzes the sample for the presence of substances that indicate the presence of a metabolic disorder. Only one of the many tests, a second level test for cystic fibrosis, analyzes DNA or RNA. If a portion of any blood sample remained after screening tests were completed, the DOH either stored the sample indefinitely or allowed the Mayo Clinic to use the samples for unrelated studies, provided the samples had been either de-identified or Mayo had received written consent from the child’s legal guardian.
Plaintiff’s claimed that the Minnesota Genetic Privacy Act required the DOH to obtain informed consent before it could collect, use, store, or disseminate the samples that remained after the newborn health screening was complete. The trial court and Minnesota Court of Appeals rejected plaintiffs’ argument, but the Minnesota Supreme Court reversed, holding that the Genetic Privacy Act placed limits on the DOH’s practices. A central question in the case was whether a blood sample was properly considered "genetic information" as the term is defined in the state law. The Court held that it was, with one justice dissenting on that question.
Minnesota’s Genetic Privacy Act was passed in 2006 as part of the Data Practices Act which governs the use and disclosure of information by state and local government. Although it is unclear whether the Minnesota Legislature intended to limit section 13.386 to public entities, the plan language of the statute suggests it may govern the collection of genetic information by private companies and employers as well. It certainly serves as a reminder that there is a growing body of federal and state regulation in the area of medical privacy. The lawsuit also highlights the public’s growing concern about the use of genetic information and may portend more litigation under federal laws such as GINA – the Genetic Information Nondiscrimination Act.