Brief Fact Summary. Nine families (Bearder) (Plaintiff) brought suit against the State of Minnesota (State) (Defendant) and its Department of Health over the practice of collecting, using, storing, and disseminating the blood samples and test results of newborns without written informed consent to do so.Â The district court granted Defendant’s motion to dismiss.Â Plaintiff appealed.
Synopsis of Rule of Law. Under Minnesota’s Genetic Privacy Act, blood samples are considered “genetic information.”
Facts. Minnesota state law allows the screening of newborns for certain metabolic disorders.Â This results in the testing of the blood of more than 73,000 children and finding about 100 affected by such disorders each year.Â The screening of newborns is done under the authority of the newborn screening statutes, which (1) require the Commissioner of Health to prescribe the manner of testing, recording, and reporting of newborn screening results; (2) require those who perform screenings to inform parents that the blood samples and test results may be kept by the Department of Health; and (3) allow parents to either decline having their infants tested or require the blood samples and test results be destroyed after the screening.
Â The screening process usually uses about 70 percent of the sample.Â If a portion of the blood sample remains after the screening tests are completed, the sample is kept indefinitely unless there is a specific request for it to be destroyed.Â The Defendant’s Department of Health contracts with Mayo Medical Laboratories to perform screening tests on newborn children’s blood samples.Â This contract allows Mayo to use excess blood samples for studies not related to the newborn screening program if, and in addition to other requirements, the samples have been de-identified or Mayo has obtained the written consent from the children’s parent or legal guardian.
Â The State Genetic Privacy Act states that “genetic information” about an individual: (1) may be collected by a government entity, or any other person only with the written informed consent of the individual; (2) may be used only for purposes the individual gave written informed consent for; (3) may be stored for only a short time which the individual gave written informed consent; and may be disseminated only: (i) with the individual’s written informed consent; or (ii) if necessary in order to achieve purposes described by clause (2).Â A consent to disseminate genetic information under item (i) must be signed and dated.Â Unless otherwise provided by law, such a consent is valid for one year or for a lesser period as specified in the consent.
Â Plaintiff and eight other families sued Defendant claiming that the Genetic Privacy Act required the Department of Health to obtain informed consent before it is permitted to collect, use, store, or disseminate the remaining blood samples after a newborn health screening has been completed.Â Defendant argued that the Genetic Privacy Act did not limit the Department’s handling of the samples because (1) blood samples received by the Department of Health are not “genetic information” under the Act, and (2) the newborn screening statutes “expressly provide” that the Department of Health may use, store, and disseminate the genetic information without first having obtained written informed consent.Â The district court granted Defendant’s motion to dismiss.Â The families (Plaintiff) appealed.
Issue. Under Minnesota’s Genetic Privacy Act, are blood samples are considered “genetic information?”
Held. (Meyer, J.)Â Yes.Â Under Minnesota’s Genetic Privacy Act, blood samples are considered “genetic information.”Â Our first job is to determine whether the blood samples the Department collected and stored are “genetic information,” as that term is used in the Genetic Privacy Act, requiring the Department to obtain informed consent prior to using, storing, or disseminating the blood samples that remain following the completed newborn health screening.Â Plaintiff argues that the Genetic Privacy Act applies to blood samples because those samples contain information in the form of DNA.Â Defendant argues that the Genetic Privacy Act does not apply to blood samples because those samples are treated as biological specimens by the Act, not genetic information.Â
Â The language of the statute includes two definitions for the term “genetic information:” (a) “Genetic information” means information about an identifiable person taken from the presence, absence, alteration, or mutation of a gene, or the presence or absence of a specific DNA or RNA marker, which has been obtained by analyzing: (1) the person’s biological information or specimen; or (2) the biological information or specimen of a person who is related.Â (b) “Genetic information” also means medical or biological information collected for a person about a particular genetic condition that is or might be used to provide medical care to that person or that person’s family members.
Â Both parties generally agree that genetic information under (a) does not include the blood samples because, by its express terms, the information must be obtained from “an analysis” of biological information.Â In other words, definition (a) protects the privacy of the test results, and not the specimen or source of the information.Â It is self-evident that the biological information being analyzed includes blood samples.Â However, the blood samples themselves are not protected under the definition (a).
Â The court must consider whether the blood samples are “genetic information” under the definition contained in subdivision 1(b).Â Under subdivision (b), genetic information “also means medical or biological information collected from an individual.”Â Unlike definition (a), definition (b) does not limit its protection to information “obtained” from an analysis of a “biological specimen.”Â Instead, the definition is broader in scope because it includes “medical or biological information” about a person.Â As noted under the analysis of subdivision 1(a), blood samples are included in biological information.Â Thus, an individual’s blood samples are biological information subject to protection under definition (b).
Â Without question, the blood samples collected from the appellants in this case contain biological information.Â The blood samples are also “biological information” under definition (b) because the genetic information in the samples may be used to provide the individuals with medical care.Â The DNA within the blood samples is the information that brings the blood sample within the protection of the Genetic Privacy Act.Â Therefore, the blood samples fit within the common understanding of “medical or biological information collected from an individual.”
Â Defendant argues that blood samples are not “genetic information” because the genetic information comes from analysis of the blood samples.Â The Defendant’s only argument is basically that the Genetic Privacy Act applies only after analysis of the blood samples is complete.Â This is not a reasonable interpretation of the language of the statute.Â “Genetic information” includes the actual blood samples as “medical or biological” information.Â Even if the Genetic Privacy Act did not define the blood samples themselves to be “genetic information,” those samples without question do contain genetic information.Â The Act limits the collection, use, storage, or dissemination of genetic information.Â It would not be possible to collect, use, store, or disseminate those samples without also collecting, using, storing, or disseminating the genetic information contained within those samples.
Â After concluding that the blood samples collected and stored by Defendant are “genetic information” and subject to the restrictions of the Genetic Privacy Act, the next question is whether Defendant is exempted from those restrictions because they are “expressly provided” with the authority to collect, use, store, and disseminate the information.Â Therefore, the Defendant may collect, use, store, or disseminate blood samples collected as part of the newborn screening program only to the extent expressly authorized by the newborn screening statutes.
Â The Genetic Privacy Act’s first restriction is on collection.Â Under the Act, genetic information “may be collected . . . only with the written informed consent of the individual.”Â Although the language of the newborn screening statutes do not explicitly state that the Department may collect blood samples, the provisions of the statute that authorize the Department to conduct tests and provide for the destruction of samples requires that the Department be able to collect the samples to be tested and destroyed.Â Although the fact that this constitutes implied rather than express authorization, the newborn screening statutes authorize the blood sample collection to the extent necessary to allow the Department to conduct the tests expressly authorized by statute.
Â The second restriction of the Genetic Privacy Act is on use.Â The Act provides that genetic information “may be used only for purposes to which the individual has given written informed consent.”Â The newborn screening statutes authorize the Commissioner to conduct “tests for heritable and congenital disorders,” and require the Commissioner to “maintain a registry of the cases of heritable and congenital disorders detected by the screening program for the purpose of follow-up services.”Â Therefore, the newborn screening statutes expressly authorize the Commissioner to use blood samples without written informed consent only to the extent necessary to complete testing for heritable and congenital disorders and perform follow-up services.
Â None of these provisions expressly requires the use of genetic information or blood samples or conflict with the Genetic Privacy Act’s requirement of obtaining informed written consent.Â The Commissioner’s power to conduct health studies does not include unlimited authority to use the genetic information obtained from newborns for screening purposes in those health studies.Â Written informed consent is required for genetic information to be used for purposes other than the screening of newborn children.
Â The Genetic Privacy Act also restricts storage.Â The Act requires that genetic information “may be stored only for a period of time to which the individual has given written informed consent.”Â The newborn screening statutes require that the Commissioner “maintain a registry of the cases of heritable and congenital disorders detected by the screening program for the purpose of follow-up services.”Â This language creates an express exception to the Genetic Privacy Act that allows the Commissioner to maintain blood samples from positive test results if there is no objection from the parents.
Â The Genetic Privacy Act’s final restriction is on dissemination.Â The Act allows genetic information to be “disseminated only: (i) with the individual’s written informed consent; or (ii) if necessary in order to accomplish purposes” for which informed consent was given.Â The newborn screening statutes expressly authorize the “reporting of test results.”Â The Commissioner is also expressly authorized to contract with a private entity to perform the Department’s functions.Â But there is no other source of law that authorizes the dissemination of blood samples or genetic information beyond that expressly authorized for the reporting of newborn test results.
Â In conclusion, the newborn screening statutes provide an express exception to the Genetic Privacy Act only to the extent that it authorizes the Department to perform newborn screening by testing the samples for heritable and congenital disorders, recording and reporting those test results, maintaining a registry of positive cases for the purpose of follow-up services, and storing those test results as required by federal law.Â The newborn screening statutes do not expressly authorize the Department to conduct any other use, storage, or dissemination of the blood samples.Â Reversed.
Dissent. (Anderson, J.)Â I concur in part and dissent in part.Â I agree with the majority that test results generated by the Department of Health’s newborn screening program are “genetic information” subject to the requirements of the Genetic Privacy Act, except to the extent otherwise expressly authorized by law.Â I also agree with the conclusion of the majority that the newborn screening statutes provide an express exception to the Genetic Privacy Act only to the extent that the Defendant is authorized to administer newborn screening by testing the samples for heritable and congenital disorders, recording and reporting those test results, maintaining a registry of positive cases for the purpose of follow-up services, and storing those test results as required by federal law.Â I concur to the extent that this conclusion applies to newborn screening test results.
Â However, I disagree with the majority’s conclusion that the Genetic Privacy Act applies to blood samples obtained in the newborn screening program.Â The Genetic Privacy Act applies to “genetic information,” which does not include specimens, as defined by the statute.Â Because newborn children’s blood samples are specimens, blood samples do not meet the definition of genetic information and the Genetic Privacy Act does not apply to them.
Â If the Genetic Privacy Act applies, then written informed consent is required to collect, use, store, or disseminate the test results or blood samples unless otherwise expressly provided by law.Â In this case, I concur with the conclusion of the majority that the test results obtained in the newborn screening program are subject to the Genetic Privacy Act.Â There must be express written informed consent before the Department may collect, use, store, or disseminate test results.Â However I do not agree that blood samples are subject to the Genetic Privacy Act and, therefore, the Department does not need to obtain written informed consent for the collection, use, storage, or dissemination of the blood samples.Â Also, because blood samples are specimens and not biological or medical information, the definition does not apply to blood samples.
Concurrence. (Stras, J.) In my view, the court reaches the correct policy result.Â If I were a legislator, I would vote for legislation that would protect blood samples under the Genetic Privacy Act.Â However, my role as a judge is not to implement my own policy preferences, but to interpret the law as written.Â Here, the court’s conclusion that the blood samples are “genetic information” is at odds with the plain and unambiguous language of the Genetic Privacy Act.Â The only reasonable reading of the Genetic Privacy Act is that blood samples are “specimens,” not “biological information,” which means that the protections of the Act do not apply to blood samples because the samples do not qualify as “genetic information.”
Discussion. Because the State’s (Defendant) Genetic Privacy Act restricts the collection, use, storage, and dissemination of blood samples collected pursuant to the newborn screening statutes, good intentions or even good science does not permit a violation of its provisions.Â The protections provided by the Act require written informed consent.Â The Bearder court took note of the underlying policy considerations, but strict interpretation of the Act lead to the conclusion of the majority that no exception was possible.Â In this case, the court was offering guidance to the Legislature to fix the issue and make it clear what is protected and what can be used for scientific research.