A.B. Doe, a minor child by and through her parent(s); individually and on behalf of all others similarly situated, Appellant-Plaintiff,
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
[Copyrighted Material Omitted]
from the Marion Superior Court. The Honorable Heather A.
Welch, Judge. Trial Court Cause No. 49D01-1409-CT-31867.
FOR APPELLANT: Jessica A. Wegg, Jonathan C. Little, Syed A.
Saeed, Saeed & Little, LLP, Indianapolis, Indiana.
FOR APPELLEES: Gregory F. Zoeller, Attorney General of
Indiana; Frances Barrow, Deputy Attorney General,
Judge. Crone, J., and Brown, J., concur.
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. 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.
and Procedural History
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.
In June 2013, ISDH changed its storage and retention
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).
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 (Complaint citing to
http://www.in.gov/isdh/20215.htm ). 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
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.
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).
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 Fatality Review Team, and the
other was a request by a doctor who needed the sample
to conduct pre-natal genetic testing at the parents'
The next day, on November 20, 2014, ISDH filed
Defendants' Motion to Dismiss, pursuant to Indiana Trial
Rule 12(B)(6), asserting that Doe's Complaint failed to
state a claim upon which relief could be granted. ISDH argued
that ISDH was not a " person" subject to suit under
42 U.S.C. § 1983 and should be dismissed, and that Doe
did not allege any personal involvement by the Commissioner
and Director, and they should be dismissed in their
individual capacities. ISDH also argued that: (1) Doe lacked
standing as she has suffered no injury in fact; (2) the
declaratory action is improper given the availability of an
administrative remedy, namely completion of a form requesting
destruction of her DBS sample; and (3) the injunctive relief
request is moot given the changes in ISDH's policy
regarding retention and storage of the DBS samples. ISDH also
filed a motion for an extension of time to respond to
Doe's motion for class certification, which the trial
On February 25, 2015, the trial court held a consolidated
hearing on both Doe's Motion for a Preliminary Injunction
and on ISDH's Motion to Dismiss. At the hearing, counsel
for each party presented argument, but presented no witnesses
or new documentary evidence. However, Counsels' arguments
addressed the materials that ISDH had attached to its
Opposition to Doe's request for a preliminary injunction,
including Bowman's Affidavit, the After Newborn Screening
pamphlet, and the available ISDH forms that allow a parent to
request destruction of his or her child's DBS sample.
Counsel also discussed the contents of the ISDH website, to
which Doe had cited in her Complaint.
On March 25, the trial court issued Findings of Fact,
Conclusions of Law, and Order denying Doe's Motion for a
Preliminary Injunction (" Findings and Conclusion"
). The trial court's Findings and Conclusions included,
but were not limited to, the following determinations: the
newborn screening laboratory released DBS samples to a third
party without signed authorization on only two occasions
(Allen County Coroner statutory request and a doctor request
related to genetic testing), neither of which involved Doe;
parents/guardians of children born between 1991 and June 2013
can at any time request destruction of their child's DBS
sample by filling out a form; DBS samples for children born
between 1991 and June 2013 have not been and will not be used
for medical research and those samples are stored for 23
years. Although Doe claimed that the storage of the DBS
samples and possible release to law enforcement and other
third parties created an irreparable harm, and that the trial
court should enjoin ...