Court Opinion

ID: 3195474
Source: CourtListenerOpinion
Date Created: 2016-04-19 16:03:20.604589+00
Date Added: 2024-06-11T09:18:09.569661
License: Public Domain

FILED
                                                                                Apr 19 2016, 7:01 am

                                                                                     CLERK
                                                                                 Indiana Supreme Court
                                                                                    Court of Appeals
                                                                                      and Tax Court

ATTORNEYS FOR APPELLANT                                    ATTORNEYS FOR APPELLEES
Jessica A. Wegg                                            Gregory F. Zoeller
Jonathan C. Little                                         Attorney General of Indiana
Syed A. Saeed                                              Frances Barrow
Saeed & Little, LLP                                        Deputy Attorney General
Indianapolis, Indiana                                      Indianapolis, Indiana

                                             IN THE
    COURT OF APPEALS OF INDIANA

A.B. Doe, a minor child by and                             April 19, 2016
through her parent(s);                                     Court of Appeals Case No.
individually and on behalf of all                          49A04-1505-CT-326
others similarly situated,                                 Appeal from the
Appellant-Plaintiff,                                       Marion Superior Court
                                                           The Honorable
        v.                                                 Heather A. Welch, Judge
                                                           Trial Court Cause No.
Jerome Adams, M.D., in his                                 49D01-1409-CT-31867
capacity as the Indiana State
Health Commissioner, and
Victoria Buchanan, in her
capacity as the Director of the
ISDH Genomics and Newborn
Screening Program,1

1
 After this appeal was filed, Jerome Adams, M.D. was substituted for William C. Vanness II, M.D. as the
current Indiana State Health Commissioner (“Commissioner”) and Victoria Buchanan was likewise

Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                           Page 1 of 28
      Appellees-Defendants.

      Kirsch, 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

      substituted for Bob Bowman as the current Director of the ISDH Genomics and Newborn Screening
      Program (“Director”).
      2
       The trial court dismissed the claims against the Commissioner and the Director in their individual
      capacities. Doe does not appeal those portions of the trial court’s decision. Claims against the
      Commissioner and the Director in their official capacities remain, although the individuals named in the
      original complaint have been substituted with the current Commissioner and Director. The trial court also
      dismissed ISDH, finding that it was not a “person,” and could not be sued under 42 U.S.C. § 1983. Doe also
      does not appeal that determination. Thus, the remaining claims are those against the current Commissioner
      and Director in their official capacities, which, for simplicity, we will continue to refer to, collectively, as
      “ISDH.”

      Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                            Page 2 of 28
      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

                                   Facts and Procedural History
[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

      3
       We held oral argument in this case on March 15, 2016, at the Indiana Court of Appeals courtroom in the
      Indiana Statehouse. We commend counsel on the quality of their oral and written advocacy.

      Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                      Page 3 of 28
      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.

      4
        Doe maintains that from 1991 to June 2013, it was ISDH’s policy to keep the DBS samples “indefinitely,”
      Appellant’s Br. at 1. However, during the course of the litigation, ISDH submitted evidence that the DBS
      samples were retained for twenty-three years. Appellant’s App. at 81-82.

      Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                       Page 4 of 28
      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 (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.

      Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 5 of 28
      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

      Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 6 of 28
      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

      Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016        Page 7 of 28
       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 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’ request.

[10]   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

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 8 of 28
       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 court granted.

[11]   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.

[12]   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

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 9 of 28
       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 ISDH from turning over DBS samples to law enforcement and other

       third parties, the trial court determined Doe had an available adequate remedy

       at law, namely requesting that the DBS sample be destroyed, and, therefore,

       was not entitled to a preliminary injunction.

[13]   The trial court’s Findings and Conclusions also addressed Doe’s claim that the

       storage “of DBS samples for infants born between 1991 and May 31, 2013”

       violates the Fourth Amendment to the United States Constitution and Article 1,

       Section 11 of the Indiana Constitution. The trial court determined that the

       initial taking of the blood for newborn screening is lawful and that “the

       subsequent storing of those DBS samples, for a definite period of time, is not a

       “search” under the Fourth Amendment, and the storage “satisfies Article 1,

       Section 11 because it is reasonable under the totality of the circumstances.”

       Appellant’s App. at 26-28. Doe did not seek interlocutory appeal of the trial

       court’s Findings and Conclusions, which denied her request for a preliminary

       injunction.

[14]   After the trial court denied Doe’s request for a preliminary injunction, Doe filed

       a motion on April 6, 2015, seeking an opportunity to conduct expedited

       discovery, specifically to conduct discovery with regard to the Child Fatality

       Review Team. ISDH opposed Doe’s request and sought a stay of discovery.

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 10 of 28
       On April 16, 2015, the trial court granted ISDH’s motion to stay discovery,

       pending its ruling on ISDH’s Motion to Dismiss.

[15]   Thereafter, on April 27, 2015, the trial court issued an Order Granting the

       Defendants’ Motion to Dismiss (“Order”). The Order found: (1) Doe lacked

       standing because (a) she had not sustained and was not in imminent danger of

       sustaining some direct injury as a result of the act of storing her DBS sample,

       (b) she had not made any request for destruction of her DBS sample that had

       been denied by ISDH, and (c) any injury is “completely speculative”; (2) her

       claim for declaratory relief was improper because an administrative remedy was

       available, namely that Doe could request that ISDH destroy her DBS sample;

       and (3) her request for equitable relief was moot because in June 2013 ISDH

       modified its storage policy. Id. at 12-14. Doe now timely appeals the trial

       court’s Order.

                                       Discussion and Decision

                                         I. Preliminary Matters
[16]   We begin by briefly clarifying what Doe is not claiming. Doe does not

       challenge the propriety of taking of her blood for testing. She does not assert

       that the newborn screening program statutes are unconstitutional. She does not

       raise any issue with regard to the records made pursuant to the testing, or the

       storage of those records. Rather, Doe challenges the continued storage of her

       DBS sample, after the time that the statutorily-mandated testing of the DBS

       samples is complete. She summarizes:

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 11 of 28
               With neither consent nor authority, the State of Indiana has
               retained the blood samples of almost every single baby born
               within its boundaries between 1991 and June 1, 2013. In other
               words, the State has complete control over and unfettered access
               to over two million unique DNA samples. The dangerous
               ramifications of this are obvious and are the subject of [Doe’s]
               lawsuit.

       Appellant’s Br. at 3.

                                             A. Class Certification

[17]   Doe’s general position, explaining why and how the trial court erred,

       presupposes the existence of a plaintiff class of persons similarly situated to her.

       For instance, Doe argues, “The State’s serious and ongoing violations of the

       Constitutional rights of over two million individuals born in Indiana (including

       Miss Doe) are unlawful and profoundly injurious,” and although she could

       request destruction of her DBS sample, millions of others who do not know to

       request destruction of his/her DBS sample face continuing irreparable harm

       and violation of his/her constitutional rights. Appellant’s Br. at 5, 15.

       Defendants argue, however, “[N]o class has been certified and only Doe’s

       claims are at issue.” Appellees’ Br. at 7-8, 10. Accordingly, we find that a brief

       discussion of the status and effect of Doe’s request for class certification is

       warranted.

[18]   In September 2014, Doe filed her Complaint as a class action, and in October

       2014, she filed a Motion for Class Certification. The trial court granted ISDH’s

       request for an enlargement of time to respond to Doe’s motion for class

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016    Page 12 of 28
       certification “until and including twenty days after [ISDH] receive[s] notice that

       the Motion to Dismiss has been [d]enied.” Appellant’s App. at 3, 9. As ISDH’s

       Motion to Dismiss was granted, it appears that ISDH never filed a response to

       Doe’s motion for class certification, the trial court did not rule on Doe’s

       motion, and it remains pending.

[19]   On appeal, Doe challenges the storage of her own blood sample, as well as that

       of millions of others whose blood was taken and stored. To the extent that she

       suggests that her action proceed as a class, prior to certification, we find this is

       not consistent with Indiana law. The general approach in Indiana is that

       “[b]efore certification, a purported class action is essentially an individual

       action in which the plaintiff wishes to assert claims as a class representative.”

       Arthur and Withered, 11 Ind. Prac., Civil Trial Practice §18.4 (2015). “Without

       certification of action as a class action and identification of class, action is not

       properly a class action.” Id. at n.1 (citing Baxter v. Palmigiano, 425 U.S. 308

       (1976)). This court has recognized that principle, stating, “[I]n the case before

       us[,] the ‘Class’ has not been certified. The complaints are merely ‘proposed’

       class actions.” Alexander v. PSB Lending Corp., 800 N.E.2d 984, 991-92 (Ind. Ct.

       App. 2003) (rejecting plaintiffs’ argument that standing may be determined on

       classwide basis), trans. denied. We thus agree with ISDH that, as no class has

       been certified, only Doe’s claims are at issue.5

       5
        We note that the record before us reflects that the trial court likewise rejected Doe’s suggestion that her case
       should proceed as a class action although no class yet had been certified. Tr. at 27-29.

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                           Page 13 of 28
                             B. Procedural Posture and Standard of Review

[20]   Doe appeals the trial court’s decision granting ISDH’s Indiana Trial Rule

       12(B)(6) Motion to Dismiss, which sought dismissal of Doe’s complaint on the

       following grounds: (1) Doe lacks standing because she has not sustained and is

       not in immediate danger of sustaining a direct injury and Doe’s fear of possible

       expropriation of her DBS sample is speculative; (2) a declaratory action is not

       proper because she has an available administrative remedy (asking ISDH to

       destroy her DBS sample); and (3) her request for injunctive relief is moot

       because ISDH changed its retention policies, now asking parents for consent to

       store the sample for three years for possible medical research and providing a

       form for the destruction of a DBS sample taken before June 2013. Following a

       consolidated hearing, the trial court granted ISDH’s motion. Appellant’s App. at

       7-14. Doe asserts on appeal that ISDH failed to meet the stringent burden to

       show that Doe’s complaint fails to state a claim upon which relief can be

       granted; therefore, the trial court’s dismissal was in error. We review a grant of

       a motion to dismiss as follows:

               The standard of review on appeal of a trial court’s grant of a
               motion to dismiss for the failure to state a claim is de novo and
               requires no deference to the trial court’s decision. The grant or
               denial of a motion to dismiss turns only on the legal sufficiency
               of the claim and does not require determinations of fact. A
               motion to dismiss under Rule 12(B)(6) tests the legal sufficiency
               of a complaint: that is, whether the allegations in the complaint
               establish any set of circumstances under which a plaintiff would
               be entitled to relief. Thus, while we do not test the sufficiency of
               the facts alleged with regards to their adequacy to provide
               recovery, we do test their sufficiency with regards to whether or

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 14 of 28
               not they have stated some factual scenario in which a legally
               actionable injury has occurred.

       Bellows v. Bd. of Comm’rs of Cnty. of Elkhart, 926 N.E.2d 96, 110 (Ind. Ct. App.

       2010) (internal citations and quotation omitted); Schulz v. State, 731 N.E.2d

       1041, 1044 (Ind. Ct. App. 2000) (“A complaint cannot be dismissed under

       12(B)(6) unless it appears to a certainty that the plaintiff would not be entitled

       to relief under any set of facts.”), trans. denied.

[21]   In their Appellees’ Brief, ISDH observes that the trial court’s Order referred to

       and relied on the contents of Bowman’s Affidavit, the attached ISDH forms,

       and the ISDH website. Thus, ISDH suggests, the trial court effectively treated

       its Motion to Dismiss as one for summary judgment. See Appellees’ Br. at 9-10,

       17. Although our review of a Rule 12(B)(6) motion to dismiss and a motion for

       summary judgment is the same, i.e., de novo, the legal standard necessary to

       succeed on each of those two motions is different, and we deem it appropriate

       to address whether we are reviewing a decision on a motion to dismiss or one

       granting summary judgment.

[22]   We turn to Indiana Trial Rule 12(B), which provides, in pertinent part:

               If, on a motion, asserting the defense number (6), to dismiss for
               failure of the pleading to state a claim upon which relief can be
               granted, matters outside the pleading are presented to and not
               excluded by the court, the motion shall be treated as one for
               summary judgment and disposed of as provided in Rule 56. In
               such case, all parties shall be given reasonable opportunity to
               present all material made pertinent to such a motion by Rule 56.

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 15 of 28
       A trial court’s failure to give explicit notice of its intended conversion of a

       motion to dismiss to one for summary judgment is reversible error only if a

       reasonable opportunity to respond is not afforded a party and the party is

       thereby prejudiced. Azhar v. Town of Fishers, 744 N.E.2d 947, 950 (Ind. Ct. App.

       2001).

[23]   After ISDH raised the matter in its Appellees’ Brief, Doe responded in her

       Reply Brief and maintained that the trial court’s decision was, in fact, a ruling

       on a motion to dismiss, noting the decision was entitled, “Order Granting the

       Defendants’ Motion to Dismiss” and that the Order specifically cited the

       standard of review for a motion to dismiss. Appellant’s App. at 7. Doe also

       argues that ISDH did not attach any materials to its Motion to Dismiss and

       thus did not actually present “matters outside the pleading” to the trial court as

       is contemplated by Rule 12(B). However, we are not persuaded by these

       arguments, as our court has recognized that what the trial court titles the order

       and whether the defendant actually submitted the outside materials with its

       motion to dismiss is not necessarily determinative. See Milestone Contractors,

       L.P. v. Ind. Bell Tel. Co., 739 N.E.2d 174, 176-77 (Ind. Ct. App. 2000) (finding

       that trial court’s order reflected that it considered matters outside pleadings that

       had been included in other briefs and discussed at hearing, and trial court

       thereby effectively treated defendant’s Rule 12(C) motion for judgment on the

       pleadings as motion for summary judgment), trans. dismissed.

[24]   Here, a review of the trial court’s Order reveals that the trial court relied on

       content from Bowman’s Affidavit and the exhibits attached thereto. For

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 16 of 28
       instance, in finding that Doe “failed to demonstrate immediate danger of

       sustaining some direct injury” as the result of the storage of her DBS sample,

       the trial court’s Order recognized: the screening cards are perforated; the section

       with the DBS sample includes only an identification number; and “Defendants

       do not know the identity of Doe.” Appellant’s App. at 10, 12. That information

       was derived from Bowman’s Affidavit. Id. at 79. The trial court also

       recognized that “Doe’s complaint does not allege that . . . a request was made

       to destroy her/his sample and that the ISDH refused.” Id. at 12. The

       information concerning the availability of a form by which an individual may

       request destruction of his or her DBS sample was derived from the ISDH

       website, as well as the ISDH form itself, which was an exhibit to Bowman’s

       Affidavit. The trial court also referred to content from the ISDH website that

       “no samples collected before June 2013 were released for medical research

       purpose[.]” Id. at 12. Given this, we find that matters outside the pleadings

       were considered and not excluded by the trial court. Accordingly, we find that

       the trial court treated ISDH’s Motion to Dismiss as one for summary judgment.

[25]   Although maintaining that the trial court’s ruling was one on a motion to

       dismiss, Doe alternatively argues that, if it was a ruling on a motion for

       summary judgment: “[T]he trial court precluded [Doe] from taking discovery

       and thus denied her any opportunity to present pertinent material,” and

       therefore, “[she] was prejudiced[.]” Appellant’s Reply Br. at 2-4. Finding as we

       do that the trial court’s Order was a grant of a motion for summary judgment,

       we thus next consider whether Doe was prejudiced. There are at least several

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 17 of 28
considerations pertinent to a determination of whether a trial court’s failure to

give express notice deprives the non-movant of a reasonable opportunity to

respond with Trial Rule 56 materials:

        First, we consider whether the movant’s reliance on evidence
        outside the pleadings should have been so readily apparent that
        there is no question that the conversion is mandated by T.R.
        12(B). Second, we consider whether there was ample time after
        the filing of the motion for the non-movant to move to exclude
        the evidence relied upon by the movant in support of its motion
        or to submit T.R. 56 materials in response thereto. Third, we
        consider whether the non-movant presented “substantiated
        argument” setting forth how she “would have submitted specific
        controverted material factual issues to the trial court if [she] had
        been given the opportunity.”

Azhar, 744 N.E.2d at 950-51 (internal citations omitted). In Azhar, the plaintiff

contended that the trial court committed reversible error because she was

surprised by the trial court’s action in converting a Rule 12(B)(6) motion into a

motion for summary judgment and that she was not given the opportunity to

put forth evidence to show the existence of a genuine issue of material fact. Id.

The Azhar court rejected her claim and found that, in that case, the movant’s

reliance on evidence outside the pleadings – which were documents attached to

its motion to dismiss – was readily apparent and “unmistakable.” Id. The

Azhar court observed, “[G]iven the mandatory wording of T.R. 12(B), Azhar

should have known that the trial court was compelled to convert the motion to

a summary judgment motion.” Id. The court also found that the three-month

period between the motion to dismiss and the hearing thereon provided “ample

Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 18 of 28
       time” within which Azhar could have moved to exclude the evidence or submit

       Indiana Trial Rule 56 materials in response. Id.

[26]   Here, ISDH filed its Motion to Dismiss on November 20, 2014; ISDH did not

       attach to the Motion any exhibits or documents, but referred to and

       incorporated some content from the ISDH website.6 The prior day, ISDH had

       filed its Opposition to Doe’s Motion for a Preliminary Injunction and attached

       to that Opposition: Bowman’s Affidavit as well as other ISDH documents,

       including ISDH’s retention policy, the After Newborn Screening pamphlet, and

       ISDH forms to request storage or destruction of one’s DBS sample. Doe did

       not seek to strike or in any other way oppose ISDH’s submitted evidence. For

       her part, Doe submitted a copy of a 2009 decision rendered by a federal Texas

       district court, but did not file any other evidence in support of her Motion for

       Preliminary Injunction or in opposition to ISDH’s Motion to Dismiss.

       Approximately three months later, in February 2015, the trial court held a

       combined hearing on Doe’s Motion for Preliminary Injunction and on ISDH’s

       Motion to Dismiss. The content of ISDH’s attachments and documents were

       discussed by counsel for both parties at the hearing, as well as Doe’s cited Texas

       district court case.

[27]   Applying the three Azhar considerations to the present case, we conclude that

       ISDH’s reliance on the outside materials was “readily apparent.” 744 N.E.2d

       6
        Doe’s Complaint cites to the ISDH website and includes some of the website’s content in her complaint.
       Appellant’s App. at 32.

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                     Page 19 of 28
       at 950. Furthermore, ISDH filed its materials, including Bowman’s Affidavit

       and the After Newborn Screening pamphlet in November, several months

       before the hearing. Doe did not conduct any discovery or submit materials of

       her own in response, or otherwise seek to oppose or strike ISDH’s evidence.

       The combined hearing was held in February 2015. We find there was “ample

       time” after the filing of ISDH’s motion and materials for Doe to move to

       exclude the evidence relied upon by the movant in support of its motion or to

       submit Trial Rule 56 materials in response thereto. Id. at 951. Lastly, our

       review of the record before us does not reveal that Doe presented “substantiated

       argument” setting forth how she “would have submitted specific controverted

       material factual issues to the trial court if [she] had been given the opportunity.”

       Id. While she contends that she sought and was denied the chance to conduct

       discovery, the record indicates that her request for expedited discovery came in

       April 2015, which was after the trial court had denied her motion for

       preliminary injunction, and further, it was limited in scope to seeking

       depositions and materials from and about the Child Fatality Review Team,

       which involved a matter not related to Doe. Based on the record before us, we

       find that Doe was not prejudiced by the fact that the trial court treated ISDH’s

       motion to dismiss as one for summary judgment.

[28]   When reviewing a grant of summary judgment, our standard of review is the

       same as that of the trial court:

               Considering only those facts that the parties designated to the
               trial court, we must determine whether there is a “genuine issue

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 20 of 28
               as to any material fact” and whether “the moving party is entitled
               to judgment as a matter of law.” In answering these questions,
               the reviewing court construes all factual inferences in the non-
               moving party’s favor and resolves all doubts as to the existence of
               a material issue against the moving party. The moving party
               bears the burden of making a prima facie showing that there are
               no genuine issues of material fact and that the movant is entitled
               to judgment as a matter of law; and once the movant satisfies the
               burden, the burden then shifts to the non-moving party to
               designate and produce evidence of facts showing the existence of
               a genuine issue of material fact.

               The party appealing from a summary judgment decision has the
               burden of persuading this court that the grant or denial of
               summary judgment was erroneous. Where the facts are
               undisputed and the issue presented is a pure question of law, we
               review the matter de novo.

       Bellows, 926 N.E.2d at 113-14 (internal citations omitted); see also Reel v. Clarian

       Health Partners, Inc., 873 N.E.2d 75, 78 (Ind. Ct. App. 2007), trans. denied. A

       trial court’s ruling on a motion for summary judgment reaches this court

       clothed with a presumption of correctness. Hibler v. Conseco, Inc., 744 N.E.2d

       1012, 1018 (Ind. Ct. App. 2001). When reviewing the trial court’s ruling we

       will affirm on any theory supported by the material properly designated to the

       trial court. Id.

                                                  II. Standing
[29]   Turning to the merits of the case, we address Doe’s claims that the trial court

       erred when it determined that she lacked standing. “Standing is a fundamental,

       threshold, constitutional issue that must be addressed by this, or any, court to

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 21 of 28
       determine if it should exercise jurisdiction in the particular case before it.”

       Alexander, 800 N.E.2d at 989.

               The main purpose of standing is to [e]nsure that the party before
               the court has a substantive right to enforce the claim that is being
               made in the litigation. The standing requirement restricts the
               courts to real controversies in which the complaining party has a
               demonstrable injury. To possess standing, a plaintiff must
               demonstrate a personal stake in the outcome of the lawsuit and
               must show that he has sustained or was in immediate danger of
               sustaining some direct injury as a result of the conduct at issue.

       Schulz, 731 N.E.2d at 1044 (internal citations omitted) (emphasis added). If

       properly challenged, when a plaintiff fails to establish standing in the pleadings,

       the court must dismiss the complaint. Alexander, 800 N.E.2d at 989. The

       question of whether a party has standing is purely one of law and does not

       require deference to the trial court’s determination. Wood v. Walden, 899

       N.E.2d 728, 731 (Ind. Ct. App. 2009).

[30]   The trial court’s Order determined, as is relevant here, that Doe lacked standing

       because (a) she had not sustained and was not in imminent danger of sustaining

       some direct injury as a result of the act of storing her DBS sample, (b) she had

       not made any request for destruction of her DBS sample that had been denied

       by ISDH, and (c) any injury is “completely speculative.” Appellant’s App. at 11-

       13. Doe argues that the trial court’s determination in that regard was in error

       and that she has standing because “ongoing governmental violations of the

       Fourth, Fifth, and Fourteenth Amendments to the Constitution constitute an

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 22 of 28
       immediate danger of sustaining some direct injury[.]” Appellant’s Br. at 7.7

       Doe’s premise is that she has a reasonable privacy interest in her DBS sample,

       which contains her DNA, and the ISDH’s continued storage beyond the time

       necessary to conduct the screening tests violates the Fourth Amendment’s

       protections against unreasonable searches and seizure.8 She explains that “the

       essential question . . . is whether the person asserting a violation has a

       reasonable expectation of privacy in the material examined.” Id. at 10. She

       urges that, as soon as the screening tests on a DBS sample are completed, “The

       State’s legal right to possess that blood ended, and its continued control over

       the blood constituted trespass.” Id. at 9.

[31]   Indiana’s body of case law concerning an individual’s privacy interests in

       biological samples exists primarily, if not entirely, in the context of criminal

       law, which we recognize presented different issues, but we nevertheless find the

       discussion of the constitutional privacy interests at stake relevant to the matter

       at hand. For instance, Indiana courts have recognized that the taking of a

       biological sample, such as a DNA sample, constitutes a “search” for purposes

       7
         Doe argues, “[T]he State’s serious and ongoing violations of the Constitutional rights of over two million
       individuals born in Indiana (including Miss Doe) are unlawful and profoundly injurious.” Appellant’s Br. at 5.
       However, as we have determined, only Doe’s rights are at issue here.
       8
         We note that Doe’s arguments on the issue of standing, presented both in her written briefs as well as at oral
       argument, focus on Fourth Amendment search and seizure analysis. See Appellant’s Br. at 7-12. Although the
       language of Article 1, Section 11 is nearly identical to its federal counterpart, “Section 11 is interpreted
       independently and separately” from the Fourth Amendment. State v. Washington, 898 N.E.2d 1200, 1205-06
       (Ind. 2008). Doe, having failed to present a separate analysis under the Indiana Constitution, has waived her
       claim that ISDH’s storage of her DBS sample constitutes a violation under Article 1 Section 11 of the Indiana
       Constitution. We likewise find that, having failed to present argument under the Fifth and Fourteenth
       Amendments to the United States Constitution, Doe has abandoned or waived those claims as well.

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                          Page 23 of 28
of the Fourth Amendment. Balding v. State, 812 N.E.2d 169, 172 (Ind. Ct. App.

2004) (citing Patterson, 742 N.E.2d at 9). The Fourth Amendment prohibits

searches and seizures that are unreasonable. Id. As such, the Fourth

Amendment “does not protect all subjective expectations of privacy, but only

those that that society deems as ‘reasonable.’” Id. at 173. Our Supreme Court

in Smith v. State, 744 N.E.2d 437, 439 (Ind. 2001), had occasion to examine the

issue of a criminal defendant’s Fourth Amendment privacy interest in his hair,

blood, and saliva samples. Smith was arrested and charged with rape, and he

was ordered to provide hair, blood, and saliva samples, which were used to

create a DNA profile. Smith’s DNA profile was compared to those from

unsolved cases, and it matched DNA from a prior unsolved rape. Smith moved

to suppress the DNA evidence on the grounds that it violated the Fourth

Amendment and Article 1, Section 11. His claim essentially was that “the

information must be destroyed after the investigation that analyzed it is

concluded, or at least cannot be used in a subsequent investigation.” Id. The

Smith Court rejected that contention, holding that a defendant has “a legitimate

expectation of privacy in his body and blood samples at the time they [are]

taken[,]” but once the DNA is used to create a profile, the profile becomes the

property of the Crime Lab, and the defendant “has no possessory or ownership

interest in it.” Id.; see also Patterson v. State, 742 N.E.2d 4, 11 (Ind. Ct. App.

2000) (once blood sample is lawfully obtained, defendant did not have

reasonable expectation of privacy in his blood sample and reuse of his DNA

sample in subsequent unrelated criminal investigation did not trigger Fourth

Amendment protections), clarified on reh’g, 744 N.E.2d 945, 947 (Ind. Ct. App.
Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016    Page 24 of 28
       2001) (“[S]ociety is not prepared to recognize as reasonable an individual’s

       expectation of privacy in a blood sample lawfully obtained by police.”), trans.

       denied, cert. denied, 534 U.S. 961 (2001).9

[32]   Applying such reasoning to the present case, it is debatable whether Doe has a

       constitutionally-protected privacy interest in the continued storage of her

       lawfully-obtained DBS sample. However, assuming without deciding that she

       does possess such an interest, Doe still has to show that she has suffered, or is in

       immediate danger of suffering, some direct injury in order to have standing.

       We find that she has not done so.

[33]   In seeking dismissal of Doe’s complaint, ISDH presented evidence that (1) the

       stored DBS samples, including Doe’s, have not been released without

       authorization for medical research and will not be released (per the ISDH

       website and the After Newborn Screening pamphlet); and (2) there have been

       only two instances when a DBS sample was released to other third parties

       without authorization (per Bowman’s Affidavit), and neither instance involved

       Doe. Bowman’s Affidavit also stated that the portion of the screening cards

       that are stored only have an identification number on them; consequently,

       ISDH argues, the stored samples are not a “treasure trove of potential DNA

       evidence,” as Doe suggests. Appellees’ Br. at 14. ISDH also presented evidence

       9
         We note that, in its Findings and Conclusions that denied Doe’s request for a preliminary injunction, the
       trial court relied, in part, on Patterson v. State when it determined that the storage of Doe’s DBS sample did
       not constitute a “search” under the Fourth Amendment. Appellant’s App. at 25-26.

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                           Page 25 of 28
       that Doe could at any time request that her sample be destroyed via the

       available ISDH form (attached to Bowman’s Affidavit).

[34]   With regard to what direct injury she has suffered as a result of the storage of

       her DBS sample, Doe asserts that she has a reasonable fear “that the blood

       samples, including hers, might be misused.”10 Appellant’s Br. at 8. In support of

       the proposition that “a reasonable fear arising out of and related to [] unlawful

       conduct,” is “enough for injury in fact,” Doe cites, in part, to Friends of the

       Earth, Inc. v. Laidlaw Environmental Services, Inc., 528 U.S. 167, 184-85 (2000).

       There, a company discharged pollutants into a waterway in excess of EPA

       limits. A number of individuals, who were members of the Friends of the Earth

       environmental organization, submitted affidavits and deposition evidence

       stating in what specific way the pollutants affected his or her specific

       recreational, aesthetic, and economic interests. The Supreme Court determined

       that the Friends of the Earth had standing to bring a Clean Water Act claim

       against the company because the affiant members had a reasonable fear arising

       out of and related to unlawful conduct that caused them “to curtail their

       recreational use of that waterway and . . . subject[ed] them to other economic

       and aesthetic harms,” and “that is enough for injury in fact.” 528 U.S. at 184-

       85. Doe maintains that, similarly, her “illegally-retained blood sample is an

       10
         By way of example, Does notes having “pervasive and reasonable fear” that the DBS samples, including
       hers, would be used by the State to “sidestep” warrant or informed consent requirements. Appellant’s Br. at
       16.

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016                        Page 26 of 28
       injury-in-fact sufficient to confer standing under Friends of the Earth.” Appellant’s

       Br. at 12.

[35]   We find, however, that the type of injury sustained by the individuals in Friends

       of the Earth is distinguishable. There, the Supreme Court’s determination that

       Friends of the Earth had standing was based on affidavits and deposition

       testimony that identified the affiant members’ reasonable concerns about the

       effects of the pollutants and how that directly affected their recreational,

       aesthetic, and economic interests – such as a member saying that he would no

       longer fish, camp, swim, and picnic near the river, another’s statement that she

       had planned to purchase a home near the river but did not do so because of

       defendant’s discharges into the river, and another’s attesting that her home

       located near defendant’s facility had a lower value than similar homes located

       farther from the facility. 528 U.S. at 183-85. ISDH contends that Doe’s

       claimed harm about her stored DBS sample is lacking this same type of direct

       effect on specific interests as was present in Friends of the Earth. We agree.

[36]   The record before us reveals that ISDH presented evidence to the trial court to

       show that Doe’s blood – which was taken pre-June 2013, when ISDH’s policy

       on retention of DBS samples was changed – was not used for medical research,

       nor will it be without parental authorization. Indeed, the ISDH website, which

       Doe cited to in her Complaint, states that DBS samples of babies born before

       June 1, 2013, which includes Doe’s, have “not been made available for medical

       research.” See http://www.in.gov/isdh/20215.htm (last visited Mar. 23, 2016).

       ISDH also presented evidence, namely Bowman’s Affidavit, that there were

       Court of Appeals of Indiana | Opinion 49A04-1505-CT-326 | April 19, 2016   Page 27 of 28
       only two instances in which DBS samples had been released without

       authorization, and neither involved Doe’s DBS sample (Allen County Child

       Fatality Review Team11 and a doctor request for parent-sought genetic testing).

       ISDH also presented evidence to demonstrate that Doe’s parents could at any

       time request that her DBS sample be destroyed. Under the facts of this case,

       Doe’s fear of potential misuse is, as the trial court found, “speculative,” and

       does not constitute the type of direct injury necessary to support a finding of

       standing. ISDH presented evidence to establish that, as a matter of law, Doe

       lacked standing, and Doe did not present evidence to create any genuine issue

       of material fact to preclude judgment in favor of ISDH.

[37]   Affirmed.12

       Crone, J., and Brown, J., concur.

       11
          Doe argues that the release of information to the Allen County Coroner is an example of an unauthorized
       release of information “to law enforcement” – just as she alleged in her complaint – which puts millions of
       Hoosiers at risk. ISDH maintains that (1) the release to the Allen County Coroner was statutorily mandated
       under Indiana Code chapter 16-49-3, and (2) the purpose of the Child Fatality Review Team is to identify
       factors surrounding a child’s death and whether similar deaths could be prevented; it is not a criminal
       investigation. ISDH noted that Review Team determinations are privileged and not subject to subpoena or
       discovery or admissible in evidence in any judicial proceedings. Ind. Code § 16-49-3-13. We do not resolve
       whether the release to the Allen County Coroner was or was not an unauthorized release to law enforcement.
       That release had nothing to do with Doe, and the question before us is whether Doe suffered or was in
       immediate danger of suffering direct injury as a result of IDSH’s storage of her DBS sample.
       12
         Because we resolve this case on the basis that Doe lacked standing, we do not reach the trial court’s
       determinations with regard to the availability of an administrative remedy or the application of the mootness
       doctrine.

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