806 N.W.2d 766
Minn.2011Background
- Nine families allege the Minnesota Department of Health violated the Genetic Privacy Act by storing, using, and disseminating newborn blood samples and test results without written consent.
- Newborn screening collects blood from newborns to test for heritable/congenital disorders; excess samples have been retained and used for research and quality assurance.
- The Department contracts with Mayo Medical Laboratories; most outside research uses de-identified samples, but consent is required for certain uses.
- The Genetic Privacy Act, enacted in 2006, requires written informed consent for collection, use, storage, and dissemination of genetic information unless expressly provided by law.
- The district court granted summary judgment for the State on all claims; the court of appeals affirmed; the Supreme Court reversed and remanded.
- This decision focuses on whether blood samples are ‘genetic information’ and whether the newborn screening statutes expressly authorize retention/use without consent.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are newborn blood samples ‘genetic information’ under Minn.Stat. § 13.386? | Bearder contends samples are genetic information. | State argues samples are not genetic information; only test results are protected. | Blood samples are genetic information under 13.386(1)(b); act requires consent for collection/use/storage/dissemination unless law provides. |
| Do the newborn screening statutes expressly authorize retention and use of samples without consent? | Statutes do not expressly authorize unrestricted retention/use beyond testing. | Statutes authorize testing, reporting, follow-up, and registry maintenance; imply authority to retain for those purposes. | Statutes provide express authorization only for testing, reporting, registry, and follow-up; do not expressly authorize broader use/storage. |
| Does the Genetic Privacy Act apply to blood samples if they are ‘genetic information’? | If samples are genetic information, the Act applies and consent is required. | Even if test results are protected, samples themselves may be exempt as specimens. | The Act applies to genetic information, and because blood samples are genetic information, consent is required for collection/use/storage/dissemination unless law provides. |
| What is the proper remedy for potential Genetic Privacy Act violations? | Remedies should address unlawful uses of samples. | Remedy depends on proving specific improper uses; record insufficient. | Remand to district court for further proceedings to determine entitlement to remedies for any violations. |
Key Cases Cited
- Bearder v. State, 788 N.W.2d 144 (Minn.App.2010) (court held blood samples qualified as genetic information under the Act)
- Patterson v. Wu Family Corp., 608 N.W.2d 863 (Minn.2000) (summary judgment standard on appeal; de novo review of statutes)
- Bus. Bank v. Hanson, 769 N.W.2d 285 (Minn.2009) (summary judgment framework; proper legal analysis)
- Premier Bank v. Becker Dev., LLC, 785 N.W.2d 753 (Minn.2010) (statutory interpretation; de novo review of law)
- Johnson v. Cook Cnty., 786 N.W.2d 291 (Minn.2010) (statutory interpretation; distinguishing terms in definitions)
- United States v. Kincade, 379 F.3d 813 (9th Cir.2004) (DNA contains health information; context of genetic data)