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

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

                                                   v.

                                            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

           I agree with the majority’s opinion that Dr. Amy Mulroy is qualified. I also concur in the

majority’s conclusion that Appellee Sushma Vora’s negligence causes of action asserted against

Appellants Diagnostic Research Group are not health care liability claims pursuant to the TMLA.

           The majority also concludes DRG failed to show it was duly licensed, certified, registered,

or chartered by the State of Texas to provide health care. I agree. I do not agree, however, with

the majority’s blanket conclusion that because DRG (1) failed to show it was “duly licensed,

certified, registered, or chartered by the State of Texas to provide health care,” and (2) failed to

show that it was an affiliate of a physician who otherwise met the statutory definition of health
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care provider, it cannot prove Ms. Vora’s claims are health care liability claims under the TMLA.

I believe there is more to this analysis than the majority’s opinion suggests. See, e.g., The

Fredericksburg Care Co. v. Perez, 461 S.W.3d 513, 522 (Tex. 2015) (making it “abundantly clear

that the TMLA and its predecessor were enacted for the purpose of making health care more

affordable in Texas” by “reducing the cost of health care liability claims.”).

        Finally, I respectfully disagree with the majority opinion’s determination on the sufficiency

of Dr. Mulroy’s report with regard to Dr. John Holcomb, the study’s principal investigator. I

would affirm the trial court’s denial of the motion to dismiss pursuant to section 74.351 of the

Texas Civil Practices and Remedies Code. TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(r)(6).

Accordingly, I dissent as follows to the majority’s conclusion that Dr. Mulroy’s report does not

meet the statutory requirements on causation.

                                    SUFFICIENCY OF EXPERT REPORT

        I disagree with the majority’s conclusion that 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.

A.      Section 74.351 Expert Report Requirement

        An expert report under section 74.351 “must provide a fair summary of the expert’s

opinions as of the date of the report regarding the applicable standards of care, how the health care

provider failed to meet the standards, and the causal relationship between that failure and the

injury, harm, or damages claimed.” Legend Oaks-South San Antonio, LLC v. Molina ex rel.

Rocamontes, No. 04-14-00289-CV, 2015 WL 693225, at *5 (Tex. App.—San Antonio Feb. 18,

2015, no pet.) (mem. op., not designated for publication) (citing TEX. CIV. PRAC. & REM. CODE

ANN. § 74.351(r)(6)). Conclusory opinions on causation are not sufficient. Jelinek v. Casas, 328



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Concurring and Dissenting Opinion                                                                    04-15-00029-CV


S.W.3d 526, 539 (Tex. 2010). “However, because one of the purposes of the expert report

requirement is to provide a basis for the trial court to conclude the claims have merit, the expert

report needs to meet the statutory requirements only as to one liability theory.” Legend Oaks-

South San Antonio, 2015 WL 693225, at *5 (citing Certified EMS, Inc. v. Potts, 392 S.W.3d 625,

630–31 (Tex. 2013)). “If the expert [report] shows that at least one of the alleged theories of

liability has expert support, the claim is not frivolous and the entire case should move forward.”

Id. (citing Nexion Health at Duncanville, Inc. v. Ross, 374 S.W.3d 619, 626 (Tex. App.—Dallas

2012, pet. denied) (holding report need not be sufficient as to, or even address, each specific act

of negligence pleaded in order to satisfy expert report requirement)). “The claimant is not required

to present evidence in the report as if he were actually litigating the merits.” Id. (citing Am.

Transitional Care Ctrs. of Tex., Inc. v. Palacios, 46 S.W.3d 873, 879 (Tex. 2001)). “And the

report may be informal in that the information in the report does not need to meet the same

requirements as the evidence offered in a summary judgment proceeding or trial.” Id. (citing

Palacios, 46 S.W.3d at 879). “If the report satisfies these requirements as to any one theory of

liability, the claimant is entitled to proceed with the suit against the health care provider and the

motion to dismiss should be denied.” Id. (citing Certified EMS, 392 S.W.3d at 630).

B.       Dr. Amy Mulroy’s Report

         Because I join with the majority holding that Ms. Vora’s causes of action are not health

care claims under the TMLA, my discussion of Dr. Mulroy’s report is limited to (1) the standard

of care owed by Dr. Holcomb, (2) Dr. Holcomb’s breach of that standard of care, and (3) the causal

relationship between Ms. Vora’s injuries and Dr. Holcomb’s breach. 1



1
 Because I also agree with the majority’s conclusion the trial court did not abuse its discretion in finding Dr. Mulroy
was qualified to opine on the causal link between Ms. Vora’s injuries and Dr. Holcomb’s alleged breach of the standard
of care, I do not address Dr. Mulroy’s qualifications.

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Concurring and Dissenting Opinion                                                     04-15-00029-CV


        1.      Standard of Care

        According to Dr. Mulroy, “[t]he standards required of a physician conducting studies of

experimental medications are the same regardless of what condition and/or symptoms the drug is

being used to treat.” She continues “[o]ne of the primary duties of a principal investigator, a study

sponsor and studying facility is to monitor the participant for ‘severe adverse events.’” Severe

adverse events, or SAEs, include significant medical problems or outcomes occurring during the

study, including hospitalizations. “If a patient reports an SAE, the standard of care requires the

principal investigator to assess the symptoms, severity, and outcome to the patient as well as if the

patient continues to meet requirements that make him or her an appropriate candidate for research.”

The investigator assesses the safety of the patient and integrity of the study protocol.

        If the investigator ultimately determines a patient may be retained in the study, “it is

paramount [for the investigator] to closely monitor the patient for the reason the SAE occurred and

for any other reason that suggest that the patient I not an appropriate candidate for a research

study.” Ultimately, the investigator must (1) assess the patient to determine whether the patient

should be removed from the study and/or (2) very closely monitor the patient thereafter. If, at any

time during the study, “the investigator determines that a patient cannot meet the requirements of

the protocol or is no longer an appropriate candidate for a research study then it is his/her duty to

remove that patient from the study.” Dr. Mulroy warns that when a patient suffers more than one

SAE during any given study, “it is paramount for the investigator to highly question the

appropriateness of that patient to the study.”

        2.      Breach of Duty

        According to Dr. Mulroy, the documentation reveals that on February 23, 2011, Ms. Vora

reported being hospitalized in January of 2011. This hospitalization qualified as an SAE. The



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Concurring and Dissenting Opinion                                                                       04-15-00029-CV


initial doctor notations indicated Ms. Vora was hospitalized for pneumonia, however Dr. Holcomb

changed the diagnosis to ileus, “a bowel condition related to the side effects of linaclotide.” The

study’s sponsor reviewed Dr. Holcomb’s report and “blessed the decision for Ms. Vora to continue

in the study.”

         Dr. Mulroy opines this was a breach of the standard of care. Because ileus is a potential

side effect of the study medication, and Ms. Vora was hospitalized for this side effect, she should

have been removed from the study. She was not; and instead, Ms. Vora was ultimately hospitalized

two more times for the very side effects being studied. 2 Additionally, when the determination was

made to allow Ms. Vora to remain in the study, the “investigator had a duty to very closely monitor

Ms. Vora.” Clearly this did not happen. Ms. Vora was hospitalized again in March of 2011—a

second SAE. This SAE apparently went undetected by the investigator. It was not until May 23,

2011, when Ms. Vora suffered her third SAE that Dr. Holcomb knew of her continued problems.

Dr. Holcomb’s failure to sufficiently monitor Ms. Vora allowed a two-month time period to pass

between the second SAE and the team’s knowledge of such.

         3.       Proximate Cause

         Dr. Mulroy opines that had Ms. Vora been closely monitored after her first SAE, the

investigator would have learned of her second SAE, “which would have required him, the study

sponsor and the studying facility to remove [Ms. Vora] from the study following the second related

SAE.” Dr. Holcomb’s failure to closely monitor Ms. Vora fell below the standard of care owed to

Ms. Vora and the “third hospitalization and the pain and suffering related thereto would have been

wholly prevented.” Dr. Mulroy contends that “the third SAE was wholly preventable and should



2
  I acknowledge that Ms. Vora’s failure to notify Dr. Holcomb of her second hospitalization may be an issue of
contributory negligence at trial, but it is not a question for review on the sufficiency of the expert report under section
74.351. See TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(r)(6).

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Concurring and Dissenting Opinion                                                    04-15-00029-CV


never have happened. Ms. Vora should have been removed from the study no later than March

2011 when the second SAE occurred. If this had been done, then the May 2011 SAE would have

been prevented.”

        Dr. Mulroy avers that Dr. Holcomb, as principal investigator for the open label study of

the drug linoclotide,

        breached the standard of care by allowing Ms. Vora to continue in the study of
        linaclotide after not one but two severe adverse events—the January and March
        2011 hospitalizations. If Dr. Holcomb had timely removed her from the study, the
        third severe adverse event—the May 2011 hospitalization for which Ms. Vora was
        removed from the study would not have occurred.

Finally, Dr. Mulroy concludes the proximate cause of Ms. Vora’s third hospitalization was the

continued use of linaclotide, and it was foreseeable the continued use of the drug would cause the

second and third SAE. But for Dr. Holcomb’s failure to monitor Ms. Vora and discontinue the

linaclotide following the second SAE, “in reasonable medical probability, Ms. Vora would not

have suffered the [symptoms], or the associated hospitalization and pain and suffering.”

C.      Conclusion

        Dr. Mulroy’s report ties the standard of care to the linaclotide study. The report indicates

Ms. Vora had three SAEs. After failing to remove Ms. Vora from the study following the first

SAE, and then subsequently failing to closely monitor and observe her, Dr. Holcomb breached the

standard of care owed to Ms. Vora. This breach resulted in Ms. Vora being hospitalized for a third

time while participating in the study.

        Contrary to the majority’s conclusion, I believe Dr. Mulroy’s opinion represents a good

faith effort to provide a fair summary of her opinions regarding the applicable standards of care,

the manner in which Dr. Holcomb failed to meet those standards, and the causal relationship


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Concurring and Dissenting Opinion                                                     04-15-00029-CV


between the failure and the harm claimed. TEX. CIV. PRAC. & REM. CODE ANN. § 74.351 (1),

(r)(6); see Bowie Mem’l Hosp. v. Wright, 79 S.W.3d 48, 51–52 (Tex. 2002) (per curiam). Dr.

Mulroy’s report constitutes a good faith effort to link the breach of duty to the third SAE and

provides enough detail to inform Dr. Holcomb of the specific conduct being questioned, i.e. fair

notice of the complaints being raised and sufficient detail upon which the trial court may conclude

the claim has merit. See Jelinek, 328 S.W.3d at 539; see also Palacios, 46 S.W.3d at 879.

        Chapter 74 does not require Dr. Mulroy’s report to present evidence sufficient for litigation

purposes. See Palacios, 46 S.W.3d at 879. The trial court could have reasonably concluded that

Dr. Mulroy’s report satisfied the expert report requirements on Dr. Holcomb’s determination to

allow Ms. Vora to continue in the study and, following that determination, his failure to closely

monitor Ms. Vora and discontinue the linaclotide following the second SAE, resulted in Ms.

Vora’s third SAE, the hospitalization, and the pain and suffering.

        For these reasons, I believe the trial court did not abuse its discretion and I would affirm

its denial of Dr. Holcomb’s motion to dismiss the complaint under the TMLA.

                                                  Patricia O. Alvarez, Justice




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