Kevin Glenn Schronk, Individually and as Representative of the Estate of Helen Patricia Schronk, and Dustin Schronk v. City of Burleson and Laerdal Medical Corp.

                                 IN THE
                         TENTH COURT OF APPEALS

                                No. 10-07-00399-CV

KEVIN GLENN SCHRONK, INDIVIDUALLY AND AS
REPRESENTATIVE OF THE ESTATE OF HELEN PATRICIA
SCHRONK, DECEASED, AND DUSTIN SCHRONK

                                                          Appellants
v.

CITY OF BURLESON AND LAERDAL MEDICAL CORP.,

                                                          Appellees



                          From the 413th District Court
                             Johnson County, Texas
                           Trial Court No. C200600118


                                    OPINION


      Kevin Schronk and his son Dustin filed a wrongful death suit against the City of

Burleson and Laerdal Medical Corporation after emergency medical technicians

employed by the City were unable to resuscitate Helen Schronk with an automatic

external defibrillator (AED) manufactured by Laerdal. The trial court granted the City’s

plea to the jurisdiction and Laerdal’s summary-judgment motion.          The Schronks
contend in four points that the court erred by: (1) granting Laerdal’s summary-

judgment motion because the motion did not address their product liability claim and

genuine issues of material fact remain on their negligence claim; (2) denying their

special exceptions to the City’s plea to the jurisdiction; (3) granting the City’s plea to the

jurisdiction; and (4) sustaining the City’s objections to evidence they offered in

opposition to the City’s plea to the jurisdiction. We will reverse and remand.

                                        Background

        Kevin Schronk called 9-1-1 when his wife Helen suffered a cardiac arrest. EMT’s

employed by the City responded and tried to resuscitate Helen with an AED

manufactured by Laerdal. However, the AED’s battery was too weak to administer a

defibrillating shock. The EMT’s made several attempts to administer a shock with the

AED but could not because of the low battery. Another AED was brought to the

location, but Helen could not be resuscitated. She was pronounced dead on arrival at

the hospital.

        Kevin and Dustin filed suit against the City and Laerdal. They alleged that the

City was liable for negligence based on its failure to properly maintain the AED and for

violations of various statutes applicable to emergency services providers. They alleged

that Laerdal was liable: (1) for negligence in the: (a) design, manufacture, marketing,

etc. of the AED; (b) training of City employees in the operation and maintenance of the

AED; (c) service and maintenance of the AED; and (d) labeling of the AED battery; and

(2) for selling an unreasonably dangerous product.




Schronk v. City of Burleson                                                             Page 2
        The City filed a plea to the jurisdiction alleging that its “sovereign immunity has

not been waived.” Laerdal filed a summary-judgment motion presenting both no-

evidence and traditional grounds. The Schronks filed pleadings responsive to the plea

to the jurisdiction and to the summary-judgment motion. They also filed a summary-

judgment motion of their own.

        The City filed objections to evidence relied on by the Schronks in their response

to the plea to the jurisdiction. Laerdal likewise filed objections to evidence relied on by

the Schronks in their summary-judgment response.

        The court conducted a hearing on the City’s plea to the jurisdiction, Laerdal’s

summary-judgment motion, and the Schronks’ summary-judgment motion. A week

later, the court signed three separate orders: (1) granting the City’s plea to the

jurisdiction; (2) granting Laerdal’s summary-judgment motion; and (3) sustaining the

City’s objections to the Schronks’ evidence.

                                    Special Exceptions

        The Schronks contend in their second point that the court abused its discretion

by denying their special exceptions to the City’s plea to the jurisdiction. The City

responds that the Schronks have failed to preserve this issue for appellate review

because they did not obtain a ruling on their special exceptions. In the alternative, the

City argues that no abuse of discretion is shown because the plea to the jurisdiction

gave the Schronks fair notice of the basis for the City’s immunity claim.




Schronk v. City of Burleson                                                          Page 3
                                        Preservation

        The trial court did not expressly rule on the special exceptions.        When the

Schronks called their special exceptions to the court’s attention at the hearing on the

plea to the jurisdiction, the court responded, “I don’t have a hearing on Special

Exceptions set. I just want to hear the Plea to the Jurisdiction and the responses to that.”

But the order granting the City’s plea to the jurisdiction reads in pertinent part:

        came on to be considered the City of Burleson’s Plea to the Jurisdiction,
        together with its Brief Supporting City of Burleson’s Plea to the
        Jurisdiction (including an Appendix); Plaintiff’s Special Exceptions and
        Response to City of Burleson’s Plea to the Jurisdiction and to Brief
        Supporting City’s Plea; Plaintiffs’ Supplemental Response to Defendant
        Burleson’s Plea to the Jurisdiction; and City of Burleson’s Objections to
        Plaintiffs’ Response; and arguments of counsel. Having considered such
        matters, the Court has determined that the Plea to the Jurisdiction is well
        founded and should be granted.

(emphases added).

        Rule of Appellate Procedure 33.1 recognizes that issues may be preserved either

by express or implicit rulings. See TEX. R. APP. P. 33.1(a)(2)(A). In the summary-

judgment context, this Court has consistently held that the grant of a summary-

judgment motion, standing alone, does not constitute an implicit ruling on objections to

the movant’s summary-judgment proof. See, e.g., Allen ex rel. B.A. v. Albin, 97 S.W.3d

655, 663 (Tex. App.—Waco 2002, no pet.). The Schronks contend that a different rule

applies for special exceptions.      See, e.g., Fieldtech Avionics & Instruments, Inc. v.

Component Control.Com, Inc., 262 S.W.3d 813, 824 n.3 (Tex. App.—Fort Worth 2008, no

pet.) (“a trial court implicitly overrules special exceptions when it grants summary




Schronk v. City of Burleson                                                           Page 4
judgment on the motion to which the special exceptions pertain”). However, we need

not decide in this case whether a different rule applies.

        The Schronks called their special exceptions to the trial court’s attention at the

hearing on the plea to the jurisdiction. The court stated on the record that it did not

want to consider the special exceptions, but stated in its written order that it did

consider them. See In re Marriage of Jordan, 264 S.W.3d 850, 855 (Tex. App.—Waco 2008,

no pet.) (written order controls over oral rulings).              Thus, the court considered the

Schronks’ challenges to the adequacy of the City’s plea to the jurisdiction and implicitly

overruled their challenges by ruling on the merits of the City’s pleading. See Clement v.

City of Plano, 26 S.W.3d 544, 550 n.5 (Tex. App.—Dallas 2000, no pet.) (by granting

summary judgment, trial court implicitly overruled special exceptions which were

“presented” to court), disapproved on other grounds by Telthorster v. Tennell, 92 S.W.3d 457,

464 (Tex. 2002).

                                    Type(s) of Immunity Alleged

        “The purpose of a special exception is to compel clarification of pleadings when

the pleadings are not clear or sufficiently specific.” Baylor Univ. v. Sonnichsen, 221

S.W.3d 632, 635 (Tex. 2007) (per curiam). Pleadings must give “fair notice” of a party’s

claims or defenses. Horizon/CMS Heathcare Corp. v. Auld, 34 S.W.3d 887, 896-97 (Tex.

2000); Schwartz v. Ins. Co. of the State of Pa., 274 S.W.3d 270, 276 (Tex. App.—Houston

[1st Dist.] 2008, pet. denied). The test long-recognized by intermediate appellate courts1

in Texas is “whether an opposing attorney of reasonable competence, perusing the

1
        According to our research, the Supreme Court has neither embraced nor rejected this test.


Schronk v. City of Burleson                                                                         Page 5
pleadings, can ascertain the nature and the basic issues of the controversy and the

testimony probably relevant.” 2 ROY W. MCDONALD & ELAINE A. GRAFTON CARLSON,

TEXAS CIVIL PRACTICE § 7:4[b] (2d ed. 2002); see Schwartz, 274 S.W.3d at 276; Schley v.

Structural Metals, Inc., 595 S.W.2d 572, 587 (Tex. Civ. App.—Waco 1979, writ ref’d n.r.e.);

Daniels v. Conrad, 331 S.W.2d 411, 415 (Tex. Civ. App.—Dallas 1959, writ ref’d n.r.e.).

        The Schronks first argue that the City’s plea to the jurisdiction does not give fair

notice of whether the City was asserting immunity from suit or immunity from liability.

It is true that the City’s pleading only uses the term “sovereign immunity” and does not

specify whether immunity from suit or immunity from liability is claimed.

        The Schronks cite Baylor College of Medicine v. Hernandez, 208 S.W.3d 4 (Tex.

App.—Houston [14th Dist.] 2006, pet. denied), for the proposition that, because the City

explicitly claimed immunity as an affirmative defense and never used the term

“immunity from suit” in its pleading, the City’s plea to the jurisdiction does not allege

immunity from suit.           In Baylor College of Medicine, however, the plaintiff did not

challenge      the    defendants’      pleadings    by   special   exceptions,   and      the

defendants/appellants did not claim immunity from suit in their appellate pleadings.

See id. at 9 n.5. Thus, the court made it clear that immunity from suit was not an issue in

that case.

               As the text of appellants’ motions and briefs make clear, Baylor and
        the Physicians interpret section 312.006 of the Health and Safety Code to
        confer immunity from liability on each of them and base their claims of
        immunity on this section and on the alleged lack of notice. Although
        appellants’ motion to dismiss also contains the conclusory statement that
        Baylor and the Physicians are immune from both liability and suit
        pursuant to “TEX. HEALTH & SAFETY CODE Section 312 et seq., TEX. CIV.


Schronk v. City of Burleson                                                            Page 6
        PRAC. & REM.CODE Section 101 et seq., and TEX. EDUC. CODE Section 61 et
        seq.,” the appellants repeatedly state that section 312.006(a) confers
        immunity from liability and present neither argument nor authority
        supporting their claim that any specific section of the globally-cited codes
        renders them immune from suit. To the extent that such an issue has been
        raised, it is waived pursuant to TEX. R. APP. P. 33.1(a)(1)(A) and 38.1(h).

Id.

        Here, the City unequivocally claims immunity from suit on appeal, so we will

examine the City’s trial pleadings to determine whether immunity from suit was

adequately pleaded in the court below.

        Sovereign or governmental immunity2 consists of immunity from suit and

immunity from liability. Reata Constr. Corp. v. City of Dallas, 197 S.W.3d 371, 374 (Tex.

2006). Immunity from suit “bars a suit unless the state has consented,” while immunity

from liability “protects the state [or a political subdivision] from judgments even if it

has consented to the suit.” Id. “[I]mmunity from suit deprives a trial court of subject-

matter jurisdiction.” Id. By contrast, immunity from liability is an affirmative defense

which must be pleaded or it is waived. Tex. Dep’t of Transp. v. Jones, 8 S.W.3d 636, 638

(Tex. 1999); City of Weslaco v. Borne, 210 S.W.3d 782, 789-90 (Tex. App.—Corpus Christi

2006, pet. denied). “Immunity from liability does not affect a court’s jurisdiction to hear

a case.” Jones, 8 S.W.3d at 638; accord Borne, 210 S.W.3d at 789.

        First, we observe that the City filed a three-part defensive pleading. In the first

part, the City generally denied the Schronks’ allegations.               In the second, the City


2
         “Sovereign immunity protects the State, state agencies, and their officers, while governmental
immunity protects subdivisions of the State, including municipalities and school districts.” Mission
Consol. Indep. Sch. Dist. v. Garcia, 253 S.W.3d 653, 655 n.2 (Tex. 2008).



Schronk v. City of Burleson                                                                     Page 7
asserted the “affirmative defense” of “sovereign immunity.” See Jones, 8 S.W.3d at 638;

Borne, 210 S.W.3d at 789-90. The City entitled the third part a “plea to the jurisdiction.”3

Paragraph 3.02 states, “Because the City’s sovereign immunity has not been waived,

Plaintiff’s claims are barred. Therefore, this Court does not have jurisdiction as to the

City.” From this allegation, “an opposing attorney of reasonable competence” would

understand that the City was claiming immunity from suit in the “plea-to-the-

jurisdiction” section of its defensive pleading. See Reata Constr. Corp., 197 S.W.3d at 374.

                                             Supporting Brief

        The Schronks also challenge the propriety of the City’s brief supporting its plea

to the jurisdiction “to the extent [the supporting brief] attempts to cure the defects or

add grounds, argument or evidence omitted from the Plea.” Restated, they contend

that a brief in support of a plea to the jurisdiction cannot: (1) cure defects in the plea to

the jurisdiction; (2) allege additional grounds on which a court may determine that it

does not have jurisdiction; (3) present additional argument regarding the grounds

stated in the plea to the jurisdiction; or (4) present evidence supporting the grounds

stated in the plea to the jurisdiction.

        We need not address the first two contentions because the City’s plea to the

jurisdiction is not “defective” and because the brief in support of the City‘s plea does
3
         The Schronks also complain about the City’s incorporating by reference in this third part of its
defensive pleading “the reasons set forth in the foregoing paragraphs numbers 2.01, 2.02, 20.3 [sic], 2.04
and 2.05” (which are paragraphs in the “immunity-from-liability” section of the pleading) as grounds for
its claim of immunity from suit. We are unpersuaded. This pleading method merely reflects the close
relationship in the Tort Claims Act between immunity from suit and immunity from liability. See TEX.
CIV. PRAC. & REM. CODE ANN. § 101.025(a) (Vernon 2005) (“Sovereign immunity to suit is waived and
abolished to the extent of liability created by this chapter.”); Tex. Dep’t of Parks & Wildlife v. Miranda, 133
S.W.3d 217, 224 (Tex. 2004) (“The Tort Claims Act creates a unique statutory scheme in which the two
immunities are co-extensive”).


Schronk v. City of Burleson                                                                             Page 8
not present additional grounds on which the Court could find that the City’s immunity

from suit is not waived.

        In Burford v. Wilson, the Tyler Court held that, under Rule of Civil Procedure

166a(c),4 exhibits attached to the appellees’ brief filed in support of their summary-

judgment motion but not referred to in the motion could not be considered as part of

the summary-judgment record. 885 S.W.2d 253, 256 (Tex. App.—Tyler 1994), rev’d on

other grounds, 904 S.W.2d 628 (Tex. 1995) (per curiam). The Supreme Court reversed

because a deposition attached to the appellees’ supporting brief was also referred to in

the appellants’ summary-judgment response. Wilson v. Burford, 904 S.W.2d 628, 629

(Tex. 1995) (per curiam). The Burford case serves to illustrate the unique provisions of

Rule of Civil Procedure 166a governing summary-judgment practice. Admittedly, the

Supreme Court has looked to summary-judgment cases for guidance in defining the

standard of review for a plea to the jurisdiction. See Tex. Dep’t of Parks & Wildlife v.

Miranda, 133 S.W.3d 217, 227-28 (Tex. 2004). But the Court has expressly rejected the




4
        Rule 166a(c) provides in pertinent part that a summary-judgment ruling must be based on:

        (i) the deposition transcripts, interrogatory answers, and other discovery responses
        referenced or set forth in the motion or response, and (ii) the pleadings, admissions,
        affidavits, stipulations of the parties, and authenticated or certified public records, if any,
        on file at the time of the hearing, or filed thereafter and before judgment with permission
        of the court.

TEX. R. CIV. P. 166a(c). Under the plain language of this rule (and contrary to the Tyler Court’s decision in
Burford), documentary evidence may be considered as part of the summary-judgment record if it is “on
file at the time of the hearing, or filed thereafter and before judgment with permission of the court.”
Enter. Leasing Co. of Houston v. Barrios, 156 S.W.3d 547, 549 (Tex. 2004) (per curiam) (quoting TEX. R. CIV. P.
166a(c)). Of course, it is preferable that a summary-judgment motion or response make specific reference
to other evidence on file but not attached to the motion or response.


Schronk v. City of Burleson                                                                               Page 9
application of the summary-judgment procedures required by Rule 166a in the context of

a plea to the jurisdiction. Id. at 228-29.

        The Tyler Court observed in Burford that “[t]he sole purpose of a brief in support

of a motion for summary judgment is to aid the court in determining whether the

summary judgment grounds and evidence in support of those grounds entitles the

movant to judgment as a matter of law.” 885 S.W.2d at 256. Thus, a brief filed in

support of a particular trial pleading should ordinarily clarify the grounds asserted in

that pleading and present additional argument and authorities in support of those

grounds.

        The City’s supporting brief is divided into eight parts: (1) authority to submit

brief and appendix; (2) general discussion of the law regarding sovereign immunity; (3)

summary of the Schronks’ claims; (4) argument and authority regarding why the City’s

immunity is not waived under the Tort Claims Act; (5) argument and authority

regarding why the City’s immunity is not waived under the Health and Safety Code; (6)

argument and authority regarding why the City’s immunity has not been waived with

regard to the Schronks’ bystander claims; (7) an alternative argument with supporting

authority that there is no evidence the AED caused a legally cognizable loss of chance of

survival; and (8) a summary and conclusion.

        In the concluding summary, the supporting brief states:

               The City’s March 20, 2006 Plea to the Jurisdiction asserted the
        City’s sovereign immunity to all of Plaintiff’s [sic] claims. The City
        asserted that the injuries and death at issue are not caused by the City’s
        property. The City asserted that bystander claims are not the type of
        claim for which sovereign immunity is waived. The City asserted that


Schronk v. City of Burleson                                                          Page 10
        Tort Claims Act § 101.055 does not waive immunity. For these reasons,
        and based upon the evidence and in the Appendix supporting this Brief,
        and based upon the legal arguments contained in this Brief, the City’s Plea
        to the Jurisdiction must be granted and the claims against the City
        dismissed.

        As clarified by this concluding summary, the City’s supporting brief offers

additional argument and authorities to support the contentions set forth in its plea to

the jurisdiction, namely: (1) the City has immunity from suit because the AED did not

cause Helen’s death; (2) there is no waiver of immunity for the Schronks’ bystander

claims; and (3) the City has immunity from suit under sections 101.055 and 101.062 of

the Tort Claims Act, which apply respectively to emergency services providers and 9-1-

1 emergency services.5 The supporting brief does not assert additional grounds for

immunity from suit.

        The supporting brief incorporates by reference an appendix containing

authenticated copies of pertinent City records, depositions and exhibits, and affidavits.

This is the evidence on which the City relies to prevail on its claim of immunity from

suit. The Schronks argue that this is improper because the supporting evidence is not

attached to the City’s plea to the jurisdiction itself. We disagree. There is no rule

specifying the manner in which a party must present evidence in support of a plea to

the jurisdiction. Although summary-judgment practice may provide a useful analytical

framework, there is no rule requiring that evidence be attached to a plea to the

jurisdiction to be considered by a trial court. Cf. TEX. R. CIV. P. 166a(c) (summary



5
       The City’s claim of immunity under section 101.062 of the Tort Claims Act relates to the
Schronks’ allegations that the City violated sections 773.042 and 779.003 of the Health and Safety Code.


Schronk v. City of Burleson                                                                     Page 11
judgment should be based in part on evidence “referenced or set forth in the motion or

response”).

        The City filed its supporting brief and appendix more than a month before the

hearing on the plea to the jurisdiction. The Schronks do not contend that they were

surprised or prejudiced by the evidence included in the appendix and referenced in the

supporting brief. Therefore, we hold that the court did not abuse its discretion by

considering the evidence the City submitted in this manner.

                              Nature of Jurisdictional Challenge

        Finally, the Schronks contend that the plea to the jurisdiction is deficient because

it does not specify whether the City is challenging the adequacy of their petition or the

existence of jurisdictional facts. See Miranda, 133 S.W.3d at 226-27 (describing two types

of challenges which may be asserted in a plea to the jurisdiction).

        The Schronks allege in their petition that the City’s use of a defective AED was a

proximate cause of Helen’s death. The Schronks further allege that the “non-waiver” of

immunity under section 101.055 for emergency services providers does not apply

because the City acted “with conscious indifference or reckless disregard for the safety

of others.” And the Schronks allege that the “non-waiver” of immunity under section

101.062 for providers of 9-1-1 emergency services does not apply because the City

violated statutes regarding the maintenance and testing of AED’s.

        The City contends in its plea to the jurisdiction that (1) it has immunity from suit

under section 101.021 because the AED did not cause Helen’s death; (2) there is no




Schronk v. City of Burleson                                                          Page 12
waiver of immunity under section 101.021 for the Schronks’ bystander claims; and (3) it

has immunity from suit under sections 101.055 and 101.062.

        A plea to the jurisdiction which challenges the plaintiff’s pleadings asserts that

the plaintiff’s pleadings fail to allege “facts that affirmatively demonstrate the court’s

jurisdiction to hear the cause.” See Miranda, 133 S.W.3d at 226. Conversely, a plea to the

jurisdiction which disputes the existence of jurisdictional facts asserts in essence that the

evidence conclusively negates the existence of the relevant jurisdictional facts. Id. at

227-28.

        The heart of the Schronks’ claims is that the City’s use of a defective AED was a

proximate cause of Helen’s death.        The City does not contend in its plea to the

jurisdiction that this allegation is not sufficient to allege a waiver of immunity under

section 101.021 or the other applicable statutes. Rather, the City disputes whether its

use of the AED was a proximate cause of Helen’s death. Thus, “an opposing attorney of

reasonable competence” would understand that the City’s plea to the jurisdiction

challenged the existence of jurisdictional facts. Id.

        The court did not abuse its discretion by overruling the Schronks’ special

exceptions. Accordingly, we overrule the Schronks’ second point.




Schronk v. City of Burleson                                                           Page 13
                               Objections to the Schronks’ Evidence

        The Schronks aver in their fourth point that the court abused its discretion by

sustaining the City’s objections to the evidence they offered in response to the City’s

plea to the jurisdiction.6

        The Schronks do not contest the applicability of the Rules of Evidence to

evidence submitted in connection with a plea to the jurisdiction. We are aware of no

reason these rules should not govern the admissibility of such evidence. See TEX. R.

EVID. 101(b) (“Except as otherwise provided by statute, these rules govern civil and

criminal proceedings (including examining trials before magistrates) in all courts of

Texas, except small claims courts.”); cf. Allbritton v. Gillespie, Rozen, Tanner & Watsky,

P.C., 180 S.W.3d 889, 892 (Tex. App.—Dallas 2005, pet. denied) (“Summary-judgment

evidence must be presented in a form that would be admissible in a conventional trial

proceeding.”); Choctaw Props., L.L.C. v. Aledo Indep. Sch. Dist., 127 S.W.3d 235, 240 (Tex.

App.—Waco 2003, no pet.) (same).

                                   Depositions Regarding Violation of
                              Section 779.003 of the Health & Safety Code

        The City raised a three-part objection to deposition excerpts from various

firefighters which the Schronks offered to establish that the AED was not maintained

and tested in accordance with manufacturer guidelines and that the City thus violated




6
         Because the admissibility of the Schronks’ evidence impacts our review of the merits of the City’s
plea to the jurisdiction, we first address their fourth point. See Torres v. GSC Enters., Inc., 242 S.W.3d 553,
557 (Tex. App.—El Paso 2007, no pet.); Choctaw Props., L.L.C. v. Aledo Indep. Sch. Dist., 127 S.W.3d 235, 240
(Tex. App.—Waco 2003, no pet.).


Schronk v. City of Burleson                                                                           Page 14
section 779.003 of the Health and Safety Code.7 The City objected that the Schronks

omitted from these excerpts the objections the City lodged at the time of the

depositions.8 But see TEX. R. CIV. P. 203.6(b) (“All or part of a deposition may be used for

any purpose in the same proceeding in which it was taken.”) (emphasis added); Jones v.

Colley, 820 S.W.2d 863, 866 (Tex. App.—Texarkana 1991, writ denied) (“[T]he

defendants, on the sole ground that the tape was out of chronological order or was not

complete, had no right to prevent the use of the edited videotape. Their remedy was to

introduce the unedited deposition or their own edited version in response to Jones’

offer.”).

        The City also objected that the testimony of these firefighters was conclusory

regarding any failure to follow the manufacturer’s guidelines because there is no

evidence in the record of: (1) the factual content of the guidelines allegedly violated; (2)

how the guidelines pertained to maintenance or testing; or (3) how the guidelines were

violated. In addition, the City objected that this testimony was conclusory regarding

any violation of section 779.003 because there is no evidence that the firefighters: (1)

knew the content of this law; (2) knew how the law was violated; or (3) were qualified

to give an opinion concerning the alleged violation.




7
         Section 779.003 provides, “A person or entity that owns or leases an automated external
defibrillator shall maintain and test the automated external defibrillator according to the manufacturer’s
guidelines.” TEX. HEALTH & SAFETY CODE ANN. § 779.003 (Vernon 2003).

8
         The City states that most of these objections were to the form of the questions posed. See TEX. R.
CIV. P. 199.5(e). The City suggests that there were other objections but does not identify the nature of the
objections.


Schronk v. City of Burleson                                                                         Page 15
        We first observe that the City’s objections appear to be directed to the excerpts of

deposition testimony included within the body of the Schronks’ response. However,

the Schronks attached more complete excerpts of these depositions as exhibits.

Regarding the manufacturer’s guidelines, counsel handed the witnesses a copy of a 46-

page document with “Directions for Use” for the AED and asked them questions about

particular instructions without objection.9 If the quoted excerpts are read standing

alone, they are somewhat conclusory, but when read in conjunction with the remainder

of each witness’s testimony, they merely summarize that witness’s previous testimony

and are supported by a written copy of the manufacturer’s guidelines attached as an

exhibit to one of the depositions.10

        Summary-judgment evidence is considered “conclusory” if it “does not provide

the underlying facts to support the conclusion.” Choctaw Props., 127 S.W.3d at 242

(quoting Dolcefino v. Randolph, 19 S.W.3d 906, 930 (Tex. App.—Houston [14th Dist.]

2000, pet. denied)) (other citations omitted). “A ‘conclusory’ statement may set forth an

unsupported legal conclusion or an unsupported factual conclusion.” Id. A lay witness

“may not give legal conclusions or interpret the law to the jury.” United Way of San

Antonio, Inc. v. Helping Hands Lifeline Found., Inc., 949 S.W.2d 707, 713 (Tex. App.—San

Antonio 1997, writ denied).
9
         This 46-page document is entitled, “Laerdal HEARTSTART 911, Automated External
Defibrillator, Directions for Use.” We refer to it hereinafter as the “instruction manual.”

10
         We have already ruled that the City’s evidence did not need to be attached to its plea to the
jurisdiction to be considered by the trial court. We likewise hold that the entirety of a responding party’s
evidence need not be quoted within the body of a response to the plea to the jurisdiction. Such evidence
may be attached to the responsive pleading or filed separately and contemporaneously thereto or
“thereafter and before judgment with permission of the court.” Cf. TEX. R. CIV. P. 166a(c).



Schronk v. City of Burleson                                                                         Page 16
        Taking as true the deposition testimony favorable to the Schronks,11 Firefighter

Steve Burchett testified that the manufacturer’s guidelines “specifically” say “you’re

supposed to check the date codes on every battery before you use them.” He did not

know of anyone in the department who did this, which was in his opinion a violation of

the guidelines. Lieutenant Michael Gloff testified that the batteries in the AED had

expired and their use on the occasion in question was a violation of the guidelines.

        In both instances, these witnesses provided an adequate factual basis for their

testimony. Thus, the court abused its discretion to the extent that it sustained the City’s

objections on the basis that the testimony of these witnesses was conclusory regarding

the City’s alleged failure to follow the manufacturer’s guidelines. See Choctaw Props.,

127 S.W.3d at 242-43.

        However, both witnesses and others were also asked whether this conduct

constituted a violation of section 779.003. This was improper. See United Way of San

Antonio, 949 S.W.2d at 713. Thus, the court did not abuse its discretion insofar as it

sustained the City’s objections that these witnesses were improperly testifying

regarding legal conclusions.

                                         Dr. Reese’s Affidavit

        The City objected to the affidavit of the Schronks’ expert Dr. Edward Reese on

the grounds that: (1) he relies on Laerdal records which cannot be used against the City;

(2) his affidavit is supported by a “random collection” of documents which are not


11
         See Miranda, 133 S.W.3d at 228 (appellate court must “take as true all evidence favorable to the
nonmovant” and “indulge every reasonable inference and resolve any doubts in the nonmovant’s
favor”).


Schronk v. City of Burleson                                                                      Page 17
properly identified or authenticated; (3) his concluding statement of opinion does not

adequately identify the bases for the opinion; and (4) he is not qualified to provide a

medical opinion on the cause of Helen Schronk’s death.

        The City states no legal basis for its initial objection regarding Dr. Reese’s use of

Laerdal records. We are aware of no such limitation. The Schronks’ theory is that City

employees used a defective AED manufactured by Laerdal which was a proximate

cause of Helen Schronk’s death. Laerdal records regarding the AED are relevant to the

Schronks’ claims and admissible even against the City. See Olympic Arms, Inc. v. Green,

176 S.W.3d 567, 578 (Tex. App.—Houston [1st Dist.] 2004, no pet.) (testimony of co-

defendant gunsmith considered in product liability suit against manufacturer of

defective rifle barrel).

        Next, the City complains that Dr. Reese’s affidavit is inadmissible because it is

supported by a “random collection” of documents which are not properly identified or

authenticated. We disagree. The affidavit specifically identifies the documents on

which Dr. Reese relied. For example, Dr. Reese relied in paragraph 21 on “Defendant

Laerdal’s ‘Incident Information’ report (see LMC 03590, also marked Exhibit #30).” In

paragraph 24, he referred to “the Med Watch Report [Mandatory Reporting FDA Form

3500A]” and provided citations to various “LMC” numbers12 in this report which

correspond to the pagination of the report attached as an exhibit to his affidavit.




12
       These “LMC” numbers apparently refer to Laerdal’s pagination of the pertinent documents.
They are similar to Bates stamp numbers.


Schronk v. City of Burleson                                                             Page 18
        Regarding the admissibility of the exhibits attached to Dr. Reese’s affidavit, Rule

of Evidence 703 provides in pertinent part, “If of a type reasonably relied upon by

experts in the particular field in forming opinions or inferences upon the subject, the

facts or data need not be admissible in evidence.” TEX. R. EVID. 703. An expert in this

case may reasonably rely on the records of the manufacturer to evaluate whether the

product in question is defective. Cf. Olympic Arms, 176 S.W.3d at 578 (experts testified

about rifle manufacturing process and about another defective rifle barrel produced by

defendant at about same time). Therefore, the admissibility of the exhibits is irrelevant.

See TEX. R. EVID. 703.

        The City also complains that Dr. Reese’s concluding statement renders his

affidavit inadmissible because it does not provide a sufficiently specific statement of the

bases for his opinion. The statement in question reads, “The opinions stated herein are

based upon information provided by the Plaintiff and my knowledge and expertise

with medical devices, the medical industry, and FDA Rules and Regulations.” Standing

alone, this probably would be insufficient. Cf. Volkswagen of Am., Inc. v. Ramirez, 159

S.W.3d 897, 902, 911 (Tex. 2004) (expert’s reliance on the “laws of physics” does not

provide a sufficient basis for his opinion). However, Dr. Reese provided much more

detail in the 15-plus pages preceding this concluding summary statement. In the body

of his affidavit, Dr. Reese relied on specified federal regulations, specified portions of

Laerdal’s guidelines for use of the AED, Laerdal’s incident information report, a

mandatory FDA “Med Watch” report regarding the incident, and other specified

documents. Therefore, his affidavit provided sufficient factual substantiation for his


Schronk v. City of Burleson                                                         Page 19
expert opinion regarding whether the AED was defective.           See Merrell v. Wal-Mart

Stores, Inc., 276 S.W.3d 117, 128 (Tex. App.—Texarkana 2009, pet. filed).

        Finally, the City challenges Dr. Reese’s qualifications to render an expert opinion

on the cause of Helen Schronk’s death. Dr. Reese is not a medical doctor. He has a

doctor of philosophy degree in medical technology studies and holds certifications as a

forensic examiner and a forensic consultant, a certification in forensic medicine, and

certification as a “Level Five” medical investigator. He states in his affidavit that he is

“a medical device expert.”      He states in his CV that his “competencies” include

determining “if a causal relationship exists between a suspect medical device and its

manufacturer, distributor, physician, and/or hospital.”   (emphasis added).   Because Dr.

Reese is not a medical doctor and because his affidavit and CV do not demonstrate any

special experience in determining medical causation, we cannot say the court abused its

discretion by determining that he is not qualified to render an expert opinion on cause

of death. See Methodist Health Ctr. v. Thomas, No. 14-07-00085-CV, 2007 Tex. App. LEXIS

6655, at *8-9 (Tex. App.—Houston [14th Dist.] 2007, no pet.) (mem. op.); Marts ex rel.

Marts v. Transp. Inc. Co., 111 S.W.3d 699, 703-04 (Tex. App.—Fort Worth 2003, pet.

denied).

                               General References to Exhibits

        The City objected to sections of the Schronks’ response, beginning with

paragraph 17, in which the Schronks refer to “ample proof” that the City’s use of a

malfunctioning AED was a proximate cause of Helen Schronk’s death. Throughout

several pages of the response beginning here, the Schronks generally refer to “exhibits


Schronk v. City of Burleson                                                         Page 20
A-F with exhibits” or “exhibits A-G” without any more specificity. It appears that the

Schronks sought to establish two things at this point in their response: (1) their petition

alleged sufficient facts to state a waiver of immunity; and (2) they provided “ample

proof” to support these allegations. The City contends that their general references to

the exhibits do not constitute competent evidence of cause of death. To the extent the

Schronks relied on these general references to show evidence of cause of death, we

agree. See State v. Life Partners, Inc., 243 S.W.3d 236, 242 (Tex. App.—Waco 2007, pet.

denied) (“A general reference to a voluminous record that does not direct the trial court

and parties to the evidence on which the movant relies is insufficient.”) (quoting Aguilar

v. Morales, 162 S.W.3d 825, 838 (Tex. App.—El Paso 2005, pet. denied)).

                                        Dr. Desser’s Affidavit

        The City objected that the affidavit of Dr. Kenneth Desser is inadmissible

because: (1) it did not comply with Rule of Civil Procedure 194.2(f)(3) by providing a

brief summary of the basis for Dr. Desser’s opinion; (2) it contains internal conflicts; and

(3) it fails to address undisputed evidence.13

        Rule 194.2(f) governs disclosure of information regarding the opposing party’s

testifying experts. See TEX. R. CIV. P. 194.2(f). Under the trial court’s scheduling order,

the deadline for disclosure of testifying experts was December 7, 2007. The Schronks




13
        The City also objected that the Schronks could not rely on Dr. Desser’s affidavit because he had
not been timely designated as an expert witness. However, the trial court did not sustain this objection,
and the City has not perfected its own appeal to challenge this ruling.



Schronk v. City of Burleson                                                                      Page 21
filed their supplemental response with Dr. Desser’s affidavit and the court heard the

City’s plea to the jurisdiction eight days before that deadline.14

        The City cites Cunningham v. Columbia/St. David’s Healthcare Sys., L.P., 185 S.W.3d

7 (Tex. App.—Austin 2005, no pet.), for the proposition that an expert’s affidavit is not

admissible summary-judgment evidence if the expert has not been properly designated

under Rule 194.2.        Id. at 12-13.      The Supreme Court has recently endorsed this

proposition. Fort Brown Villas III Condominium Ass’n v. Gillenwater, 52 Tex. Sup. Ct. J.

632, 633-34, 2009 Tex. LEXIS 125, at *3-7 (Tex. Apr. 17, 2009) (per curiam). However, we

are unaware of any decision applying this same principle in the context of a plea to the

jurisdiction, and we decline to do so.

        Summary judgments are rendered where: (1) a plaintiff conclusively establishes

each element of his claim; (2) a defendant conclusively negates a single element of a

plaintiff’s claim; or (3) a defendant conclusively establishes an affirmative defense. See

U.S. Fire Ins. Co. v. Scottsdale Ins. Co., 264 S.W.3d 160, 165 (Tex. App.—Dallas 2008, no

pet.); Van Es v. Frazier, 230 S.W.3d 770, 784 (Tex. App.—Waco 2007, pet. denied). Thus,

a summary-judgment proceeding focuses on the merits of the plaintiff’s claim or of an

affirmative defense.

        By contrast, “[a] plea to the jurisdiction is a dilatory plea, the purpose of which is

to defeat a cause of action without regard to whether the claims asserted have merit.”

Bland Indep. Sch. Dist. v. Blue, 34 S.W.3d 547, 554 (Tex. 2000). Although the State or other



14
        The Schronks filed a formal designation of their experts, including Dr. Desser, on December 6.



Schronk v. City of Burleson                                                                       Page 22
governmental unit bears the burden of conclusively establishing that its immunity has

not been waived, “we protect the plaintiffs from having to ‘put on their case simply to

establish jurisdiction.’” Miranda, 133 S.W.3d at 228 (quoting Blue, 34 S.W.3d at 554).

“The purpose of a dilatory plea is not to force the plaintiffs to preview their case on the

merits but to establish a reason why the merits of the plaintiffs’ claims should never be

reached.” Blue, 34 S.W.3d at 554; cf. Kelly v. Rendon, 255 S.W.3d 665, 672 (Tex. App.—

Houston [14th Dist.] 2008, no pet.) (expert report in healthcare liability case “need not

marshall all of the plaintiff’s proof” and need not satisfy same admissibility standards

as evidence offered in summary-judgment proceeding or at trial) (citing Am. Transitional

Care Ctrs. of Tex., Inc. v. Palacios, 46 S.W.3d 873, 878-79 (Tex. 2001)); Baylor Univ. Med.

Ctr. v. Rosa, 240 S.W.3d 565, 570 (Tex. App.—Dallas 2007, pet. denied) (same).

        Although evidence offered in support of or in response to a plea to the

jurisdiction must satisfy the requirements of the Rules of Evidence, we hold that an

expert need not be properly designated under Rule of Civil Procedure 194.2 before he can

offer evidence relevant to the jurisdictional issues in dispute. This is particularly true

when, as here, the deadline for designation of testifying experts had not passed.

        Finally, the City objected to Dr. Desser’s affidavit because it has internal conflicts

and fails to address undisputed evidence.          Here, the City refers primarily to Dr.

Desser’s assumption that there was “a 6 minute delay from cardiac arrest to attempted

electrical defibrillation” while other evidence in the record suggests that the period of

delay may have been more than 20 minutes. However, these complaints go to the

credibility of Dr. Desser’s statements and not the admissibility of his affidavit.


Schronk v. City of Burleson                                                            Page 23
               If a party provides inconsistent or conflicting summary judgment
        proof, that party has created a fact issue for the trier of fact to resolve. As
        the Supreme Court has stated, “If the motion involves the credibility of
        affiants or deponents, or the weight of the showings or a mere ground of
        inference, the motion should not be granted.”

Thompson v. City of Corsicana Hous. Auth., 57 S.W.3d 547, 557 (Tex. App.—Waco 2001, no

pet.) (quoting Great Am. Reserve Ins. Co. v. San Antonio Plumbing Supply Co., 391 S.W.2d

41, 47 (Tex. 1965)) (other citations omitted); accord Pierce v. Washington Mut. Bank, 226

S.W.3d 711, 717-18 (Tex. App.—Tyler 2007, pet. denied); Shaw v. Maddox Metal Works,

Inc., 73 S.W.3d 472, 478 (Tex. App.—Dallas 2002, no pet.); Larson v. Family Violence &

Sexual Assault Prevention Ctr. of S. Tex., 64 S.W.3d 506, 513 (Tex. App.—Corpus Christi

2001, pet. denied). We have previously applied this principle in an appeal involving a

plea to the jurisdiction in which a political subdivision claimed immunity from suit. See

Stewart v. City of Corsicana, 211 S.W.3d 844, 849-50 (Tex. App.—Waco 2006), rev’d on

other grounds, 249 S.W.3d 412 (Tex. 2008).

        Accordingly, the court abused its discretion by sustaining the City’s objections to

Dr. Desser’s affidavit.

                                          Summary

        The trial court did not abuse its discretion when it sustained the City’s objections

that: (1) the firefighters were improperly testifying regarding legal conclusions; (2) Dr.

Reese was not qualified to render an expert opinion on Helen’s cause of death; and (3)

the Schronks provided general references to their supporting evidence to show cause of

death. The trial court abused its discretion when it sustained the City’s objections that:

(1) the Schronks provided only selected excerpts of deposition testimony in the body of


Schronk v. City of Burleson                                                               Page 24
their response to the plea to the jurisdiction; (2) the firefighters were improperly

testifying regarding factual conclusions; (3) Dr. Reese’s affidavit was otherwise

objectionable; and (4) Dr. Desser’s affidavit was inadmissible. Accordingly, we sustain

the Schronks’ fourth point in part and overrule it in part.

                                  Plea to the Jurisdiction

        The Schronks contend in their third point that the court erred by granting the

City’s plea to the jurisdiction. As we have already observed, the primary focus of the

City’s plea to the jurisdiction is whether the use of the AED was a proximate cause of

Helen’s death.

        When, as here, a plea to the jurisdiction challenges the existence of jurisdictional

facts, we “take as true all evidence favorable to the [plaintiffs]” and “indulge every

reasonable inference and resolve any doubts in the [plaintiffs’] favor.” Miranda, 133

S.W.3d at 228; Johnson v. Johnson County, 251 S.W.3d 107, 109 (Tex. App.—Waco 2008,

pet. denied). To avoid dismissal, the plaintiffs must “show that there is a disputed

material fact regarding the jurisdictional issue.” Miranda, 133 S.W.3d at 228.

        Section 101.021(2) waives a governmental unit’s immunity from suit and liability

for personal injury or death proximately caused by a condition or use of tangible

personal property if a private person would be liable under the same circumstances.

See TEX. CIV. PRAC. & REM. CODE ANN. §§ 101.021(2), 101.025(a) (Vernon 2005); City of

Grapevine v. Sipes, 195 S.W.3d 689, 691-92 (Tex. 2006); Wise Reg’l Health Sys. v. Brittain,

268 S.W.3d 799, 807 (Tex. App.—Fort Worth 2008, no pet.).




Schronk v. City of Burleson                                                          Page 25
        The City relies on cases distinguishing “use” and “non-use” of tangible personal

property with the former being necessary to waive immunity. See, e.g., Tex. Dep’t of

Criminal Justice v. Miller, 51 S.W.3d 583, 587 (Tex. 2001) (“our cases have distinguished

claims involving the failure to use, or the non-use of property, which do not waive

sovereign immunity, from claims involving a ‘condition or use’ of tangible personal

property that causes injury, which do effect a waiver”). “’Use’ means ‘to put or bring

into action or service; to employ for or apply to a given purpose.’” Id. at 588 (quoting

Tex. Natural Res. Conservation Comm’n v. White, 46 S.W.3d 864, 869 (Tex. 2001)). Here,

there is no dispute that City firefighters “used” the AED in an effort to resuscitate

Helen. The primary dispute is whether their use of this AED was a proximate cause of

Helen’s death.

                                              Proximate Cause

        The Schronks cite Salcedo v. El Paso Hospital District, 659 S.W.2d 30 (Tex. 1983),15

and related authorities for the proposition that the requisite causation is established by

evidence that the use of the AED was “a contributing factor” to Helen’s death. See id. at

32. The City responds by citing Miller for the proposition that the use of the AED must

have “actually caused” Helen’s death. See Miller, 51 S.W.3d at 588 (citing White, 46

S.W.3d at 869). The correct standard of causation lies somewhere in between. See Wise
15
         The Supreme Court has “limited [Salcedo] to its facts.” Dallas County Mental Health & Mental
Retardation v. Bossley, 968 S.W.2d 339, 342 (Tex. 1998). There is a vigorous debate among the intermediate
appellate courts about the continuing viability of Salcedo. Compare Tex. Tech. Univ. Health Sciences Ctr. v.
Lucero, 234 S.W.3d 158, 168-72 (Tex. App.—El Paso 2007, pet. denied), with Anderson v. City of San Antonio,
120 S.W.3d 5, 7-9 (Tex. App.—San Antonio 2003, pet. denied). However, we need not wade into that fray.
The statute establishes the requisite causation as “proximate cause.” TEX. CIV. PRAC. & REM. CODE ANN. §
101.021; City of Grapevine v. Sipes, 195 S.W.3d 689, 691-92 (Tex. 2006); Wise Reg’l Health Sys. v. Brittain, 268
S.W.3d 799, 807 (Tex. App.—Fort Worth 2008, no pet.). We will apply settled precedent defining the term
“proximate cause.”


Schronk v. City of Burleson                                                                            Page 26
Reg’l Health Sys., 268 S.W.3d at 808 (“The causation requirement in section 101.021(2) is

one of proximate cause—not a heightened standard such as sole cause.”); Univ. of Tex.

Med. Branch v. Estate of Blackmon, 169 S.W.3d 712, 717 (Tex. App.—Waco 2005) (“The

court in White did not expressly or implicitly abandon the TTCA’s proximate-cause

requirement for a different standard such as immediate cause, direct cause, or sole

cause.”), vacated on other grounds, 195 S.W.3d 98 (Tex. 2006) (per curiam).

        Section 101.021 provides that “proximate cause” is the applicable standard. See

TEX. CIV. PRAC. & REM. CODE ANN. § 101.021(1) (“proximately caused”), § 101.021(2) (“so

caused”); see Sipes, 195 S.W.3d at 691-92; Dallas County Mental Health & Mental

Retardation v. Bossley, 968 S.W.2d 339, 342-43 (Tex. 1998); Wise Reg’l Health Sys., 268

S.W.3d at 807.      “Proximate cause includes both cause in fact and foreseeability.”16

Columbia Med. Ctr. of Las Colinas, Inc. v. Hogue, 271 S.W.3d 238, 246 (Tex. 2008). “In

particular, cause in fact requires that the allegedly negligent act or omission constitute

‘a substantial factor in bringing about the injuries, and without it, the harm would not

have occurred.’” Id. (quoting IHS Cedars Treatment Ctr. of DeSoto, Tex., Inc. v. Mason, 143

S.W.3d 794, 799 (Tex. 2004)). This principle has been applied in cases governed by the

Tort Claims Act, although not consistently. See, e.g., Travis v. City of Mesquite, 830

S.W.2d 94, 98 (Tex. 1992); Wise Reg’l Health Sys., 268 S.W.3d at 807; Ordonez v. El Paso

County, 224 S.W.3d 240, 244 (Tex. App.—El Paso 2005, no pet.).




16
        The City contends that the use of the AED was not a cause in fact of Helen’s death. The issue of
foreseeability is not before us.



Schronk v. City of Burleson                                                                     Page 27
        Cause in fact is proven in negligence cases involving injury or death by evidence

that the injury or death was in “reasonable medical probability” or in “reasonable

probability” caused by the defendant’s negligent act or omission.17 Park Place Hosp. v.

Est. of Milo, 909 S.W.2d 508, 511 (Tex. 1995); Kramer v. Lewisville Mem’l Hosp., 858 S.W.2d

397, 400 (Tex. 1993); see Columbia Rio Grande Healthcare, L.P. v. Hawley, 52 Tex. Sup. Ct. J.

804, 808, 2009 Tex. LEXIS 323, at *16 (Tex. June 5, 2009). This means “simply that it is

‘more likely than not’ that the ultimate harm or condition resulted from such

negligence.” Kramer, 858 S.W.2d at 400 (quoting Lenger v. Physician’s Gen. Hosp., Inc.,

455 S.W.2d 703, 707 (Tex. 1970)); accord Thomas v. Farris, 175 S.W.3d 896, 899 (Tex.

App.—Texarkana 2005, pet. denied); Marvelli v. Alston, 100 S.W.3d 460, 480 (Tex. App.—

Fort Worth 2003, pet. denied).

        The Supreme Court has explained in more detail how this requirement is met

“where preexisting illnesses or injuries have made a patient’s chance of avoiding the

ultimate harm improbable even before the allegedly negligent conduct occurs—i.e., the

patient would die or suffer impairment anyway.” Kramer, 858 S.W.2d at 400; Arredondo

v. Rodriguez, 198 S.W.3d 236, 239 (Tex. App.—San Antonio 2006, no pet.); Hodgkins v.

Bryan, 99 S.W.3d 669, 673 (Tex. App.—Houston [14th Dist.] 2003, no pet.). In this

instance, “recovery is barred when the defendants’ negligence deprived the [plaintiff] of

only a fifty percent or less chance of survival.” Park Place Hosp., 909 S.W.2d at 511

(citing Kramer, 858 S.W.2d at 400); Arredondo, 198 S.W.3d at 239; accord Columbia Rio


17
        Although these precise terms need not be used, the evidence must demonstrate “to a reasonable
degree of medical certainty” that the injury or death was caused by the defendant’s negligence. Columbia
Med. Ctr. of Las Colinas, Inc. v. Hogue, 271 S.W.3d 238, 247 (Tex. 2008).


Schronk v. City of Burleson                                                                     Page 28
Grande Healthcare, 52 Tex. Sup. Ct. J. at 808, 2009 Tex. LEXIS 323, at *17; Hodgkins, 99

S.W.3d at 673.

        Here, it is undisputed that City employees actually used the AED in an attempt

to resuscitate Helen. It is likewise undisputed that the AED did not work because the

battery did not have a sufficient charge. Thus, the “dispositive issue as to the claims

against the [City] is whether [Helen] could have survived if [a properly functioning

AED had been used].” See Park Place Hosp., 909 S.W.2d at 511; Arredondo, 198 S.W.3d at

239.

        The City refers to alleged “judicial admissions” by the Schronks’ counsel as

establishing that the use of the AED was not a proximate cause of Helen’s death.18 The

two statements are: “There’s no contention the AED caused the underlying heart

condition”; and “there’s not been any allegations by anyone that the AED itself killed

her or caused her to die.”

        “A judicial admission must be a clear, deliberate, and unequivocal statement.”

Givens v. Ward, 272 S.W.3d 63, 70 (Tex. App.—Waco 2008, no pet.) (quoting

Horizon/CMS Healthcare, 34 S.W.3d at 905). The first quoted statement, which refers to

Helen’s “underlying heart condition,” does not constitute “a clear, deliberate, and

unequivocal statement” that the use of the AED was not a proximate cause of her death.


18
         The Schronks allege for the first time on appeal that the City judicially admitted causation in its
defensive pleadings by stating that Laerdal’s negligent design, etc. of the AED “was a proximate cause or
the proximate cause of the incident, injuries and death and damages at issue.” However, the Schronks
did not rely on this “admission” in the trial court as a basis for denial of the City’s plea to the jurisdiction
or Laerdal’s summary-judgment motion. Because they did not raise it in the trial court, they cannot rely
on it on appeal. See Sherman v. Merit Office Portfolio, Ltd., 106 S.W.3d 135, 140-41 (Tex. App.—Dallas 2003,
pet. denied); Smith v. Altman, 26 S.W.3d 705, 709 (Tex. App.—Waco 2000, pet. dism’d w.o.j.).


Schronk v. City of Burleson                                                                            Page 29
The second statement must be read in context with a follow-up statement by counsel,

namely, “What’s been alleged by the plaintiffs in this case is that the AED didn’t work

and so therefore she couldn’t be rescued from her ventrical fibrillation.” When read in

context, this second statement likewise does not constitute “a clear, deliberate, and

unequivocal” admission. Thus, the statements in question do not constitute judicial

admissions. See id.

        Dr. Desser concludes in his report that “[t]o a reasonable degree of medical

probability exceeding 51%, Mrs. Schronk would have been successfully defibrillated

had    the   Laerdal Heartstart    911   automatic   electrical   defibrillator   functioned

appropriately.” This conclusion was based on his review of the medical records, the fire

department records including the monitor strip from the AED, the deposition testimony

of various firefighters who responded to the Schronks’ home, and “[p]opulation-based

cohort studies.”

        Dr. Desser explains that a “10% increment of ventricular fibrillation mortality per

minute without electrical defibrillation statistic applies to subjects who are not

undergoing cardiopulmonary resuscitation by a bystander who is trained in the

technique.” He notes, however, that Helen did receive CPR from a trained EMT. He

opines that the performance of CPR while awaiting the AED “would, to a reasonable

degree of medical probability, have increased her chance of successful electrical

defibrillation and survival to over 51%.” He describes this as “a conservative estimate

since success rates for non-physician bystanders who are trained in [CPR] in

combination with electrical defibrillation has [sic] a success rate which exceeds 80%.”


Schronk v. City of Burleson                                                           Page 30
Desser noted that this survival rate is based on “data which has been accumulated from

free-standing cardiac rehabilitation units where cardiac arrests have occurred in

subjects with serious cardiovascular disorders.” He also observed that the survival rate

is “even higher” for “non-medical environments with access to [EMT’s] and

defibrillators.”

        To summarize, Desser took into account Helen’s heart condition before she

suffered the cardiac arrest, examined studies regarding cardiac patients who received

CPR “in combination with electrical defibrillation,” and concluded that, in reasonable

medical probability, there is a better than 51% chance that Helen would have been

successfully defibrillated and would have survived her cardiac arrest if the AED had

functioned properly.

        Because we “take as true all evidence favorable to the [Schronks]” and “indulge

every reasonable inference and resolve any doubts in [their] favor,” we conclude “that

there is a disputed material fact” regarding whether the use of the AED was a

proximate cause of Helen’s death. See Bustillos v. Rowley, 225 S.W.3d 122, 129-31 (Tex.

App.—El Paso 2005, no pet.) (expert report that it was “more likely than not” that

patient would have survived adequately addressed causation regarding failure to

monitor cardiac patient); Marvelli, 100 S.W.3d at 481 (expert’s testimony that plaintiff’s

vision would have “in reasonable medical probability” been saved held legally

sufficient to establish cause-in-fact); Bottoms v. Smith, 923 S.W.2d 247, 251-52 (Tex.

App.—Houston [14th Dist.] 1996, no writ) (expert’s testimony that, if appropriate tests

had been done, polyp would have been identified and patient would have better than


Schronk v. City of Burleson                                                        Page 31
70% survival rate held sufficient to create fact issue on proximate cause regarding

patient’s death).

                               Exception for Emergency Responders

        According to section 101.055(2) of the Tort Claims Act, there is no waiver of

immunity under the Act19 for the conduct of an emergency responder “if the action is in

compliance with the laws and ordinances applicable to emergency action, or in the

absence of such a law or ordinance, if the action is not taken with conscious indifference

or reckless disregard for the safety of others.” TEX. CIV. PRAC. & REM. CODE ANN. §

101.055(2) (Vernon 2005). The Schronks argue that in this instance the City’s failure to

maintain the AED in accordance with the manufacturer’s guidelines constitutes a

violation of law (section 779.003 of the Health and Safety Code) and removes the

conduct of the emergency responders from the exception provided by section

101.055(2).

        Section 779.003 states, “A person or entity that owns or leases an automated

external defibrillator shall maintain and test the automated external defibrillator

according to the manufacturer's guidelines.”             TEX. HEALTH & SAFETY CODE ANN. §

779.003 (Vernon 2003). This statute is found in title 9, subtitle B of the Health and Safety

Code. See Act of May 26, 1999, 76th Leg., R.S., ch. 679, § 1, 1999 Tex. Gen. Laws 3250.

Title 9 is entitled “Safety” and subtitle B is entitled “Emergencies.” See Act of May 18,


19
        Neither section 101.055 nor section 101.062, which we discuss hereinafter, provides an
independent waiver of immunity. Rather, even if a waiver of immunity is established under section
101.021, a governmental unit may nonetheless retain its immunity if it meets the requisites of section
101.055 or section 101.062. See Gipson v. City of Dallas, 247 S.W.3d 465, 470-71 (Tex. App.—Dallas 2008,
pet. denied); City of El Paso v. Hernandez, 16 S.W.3d 409, 415-16 (Tex. App.—El Paso 2000, pet. denied).


Schronk v. City of Burleson                                                                     Page 32
1989, 71st Leg., R.S., ch. 678, § 1, 1989 Tex. Gen. Laws 2230, 2235 (table of contents).

Subtitle B also includes statutory provisions governing, among other things,

“emergency communications,” “emergency medical services,” and “emergency services

districts.” Id. Thus, we hold that section 779.003 is a law “applicable to emergency

action.” See TEX. CIV. PRAC. & REM. CODE ANN. § 101.055(2); Mejia v. City of San Antonio,

759 S.W.2d 198, 200 (Tex. App.—San Antonio 1988, no writ).

        The Schronks presented the deposition testimony of several firefighters detailing

how the Burleson Fire Department failed to maintain the AED in accordance with the

manufacturer’s guidelines. Taking as true all evidence favorable to the Schronks and

indulging every reasonable inference and resolving any doubts in their favor, we

conclude “that there is a disputed material fact” regarding whether the City failed to

comply with a law “applicable to emergency action.” See Mejia, 759 S.W.2d at 200-01.

                              Exception for 9-1-1 Emergency Services

        According to section 101.062 of the Tort Claims Act, there is a waiver of

immunity for:

        a claim against a public agency that arises from an action of an employee
        of the public agency or a volunteer under direction of the public agency
        and that involves providing 9-1-1 service or responding to a 9-1-1
        emergency call only if the action violates a statute or ordinance applicable
        to the action.

TEX. CIV. PRAC. & REM. CODE ANN. § 101.062(b) (Vernon 2005).

        Under section 101.062(b), the City’s immunity is waived only if the Schronks’

claims arise from the action of a City employee (1) “that involves . . . responding to a

9-1-1 emergency call” and (2) that “violates a statute or ordinance applicable to the


Schronk v. City of Burleson                                                            Page 33
action.” Here, the Department’s maintenance of the AED is directly involved with its

response to 9-1-1 calls.      As noted, the Schronks have presented evidence that the

Department failed to maintain the AED in accordance with the manufacturer’s

guidelines, which would be a violation of section 779.003.

        Taking as true all evidence favorable to the Schronks and indulging every

reasonable inference and resolving any doubts in their favor, we conclude “that there is

a disputed material fact” regarding whether an action of a City employee that involved

responding to a 9-1-1 call violated a statute applicable to the action. See City of Dallas v.

Porter, No. 05-02-00364-CV, 2002 Tex. App. LEXIS 5658, at *7-10 (Tex. App.—Dallas

Aug. 2, 2002, no pet.) (not designated for publication).

                                         Summary

        The Schronks presented evidence raising “a disputed material fact” regarding

whether the City’s use of the AED was a proximate cause of Helen’s death, whether the

City failed to comply with a “law[ ] applicable to emergency action,” and whether an

action of a City employee that involved responding to a 9-1-1 call violated a statute

applicable to the action. Therefore, the court erred by granting the City’s plea to the

jurisdiction. We sustain the Schronks’ third point.

                                    Summary Judgment

        The Schronks contend in their first point that the court erred by granting

Laerdal’s summary-judgment motion.         In particular, they argue: (1) the trial court

granted only Laerdal’s traditional summary-judgment motion; (2) Laerdal’s motion

addressed only their negligence claim and thus summary judgment was improper on


Schronk v. City of Burleson                                                           Page 34
their strict product liability claim; and (3) genuine issues of material fact remain on both

claims. Laerdal also presents a procedural issue, contending that Dr. Reese’s affidavit

cannot be considered part of the summary-judgment record on appeal because the trial

court sustained the City’s objections to the affidavit.

                                    Standards of Review

        In reviewing a traditional summary judgment, we must consider whether

reasonable and fair-minded jurors could differ in their conclusions in light of all of the

evidence presented. See Goodyear Tire & Rubber Co. v. Mayes, 236 S.W.3d 754, 755 (Tex.

2007) (per curiam) (citing Wal-Mart Stores, Inc. v. Spates, 186 S.W.3d 566, 568 (Tex. 2006)

(per curiam); City of Keller v. Wilson, 168 S.W.3d 802, 822-24 (Tex. 2005)). We must

consider all the evidence in the light most favorable to the nonmovant, indulging every

reasonable inference in favor of the nonmovant and resolving any doubts against the

movant. See Goodyear Tire, 236 S.W.3d at 756 (citing Sudan v. Sudan, 199 S.W.3d 291, 292

(Tex. 2006) (per curiam); Spates, 186 S.W.3d at 568).

        We apply the same standard in reviewing a no-evidence summary judgment as

we would in reviewing a directed verdict. See Mack Trucks, Inc. v. Tamez, 206 S.W.3d

572, 581 (Tex. 2006). “We review the evidence presented by the motion and response in

the light most favorable to the party against whom the summary judgment was

rendered, crediting evidence favorable to that party if reasonable jurors could, and

disregarding contrary evidence unless reasonable jurors could not.” Id. at 582. A no-

evidence summary judgment will be defeated if the nonmovant produces some




Schronk v. City of Burleson                                                          Page 35
evidence “raising an issue of material fact” on the elements challenged by the movant.

Id.

                                     Procedural Issues

        Laerdal filed a summary-judgment motion presenting both no-evidence and

traditional grounds. They entitled this pleading “Defendant Laerdal Medical Corp.’s

Motion for Summary Judgment and No Evidence Motion for Summary Judgment.”

With regard to the Schronks’ negligence claims, Laerdal alleged that there was no

evidence that: (1) the AED or its battery was “defectively manufactured, designed,

supplied, sold or marketed to the City”; or (2) any act or failure to act on Laerdal’s part

was a proximate cause of Helen’s injuries. With regard to the Schronks’ strict product

liability claim, Laerdal alleged that there was no evidence that the AED or its battery

was defective. As a traditional ground for summary judgment, Laerdal alleged that the

“undisputed evidence demonstrates neither the HeartStart 911 AED or the

accompanying battery used during the attempted resuscitation were defective.”

        In the Schronks’ summary-judgment response, they argued that genuine issues

of material fact remained concerning whether: (1) the AED malfunctioned according to

FDA regulations; (2) the AED battery was “misbranded” (i.e., mislabeled) under FDA

regulations regarding replacement of batteries; (3) Laerdal failed to provide adequate

training and service to the City regarding battery maintenance; and (4) these were

proximate causes of Helen’s death.

        In its order granting summary judgment, the court stated that it had considered

and was granting the “Motion for Summary Judgment.” The court rendered judgment


Schronk v. City of Burleson                                                         Page 36
that the Schronks take nothing on their claims against Laerdal. The Schronks first

contend that, in view of the two-part title Laerdal gave to its summary-judgment

pleading, the court’s reference to the “Motion for Summary Judgment” is necessarily a

reference to only the traditional grounds for summary judgment stated in the motion.

We disagree.

        At the summary-judgment hearing, the court informed the parties that it wanted

to hear “Laerdal’s Motion for Summary Judgment.”                         Laerdal’s counsel promptly

advised the court that Laerdal’s motion encompassed both traditional grounds and no-

evidence grounds for summary judgment.                      The Schronks did not object to this

characterization. Thus we hold that the trial court’s order granted both the traditional

and no-evidence portions of Laerdal’s summary-judgment motion. This holding also

answers the Schronks’ next argument, namely, that the court granted summary

judgment only on the Schronks’ negligence claim because that is the only claim

challenged by the traditional portion of Laerdal’s summary-judgment motion.

        Laerdal contends that Dr. Reese’s affidavit is not part of the summary-judgment

record because the trial court sustained the City’s objections to the affidavit. Laerdal

filed written objections to Dr. Reese’s affidavit but did not call those objections to the

trial court’s attention at the summary-judgment hearing and did not obtain a ruling on

the objections.20




20
          Laerdal also filed written objections to Dr. Desser’s affidavit but did not call those objections to
the trial court’s attention at the summary-judgment hearing and did not obtain a ruling on the objections.
Laerdal does not challenge the admissibility of Dr. Desser’s affidavit on appeal.


Schronk v. City of Burleson                                                                          Page 37
        Objections to the form of summary-judgment evidence are preserved for

appellate review only if those objections are made and ruled on in writing by the trial

court. See Choctaw Props., 127 S.W.3d at 241; Trusty v. Strayhorn, 87 S.W.3d 756, 762 (Tex.

App.—Texarkana 2002, no pet.).              By contrast, objections to the substance of such

evidence may be raised for the first time on appeal. See Choctaw Props., 127 S.W.3d at

241; Trusty, 87 S.W.3d at 765.

        We assume without deciding that Laerdal may rely on the City’s objections and

the court’s rulings thereon. As we have determined, however, the only objection which

the trial court properly sustained was the objection that Dr. Reese was not qualified to

give an expert opinion on Helen’s cause of death. Nevertheless, because Laerdal’s

primary objection is that Dr. Reese’s affidavit is conclusory, we may consider that

objection for the first time on appeal because it challenges the substance of the evidence.

Id.

        Laerdal contends that Dr. Reese’s affidavit is conclusory because it is “not based

on anything remotely related to the facts,” because it is “instead based solely on his own

conjecture and conclusions,” and because there is “no evidence he inspected, evaluated

or tested the device or battery in question.” Because Laerdal makes only these general

objections and provides scant argument or authority,21 we limit our analysis to the issue



21
        Laerdal’s argument and authority on the allegedly conclusory nature of Dr. Reese’s affidavit is
contained in a footnote in its brief which reads as follows:

        Mr. Reese’s affidavit failed to satisfy Appellants’ burden because Mr. Reese cannot
        establish that the AED battery, had it been properly charged, would not have functioned
        appropriately. His affidavit was wholly conclusive, not based on anything remotely
        related to the facts, instead based solely on his own conjecture and conclusions. There is


Schronk v. City of Burleson                                                                          Page 38
of whether Dr. Reese’s affidavit is conclusory because he did not personally inspect the

AED or its battery. Summary-judgment evidence is considered “conclusory” if it “does

not provide the underlying facts to support the conclusion.” Choctaw Props., 127 S.W.3d

at 242 (quoting Dolcefino, 19 S.W.3d at 930)).

        Under Rule of Evidence 703, an expert’s opinion may be based on facts or data

“perceived by, reviewed by, or made known to the expert at or before the hearing.”

TEX. R. EVID. 703. Such facts or data need not be admissible in evidence if they are “of a

type reasonably relied upon by experts in the particular field.” Id. Personal knowledge

of the underlying facts or data is not required. See id. 602, 703; Henderson v. State, 14

S.W.3d 409, 412 (Tex. App.—Austin 2000, no pet.); 2 STEVEN GOODE ET AL., GUIDE TO THE

TEXAS RULES OF EVIDENCE § 703.3 (3d ed. 2002). Thus, it is not necessary for a testifying

expert to have personally inspected an object as a prerequisite to offering expert

testimony regarding that object. See SPT Fed. Credit Union v. Big H Auto Auction, Inc.,

761 S.W.2d 800, 802-03 (Tex. App.—Houston [1st Dist.] 1988, no writ) (expert permitted

to testify to value of shrimp boat even though he had never inspected or viewed the

boat). That the expert had not personally inspected the object would go to the weight of

his testimony and not its admissibility. See LMC Complete Automotive, Inc. v. Burke, 229

S.W.3d 469, 478 (Tex. App.—Houston [1st Dist.] 2007, pet. denied) (“The weakness of

facts in support of an expert’s opinion generally goes to the weight of the testimony

rather than the admissibility.”).

        further no evidence he inspected, evaluated or tested the device or battery in question.
        (C.R. V7, 1461) Laerdal continues to assert these substantive objections to this Court and
        argues that, as such, Mr. Reese’s Affidavit is not competent summary judgment evidence.
        Rizkallah v. Conner, 952 S.W.2d 580, 587 (Tex. App.—Houston [1st Dist.] 1997, no pet.).


Schronk v. City of Burleson                                                                          Page 39
        Accordingly, we reject Laerdal’s challenge to the admissibility of Dr. Reese’s

affidavit.

                                         Defective Product

        The Schronks contend that genuine issues of material fact remain on the question

of whether the AED or its battery was defective.22 Laerdal alleged in its summary-

judgment motion that: (1) the evidence conclusively establishes that the AED and its

battery were not defective and were “fully functional and operational” on the occasion

in question; and (2) there is no evidence that (a) the AED or its battery was defective or

(b) the AED or its battery was “defectively manufactured, designed, supplied, sold or

marketed to the City.”

        The Schronks relied primarily on Dr. Reese’s affidavit in their summary-

judgment response to establish that the AED was defective. They assert essentially four

defects: (1) the AED malfunctioned because it did not provide defibrillating shocks after

giving a “low battery” warning; (2) the AED malfunctioned because it never gave a

“replace battery” warning; (3) the AED battery is misbranded because it is labeled with

a “recommended replacement” date rather than an “expiration date”; and (4) the AED

battery is misbranded because its labeling is not sufficiently prominent.

        According to pertinent FDA regulations:




22
        The Schronks’ defective product claim is based on section 402A of the Restatement (Second) of
Torts. See RESTATEMENT (SECOND) OF TORTS § 402A (1965). The elements for a strict product liability
claim under section 402A are: (1) a product defect; (2) that existed at the time the product left the
manufacturer’s hands; (3) made the product unreasonably dangerous; and (4) was a producing cause of
the plaintiff’s injuries. Parsons v. Ford Motor Co., 85 S.W.3d 323, 329 (Tex. App.—Austin 2002, pet.
denied).


Schronk v. City of Burleson                                                                  Page 40
        “Malfunction” means the failure of a device to meet its performance
        specifications or otherwise perform as intended. Performance
        specifications include all claims made in the labeling for the device. The
        intended performance of a device refers to the intended use for which the
        device is labeled or marketed, as defined in § 801.4 of this chapter.

21 C.F.R. § 803.3.

        Section 301 of the Federal Food, Drug and Cosmetic Act prohibits the sale or

distribution of “misbranded”23 drugs and medical devices.24                       21 U.S.C.S. § 331(a)

(LexisNexis 2006). Section 502 defines a “misbranded” drug or device in pertinent part

as follows:

        False or misleading label. If its labeling is false or misleading in any
        particular.

        Prominence of information on label. If any word, statement, or other
        information required by or under authority of this Act [21 USCS §§ 301 et
        seq.] to appear on the label or labeling is not prominently placed thereon
        with such conspicuousness (as compared with other words, statements,
        designs, or devices, in the labeling) and in such terms as to render it likely
        to be read and understood by the ordinary individual under customary
        conditions of purchase and use.

        Restricted devices using false or misleading advertising or used in
        violation of regulations. In the case of any restricted device distributed or
        offered for sale in any State, if (1) its advertising is false or misleading in
        any particular, or (2) it is sold, distributed, or used in violation of
        regulations prescribed under section 520(e) [21 USCS § 360j(e)].




23
           A claim that a drug or medical device is “misbranded” is in essence a marketing defect claim.
See, e.g., Merck & Co. v. Garza, 277 S.W.3d 430, 437 (Tex. App.—San Antonio 2008, pet. filed).

24
        It is undisputed that an AED is a medical device governed by the Federal Food, Drug and
Cosmetic Act. See United States v. Laerdal Mfg. Corp., 853 F. Supp. 1219, 1238 (D. Or. 1994), aff’d, 73 F.3d
852 (9th Cir. 1995).



Schronk v. City of Burleson                                                                         Page 41
Id. § 352(a), (c), (q) (LexisNexis 2006); see also TEX. HEALTH & SAFETY CODE ANN. §

431.112(a)(1), (c), (o) (Vernon Supp. 2008) (similar definitions for misbranded drug or

device in Texas Food, Drug, and Cosmetic Act).

        Dr. Reese noted that, according to the instruction manual for the AED, “a low

battery signal indicates that there is sufficient energy remaining in the battery to allow

four (4) additional shocks.” Firefighter Burchett testified that when the AED indicated

that a defibrillating shock should be administered to Helen, the AED “said audibly

‘Low Battery’” but failed to administer a shock. The evidence is undisputed that the

AED never administered a defibrillating shock on that occasion.

        Dr. Reese also observed that, according to the instruction manual, “when the

battery does not have enough charge to allow four (4) additional shocks, the device will

signal a “Replace Battery warning.”25 According to Laerdal records, the AED gave a

“low battery warning” each time it failed to administer a shock “and then powered

down because of a low battery, notated on the printout as ‘BAT.FAIL.’” The instruction

manual explains that “BAT.FAIL” indicates that the AED has shut down because of a

low battery.      The Laerdal incident report does not indicate that the “REPLACE

BATTERY” warning was given on the occasion in question.




25
        Section 4.8.2 of the instruction manual provides in pertinent part, “If three more charge-to-shock
cycles are initiated after the ‘BATTERY LOW’ warning, a ‘REPLACE BATTERY’ warning will be given.”
“‘REPLACE BATTERY’ indicates that there may not be enough capacity in the battery to deliver another
shock.”


Schronk v. City of Burleson                                                                       Page 42
         Dr. Reese opines that these failures of the AED to perform in accordance with the

instruction manual constitute “malfunctions” as defined by 21 C.F.R. § 803.3.26

         Viewing the evidence in the light most favorable to the Schronks and indulging

every reasonable inference and resolving any doubts in their favor, we hold that the

Schronks produced some evidence “raising an issue of material fact” on the question of

whether the AED malfunctioned.

         With regard to the Schronks’ “misbranding” claims, they first complain that the

AED battery label is misleading because it is labeled with a “recommended

replacement” date rather than an “expiration date.”                  According to the deposition

testimony of Laerdal employee Linda Riedeburg, the pertinent portion of the battery

label has a box with the printed notation “Recommended Replacement” beside it.

Riedeburg examined an enlarged photograph of the battery label and testified that the

box beside the “recommended replacement” notation was blank, that is, it did not

provide a recommended replacement date.

         Dr. Reese opined that the use of the term “recommended replacement” or

“recommend replacement” instead of “expiration date” is misleading. According to Dr.

Reese:

         The use of these terms is potentially hazardous and even life threatening
         because in order to assure that the AED’s are capable of functioning in
         response to their design objective intent, these batteries MUST be changed
         no later than upon an identified “Expiration Date” of no more than two (2)

26
         Because the Schronks seek only to enforce federal regulations for medical devices in their suit,
their product liability claims are not preempted by the FDCA. See Riegel v. Medtronic, Inc., ___ U.S. ___,
128 S. Ct. 999, 1011, 169 L. Ed. 2d 892 (2008) (FDCA “does not prevent a State from providing a damages
remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’
rather than add to, federal requirements”).


Schronk v. City of Burleson                                                                       Page 43
        years.  The terms “Recommended Replacement” or “Recommend
        Replacement” are clearly subjective, open-ended and not interpreted as a
        mandatory requirement by Laerdal, which in reality it is.

        The instruction manual provides, “Replace batteries every two years. Check date

codes on a regular basis.”       However, Battalion Chief Tom Foster testified in his

deposition that, when he contacted Laerdal about ordering new batteries, a Laerdal

representative informed him that the AED batteries had “a seven-year shelf life.” Foster

understood this to mean that the “[b]atteries were good for seven years.”

        A medical device is “misbranded” if “its labeling is false or misleading in any

particular.” 21 U.S.C.S. § 352(a).

               If an article is alleged to be misbranded because the labeling or
        advertising is misleading, then in determining whether the labeling or
        advertising is misleading there shall be taken into account (among other
        things) not only representations made or suggested by statement, word,
        design, device, or any combination thereof, but also the extent to which
        the labeling or advertising fails to reveal facts material in the light of such
        representations or material with respect to consequences which may result
        from the use of the articles to which the labeling or advertising relates
        under the conditions of use prescribed in the labeling or advertising
        thereof or under such conditions of use as are customary or usual.

Id. § 321(n) (LexisNexis 2006). Thus, Laerdal’s representations are relevant to this

inquiry.

               The [FDCA] is plain and direct. Its comprehensive terms condemn
        every statement, design and device which may mislead or deceive.
        Deception may result from the use of statements not technically false or
        which may be literally true. The aim of the statute is to prevent that
        resulting from indirection and ambiguity, as well as from statements
        which are false. It is not difficult to choose statements, designs and
        devices which will not deceive. Those which are ambiguous and liable to
        mislead should be read favorably to the accomplishment of the purpose of
        the act.



Schronk v. City of Burleson                                                               Page 44
United States v. Ninety-Five Barrels (More or Less) Alleged Apple Cider Vinegar, 265 U.S. 438,

442-43, 44 S. Ct. 529, 531, 68 L. Ed. 1094 (1924); accord United States v. An Article . . . ACU-

DOT, 483 F. Supp. 1311, 1315 (N.D. Ohio 1980); Edward M. Basile et al., Medical Device

Labeling and Advertising: An Overview, 54 FOOD & DRUG L.J. 519, 521 (1999).

        Viewing the evidence in the light most favorable to the Schronks and indulging

every reasonable inference and resolving any doubts in their favor, we hold that

genuine issues of material fact remain on the question of whether the AED battery is

misbranded because of the manner in which the replacement date is indicated on the

label. Cf. United States v. Jamieson-McKames Pharms., Inc., 651 F.2d 532, 545-46 (8th Cir.

1981) (drugs misbranded because labels depicted false expiration date).

        The Schronks also contend that the AED battery is misbranded because its

labeling is not sufficiently prominent. A drug or medical device does not satisfy the

prominence requirements of the FDCA if “the information is presented in type that is

too small, fades into the background, is obscured, or crowded with other graphic

matter.” Basile, supra, 54 FOOD & DRUG L.J. at 522-23 (citing 21 C.F.R. § 801.15(a)(6)). A

drug or medical device also fails to satisfy these requirements if required information

does not “appear on the part or panel of the label which is presented or displayed under

customary conditions of purchase.” 21 C.F.R. § 801.15(a)(1).

        Laerdal employee Riedeburg testified that the box beside the “recommended

replacement” notation was blank, that is, it did not provide a recommended

replacement date. Viewing the evidence in the light most favorable to the Schronks and

indulging every reasonable inference and resolving any doubts in their favor, we hold


Schronk v. City of Burleson                                                             Page 45
that genuine issues of material fact remain on the question of whether the AED battery

is misbranded because it does not depict an expiration date. See United States v. Dino,

919 F.2d 72, 75 (8th Cir. 1990) (sample drugs misbranded because they were not marked

with lot numbers or expiration dates).

        Thus, genuine issues of material fact remain on the questions of whether the

AED or its battery was defective and whether the AED or its battery was “defectively

manufactured, designed, supplied, sold or marketed to the City.”

                                         Causation

        Laerdal alleged in its summary-judgment motion that it is entitled to judgment

on the Schronks’ negligence claim because there is no evidence any act or failure to act

on Laerdal’s part was a proximate cause of Helen’s injuries.

        The Schronks allege, among other things, that Laerdal was negligent because it:

(1) failed to properly train employees of the City on maintenance, testing and upkeep of

the AED and/or its batteries; (2) advised Battalion Chief Foster that the batteries were

good for seven years; and (3) failed to label the batteries with expiration dates.

Battalion Chief Foster testified that the AED batteries were not replaced every two years

because Laerdal advised that they were good for seven years.

        Dr. Reese opined that Laerdal’s negligence resulted in the AED not “being fully

functional” and “denied life saving therapy” to Helen. Dr. Desser concluded that, in

reasonable medical probability, there is a better than 51% chance that Helen would have

been successfully defibrillated and would have survived her cardiac arrest if the AED

had functioned properly.


Schronk v. City of Burleson                                                       Page 46
        Viewing the evidence in the light most favorable to the Schronks and indulging

every reasonable inference and resolving any doubts in their favor, they produced some

evidence “raising an issue of material fact” on the question of whether Laerdal’s

negligence was a proximate cause of Helen’s death.

        We sustain the Schronks’ first point.

                                        Conclusion

        The trial court erred by granting the City’s plea to the jurisdiction and by

granting Laerdal’s summary-judgment motion. Accordingly, we reverse the judgment

and remand this cause to the trial court for further proceedings consistent with this

opinion.



                                                      FELIPE REYNA
                                                      Justice
Before Chief Justice Gray,
       Justice Reyna, and
       Justice Davis
       (Chief Justice Gray dissenting in part
       and concurring in part with note)*
Reversed and remanded
Opinion delivered and filed July 22, 2009
[CV06]

*      (Chief Justice Gray dissents in part and concurs in part with the judgment of the
Court. A separate opinion will not issue. He notes, however, that the claims against the
City of Burleson were properly dismissed. The claim is based entirely on the fact that
the AED the fire department first attempted to use did not work properly. As such, it is
either a suit for the failure to use a working AED device--in essence non-use of tangible
personal property which is not actionable. In the alternative, it was for the use of an
AED that did not work. But it is undisputed that the AED device did not cause her
death. The Court gets around this problem by finding the Fire Department violated the
law in an emergency by failing to properly check or test the AED batteries. But that
negligence, if any, was not part of the emergency, and the waiver of immunity for such


Schronk v. City of Burleson                                                       Page 47
activity is not implicated--if anything, it was simple negligence of a governmental
employee for which sovereign immunity is not waived. For these and other reasons, I
join no part of the Court’s opinion and respectfully dissent to that portion of the
judgment which reverses the judgment in favor of the City of Burleson. And though I
join no part or portion of the opinion, I concur in the reversal of the judgment to the
extent it reverses and remands the judgment in favor of Laerdal for further
proceedings.)




Schronk v. City of Burleson                                                     Page 48