Bearder v. Minnesota

Case Summary for my Law & Bioethics graduate school course

by Don Stacy

 

BEARDER, Appellant, v. STATE of MINNESOTA, Appellee, Minn. Sup. Ct.,, 806 N.W.2d 766 (2011)

 

COURT

Supreme Court of Minnesota

 

PARTIES

Plaintiff/Appellant: Bearder

Defendant/Appellee: State of Minnesota

 

FACTS

Minnesota state law allows the screening of newborns for certain metabolic disorders, which results in the testing of the blood of more than 73,000 children and finding about 100 affected by such disorders annually.  The screening of newborns is performed 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. The screening process typically uses about 70 percent of the sample.  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.  The Minnesota Department of Health contracts with Mayo Medical Laboratories to perform screening tests on newborn children’s blood samples.  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. 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: (a) with the individual’s written informed consent; or (b) if necessary in order to achieve purposes described by clause (2).  Informed consent to disseminate genetic information under item (a) must be signed and dated.  Unless otherwise provided by law, such informed consent is valid for one year or for a lesser period as specified in the consent.

Nine families brought suit against the State of Minnesota 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.

 

PLAINTIFF/APPELLANT’S CONTENTIONS

Nine families brought suit against the State of Minnesota and its Department of Health claiming that the Genetic Privacy Act required the Department of Health to obtain written informed consent before it is permitted to collect, use, store, or disseminate the remaining blood samples after a newborn health screening has been completed.

 

DEFENDANT/APPELLEE’S CONTENTIONS

The State of Minnesota 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.

 

PROCEDURAL HISTORY

The district court granted the State of Minnesota’s motion to dismiss. The court of appeals affirmed. The plaintiffs then appealed to the Supreme Court of Minnesota.

           

ISSUES

  • Under Minnesota’s Genetic Privacy Act, are blood samples considered to be “genetic information”?
  • Is the State of Minnesota exempt from the restrictions of the Genetic Privacy Act because it is “expressly provided” with the authority to collect, use, store, and disseminate the information via the newborn screening statutes?
  • Do the newborn screening statutes authorize the State of Minnesota to conduct any other use, storage, or dissemination of blood samples?

 

HOLDINGS

  • Under Minnesota’s Genetic Privacy Act, blood samples are considered to be “genetic information”.
  • The newborn screening statutes provide an express exception to the restrictions of the Genetic Privacy Act only to the extent that it authorizes the State of Minnesota 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.
  • The newborn screening statutes do not authorize the State of Minnesota to conduct any other use, storage, or dissemination of blood samples.

 

RULES

See HOLDINGS.

 

RESULT

The Supreme Court of Minnesota reversed and remanded to the district court.

 

IMPLICATIONS/ETHICAL CONSIDERATIONS

This case clarified the role of written informed consent in scientific research.