Diagnostic Research Group and John R. Holcomb, M.D. v. Sushma Vora ( 2015 )

ACCEPTED
04-15-00029-CV
FOURTH COURT OF APPEALS
SAN ANTONIO, TEXAS
4/8/2015 11:57:28 PM
KEITH HOTTLE
CLERK
NO. 04-15-00029-CV
FILED IN
IN THE FOURTH COURT OF APPEALS 4th COURT OF APPEALS
SAN ANTONIO, TEXAS SAN ANTONIO, TEXAS
04/8/2015 11:57:28 PM
KEITH E. HOTTLE
Clerk
DIAGNOSTICS RESEARCH GROUP, L.L.C. AND
JOHN R. HOLCOMB, M.D., APPELLANTS
V.
SUSHMA VORA, APPELLEE
BRIEF OF APPELLEE
SUSHMA VORA
`` CHRISTOPHER J. DEEVES
State Bar No. 00790575
THE LAW OFFICE OF
CHRISTOPHER DEEVES, P.C.
1370 Pantheon Way, Suite 110
San Antonio, Texas 78232
(210) 445-8807
(210) 501-0915 (telecopier)
chrisdeeves@att.net (e-mail)
ATTORNEY FOR APPELLEE
SUSHMA VORA
TABLE OF CONTENTS
TABLE OF AUTHORITIES ....................................................................................iv
ISSUES PRESENTED..............................................................................................vi
STATEMENT REGARDING ORAL ARGUMENT ..............................................vi
STATEMENT OF FACTS ........................................................................................1
A. BACKGROUND FACTS ..................................................................... 1
B. PROCEDURAL HISTORY .................................................................. 1
SUMMARY OF THE ARGUMENT ........................................................................ 8
ARGUMENT AND AUTHORITIES ........................................................................ 8
I. EXPERT REPORT REQUIREMENTS ...................................................... 11
II. STANDARDS OF REVIEW ...................................................................... 11
III. THE CLAIMS AGAINST DIAGNOSTICS RESEARCH GROUP
ARE NOT HEALTH CARE LIABILITY CLAIMS ....................................14
IV. DR. MULROY WAS QUALIFIED TO OPINE IN THIS MATTER .......... 15
V. DR. MULROY PROPERLY EXPLAINED THE CAUSAL
RELATIONSHIP BETWEEN THE CONDUCT AT ISSUE
AND MS. VORA’S INJURIES.....................................................................16
VI. DR. MULROY’S REPORT WAS A GOOD FAITH EFFORT
TO COMPLY WITH THE STATUTE AND THUS MS. VORA
HAS THE OPPORTUNITY TO CURE ANY DEFECTS
FOUND BY THIS COURT UPON REMAND ............................................19
CONCLUSION AND PRAYER .............................................................................20
CERTIFICATE OF COMPLIANCE .......................................................................20
ii
CERTIFICATE OF SERVICE ................................................................................22
APPENDIX ..............................................................................................................23
ORDER AT ISSUE
DR. MULROY’S REPORT
DR. MULROY’S CV
SALVATO v. ANGELO
iii
TABLE OF AUTHORITIES
Page
CASES
Am. Transitional Care Ctrs. of Tex., Inc. v. Palacios, 46 S.W.3d 873 (Tex.2001) ....
Birdwell v. Texarkana Memorial Hospital, 122 S.W.3d 473
(Tex.App.—Texarkana 2003, pet. den.) ............................................................
Bowie Mem’l Hosp. v. Wright, 79 S.W.3d 48 (Tex. 2002)..........................................
Chandler v. Singh, 129 S.W.3d 184 (Tex.App.—Texarkana 2004, no pet.)...............
Longino v. Crosswhite, 183 S.W.3d 913 (Tex.App.—Texarkana 2006, no pet.) ......
Murphy v. Russell, 167 S.W.3d 835 (Tex. 2005) ........................................................
Philipp v. McCreedy, 298 S.W.3d 682 (Tex.App.—San Antonio 2009, no pet.)
Poindexter v. Bonsukan, 145 F. Supp. 2d 800, 811 (E.D.Tex—Lufkin Div., 2001)
Salvato v. Angelo, No. 14-07-0748-CV, Tex.App.—Houston [14th Dist.]
April 8, 2008, no pet.) ..................................................................................................
Schmidt v. Dubose, 259 S.W.3d 213 (Tex.App.—Beaumont 2008, no pet.) ..............
VHS San Antonio Partners v. Garcia, 2009 WL 3223178 (Tex.App.—San
Antonio, Oct. 7, 2009, pet. den.)(mem.op.) .................................................................
iv
STATUTES
TEX. CIV. PRAC. & COMM. CODE § 74.351 ........................................................passim
RULES
TEX.R.APP.P. 39 .........................................................................................................v
v
ISSUES PRESENTED
Did the trial court properly hold that the claim against DRG was not a
healthcare liability claim because (1) DRG was not a healthcare provider or
physician and (2) DRG did not treat Ms. Vora but only studied a pre-market
medication on her?
Did the trial court properly hold that Dr. Mulroy was qualified to opine
about the standard of care, breach thereof and causation because she had conducted
numerous similar studies of pre-market medications and was familiar with when
patients should be removed from such studies following severe adverse events?
Did the trial court properly hold that Dr. Mulroy’s expert report adequately
addressed the element of causation?
STATEMENT REGARDING ORAL ARGUMENT
Appellee believes oral argument will benefit the Court in this matter. While
the applicable law in this area is clear, the application of the law to the facts of this
case presents matters for which oral argument will benefit the court. TEX.R.APP.P.
39.
vi
TO THE HONORABLE COURT OF APPEALS:
Appellee/Plaintiff, Sushma Vora (“Vora”), respectfully presents her
response brief. For the sake of clarity, Appellant John R. Holcomb, M.D. will be
referred to as “Dr. Holcomb.” Appellant Diagnostics Research Group, L.L.C. will
be referred to as “DRG.” Appellee Sushma Vora will be referred to as “Ms. Vora.”
STATEMENT OF FACTS
I. BACKGROUND FACTS
Ms. Vora participated in a pre-market study of linaclotide conducted by
DRG, the studying facility, with Dr. Hoclomb serving as the principal investigator.
During the study, Ms. Vora suffered a series of severe adverse events. On or about
January 11, 2011, Ms. Vora suffered her first severe adverse event--ileus (a bowel
condition related to the side effects of linaclotide) and was hospitalized. CR 30. In
March 2011, Ms. Vora had second severe adverse event---another hospitalization
from a bowel ailment. CR 30. In May 2011, Ms. Vora was hospitalized for a third
time as a result of vomiting and distended abdomen, another severe adverse event.
CR 31. Thereafter, Ms. Vora was removed from the study after the third
hospitalization—her third severe adverse event.
II. PROCEDURAL HISTORY
Ms. Vora filed suit against Dr. Holcomb and DRG amongst others on
January 8, 2013. CR 1-6 . She then served the statutorily required expert report on
May 8, 2013. TEX. CIV. PRAC. & REM. CODE § 74.351. On May 30, 2013, Dr.
Holcomb and DRG filed objections to the expert report. CR 7-37. Those
objections were then considered by the Honorable Larry Noll who found (1) the
claims against DRG were not health care liability claims and (2) that Dr. Mulroy’s
expert report adequately notified Dr. Holcomb regarding the health care liability
claims against him. CR 50-51.
SUMMARY OF THE ARGUMENT
The parties do not dispute the legal standards in this area which are well
established. The issues before this Court are whether the trial court properly
applied them to the facts of this case, which he did.
First, DRG does not qualify a “physician” or “healthcare provider.” While
DRG cleverly presents this Court with new evidence never before the trial court to
attempt to show that DRG so qualifies. This Court, however, may not consider this
evidence because it is outside the four corners of the expert report and, most
importantly, was never before the trial court.
Next, the claim against DRG is not a “health care liability claim.” There
was no care being provided to Ms. Vora as part of an experimental study conduct
by DRG—which is a study facility.
However, even if the causes of action against DRG were “health care
liability claims,” the report as to DRG was sufficient just as it was to Dr. Holcomb.
8
Dr. Mulroy was qualified to opine her because she conducts studies and looks for
severe adverse events—such as hospitalizations related to side effects of the
medication and then evaluates whether to continue the person in the study. Dr.
Mulroy has conducted numerous such studies and was conducting such studies at
the time of the event at issue. CR 24-32.
Appellants’ argument that a person asserting a “health care liability claim”
involving a side effect of a pre-market medication needs to provide an expert
specifically trained in such side effects defies logic. A psychiatric medication
could have side effects such as diarrhea, skin rash and heart murmur. Would Dr.
Mulroy need to enlist a gastroenterologist, dermatologist and cardiologist to
conduct a study of such a medication? Would Dr. Mulroy need to enlist the aid of
such a lengthy crew of doctors in prescribing such a medication? Of course, not.
If the patient appeared with a skin rash after being prescribed the medication then
Dr. Mulroy, even though she is a psychiatrist, could determine the need to take the
patient off the medication. She would not need to refer the patient to a
dermatologist. However, Appellants want to avoid the real world and claim that
only a doctor specifically familiar with linaclotide could serve as an expert. One
must ask where would such a doctor be found given Ms. Vora was involved with a
pre-market study of the drug? Indeed, on page 23 of their brief, Appellants, in
essence, contend that Dr. Mulroy cannot testify because studies of the prolonged
9
use of linaclotide is not a matter developed in various fields. Of course, it isn’t—
it’s a pre-market drug. The bar cannot be set so high for a claimant that she cannot
overcome it. Dr. Mulroy is fully qualified to testify that when a study participant
suffers severe adverse events (in this case, a hospitalizations) for a known side
effect of the drug, that the participant should not continue in the study. The trial
court did not abuse its discretion in finding Dr. Mulroy qualified.
Finally, Appellants contend that Dr. Mulroy’s opinion on causation is
conclusory. Rather, Dr. Mulroy’s opinion in this regard is simply short and direct.
If you remove a study participant from the study after severe adverse event(s)
related to the study medication then the patient will not suffer another one. Indeed,
Ms. Vora was pulled from the study after the third severe adverse event by
Appellants for this very reason.
In sum, Appellants want to make this case more complicated than it is. Dr.
Mulroy conducts research studies, monitors participants for severe adverse events
and then removes patients who incur them so that the severe adverse events do not
continue. Dr. Mulroy, in her detailed report, then explained how Dr. Holcomb and
DRG did not do that and how an unnecessary severe adverse event occurred. The
trial court did not abuse its discretion in denying the motions to dismiss.
10
ARGUMENT AND AUTHORITIES
I. EXPERT REPORT REQUIREMENTS
Pursuant to § 74.351(a), a plaintiff asserting a health care liability claim is
required to serve one or more expert reports and a curriculum vitae for each health
care provider or physician against whom a liability claim is asserted. The expert
report is to include: (1) a fair summary of the expert’s opinions about the standard
of care; (2) the manner in which the care failed to meet the standard; and (3) the
causal relationship between the failure and the claimed injury. See TEX. CIV.
PRAC. & REM. CODE § 74.351(r)(6); Am. Transitional Care Ctrs. of Tex., Inc. v.
Palacios, 46 S.W.3d 873, 879 (Tex.2001). The report must fulfill the dual purpose
of notifying each defendant of the specific conduct called into question and
providing support for the trial court to conclude that the claims have merit. Bowie
Mem’l Hosp. v. Wright, 79 S.W.3d 48, 52 (Tex. 2002). The report should
“represent an objective good faith effort to comply with the definition of an expert
report in Subsection (r)(6).” TEX. CIV. PRAC. & REM. CODE § 74-351(l). The court
looks only to the report in conducting a good faith inquiry. Palacios, 46 S.W.3d at
878.
As is clear from the statute, § 74.351 merely “establishes a threshold over
which a claimant must proceed to continue a lawsuit.” Murphy v. Russell, 167
11
S.W.3d 835, 838 (Tex. 2005); see also Schmidt v. Dubose, 259 S.W.3d 213, 217
(Tex.App.—Beaumont 2008, no pet.). These statutory provisions are virtually
identical to the provisions of TEX. REV. CIV. STAT. ART. 4590i interpreted in
American Transitional Care Centers of Texas v. Palacios, 46 S.W.3d 873 (Tex.
2001). To constitute a good faith effort, the report must inform the defendant of
the conduct the plaintiff has called into question as well as provide a basis for the
trial court to conclude that the claims have merit. Palacios, 46 S.W.3d at 879.
According to Palacios, the trial court should look no further than the four corners
of the report itself to determine its adequacy. Id. at 878. While the report must
address the statutory elements set forth in Art. 4590i Sec. 13.01(r)(6) (now TEX.
CIV. PRAC. & REM. CODE § 74.351(r)(6)), the Court held that the report need not
marshal all the plaintiff’s proof, nor is a plaintiff required to present evidence in
the report as if it were actually litigating the merits. Id. at 879. Stated another
way, the expert report need not prove liability, but need only provide notice of
what conduct provides the bases of the plaintiff’s complaints. Chandler v. Singh,
129 S.W.3d 184, 188 (Tex.App.—Texarkana 2004, no pet.); Longino v.
Crosswhite, 183 S.W.3d 913, 916 (Tex.App.—Texarkana 2006, no pet.). No
magic words are necessary, and the report need only be a summary of the expert’s
opinions. See Birdwell v. Texarkana Memorial Hospital, 122 S.W.3d 473
(Tex.App.—Texarkana 2003, pet. den.). Finally, in determining whether an expert
12
report adequately sets forth any particular element, the court is not limited to any
given sentence in isolation, but, rather, the report should be read in its entirety. See
Poindexter v. Bonsukan, 145 F. Supp. 2d 800, 811 (E.D.Tex—Lufkin Div.,
2001)(arising out of TMLIIA); see also VHS an Antonio Partners v. Garcia, 2009
WL 3223178 at *3 (Tex.App.—San Antonio, Oct. 7, 2009, pet. den.)(mem.op.);
Philipp v. McCreedy, 298 S.W.3d 682, 690 (Tex.App.—San Antonio 2009, no
pet.).
An expert report in a health care liability claim is not required to be an all-
encompassing text that addresses every factual aspect of the claim. Instead, the
report need only provide a “fair summary of the expert’s opinions.” The system of
challenging an expert report is not intended to be a forum to debate the facts of the
case or of an attorney’s opinions of the case. See Palacios, 46 S.W.3d at 878 (trial
court should look no further than the four corners of the report). The fact that the
defendant may disagree with the expert’s opinions, while perhaps proper for a
motion for summary judgment, is not an appropriate basis for challenging the
experts Chapter 74 report. The Methodist Hospital v. Shepherd-Sherman, 296
S.W.3d 193, 199 n. 2 (Tex.App.—Houston [14th Dist.] 2009, no pet.)(whether an
expert’s opinions are correct is an issue for summary judgment, not a motion to
dismiss under Chapter 74); see, e.g., Sanjay v. Turner, 252 S.W.3d 460, 467 n. 6
(Tex.App.—Houston [14th Dist.] 2008, no pet.)(concluding that doctor’s
13
arguments that he did not owe duty to patient as described in expert report was an
issue for summary judgment rather than a motion to dismiss); Wissa v. Voosen, 243
S.W.3d 165, 169-170 (Tex.App.—San Antonio 2007, pet. den.)(same). Instead,
the plaintiff’s burden is much lower at this stage of the litigation.
II. STANDARDS OF REVIEW
This Court reviews whether a claim is a “health care liability claim” de
novo as it is a question of law. Bioderm Skin Care, LLC v. Sok, 426 S.W.3d 753
(Tex. 2014). Thereafter, the court applies an abuse of discretion standard.
The standard of review on an appeal of an order either granting or denying a
motion to dismiss on the grounds of an insufficient expert report is abuse of
discretion. Hillcrest Baptist Med. Ctr. v. Wade, 172 S.W.3d 55, 60 (Tex.App.—
Waco 2005, pet. dism’d by agr.). Likewise, abuse of discretion is the standard by
which a trial court’s determination of whether an expert is qualified to give an
opinion in a health care liability claim is reviewed. Larson v. Downing, 197
S.W.3d 303, 304-305 (Tex. 2006)(per curiam); Baylor Coll. of Med. v. Pokluda,
283 S.W.3d 110, 116-117 (Tex.App.—Houston [14th Dist.] 2009, no pet.). An
abuse of discretion occurs when a trial court acts in an arbitrary or unreasonable
manner or without reference to any guiding rules or principles. Bowie Mem’l
Hosp. v. Wright, 79 S .W.3d 48, 52 (Tex.2002). Only clear failure by the trial
court to analyze or apply the law correctly will constitute an abuse of discretion.
14
Walker v. Packer, 827 S.W.2d 833, 840 (Tex. 1992).
III. THE CLAIMS AGAINST DIAGNOSTICS RESEARCH GROUP ARE
NOT HEALTH CARE LIABILITY CLAIMS
The trial court correctly found that the statutory expert report requirement
did not apply to DRG because Ms. Vora did not assert a “health care liability
claim.” A “health care liability claim" means 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
74.001(13) (emphasis added). Thus, to be a healthcare liability claim, it must be
shown that (1) the defendant is a health care provider or physician; (2) the claim at
issue concerns treatment, lack of treatment, or other claimed departure from
accepted standards of medical care, or healthcare, or safety or professional or
administrative services directly related to health care; and (3) the defendant's
alleged act or omission proximately caused the injury. Loaisiga v. Cerda, 379
S.W.3d 248, 255 (Tex. 2012).
First, DRG is not a physician or healthcare provider. “Health care" is "any
act or treatment performed or furnished, or that should have been performed or
furnished, by any health care provider for, to, or on behalf of a patient during the
15
patient's medical care, treatment, or confinement." TEX. CIV. PRAC. & REM. CODE
ANN. § 74.001(a)(10). DRG does not provide health care but conducts analysis of
pre-market medications on participants—not patients. It is a study facility.
Presenting new evidence on appeal, DRG now tries to argue that it is a
physician or physician affiliate. This evidence, not before the trial court, cannot be
considered. DRG also makes the argument that because DRG and Dr. Holcomb
are subject to the same standards that they are somehow one and the same and thus
DRG is then somehow an entity subject to the statute. However, the mere use of
the word “and” between discussing two entities does not join them. If Dr. Mulroy
referenced the other unrelated study sponsor, Forest Research Institute, in one of
these sentences, it is doubtful that the logic that everyone is one and the same
would be so willingly applied by DRG. Furthermore, Dr. Mulroy did not clump
these entities together when stating her conclusions. CR 31. In her report Dr.
Mulroy outlines each parties role (principal investigator, studying facility and
study sponsor). While the duties and standards may be similar, the entities do not
become joined as a result thereof.
Based upon the evidentiary record developed in the trial court, DRG is not
an entity subject to the statutory expert requirements and thus Ms. Vora did not
have to produce a report as to it. However, even if such a report was required, the
report at issue was more than sufficient as to DRG.
16
IV. DR. MULROY WAS QUALIFIED TO OPINE IN THIS MATTER
To be able to provide a report under Section 74.351, an expert must have
"knowledge, skill, experience, training, or education" regarding the specific issue
before the court which would qualify the expert to opine. Broders v. Heise, 924
S.W.2d 148,153 (Tex. 1996). The issue before the Court is the duties owed to a
participant in a study of a pre-market medication.
As Dr. Mulroy states in her report that standard is the same whether the
medication is an anti-depressant or a gastroenterological drug. CR 29. From her
CV and report, it is abundantly clear that Dr. Mulroy has the qualifications to opine
about how to conduct a study of a pre-market medication. CR 24-37. She
conducted such studies for ten years and was doing so at the time of the study in
question. CR 25. The list of studies she has done is immense. CR 25-28.
Additionally, in conducting the studies of the medications she has done, Dr.
Mulroy monitors for severe adverse events just as Dr. Holcomb and DRG would.
CR 29. Clearly, psychiatric medications have gastroenterological side effects
which must be monitored. It does not though require take the involvement of a
gastroenterologist to conduct such studies. Thus, even though the ailments Ms.
Vora incurred were gastroenterological this does not make Dr. Mulroy unqualified
to opine on them. Ms. Vora would direct the Court to the Houston Court of
Appeals decision in Salvato v. Angelo, No. 14-07-0748-CV, (Tex.App.—Houston
17
[14th Dist.] April 8, 2008, no pet.) In that similar case involving a research study,
the court held that the key qualification for a qualified statutory expert was
conducting studies and knowing how to identify potential adverse outcomes. Just
as the doctor in Salvato was qualified so is Dr. Mulroy here.
Instead, Appellants seek to apply an impossible standard, as set forth in the
brief on page 22, that because Dr. Mulory is not familiar with adverse effects of the
long term use of linaclotide that she cannot opine here. There is no way to meet
that standard as the drug at issue was experimental at the time Ms. Vora used it.
Of course, there is not a body of research that Dr. Mulroy can rely upon from 2011
on this issue. While the bar may be high for an expert to qualify under Chapter
74, the bar cannot be set where not party can achieve it.
What qualifies Dr. Holcomb and DRG to conduct such studies is that they
adhere to the standard of care for a physician or institute conducting such studies—
not that the condition the drug is being used to treat. Dr. Mulroy knows those
standards of care and they are the same for whatever drug is being studied. The
trial court did not abuse its discretion in denying the motion to dismiss on Dr.
Mulroy’s qualifications.
18
V. DR. MULROY PROPERLY EXPLAINED THE CAUSAL
RELATIONSHIP BETWEEN THE CONDUCT AT ISSUE AND MS.
VORA’S INJURIES
Appellants complain that Mulroy’s report is conclusory. In reality, what is
at issue is that Dr. Mulroy’s opinion is so straightforward. When a patient is
hospitalized, in this case repeatedly, for the side effect of the medication being
studied then you remove the patient from the study. For Dr. Holcomb and DRG to
now challenge that conclusion is wholly spurious as that is what did after Ms.
Vora’s third hospitalization for gastrointestinal issues while on the study
medication. What Dr. Mulroy makes clear in her report is that it never should have
taken three hospitalizations to reach this point and that after the first hospitalization
or the second hospitalization for the side effects being studied, Ms. Vora should
have been removed from the study. Dr. Mulroy states, “a hospitalization for a
potential side effect of a drug that is under study and not yet FDA approved is
enough to warrant a decision to remove the patient from the study” (CR 30) and if
removed from the study the side effects leading to hospitalization would not have
occurred. It does not get much simpler than that—do not let the patient remain in
the study to incur the repeated severe adverse events and removing the patient from
the study will stop them. The trial court did not abuse its discretion in concluding
Dr. Mulroy sufficient explained the causal relationship between the breach of the
19
standard of care and the damages Ms. Vora suffered.
VI. DR. MULROY'S REPORT WAS A GOOD FAITH EFFORT
TO COMPLY WITH THE STATUTE AND THUS MS. VORA
SHOULD BE GIVEN THE OPPORTUNITY TO REQUEST TO
CURE ANY DEFECTS FOUND BY THIS COURT UPON REMAND
If this court finds that Dr. Mulroy’s report is deficient, it was clearly a good
faith effort to comply with the statutory. Thus, this matter should be remanded to
allow Ms. Vora to ask the trial court for thirty days to cure any defects in the
report. TEX. CIV. PRAC. & REM. CODE § 74.351(c).
CONCLUSION AND PRAYER
WHEREFORE, PREMISES CONSIDERED, Appellee Sushma Vora, asks
the Court to affirm the denial of John Holcomb, M.D. and Diagnostics Research
Group’s motion to dismiss. Alternatively, should the Court find that Dr. Mulroy’s
report is, in any way, defective that Sushma Vora would ask the Court to remand
the matter for consideration of a motion to allow Ms. Vora to cure any defects
under Section 74.351(c). Appellee further prays for such other relief to which they
may be entitled consistent with this Court’s opinion.
20
Respectfully submitted,
/s/ Christopher J. Deeves
CHRISTOPHER J. DEEVES
State Bar No. 00790575
THE LAW OFFICE OF
CHISTOPHER DEEVES, P.C.
1370 Pantheon Way, Suite 110
San Antonio, Texas 78232
(210) 445-8807 (Telephone)
(210) 501-0915 (Facsimile)
chrisdeeves@att.net (e-mail)
ATTORNEY FOR APPELLEE,
SUSHMA VORA
21
CERTIFICATE OF COMPLIANCE
Pursuant to Texas Rule of Appellate Procedure 9.4(i)(3), I hereby certify that
this brief contains 3,522 words (excluding the caption, table of contents, table of
authorities, signature, proof of service, certification, and certificate of compliance).
This is a computer-generated document created in Microsoft Word, using 14-point
typeface for all text, except for footnotes which are in 12-point typeface. In
making this certificate of compliance, I am relying on the word count provided by
the software used to prepare the document.
/s/ Christopher J. Deeves
CHRISTOPHER J. DEEVES
CERTIFICATE OF SERVICE
This will certify that a true and correct copy of the above and foregoing
document was served as indicated to the following counsel of record listed below
on April 8, 2015:
Brett B. Rowe
Matthew M. Edwards
Christine Herrera
Evans, Rowe & Holbrook, P.C.
10101 Reunion Place, Suite 900
San Antonio, Texas 78216
Via Facsimile or Electronic Service:
ATTORNEY FOR APPELLANTS
DIAGNOSTIGS RESEARCH GROUP, L.L.C. AND
JOHN R. HOLCOMB, M.D.
/s/ Christopher J. Deeves
CHRISTOPHER J. DEEVES
22
APPENDIX
ORDER
MULROY REPORT
MULROY CV
SALVATO
23
50
51
PATRICIA D. SALVATO, M.D. AND DIVERSIFIED Mr. Angelo exhibited side effects of steroid use
MEDICAL PRACTICES, PA, Appellants during the study, including hypertension, testicular
atrophy, worsening anxiety, and insomnia. Mr. Angelo
v. also complained of chest discomfort and exhibited signs
of left ventricular hypertrophy in ECG readings that
FAUSTINA ANGELO, INDIVIDUALLY AND AS showed elevated QRS voltage attributable to left
REPRESENTATIVE OF THE ESTATE OF ventricular hypertrophy.[1] Dr. Salvato continued to
ARTHUR LEON ANGELO, JR., DECEASED, prescribe anabolic steroids and human growth hormones
LUCAS ANGELO, SOFIA ANGELO, ARTHUR to Mr. Angelo.
ANGELO, SR. AND CONNIE ANGELO, Appellees
Mr. Angelo last communicated with Dr. Salvato
No. 14-07-00784-CV concerning his treatment sometime between March 1,
2004 and September 7, 2004. Mr. Angelo was found dead
Court of Appeals of Texas, Fourteenth District
in his home on October 31, 2004. Mr. Angelo's death was
attributed to hypertensive and atherosclerotic
April 8, 2008
cardiovascular disease.[2]
On Appeal from the 281st District Court Harris
County, Texas Trial Court Cause No. 2007-02024. Suit was filed on January 11, 2007, contending that
Dr. Salvato was negligent in prescribing medications
Panel consists of Chief Justice Hedges, and Justices which were inappropriate, unlawful, and not in
Anderson and Boyce. accordance with the standards of medical care in and
around Harris County, Texas at the time. It was further
MEMORANDUM OPINION alleged that these acts and omissions were the proximate
cause of Arthur Angelo's death.
William J. Boyce, Justice
Pursuant to statute, an expert report from Nancy
In this interlocutory appeal, appellants Patricia D. Campbell, M.D. was timely served on May 3, 2007. See
Salvato, M.D. and Diversified Medical Practices, PA Tex. Civ. Prac. & Rem. Code Ann. '' 74.351, 74.401
(collectively "Dr. Salvato") appeal the trial court's denial (Vernon 2005). In that report, Dr. Campbell opined that
of a motion to dismiss a medical malpractice action. See Dr. Salvato departed from the normal standard of care by
Tex. Civ. Prac. & Rem. Code Ann. ' 74.351 (Vernon (1) failing to obtain IRB approval[3] and continuing
2005). Dr. Salvato contends the expert report served by review of the clinical study; (2) failing to maintain an
appellees Faustina Angelo, individually and as adverse event log; (3) failing to maintain records of
representative of the estate of Arthur Leon Angelo, Jr., proper oversight and monitoring by another party; (4)
deceased, Lucas Angelo, Sofia Angelo, Arthur Angelo, continuing to prescribe anabolic steroids for more than
Sr., and Connie Angelo (collectively "Angelo") was three years despite the appearance of known side effects
insufficient. Finding no abuse of discretion, we affirm. of anabolic steroid use in Mr. Angelo's examinations; (5)
failing to conduct necessary lab work related to known
I. Background side effects of anabolic steroid use; and (6) failing to
conduct further tests when medical examinations
On December 14, 2000, Arthur Angelo, a
indicated and Mr. Angelo reported signs of heart disease.
body-builder with a history of anabolic steroid use, came
Dr. Campbell further opined that Dr. Salvato's continued
to Dr. Salvato for treatment of low testosterone levels and
prescription of anabolic steroids led to cardiomegaly[4]
generalized anxiety disorder. Mr. Angelo was informed
with left ventricular hypertrophy and stenosis of 70% of
that he could receive prescriptions for anabolic steroids
the left anterior descending coronary artery, which in turn
only if he joined a clinical study being conducted by Dr.
led to Mr. Angelo's death from hypertensive and
Salvato focusing on the efficacy of anabolic steroids in
atherosclerotic cardiovascular disease.
HIV/AIDS patients suffering from wasting syndrome.
Mr. Angelo volunteered and was enrolled as a member of Dr. Salvato moved to dismiss Angelo's suit in trial
the control group in Dr. Salvato's clinical study. The court under section 74.351(b).[5] The trial court denied
initial study included the prescription of anabolic steroids the motion to dismiss.
and human growth hormone over a nine-month period,
beginning on December 14, 2000. Following the initial Dr. Salvato contends on appeal that Dr. Campbell's
nine-month study, Dr. Salvato enrolled Mr. Angelo in expert report does not satisfy sections 74.351 and 74.401.
extensions over the next several years. In addition to Dr. Salvato contends that (1) Dr. Campbell is not
anabolic steroids and human growth hormone, Dr. qualified to opine on key issues in this case; and (2) Dr.
Salvato also prescribed Valium to Mr. Angelo for pain. Campbell's report is deficient because it is conclusory
with regard to the standard of care and causation. appeal statute authorizes immediate appellate review of
an order denying dismissal under section 74.351(b) based
II. Appellate Jurisdiction on the failure to file a report - but not an order denying
dismissal under section 74.351(c) based on the filing of a
We first consider this court's appellate jurisdiction. deficient report.
This is a question of law reviewed de novo. State v.
Holland, 221 S.W.3d 639, 642 (Tex. 2007). Angelo's argument fails for two reasons. First, Dr.
Salvato specifically invoked section 74.351(b) in the
When, as here, a trial court has not signed a final motion to dismiss filed in the trial court. Second, this
and appealable order, we may not proceed unless an court already has held that the denial of a motion to
interlocutory appeal is allowed. Tex. A&M Univ. Sys . v. dismiss based upon an assertedly deficient report under
Koseoglu, 233 S.W.3d 835, 840 (Tex. 2007). When section 74.351(c) is appealable under section
reviewing a statutory grant of interlocutory appellate 51.014(a)(9), reasoning that "[a]n expert report 'has not
jurisdiction, we look to the legislature's intent as been served, for purposes of section 74.351(b), if
expressed in the statute's plain words and consider elements of the report are found to be deficient.'" Group
disputed provisions in context. See id.; Tex. Dep't of v. Vicento, 164 S.W.3d 724, 726 n.2 (Tex. App.-Houston
Transp. v. Needham , 82 S.W.3d 314, 318 (Tex. 2002). [14th Dist.] 2005, pet. filed). Therefore, this court has
Civil Practice and Remedies Code section 51.014 governs jurisdiction to review the denial of Dr. Salvato's motion
appeals from interlocutory orders; it should be strictly to dismiss a timely served but allegedly deficient expert
construed as "a narrow exception to the general rule that report.[7]
only final judgments and orders are appealable." Bally
Total Fitness Corp. v. Jackson, 53 S.W.3d 352, 355 (Tex. III. Sufficiency of the Expert Report
2001).
A. Standard of Review
Section 51.014(a)(9) allows an immediate appeal
from an interlocutory order that "denies all or part of the Dr. Salvato contends the trial court erred in failing
relief sought by motion under section 74.351(b), except to dismiss the case with prejudice because Angelo's
that an appeal may not be taken from an order granting an expert report from Dr. Campbell is deficient. Dr. Salvato
extension under Section 74.351."[6] Tex. Civ. Prac. & contends the report is deficient because Dr. Campbell is
Rem. Code Ann. ' 51.014(a)(9) (Vernon Supp. 2007). In not qualified to opine in this case, and because portions
turn, section 74.351(b) states: of her expert report are conclusory.
(b) If, as to a defendant physician or health care provider, We review a trial court's determination under
an expert report has not been served within the period section 74.351 for abuse of discretion. Larson v. Dowing,
specified by Subsection (a), the court, on the motion of 197 S.W.3d 303, 304-305 (Tex. 2006); Mem'l Herman
the affected physician or health care provider, shall, Healthcare Sys. v. Burrell, 230 S.W.3d 755, 757 (Tex.
subject to Subsection (c), enter an order that: App.-Houston [14th Dist.] 2007, no pet.). Similarly, we
review a trial court's ruling regarding the adequacy of an
(1) awards to the affected physician or health care expert report for abuse of discretion. Am. Transitional
provider reasonable attorney's fees and costs of court Care Ctrs. of Tex., Inc. v. Palacios, 46 S.W.3d 873, 877
incurred by the physician or health care provider; and (Tex. 2001); Group, 164 S.W.3d at 727. A trial court
commits an abuse of discretion when it acts in an
(2) dismisses the claim with respect to the physician or arbitrary or unreasonable manner without reference to
health care provider, with prejudice to the refiling of the guiding rules or principles. See Dowing , 197 S.W.3d at
claim. 304-305; Jernigan v. Langley , 195 S.W.3d 91, 94 (Tex.
2006). Under this standard, an appellate court may not
Tex. Civ. Prac. & Rem. Code Ann. ' 74.351(b) (Vernon
substitute its judgment for that of the trial court. Gray v.
Supp. 2007).
CHCA Bayshore L.P., 189 S.W.3d 855, 858 (Tex.
Angelo argues that an interlocutory appeal is not App.-Houston [1st Dist.] 2006, no pet.).
available for the denial of Dr. Salvato's motion to
Analysis of expert qualifications under section
dismiss. Angelo seizes on this statement from Dr.
74.351 is limited to the four corners of the expert's report
Salvato's brief: "This interlocutory appeal seeks relief
and the expert's curriculum vitae. See Palacios, 46
from the August 6, 2007 denial of Appellants' Motion to
S.W.3d at 878; Mem'l Herman Healthcare Sys., 230
Dismiss filed pursuant to Tex. Civ. Prac. & Rem. Code '
S.W.3d at 758; Gray, 189 S.W.3d at 859. Qualifications
74.351(c) for failure to serve a competent expert report as
cannot be inferred, but must be present in the expert
required by ' 74.351(a) in this healthcare liability claim."
report. See Olveda v. Supulveda , 141 S.W.3d 679, 683
Based on this statement, Angelo contends that Dr.
(Tex. App.-San Antonio 2004, pet. denied); Hansen v.
Salvato challenged the sufficiency of Dr. Campbell's
Starr, 123 S.W.3d 13, 19 (Tex. App.-Dallas 2003, pet.
report only under section 74.351(c). Angelo seeks
denied). To be qualified to provide opinion testimony
dismissal of this appeal, arguing that the interlocutory
regarding whether a physician departed from the accepted conclusions concerning the standard of care, breach, and
standard of health care, an expert must satisfy section causation fails to fulfill these purposes." Patel, 237
74.401. See Tex. Civ. Prac. & Rem. Code Ann. ' S.W.3d at 904 (citing Palacios, 46 S.W.3d at 879). The
74.351(r)(5)(A) (Vernon 2005). Section 74.401 provides: expert's report need not identify all evidence necessary to
litigate the merits of the plaintiff's case, but it must link
(a) In a suit involving a health care liability claim against the expert's opinions on these elements to the facts in the
a physician for injury to or death of a patient, a person case. Wright, 79 S.W.3d at 52; Palacios, 46 S.W.3d at
may qualify as an expert witness on the issue of whether 879.
the physician departed from accepted standards of
medical care only if the person is a physician who: B. Dr. Campbell's Qualifications
(1) is practicing medicine at the time such testimony is Angelo contends that Dr. Salvato was negligent in
given or was practicing medicine at the time the claim prescribing anabolic steroids to Mr. Angelo as part of her
arose; clinical study of the effects of anabolic steroids on
HIV/AIDS patients suffering from wasting syndrome.
(2) has knowledge of accepted standards of medical care Angelo further contends that these acts and omissions
for the diagnosis, care, or treatment of the illness, injury, were the proximate cause of Mr. Angelo's death. Angelo
or condition involved in the claim; and relies on Dr. Campbell to support these contentions.
(3) is qualified on the basis of training or experience to Angelo retained Dr. Campbell to review the medial
offer an expert opinion regarding those accepted records from Dr. Salvato's office, the autopsy report from
standards of medical care. the medical examiner, and the death certificate. Based
upon these records, and her experience, training,
Tex. Civ. Prac. & Rem. Code Ann. ' 74.401(a) (Vernon knowledge, and qualifications as a physician, Dr.
2005). Campbell opined that Dr. Salvato departed from the
normal standard of care by (1) failing to obtain IRB
Under section 74.351, health care liability claimants
approval and continuing review of the clinical study; (2)
must provide an expert report to the defendant no later
failing to maintain an adverse event log; (3) failing to
than 120 days after filing the original petition. See Tex.
maintain records of proper oversight and monitoring by
Civ. Prac. & Rem. Code Ann. ' 74.351(a) (Vernon Supp.
another party; (4) continuing to prescribe anabolic
2007). A defendant may file a motion challenging the
steroids to Mr. Angelo for more than 40 months despite
adequacy of the report; the trial court should grant the
the appearance of known side effects of anabolic steroid
motion only when it appears that the report does not
use; (5) failing to conduct necessary lab work related to
represent a good faith effort to comply with the statutory
known side-effects of anabolic steroid use; and (6) failing
definition of an expert report. See Tex. Civ. Prac. & Rem.
to conduct further tests when medical examinations
Code Ann. ' 74.351(l) (Vernon Supp. 2007).
indicated and Mr. Angelo reported signs of heart disease.
When determining if a good faith effort has been Dr. Campbell further opined that Dr. Salvato's continued
made, the trial court is limited to the four corners of the prescription of anabolic steroids led to cardiomegaly with
report and cannot consider extrinsic evidence. See left ventricular hypertrophy and stenosis of 70% of the
Palacios, 46 S.W.3d at 878; Mem'l Herman Healthcare left anterior descending coronary artery; this in turn
Sys., 230 S.W.3d at 758; Gray, 189 S.W.3d at 859 ("in caused Mr. Angelo's death from hypertensive and
assessing the report's sufficiency, the trial court may not atherosclerotic cardiovascular disease.
draw any inferences, and must instead rely exclusively on
Under section 74.401(a), only a physician can opine
the information contained within the report's four
as an expert against another physician. It does not follow,
corners"). An expert report must provide a fair summary
however, that every physician is a qualified expert. See
of the expert's opinion regarding (1) the applicable
Broders v. Heise, 924 S.W.2d 148, 152 (Tex. 1996).
standard of care; (2) the manner in which the care
While "expert qualifications should not be too narrowly
provided failed to meet that standard; and (3) the causal
drawn . . . given the increasing specialization and
relationship between the failure and the injury, harm or
technical nature of medicine, there is no validity, if there
damages claimed. See Tex. Civ. Prac. & Rem. Code Ann.
ever was, to the notion that every licensed medical doctor
' 74.351(r)(6) (Vernon Supp. 2007); Patel, 237 S.W.3d at
should be automatically qualified to testify as an expert
904.
on every medical question." Larson, 197 S.W.3d at 305
To satisfy these standards, the expert report must (citing Broders, 924 S.W.2d at 152). However, when a
include enough information to satisfy two requirements. subject matter is common to and equally recognized in all
The report must (1) inform the defendant of the specific fields of practice, any physician familiar with the subject
conduct the plaintiff has called into question; and (2) may testify as to the standard of care. See Keo v. Vu, 76
provide a basis for the trial court to conclude the claims S.W.3d 725, 732 (Tex. App.-Houston [1st Dist.] 2002,
are meritorious. Palacios, 46 S.W.3d at 879; Patel, 237 pet. denied). Likewise, where two fields of medicine
S.W.3d at 904. "A report merely expressing the expert's overlap, and a procedure is common to more than one
field, a physician in one of these fields may opine as to matter common to all physicians. Id.; see also McKowen
the standard of care for that procedure in the other field. v. Ragston, S.W.3d, 2007 WL79330, at *5 (Tex.
Id. App.-Houston [1st Dist.] Jan. 11, 2007, no pet.) (when
"the subject of inquiry is common to and equally
Dr. Campbell's curriculum vitae recites that she recognized and developed in all fields of practice, then
spent three years in residency at Memorial Hospital any physician familiar with the subject may testify as to
Southwest, and that she has been board certified in family standard of care") (citing Sears v. Cooper , 574 S.W.2d
practice for more than 13 years. She states that her 612, 614 (Tex. App.-Houston [14th Dist.] 1978, writ ref'd
opinions in the report are based upon her experience, n.r.e.)).
training, knowledge, and qualifications as a physician. As
a board certified family practitioner who has been an Here, the trial court acted within its discretion by
active staff member of Memorial Hospital Southwest for applying this teaching and concluding that Dr. Campbell
more than a decade, has been Medical Director of Brenco is qualified to opine about specific areas - such as the
Research, and has conducted more than 100 clinical conduct of a clinical study and cardiac health - that are
studies, Dr. Campbell has experience in treating patients common to multiple fields of practice.
with a wide range of maladies. Dr. Campbell described
her knowledge regarding the standard of care governing Dr. Campbell's curriculum vitae and report also
clinical studies like the one conducted by Dr. Salvato, provide a reasonable basis for the trial court to have
and regarding the monitoring of cardiovascular health for concluded that Dr. Campbell is qualified to opine about
each participant as part of the overseeing physician's the effects of hormones. Dr. Salvato acknowledged at
responsibility. We cannot say that the trial court abused oral argument that one need not necessarily be an
its discretion in concluding that Dr. Campbell endocrinologist to address issues regarding the effects of
demonstrated sufficient qualifications to opine about hormones. Dr. Campbell's curriculum vitae demonstrates
standards of care in connection with monitoring the experience with clinical studies involving
health, including cardiovascular health, of patients hormone-related research. These studies include research
participating in clinical studies. regarding the prescription of Eclomiphene to treat low
testosterone in men and parathyroid hormone studies in
Dr. Salvato concedes that Dr. Campbell may be women. Thus, while Dr. Campbell is not an
qualified to opine about the standard of care governing endocrinologist, she provides sufficient evidence of her
Dr. Salvato's research methodology and findings. Dr. knowledge in connection with studies prescribing and
Salvato nonetheless maintains that Dr. Campbell is not monitoring hormones in patients. See McKowen , S.W.3d,
qualified to opine about standards of care governing the 2007 WL79330, at *5 ("A medical witness from one
prescribing of anabolic steroids or about cardiovascular practice area may be qualified to testify if he has practical
disease. Dr. Salvato contends that Dr. Campbell is not a knowledge of what is customarily done by other
cardiologist and lacks other experience that would qualify practitioners under circumstances similar to those at issue
her to give expert testimony on the treatment of in the case"); Blan, 7 S.W.3d at 745 (the emphasis is on
cardiovascular disease; Dr. Salvato also emphasizes that the plaintiff's condition, not the defendant's expertise, and
Dr. Campbell is not an endocrinologist, and asserts that physician expert need not be a specialist to opine).
she is not otherwise qualified to testify about the side
effects of anabolic steroids. While Dr. Salvato concedes The trial court found that Dr. Campbell is qualified
that some family practitioners might be qualified to opine to opine as an expert on medical treatment of Mr. Angelo.
about steroid use or cardiovascular disease, Dr. Salvato The trial court's decision comported with guiding
contends that Dr. Campbell's curriculum vita and report principles and rules governing sufficiency of expert
fail to establish her particular experience or qualifications reports. The trial court acted within its discretion. See
to opine on these areas of medical expertise. Dr. Salvato's Larson, 197 S.W.3d at 304-05 ("expert qualifications
contentions fall short of establishing an abuse of should not be too narrowly drawn;" in a close call, the
discretion. "Despite the fact that we live in a world of decision as to whether expert testimony qualifies must go
niche medical practices and multilayer specializations, to the trial court).
there are certain standards of medical care that apply to
multiple schools of practice and any medical doctor." We overrule Dr. Salvato's first issue.
Blan v. Ali, 7 S.W.3d 741, 746 (Tex. App.-Houston [14th
C. Standard of Care and Causation
Dist.] 1999, no pet.).
Dr. Salvato argues next that the expert report is
The facts in Blan are instructive. The physician at
deficient. Dr. Salvato argues that Dr. Campbell's report
issue properly was able to opine about the standard of
does not set forth the standard of care for conducting a
care for a stroke patient, and was not purporting to offer
clinical study or for prescribing anabolic steroids. Dr.
expert medical opinions peculiar to the field of
Salvato claims that Dr. Campbell's report does not
cardiology. For that reason, the trial court in Blan abused
"convincingly tie the alleged departure from the standard
its discretion by excluding the expert's testimony about
of care to specific facts of the case." Dr. Salvato argues
the standard of care when his testimony concerned a
that because Dr. Campbell's report does not set forth a report gives Dr. Salvato adequate notice of the alleged
standard of review, it does not inform Dr. Salvato as to breaches of the standard of care in her treatment of Mr.
how he breached that standard of care. Dr. Salvato also Angelo during his participation in Dr. Salvato's clinical
contends that Dr. Campbell's report does not link the study. See Palacios , 46 S.W.3d at 878-79; Biggs, 237
allegations of negligence to the damages Angelo claims. S.W.3d at 916-17; Gray, 189 S.W.3d at 859.
Dr. Salvato therefore concludes that Dr. Campbell's
opinions concerning causation are impermissibly Dr. Campbell's report does not state conclusions
conclusory. without reference to the underlying facts upon which she
has premised her opinion. Patel, 237 S.W.3d at 904
An expert report need not marshal all of the (citing Palacios, 46 S.W.3d at 879). She links each
plaintiff's proof, but it must include the expert's opinions element of the standard of care in the treatment of a
on the three statutory elements - standard of care, breach, participant in a clinical study to the facts of the case,
and causation. Gray, 189 S.W.3d at 859. Likewise, a trial noting where and how Dr. Salvato departed from that
court shall grant a motion challenging the adequacy of a standard of care. Dr. Campbell opined that Dr. Salvato
report only if it appears to the court that the report does failed to correctly monitor Mr. Angelo. As an example,
not represent a good faith effort to comply with the she focused on Dr. Salvato's failure to monitor Mr.
definition of an expert report in section 74.351(r)(6). See Angelo's lipid levels in light of the known increase in
Tex. Civ. Prac. & Rem. Code ' 74.351(l) (Vernon Supp. lipid levels associated with anabolic steroid use that were
2007); Palacios, 46 S.W.3d at 879 (if any of the three noted in Dr. Salvato's notes. Dr. Campbell opined that Dr.
statutory elements are missing, the report is not a good Salvato assessed Mr. Angelo's lipid levels in 2001, but
faith effort). An expert report must provide enough then failed to do so for the following three years. Dr.
information to fulfill two purposes to constitute an Campbell noted that Dr. Salvato failed to monitor lipid
objective good faith effort. The report must inform the levels even while aware that it was important for cardiac
defendant of the specific conduct the plaintiff has called health to watch them. Dr. Campbell's report noted that
into question, and it must provide a basis for the trial Mr. Angelo suffered chest pains, elevated blood pressure,
judge to conclude the claims have merit. See Palacios, 46 and increased QRS voltage, all symptoms of heart
S.W.3d at 878-79; Baylor Univ. Med. Ctr. v. Biggs, 237 disease. Dr. Salvato's notes also revealed that Mr. Angelo
S.W.3d 909, 916-17 (Tex. App.-Dallas 2007, pet. filed); complained of worsening anxiety, insomnia, and
Gray, 189 S.W.3d at 859. testicular atrophy, all known side effects of anabolic
steroid abuse. Dr. Campbell noted that no adverse event
Applying these precepts in light of the standard of log was maintained; that symptoms of cardiac disease
review, we conclude that the trial court acted within its were overlooked or mis-diagnosed; and that Mr. Angelo
discretion in concluding that Dr. Campbell's report was prescribed additional steroids. Even when Mr.
provided sufficient specificity regarding the standard of Angelo was diagnosed with hypertension, Dr. Salvato
care and causation. continued to prescribe anabolic steroids to Mr. Angelo in
violation of the standard of care associated with a clinical
Dr. Campbell's report addresses the standard of care study and the prescription of a drug. The trial court acted
required for a clinical study in which the physician is within its discretion in concluding that these opinions
prescribing a medication with known side effects. Dr. suffice to identify specific conduct and to provide a basis
Campbell describes the proper conduct of a clinical for concluding the claims have merit.
study, noting the FDA's requirement of IRB approval of
any clinical study; the need for oversight; the need to As to causation, Dr. Campbell opines that the
monitor the patient's health; the need to record potential warning signs of cardiac disease should have led Dr.
adverse effects; the preeminence of patient health Salvato to (1) exclude Mr. Angelo from the study; (2)
throughout; the need to determine the cause of apparent cease prescribing anabolic steroids to Mr. Angelo once
adverse health indicators; and the need to withdraw a adverse health indicators were noted; and (3) conduct
patient from a study when that patient demonstrates further cardiovascular evaluation to properly diagnose
indicators of adverse health. Dr. Campbell opines as to left ventricular hypertrophy, an abnormality related to the
the standard of care required for any doctor prescribing abuse of anabolic steroids. Dr. Campbell opines that these
medicine to a patient, especially with heart disease failures, and the continued prescription of anabolic
symptoms like those exhibited by Mr. Angelo, including steroids, caused the left ventricular hypertrophy and
the need for further tests, proper diagnosis, and cessation related chronic hypertension that proximately caused Mr.
of the test medication. Angelo's death - which the autopsy attributed to cardiac
disease. According to Dr. Campbell's report, Dr. Salvato
Dr. Campbell opined that Dr. Salvato's continued failed to accurately monitor Mr. Angelo's health and
prescription of anabolic steroids when Mr. Angelo was withdraw him from the study given the harm that the
experiencing "known toxic side-effects of those steroids" anabolic steroids were causing.
was a breach of the standard of care for a doctor
conducting a clinical study and having the obligation to The trial court found that Dr. Campbell's report was
put the health of the participant first. Dr. Campbell's sufficient to apprise Dr. Salvato of the specific conduct
Angelo alleges was a departure from the standard of care, [4] Cardiomegaly is a medical condition wherein the
and the basis for establishing a causal link between the heart is enlarged.
departures and Mr. Angelo's death. Gray, 189 S.W.3d at
859. The trial court's decision was within the scope of its [5] Defendants' motion to dismiss, filed June 7, 2007,
discretion. Larson, 197 S.W.3d at 304-05; see also Mem'l sought dismissal pursuant to Texas Civil Practice and
Herman Healthcare Sys., 230 S.W.3d at 757. Remedies Code section 74.351(b); the motion did not
assert that Angelo failed to file a report, but rather that
We overrule Dr. Salvato's second issue. Angelo failed to file a "competent expert report by a
qualified expert."
IV. Conclusion
[6] Section 51.014(a)(10) also allows an interlocutory
The trial court found that Dr. Campbell's report, appeal from the granting of a motion to dismiss under
coupled with her curriculum vitae, provided a sufficient section 74.351(l), which provides that a court "shall grant
basis to conclude she is qualified to offer expert a motion challenging the adequacy of an expert report
testimony in this case. The trial court concluded that the only if it appears to the court, after hearing, that the
requisite specificity regarding standard of care and report does not represents an objective good faith effort
causation are present in Dr. Campbell's report. The trial to comply with the definition of an expert report in
court acted within its discretion in so doing. Subsection (r)(6)." See Tex. Civ. Prac. & Rem. Code '
74.351(l) (Vernon Supp. 2007).
The trial court's order is affirmed.
[7] The following decisions adopt Group's reasoning or
Judgment rendered and Memorandum Opinion filed employ similar reasoning: CHCA Mainland, L.P. v.
April 8, 2008. Burkhalter, 228 S.W.3d 221, 224-25 (Tex. App.-Houston
[1st Dist.] 2007, no pet.); HealthSouth Corp. v. Searcy ,
---------
227 S.W.3d 907, 908 (Tex. App.-Dallas 2007, no pet.) ;
Notes: Sides v. Guevara, S.W.3d, 2007 WL 2456882, at *2 (Tex.
App.-El Paso Aug. 30, 2007, no pet.). Other decisions
[1] The QRS complex is a structure on the conclude there is no appellate jurisdiction under these
electrocardiogram (ECG) that corresponds to the Q, R, circumstances. See, e.g., Jain v. Stafford, 214 S.W.3d 94,
and S waves representing the depolarization of the 97 (Tex. App.-Fort Worth 2006, no pet.); Lewis v.
ventricles. A proper ECG reading can measure the rate Funderburk, 191 S.W.3d 756, 759 (Tex. App.-Waco,
and regularity of heartbeats, as well as determine the size 2006, pet. granted) . The Texas Supreme Court has not
and position of the chambers. This enables a practitioner decided this issue, which is pending before the court in
to assess the presence of any damage to the heart and the Funderburk.
effects of drugs or devices to regulate the heart. Elevated
QRS readings have been linked to left ventricular ---------
hypertrophy - a condition that may occur naturally but
also has been linked to certain conditions. Left
ventricular hypertrophy is a thickening of the muscle on
the left ventricle of the heart, and has been linked to
aortic stenosis (a malfunction of the valve between the
left ventricle and the aorta which impedes blood flow);
aortic insufficiency (a malfunction of the valve between
the left ventricle and the aorta which allows blood to flow
in the wrong direction); and hypertension (chronic high
blood pressure).
[2] Atherosclerotic cardiovascular disease is a disease
that affects the arterial blood vessels, often referred to as
"hardening" or "furring" of the arteries.
[3] All clinical studies are required to have Institutional
Review Board (IRB) approval before commencing.
Universities and medical establishments that conduct
clinical trials appoint knowledgeable individuals to sit on
these boards and to screen all trials to insure that they are
ethical, protective of the health of the individuals, and
conducted in accordance with solid methodological
standards.