Higgins et al v. Lakey

Filing 24

ORDER GRANTING IN PART AND DISMISSED AS MOOT IN PART 4 Motion to Dismiss ; DISMISSING AS MOOT 19 Motion for Leave to File Motion to Certify the Class. This Order diposes of all claims and parties. The Clerk's Office is directed to enter a final judgment to close this case. Signed by Judge Xavier Rodriguez. (ga)

In the United States District Court
for the
Western District of Texas
JEFFREY HIGGINS, On Behalf
of His Infant Daughter and of the
Class Similarly Situated and
ANDROMIDA A. McCALL, On
Behalf of Her Infant Daughter
and of the Class Similarly
Situated,
Plaintiffs,
v.
TEXAS DEPARTMENT OF
HEALTH SERVICES and DAVID
L. LAKEY, M.D., In His Official
Capacity as Commissioner,
Defendants.

§
§
§
§
§
§
§
§
§
§
§
§
§
§
§
§
§
§

Civil Action No. SA-10-CV-990-XR

ORDER
On this date, the Court considered Defendants’ Motion to Dismiss (docket no. 4) and the
Response and Reply thereto. After careful consideration, the Court will grant the motion in part and
dismiss it as moot in part.
I. Background
Plaintiffs bring suit against the Texas Department of Health Services (“the Department”) and
David L. Lakey, in his Official Capacity as Commissioner of the Department. Plaintiffs are the
parents of infants whose blood samples were taken in 2007 and 2008 as part of the State’s newborn
screening program. Both at that time and thereafter, Section 33.011 of the Texas Health & Safety

1

Code required physicians and others attending a newborn child to “subject the child to screening
tests approved by the department for phenylketonuria, other heritable diseases, hypothyroidism, and
other disorders for which screening is required by the department.” TEX . HEALTH & SAFETY CODE
§ 33.011. Until May 2009, Chapter 33 did not specify what would happen to the blood specimens
obtained as part of the screening program after screening was completed. Apparently, the blood
specimens were being kept and stored after the screening.
Parents concerned about this storage filed the Beleno lawsuit in March 2009. The Amended
Complaint in Beleno complained that the Department collected the blood specimens and stored them
indefinitely for the purpose of undisclosed research, and that the Department had not disclosed any
transactions related to the specimens. During the pendency of the Beleno lawsuit, the Texas
Legislature amended Chapter 33, effective May 27, 2009. See Act of May 27, 2009, 81st Leg., R.S.,
ch. 179. The amendments included the addition of sections 33.0111 (“Disclosure”), 33. 0112
(“Statement Prohibiting Retention of Genetic Material”), and 33.017 (“Confidentiality”).
Section 33.0111 requires that the Department “develop a disclosure statement that discloses
to the parent or guardian of a newborn child subjected to screening under § 33.011 that the
department or a laboratory established or approved by the department under Section 33.016 may
retain for use by the department or laboratory genetic material used to conduct the newborn
screening tests and discloses how the material is managed and used; and (2) that the parent,
managing conservator, or guardian may limit the use of the genetic material by providing to the
department in accordance with Section 33.0112 a written statement prohibiting the department or
laboratory from retaining the genetic material or using the genetic material for any purpose other
than the conduct of newborn screening tests authorized under this chapter.” TEX . HEALTH & SAFETY

2

CODE § 33.0111(a). This disclosure must be presented to a parent or guardian at the time the
newborn is subjected to the screening tests. Id. § 33.0111(c).
Section 33.0112 also provides that a parent or guardian “of a newborn child may file with
the department a signed written statement prohibiting the department or a laboratory established or
approved by the department from retaining any genetic material related to the newborn screening
tests conducted under this chapter or using the genetic material for any purpose other than the
conduct of the newborn screening tests.” Id. § 33.0112(a). Within 60 days of receiving such a
statement, “the department or laboratory shall destroy the genetic material used in the screening
tests.” Id. § 33.0112(b). Further, an adult individual may file a written statement instructing the
department or a laboratory to destroy any genetic material of the individual that is retained and used
under the chapter. Id. § 33.0112(c).
Section 33.017, entitled “Confidentiality,” makes confidential all reports, records, and
information obtained or developed by the Department under Chapter 33, allowing their disclosure
only (1) for purposes of diagnosis or follow-up authorized under Section 33.014, with the consent
of each identified individual or someone authorized to consent on behalf of an identified individual;
(2) as authorized by court order; (3) to a medical examiner authorized to conduct an autopsy on a
child or an inquest on the death of a child; or (4) to public health programs of the department for
public health research purposes provided that the disclosure is approved by an institutional review
board or privacy board of the department as authorized by the federal privacy requirements adopted
under HIPAA. Id. § 33.017(a),(b). However, “reports, records, and information that do not identify
a child or the family of a child may be released without consent” if the disclosure is for: (1)
statistical purposes; (2) purposes related to obtaining or maintaining certification, approval, or

3

quality assurance for the department’s laboratory or a public or private laboratory to perform
newborn screening tests; (3) purposes relating to review, quality assurance, or improvement of the
department’s newborn screening or newborn screening program services; (4) research purposes,
provided that the disclosure is approved by an institutional review board or privacy board of the
department; or (5) quality assurance.
The parties settled the Beleno case in November 2009. Pursuant to the settlement agreement,
the Department agreed to destroy all blood specimens that were taken as part of the newborn
screening program and received by the Department before May 27, 2009 in its or Texas A&M
Health Science Center’s possession (Texas A&M facilities were used to store the specimens) for
which it did not have written consent for continued retention and use. The Department further
agreed to post on the newborn screening program website a list of all research projects for which
the defendants had provided blood specimens, and also agreed to post a comprehensive list of
categories of quality assurance and quality control uses for which defendants provided the blood
specimens. Last, the Department agreed to inform the named plaintiffs in writing of the uses to
which their children’s blood specimens had been put, as well as any financial transactions regarding
those specimens.
Plaintiffs Higgins and McCall filed this lawsuit in December 2010, asserting violations of
their rights based on the distribution of the newborn screening blood samples to private research
companies, government agencies, and other third parties without knowledge or consent. Citing the
information posted on the Department’s website pursuant to the Beleno settlement, Plaintiffs note
that “Defendants have distributed, sold, bartered, and traded at least 8,800 blood samples” and
“[t]here is no compelling state justification for such secretive, deceptive, and non-consensual

4

activity.” Plaintiffs complain “that Defendants deceptively and unlawfully sold, traded, bartered,
and distributed blood samples collected from their children . . . for fees, various lab equipment, and
various other purposes” and that the blood samples “were made available to private companies for
undisclosed purposes and to the Armed Forces Institute of Pathology, without Plaintiffs’ knowledge
or consent.” Plaintiffs complain that “Defendants knowingly and deceptively withheld this
information during settlement negotiations in Beleno.” Plaintiffs allege that Defendants were asked
during the settlement negotiation process whether they ever distributed or sold blood samples to
third parties, and Defendants consistently denied that they had.
Plaintiffs “object to Defendants expropriating an infant’s blood sample and any data obtained
from it through research or other means, without their knowledge or consent, effectively making it
Defendants’ property for undisclosed non-consensual purposes, unrelated to the purposes for which
the infants’ blood was originally drawn, and deriving profit therefrom.” Plaintiffs assert that
“[g]iven the sensitive and highly personal information contained in the blood samples, such as DNA,
and the fact that such data has been indiscriminately disclosed to private companies and federal
agencies, Plaintiffs are deeply and rightfully concerned about the potential misuse of that
information.” “Plaintiffs fear the possibility of discrimination against their children and perhaps
even relatives through the use of such blood samples and research activity thereon.”
Thus, Plaintiffs’ complaint is based on the possibility that their children’s blood samples,
which were taken in 2007 and 2008, have been distributed to third parties without their knowledge
or consent, and their fear that the blood and the information contained therein, such as DNA, may
be misused. On behalf of themselves and a proposed class of similarly situated parents, Plaintiffs
sue under 28 U.S.C. § 1983 for violations of the Fourth and Fourteenth Amendments, seeking

5

declaratory and injunctive relief.
With regard to themselves, Plaintiffs seek a declaration that Defendants violated their rights
under the Fourth and Fourteenth Amendments, and seek an injunction: (1) commanding Defendants
to account for and destroy all blood samples and spots of Plaintiffs’ children, whether or not in
Defendants’ possession, that Defendants have distributed, sold, bartered, or traded without informed
parental consent and guarantee that they have done so; and (2) commanding Defendants to advise
Plaintiffs for what purposes Defendants used the blood samples and spots of Plaintiffs’ children and
disclose all financial transactions involved with the use of such samples and blood.
With regard to the proposed class, Plaintiffs ask the Court to certify a class action on behalf
of all similarly situated parents whose infants’ blood samples or spots were or will be sold, traded,
or distributed by Defendants for purposes unrelated to the newborn screening without the knowledge
or consent of the parents, and then: (1) enter the same declaratory relief as for the named Plaintiffs
and determine the extent to which HB-1672, as codified in Chapter 33 of the Texas Health and
Safety Code and implemented by the Defendants, satisfies the requirements of the Fourth and
Fourteenth Amendments; (2) issue an injunction commanding Defendants to account for and destroy
all blood samples and spots sold, traded, bartered, or distributed without informed parental consent
and guarantee that they have done so; (3) issue an injunction commanding Defendants to advise each
class member for what purposes Defendants used the blood samples and spots of the class members
and disclose all financial transactions involved with the use of such samples and blood; and (4) issue
an injunction commanding Defendants, their agents, successors in office, and all those acting in
concert with them to cease and desist immediately from the actions complained of herein.

6

II. Standard of Review
Defendants move to dismiss for lack of jurisdiction pursuant to Rule 12(b)(1) based on
Eleventh Amendment immunity, standing, and mootness. In the alternative, Defendants move to
dismiss under Rule 12(b)(6) for failure to state a claim. “When a Rule 12(b)(1) motion is filed in
conjunction with other Rule 12 motions, the court should consider the Rule 12(b)(1) jurisdictional
attack before addressing any attack on the merits.” Ramming v. United States, 281 F.3d 158, 161
(5th Cir. 2001). This requirement prevents a court without jurisdiction from prematurely dismissing
a case with prejudice. Id.
The Court must dismiss a cause for lack of subject matter jurisdiction “when the court lacks
the statutory or constitutional power to adjudicate the case.” See Home Builders Assn of Mississippi,
Inc. v. City of Madison, 143 F.3d 1006, 1010 (5th Cir. 1998). A motion to dismiss for lack of Article
III standing is properly considered under Rule 12(b)(1). Harold H. Huggins Realty, inc. v. FNC,
Inc., 634 F.3d 787, 795 n.2 (5th Cir. 2011). A motion to dismiss for lack of jurisdiction under
12(b)(1) may be decided on: (1) the complaint alone; (2) the complaint supplemented by undisputed
facts evidenced in the record; or (3) the complaint supplemented by undisputed facts, plus the
Court’s resolution of disputed facts. Freeman v. United States, 556 F.3d 326, 334 (5th Cir. 2009).
Unlike a 12(b)(6) motion, the district court is empowered to consider matters outside the Complaint
and matters of fact that may be in dispute. Ramming v. United States, 281 F.3d 158, 161 (5th Cir.
2001).
III. Analysis
A. Rule 12(b)(1) Motion to Dismiss based on Eleventh Amendment Immunity
1. the § 1983 claims against the Department directly are barred by the Eleventh Amendment

7

The Department contends that Plaintiffs’ claims made directly against it are barred by the
Eleventh Amendment. The Department, as an arm of the State of Texas, retains its immunity from
suit by individuals under § 1983. Plaintiffs apparently concede that the claims against the
Department directly should be dismissed, stating that the Department “was named initially to
provide notice to the agency of its official as a Defendant.” Thus, the motion to dismiss the claims
against the Department based on Eleventh Amendment immunity is granted.
2. claims against Lakey in his official capacity
Plaintiffs contend that they may assert their claims for prospective equitable relief against
Lakey in his Official Capacity pursuant to Ex parte Young, 209 U.S. 123 (1908). Ex parte Young
established a limit on the sovereign immunity principle. Therein, the Supreme Court explained that
because an unconstitutional legislative enactment is “void,” a state official who enforces that law
“comes into conflict with the superior authority of [the] Constitution,” and therefore is “stripped of
his official or representative character and is subjected in his person to the consequences of his
individual conduct. The State has no power to impart to him any immunity from responsibility to
the supreme authority of the United States.” Virginia Office for Protection & Advocacy v. Stewart,
131 S. Ct. 1632, 1638 (2011). Ex parte Young “rests on the premise . . . that when a federal court
commands a state official to do nothing more than refrain from violating federal law, he is not the
State for sovereign-immunity purposes.” Id.
“In determining whether the doctrine of Ex parte Young avoids an Eleventh Amendment bar
to suit, a court need only conduct a ‘straightforward inquiry into whether [the] complaint alleges an
ongoing violation of federal law and seeks relief properly characterized as prospective.’” Id.
(quoting Verizon Md. Inc. v. Public Serv. Comm'n of Md., 535 U.S. 635, 645 (2002)). The Fifth

8

Circuit has held that, in order to use the Ex Parte Young exception, the plaintiff must demonstrate
that the state actor has “some connection” with a disputed act’s enforcement. K.P. v. LeBlanc, 627
F.3d 115, 124 (5th Cir. 2010) (citing Ex Parte Young, 209 U.S. at 157). “Enforcement” typically
involves compulsion or constraint. Id. Plaintiffs make no allegation or argument concerning
Lakey’s connection to the disputed actions. Their only allegation in the Amended Complaint
concerning Lakey specifically is that he is the Commissioner of the Department. All allegations in
the complaint state that “Defendants” committed the alleged various actions.
Though Defendants’ motion makes assertions regarding Lakey’s role (or lack thereof) with
regard to the release of newborn screening blood specimens, they do not appear to be contesting
Plaintiffs’ claim that they may pursue their claims against Lakey under Ex parte Young. In a
footnote, Defendants complain that Plaintiffs “ignored Defendants’ assertion of DSHS’s Eleventh
Amendment sovereign immunity and focused instead only on the Ex parte Young exception for
official-capacity suits against state officials for prospective injunctive relief, for which Defendants
made no Eleventh Amendment challenge.” Thus, for purposes of deciding this motion, the Court
will presume that Plaintiffs’ claim are appropriately brought against Lakey under Ex parte Young.
B. Rule 12(b)(1) Motion to Dismiss based on Lack of Standing and Mootness
1. what may be considered in resolving the motion
The parties dispute the extent to which consideration of matters outside the pleadings is
permitted in deciding this motion. Without differentiating between a 12(b)(1) and a 12(b)(6)
motion, Plaintiffs assert that “[t]he law is well-settled that a court may not ‘go outside the complaint’
when considering a motion to dismiss by considering any evidence.” Response at 4. Plaintiffs
further assert that Defendants’ statement of undisputed facts “quite regularly contradict[s] Plaintiffs’

9

Complaint,” and the Court must assume all facts and inferences in Plaintiffs’ favor when deciding
a Rule 12(b)(6) motion. Id. Plaintiffs then state that “Defendants’ motion attempts to prove their
case prematurely by introducing nineteen separate documents, consisting primarily of affidavits and
other evidence from Defendants themselves, none of which are permissible at this stage of the
proceedings.” Id at 5. Plaintiffs assert that Defendants “argue about facts which are far from
undisputed, and cite extensively to external evidence which was not introduced in Plaintiffs’
pleading and cannot be considered by the Court on a Rule 12 motion.” Id. Plaintiffs then contend
that Defendants’ motion should be denied in its entirety “because it is so heavily reliant on
inappropriate evidence that the Court could not properly rule on their arguments at the motion to
dismiss stage.” Id. at 6.
As noted, Plaintiffs’ arguments conflate the applicable standards under Rule 12(b)(1) and
12(b)(6). When evaluating jurisdiction, “a [federal] court is free to weigh the evidence and satisfy
itself as to the existence of its power to hear the case.” MDPhysicians & Assoc., Inc. v. State Bd.
of Ins., 957 F.2d 178, 181 (5th Cir. 1992). Thus, it is well established that a motion to dismiss for
lack of jurisdiction under 12(b)(1) may be decided on: (1) the complaint alone; (2) the complaint
supplemented by undisputed facts evidenced in the record; or (3) the complaint supplemented by
undisputed facts, plus the Court’s resolution of disputed facts. Freeman v. United States, 556 F.3d
326, 334 (5th Cir. 2009).
When a motion to dismiss is based on the lack of jurisdiction on the face of the complaint,
the plaintiff is left with safeguards similar to those retained when a Rule 12(b)(6) motion to dismiss
for failure to state a claim is raised – the court will consider the allegations in the plaintiff’s
complaint as true and determine whether they sufficiently state a basis for jurisdiction. Williamson

10

v. Tucker, 645 F.2d 404, 412 (5th Cir. 1981). However, when the court considers disputed facts
“[i]n evaluating jurisdiction, the district court must resolve [such] disputed facts without giving a
presumption of truthfulness to the plaintiff’s allegations.” Vantage Trailers, Inc. v. Beall Corp., 567
F.3d 745, 748 (5th Cir. 2009) (citing Williamson, 645 F.2d at 413). In other words, where the
defendant supports the 12(b)(1) motion with evidence, then the attack is factual and “no presumptive
truthfulness attaches to plaintiff’s allegations, and the existence of disputed material facts will not
preclude the trial court from evaluating for itself the merits of jurisdictional claims.” Williamson,
645 F.2d at 413.1 Under either standard, the party asserting jurisdiction maintains the burden of
proving that jurisdiction does exist. Ramming v. United States, 281 F.3d 158, 161 (5th Cir. 2001)
(per curiam).
Defendants contend that this case can be decided on the complaint supplemented by
undisputed facts in the record, and has submitted a statement of assertedly undisputed facts.
Plaintiffs appear to argue that some of the facts therein are disputed because they “quite regularly
contradict Plaintiffs’ Complaint.” Response at 4. Plaintiffs provide no statement of supposedly
disputed facts, however, and provide no evidence in support of their alleged facts, despite being put
on notice by Defendants’ reply that matters outside the pleadings are appropriately considered in
deciding a 12(b)(1) motion.

1

“The distinction between factual Rule 12(b)(1) motions and factual Rule 12(b)(6) motions
is rooted in the unique nature of the jurisdictional question. It is elementary that a district court has
broader power to decide its own right to hear the case than it has when the merits of the case are
reached. Jurisdictional issues are for the court-not a jury-to decide, whether they hinge on legal or
factual determinations. The unique power of district courts to make factual findings which are
decisive of jurisdiction is, therefore, not disputed. This means that the district court is not limited
to an inquiry into undisputed facts. It may hear conflicting written and oral evidence and decide for
itself the factual issues which determine jurisdiction.” Id. (citations omitted).
11

However, there is an exception to the Court’s power to resolve disputed facts when the
jurisdictional fact issues overlap with the merits. Neither party addresses this issue. Part of
Defendants’ “undisputed” evidence is that Plaintiffs’ children’s blood specimens were never
distributed and have been destroyed. It is not clear whether the issue of whether Defendants in fact
distributed Plaintiffs’ children’s blood specimens, which is related to the mootness argument, is a
merits issue that cannot be decided at the 12(b)(1) stage. The Court does consider that evidence with
regard to Defendants’ mootness arguments because Plaintiffs have not disputed it or asked for
discovery to be able to dispute it. However, the Court concludes that it need not consider that
evidence to decide the standing issue, and that Plaintiffs’ lack of standing can be determined based
on the face of the Complaint. Thus, mootness is an alternative holding to the Court’s conclusion that
Plaintiffs lack standing based on the face of the Complaint.
2. factual allegations in the complaint
Plaintiffs’ Complaint contains the following facts and allegations: Texas has a mandatory
newborn screening program in which hospitals, birthing centers, and midwives draw blood from the
infant’s heel so that the state can test for a variety of birth defects. Am. Compl. ¶ 11. Since 2003,
if not before, Defendants have sold, traded, bartered, and distributed blood samples obtained through
the newborn screening program to private research companies, government agencies, and other third
parties, without the knowledge or consent of the infants’ parents. Am. Compl. ¶ 8. Defendants
provided blood samples to private companies such as PerkinElmer in exchange for a fee or various
lab and testing equipment. Id. Defendants also secretly distributed the blood samples to the United
States Armed Forces Institute of Pathology. Id. Defendants have not as of yet accounted for and
destroyed all of the outstanding blood samples that they unlawfully distributed, sold, or traded. Id.

12

¶ 17.
Plaintiff Jeffrey Higgins is the father of an infant born on September 26, 2007. Id. ¶ 4.
Andromida McCall is the mother of an infant born March 7, 2008. Id. ¶ 5. Plaintiffs do not object
to the screening program so long as safeguards are in place to prevent the unlawful distribution of
blood samples. Id. ¶ 12. They do object to the Defendants’ expropriating an infant’s blood sample
and any data obtained from it through research or other means without their knowledge or consent,
effectively making it Defendants’ property for undisclosed, non-consensual purposes, unrelated to
the purposes for which it was originally drawn, and deriving profit therefrom. Id. Plaintiffs allege
that, given the sensitive and highly personal information contained in the blood samples, such as
DNA, and the fact that such data has been indiscriminately disclosed to private companies and
federal agencies, Plaintiffs “are deeply and rightfully concerned about the potential misuse of that
information” and “fear the possibility of discrimination against their children and perhaps even
relatives through the use of such blood samples and research activity thereon.” Id. ¶ 13.
3. relief sought by the named Plaintiffs Higgins and McCall
Plaintiffs seek declaratory relief for the Plaintiff individuals that “Defendants intentionally,
and with complete and deliberate indifference to the rights of Plaintiffs’ children, unlawfully
deprived them of their right to be free from unlawful search and seizure, as guaranteed by the Fourth
Amendment” and that “Defendants intentionally, and with complete and deliberate indifference to
the rights of Plaintiffs’ children, unlawfully deprived them of their liberty and privacy interests, as
guaranteed by the Fourteenth Amendment.”
Plaintiffs seek injunctions commanding Defendants (1) to forthwith account for and destroy
all blood samples and spots of Plaintiffs’ children, whether or not in Defendants’ possession, which

13

Defendants have distributed, sold, bartered, or traded without informed parental consent and
guarantee to the Court within ten days of the order that they have done so; and (2) to advise
Plaintiffs for what purposes Defendants used the blood samples and spots of Plaintiffs’ children and
disclose all financial transactions involved with the use of such samples and blood, within ten days
of the order.
4. standing analysis
“[T]he irreducible constitutional minimum of standing contains three elements.” Lujan v.
Defenders of Wildlife, 504 U.S. 555, 560 (1992). These elements are (1) an injury in fact that is (a)
concrete and particularized and (b) actual or imminent, not conjectural or hypothetical; (2) a causal
connection between the injury and the conduct complained of – the injury has to be fairly traceable
to the challenged action of the defendant and not the result of independent action of some third party
not before the court; and (3) the likelihood that a favorable decision will redress the injury. Id.;
Croft v. Governor of Texas, 562 F.3d 735, 745 (5th Cir. 2009). Particularized means “that the injury
must affect the plaintiff in a personal and individual way.” Lujan, 504 U.S. at 560 n.1. “The party
invoking federal jurisdiction bears the burden of establishing these elements.” Lujan, 504 U.S. at
561.
Defendants argue that Plaintiffs lack standing because Plaintiffs have suffered no injury in
fact and Plaintiffs’ injuries are not redressable by the injunctive relief they seek. Defendants argue
that Plaintiffs’ claim of injury is only conjectural and hypothetical because the only arguable
assertion of future injury in their complaint is that they are “deeply and rightfully concerned about
the potential misuse” of information contained in the blood spots, and that they fear the possibility
of discrimination against their children and perhaps their relatives through research done on the

14

spots.” Defendants argue that this is merely abstract injury, and that Plaintiffs do not allege that any
misuse has occurred or is even likely, much less that it is threatened or imminent.
Plaintiffs state that Judge Biery “recently held that similar plaintiffs complaining of DSHS’s
unlawful uses of infant blood samples had standing to pursue their claims.” In Beleno, Judge Biery
concluded that the plaintiffs had suffered an injury in fact because the storage of the blood was an
injury that had occurred and continued to occur, and there was reasonable fear of the potential for
misuse because of the continued storage by the Department. However, a number of circumstances
have changed since Beleno, including the fact that the Department may no longer store newborn
blood specimens after testing if the parents request destruction of the specimens. Thus, Defendants
contend that, to the extent Plaintiffs argue that Defendants released the blood spots to outside
entities, there is no reasonable fear of future misuse by the Defendants because Defendants no longer
have them. Further, Defendants argue, to the extent Plaintiffs’ fears are directed at future alleged
wrongful releases, rather than the past releases they address in their pleading, they have not
established any real and immediate threat of future injury because all previously stored specimens
in Defendants’ possession were destroyed pursuant to the Beleno settlement and thus cannot be
released or misused by Defendants. Defendants contend that any releases after May 2009 are
governed by the additional protections afforded by amendments made to Chapter 33, which were
not yet in effect at the time of the releases complained of by Plaintiffs, and Plaintiffs have pled no
facts to support any alleged injury or likelihood of injury under the new law.
Plaintiffs may have suffered a past injury in fact if their children’s blood samples were
retained after the newborn screening was completed. In Beleno, the plaintiffs alleged that all the
blood samples had been retained, and thus were subject to potential misuse. However, Defendants

15

were required to destroy all blood samples in the Department’s possession for which no consent was
had to retain them, pursuant to the terms of the Beleno settlement. Thus, that injury – the
Department’s indefinite retention of specimens – is not ongoing, and Plaintiffs’ complaint in this
case is not based on that alleged injury.
Regardless of whether they suffered a past injury by such retention, in order to have standing
to seek injunctive relief, they must demonstrate that they are “likely to suffer future injury by the
defendant.” K.P., 627 F.3d at 123 (quoting James v. City of Dallas, 254 F.3d 551, 563 (5th Cir.
2001)). Because a federal plaintiff must demonstrate standing for each type of relief sought, and the
only relief available to Plaintiffs is prospective equitable relief, Plaintiffs must satisfy the Article
III standing requirements for injunctive and declaratory relief. Grant ex rel. Family Eldercare v.
Gilbert, 324 F.3d 383, 387-88 (5th Cir. 2003) (noting that plaintiff had suffered past injury in fact,
but “[b]ut because he [sought] only declaratory and injunctive relief, he must ‘demonstrate either
continuing harm or a real and immediate threat of repeated injury in the future’”). As the Fifth
Circuit recently noted, “This principle is rote. To obtain forward-looking equitable remedies, a
plaintiff must show she faces imminent threat of future injury.” Fisher v. Univ. of Tex. at Austin,
631 F.3d 213, 217 (5th Cir. 2011). The Court distinguished this aspect of standing from standing
to seek money damages for past injury. Id.
Because all blood specimens in the Department’s possession were destroyed in 2009 (or
would be destroyed upon the Plaintiffs’ written request under section 33.0112), the only potential
continuing injury that existed at the time Plaintiffs filed this lawsuit was the possibility that
Plaintiffs’ children’s blood spots were among the blood spots that had been distributed to third
parties and used for purposes other than newborn screening before the Beleno settlement. The

16

Amended Complaint makes clear that this is the named Plaintiffs’ concern. Plaintiffs allege that
“Defendants have not as of yet accounted for and destroyed all of the outstanding blood samples that
they unlawfully distributed, sold, or traded” and state that “injunctive relief is necessary to account
for the blood samples not currently in Defendants’ possession which they distributed wrongfully and
illegally and without the consent of the Plaintiffs and the class, and will continue to do.” Thus, the
relief sought by Plaintiffs (as opposed to the proposed class) is three-fold: (1) for Defendants to
account for all blood samples and spots of Plaintiffs’ children, whether or not in Defendants’
possession, which Defendants have distributed, sold, bartered, or traded without informed parental
consent; (2) for Defendants to advise Plaintiffs for what purposes Defendants used the blood
samples and spots of Plaintiffs’ children and disclose all financial transactions involved with the use
of such samples and blood; and (3) for Defendants to destroy all such blood samples.
Plaintiffs’ alleged ongoing harm is the possible expropriation of their children’s previously
taken blood by its release to third parties and those third parties’ retention and use of the blood
specimens. Two of the three forms of relief requested by Plaintiffs are informational, and the third
(destruction) is relevant only if the informational relief discloses that Plaintiffs’ children’s blood has
in fact been released. An inability to obtain information may be an injury in fact in some
circumstances. See Fed. Election Comm’n v. Akins, 524 U.S. 11, 21 (1998) (a plaintiff suffers an
injury in fact when the plaintiff fails to obtain information that must be publicly disclosed pursuant
to a statute). But there is no allegation that, at the time Plaintiffs filed this suit, they had even
requested information about the fate of their children’s blood specimens, much less that they had
done so and were refused. Nor had they requested that the blood specimens be destroyed and been
informed that this was not possible due to their release to third parties. Thus, their informational

17

claims were not ripe at the time they filed suit and/or they lacked standing because they had suffered
no injury in fact with regard to the denial of information or the denial of a request for destruction.
Further, at the time they filed suit, Plaintiffs lacked standing to assert their claim for
injunctive relief requiring destruction of released blood specimens because whether they had
suffered the injury in fact of blood specimen release and thus would suffer possible future injury
from that release was entirely speculative. Plaintiffs assert that “the unlawful distribution and sale
of the infants’ blood samples is an injury that has occurred” and “with thousands of samples
remaining in circulation which may be redistributed or re-identified, there is a reasonable fear of the
potential for misuse because of Defendants’ actions.” However, Plaintiffs conflate their claims with
the potential class claims. Whether Plaintiffs’ children’s blood was distributed and could be
potentially misused in the future was speculative at the time they filed their complaint, and it was
speculative because Plaintiffs had not requested destruction or requested information about their
children’s blood specimens. While it may be true that some blood specimens were distributed to
third parties before the Beleno settlement, Plaintiffs simply did not know at the time they filed their
complaint whether their children’s blood had been distributed or destroyed (nor, as noted, had they
asked for this information or requested destruction). Thus, this alleged ongoing injury was
speculative at the time the Complaint (and Amended Complaint) was filed. Such speculation is
insufficient to demonstrate a real and immediate threat of future injury.2 Thus, Plaintiffs lack

2

Plaintiffs assert that, if a police officer takes someone’s diary or personal financial
information without a warrant and proceeds to hold it indefinitely for undisclosed purposes without
consent, that is an injury per se. But in their hypothetical, the plaintiff knew that their diary or
personal financial information was taken, whereas in this case Plaintiffs did not know if their blood
specimens were ever distributed, nor do they allege that Defendants had refused to disclose whether
the specimens were distributed.
18

standing.
5. mootness
Even if Plaintiffs had standing, their claims are now moot. The harm alleged by Plaintiffs
was the distribution of the blood spots and the potential misuse resulting therefrom. But Defendants
have offered (undisputed) evidence that Plaintiffs’ children’s blood spots were never released to any
other entity and have been destroyed. The affidavit of Dr. Adolfo Valadez, the Assistant
Commissioner for the Division of Prevention and Preparedness Services “affirm[s] that as of April
12, 2010 DSHS has destroyed all blood specimens in its or Texas A&M University Health Science
Center’s possession which were taken from infants born in Texas as part of the Newborn Screening
Program and received by DSHS prior to May 27, 2009, for which DSHS does not have written
consent from the parent/guardian/managing conservator to retain and use those specimens.” Ex. 1B.
Defendants also provide the affidavit of Susan M. Tanksley, the Biochemistry and Genetics
Branch Manager for the Department. Ex. 3 (Feb. 15, 2011 Affidavit). She states that, using the
name and birthday information provided in the Complaint, the Department was able to determine
from its records the status of Plaintiffs’ children’s samples. She states that, with regard to the
Higgins infant: (1) newborn screening was conducted under Chapter 33 on blood spots from an
infant Higgins born on September 26, 2007; (2) the Higgins blood spots were never used for any
purpose other than newborn screening conducted at the DSHS newborn screening laboratory; (3)
other than for storage at Texas A&M University, the spots were not distributed to any individual or
entity at any time for any purpose, including research; and (4) the Higgins blood spots were
destroyed on or before April 12, 2010, in compliance with the Beleno settlement.
Similarly, with regard to the McCall infant, Tanksley attests that the records indicate that:

19

(1) newborn screening was conducted pursuant to Chapter 33 on blood spots from an infant McCall
born on March 7, 2008, whose mother was listed as Andromida McCall; (2) the blood spots were
never used for any purpose other than newborn screening conducted at the DSHS Laboratory; (3)
the blood spots were never distributed to any individual or entity at any time, for research or any
other purpose; and (4) DSHS records indicate that the McCall blood spots were destroyed on or
before April 12, 2010 in compliance with the Beleno settlement.
Plaintiffs never refute Defendants’ evidence that Plaintiffs’ children’s blood samples were
not distributed and have in fact been destroyed. Accordingly, even if Plaintiffs had standing, their
claims are now moot.
6. class claims
The Court finds that Plaintiffs’ claims must be dismissed for lack of jurisdiction. Plaintiffs
may not rely on the claims of class members to establish their own standing. As the Fifth Circuit
has explained,
Standing is a jurisdictional requirement that focuses on the party seeking to get his
or her complaint before a federal court and not on the issues he or she wishes to have
adjudicated. “A litigant must be a member of the class which he or she seeks to
represent at the time the class action is certified by the district court.” If the litigant
fails to establish standing, he or she may not seek relief on behalf of himself or
herself or any other member of the class.
James v. City of Dallas, Tex., 254 F.3d 551, 562-63 (5th Cir. 2001). Accordingly, dismissal of
Plaintiffs’ claims requires dismissal of the proposed class claims as well.
Conclusion
Defendants’ Motion to Dismiss (docket no. 4) is GRANTED IN PART and DISMISSED AS
MOOT IN PART. Specifically, the motion to dismiss under Rule 12(b)(1) for lack of jurisdiction
is granted, and the 12(b)(6) motion is dismissed as moot.
20

Plaintiffs’ claims are therefore

DISMISSED WITHOUT PREJUDICE for lack of jurisdiction. Further, Plaintiffs’ Opposed Motion
for Leave to File Motion to Certify the Class (docket no. 19) is DISMISSED AS MOOT.
This Order disposes of all claims and parties. The Clerk’s office is directed to enter a final
judgment pursuant to Rule 58 dismissing all claims without prejudice, and to close this case.
It is so ORDERED.
SIGNED this 7th day of July, 2011.

_________________________________
XAVIER RODRIGUEZ
UNITED STATES DISTRICT JUDGE

21