                               Fourth Court of Appeals
                                      San Antonio, Texas
                                                 OPINION
                                         No. 04-15-00029-CV

                 DIAGNOSTIC RESEARCH GROUP and John R. Holcomb, M.D.,
                                   Appellants

                                                  v.
                                                Sushma
                                            Sushma VORA,
                                               Appellee

                      From the 407th Judicial District Court, Bexar County, Texas
                                   Trial Court No. 2013-CI-00357
                                Honorable Larry Noll, Judge Presiding

Opinion by: Jason Pulliam, Justice
Concurring and Dissenting Opinion by: Patricia O. Alvarez, Justice

Sitting:          Karen Angelini, Justice
                  Patricia O. Alvarez, Justice
                  Jason Pulliam, Justice

Delivered and Filed: August 19, 2015

AFFIRMED IN PART; REVERSED AND REMANDED IN PART

           This is an interlocutory appeal of the trial court’s denial of a motion to dismiss filed by

Appellants Diagnostic Research Group (DRG) and Dr. John Holcomb. DRG and Dr. Holcomb

contend the trial court abused its discretion in denying the motion to dismiss, finding the causes of

action asserted against DRG are not health care liability claims under the Texas Medical Liability

Act (TMLA). Further, DRG and Dr. Holcomb contend the trial court abused its discretion by

denying their challenges to the expert report of Plaintiff Sushma Vora’s (Vora) expert, Dr. Amy

Mulroy.
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       Based upon the particular record in this case, we affirm in part and reverse in part the trial

court’s order denying DRG and Dr. Holcomb’s motion to dismiss. We remand for further

proceedings consistent with this opinion.

                                            BACKGROUND

       This case arises from Vora’s participation in the pre-market study of a drug, linaclotide,

anticipated to treat irritable bowel syndrome. The drug study was conducted by DRG, with Dr.

Holcomb serving as the Principal Investigator. It is undisputed that during her participation in the

study, Vora experienced three severe adverse events, each resulting in hospitalization. After the

third event, Vora was removed from the pre-market drug study. Vora later suffered seizures and

strokes, which she alleges severely disabled her.

       Vora filed suit against DRG and Dr. Holcomb asserting causes of action of negligence and

gross negligence. In her petition, Vora asserts DRG and Dr. Holcomb departed from accepted

standards of medical care “by conducting a study of a dangerous medication and allowing Ms.

Vora to receive linaclotide which had serious side effects ….” Vora asserts this conduct caused

preventable, permanent and debilitating injury.

       Although Vora maintains her negligence claims do not fall within the ambit of the TMLA,

in the interest of caution, she timely served upon all defendants the expert report and curriculum

vitae of Dr. Amy Mulroy, as required by Section 74.351 of the TMLA. See TEX. CIV. PRAC. &

REM. CODE ANN. § 74.351(a)(West Supp. 2014). DRG and Dr. Holcomb timely objected to Dr.

Mulroy’s report based upon her lack of qualifications to serve as an expert on causation. DRG

and Dr. Holcomb also timely filed a motion to dismiss Vora’s negligence claims asserting the

causes of action are health care liability claims, and as such, Vora was required to timely serve an

expert report. Because Vora’s expert report did not meet the statutory requirements, DRG and Dr.

Holcomb contended the suit should be dismissed.
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                                                                                     04-15-00029-CV


       Following a hearing on the motion to dismiss, the trial court overruled the objections to Dr.

Mulroy’s expert report and denied DRG and Dr. Holcomb’s motion to dismiss. In its denial of

their motion to dismiss, the trial court found Vora’s suit against Dr. Holcomb asserts health care

liability claims; however, Vora’s suit against DRG does not assert health care liability claims.

Also, the trial court found Dr. Mulroy’s expert report was “adequate as to Dr. Holcomb as it puts

him on notice of the claims asserted by Plaintiff.” DRG and Dr. Holcomb then perfected this

interlocutory appeal.

                                            ANALYSIS

Issue One:              Whether Vora’s causes of action asserted against DRG are “Health Care
                        Liability Claims”

       DRG and Dr. Holcomb first contend Vora’s negligence causes of action asserted against

DRG are health care liability claims pursuant to the TMLA because DRG is a health care provider,

and the nature of her claims concern the care and treatment rendered to Vora during her

participation in the drug study. DRG and Dr. Holcomb assert DRG satisfies the statutory definition

of “health care provider” because DRG is an affiliate of a physician, Dr. Holcomb.

                                       Standard of Review

       Ordinarily, an appellate court reviews a trial court’s determination of a motion to dismiss

for failure to comply with Section 74.351 of the TMLA under an abuse of discretion standard. San

Antonio Extended Med. Care, Inc. v. Vasquez, 327 S.W.3d 193, 196-97 (Tex. App.—San Antonio

2010, no pet.). However, determination whether a petition asserts a health care liability claim

under the TMLA is a question of law, to which we apply a de novo standard of review. Id.; Inst.

for Women’s Health, P.L.L.C. v. Imad, No. 04–05–00555–CV, 2006 WL 334013, *1 (Tex. App.—

San Antonio 2006, no pet.) (mem. op.). “[W]hen making that determination courts should consider

the entire court record, including the pleadings, motions and responses, and relevant evidence


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                                                                                                       04-15-00029-CV


properly admitted.” Loaisiga v. Cerda, 379 S.W.3d 248, 258 (Tex. 2012). In construing a statute,

an appellate court must give it the effect the Legislature intended as found in the plain meaning of

the statute’s text. Bioderm Skin Care, LLC v. Sok, 426 S.W.3d 753, 757-58 (Tex. 2014); Lopez v.

Osuna, 453 S.W.3d 60, 64 (Tex. App.—San Antonio 2014, no pet.).

                                                  Applicable Law

         A “health care liability claim” is defined as:

         [A] cause of action against a health care provider or physician for treatment, lack
         of treatment, or other claimed departure from accepted standards of medical care,
         or health care, or safety or professional or administrative services directly related
         to health care, which proximately results in injury to or death of a claimant, whether
         the claimant’s claim or cause of action sounds in tort or contract.

TEX. CIV. PRAC. & REM. CODE ANN. § 74.001(a)(13) (West Supp. 2014). Following this statutory

definition, a health care liability claim under the TMLA has three elements: (1) the defendant is a

health care provider or physician; (2) the essence of the nature of the underlying claim concerns

treatment, lack of treatment or other departure from accepted standards of medical care, or health

care, or safety or professional or administrative services directly related to health care; and (3) the

defendant’s alleged act or omission was a proximate cause of the claimant’s alleged injury. 1

Loaisiga, 379 S.W.3d at 255. The party asserting application of the TMLA carries the burden to

show the causes of action asserted are health care liability claims. Bioderm Skin Care, 426 S.W.3d

at 758; Brown v. Villegas, 202 S.W.3d 803, 806 (Tex. App.—San Antonio 2006, no pet.).

         With regard to the first definitional element, a health care provider is “any person,

partnership, professional association, corporation, facility, or institution duly licensed, certified,

registered, or chartered by the State of Texas to provide health care.” TEX. CIV. PRAC. & REM.



1
 The parties’ dispute in the trial court and on appeal focuses on the first two definitional elements. The parties do not
dispute the third element: causation. Therefore, the third element is not discussed.


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                                                                                      04-15-00029-CV


CODE ANN. § 74.001(a)(12)(A) (West Supp. 2014). The term includes an officer, director,

shareholder, member, partner, manager, owner, or affiliate of a health care provider or physician.

See id. at § 74.001(a)(12)(B)(i).

       Following the statutory definition, the crux of classification as a “health care provider” is

the initial requirement that the party be licensed or certified to provide health care. See id. at

§ 74.001(a)(12)(A). As the party asserting application of the TMLA, DRG had the burden to

present evidence to establish this licensure or certification. See Bioderm Skin Care, 426 S.W.3d

at 758; Brown v. Villegas, 202 S.W.3d at 806. DRG failed to provide any such evidence, however,

as the record is silent as to any licensure or certification to provide health care. Without this

evidence of licensure or certification, generally, a court cannot determine whether DRG satisfies

the statutory definition of “health care provider.” See e.g. Shiloh Treatment Ctr., Inc. v. Ward, No.

01-14-00626-CV, 2015 WL 1825757, at *4 (Tex. App.—Houston [1st Dist.] 2015, no pet.);

Doctors Data, Inc. v. Stemp, No. 03-12-00079-CV, 2014 WL 3809742, at *3 (Tex. App.—Austin

2014, pet. denied) (mem. op.); Brown v. Villegas, 202 S.W.3d at 806. However, in this factual

situation, the analysis need not end with this omission of important evidence because the statutory

definition of health care provider goes on to encompass any affiliate of a physician. See Bioderm

Skin Care, 426 S.W.3d at 758.

       The TMLA defines a health care provider to include, inter alia, an affiliate of a physician.

See TEX. CIV. PRAC. & REM. CODE ANN. § 74.001(a)(12)(B)(i); Bioderm Skin Care, 426 S.W.3d

at 758. The TMLA then defines “affiliate” as “a person who, directly or indirectly, through one

or more intermediaries, controls, is controlled by, or is under common control with a specified

person, including any direct or indirect parent or subsidiary.” TEX. CIV. PRAC. & REM. CODE ANN.

§ 74.001(a)(1). Further, the statute defines “control” as “the possession, directly or indirectly, of

the power to direct or cause the direction of the management and policies of the person, whether
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                                                                                                    04-15-00029-CV


through ownership of equity or securities, by contract, or otherwise.” Id. at § 74.001(a)(3).

Therefore, if DRG is an affiliate of Dr. Holcomb, then it is a health care provider under the first

element of the three-prong test to determine whether the claim against it is a health care liability

claim. Id. at §§ 74.001(a)(1), 74.001(a)(12)(B)(i); see Bioderm Skin Care, 426 S.W.3d at 758-59;

Doctors Data, Inc., 2014 WL 3809742, at *3.

         DRG attached no evidence to its motion to dismiss and presented no evidence during the

hearing on the motion to dismiss.2 Due to this sparse record, the only facts upon which this court

may rely to make any determination regarding whether DRG is an affiliate of Dr. Holcomb are the

undisputed facts derived from Vora’s petition and the appellate briefs. As stated, no party disputes

that Dr. Holcomb is a physician duly licensed in Texas to practice medical care and is employed

by DRG. The trial court found Dr. Holcomb to be a physician and found Vora’s negligence claims

against Dr. Holcomb to be health care liability claims as defined by the TMLA. This holding is

not challenged on appeal, and therefore, will be accepted as a given fact. It is also undisputed that

Dr. Holcomb, as DRG’s employee, was the Principal Investigator of the subject drug study in

which Vora participated. Vora’s petition states DRG is a Texas Limited Liability Corporation and

may be served with process through its registered agent, Charles Andrews.

         This limited record contains no evidence that Dr. Holcomb held any ownership of DRG or

exercised any control over DRG’s management and policies. The limited record contains no

evidence of Dr. Holcomb’s scope of employment or job description. The undisputed facts provide

no basis from which this court could determine whether DRG satisfies the statutory definition of




2
 Although DRG and Dr. Holcomb attach evidence to their appellate brief, this evidence was not presented to the trial
court in its determination of the motion to dismiss and objections to Vora’s expert report. For this reason this court
may not consider the evidence. See e.g. Crutcher v. Dallas Indep. Sch. Dist., 410 S.W.3d 487, 492 (Tex. App.—
Dallas 2013, no pet.); Hendee v. Dewhurst, 228 S.W.3d 354, 376 (Tex. App.—Austin 2007, pet. denied) (citing
Cincinnati Life Ins. Co. v. Cates, 927 S.W.2d 623, 626 (Tex. 1996)) (in summary judgment context).

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                                                                                                    04-15-00029-CV


“affiliate” or “control” to determine whether DRG is an affiliate of Dr. Holcomb. TEX. CIV. PRAC.

& REM. CODE ANN. § 74.001(a)(3); but see Bioderm Skin Care, 426 S.W.3d at 758-59 (record

contained evidence Dr. Nguyen was the sole owner of the clinic, possessed power to direct its

management and policies and was responsible for its operations.).

         Given the sparse record evidence, DRG has failed to show it “was duly licensed, certified,

registered, or chartered by the State of Texas to provide health care.” See Shiloh Treatment Ctr.,

Inc., 2015 WL 1825757, at *4; TEX. CIV. PRAC. & REM. CODE ANN. § 74.001(a)(12)(A). Further,

given the sparse record evidence, DRG has failed to show that DRG is an affiliate of a physician

to otherwise meet the statutory definition of health care provider. See TEX. CIV. PRAC. & REM.

CODE ANN. § 74.001(a)(12)(B)(i); Bioderm Skin Care, 426 S.W.3d at 758. Because there is no

evidence, based upon the limited undisputed facts before this court, this court cannot conclude

DRG is a health care provider as defined by the TMLA. Because DRG failed to show it is a health

care provider, it also cannot show Vora’s claims against it are health care liability claims. See

Loaisiga, 379 S.W.3d at 255. 3

         Based upon this particular record, DRG’s first issue is overruled, and we affirm the trial

court’s order concluding Vora’s causes of action asserted against DRG are not health care liability

claims under the TMLA.

Issue Two:                 Dr. Mulroy’s Qualifications to Opine on the Issue of Causation

         DRG and Dr. Holcomb 4 assert the trial court abused its discretion by denying their motion

to dismiss because Dr. Mulroy is not qualified to opine on causation. Without expert opinion on



3
  Because we make this determination, the court will not reach the second prong of the analysis whether Vora’s
asserted causes of action are health care liability claims: the essence of the nature of the asserted claims.
4
  DRG makes these assertions assuming this court concluded the claims asserted against it are health care liability
claims, and therefore, the suit against it falls within the purview of the TMLA. Because we do not conclude the claims
asserted against DRG are health care liability claims under the facts and evidence before the court, we address this
issue only as it applies to Dr. Holcomb.

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                                                                                      04-15-00029-CV


causation, Dr. Holcomb contends Vora fails to meet the requirements of the TMLA, and therefore,

her claims against him should be dismissed. Specifically, Dr. Holcomb argues Dr. Moyer’s report

fails to establish she is qualified to testify on the issue of the causal relationship between Dr.

Holcomb’s decision to prescribe linaclotide and the claimed side effects. Dr. Holcomb argues Dr.

Mulroy’s report does not “state that she has any experience or training regarding linaclotide or

gastrointestinal conditions” and fails to indicate whether Dr. Mulroy has any specific knowledge

or experience in assessing the causal relationship between the prolonged use of linaclotide and the

alleged side effects and injuries.

                                        Standard of Review

       We review a trial court’s determination with regard to an expert’s qualifications to assert

an opinion pursuant to Section 74.351 for an abuse of discretion. See Am. Transitional Care Ctrs.

of Tex., Inc. v. Palacios, 46 S.W.3d 873, 875 (Tex. 2001). A trial court abuses its discretion if its

decision is arbitrary, unreasonable, and without reference to any guiding principles and rules.

Bowie Mem’l Hosp. v. Wright, 79 S.W.3d 48, 52 (Tex. 2002) (per curiam). Under this standard,

when reviewing factual matters committed to a trial court’s discretion, an appellate court may not

substitute its own judgment for the trial court’s judgment. Gray v. CHCA Bayshore L.P., 189

S.W.3d 855, 858 (Tex. App.—Houston [1st Dist.] 2006, no pet.). Merely because a trial court

may decide a matter within its discretion in a different manner than an appellate court would in a

similar circumstance does not demonstrate that an abuse of discretion has occurred. Davisson v.

Nicholson, 310 S.W.3d 543, 548 (Tex. App.—Fort Worth 2010, no pet.). A trial court does not

abuse its discretion if it commits a mere error in judgment. See E.I. du Pont de Nemours & Co. v.

Robinson, 923 S.W.2d 549, 558 (Tex. 1995).




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                                           Applicable Law

        In determining whether the report constitutes a good faith effort to comply with the

statutory requirements, the trial court’s inquiry is limited to “the four corners” of the report.

Palacios, 46 S.W.3d at 878; Mem’l Hermann Healthcare Sys. v. Burrell, 230 S.W.3d 755, 758

(Tex. App.—Houston [14th Dist.] 2007, no pet.); Gray, 189 S.W.3d at 859. Thus, an expert’s

qualifications cannot be inferred, but must be present in the expert report and the curriculum vitae.

See Olveda v. Supulveda, 141 S.W.3d 679, 683 (Tex. App.—San Antonio 2004, pet. denied).

Should a plaintiff fail to establish the purported expert’s qualifications to submit the report, it is

deficient and does not comply with Section 74.351. Collini v. Pustejovsky, 280 S.W.3d 456, 464-

66 (Tex. App.—Fort Worth 2009, no pet.); see TEX. CIV. PRAC. & REM. CODE ANN. §§ 74.351(l),

(r)(5)-(6) (West Supp. 2014).

        A person is qualified to give opinion testimony concerning the causal relationship between

the alleged injury and the alleged departure from the applicable standard of care only if the person

is a physician and is otherwise qualified to render opinions on that causal relationship under the

Texas Rules of Evidence. See TEX. CIV. PRAC. & REM. CODE ANN. §§ 74.351(r)(5)(C) (West Supp.

2014), 74.403(a) (West 2011). To be so qualified under the Texas Rules of Evidence, an expert

must have “knowledge, skill, experience, training, or education” regarding the specific issue before

the court. TEX. R. EVID. 702 (West 2014); Broders v. Heise, 924 S.W.2d 148, 153 (Tex. 1996).

Sections 74.351 and 74.403(a) do not require that the physician serving as an expert be a

practitioner in the same medical specialty as the defendant. Accordingly, the proper inquiry

concerning whether a doctor is qualified to testify regarding causation is not the doctor’s area of

practice or expertise, but rather the doctor’s familiarity with the issues involved in the factual claim

before the court. Roberts v. Williamson, 111 S.W.3d 113, 121 (Tex. 2003); Collini, 280 S.W.3d

at 464; Blan v. Ali, 7 S.W.3d 741, 745 (Tex. App.—Houston [14th Dist.] 1999, no pet.). “A
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                                                                                     04-15-00029-CV


physician who is not of the same school of medicine may be competent [to testify as to causation]

if he has practical knowledge of what is usually and customarily done by a practitioner under

circumstances similar to those confronting the defendant.” Estorque v. Schafer, 302 S.W.3d 19,

26 (Tex. App.—Fort Worth 2009, no pet.); see also Ehrlich v. Miles, 144 S.W.3d 620, 625 (Tex.

App.—Fort Worth 2004, pet. denied).

                                             Analysis

        Following these guidelines, to establish Dr. Mulroy’s qualifications to opine on causation,

Vora was required to demonstrate Dr. Mulroy’s knowledge, skill, experience, training, or

education that would qualify her to opine regarding the specific issues raised in Vora’s petition.

See Roberts, 111 S.W.3d at 120-21; Ehrlich, 144 S.W.3d at 625. Vora’s original petition states

Dr. Holcomb was “negligent in conducting a study of a dangerous medication and allowing Ms.

Vora to receive Linaclotide which had serious side effects including, but not limited to, bowel

obstructions, seizure and stroke.” Vora contends Dr. Holcomb’s acts and omissions caused her

asserted injuries.

        Thus, the issues involved in the factual claim before the court are Dr. Holcomb’s conduct

in facilitating a drug study and Dr. Holcomb’s continued prescription of linaclotide to Vora after

she exhibited side-effect symptoms while participating in the study. Based upon the allegation in

the petition, the specialized branches of internal medicine or gastroenterology are not implicated

by Dr. Holcomb’s alleged negligence in conducting the drug study or continuing to prescribe

linaclotide, nor is experience with linaclotide or knowledge of its side effects implicated. Rather,

the factual issues raised in Vora’s petition pertain to a doctor’s standard of care in conducting a

study of an experimental drug and in continuing a person in a drug study after exhibition of

potential side effects. Thus, Vora must demonstrate Dr. Mulroy’s knowledge, skill, experience,



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training, or education in the field of conducting a drug study of an experimental drug and in

treatment of a participant should potential side-effect symptoms arise. 5

         Dr. Mulroy’s curriculum vitae shows she has been a licensed physician in the State of

Texas since 1994 and has been board certified in psychiatry and neurology since 1998. Dr. Mulroy

is a practicing adult psychiatrist, and outside of her private practice, Dr. Mulroy served as a

Principle Investigator for at least 45 pre-market drug studies from 2003 to 2012. These pre-market

studies included “open label studies”, as in this case, as well as “double blind studies.” The

majority of these drug studies in which Dr. Mulroy served as the Principal Investigator involved

medication used primarily in the practice of psychiatry; however, many involved medication

relevant to other medical fields. Through this experience as a Principal Investigator, Dr. Mulroy

states she has an understanding of, and is qualified to testify to, the responsibilities and standards

required of a physician conducting a study of an experimental drug. Dr. Mulroy states these

responsibilities and standards in conducting a drug study are the same regardless of the condition

and/or symptoms the experimental medication is used to treat.

         Based upon independent review of Dr. Mulroy’s curriculum vitae and expert report, we

conclude the trial court did not abuse its discretion in finding Dr. Mulroy’s credentials and

experience provide adequate qualifications to express an expert opinion on causation under these

facts. The relevant inquiry under these facts is whether Dr. Mulroy’s experience in conducting

pre-market drug studies provides sufficient familiarity with the presented issues whether Dr.

Holcomb acted pursuant to the standard of care in conducting the subject drug study and whether


5
 Although Dr. Holcomb asserts the factual issues before the court are “the causal relationship between the prolonged
use of linaclotide and the alleged side effects and injuries”, this is a mischaracterization of the allegations in the
original petition against Dr. Holcomb. This characterization pertains to the strict product liability claim asserted
against the drug manufacturer. Dr. Holcomb also argues Dr. Mulroy’s report does not “state that she has any
experience or training regarding linaclotide or gastrointestinal conditions” and fails to indicate whether Dr. Mulroy
has any specific knowledge or experience in assessing the causal relationship between the prolonged use of linaclotide
and the alleged side effects and injuries; however, this is a mischaracterization of the required specialization.

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Vora’s continuation in the study after her hospitalizations caused her alleged injuries. Dr. Mulroy

exhibits extensive experience as a Principal Investigator in these numerous studies of experimental

medication, the same position held by Dr. Holcomb. Dr. Mulroy’s practice as a Principal

Investigator in a drug study provides sufficient knowledge, experience and training for the trial

court to conclude she possesses sufficient qualifications to opine on the causal link between Vora’s

alleged injuries and Dr. Holcomb’s alleged acts or omissions in allowing Vora to continue

participating in the drug study following two hospitalizations. Based upon this review of Dr.

Mulroys curriculum vitae and report, the trial court’s conclusion is not arbitrary, unreasonable,

and without reference to any guiding principles and rules.

        For this reason, we conclude the trial court did not abuse its discretion in finding Dr.

Mulroy qualified to opine on causation, and thus, overruling Dr. Holcomb’s objections to Dr.

Mulroy’s expert report. Dr. Holcomb’s second issue is overruled, and the trial court’s order is

affirmed in part in this respect.

Issue Three:             Sufficiency of Dr. Mulroy’s Expert Report on Causation

        Dr. Holcomb argues the trial court abused its discretion in denying his motion to dismiss

because Dr. Mulroy’s expert report is merely conclusory on the issue of causation, and therefore,

does not constitute a good faith effort to comply with the statutory expert report requirement of

Section 74.351. Dr. Holcomb contends Dr. Mulroy’s report contains only a series of repetitious,

conclusory statements regarding causation and does not provide the necessary medical detail and

explanation of the causal relationship between Dr. Holcomb’s prescription of linaclotide and

Vora’s alleged injury.

                                        Standard of Review

        Again, we review a trial court’s denial of a motion to dismiss pertaining to an expert’s

report served pursuant to Section 74.351 for an abuse of discretion. See Palacios, 46 S.W.3d at
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875. A trial court abuses its discretion if its decision is arbitrary, unreasonable, and without

reference to any guiding principles and rules. Bowie Mem’l Hosp., 79 S.W.3d at 52.

                                          Applicable Law

       Pursuant to Section 74.351, a plaintiff who brings a health care liability claim must serve

on the defendant an expert report that addresses standard of care, liability and causation no later

than the 120th day after the claim is filed.             See TEX. CIV. PRAC. & REM. CODE ANN.

§ 74.351(r)(6) (West Supp. 2014); HEB Grocery Co., L.L.P. v. Farenik, 243 S.W.3d 171, 173

(Tex. App.—San Antonio 2007, no pet.). If an expert report has not been served on a defendant

within the 120–day period, then on the motion of the affected defendant, the trial court must

dismiss the claim with prejudice and award the defendant reasonable attorney’s fees and costs.

TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(b); Barber, 303 S.W.3d at 790-91. A report has not

been served under the statute if it is found to be deficient. Lewis v. Funderburk, 253 S.W.3d 204,

207-08 (Tex. 2008); Barber, 303 S.W.3d at 790-91. In such instance, the trial court has discretion

to grant one thirty-day extension to allow the plaintiff the opportunity to cure the deficiency. See

TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(c); Barber, 303 S.W.3d at 790-91. If the deficiency

is not cured or cannot be cured, the case must be dismissed. Id. § 74.351(b)(2).

       A report is deficient if it does not represent an objective good faith effort to comply with

the definition of an expert report. TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(l); Barber, 303

S.W.3d at 791. To qualify as a good faith effort, the report must “discuss the standard of care,

breach, and causation with sufficient specificity to inform the defendant of the conduct the plaintiff

has called into question and to provide a basis for the trial court to conclude that the claims have

merit.” TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(r)(6); Palacios, 46 S.W.3d at 878; Barber,

303 S.W.3d at 791. A report does not fulfill this requirement if it merely states the expert’s



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                                                                                       04-15-00029-CV


conclusions or if it omits any of the statutory requirements. Palacios, 46 S.W.3d at 879; Barber,

303 S.W.3d at 790-91.

       When reviewing the adequacy of a report, the only information relevant to the inquiry is

the information contained within the four corners of the document alone. Palacios, 46 S.W.3d at

878; Barber, 303 S.W.3d at 790-91. This requirement precludes a court from filling gaps in a

report by drawing inferences or guessing as to what the expert likely meant or intended. Barber,

303 S.W.3d at 790-91; see Austin Heart, P.A. v. Webb, 228 S.W.3d 276, 279 (Tex. App.—Austin

2007, no pet.) (citing Bowie Mem’l Hosp., 79 S.W.3d at 53).

       Although the report need not marshal all of a plaintiff’s proof, it must do more than merely

state conclusions; rather, it must explain the basis for the expert’s causation opinions by linking

the expert’s conclusions to the relevant facts. Palacios, 46 S.W.3d at 878-79; Bogar v. Esparza,

257 S.W.3d 354, 364 (Tex. App.—Austin 2008, no pet.). Thus, to satisfy the statutory purpose

with regard to causation, an expert report must provide a fair summary of the expert’s opinions on

the causal relationship between a breach in the standard of care and the alleged harm with enough

specificity to allow the trial court to conclude the plaintiff’s claims have merit. Palacios, 46

S.W.3d at 878-79; TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(r)(6). The report must explain

how any breach in the standard of care caused the alleged injury. Jones v. King, 255 S.W.3d 156,

160 (Tex. App.—San Antonio 2008, no pet.).

                                             Application

       Dr. Mulroy states in her report that Dr. Holcomb “breached the standard of care and that

as a result of this breach Ms. Vora was hospitalized for a third time while participating in the study.

Ms. Vora’s third hospitalization and the pain and suffering related thereto would have been wholly

prevented if Dr. Holcomb … had withdrawn Ms. Vora from the study after her first two

hospitalizations ….” To reach this conclusion, Dr. Mulroy began by explaining the standard of
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care of a Principal Investigator of a drug study. The first responsibility is to monitor a participant

for “severe adverse events.” If one occurs, the second responsibility is to re-assess the safety of

the participant, the appropriateness of the participant’s continued involvement in the study and the

integrity of the study. Dr. Mulroy explained that upon the occurrence of more than one severe

adverse event, such as hospitalization, the Principal Investigator must “highly question the

appropriateness of that patient in the study” and “hospitalization for a potential side effect … is

enough to warrant a decision to remove the patient from the study.” Finally, Dr. Mulroy opines

that after the first hospitalization, Dr. Holcomb had a duty to closely monitor and communicate

with Vora; however, Dr. Holcomb failed to do so, and therefore, was not aware of Vora’s second

hospitalization. Dr. Mulroy opines, then, under the standard of care of a doctor conducting a drug

study, discovery of the second hospitalization would have required Dr. Holcomb to remove Vora

from the study. Because Dr. Holcomb did not discover the second hospitalization, and therefore,

did not remove Vora from the study, Dr. Mulroy opines Vora continued to ingest a drug that

presented dangerous side effects to her. Dr. Mulroy concludes that if Dr. Holcomb had removed

Vora from the study, she would not have continued this use of linaclotide. Based upon this

premise, Dr. Mulroy concluded “the proximate cause of the third hospitalization was the continued

use of linaclotide. The third hospitalization was for a distended abdomen and vomiting, which

was a known risk of the drug. Therefore, it was foreseeable that the continued use of the drug

could cause distended abdomen and vomiting. Ms. Vora had already been hospitalized twice for

similar injuries while taking the drug, making it foreseeable that continued use of the drug would

result in distended abdomen and vomiting.”

       Upon review of Dr. Mulroy’s expert report, we conclude the report is conclusory with

regard to causation.    Dr. Mulroy adequately explained the standard of care of a Principal

Investigator of an experimental drug study, explained how Dr. Holcomb breached the standard of
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care and explained how Dr. Holcomb should have acted under these facts. However, Dr. Mulroy

failed to provide sufficient facts to support her opinion that Dr. Holcomb’s failure to comply with

the standard of care, i.e. failing to monitor Vora closely after the first hospitalization and failing to

remove Vora from participation in the study following the second hospitalization, caused Vora’s

third hospitalization and other alleged resulting injuries. The report fails to set forth a specific link

between Dr. Holcomb’s alleged omissions with Vora’s alleged injuries and fails to discuss the

factual basis of her opinion that Vora’s continued ingestion of linaclotide caused Vora’s third

hospitalization. Particularly, Dr. Mulroy fails to state she reviewed Vora’s medical records

pertaining to her hospitalizations. Dr. Mulroy’s report does not provide a fair summary of her

opinions on the causal relationship between the asserted breach in the standard of care and the

alleged harm with enough specificity to allow the trial court to conclude Vora’s claims have merit

and to adequately inform Dr. Holcomb of the specific conduct that Vora calls into question. For

these reasons, Dr. Mulroy’s expert report is deficient.

        Accordingly, we conclude the trial court abused its discretion by denying Dr. Holcomb’s

motion to dismiss based upon insufficiency of Dr. Mulroy’s expert report on the element of

causation. Dr. Holcomb’s third issue is sustained.

        Although Dr. Holcomb contends the proper resolution is to render a judgment dismissing

Vora’s claims against him, the Texas Supreme Court has held that should a court of appeals

conclude an expert report is deficient in a manner that can be cured, Section 74.351 permits one

thirty-day extension to cure the specified deficiency. Leland v. Brandal, 257 S.W.3d 204, 207

(Tex. 2008); Collini, 280 S.W.3d at 468. Accordingly, the trial court should have an opportunity

to consider granting Vora an extension to cure the deficiencies detailed in this opinion.




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                                         CONCLUSION

       Based upon the foregoing reasons and based upon the limited appellate record, we affirm

in part and reverse in part the trial court’s order denying DRG and Dr. Holcomb’s motion to

dismiss. We remand for further proceedings consistent with this opinion.


                                                Jason Pulliam, Justice




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