Doe v. Adams
| Decision Date | 19 April 2016 |
| Docket Number | No. 49A04–1505–CT–326.,49A04–1505–CT–326. |
| Citation | 53 N.E.3d 483 |
| Parties | A.B. DOE, a minor child by and through her parent(s); individually and on behalf of all others similarly situated, Appellant–Plaintiff, v. Jerome ADAMS, M.D., in his capacity as the Indiana State Health Commissioner, and Victoria Buchanan, in her capacity as the Director of the ISDH Genomics and Newborn Screening Program, Appellees–Defendants. |
| Court | Indiana Appellate Court |
Jessica A. Wegg, Jonathan C. Little, Syed A. Saeed, Saeed & Little, LLP, Indianapolis, IN, Attorneys For Appellant.
Gregory F. Zoeller, Attorney General of Indiana, Frances Barrow, Deputy Attorney General, Indianapolis, IN, Attorneys For Appellees.
, Judge.
[1] A.B. Doe, a minor child, by and through her parents (“Doe”) brought an action against the Indiana State Health Commissioner and the Director of the Indiana State Department of Health Genomics and Newborn Screening Program, in their individual and official capacities, and the Indiana State Department of Health (collectively, “ISDH”), alleging violations of the United States and Indiana constitutions and state law for retaining her newborn dried blood spot sample without permission.2 The trial court granted ISDH's Indiana Trial Rule 12(B)(6)
motion to dismiss, and Doe appeals, raising three issues, of which we find the following one dispositive: whether the trial court erred when it determined that Doe had not sustained, nor was she in immediate danger of sustaining, a direct injury as a result of the storage of her dried blood spot sample, and, therefore, she lacked standing.
[2] We affirm.3
[3] Doe was born in 2006. At the time of her birth, a small amount of blood was collected from Doe, pursuant to Indiana's newborn screening program, which is codified at Indiana Code chapter 16–41–17. Indiana's newborn screening program is a public health measure aimed at identifying, treating, and preventing serious conditions and diseases in infants, such as phenylketonuria
, hypothyroidism, sickle cell anemia, cystic fibrosis, critical congenital heart disease, and other serious disorders. Indiana Code section 16–41–17–8 requires hospitals to take a blood sample from every infant born under their care. The blood is obtained from the infant, usually by a heel-stick test, before he or she leaves the hospital or within one week of birth, if born outside of a hospital. The blood is collected in five circles on a newborn screen card, which is referred to as a “DBS sample,” and the DBS sample is transported to a designated laboratory for testing. Ind.Code § 16–41–17–7. The Genomics & Newborn Screening Program division of ISDH is responsible for carrying out the testing prescribed by the legislature. The laboratory performs the screen by punching out small pieces from the DBS sample. If the test results indicate anything of concern, the laboratory contacts the newborn's doctor. Sometimes the laboratory may repeat a screening test, but often, not all of the five DBS circles on the newborn screen card are used. Nothing in the newborn screening program statutes directs if and how the ISDH may store the DBS samples. However, from approximately 1991 to June 2013, ISDH retained and stored that portion of the newborn screen card that contained the DBS sample taken from each infant.4
[4] In June 2013, ISDH changed its storage and retention policies:
As of June 2013, parents or guardians of newborns indicate whether or not to allow their child's DBS to be made available for medical research purposes. If a parent or guardian chooses to have their child's DBS saved, it will be stored and made available for medical research purposes for a period of three years and then destroyed. Although saved DBS, as of June 2013, will be available for medical research, no identifiable information about your baby will ever be released. If a parent or guardian indicates they do not want a baby's DBS used for medical research, then the DBS is kept for 6 months to ensure additional screening is not necessary and then destroyed.
See http://www.in.gov/isdh/20215.htm (last visited Mar. 23, 2016).
[5] On September 25, 2014, Doe filed a Class Action Complaint and Request for Emergency Declaratory and Injunctive Relief (“Complaint”) against ISDH. The proposed class is defined as “[a]ll individuals who had a blood sample taken pursuant to IC 16–41–17–8
that has been or will be stored by the [ISDH] for more than six months without any documentation of consent.” Appellant's App. at 37. Doe brought the action “pursuant to 42 U.S.C. § 1983 for violations of the Fourth, Fifth, and Fourteenth Amendments to the United States Constitution, for violations of the Indiana Constitution, and violations of Indiana State Law.” Id. at 30. The Complaint referred to Indiana's Newborn Screening Program statutes, including Indiana Code section 16–41–17–8, as well as the ISDH website. Id. at 32 (). In her Complaint, Doe asserted the following facts: ISDH took and stored blood samples from her; her blood samples continue to be stored “at an undisclosed location”; her blood samples or information derived therefrom “was shared with unauthorized third parties”; neither she nor her guardians were informed that her blood samples may be used for medical research or may be provided to any third parties; and neither she nor her guardians were notified that ISDH “continues to store her blood samples.” Id. at 32–33. She alleged that the storage of her blood samples without her knowledge or permission was an unreasonable search and seizure, was a taking of private property for public use without just compensation, and the conduct deprived her of life, liberty, or property without due process of law. She claimed violations of 42 U.S.C. §§ 1983 and 1988 and asked for an award of attorneys' fees.
[6] On October 1, 2014, Doe filed a Motion for Class Certification. A few weeks later, on October 20, 2014, Doe filed her Plaintiff's Motion for Preliminary Injunction, requesting that the trial court enjoin ISDH from sharing any data or information obtained through the DBS samples of Doe and others similarly situated with any third party, including local, state, and federal law enforcement. Doe also requested that the trial court order ISDH to disclose the identity of every third party, including law enforcement agencies, that has received information related to the blood sample of any proposed class member.
[7] On November 19, 2014, ISDH filed a Response in Opposition to Motion for Preliminary Injunction (“ISDH's Opposition”) and attached thereto, among other things, the affidavit of Bob Bowman (“Bowman Affidavit”), who at that time was the Director of the Maternal and Child Health Division for the ISDH, and prior to that, was the Director of Genomics and Newborn Screening within the Maternal and Child Health Division. The Bowman Affidavit averred, among other things, that the blood is collected in five circles on the newborn's screening card; the screening cards are perforated and one section contains the DBS sample and an identification number, but “no information about the identity of the newborn is contained with the [DBS] sample”; and the DBS samples are stored at the Indiana University Newborn Screening Laboratory. Id. at 79. The Bowman Affidavit also addressed ISDH's policy regarding retention of the DBS samples. The original policy “required the DBS samples to be stored for 23 years,” but in 2013, the ISDH changed the retention policy “and the samples are now only stored for three years prior to destruction,” if the child's parents consent to use for medical research; if the parents do not so consent, the sample is destroyed in six months. Id. For those parents whose babies were born before June 2013, “[T]hey may request that the DBS sample be destroyed” by completing an ISDH form and returning it to ISDH. Id. at 80. Under the new June 2013 policy, parents may also complete an available form requesting that the DBS sample be stored for medical research purposes. ISDH attached the referenced forms, such as the “Request for Destruction of Dried Blood Spot,” as exhibits. Id. at 83, 87–90.
[8] Also attached to the Bowman Affidavit was the “After Newborn Screening” pamphlet, published by ISDH and distributed to parents at their child's birth. Id. at 84–85. The pamphlet provides this explanation as to why DBS samples are retained:
There are several reasons why dried blood spots are kept. First, good laboratory practices require that samples (such as DBS) be kept for a period of time after testing is done, in case a test needs to be checked or repeated. DBS are also used by Indiana's newborn screening laboratory to help develop tests for newborn screening and to make sure that equipment is working correctly.
Id. at 85. The After Newborn Screening pamphlet advises parents that “you don't have to allow your child's DBS to be used for medical research.” Id. at 84. The pamphlet also states that DBS samples that were collected pre-June 2013–and thus “before parents/guardians were asked to decide whether a child's DBS sample could be used for medical research”—are “NOT available ” for use in research. Id. at 85 (emphasis in original). The ISDH website likewise states that “[i]f your baby was born before June 1, 2013, your baby's DBS has not been made available for medical research.” http://www.in.gov/isdh/20215.htm (last visited Mar. 23, 2016).
[9] Presumably in response to Doe's allegations in her Complaint that her DBS sample had been “shared with unauthorized third parties,” Bowman stated in his Affidavit that, in his review of records retained by the laboratory, “there have been only two instances in which a DBS sample has been released to a third party without signed authorization[.]” Id. at 33, 79–80. One was pursuant to a request from the Allen County Coroner as provided by Indiana Code section 16–49–3–5
, regarding an investigation by the Child...
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