### IN THE TENTH COURT OF APPEALS
No. 10
- 07
- 00399
- CV KEVIN GLENN SCHRONK, INDIVIDUALLY AND AS REPRESENTATIVE OF TH E ESTATE OF HELEN PA TRICIA SCHRONK, DECEASED , AND DUSTIN SCHRONK Appellant s v. CITY OF BURLESON AND LAERDAL MEDICAL CORP
. , Appellee s

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

O P I N I O N

Kevin Schronk and his son Dustin filed a wrongful death suit against the City of Burleson and Laerdal Medical Corporation after emergency medical technicians
emp loyed 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 Schronk sSchronk v. City of Burleson Page 2

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 t he y 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
defibril l ating shock. T he EMT’s made several attempts to administer a shock with the AED but could not because of the low battery. A nother AED was brought to the location, but Helen could not be resuscitated. She was pronounced dead on arrival at
the hospital.
Kevin and Dusti n filed suit against the City and Laerdal . They alleg ed 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) fo r selling an unreasonably dangerous product

.Schronk v. City of Burleson Page 3

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 ju risdiction. 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

- jud gment 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
T he 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 4 Preservatio n
T he 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 Excepti ons 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 w ith 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 T EX
. R. A PP
. P. 33.1(a)(2)(A). In the summary

judgment context, this Court has consistently held that the gr ant 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 20 08, no pet.) (“ a trial court implicitly overrules special exceptions w hen it grants summarySchronk v. City of Burleson Page 5

judgment on the motion to which th e special exceptions pertain”). However, we need
not de cid e in this case whether a different rule applies.
T he 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 the m . See In re Marriage of Jordan , 264 S.W.3d 850, 855 (Tex. App.

— Waco 20 08,

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 Cl ement v. City of Plano , 26 S.W.3d 544, 550 n.5 (Tex. App.

— Dallas 20 00, 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. 20 02). 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. 20 07) ( 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.
20 00); Schwartz v. Ins. Co. of the State of Pa. , 274 S.W.3d 270, 276 (Tex. App.

— Houston [1st Dist.] 20 08, pet . denied). The test long

- recognized by intermediate appellate courts 1
in Texas is “ whether an opposing attorney of reasonable competence, perusing the

1 According to our research, the Supreme Court has neither em braced nor rejected this test.Schronk v. City of Burleson Page 6

pleadings, can ascertain the nature and the basic issues of the controversy and the testimony probably r elevant.” 2 R OY W. M C D ONALD & E LAINE A. G RAFTON C ARLSON , T EXAS C IVIL P RACTICE § 7:4[b] (2d ed. 200 2 ); see Schwartz , 274 S.W.3d at 276; Schley v. Structural Metals, Inc. , 595 S.W.2d 572, 587 (Tex. Civ. App.

— Waco 19 79, writ ref’d n.r.e.);
Daniels v. Conrad , 331 S.W.2d 411, 415 (Tex. Civ. App.

— Dallas 19 59, 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 immun ity 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 , h owever , 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 c lear 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 b ase 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 “ T EX
. H EALTH & S AFETY C ODE Section 312 et seq. , T EX
. C IV
.Schronk v. City of Burleson Page 7

P RAC
. & R EM .C ODE Section 101 et seq. , and T EX
. E DUC
. C ODE Section 61 et seq. ,” the appellants repeatedly state that section 312.006(a) confers immunity from liability and present neither argument nor authority su pporting 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 T EX
. R. A PP . P. 33.1(a)(1)(A) and 38.1(h).
Id. Here, the City unequivoca lly 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 immunity 2 consists of immunity from suit and immunity from liability. Reata Constr. Corp. v. City of Dallas , 197 S.W.3d 371, 374 (Tex.
20 06). Immunity from suit “ bars a suit u nless the state has consented,” while immunity from liability “ protects the state [or a political subdivision] from judgments even if it
h as 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. 19 99); City of Weslaco v. Borne , 210 S.W.3d 782, 789

- 90 (Tex. App.

— Corpus Christi
20 06, 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 munic ipalities and school districts.” Mission Consol. Indep. Sch. Dist. v. Garcia , 253 S.W.3d 653, 655 n.2 (Tex. 20 08).Schronk v. City of Burleson Page 8

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 j urisdiction 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 fro m 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) presen t 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 jurisdi ction 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 immu nity from suit and immunity from liability. See T EX

. C IV
. P RAC

. & R EM
. C ODE A NN
. § 101.025(a) (Vernon 20 05) (“ Sovereign immunity to suit is waived and abolished to the extent of liability created by this chapter. ”); Tex. Dep’t of Parks & Wildlife v. Miran da , 133 S.W.3d 217, 224 (Tex. 20 04) (“ The Tort Claims Act creates a unique statutory scheme in which the two immunities are co

- extensive”).Schronk v. City of Burleson Page 9

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 C ourt 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 1 994), rev’d on other grounds , 904 S.W.2d 628 (Tex. 19 95) (per curiam)

. The Supreme Court reversed because a deposition attached to the appellees’ supporting brief was also refer r ed to in the appellant s ’ summary

- judgment response. Wilson v. Burford , 904 S .W.2d 628, 629 (Tex. 19 95) (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 case s for guidance in d efining the standard of review for a plea to the jurisdiction. See Tex. Dep’t of Parks & Wildlife v.
Miranda , 133 S.W.3d 217, 22 7

- 28 (Tex. 20 04) . 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 tran scripts, 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 judgme nt with permission of the court.
T EX

. R. C IV
. 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. 20 04) (per curiam) (quoting T EX

. R. C IV
. 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 10

application of the summary

- judgment procedures required by Rule 166 a 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 additi onal 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’ cl aims; (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 wh y 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 c onclusion. 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 n ot 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 thatSchronk v. City of Burleson Page 11

Tort Claims Act § 101.055 does not waive immunity. For these reasons, and based upon the e vidence 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 Cit y’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 immunit y 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.
T he supporting brief incorporate s by reference an appendix containing authenticated copies of pertinent City records, depositions and exhibits, and affidavits. This is the evidence on which the City relie s 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 c ourt. Cf. T EX
. R. C IV
. P. 166a(c) (summary

5 The City’s claim of immunity under section 101.062 of the Tort C laims 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 12

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 jurisdi ction. 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 juris dictional facts. See Miranda , 133 S.W.3d at 226

- 27 ( describ ing 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 dea th. 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 th at (1) it has immunity from suit under section 101.021 because the AED did not cause Helen’s death; (2) there is noSchronk v. City of Burleson Page 13

waiver of immunity under section 101.021 for the Schronks’ bystander claims; and (3) it has immunity from suit under sections 101.055 and 10 1.062. 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. 3 d at 226. Convers ely, 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 th e 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 14 Objections to the Schronks’ Evidence The Schronks aver in their fourth point that the court abused its di scretion 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 ju risdiction. We are aware of no
reason the se rules should not govern the admissibility of such evidence. See T EX
. R.
E VID
. 101(b) (“ Except as otherwise provided by statute, these rules govern civil and criminal proceedings (including examining trials befo re 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 20 05, 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 20 03, no pet.) (same). Depositions Regarding Violation of Section 779.003 of the Health & Safety Code The City raise d a three

- part object ion 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 20 07, no pet.); Choctaw Props., L.L.C. v. Aledo Indep. Sch. Dist. , 127 S.W.3d 235, 240 (Tex. App.

— Waco 20 03, no pet.).Schronk v. City of Burleson Page 15

section 779.003 of the H ealth and Safety Code

. 7 The City objected that the Schronks
omitted from these excerpts the objections the City lodged at the time of the deposition s . 8 But see T EX
. R. C IV
. 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 19 91, 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 pre vent 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 t o 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 add ition, 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 provid es, “A person or entity that owns or leases an automated external defibrillator shall maintain and test the automated external defibrillator according to the manufa cturer’ s guidelines. ” T EX

. H EALTH & S AFETY C ODE A NN
. § 779.003 (Vernon 20 03).

8 The City states that most of these objections were to the form of the questions posed. See T EX

. R. C IV
. 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 16

We first observe that the City’s objections appear to be directed to the excerpts of deposition testimony included with in 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 th at witness ’ s previous testimony and are supported by a written copy of the manufactu rer’s guidelines attached as an exhibit to one of the deposition s . 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. Rand olph , 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 un supported 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 19 97, writ denied).

9 This 46

- page document is entitled, “Laer dal 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 consid ered 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 an d contemporaneously thereto or

“ thereafter and before judgme nt with permission of the court.” Cf. T EX

. R. C IV
. P. 166a(c).Schronk v. City of Burleson Page 17

Tak ing as true the deposition testimony favorable to the Schronks, 11 Fire fighter 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 vio lation 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. S ee 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 ab use 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 r easonable inference and resolve any doubts in the nonmovant’s favor”).Schronk v. City of Burleson Page 18

properly identified or authenticated; (3) his concluding statement of opinion does not adequate ly identify the bas e s 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.] 20 04, 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 rel ied. 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 c itations to various “LMC” numbers 12 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 19

Regarding the admissibility of the exhibits attached to Dr. Reese’s affidavit, Rule of Evidence 703 provides in per tinent 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. ” T EX
. R. E VID
. 703. An expert in this

case may reasonab ly 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 s ame time). Therefore, the admissibility of the exhibits is irrelevant.
See T EX
. R. E VID
. 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.” Sta nding alone, this probably would be insufficient. Cf. Volkswagen of Am., Inc. v. Ramirez , 159
S.W.3d 897, 902, 911 (Tex. 20 04) (expert’s reliance on the “laws of physics” does not provide a sufficient basis for his opinion). However, Dr. Reese provided m uch 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 informatio n report, a mandatory FDA “Med Watch” report regarding the incident, and other specified documents. Therefore, his affidavit provided sufficient factual substantiation for hisSchronk v. City of Burleson Page 20

expert opinion regarding whether the AED was defective. See Merrell v. Wal

- Mar t Stores, Inc. , 276 S.W.3d 117, 128 (Tex. App.

— Texarkana 20 09, 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 i s “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 20 03, 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 “exhibitsSchronk v. City of Burleson Page 21

A

- F with exhibits” or “exhibits A

- G” without any more specificity. It appears that the Schronks sought to estab lish two things at this poi nt 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 20 07, pet. denied) (“ A general reference to a vo luminous record that does not direct the trial court and parties to the evidence on which the mo vant relies is insufficient.”) (quoting Aguilar
v. Morales , 162 S.W.3d 825, 838 (Tex. App.

— El Paso 20 05, pet. denied)).
Dr. Desser ’s Affidavit The City objecte d 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 a ddress undisputed evidence. 13
Rule 194.2 (f) governs disclosure of information regarding the opposing party’s testifying experts. See T EX
. R. C IV
. 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 n ot 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 22

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 20 05, 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 end orsed 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, w e are unaware of any decision applying this same principle in the c ontext of a plea to the jurisdiction , and we decline to do so.
S ummary 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 20 08, no pet.); Van Es v. Frazier , 230 S.W.3d 770, 784 (Tex. App.

— Waco 20 07, pet. denied). Thus,
a summary -

ju dgment 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. 20 00). Although the State or other

14 The Schronks filed a for mal designation of their experts, including Dr. Desser, on December 6.Schronk v. City of Burleson Page 23

governmental unit bears the burden of conclusively establishing that its immunity has not been waived, “we protect the plaintiffs from having to ‘p ut 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 ’ cl aims 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. 20 01)); Baylor Univ. Med.
Ctr. v. Rosa , 240 S.W.3 d 565, 570 (Tex. App.

— Dallas 20 07, 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 und er 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 ot her 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 24 If a party provides inconsistent or co nflicting 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 in ference, the motion should not be granted. ” Thompson v. City of Corsicana Hous. Auth. , 57 S.W.3d 547, 557 (Tex. App.

— Waco 20 01, no pet.) (quoting Great Am. Reserve Ins. Co. v. San Antonio Plumbing Supply Co. , 391 S.W.2d 41, 47 (Tex. 19 65)) (other citati ons omitted); accord Pierce v. Washington Mut. Bank , 226
S.W.3d 711, 717

- 18 (Tex. App.

— Tyler 20 07, pet. denied); Shaw v. Maddox Metal Works,
Inc. , 73 S.W.3d 472, 478 (Tex. App.

— Dallas 20 02, no pet.); Larson v. Family Violence &
Sexual Assault Prevention Ct r. of S. Tex. , 64 S.W.3d 506, 513 (Tex. App.

— Corpus Christi
20 01, 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 o

f Corsicana , 211 S.W.3d 844, 849

- 50 (Tex. App.

— Waco 20 06), rev’d on other grounds , 249 S.W.3d 412 (Tex. 20 08). Accordingly, the court abused its discretion by sustaining the City’s objections to
Dr. Desser ’s affidavit. Summary
The trial court did not abu se 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 provide d 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 ofSchronk v. City of Burleson Page 25

their res ponse 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 Schro nks’ 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 [plaintiff s ]” 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 20 08, pet. denied)

. To avoid dismissal, the plaintiff s must “show that there is a d isputed 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
pers onal property if a private person would be liable under the same circumstances.
See T EX
. C IV
. P RAC
. & R EM
. C ODE A NN
. §§ 101.021(2) , 101.025(a) (Vernon 20 05); City of Grapevine v. Sipes , 195 S.W.3d 689, 691

- 92 (Tex. 20 06); Wise Reg’l Health Sys. v. Brittai n , 268 S.W.3d 799, 807 (Tex. App.

— Fort Worth 20 08, no pet.).Schronk v. City of Burleson Page 26

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. 20 01) (“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 inju ry, 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. 20 01)). Here,
there is no dis pute 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. 19 83), 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 i d. at
32. The City responds by cit ing Miller for the propositi on 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 am ong 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 20 07, pet. denied), with Anderson v. City of San Antonio , 120 S.W.3d 5, 7

- 9 (Tex. App.

— San Antonio 20 03, pet. denied). However, we need not wade into that fray. The statute establishes the requisite causation as “proximate cause.” T EX

. C IV
. P RAC

. & R EM
. C ODE A NN
. § 101.021; City of Grapevine v. Sipes , 195 S.W.3d 689, 691

- 92 (T ex. 20 06); Wise Reg’l Health Sys. v. Brittain , 268 S.W.3d 799, 807 (Tex. App.

— Fort Worth 20 08, no pet.). We will apply settled precedent defining the term “proximate cause.”Schronk v. City of Burleson Page 27

Reg’l Health Sys. , 268 S.W.3d at 808 (“ The causati on 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 20 05) (“ 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. 20 06) (per curiam). Section 101.021 provides that “proximate cause” is the appli cable standard. See
T EX
. C IV
. P RAC
. & R EM
. C ODE A NN
. § 101.021(1) (“proximate ly cause d ” ), § 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 Re g’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. 20 08). “ 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 occ urred.’” Id. (quoting IHS Cedars Treatment Ctr. of DeSoto, Tex., Inc. v. Mason , 143
S.W.3d 794, 799 (Tex. 20 04)) . This principle has been applied in cases governed by the Tort Claims Act, although not consistently. See, e.g., Travis v. C ity of Mesquite , 830
S.W.2d 94, 98 (Tex. 19 92); 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 20 05, no pet.)

.

16 The City contends that the use of the AED was not a cause in fact of Helen’s d eath. The issue of foreseeability is not before us.Schronk v. City of Burleson Page 28

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. 19 95); Kramer v. Lewisville Mem’l Hosp. , 858 S.W.2d 397, 400 (Tex. 19 93) ; see Columbia Rio Grande Healthcare, L.P. v. Hawley , 52 Tex. Sup. Ct. J. 804, 808 , 2009 Tex. LEXIS 323, at *16 (Tex. Ju ne 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. 19 70)) ; accord Thom as v. Farris , 175 S.W.3d 896, 899 (Tex. App.

— Texarkana 20 05, pet. denied); Marvelli v. Alston , 100 S.W.3d 460, 480 (Tex. App.

— Fort Worth 20 03, pet. denied). The Supreme Court has explained in more detail how this requirement is met

“ where preexisting illn esses 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 20 06, 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 percen t 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 c ertainty” 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. 20 08).Schronk v. City of Burleson Page 29

Grande Healthcare , 52 Tex. Sup. Ct. J. at 808, 2009 Tex. LEXIS 323, at *17; Hodgkins , 99
S.W.3d at 673

. Here, i t 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 claim s 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 a s 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
h er 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 20 08, no pet.) (quoting Horizon/CMS Healthcare , 34 S.W.3d at 905 ). The first quoted statement , whi ch 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 AE D “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 20 03, pet. denied); Smith v. Altman , 26 S.W.3d 705, 709 (Te x. App.

— Waco 20 00, pet. dism’d w.o.j.).Schronk v. City of Burleson Page 30

The second statement must be read in context with a follow

- up statement by counsel, namely, “What’s been alleged by the p laintiffs 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 cle ar, deliberate, and unequivocal ” admission. Thus, the statement s in question do not constitute judicial
admission s . See id. Dr. Desser concludes in his report that “[t]o a reasonable degree of medical probability exceeding 51%, Mrs. Schronk would have b een successfully defibrillated
had the Laerdal Heartstart 911 automatic electrical defibrillator functioned appropriate ly.” This conclusion was based on his review of the medical records, the fire department records including the monitor strip from the AE D, 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 31

Desser noted that this survival rate is based on “data which has been accumulated from
free

- standing cardiac rehabilitation units where cardiac ar rests 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 hear t 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 doub ts in [their] favor,” we conclude “ that

t here 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 20 05, no pet.) (expert report that i t 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 probabili ty” 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 p atient would have better thanSchronk v. City of Burleson Page 32

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 u nder the Act 19 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 rec kless disreg ard for the safety of others.” T EX
. C IV
. P RAC
. & R EM
. C ODE A NN
. § 101.055(2) (Vernon 20 05). The Schronks argue that in this instance the City’s failure to maintain the AED in accordance with the manufacturer’s guidelines constitutes a
violati on 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 defibril lator shall maintain and test the automated external defibrillator according to the manufacturer's guidelines. ” T EX
. H EALTH & S AFETY C ODE A NN
. §
779.003 (Vernon 20 03). This statute is found in title 9, subtitle B of the Health and Safety
Code. See Act o f 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 uni t 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 20 08, pet. denied); City of El Paso v. Hernandez , 16 S.W.3d 409, 415

- 16 (Tex. Ap p. — El Paso 20 00, pet. denied).Schronk v. City of Burleson Page 33

1989, 71st Leg., R.S., ch. 678, § 1, 1989 Tex. Gen. Laws 2230, 2235 (table of contents).
S ubtitle 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 .” S ee T EX
. C IV
. P RAC
. & R EM
. C ODE A NN
. § 101.055(2); Mejia v. City of San Antonio , 759 S.W.2d 198, 200 (Tex. App.

— San Antonio 19 88, no writ). The Schronks presented the deposition testimony of several firefighters detailing
how the Burleson Fire Department f ailed 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 mater ial 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 vi olates a statute or ordinance applicable to the action.
T EX
. C IV
. P RAC
. & R EM
. C ODE A NN
. § 101.062(b) (Vernon 20 05). 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 i nvolves . . . responding to a
9

- 1

- 1 emergency call” and (2) that “violates a statute or ordinance applicable to theSchronk v. City of Burleson Page 34

action.” Here, the Department’s maintenance of the AED is directly involved with its response to 9

- 1

- 1 calls. As noted, the Schronks h ave 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 inf erence 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, 20 02, no pet.) (not designated for publication). Summary
T he 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. Th erefore, the court erred by granting the City’s plea to the jurisdiction. W e 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 onSchronk v. City of Burleson Page 35

their strict product liability claim; and ( 3 ) genuine issues o f 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 affida vit. 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 th e 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 lig ht 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 summa ry judgment will be defeated if the nonmovant produces someSchronk v. City of Burleson Page 36

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 g rounds. 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, Lae rdal alleged that there was no evidence that the AED or its battery

w as 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 dur ing 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 “mis branded” ( 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 judgmentSchronk v. City of Burleson Page 37

that the Schronks take nothing on their claims against Laerdal. The Schronks first contend that, in view o f 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 summa ry -

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 Laer dal’s summary

- judgment motion.
Laerdal contends that Dr. Reese’s affidavit is not part of t he 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 38

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 ; T rusty 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 assu me 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 e xpert 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 challenge s the substance of the evidence.
Id.
Laerdal contends that Dr. Reese’s affidavit is conclus ory 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, evalu ated 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 fa iled 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, in stead based solely on his own conjecture and conclusions. There isSchronk v. City of Burleson Page 39

of whether Dr. Reese’s affidavit is conclusory because he did not personal ly 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 Evid ence 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.”
T EX
. R. E VID
. 703. Such facts or data need not be admissible in evidence if they are “of a type reasonabl y reli ed 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 20 00, no pet.) ; 2 S TEVEN G OODE ET AL ., G UIDE TO THE
T EXAS R UL ES OF E VIDENCE § 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. , 76 1 S.W.2d 800, 802

- 03 (Tex. App.

— Houston [1st Dist.] 19 88, no writ) (expert permitted to testify to value of shrimp boat even though he had never inspected or viewed the boat)

. T hat 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.] 20 07, pet. denied) (“ The weakness of facts in support of an expert ’ s opinion generally goes to the weight of the tes timony

r ather 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.] 19 97, no pet.).Schronk v. City of Burleson Page 40

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 it s 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 w as 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 “rep lace 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 p ertinent FDA regulations:

22 The Schronks’ defective product claim is based on section 402A of the Restatement (Second) of Torts. See R ESTATEMENT (S ECOND ) OF T ORTS § 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 produ ct 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 20 02, pet. denied).Schronk v. City of Burleson Page 41

“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 t he Federal Food, Drug and Cosmetic Act prohibits the sale or
distribution of “ misbranded ” 23 drugs an d 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 o n 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, stateme nts, 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 vi olation 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 unde r section 520(e) [21 USCS § 360j(e)].

23 A claim that a drug or medical device is “misbranded” is in essence a marketing de fect claim. See , e.g., Merck & Co. v. Garza , 277 S.W.3d 430, 437 (Tex. App.

— San Antonio 20 08, 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 42

Id. § 352(a), (c), (q) (LexisNexis 2006 ); see also T EX
. H EALTH & S AFETY C ODE A NN
. § 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 indic ated 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 ob served 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” ea ch 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 in cident 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’ warn ing 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 43

Dr. Reese opines that th e s e failure s of the AED to perform in accordance with the
instruction manual constitute “malfunction s ” 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 produce d some evidence “ raising an issue of material fact ” on the ques tion 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 testif ied 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 dat e” 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 cl aims 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 stat e duties in such a case ‘ parallel, ’ rather than add to, federal requirements ”).Schronk v. City of Burleson Page 44

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 testifi ed in his deposition t hat, when he contacted Laerdal about ordering new batteries, a L aerdal 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 part icular.” 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 o nly 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 c onsequences 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) (L exisNexis 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 statem ents 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 45

United States v. Ninety

- Five Barrels (More or Less) Alleged Apple Cider Vinegar , 265 U.S. 438,
44 2

- 4 3, 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 F OOD & D RUG L.J. 519, 521 (1999). Viewing the ev idence 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 th e 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 obs cured, or crowded with other graphic matter.” Basile, supra , 54 F OOD & D RUG 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 recom mended 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 holdSchronk v. City of Burleson Page 46

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 mater ial 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 becau se 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 expira tion 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 fun ctioned properly.Schronk v. City of Burleson Page 47

View ing the evidence in the light most favorable to the Schronks and indulging every reasonable inference and resolving any doubts in their favor, they produce d 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 revers e 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 w ith 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 claim s against th e 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

- us e 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 Departm ent 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 suchSchronk v. City of Burleson Page 48

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.)