Bearder v. State

806 N.W.2d 766

Alan and Keri BEARDER, individually and as parents and natural guardians of Josiah and Alexa Bearder, minors; et al., Appellants,

v.STATE of Minnesota, et al., Respondents.

No. A10–0101.

Supreme Court of Minnesota.

Nov. 16, 2011.

Syllabus by the Court

1. The Genetic Privacy Act, Minn.Stat. § 13.386 (2010), restricts the collection, use, storage, and dissemination of blood samples collected pursuant to the newborn screening statutes, Minn.Stat. §§ 144.125–.128 (2010).

2. The newborn screening statutes provide an express exception to the Genetic Privacy Act only to the extent that the Department 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. Randall G. Knutson, Daniel J. Bellig, Farrish Johnson Law Office, Chtd., Mankato, MN; and Sam Hanson, Briggs and Morgan, P.A., Minneapolis, MN, for appellants.

Lori Swanson, Attorney General, Jocelyn F. Olson, Assistant Attorney General, St. Paul, MN, for respondents.

OPINION

MEYER, Justice.

At issue in this case is the interplay between the newborn screening statutes, Minn.Stat. §§ 144.125–.128 (2010), and the Genetic Privacy Act, Minn.Stat. § 13.386 (2010).¹ The Minnesota Department of Health, as part of its newborn screening program, collects blood samples of newborn children to test for various disorders. The Department has retained the excess blood samples and the test results. The Department has used the blood samples for purposes other than the initial screening of newborn children and has allowed outside research organizations to use the blood samples to conduct health studies. Nine families (the appellants) sued the State of Minnesota, the Department, and the Commissioner of the Department over the Department's practice of collecting, using, storing, and disseminating the children's blood samples and test results without obtaining written informed consent in violation of the Genetic Privacy Act. The district court granted the State's motion to dismiss or, in the alternative, the State's motion for summary judgment. The court of appeals affirmed. We reverse and remand to the district court.

Appellants are nine families with twenty-five children, born between 1998 and 2008, whose blood was sampled and tested for heritable and congenital disorders as part of the State's newborn screening program.² Appellants commenced an action against the State of Minnesota, the Department of Health, and the Commissioner of Health (collectively, the State), alleging a violation of the Genetic Privacy Act. Appellants claim that the Genetic Privacy Act requires written parental consent before the Department may store newborn blood specimens collected through the newborn screening program or authorize public-health research to be conducted with those samples. The complaint was later amended to include various tort and constitutional claims. The State moved to dismiss or, in the alternative, for summary judgment.

The district court granted the State's motion for summary judgment on all claims. The court held that appellants had failed to state a claim upon which relief could be granted on all claims except for the statutory claim. As to that claim, the court concluded (1) that the Genetic Privacy Act did not apply to children born before August 1, 2006, (2) that the blood samples were not “genetic information” under the Genetic Privacy Act, and (3) that the Genetic Privacy Act did not supersede existing laws such as the newborn screening statutes.

On appeal, the court of appeals held that the blood samples qualified as “genetic information” under the Genetic Privacy Act. Bearder v. State, 788 N.W.2d 144, 150 n. 6 (Minn.App.2010). But the court affirmed the grant of summary judgment, concluding that the Department of Health possesses broad statutory authority to operate the newborn screening program and that the Genetic Privacy Act does not apply. Id. at 150. The court concluded that using newborn children's blood samples for purposes other than screening could violate the Genetic Privacy Act but that appellants had not presented specific facts to support their claims that the children's blood samples were being used improperly. Id. at 150–51. The court of appeals, therefore, affirmed summary judgment on all claims. Id. at 152. Appellants appeal the decision to affirm summary judgment on the Genetic Privacy Act claim.

I.

“On appeal from a grant of summary judgment, we must determine whether any genuine issues of material fact exist and whether the district court erred in its application of the law.” Patterson v. Wu Family Corp., 608 N.W.2d 863, 866 (Minn.2000). We review a district court's decision to grant summary judgment to determine (1) whether any issues of material fact exist, and (2) whether the district court misapplied the law to the facts. Bus. Bank v. Hanson, 769 N.W.2d 285, 288 (Minn.2009). We construe the facts in the light most favorable to the party opposing summary judgment and review questions of law, including the interpretation of statutes, de novo. See id.; see also Premier Bank v. Becker Dev., LLC, 785 N.W.2d 753, 758 (Minn.2010).

In 1965 Minnesota began to test newborns for certain metabolic disorders. See Act of Apr. 15, 1965, ch. 205, 1965 Minn. Laws 312 (codified as amended at Minn.Stat. §§ 144.125–.128). The current program screens newborns for more than 50 disorders. Each year, more than 73,000 Minnesota newborns are screened; approximately 100 are discovered to have a confirmed disorder.

Newborn screening is conducted 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 advise parents that the blood samples and test results may be retained by the Department of Health; and (3) permit parents either to decline to have their infants tested or to require destruction of the blood samples and test results following screening. See Minn.Stat. §§ 144.125–.128; Minn. R. 4615.0300–.0700 (2011).

The newborn screening program requires certain individuals to collect blood samples from newborn children by the fifth day after birth. Minn. R. 4615.0500. A sample consists of a few blood drops collected on a specimen card. The blood sample is sent to the Department within 24 hours of collection. Id. Screening tests are then run on the blood sample.

Almost all of the screening tests analyze the blood sample for the presence of substances that indicate the possible presence of a disorder. The only test that analyzes the DNA or RNA of the blood is the second-level test for cystic fibrosis, which is performed only if the first test indicates the presence of a certain substance in the blood. The screening process typically uses 70% of the sample.

If a portion of the blood sample remains after the screening tests are completed, the sample is retained indefinitely unless there is a specific request to have it destroyed. As of December 31, 2008, there were more than 800,000 newborn screening samples in storage, dating back to samples taken as early as 1997. More than 50,000 blood samples have been used in studies for purposes beyond the initial screening of the newborn children. These studies have included developing new tests and assuring the quality of existing tests. Blood samples have also been used for studies unrelated to the newborn screening program. A blood sample is capable of being used for research for up to 20 years.

The State asserts that a federal law requires the Department to retain newborn screening test results for two years. See 42 C.F.R. § 493.1105 (2010). After this two-year period, the test results are retained indefinitely unless the Department receives a request to destroy the results. The Department currently has electronic test results dating back to 1986 and “a small amount of paper records dating back to the 1960s.” The appellants allege that the Department possesses more than 1.5 million screening test results.

The 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 unrelated to the newborn screening program if—in addition to other requirements—the samples have been de-identified or Mayo has received written consent from the children's parent or legal guardian. The majority of the studies performed by outside research institutions use de-identified blood samples.

In 2006 the Legislature amended the Minnesota Government Data Practices Act to include a section regulating the treatment of genetic information. Act of June 1, 2006, ch. 253, § 4, 2006 Minn. Laws 424, 426 (codified at Minn.Stat. § 13.386). This amendment prohibits the collection, use, storage, or dissemination of a person's genetic information without the written informed consent of that person:

Unless otherwise expressly provided by law, genetic information about an individual:

(1) may be collected by a government entity, as defined in section 13.02, subdivision 7a, or any other person only with the written informed consent of the individual;

(2) may be used only for purposes to which the individual has given written informed consent;

(3) may be stored only for a period of time to which the individual has given written informed consent; and

(4) may be disseminated only:

(i) with the individual's written informed consent; or

(ii) if necessary in order to accomplish purposes described by clause (2). A consent to disseminate genetic information under item (i) must be signed and dated. Unless otherwise provided by law, such a consent is valid for one year or for a lesser period specified in the consent.

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