Opinion

Nancy Jo Rodriguez v. the Walgreen Company and Sara Elizabeth McGuire

Court: Texas Court of Appeals, 3rd District (Austin)
Filed: Mar 6, 2015
Status: Published
Cited by: 0 cases
Authority: More cited than 3.1%

affirming trial court’s dismissal of suit because expert reports omitted any allegation about how doctor breached standard of care and causation

How later courts described this case

affirming trial court’s dismissal of suit because expert reports omitted any allegation about how doctor breached standard of care and causation
finding that report that depended on unsupported assumptions about what a defendant knew and when he knew it was speculative
finding deficient expert report that was “silent as to whether a single physician, multiple physicians, or all physicians’ mentioned in the report failed to meet the standard of care and caused injury to [the patient]”
concluding that report did not implicate defendant when it did not allege breach by defendant or any causal link between defendant’s breach and injury

Written by the judges who cited it.

The opinion

ACCEPTED

03-14-00765-CV

4402607

THIRD COURT OF APPEALS

AUSTIN, TEXAS

3/6/2015 2:11:03 PM

JEFFREY D. KYLE

CLERK

NO. 03–14–00765–CV

IN THE COURT OF APPEALS

FILED IN

FOR THE THIRD DISTRICT OF TEXAS 3rd COURT OF APPEALS

AT AUSTIN AUSTIN, TEXAS

3/6/2015 2:11:03 PM

JEFFREY D. KYLE

NANCY JO RODRIGUEZ, Clerk

APPELLANT,

THE WALGREEN COMPANY AND SARA ELIZABETH MCGUIRE,

APPELLEES.

On Appeal from the 419th District Court

Travis County, Texas

BRIEF OF APPELLEES

JUDITH R. BLAKEWAY

State Bar No. 02434400

judith.blakeway@strasburger.com

CYNTHIA DAY GRIMES

State Bar No. 11436600

Cynthia.Grimes@strasburger.com

STRASBURGER & PRICE, LLP

2301 Broadway

San Antonio, Texas 78215

(210) 250-6003 Telephone

(210) 258-2706 Facsimile

ATTORNEYS FOR APPELLEES

1751449.6/SPSA/87282/0138/030615

Identity of Parties and Counsel

In accordance with Rule 38.1(a) of the Texas Rules of Appellate Procedure,

Appellees provide the following complete list of all parties and counsel to the trial

court’s order that forms the basis of this appeal.

Party Trial Counsel

NANCY JO RODRIGUEZ Lannie Todd Kelly

Appellant State Bar No. 24035049

THE CARLSON LAW FIRM, P.C.

11606 N. IH–35

Austin, TX 78753

Telephone: (512) 346–5688

Facsimile: (512) 719–4362

tkelly@carlsonattorneys.com

THE WALGREEN COMPANY, INC. CYNTHIA DAY GRIMES

and State Bar No. 11436600

SARA ELIZABETH MCGUIRE Cynthia.Grimes@strasburger.com

Appellees STRASBURGER & PRICE, LLP

2301 Broadway

San Antonio, Texas 78215

(210) 250-6003 Telephone

(210) 258-2706 Facsimile

Trial Counsel

JUDITH R. BLAKEWAY

State Bar No. 02434400

judith.blakeway@strasburger.com

CYNTHIA DAY GRIMES

State Bar No. 11436600

Cynthia.Grimes@strasburger.com

STRASBURGER & PRICE, LLP

2301 Broadway

San Antonio, Texas 78215

(210) 250-6003 Telephone

(210) 258-2706 Facsimile

Appellate Counsel

1751449.6/SPSA/87282/0138/030615

VIVEK GOSWAMI, M.D. and Chris Knudsen

AUSTIN HEART, PLLC State Bar No. 24041268

Defendants (not parties to this cknudsen@serpejones.com

appeal) nandrews@serpejones.com

Nicole Andrews

State Bar No. 00792335

SERPE JONES ANDREWS

CALLENDER & BELL, PLLC

2929 Allen Parkway, Suite 1600

Houston, Texas 77019

(713) 452–4400 Telephone

(713) 452–4499 Facsimile

ST. DAVID’S HEALTH CARE Missy Atwood

PARTNERSHIP State Bar No. 01428020

Defendant (not a party to this GERMER, BEAMAN & BROWN, PLLC

appeal) 301 Congress Avenue, Suite 1700

Austin, Texas 78701

(512) 472–0288 Telephone

(512) 472–0721 Facsimile

matwood@germer-austin.com

iii

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Table of Contents

Identity of Parties and Counsel ................................................................................. ii

Table of Contents ......................................................................................................iv

Table of Authorities ..................................................................................................vi

Statement of the Case................................................................................................. 1

Issue Presented ........................................................................................................... 1

Did the trial court abuse its discretion in dismissing Plaintiff’s claims

against Walgreen and McGuire? ..................................................................... 1

Statement of Facts ...................................................................................................... 1

Summary of Argument .............................................................................................. 4

Standard of Review .................................................................................................... 6

Argument.................................................................................................................... 8

I. A Chapter 74 report must be from a qualified expert and

address in non–conclusory terms the standard of care, breach

and causation. ........................................................................................ 8

II. The trial court did not abuse its discretion in dismissing claims

against Walgreen and McGuire. ............................................................ 9

A. Mr. Hardy’s report is deficient.................................................... 9

1. Mr. Hardy’s opinion is speculative and conclusory. ........ 9

2. Mr. Hardy is statutorily disqualified from

addressing causation. ...................................................... 11

3. Mr. Hardy’s report fails to distinguish between

multiple defendants......................................................... 13

4. Mr. Hardy is not qualified as a practicing

pharmacist. ...................................................................... 14

1751449.6/SPSA/87282/0138/030615

B. Dr. Breall’s expert report is deficient. ...................................... 15

1. Dr. Breall’s report does not even mention

Walgreen or McGuire. .................................................... 16

2. Dr. Breall’s report is speculative and conclusory. .......... 17

3. Dr. Breall is not qualified to testify to the standard

of care for a pharmacy or pharmacist. ............................ 19

Conclusion ............................................................................................................... 19

Certificate of Service ............................................................................................... 21

Certificate of Compliance ........................................................................................ 21

Appendix .................................................................................................................. 22

1. Order dated December 3, 2014 ........................................................... 22

2. Mr. Hardy’s CV and report ................................................................. 22

3. Dr. Breall’s CV and report .................................................................. 22

4. TEX. CIV. PRAC. & REM. CODE §74.351 .............................................. 22

5. TEX. CIV. PRAC. & REM. CODE §74.402 .............................................. 22

1751449.6/SPSA/87282/0138/030615

Table of Authorities

Page(s)

CASES

American Transitional Care Centers of Texas Inc. v. Palacios,

46 S.W.3d 873 (Tex. 2001).......................................................................6, 7, 8, 9

Apodaca v. Russo,

228 S.W.3d 252 (Tex. App.–Austin 2007, no pet.) ............................................ 17

Austin Heart, P.A. v. Webb,

228 S.W.3d 276 (Tex. App.–Austin 2007, no pet.) ................................13, 14, 17

Austin Regional Clinic v. Power,

2012 Tex. App. LEXIS 5242 (Austin 2012, no pet.).......................................... 17

Bogar v. Esparza,

257 S.W.3d 354 (Tex. App.–Austin 2008, no pet.) ............................................ 17

Bowie Mem’l Hosp. v. Wright,

79 S.W.3d 48 (Tex. 2002)...............................................................7, 9, 12, 13, 18

Broders v. Heise,

924 S.W.2d 148 (Tex. 1996) .............................................................................. 15

Constancio v. Bray,

266 S.W.3d 149 (Tex. App.–Austin 2008, no pet.) ............................................ 18

Cooper v. Arizpe,

No. 04–07–00743, 2008 Tex. App. LEXIS 2506 (Tex. App.–San

Antonio, April. 9, 2008, pet. denied) .................................................................. 10

Doades v. Syed,

94 S.W.3d 664 (Tex. App.–San Antonio 2002, no pet.) .................................... 13

Estate of Allen v. Polly Ryon Hosp. Auth.,

No. 01–04–00151–CV, 2005 Tex. App. LEXIS 1691 (Tex. App.–

Houston [1st Dist.] Mar. 3, 2005, no pet.) (mem. op.) ....................................... 12

Fung v. Fischer,

365 S.W.3d 507 (Tex. App.–Austin 2012), overruled in part by Certified

EMS, Inc. v. Potts, 392 S.W.3d 625 (Tex. 2013) .........................................10, 16

1751449.6/SPSA/87282/0138/030615

Jelinek v. Casas,

328 S.W.3d 526 (Tex. 2010) ................................................................................ 7

Jernigan v. Langley,

195 S.W.3d 91 (Tex. 2006)...........................................................................6, 7, 9

Kocerek v. Colby,

No. 03–13–0057–CV, 2014 Tex. App. LEXIS 9336 (Tex. App.–Austin

2014, no pet.) ...................................................................................................... 18

Lenger v. Physician’s Gen. Hosp.,

455 S.W.2d 703 (Tex. 1970) .............................................................................. 12

McMenemy v. Holden,

No. 14–07–00365–CV, 2007 Tex. App. LEXIS 8830 (Tex. App.–

Houston [14th Dist.] Nov. 1, 2007, pet. denied) (mem. op.) .............................. 12

Murphy v. Mendoza,

234 S.W.3d 23 (Tex. App.–El Paso 2007, no pet.) ............................................ 11

Perez v. Daughters of Charity Health Servs. of Austin,

No. 03–08–00200–CV, 2008 WL 4531558 (Tex. App.–Austin, Oct. 10,

2008, no pet.) (mem. op.).................................................................................... 18

Reddy v. Hebner,

435 S.W.3d 323 (Tex. App.–Austin 2014, pet. filed) ........................................ 16

Rittmer v. Garza,

65 S.W.3d 718 (Tex. App.–Houston [14th Dist.] 2001, no pet.) ....................... 13

Samlowski v. Wooten,

332 S.W.3d 404 (Tex. 2011) ............................................................................ 7, 9

Scoresby v. Santillan,

346 S.W.3d 546 (Tex. 2011) ................................................................................ 9

Smith v. Wilson,

368 S.W.3d 574 (Tex. App.–Austin 2012, no pet.) ........................................ 7, 18

Taylor v. Christus Spohn Health Sys. Corp.,

169 S.W.3d 241 (Tex. App.–Corpus Christi 2004, no pet.) ............................... 14

vii

1751449.6/SPSA/87282/0138/030615

Tenet Hospitals Ltd. v. De La Riva,

351 S.W.3d 398 (Tex. App.–El Paso 2011, no pet.) .......................................... 14

Walgreen Co. v. Hieger,

243 S.W.3d 183 (Tex. App.–Houston [14th Dist.] 2007, pet. denied) ............... 12

Walker v. Gutierrez,

111 S.W.3d 56 (Tex. 2003)................................................................................... 7

STATUTES

TEX. CIV. PRAC. & REM. CODE 74.001(a)(10) .......................................................... 15

TEX. CIV. PRAC. & REM. CODE § 74.351 .................................................................... 8

TEX. CIV. PRAC. & REM. CODE ANN. § 74.351(i)..................................................... 16

TEX. CIV. PRAC. & REM. CODE § 74.351(r)(6) ...................................................13, 18

TEX. CIV. PRAC. & REM. CODE § 74.402 ..................................................................... 19

TEX. CIV. PRAC. & REM. CODE § 74.402(b)(1)–(3) .................................................. 14

TEX. CIV. PRAC. & REM. CODE § 74.402(c) ............................................................. 15

TEX. CIV. PRAC. & REM. CODE § 74.403(a).............................................................. 11

viii

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Statement of the Case

This is an interlocutory appeal from an order dismissing a health care

liability claim against Walgreen and its pharmacist McGuire for failure to serve

adequate expert reports. Ms. Rodriguez claims that the district court abused its

discretion in concluding that she failed to serve expert reports that comply with

Chapter 74 of the Texas Civil Practice and Remedies Code.

Issue Presented

Did the trial court abuse its discretion in dismissing Plaintiff’s claims

against Walgreen and McGuire?

Statement of Facts

Ms. Rodriguez sued her cardiologist, Dr. Goswami, Walgreen and its

pharmacist, McGuire, claiming that Defendants were negligent because after

Dr. Kessler (who was in the same group as Dr. Goswami) advised that Pradaxa be

discontinued, Walgreen continued to fill a prescription previously issued by

Dr. Goswami. C.R. 6. Dr. Goswami issued the prescription on February 14, 2012,

C.R. 335, with a prescription refill on March 16, 2012. C.R. 336. Ms. Rodriguez

alleged that continued use of Pradaxa caused her to be admitted to the hospital with

hypertension, acute kidney injury and gastrointestinal bleeding. C.R. 6. In support

of her claim, she served reports from Jeffrey Hardy, Pharm. D., M.S., C.R. 39–42,

and Dr. Jeffrey Breall, a professor of clinical medicine. C.R. 43–44.

1751449.6/SPSA/87282/0138/030615

Mr. Hardy opined that Walgreen, McGuire and a pharmacist with the initials

MDD breached the applicable standard of care because (1) they failed to verify

whether the prescription previously written by Dr. Goswami for Pradaxa should be

continued and (2) dispensed a prescription for Pradaxa after Dr. Kessler indicated

that it be discontinued.

His report stated:

Standards of Care

The standard of care required to fill Ms. Rodriguez’s dabigatran

etexilate (PRADAXA) prescription are as follows:

 Pharmacists have a duty to contact the prescribing

physician if patient harm is possible to validate the

prescription

 Pharmacists are responsible for ensuring a prescription is

accurately communicated and dispensed as intended by

the prescriber

 Pharmacists are responsible for communicating with the

prescribing physician to validate continuation of therapy

when no refills remain on a prescription

Breach of Standard of Care

Walgreens, Sara Elizabeth McGuire (pharmacist), and pharmacist

with initials MDD breached the applicable standards of care.

Specifically, Walgreens, Sara Elizabeth McGuire (pharmacist), and

pharmacist with initials MDD conduct fell below the standard of care

by:

 Continuing to dispense a prescription for dabigatran

etexilate (PRADAXA) after the prescribing physician

indicated it should be discontinued; and

1751449.6/SPSA/87282/0138/030615 2

 Failing to verify if the prescription for dabigatran

etexilate (PRADAXA) should be continued with the

prescribing physician

Walgreens, Sara Elizabeth McGuire (pharmacist), and pharmacist

with initials MDD should have provided Ms. Rodriguez with the care

and treatment in the standard of care paragraph above. However, this

expected care was not provided to Ms. Rodriguez as set forth in the

preceding paragraph.

C.R. 40–41.

Plaintiff did not offer Mr. Hardy’s opinion as to causation, but instead relied

on the report of Dr. Breall. C.R. 359; R.R. 32. Dr. Breall’s report did not mention

Walgreen or McGuire; it was instead directed solely to the conduct of Dr.

Goswami. C.R. 44. Dr. Breall stated the following about causation:

Failure to discontinue the use of Pradaxa was a direct cause of her

subsequent acute admission to the hospital with hypotension, acute

kidney injury and apparent gastrointestinal bleeding – known side

effects of the over–use of Pradaxa. Ms. Rodriguez’s entire

hospitalization was attributable to the failure to stop Pradaxa therapy

as ordered by Dr. Kessler. More likely than not, had the Pradaxa

medication been discontinued as requested, Ms. Rodriguez’s

hospitalization would never have needed to take place.

C.R. 44.

Walgreen and McGuire objected to both reports, C.R. 64–74, and moved to

dismiss. C.R. 212–20. The trial court granted their motion. C.R. 375–76.

Ms. Rodriguez appeals. Supp. C.R. 3–4.

1751449.6/SPSA/87282/0138/030615 3

Summary of Argument

The trial court did not abuse its discretion in dismissing Ms. Rodriguez’s

claims against Walgreen and McGuire. Her experts were not shown to be qualified

and their reports failed to implicate Walgreen or its pharmacists. Neither expert

provided a factual basis for his opinions. Both reports were based on the unstated

assumption that Walgreen and McGuire knew Dr. Kessler had instructed Ms.

Rodriguez to discontinue Pradaxa. Even when read together, there was no report

that implicated the conduct of Walgreen or its pharmacists because Mr. Hardy was

incompetent to render a report as to causation and Dr. Breall never even mentioned

Walgreen or McGuire in his report. The trial court’s dismissal should be affirmed.

The trial court did not abuse its discretion in finding Mr. Hardy’s report

deficient. First, his report is conclusory ––he fails to provide any facts to support

his conclusion about why Walgreen and its pharmacists failed to meet the standard

of care. He does not recite any facts about the date of Dr. Kessler’s advice to stop

Pradaxa, to whom the instruction may have been communicated, whether

Walgreen or its pharmacists ever had any notice of the advice, the circumstances

under which Walgreen continued to refill her Pradaxa prescription, or any other

relevant facts. If Walgreen received the prescription written by Dr. Goswami,

C.R. 335, and the five refills of Pradaxa, C.R. 336, and was not aware of

Dr. Kessler’s subsequent indication to stop using Pradaxa, there would be no

1751449.6/SPSA/87282/0138/030615 4

reason for Walgreen to refuse to refill her prescription using the prescription it had

on file. Nevertheless, Mr. Hardy’s report does not even mention the fact that

Walgreen had a prescription refill that predated the hospital admission during

which Dr. Kessler said to stop Pradaxa. Nor does it mention whether Walgreen or

McGuire were ever informed of Dr. Kessler’s instruction.

Second, Mr. Hardy was statutorily disqualified from testifying to causation.

Ms. Rodriguez concedes that Mr. Hardy was unqualified to render an opinion

regarding causation; only a physician may render opinions regarding causation.

Nevertheless, Ms. Rodriguez asserts that when Mr. Hardy’s report is read in

conjunction with Dr. Breall’s report, the causation requirement is satisfied. While

it is true that the expert report requirement may be satisfied by utilizing more than

one expert report, Dr. Breall’s report does not supply the missing causation.

Dr. Breall’s report does not even mention Walgreen or its pharmacists much less

identify any conduct, act or omission attributable to them.

Third, when a plaintiff sues more than one defendant, the expert report must

set forth the standard of care applicable to each defendant and explain the causal

relationship between each defendant’s acts and the plaintiff’s injury. A claimant

must provide each defendant with an expert report that sets forth the manner in

which the care rendered by that defendant failed to meet the standard of care and

1751449.6/SPSA/87282/0138/030615 5

the causal relationship between that failure and the injuries claimed. This Mr.

Hardy and Dr. Breall failed to do.

Fourth, Mr. Hardy was not qualified. There is nothing in the four corners of

his report to indicate that he was a practicing pharmacist filling prescriptions at the

time the claim arose or when he made his report.

The trial court did not abuse its discretion in finding that Dr. Breall’s report

does not bridge the gaps in Mr. Hardy’s report. First, his report does not even

mention Walgreen or McGuire much less recite any facts that Walgreen’s

pharmacists were on notice of Dr. Kessler’s instruction. Second, his report is

speculative and conclusory on the issue of causation. It fails to identify the

prescription used by Ms. Rodriguez after Dr. Kessler said to stop using Pradaxa,

the circumstances under which Walgreen continued to refill the prescription, or

how doing so contributed to Ms. Rodriguez’s injury. Third, Dr. Breall is not

qualified to testify to the standard of care for a pharmacist.

The trial court’s dismissal should be affirmed.

Standard of Review

A trial court’s rulings on motions to dismiss health care liability claims are

reviewed for an abuse of discretion. Jernigan v. Langley, 195 S.W.3d 91, 93

(Tex. 2006); American Transitional Care Centers of Texas Inc. v. Palacios,

46 S.W.3d 873, 877 (Tex. 2001). A trial court abuses its discretion by rendering an

1751449.6/SPSA/87282/0138/030615 6

arbitrary and unreasonable decision lacking support in the facts or circumstances of

the case or by acting in an arbitrary or unreasonable manner without reference to

guiding rules or principles. Samlowski v. Wooten, 332 S.W.3d 404, 410 (Tex.

2011) (plurality op.) When reviewing matters committed to the trial court’s

discretion, an appellate court may not substitute its own judgment for that of the

trial court. Bowie Mem’l Hosp. v. Wright, 79 S.W.3d 48, 52 (Tex. 2002). A trial

court does not abuse its discretion merely because it decides a discretionary matter

differently than an appellate court would in a similar circumstance. Id.; see also

Jelinek v. Casas, 328 S.W.3d 526, 542 (Tex. 2010) (Jefferson, C.J., dissenting)

(“The dividing line between a sufficient and an inadequate report is impossible to

draw precisely. We have said, therefore, that the determination must be made in

the first instance by the trial court, and review of that decision asks not how an

appellate court would have resolved that issue, but instead whether the trial court

abused its discretion.”) (citing Jernigan v. Langley, 195 S.W.3d 91, 93 (Tex.

2006); Walker v. Gutierrez, 111 S.W.3d 56, 63 (Tex. 2003)). But if an expert

report contains only conclusions about the statutory elements, a trial court has “no

discretion but to conclude . . . that the report does not represent a good–faith

effort” to satisfy the statute. Palacios, 46 S.W.3d at 877, 880; Smith v. Wilson,

368 S.W.3d 574 (Tex. App.–Austin 2012, no pet.).

1751449.6/SPSA/87282/0138/030615 7

Argument

I. A Chapter 74 report must be from a qualified expert and address in

non–conclusory terms the standard of care, breach and causation.

Pursuant to Section 74.351, medical–malpractice plaintiffs must provide

each defendant health care provider with an expert report or voluntarily nonsuit the

action. TEX. CIV. PRAC. & REM. CODE §74.351. If a claimant timely furnishes an

expert report, a defendant may file a motion challenging the report’s adequacy. Id.

The trial court shall grant the motion only if it appears, after hearing, that the report

does not represent a good faith effort to comply with the statutory definition of an

expert report. See id. §74.351(l). The statute defines an expert report as a written

report by an expert that provides, as to each defendant, a fair summary of the

expert’s opinions, as of the date of the report, regarding: (1) the applicable

standards of care; (2) the manner in which the care provided failed to meet the

standards; and (3) the causal relationship between that failure and the injury, harm,

or damages claimed. See id. §74.351(r)(6).

Although the report need not marshal all the plaintiff’s proof, it must include

the expert’s opinions on the three statutory elements––standard of care, breach and

causation. See Palacios, 46 S.W.3d at 878. In detailing these elements, the report

must provide enough information to fulfill two purposes: first, it must inform the

defendant of the specific conduct the plaintiff has called into question, and, second,

it must provide a basis for the trial court to conclude that the claims have merit.

1751449.6/SPSA/87282/0138/030615 8

Scoresby v. Santillan, 346 S.W.3d 546, 556 (Tex. 2011) (citing Palacios,

46 S.W.3d at 879). A report that merely states the expert’s conclusions as to the

standard of care, breach, and causation does not fulfill these two purposes. Id. A

report that omits one or more of these required elements, or states the expert’s

opinions as merely conclusions without supporting facts, is insufficient to

constitute a “good faith effort” at compliance with Chapter 74. See Samlowski v.

Wooten, 332 S.W.3d 404, 409–10 (Tex. 2011); Jernigan v. Langley, 195 S.W.3d

91, 93–94 (Tex. 2006) (affirming trial court’s dismissal of suit because expert

reports omitted any allegation about how doctor breached standard of care and

causation); Bowie Mem’l Hosp., 79 S.W.3d at 52. (“[T]he expert must explain the

basis of his statements and link his conclusions to the facts.”) Furthermore, in

assessing a report’s sufficiency, a trial court may not draw any inferences, and

instead must rely exclusively on the information contained within the report’s four

corners. See Scoresby v. Santillan, 346 S.W.3d 546, 556 (Tex. 2011) (citing

Palacios, 46 S.W.3d at 878).

II. The trial court did not abuse its discretion in dismissing claims against

Walgreen and McGuire.

A. Mr. Hardy’s report is deficient.

1. Mr. Hardy’s opinion is speculative and conclusory.

Mr. Hardy’s report is speculative because it relies on the assumption that

Walgreen and McGuire were aware of Dr. Kessler’s advice to discontinue the use

1751449.6/SPSA/87282/0138/030615 9

of Pradaxa. It fails to make a causal link between an allegedly breached standard of

care and injury by requiring an inference that if Walgreen and McGuire had known

of Dr. Kessler’s advice, then Ms. Rodriguez’s outcome would have been different.

His opinions all hinge on Walgreen and McGuire knowing of Dr. Kessler’s advice.

Yet there is nothing in Mr. Hardy’s report that affirmatively shows that Walgreen

and McGuire were aware of the information that is identified as key to their

liability. Any breach of the standard of care discussed in Mr. Hardy’s report is

entirely dependent on what Defendants knew and when. Yet Mr. Hardy’s report is

silent on these crucial facts. Further, Mr. Hardy’s report says Walgreen should

have contacted the prescribing physician––Dr. Goswami. But there is no indication

that at that time Dr. Goswami even knew of Dr. Kessler’s advice or would have

communicated it to Walgreen or McGuire.

By relying on assumptions instead of facts, the report provides no basis for a

trial court to conclude that the claims against Defendants have merit. Fung v.

Fischer, 365 S.W.3d 507, 533 (Tex. App.–Austin 2012), overruled in part by

Certified EMS, Inc. v. Potts, 392 S.W.3d 625 (Tex. 2013) (finding that report that

depended on unsupported assumptions about what a defendant knew and when he

knew it was speculative); Cooper v. Arizpe, No. 04–07–00743, 2008 Tex. App.

LEXIS 2506 at *9–10 (Tex. App.–San Antonio, April. 9, 2008, pet. denied)

(holding that report that relied on assumption that notes were in chart was

1751449.6/SPSA/87282/0138/030615 10

conclusory and speculative); Murphy v. Mendoza, 234 S.W.3d 23, 28 (Tex. App.–

El Paso 2007, no pet.) (holding that expert’s opinion as to breach of the standard of

care was speculative and conclusory as it was unsupported by facts in report’s four

corners and relied on assumption).

Mr. Hardy’s opinions regarding Walgreen’s negligence, breach of the

standard of care, and causation––which depend on unsupported assumptions as to

what Walgreen and McGuire knew and when they knew it––are conclusory and

speculative at best. They do not provide a basis for the court to conclude that

Ms. Rodriguez’s healthcare liability claim against Walgreen and McGuire has

merit.

2. Mr. Hardy is statutorily disqualified from addressing

causation.

Mr. Hardy, Pharm. D., M.S., is a pharmacist and not a medical doctor. Only

a physician can render an opinion on causation. TEX. CIV. PRAC. & REM. CODE

§74.403(a). Therefore, Mr. Hardy, by statute, cannot render an opinion on

causation.

Moreover, Mr. Hardy’s statement of causation is entirely conclusory in that

it fails to explain the relationship between the alleged injuries and the failure to act

according to the standard of care. He simply states “…It is clear that the long-term

use of dabigatran etexilate (Pradaxa) as dispensed by Walgreens and Sara

Elizabeth McGuire (pharmacist), and pharmacist with initials MDD caused

1751449.6/SPSA/87282/0138/030615 11

Ms. Rodriguez’s acute kidney injury, anemia, and gastrointestinal bleeding (which

have led to her long-term clinical demise and medical injuries).” C.R. 42.

The causal connection in healthcare malpractice suits must be made “beyond

the point of conjecture” and “must show more than a possibility” to warrant

submission of the issue to a jury. Lenger v. Physician’s Gen. Hosp., 455 S.W.2d

703, 706 (Tex. 1970); see Bowie Mem’l Hosp., 79 S.W.3d at 53. Reports providing

a “description of only a possibility of causation do not constitute a good–faith

effort to comply with the statute.” Walgreen Co. v. Hieger, 243 S.W.3d 183, 186–

87 (Tex. App.–Houston [14th Dist.] 2007, pet. denied) (holding that expert report

stating claimant had symptoms “consistent with” known side effects of medication

was insufficient to demonstrate causal link); see McMenemy v. Holden, No. 14–

07–00365–CV, 2007 Tex. App. LEXIS 8830, at *15–16 (Tex. App.–Houston

[14th Dist.] Nov. 1, 2007, pet. denied) (mem. op.) (concluding that expert’s report

expressing uncertainty about possibility of positive outcome for patient failed to

make causal link indicating plaintiffs’ claim had merit); Estate of Allen v. Polly

Ryon Hosp. Auth., No. 01–04–00151–CV, 2005 Tex. App. LEXIS 1691, at *16–17

(Tex. App.–Houston [1st Dist.] Mar. 3, 2005, no pet.) (mem. op.) (holding that

expert’s report failed to meet statutory causation requirement by opining merely

that breach of standard of care “could have contributed” to decline in claimant’s

condition).

1751449.6/SPSA/87282/0138/030615 12

Further, a court may not fill in gaps in a report by drawing inferences or

guessing what the expert meant or intended. Austin Heart, P.A. v. Webb,

228 S.W.3d 276, 279 (Tex. App.–Austin 2007, no pet.). Instead, the report must

include the required information within its four corners. Bowie Mem’l Hosp.,

79 S.W.3d at 53. This Mr. Hardy’s report fails to do. The trial court thus did not

abuse its discretion in finding it inadequate.

3. Mr. Hardy’s report fails to distinguish between multiple

defendants.

Also, Mr. Hardy’s report does not separately set out the alleged acts of

negligence and causal connection for each of the multiple defendants. When a

plaintiff sues more than one defendant, the expert report must set forth the standard

of care applicable to each defendant and explain the causal relationship between

each defendant’s individual acts and the injury. See TEX. CIV. PRAC. & REM. CODE

§74.351(r)(6) (a claimant must provide each defendant with an expert report that

sets forth the manner in which the care rendered failed to meet the standard of care

and the causal relationship between that failure and the injuries claimed); Doades

v. Syed, 94 S.W.3d 664, 671-72 (Tex. App.–San Antonio 2002, no pet.); Rittmer v.

Garza, 65 S.W.3d 718, 722-23 (Tex. App.–Houston [14th Dist.] 2001, no pet.).

An expert report may not assert that multiple defendants are all negligent for

failing to meet the standard of care without providing an explanation of how each

defendant breached the standard of care and how that breach caused or contributed

1751449.6/SPSA/87282/0138/030615 13

to cause the injury. Austin Heart, 228 S.W.3d at 282-83 (finding deficient expert

report that was “silent as to whether a single physician, multiple physicians, or all

physicians’ mentioned in the report failed to meet the standard of care and caused

injury to [the patient]”); Tenet Hospitals Ltd. v. De La Riva, 351 S.W.3d 398 (Tex.

App.–El Paso 2011, no pet.) (finding deficient expert report that failed to state who

among multiple defendants caused the injuries); Taylor v. Christus Spohn Health

Sys. Corp., 169 S.W.3d 241, 245–46 (Tex. App.–Corpus Christi 2004, no pet.)

(finding deficient expert report that failed “to state what each defendant should

have done in order to meet the standard of care, what each defendant failed to do,

and how such failure led to [the patient’s] death”).

Because Mr. Hardy’s report does not explain what conduct, act or omissions

are attributable to which of the defendants, it is deficient, and the trial court did not

abuse its discretion in finding it did not satisfy the statutory requirements.

4. Mr. Hardy is not qualified as a practicing pharmacist.

A person may qualify as an expert witness on whether a health care provider

departed from accepted standards of care only if, at the time the claim arose or at

the time the testimony is given, he is practicing the same type of care or treatment

as the defendant, and is qualified by training or experience. TEX. CIV. PRAC. &

REM. CODE §74.402(b)(1)–(3). In determining whether a witness is qualified, a

court considers whether the witness (1) is certified by the licensing agency, and

1751449.6/SPSA/87282/0138/030615 14

(2) is actively practicing health care in rendering health care services relevant to

the claim. TEX. CIV. PRAC. & REM. CODE §74.402(c). “Health care” is defined as

“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

patient’s medical care, treatment, or confinement.” TEX. CIV. PRAC. & REM. CODE

74.001(a)(10). A plaintiff offering medical testimony must establish that the expert

has expertise regarding “the specific issue before the court which would qualify the

expert to give an opinion on that particular subject.” Broders v. Heise, 924 S.W.2d

148, 153 (Tex. 1996). The analysis focuses on “the very matter” on which the

expert is to give an opinion. Id.

Here, there is no showing in the four corners of his report that Mr. Hardy is

practicing and rendering health care in “the very matter” on which he is giving an

opinion. Mr. Hardy’s CV shows only that he is involved in pharmacy “information

technology.” There is no showing that he was, at the pertinent times, filling

prescriptions for patients. Nothing in the four corners of Mr. Hardy’s report

indicates that he is qualified to opine on the standard of care, breach or causation.

B. Dr. Breall’s expert report is deficient.

Conceding that Mr. Hardy is prohibited by statute from stating any opinions

on causation, Ms. Rodriguez still asserts that when Mr. Hardy’s report is read in

conjunction with the report provided by Dr. Breall, causation is found. While it is

1751449.6/SPSA/87282/0138/030615 15

true that the expert report requirement may be satisfied by utilizing more than one

expert report, and thus, a court may read those reports together to supply missing

elements, see TEX. CIV. PRAC. & REM. CODE ANN. §74.351(i), Dr. Breall’s report

does not supply the missing causation.

1. Dr. Breall’s report does not even mention Walgreen or

McGuire.

Dr. Breall does not mention Walgreen or McGuire, does not discuss any

standard of care pertaining to Walgreen or McGuire, and does not discuss any

causal connection between anything done or failed to be done by Walgreen or

McGuire and the injuries sustained by Ms. Rodriguez. In fact, the report does not

mention Walgreen or McGuire at all; instead, the report discusses only

Dr. Goswami. His report thus does not constitute an expert report as required to

maintain a suit against Walgreen and McGuire. Accordingly, the trial court was

correct to grant the motion to dismiss.

When a defendant is not identified within the four corners of a report, the

report is, for that reason alone, deficient as to that defendant because it requires the

reader to infer or make an educated guess as to whose actions caused the injuries.

See Reddy v. Hebner, 435 S.W.3d 323, 328 (Tex. App.–Austin 2014, pet. filed)

(finding report that did not mention doctor or discuss how doctor’s treatment did

not meet the standard of care, did not constitute a good-faith effort to comply with

the statutory requirements); Fung v. Fischer, 365 S.W.3d 507, 529 (Tex. App.–

1751449.6/SPSA/87282/0138/030615 16

Austin 2012, no pet.) overruled on other grounds by Certified EMS, Inc. v. Potts,

392 S.W.3d 625 (Tex. 2013) (concluding that report did not implicate defendant

when it did not allege breach by defendant or any causal link between defendant’s

breach and injury); Austin Regional Clinic v. Power, 2012 Tex. App. LEXIS 5242

(Austin 2012, no pet.) (concluding that trial court abused its discretion by denying

motion to dismiss claims against certain defendant when the expert report did not

mention that defendant); see also Bogar v. Esparza, 257 S.W.3d 354, 363 (Tex.

App.–Austin 2008, no pet.); Austin Heart P.A. v. Webb, 228 S.W.3d 276, 281

(Tex. App.–Austin 2007, no pet.); Apodaca v. Russo, 228 S.W.3d 252, 257-58

(Tex. App.–Austin 2007, no pet.). Dr. Breall’s report falls below the minimal

standard and thus does not constitute an expert report as required to maintain a suit

against Walgreen and McGuire.

2. Dr. Breall’s report is speculative and conclusory.

Like Mr. Hardy’s, Dr. Breall’s report would have to be based on the

assumption that Walgreen and McGuire––although they are never mentioned––

knew about Dr. Kessler’s advice to stop Pradaxa. But there is nothing in his report

about to whom the advice was communicated, whether the prescription that was

used by Ms. Rodriguez predated the advice, or any other circumstances under

which Ms. Rodriguez continued to refill her prescription. Dr. Breall simply does

not provide facts to establish the causal link between Walgreen’s alleged breach

1751449.6/SPSA/87282/0138/030615 17

and Ms. Rodriguez’s injuries, one of the required statutory elements of an expert

report. See TEX. CIV. PRAC. & REM. CODE §74.351(r)(6). “To avoid being

conclusory, an expert must explain the basis of the statements to link his

conclusions to the facts.” Bowie Mem’l Hosp. v. Wright, 79 S.W.3d 48, 52 (Tex.

2002).

This Court has consistently required more than what Dr. Breall has provided

in terms of expert testimony on causation. See Kocerek v. Colby, No. 03–13–

0057–CV, 2014 Tex. App. LEXIS 9336 (Tex. App.–Austin 2014, no pet.)(holding

insufficient expert report that failed to show specific actions defendant did or did

not take would have prevented patient’s injuries); Smith v. Wilson, 368 S.W.3d

574, 578 (Tex. App.–Austin 2012, no pet.)(holding that expert failed to show how

doctor’s alleged breach of standard of care caused patient to commit suicide);

Constancio v. Bray, 266 S.W.3d 149, 157–58 (Tex. App.–Austin 2008, no pet.)

(holding insufficient expert report that alleged that breach of standard of care by

doctor caused patient’s death when report did not explain how increased

monitoring of patient, detection of hypoxemia, and other consequence would have

prevented patient’s death); Perez v. Daughters of Charity Health Servs. of Austin,

No. 03–08–00200–CV, 2008 WL 4531558, at *4 (Tex. App.–Austin, Oct. 10,

2008, no pet.) (mem. op.) (concluding expert report insufficient on causation

because it did not link hospital’s actions to patient’s death or any cause of death

1751449.6/SPSA/87282/0138/030615 18

and did not identify any specific injury that would have been prevented had

hospital complied with standard of care). To find Dr. Breall’s report sufficient on

causation, the trial court would have had to make inferences beyond the four

corners of his report, which it could not do. For this additional reason, the trial

court was correct to grant the motion to dismiss.

3. Dr. Breall is not qualified to testify to the standard of care

for a pharmacy or pharmacist.

An expert report must demonstrate within the four corners of the report that

the purported expert is qualified to testify about the particular matters for which the

opinion is offered. TEX. CIV. PRAC. & REM. CODE §74.351, 74.402. Dr. Breall is

not a pharmacist qualified on the basis of training or experience to offer an expert

report regarding accepted standards for a pharmacy or pharmacist. Because he is

not qualified to give opinions as to the standard of care, he cannot connect any

breaches of the standard of care with the damages claimed. Therefore, the Court’s

dismissal of Ms. Rodriguez’s claims against Walgreen and McGuire was correct.

CONCLUSION

The trial court was correct in dismissing the claims against Walgreen and

McGuire. Its order should be affirmed.

1751449.6/SPSA/87282/0138/030615 19

Respectfully submitted,

/s/ Judith R. Blakeway

JUDITH R. BLAKEWAY

State Bar No. 02434400

judith.blakeway@strasburger.com

CYNTHIA DAY GRIMES

State Bar No. 11436600

Cynthia.Grimes@strasburger.com

STRASBURGER & PRICE, LLP

2301 Broadway

San Antonio, Texas 78215

(210) 250-6003 Telephone

(210) 258-2706 Facsimile

ATTORNEYS FOR APPELLEES

THE WALGREEN COMPANY AND

SARA ELIZABETH MCGUIRE

1751449.6/SPSA/87282/0138/030615 20

CERTIFICATE OF SERVICE

Pursuant to E-Filing Standing Order, I certify that on March 6, 2015, I

electronically filed the foregoing with the Clerk of Court using the

EFile.TXCourts.gov electronic filing system which will send notification of such

filing to the following:

Lannie Todd Kelly

State Bar No. 24035049

THE CARLSON LAW FIRM, P.C.

11606 N. IH–35

Austin, TX 78753

Telephone: (512) 346–5688

Facsimile: (512) 719–4362

tkelly@carlsonattorneys.com

Attorneys for Appellant Nancy Jo Rodriguez

/s/ Judith R. Blakeway

JUDITH R. BLAKEWAY

CERTIFICATE OF COMPLIANCE

In accordance with Tex. R. App. P. 9.4(i)(1), I hereby certify that this Brief

of Appellees contains no more than 4,460 words.

/s/ Judith R. Blakeway

JUDITH R. BLAKEWAY

1751449.6/SPSA/87282/0138/030615 21

NO. 03–14–00765–CV

IN THE COURT OF APPEALS

FOR THE THIRD DISTRICT OF TEXAS

AT AUSTIN

NANCY JO RODRIGUEZ

APPELLANT,

THE WALGREEN COMPANY AND SARA ELIZABETH MCGUIRE

APPELLEES.

On Appeal from the 419th District Court

Travis County, Texas

APPENDIX

1. Order dated December 3, 2014

2. Mr. Hardy’s CV and report

3. Dr. Breall’s CV and report

4. TEX. CIV. PRAC. & REM. CODE §74.351

5. TEX. CIV. PRAC. & REM. CODE §74.402

1751449.6/SPSA/87282/0138/030615 22

APPENDIX 1

DEC-03-2014 14:56 P.002/006

FHed In The District Court

of Travis County, Texas

DEC 03 2014 {If1-

CAUSE NO. D-l-GN-000903

AL ' :~l1 fa:' _M.

a; Clark

Amalia RJdriguez.Mendo

NANCY.TO RODRIGUEZ § IN THE DISTRICT COURT OF

PLAINTIFF, §

vs, §

§ TRAVIS COUNTY, TEXAS

THE WALGREEN COMPANY, SARA §

ELIZA6ETH MCGUIRE, AUSTIN HEART §

PLLC, sr.

DAVID'S HEALTH CARE §

PARTNERSHIP, DA YID 1<ESSLERt MD, §

AND VIVEK GOSWAMl, MD §

DEFENDANT. § 419TR JUDICIAL DISTRICT

ORDER

On the 291h of October, 2014, the Court considered the Chapter 74 Motion to Dismiss and for

Attorneys' Fees filed by Walgreen Co. and Sara Elizabeth McGuire. After considering the motion.

any responses thereto, arguments of counsel, and all other relevant matters of record, the Court is of

the opinion that the motion is meritorious and Should be GRANTED IN PART and DENlED IN

PART. It is therefore.

ORDBRED that Walgreen Co. and Sara Elizabeth McGuire's Chapter 74 Motion to Dismiss

is granted. It is therefore,

ORDERED that all of Plaintiff Nancy 10 Rcdrigucz' claims and causes of action, as well as

those that could have been asserted, against Walgreen Co. and Sara Elizabeth McGuire arc hereby

dismissed with prejudice. It is further,

ORDERED that Walgreen Co. and Sara. Elizabeth McGuire's request for attorneys' fees is

DENIED.

All other relief not granted herein with respect to the the Chapter 74 Motion to Dismiss and

for Attorneys' Fees filed by Walgreen Co. and Sara Elizabeth McGuire is Denied.

DEC-03-2014 14:56 P.003/006

O..c" C- ~ f, l(""- I

Signed this 3- ~¥-6MBER, 2014.

APPROVED AS TO FORM:

IA DAVG

State Bar No. 1143

STRASBURCER & PRICE, LLP

230 I Broadway

San Antonio, Texas 78215-1157

(210) 250-6000 - Main

(2 ! 0) 250-6100 - Pax

(210) 250-6003 - Direct

CynthL:"t..ril·ilncl:l(d'Slrasbllrg~l',!t.\ll.D.

Attorneys/or Defendants Walgreen Co. and Sara Bllzabeth McGuire

L. TODD KELLY

State Bar No. 24035049

ELIZABETH A. RHODES

State Bar No. 24083726

THE CARLSON LAW FIRM~ PC

11606N.1H35

Austin, Texas 78753

(512) 346-5688 - Telephone

(512) 719.4362 - Fax.

tkell V (ci'J\:l\ rI sonattornevs.colll

f.: rhod es(Ci'!cItrlsOnll (torn evs.com

Attorneys for Plaintiff

DEC-03-2014 14:57 P.004/006

Signed this __ NOVEMBER,2014.

..--'-"~---'--:-C"""""" -=-:------

HONORABLE GUS J. STRAUSS

PRESIDlNO JUDOE

APPROVEll AS TO .FORM:

CYNTHIA DAY GRlMES

State: BarNo. 11436600

STRASBURGER & PRJCE,I,LP

2301 Broadway

San Antonio, Te:t8S 7821 :;-1157

(210) 250-6000 - Main

(210) 250-6100 - Fax

(210) 250~6003 - Direct

Cynthia.Grimes@strasburger.!?olTI

Attorneys /01' De/emuwts Walgreen Co. and Sara Elizabeth ll'fc(iuiTI!

/~"--,=-L:W--,,gd-__

//l.:~;;~~~YsJ49

/...././ :ett?*B-E-Hi-*~-Rtiel'fffiS

Sta!~~

THE CARLSON LAW FIRM, PC

1t606 N. IH 35

Austin, Texas 78753

(512) 346-5688 - Telephone

(512) 719-4362 - Fax:

tkclly(&,cnrlsonllttomeys.com

erhodes@car)sQnattomeys.com

Attorneys for Plaintiff

16l26ll.~ISPSAIR'721!.2101JRIII0611

DEC-03-2014 14:57 P.005/006

!COLE G. AND EWS

State Bar No. 00792335

MARGARET GARIS

State Bar No. 24072108

SERPE JON!'': ANDREWS CALLENDER & BELL, PLLC

America Tower

2929 Allen Parkway, Suite 1600

Houston, Texas 77019

IN;erib@serpejones.cotn

nf\l1drcws@sel'Peione~.com

Attorneys/or Defendants Austin Hearl, PLL(,.~ David Kessler, MD

And Vivek Goswaml, MD

MISSY ATWOOD

State Bar No. 01428020

R. CHAD GElSLER

State Bar No. 00793793

GERMER BEAMAN & BROWN, PLLC

301 Congress Avenue, Suite 1700

Austin, Texas 78701

(5 J 2) 472-0288 ~ Main

(512) 472-9280 - Fax

(512) 482-5 J 71 - Direct

1J)!~~N.t!(w~(!nner.allstin.colll

Attorneys for Defendant Sf. David's Health Care Partnership

DEC-03-2014 14:57 P.006/006

NICOLE G. ANDREWS

State Bar No. 00792335

MARGARET GARIB

State BarNo. 24072108

SERPE JON!!; ANOREWS CALLENDER & BELL, PLLC

America Tower

2929 Allen Parkway, Suite 1600

Houston. Texas 77019

mgl\riQ@llerpcionc,'i.colli

n.OJ.~@.s.r:!lt~i5In~K.c.Qm

Attorneys for Defendant» Austin Heart, PLLC, David Kessler, MD

And Vivek Goswami, MD

State Bar No. 01428020

R. CHAO GEISLER

State Bar No. 00793793

GERMER BEAMAN & BROWN, PLLC

301 Congress Avenue, Suite 1700

Austin, Texas 7870]

(512) 472-0288 - Main

(512) 472-9280 - Fax

(512) 482·5171 - Direct

mat):'LQQQ@g"e);mer-(LlIslin.com

Attorneysfor Defendant St. David's Health Cure Partnership

1631G31.4I6PSNBm2/illlRllla~ 14

'I'O'l'AT. P. nos

APPENDIX 2

62 W. Tapestry Park Cr.Th& Woodlands, TX 17381

Phone: 281.352.3038 • FaIC:281.203.0816 • E-Moll: chad@rxpolnlconsuHing.com

Summary

An experienced healthcore information solutions and pharmacy operations manager. Experience in

Implementation and management of heolthcore information technologies and operational practices In

military and private sectors. Demonstrated accomplishment managing and implementing clfnlcal policies and

procedures in healthcare systems. Trained cnmctcn and heolthccre provider with experience in parenteral

nutrition. neonatal, pedlatric and general medlcine populations. Well-organized, goal oriented professional

wIth abnity to implement standards, procedures, and processes that improve heclthcore and pallent safety.

Proven management skllls,capable of leading and rnotlvotlnq individuals to augment efficiency and

productivity In a team oriented environment. Exceptional communicator and negotiator.

Experience

~hormClcy Consultant, Houston TX July 201' - Pre$ent

operations and standards consultant to some of the leading heolthcore systems In the Uniled states. Design

and support expert on Medication Use tools In electronic neottn records. Provides experience in policy and

procedure implementation. Works closely with pharmacy and heolthcore leaders to optimize poilent care

workflows and pharmaceutical care delivery systems. leverages knowledge of technology and pharmacy

practice 10 solve complex clinical workllows. Expert pharmacy witness providing services to a brood range of

clients in the US.

Phcrrnccy Opercrllons Monogement, Houston TX Mor. 05 - Apr, 12

ResponsIble for direction and management of technology-related pharmacy services, including practice

stondords and worknows for most areas of practice. Team oriented leader of pharmacy staff members,

providing assessment, Implementation, support, and maintenance of healthcare systems. Operational

inforrnatlon systems clinical content manager tor both Inpatient and outpotient operations. Responsible for 3

inpatient hospitals and 16 outpatient pharmacies. Works to better the department wilh the application of

clinical knowledge to ensure proper effective and timely patient core. Involved in fiscal planning. contract

negotiation. and vendor interactions. ExperIence with clinical medIcation parameters and advanced decision

support for Epic Ambulatory. EpicRX. and Epic Inpatient. Represents Pharmacy on multidisciplinary project

teams and Inttlatives. Responsible for clinical systems and process compliance with regulatory governance and

The Joint Commission. Reports to Chief Pharmacy Officer. Currently serving In a consulting capacity.

strafegic Accounts Manager, McKesson Jut 03 - Mar. 05

strategic representative for heoltncore automation cvslomers. Responsible for all account activities Including:

finance, upgrades, technical support, engineering, soles, pharmacy practice consulting, and customer

service. Regional responsibilities Include Texas. Oklahoma. New MexIco, Kansas, Nevada, Wyoming, Nebraska,

Minnesota, California, and Colorado. In addition. program Manager for Department of Defense security

inltiotives to ensure standardization and Increased security posture for all products, HIPAA Security consultant

for engineering group. Pharmacy prcctlce consultant for executive management Responsible for managing

projects involving department or cross-functional teams focused on the denverv of HIPAA and DoD approved

products,

EXHIB'T

I A 13

Department Head, US Navy Sep. 01 - Jut OS

Motivational and logistical leader. Responsible for clinIcal practice, formulary, supply, financial. and personnel

management. Managed an annual operational budget of $25 million. Visionary for 3 facilities and over 40

personnel. Inpotient, outpotlent, and hospital wide multifunctional officer. Accomplished healthcare IT

lecturer and mentor. Command technology leader and cross-tunctlonol team champion. Recipient of Naval

Medal of Commendation, 2003,

Division Officer. US Navy Jun. 00 - Sep. 01

Managed the inpatient pharmacy operation in a 350-bed state of the art focllrty, Responsible for business

planning. operational readiness, clinical coordination and sterile product compounding for a dolly census of

over 200 patients. ResponsIble lor annual combined budget of $25 million. Manager for 38 subordinates,

Automated Medication System upgrade implementation lead, totaling a .$2.8 million purchase, Senior

command member of JCAHO compliance team. Total Parenteral Nutrition Upgrade implementation lead.

responsible for decreasing medication errors, improving efficiency, and providIng pharmac:eutical care to

critical patients. Senior TPN Pharmacist. Credentialed in Total Porenteral Nutrition, PharmacokInetics, and

inpatient pharmacy practice, Experiential Coordinator for 6 area colleges of obormccv and 30 students

annually. Design lead for Neonatal, Chemotherapy and Discharge pharmacy satellites,

Historical Experience

Flooler Pharmacist, Wal·Mort stores, VirgInia Beach, VA: Aug. 00 - Sep, 03

Chief Information Officer, Prniing Technology, Dallas, TX: Jun. 97 - May 00

Systems Analyst, Unlv, of Texas at AustIn. TX: Aug, 96 - Jun. 98

Certified Pllorrnocy Technician, Tom Thumb Pharmacy, TX: Aug. 92 - Dec. 98

Education

Univ. 01 Texas (II Austin. Doctorate of Pharmacy 2000

Capella University, MS In Inlormatlon Technology 2005

PresentatIons and Publications

ClinIcal decision support for drug-drug Interactions: Improvement needed, Am ,J Health Syst Phorm May 15,

2013 70:905-909.

Computerized Pharmacy Order Entry Guidelines ......m J heotlh-Svst Phorrn, published 2010.

Technology Enabled Practice'. A Vision Statement by ASHPSection of Pharmacy Informatics and Technology,

Am J heallh·Syst Phorm, 2009; 661573-1577.

Maxirnlzing 340B Savings with an Autornoted Solution. Pharmacy Purchasing and Products, June 2009;VoI6 No 6

pg 10-12.

Pharmacy Information Systems. The Pharmacy Informatics Primer, 1st ed., Ch <1 pg, 65-76. 2008.

American Society of Health System Pharmacists IASHP) Informatics Bytes, Midyear Meeting 2007.

Texas SOCiety of Health System Pharmacists (TSHP)Technicians In Automation. Annual Meeting 2008.

Medication Use Technology: PHCA 6397. Lecture. University of Houston College of Pharmacy 2013.

What is Pharmacy Informatics. ASHP funded webinar. 8/23/10.

Pharmacy Informatics and Residency Opportunities. Lecture. Texas Southern University and University of Houston

College of Pharmacy. 2007-2011

Nursing satisfaction with Barcoded Medication Adminislra1ion. poster presentation. ASHP Summer Meeting 2009.

Moderator, Ambulatory Care Informatics Networking Session. ASHP Midyear Meeting 2009.

Moderator. Provider Order Entry Networking SeSSion.ASH? Midyear Meeting 2008.

Moderator, Provider Order Entry Networking Session. ASHP Midyear Meeting 2007.

Professionallnvolvemenf

ASHP Committee on Nornlnotlons 20 I a-present

ASHP Executive Committee. 2008-2011.

ASH? Immediate Past Chair. 2010-2011

ASHP Seclion of Pharmacy Informatics and Technology Chair, 2009-2010.

ASHP Cholr Elect. 2008-2009.

ASHP Section of Pharmacy Informatics and Technology Advisory Group Chair. 2007-2008.

Gulf Coast Society of Health Systems Pharmacists Member at Large. 2007-2011.

February 21, 2014

VIA EMAIL

L. Todd Kelly

The Carlson Law Firm. P.C.

11606 North Interstate Highway 35

Austin, Texas 78753

Re: Nancy Jo Rodriguez File Number 32-4438

Mr. Kelly:

My name is Jeffrey Chad Hardy. ! am a licensed pharmacist in the State of

Texas.

I have been asked in my capacity as an expert in pharmacy operations to

evaluate the conduct and actions of Walgreens Pharmacy ("Walgreens"),

Sara Elizabeth McGuire (pharmacist) and pharmacist with initials MDO as it

relates to the dabigatran etexllate (PRADAXA) of patient Nancy Rodriguez

filled by Walgreens pharmacy on 4/26/2012 and 6/15/2012. Based on

the information available to me at this time, the medication provided to

Ms. Rodriguez was not authorized by her physician. Ms. Rodriguez's

resulting complications and clinical demise were most likely related to the

extended. unauthorized use of dabigatran etexilate (PRAOAXA) and its

impact on her health.

I have reviewed the information provided to me regarding the potential

pharmacy malpractice case against Walgreens, Sara Elizabeth McGuire

(pharmacist), and pharmacist with initials MOD. In preparation of this

report I reviewed the following documentation:

1. Insurance Profile of Nancy Rodriguez as printed by Walgreens

Pharmacy for 1/1/06 to 12/11/12

EXHIBIT

I C 39

2. Images of Prescription # 2046442-06861 as filled by Walgreens

Pharmacy on 6/15/12

3. Cardiology Consultation Note performed by Vivek Goswami on

patient Nancy Rodriguez on 2/10/12

4. Visit notes from Austin Heart on 2115/12, 3/27/12, and 8/14/12.

S. Medical Records of Nancy Rodriguez from Seton Hospital

emergency room and Intensive Care Unit visits

t conclude that the applicable standards of care and pharmacy practice

regarding Walgreens, Sara Efizabeth McGuire (pharmacist), and pharmacist

with initials MDD handling of Ms. Rodriguez's prescription of dabigatran

etexilate (PRADAXA) were not met, resulting in Ms. Rodriguez's injuries.

[~!.!1!l.!iil[l1:Y yv!tb...,tJ:t~_~t~nq~rd..9f" Cru-!l

I am familiar with the standard of care for pharmacy operations, including

the handling of prescriptions in situations similar to that of Ms.

Rodriguez's prescription of dablqatran etexilate (PRADAXA), including the

refilling and processing of the prescription through my education, training,

experience, continual interdisciplinary pharmacological education and

review of specialty medical texts as well as medical articles covering

pharmacy operations. As a pharmacy operations specialist, I have

experience in multiple pharmacy settings in the US. In addition, I am

currently practicing as a Pharmacy Operations Consultant, helping

pharmacies implement regulatory compliance, procedural, and operations

standards. I am specifically familiar with the standard of care applicable

to pharmacists in situations like this for Walgreens, Sara Elizabeth McGuire

(pharmacist), and pharmacist with initials MOD based on my work in these

areas of practice. Please also see my C.V. which is attached hereto and

incorporated by reference for a full list of my education and experience.

St~!l~ards.9..f Car~

The standard of care required to fill Ms. Rodriguez's dabigatran etexilate

(PRADAXA) prescription are as follows:

• Pharmacists have a duty to contact the prescribing physician if

patient harm is possible to validate the prescription

• Pharmacists are responsible for ensuring a prescription is accurately

communicated and dispensed as intended by the prescriber

• Pharmacists are responsible for communicating with the prescribing

physician to validate continuation of therapy when no refills remain

on a prescription

i31eJ!.I;.h 9f.S_t~.rlg!:!n;t Qf_-C\!fJil

Walgreens, Sara Elizabeth McGuire (pharmacist), and pharmacist with

initials MDD breached the applicable standards of care. Specifically,

Walgreens, Sara Elizabeth McGuire (pharmacist), and pharmacist with

initials MODconduct fell below the standard of care by:

• Continuing to dispense a prescription for dabigatran etexilate

(PRADAXA) after the prescribing physician indicated it should be

discontinued; and

• Failing to verify if the prescription for dabigatran etexllate

(PRADAXA) should be continued with the prescribing physician

Walgreens, Sara Elizabeth McGuire (pharmacist), and pharmacist with

initials MDD should have provided Ms. Rodriguez with the care and

treatment In the standard of care paragraph above. However, this

expected care was not provided to Ms. Rodriguez as set forth in the

preceding paragraph.

C~JJ.~. ofJ-f~rm

In reasonable medical probability, the above itemized breaches in the

standard of care resulted in Ms. Rodriguez's continued long term use of

dabigatran etexllate (PRADAXA). Therefore it is clear that the long term

use of dabigatran etexllate (PRADAXA) as dispensed by Walgreens, Sara

Elizabeth McGuire (pharmacist), and pharmacist with initials MDD caused

Ms. Rodriguez's acute kidney injury, anemia, and gastrointestinal bleeding

(which have lead to her long term clinical demise and medical injuries).

I reserve the right to amend this report should further discovery be made

available.

Sincerel • .'/1

d;£~'~·

/f;1 C

7(Y

Dr.~tefffey Chad'Hardy, Pharm.D., M.S.

APPENDIX 3

CURRICULUM VITAE

Prepared 01/01114

Name: Jeffrey Alan BreaU, M.D., Ph. D.

Address: Krannert Institute of Cardiology

Indiana University School of Medicine

1800 North Capitol Avenue, Room E-490

Indianapolis, IN 46202

Phone: Home: (317) 496-8680 e-mail: jbreall@iu.edu

Work: (317) 962-0561 FAX: (317) 962-0566

Date of Birth: May28,1956

Place of Birth: San Francisco, California

Citizenship: United States

Education:

1978 B.A. in Physiology, University of California,

Berkeley, CA

1983 Ph.D. in Physiology, University of California,

San Francisco, CA

1987 M.D., Albert Einstein College of Medicine,

Bronx, NY

Postdoctoral Training Internship and Residencies:

1987-1988 Intern in Medicine, Beth Israel Hospital,

Boston, MA

1988-1989 Junior Assistant Resident, Internal Medicine,

Beth Israel Hospital, Boston, MA

1989-1990 Senior Assistant Resident, Internal Medicine,

Beth Israel Hospital, Boston, MA

1990-1993 Research and Clinical Fellow in Cardiology,

Harvard Medical School and

Beth Israel Hospital Boston, MA

Research Fellowships:

1978-1979 Regent's Fellow in Physiology, University ofCaIifornia,

San Francisco

1984 Research Fellow, Coronary Research Laboratory,

Albert Einstein College of Medicine

1990, 1992 Cardiovascular Research Training Grant,

Harvard Medical School and Beth Israel Hospital

EXHIBIT

j B

Jeffrey Alan Breall (2)

Licensure and Certification:

1989-1994 Massachusetts License for Medicine and Surgery #7133 (inactive)

1990-2000 Diplomate-American Board of Internal Medicine #133098

1993-2001 D. C. License for Medicine and Surgery #20206 (inactive)

1993-2003 Diplomate-American Board of Internal Medicine,

2012-2022 Subspecialty in Cardiovascular Diseases #133098

1999-2009 Diplomate-American Board of Internal Medicine,

2013-2023 Subspecialty in Interventional Cardiology #133098

2000- Indiana License for Medicine and Surgery #01052687 A

Academic Appointments:

July 1987-June 1992 Clinical Fellow in Medicine, Harvard Medical School,

Boston, MA

July] 992-June 1993 Instructor in Medicine, Harvard Medical School,

Boston; MA

July 1993-June 1998 Assistant Professor of Medicine (Cardiology)

Georgetown University, Washington, D.C.

July 1998-June 2000 Associate Professor of Medicine (Cardiology)

Georgetown University, Washington, D.C.

July 2000- Present Professor of Clinical Medicine (Cardiology)

Indiana University School of Medicine, Indianapolis, IN

Hospital/Clinical Appointments:

July1989-June 1990 Physician of the Day, Boston Veterans

Administration Hospital, Boston, MA

JuJy1989-June 1993 Medical Officer of the Day, Brockton Veterans

Administration Hospital, Brockton, MA

July1990-June 1993 Urgent Care Physician, Peabody Medical Associates,

Peabody,MA

July1990-June 1993 Urgent Care Physician, Walk-In Center,

Beth Israel Hospital, Boston, MA

July 1990-June 1993 Clinical Fellow, Cardiovascular Division,

Beth Israel Hospital, Boston, MA

July 1992-June 1993 Attending Physician, Emergency Room,

Beth Israel Hospital, Boston, MA

July 1993-June 2000 Attending Cardiologist and Associate Director,

Cardiac Catheterization Laboratory

Georgetown University Medical Center, Washington, D.C.

July I 994-June 2000 Attending Physician (WOC), Cardiology Section

Washington Veterans Administration Hospital

Jeffrey Alan Breall (3)

Hospital/Clinical Appointments (continued):

July2000- Present Attending Cardiologist, Cardiac Catheterization Laboratories and

Interventional Cardiology, Indiana University

July 2000-Present Attending Cardiologist, Methodist, University, West and North

Hospitals (Indiana University Health), Indiana University

July 2000-Present Attending Cardiologist, Wishard Memorial Hospital

Indiana University, IUPUI

July 2000-Present Attending Cardiologist, Richard 1. Roudebush V. A. Hospital

Indiana University, IUPUI

July 2000-2012 Director, Cardiac Catheterization Laboratories and Interventional

Cardiology, Indiana University

2012- Present Chief Information Technology and Safety Officer,

Cardiovascular Service Line, Indiana University Health

Awards and Honors:

1978 Baccalaureate with Honors, University of California,

Berkeley, CA

1979-1980 Teaching Assistantship, University of California,

San Francisco, CA

1982-1983 Patent Fund Recipient, University of California

San Francisco, CA

1987 Alpha Omega Alpha - Albert Einstein College of Medicine

1996 Excellence in Teaching Award, Cardiology

Georgetown University Medical Center

1997 Outstanding VisitlExcellence in Teaching Award

Georgetown University Medical Center, Dept of Medicine

2000 Lawrence A. Kyle Award for Excellence in House Staff Education

Georgetown University Medical Center, Department of Medicine

2000 Sol Katz Society Award for Consistent Teaching Excellence

Georgetown University Medical Center, Department of Medicine

2009-2010 Outstanding Teacher Award

Indiana University School of Medicine Junior Medical Students

2010-2011 Department of Medicine Teaching Award

Indiana University School of Medicine

Invited Lectures:

1984 Perinatal Research Conference Lecturer,

The New York Hospital-Cornell Medical Center

1992 Emergency Medicine Lecturer,

Beth Israel Hospital, Boston, MA

Jeffrey Alan Breall (4)

Inv:ited Lectures (continued):

1993 Cardiovascular Grand Rounds

LAC + USC Medical Center, Los Angeles, CA

1993,1995 Department of Surgery Grand Rounds

Georgetown University Medical Center

1994-1998 Current Trends in Cardiology

Sacred Heart Medical Center, Cumberland, MD

1995 Department of Medicine Grand Rounds

Georgetown University Medical Center

1995 Rockingham Memorial Hospital Continuing Medical Education

Rockingham Memorial Hospital, Harrisonburg, VA

1996 NYLCare/Georgetown University Physician Update

Cardiology in General Medicine, Rockville, MD

1996-1999 American College of Physicians Internal Medicine Board Review

Georgetown University Medical Center

1996 Multi Disciplinary Grand Rounds

Georgetown University Medical Center

1996 Health Care Finance Administration/Peer Review Organization

Forum on Quality Improvement Interventions, Boston, MA

1996 Third Annual Mid-Atlantic Conference for Cardiovascular

Fellows, Georgetown University Medical Center

1996 MAMSIJGeorgetown University

Chest Pain Update, Bethesda, MD

1996 Vencor Hospital-Cardiology Update

When to use Primary Angioplasty, Alexandria, VA

1997 Acute Myocardial Tnfarction- The First 72 Hours

ACCess AMI Teleconference, American College of Cardiology

1997 Harvey-Hufnagel Symposium

Georgetown University Medical Center

1998 Cardiology for the General Practitioner

Georgetown University Medical Center

1998 Management of Non Q-Wave Myocardial Infarction

University of Maryland Medical Center

2000-2008 Cardiology Update for Primary Care Physicians

Krannert Institute of Cardiology, Indiana University

2001 Invited Debate: The Radial Approach to Coronary Intervention:

Not Routinely in the Patient's Best Interest

American College of Cardiology, Orlando, FL

Jeffrey Alan Breall (5)

Invited Lectures (continued):

2001 Acute Coronary Syndromes-the current era

Indiana University Internal Medicine Board Review

2001 Current Management of Acute Coronary Syndromes

Cardiac Surgery Grand Rounds, Indiana University

2002 Session Co-Chair: Optimal Stent Results

American College of Cardiology, Atlanta, GA

2002 Panelist: Atherectomy-When, Where, Why and How

American College of Cardiology, Atlanta, GA

2002 Session Co-Chair: Stent Selection

American College of Cardiology, Atlanta, GA

2002 Division of Cardiology Grand Rounds: Peripheral Vascular

Disease for the Cardiologist

Indiana University School of Medicine

2002 Department of Medicine Grand Rounds: Optimal Reperfusion

Therapy for Acute Myocardial Infarction

Indiana University School of Medicine

2002 Department of Medicine Grand Rounds: Management of Acute

Coronary Syndromes

Indiana University School of Medicine

2001- Department of Medicine Noon Lecture Series:

Treatment of Acute Myocardial Infarction

Indiana University School of Medicine

2003 Drug Coated Stents, Cardiovascular Nursing Update,

Clarian Health Partners

2004 Update in Thrombosis Symposium, Acute Coronary Syndromes

The CARE Group

2004 Division of Cardiology Grand Rounds: Treatment of Unstable

Angina

2004 Applications in Diagnostic Imaging,

American Roentgen Ray Society, Indianapolis/Chicago

Administrative Positions and Committees:

1978-1981 Committee on Human Research, University of California,

San Francisco, CA

1980-1983 Graduate Student's Council, University of California,

San Francisco, CA

1983-1987 Committee on Admissions, Albert Einstein College of Medicine,

Bronx,NY

1984-1986 Faculty-Student Senate, Albert Einstein College of Medicine

Jeffrey Alan Breall (6)

Administrative Positions and Committees (continued):

1993-2000 Associate Director, Cardiac Catheterization Laboratories and

Interventional Cardiology, Georgetown University Medical Center

1993-2000 Residency Selection Committee, Department of Medicine

Georgetown University Medical Center

1993-1997 Chair, Cardiopulmonary Resuscitation Committee

Georgetown University Medical Center

1994-1997 Animal Care and Use Committee

Georgetown University Medical Center

1994-1995 Research Planning and Operations Committee,

Dept of Medicine, Georgetown University Medical Center

1995-1996 Chair, PTCA Clinical Process Committee,

Georgetown University Medical Center

1995-2000 Cardiac Catheterization Credentials Committee,

Georgetown University Medical Center

1995 Chair, Chest Pain Clinical Process Committee,

Georgetown University Medical Center

1996,2002- Ad Hoc Reviewer; National Heart, Lung, and Blood Institute,

Clinical Trials Review Committee

1996-1997 Clinical Resource Steering Committee,

Georgetown University Medical Center

1996-1999 Quality hnprovement Committee, Department of Medicine

Georgetown University Medical Center

1996-1997 Quality bnprovement Council.

Georgetown University Medical Center

1997 Chair, Task Force on Graduate Training Opportunities,

Department of Medicine, Georgetown University Medical Center

1997 Co-Chair, Hospital Task Force on Case Management,

Georgetown University Medical Center

1997-2000 American Heart Association-

Committee on Cardiac Catheterization

1997-2000 University Faculty Senate-Georgetown University

1997 Clinical Service Standard Subcommittee

Georgetown University Medical Center

1998-2000 At-Large Member, Faculty Practice Group Board

Georgetown University Medical Center

1998-2000 Vice Chair. Pharmacy and Therapeutics Committee

Georgetown University Medical Center

1998-2000 Committee on Medical Education

Georgetown University Medical Center

2001- Peripheral Vascular Disease Committee

American College of Cardiology

Jeffrey Alan Breall (7)

Administrative Positions and Committees (continued):

2001-2008 Abstract Grader, Scientific Sessions, American Heart Association

2000- Director, Interventional Cardiology Section, Krannert Institute of

Cardiology, Indiana University

2000- Cardiology Fellowship Selection Committee, Krannert Institute of

Cardiology, Indiana University

2000- Director, Cardiac Catheterization Laboratories and

Interventional Cardiology, Methodist Hospital,

Indiana University Health

2001- Co-Chair, AMI Clinical Process Committee, Methodist Hospital,

Methodist Hospital, Indiana University Health

2002- Member, Cardiovascular Operations Committee,

Methodist Hospital, Indiana University Health

2002- Member, Cardiovascular Program Care Data Management

Committee, Methodist Hospital, Indiana University Health

2003- Member, Executive Committee, Krannert Institute of Cardiology,

Indiana University

2003- Member, Krannert Institute of Cardiology-Director-

Search Committee, Indiana University

2005- Member, Pharmacy and Therapeutics Committee, Methodist

Hospital, Indiana University Health

2006- Member, Levell Heart Attack Program Committee,

Methodist Hospital, Indiana University Health

2006- Chair, Cardiovascular PCI Process Committee,

Methodist Hospital, Indiana University Health

2009- Board of Directors, Indiana Chapter,

American College of Cardiology

SUMMARY OF CLINICAL ACTNITIES

During the past twelve years I have continued teaching medicine. 1 at1end2 weeks per year on

the general cardiology service at Indiana University Health Methodist Hospital. During this time

the team admits 40 new patients for initial evaluation. The team consists of a second or third

year medical resident, two first year medical resident and frequently a third and fourth year

medical student. The team may include pharmacy students, pharmacy residents, nursing

students, physician assistants and nurse practitioners. In addition, I perform diagnostic and

therapeutic cardiac catheterization procedures three days per week at the Indiana University

Health Methodist Hospital and the Richard L. Roudebush Veterans Administration Medical

Center. I specialize in teaching and performing high-risk percutaneous coronary interventions.

Teaching Assignments:

Jeffrey Alan Breall (8)

Ambulatory (Outpatient) Cardiology Elective:

Serving as a preceptor for house-staff and junior medical students in outpatient cardiology

clinic (four hour/week, Direct contact- cardiology system, history taking, bedside

examination, and management plan formulation). 1993-present

The time spent in teaching medical students, residents and fellows on the cardiology service is a

highlight of my academic year. I have spent years developing an approach to teaching that

involves teaching the process of developing clinical judgment, disease pathogenesis, physical

examination skills and presentation skills. The experience of teaching the eager students and

residents continues to excite me as I remember my own experience on the medical service at the

Bronx Municipal Hospital as a student. I continue to teach medical students, interns and

residents, and fellows on the cardiology service at Indiana University Health Methodist Hospital

and the Richard L. Roudebush Veterans Administration Medical Center-all under the auspices

of Indiana University.

Weekly Conferences:

Interventional Cardiology Conference (Every Tuesday),

One hour conference dedicated to clinical case presentation, and year-long didactic

lecture series devoted to invasive and interventional cardiology fellows.

Clinical Decision Making Conference (Every Friday)

One hour conference dedicated to clinical decision making and cardiac catheterization.

Conference attended by cardiology fellows, medicine house-staff and medical students on

cardiology rotation.

Monthly Conference:

Co-chair: Morbidity and Mortality Conference

One hour conference dedicated to morbidity and mortality in cardiac catheterization

laboratories including didactic presentations.

Hands-on-training and supervision for general cardiology fellows during cardiac catheterization

rotation. Teaching basic principles of radiation safety, X-ray imaging, and all diagnostic aspects

of cardiac catheterizations (3 days/week)

Hands-an-training and supervision for interventional cardiology fellows during their one-year

interventional cardiology fellowship. Teaching principles and practice of interventional

cardiology procedures including balloon angioplasty, stent, atherectomy and valvuloplasty

procedures. Advanced invasive diagnostic procedures such as intravascular ultrasonography

(NUS), intracoronary physiologic lesion assessment (Doppler and pressure wire) (4 days/week)

JefIrey Alan Breall (9)

Administrative Assignments:

Assist with advancing appropriate use criteria and quality indicators for cardiology across

all ru Health facilities

Assist with procurement and standardization of all interventional cardiology equipment

across all ill Health facilities

Assist with procurement and standardization of a cardiovascular picture and archiving

system across all ill Health facilities

SUMMARY OF ADMINISTRATIVE ACTIVITIES

I have continued the work that I began nearly 20 years agcr-building a superb clinical program,

For the past twelve years this was as director of the interventional cardiology program at Indiana

University Health. As such Ihelped develop protocols for best outcomes, helped establish the

use of new procedures and devices for percutaneous intervention, and administered over a busy,

high quality laboratory. Ihave now directed my efforts more recently on device standardization

and price reduction across the Indiana University Health System. I am also serving as the clinical

liaison as we implement a state-wide cardiovascular picture and report archiving system. Iam

also the clinical liaison for regulatory compliance for the cardiovascular service line, making

recommendations about rules and regulations with respect to appropriate usc, documentation and

privacy.

Multi-center Clinical Investigations:

1991 Co- investigator, Zatebradine trial for chronic stable angina

1992 Co-investigator, Thrombolysis in Myocardial Ischemia Study

(TIMI 3), Beth Israel Hospital

1992 Associate-Director, Core Angiographic Laboratory,

Thrombolysis in Myocardial Infarction Study (TIMI 4),

Beth Israel Hospital

1992 Co-investigator, Thrombolysis in Myocardial Ischemia

Study (TIMI 7), Beth Israel Hospital

1993 Co-Principal Investigator, Biobehavioral Triggers of

Myocardial Ischemia Study (TOMIS),

Georgetown University Medical Center

1993 Co-Principal Investigator, Coronary Regression with Estrogen

in Women, Study (CREW), Georgetown University

1994 Co-investigator, Balloon versus Optimal AtherectomyTrial

(BOAT), Georgetown University Medical Center

1994 Co-investigator, Thrombolysis and Thrombin Inhibition and

Acute Myocardial Infarction Study (TIMI 9),

Georgetown University Medical Center

Jeffrey Alan Breall (10)

Multi-center Clinical Investigations (continued):

1995 Co-investigator, Randomized Efficacy Study of Tiro fiban

(MK-383) for Outcomes and Restenosis (RESTORE)

Georgetown University Medical Center

1995 Co-investigator, Randomized trial of aspirin versus aspirin plus

heparin, versus aspirin plus hirudin in patients with acute

myocardial infarctions not receiving thrombolytic therapy

(ASIS-I), Georgetown University Medical Center

1995 Co-investigator, Stent Anti-thrombosis Regimen Study (STARS)

Georgetown University Medical Center

1996 Co-investigator, Myocardial Infarction with Novastan and t-PA

(MINT) Trial, Georgetown University Medical Center

1996 Co-investigator, ACS Multi-Link Stent Clinical Equivalencein

De Novo Lesions Trial (ASCENT),

Georgetown University Medical Center

1996 Co-investigator, Carotid Stent Supported Angioplasty (CSSA)

Georgetown University Medical Center

1996 Co-investigator, Reduced Anticoagulation after Vein Graft

Stenting Pilot Study (RA YES Pilot),

Georgetown University Medical Center

1997 Co-investigator, Palmaz-Schatz Crown Balloon Expandable

Stent with Power Grip Study,

Georgetown University Medical Center

1997 Co-investigator, Medinol Nirvana Balloon Expandable Stent

Georgetown University Medical Center

1997 Principal Investigator, EXCITE Trial (Evaluation of oral

Xemilofiban in Controlling Thrombotic Events in patients

undergoing coronary angioplasty or stent placement)

1997 Co-investigator, Bard EXTRA Trial (Evaluation of the XT

stent for Restenosis in native Arteries)

1998 Clinical Events Committee

Biocompatibles div Ysio Stent Randomized Control Trial

1999 SCIMED SYMBIOT Covered Stent Feasibility Study

Clinical Events Committee

1999 Co-investigator, Prevention of Rest enos is with Tranilast

and Its Outcomes (PRESTO)

Georgetown University Medical Center

1999 Principal Investigator, Norvasc for Regression of Minimal

to Moderate Atherosclerotic Lesions by Intravascular Sonographic

Evaluation (NORMALISE)

Georgetown University Medical Center

2000 Embol-X Aortic Cannula Feasibility Study

Clinical Events Committee

Jeffrey Alan Breall (11)

Multi-center Clinical Investigations (continued):

200 1 Principal Investigator, Phannakokinetic Study of Enoxaparin in

Patients Undergoing Percutaneous Coronary Intervention (PEPCI)

Indiana University Medical Center

2000 Principal Investigator, Coronary Revascularization.Utilizing

INTEGRJLIN and Single-bolus Enoxaparin (The Cruise Study)

Indiana University Medical Center

2001 Principal Investigator, Sound Wave Inhibition of'Neointimal

Growth (The Swing Study) Indiana University Medical Center

2001 Principal Investigator, Sonotherapy Prevention of Late Arterial

In-Stent Hyperplasia (The SPLASH Study) Indiana University

Medical Center

2001 Co-Investigator, Evaluation of the RX ACHIEVE Drug Coated

Coronary Stent System in the Treatment of Patients with De Novo

Coronary artery Lesions (DELIVER Clinical Trial)

Indiana University

2002 Study Assessing Goals in the Elderly (SAGE) Trial

Chairman, Cardiovascular Events Adjudication Committee

2002 Co-investigator, A Prospective Randomized Trial Evaluating the

Symbiot ill Covered Stent System in Saphenous Vein Grafts

(SYMBIOT III) Indiana University

2003 Principal Investigator, Investigator, Protection During Saphenous

Vein Graft Intervention to Prevent Distal Embolization (PRIDE

Study), Indiana University

2002 Principal Investigator, Spinal Cord Stimu1ation for the Treatment

of Refractory Angina, Indiana University

2002 Principal Investigator, ACT Guided Coronary Interventions

Registry using Dalteparin (ACT - 1), Indiana University

2003 Steering Committee, ACT Guided Coronary Interventions Registry

using Dalteparin (ACT -1), Indiana University

2004 Co-investigator, Proximal Protection during Coronary Intervention

using the Proxis Embolic Protection System: A Randomized

Multicenter Clinical Trial

2003 Principal Investigator, A Multicenter, Randomized, Double Blind

Controlled Study to Evaluate the Efficacy and Safety of AdSFGF-4

in Patients with Stable Angina (AGb""NT-3),Indiana University

2003 Principal Investigator, e-Cypher Registry, Indiana University

2004 Principal Investigator, The Assessment of the Medtronic AVB

Interceptor Saphenous Vein Graft Filter System (AMEthyst),

Indiana University

2005 Principal Investigator, Safety and Efficacy of Enoxaparin in PCI

patients, an international randomized Evaluation (STEEPLE),

Indiana University

Jeffrey Alan Breall (J 2)

Multi-center Clinical Investigations (continued):

2004 Principal Investigator, A randomized comparison of Angiomax

versus Lovenox in patients undergoing early invasive management

for acute coronary syndromes without ST -segment elevation (The

ACUITY Trial), Indiana University

2004 Principal Investigator, (ARRIVE 2), Multi-Center Safety

Surveillance Program, Taxus Express Drug Eluting Stent Platform,

Indiana University

2005 Principal Investigator, A comparison ofCS-747 and clopidogrel in

acute coronary syndrome subjects who are to undergo percutaneous

coronary intervention (TIMI-38), Indiana University

2005 Co-investigator, Multicenter trial of the Orqis Medical CRS for the

Enhanced Treatment of CHF Unresponsive to Medical Therapy

(MOMENTUM), Indiana University

2005 Principal Investigator, FREEDOM TRIAL: Future

Revascularization Evaluation in Patients with Diabetes Mellitus:

Optimal Management of Multi vessel disease, Indiana University

2006 Principal Investigator, ENDEAVOR IV Trial: A Randomized

Controlled Trial of the Medtronic Endeavor Drug (ABT -578)

Eluting Coronary Stent System versus the Taxus Paclitaxel-Eluting

Coronary Stent System in De novo Native Coronary Artery

Lesions, Indiana University

2006 Co-investigator, VA Coronary Artery Revascularization in

Diabetes Study-VA CARDS, Roudebush VA Medical Center

2006 Principal Investigator, ZoMaxx II Trial: A Randomized Controlled

Trial of the ZoMaxx Drug Eluting Coronary Stent System versus

the Taxus Express Paclitaxel-Eluting Stent System in do novo

Coronary Artery Lesions

2007 Principal Investigator, PERSEUS Trial: A Randomized Controlled

Trial of the Taxus Element Drug Eluting Coronary Stent System

versus the Taxus Liberte' Paclitaxel-Eluting Stent System in do

novo Coronary Artery Lesions

2008 Abbott Vascular SPIRIT SV and SPIRIT PRIME DES trials

Chairman, Data and Safety Monitoring Committee

2009 Principal Investigator, PLATINUM Trial: A Randomized

Controlled Trial of the Promus Element Drug Eluting Coronary

Stent System versus the Promus Everolimus-Eluting Stent System

in do novo Coronary Artery Lesions

2013 Chairman, Safety Oversight Committee: ABSORB Japan: A

Clinical Evaluation of AVJ-301 Comparing with Metallic Drug-

eluting Stent in the Treatment of Subjects with Ischemic Heart

Disease in Japan

Jeffrey Alan Breall (13)

Organizations and Societies:

1983 American Medical Association

1984 New York Academy of Sciences

1989-1993 Massachusetts Medical Society

1994- Fellow, American Heart Association,

Council on Clinical Cardiology

1994-1996 Affiliate, Society for Cardiac Angiography and Interventions

1994- Abraham M. Rudolph Developmental Cardiology Society

1995- Fellow, American College of Cardiology

1995- Fellow, American College of Chest Physicians

1995- Fellow, American College of Physicians

Manuscript Review:

1. Cardiovascular Drugs and Therapy

2. Catheterization and Cardiovascular Intervention

3. Journal of the American College of Cardiology

4. Journal of the American Medical Association

5. American Journal of Cardiology

6. Coronary Artery Disease

7. Journal of the American Society of Echocardiography

Editorial Boards:

1. Diagnostic and Invasive Cardiology

2. Cardiology Case Reports

3. World Journal of Clinical Case Conference

Research Interests:

1. New devices for coronary interventionlhigh risk angioplasty

2. Quality Assurance in the Cardiac Catheterization Laboratory

3. Cost-effectiveness of coronary interventions

4. Primary angioplasty in acute myocardia] infarction

5. Peripheral Vascular Disease

Jeffrey Alan Breall (I4)

Publications

Articles:

1. BreaU JA, Rudolph AM, Heymann MA: Role of thyroid hormone in postnatal circulatory

and metabolic adjustments. J Clin Invest 1984; 73:1418-1424.

2. Khayyal MA, Eng C, Franzen D, Brean JA, Kirk ES: The effects of vasopressin

on the coronary circulation: reserve and regulation during ischemia. Am J Physiol1985;

248 :H516- H522.

3. Levine MJ, Harada K, Meuse Al, Watanabe J, BrealJ l. Carrozza JP, Bentivegna L,

Franklin A, Johnson RG, Grossman W, & Morgan JP: Excitation -contraction uncoupling

during ischemia in the blood perfused dog heart. Biochem Biophys Res Commun 1991;

179:502-6.

4. Breall JA, Kim 0, Bairn DS, Skillman JJ, Grossman W: Coronary-subclavian steal; an

unusual cause of angina pectoris after successful internal mammary coronary artery

bypass grafting. Cathet Cardiovasc Diagn 1991; 24:274-276.

5. BreaU JA, Goldberger AL, Warren SE, Diver OJ, Sellke FW: Posterior mediastinal

masses: rare causes of cardiac compression. Am Heart J 1992; 124:523-526.

6. Breall lA, Watanabe J, & Grossman W: The effect ofzatebradine on contractility,

relaxation and coronary blood flow. JAm Coli Cardiol1993; 21:471-477.

7. BreaU JA, Grossman W, Stil1man IE, Gianturco LE, Kim D: Atherectomy of the

subclavian artery for patients with symptomatic coronary-subclavian steal syndrome. J

Am Coil Cardiol1993; 21: 1564-1567.

8. Cohen OJ, BreaU JA, Ho KKL, Weintraub RM, Kuntz RE, Weinstein MC, Baim DS: The

economics of coronary revascularization: comparison of costs and charges for

conventional angioplasty, directional atherectomy, stenting and bypass surgery. JAm

Coli Cardiol1993; 22: 1052-1059.

9. Gordon PC, Kugelmass AD, Cohen DJ, BreaU JA, Friedrich SP, Carrozza JP Jr, Diver

DJ, Kuntz RE, Bairn DS: Use of balloon post-dilation to safely improve the results of

successful (but SUb-optimal) directional coronary atherectomy. Am J Cardiol 1993;

72:71E-79E.

10. The TIMI IIIB Investigators: Effects of tissue plasminogen activator and a comparison of

early invasive and conservative strategies in unstable angina and non-Q-wave myocardial

infarction: Results of the TIM! IDB Trial. Ore 1994; 89; 1545-1556.

11. Cohen DJ, BreaU JA, Ho KKL, Kuntz RE, Goldman L, Bairn DS, Weinstein MC:

Evaluating the potential cost-effectiveness of stenting as a treatment for symptomatic

single-vessel coronary artery disease: use of a decision-analytic model. eire 1994;

89: 1959-] 874.

12. Gibson eM, Cannon CP, Piana RN, BreaU JA, Sharaf B, Flatley M, Davis V, Diver DJ,

McCabe CR, Flaker Ge, Bairn DS, Braunwald E, for the TIMI 4 Study Group:

Angiographic predictors of'reocclusion following thrombolysis: results from the TIMI 4

study. JAm Col! Cardiol1995; 25:582-589.

Jeffrey Alan Breall (IS)

Articles (continued):

13. Colleran JA, Burke AB, Moseley AL, Green SE, BreaU JA, Vinnani R: Subvalvular left

ven1ricular outflow tract obstruction caused by "rhino-nodular" calcification. Cardiovasc

Patlzo11995; 4:123-126.

14. BreaU JA., Gersh BJ: Common manifestations of valvular heart disease in the elderly.

Cardiology in Review 1995; 3:150-157.

15. Colleran JA, Tierney JP, Prokopchak R, Diver DJ, BreaU JA: Angiographic presence of a

myocardial bridge after successful percutaneous transluminal coronary angioplasty. Am

Heart J 1996; 131: 196-198.

16. Bui MN, Sack MN, Moutsatsos G, Lu DY, Katz P, McCown R, Breall JA, Rackley CE:

Autoantibodies titers to oxidized low-density lipoprotien in patients with coronary

atherosclerosis. Am Heart J 1996; 131:663-667.

17. Schultz SC, BreaU J, Hannan R: Acute cardiac tamponade secondary to congenital factor

V deficiency. Cardiology 1997; 88:48-9.

18. Berger AK, Breall JA, Gersh BJ: When is PTCA the treatment of choice for acute MI?

Contemporary lntrnal Medicine 1997; 9:45-55.

19. Tavel ME, Brean JA, Gersh BJ: Ischemic heart disease with congestive heart failure. In:

Tavel M ed. Clinical Problems in Cardiopulmonary Disease Chest 1998; 113:1119-1122.

20. Berger AK, Edris DW, Breall.TA, Oetgen WJ, Marciniak TA, Molinari GF: Resource

utilization and quality of care for Medicare patients with acute myocardial infarction in

Maryland and the District of Columbia; Analysis of data from the Cooperative

Cardiovascular Project. Am Heart J 1998; 135:349-356.

21. Breall JA, Solomon AJ, Gersh BJ: Non-Q wave myocardial infarction: You cannot

judge a book by its cover. ACC Current Journal Review May/June 1998: 15-18.

22. Solomon AJ, BreaU JA, Gersh BJ: Unstable angina: Current recommendations and new

directions. ACC Current Journal Review May/June 1998: 18-23.

23. Weissman NJ, Sheris SJ, Chari R, Mendelsohn FO, Anderson WD, BreaU JA, Tanguay J-

F, Diver DJ:Intravascuiar Ultrasonic analysis of plaque characteristics associated with

coronary artery remodeling. Am J Cardiol1999; 84:37-40.

24. Berger AK, Schulman KA, Gersh BJ, Pirzada S, BreaU JA, Johnson AB, Every NR:

Primary coronary angioplasty vs thrombolysis for the management of acute myocardial

infarction in elderly patients. JAMA 1999; 282:341-348.

25. Rashid H, Marshall R.T, Diver DI, Breall JA: Spontaneous and diffuse coronary ru1ery

spasm unresponsive to conventional intracoronary pharmacologic therapy. A case report.

Cathet CardiovascInterv 2000; 49:188-191.

26. Rashid H, Marshall RJ, Diver DJ, Breall JA: Use of atropine in the treatment of

spontaneous coronary artery. Cathet Cardiovasc Interv. 2000; 50:375B-376.

27. Patel SR, Breall JA, Diver DJ, Gersh BJ, Levy AP: Does bradycardia promote coronary

collateral growth in humans? Coronary Artery Disease. 2000; 11:467-472.

28. Sheifer SE, Rathore SS, Gersh BJ, Weinfurt KP, Oetgen WJ, Breall JA, Schulman KA:

Time to presentation with acute myocardial infarction in the elderly. Association with

race, gender, and socioeconomic status. Circ 2000; 102: 1651-6.

Jeffrey Alan Breall (16)

Articles (continued):

29. Berger AK, BreaU JA, Gersh BJ, Johnson AE, Oetgen WJ, Marciniak TA, Schulman KA

Effect of diabetes mellitus and insulin use on survival after acute myocardial infarction in

the elderly (The Cooperative Cardiovascular Project). Am J Cardiol2001; 87:272-277.

30. Kalaria VO, Rouch C, Bourdillon PD, BreaU JA: Distal emboli protection in patients

undergoing percutaneous coronary intervention after a recent myocardial infarction.

Cathet Cardiovasc Interv. 2002; 57:54-60.

31. Panchal VR, Kalaria V, Breall JA, March KL: Catheter-based gene therapy for

angiogenesis. Applications in Imaging Cardiac Interventions: Oct 2002

32. Kalaria VG, Koradia N, Breall JA: Myocardial bridge: A clinical review. Cathet

Cardiovasc Interv 2002; 57:552-556.

33. Bhatt DL, Lee BI, Castrella PJ, Pulsipher M, Rogers M, Cohen M, Corrigan VE, Ryan

TJ Jr, BreaU JA, Moses JW, Eaton OM, Sklar MA, Lincoff AM: Safety of concomitant

therapy with eptifibatide and enoxaparin in patients undergoing percutaneous coronary

intervention-results of the CRUISE study. J Am Coli Cardiol 2003; 41 :20-25.

34. Bhakta D, Breall JA, Kalaria VO: Complete sinus inversus and bicuspid aortic valve

stenosis. J Invas Cardiol 2003; 15:213-215.

35. Cline SL, Kalaria VO, von der Lohe E, Breall JA: Cerebrovascular complications of

Cardiac Catheterization. In: Biller and O'Donnell, eds, Seminars in Cerebrovascular

Disease and Stroke, New York, NY Elsevier, 2003, 3: 194-199.

36. Ramanuja S, BreaU JA, Kalaria VO: The approach to "aspirin allergy" in cardiovascular

patients. Cire. 2004; 11 0: el-e4.

37. Carrozza JP Jr, Caussin C, Braden G, Braun P, Hansell F, Fatzinger R, Walters G,

Kussmaul W, BreaU J; TriActiv Pilot Study Investigators. Embolic protection during

saphenous vein graft intervention using a second-generation balloon protection device:

results from the combined US and European pilot study of the TriActiv Balloon Protected

Flush Extraction System. Am Heart J. 2005,149:1136.

38. Coram R, Oeorge Z, Breall JA: Percutaneous intervention through a Cabrol composite

graft. Cathet Cardiovasc Interv. 2005 66:356.

39. Carrozza JP Jr, Mumma M, BreaU JA, Fernandez A, Heyman E, Metzger C and for the

PRIDE Study Investigators; Randomized Evaluation of the TriActiv Balloon-Protection

Flush and Extraction System for the Treatment of Saphenous Vein Graft Disease

J Am Call Cardiol. JAm Coli Cardiol2005 46: 1677.

40. Karlsson G, Rehman J, Meltser HM, Kalaria VO, BreaU JA: Increased Incidence of Stent

Thrombosis in Patients with Cocaine Use. Cathet Cardiovasc Interv. 2007 69:955.

41. Kirtane AJ, Heyman ER, Metzger C, BreaU JA, Carrozza JP Jr: Correlates of adverse

events during saphenous vein graft intervention with distal embolic protection: A PRIDE

Sub Study. JAm Coil CardiolIntv 2008 1: 186

42. Kereiakes DJ, Turco MA, Breall J Farhat NZ, Feldman RL, McLaurin B, Popma JJ,

Mauri L, Zirnetbaum P, Massaro J, Cutlip DE, on behalf of the AMEthyst Study

Investigators. A novel filter-based Embolic protection device for percutaneous

intervention of saphenous vein graft lesions: Results of the AMEthyst randomized

controlled trial. JAm Coil Cardiol In tv 2008. 1: 248

Jeffrey Alan BreaU (17)

Articles (continued):

43. El Masry H, BreaU JA: Alcohol septal ablation tor hypertrophic obstructive

cardiomyopathy: A review. Curr Cardiol Rev 2008, Volume 04, No. 03.

44. Antoun P, EI Masry H, Breall JA: Sudden cardiac death complicating alcohol septal

ablation: a case report and review of literature. Cathet Cardiovasc Interv. 73: 9562009.

45. Benson MD, BreaU J, Cummings OW, Liepnieks JJ: Biochemical characterization of

amyloid by endomyocardial biosy. Amyloid. 2009. 16:9.

46. Lasala JM, Cox DA. Morris L, BreaU JA, MahoneyPD, Horwitz PA, Shaw D, Hood KL,

Mandinov L, Dawkins KD: Two-year results of paclitaxel-eluting stents in patients with

medically treated diabetes mellitus from the TAXUS ARRIVE program. Am J Cardiol

2009, 103:1663.

47, Lasala JM, Cox DA, Dobies D, Baran K, Bachinsky WB, Rogers E, BreallJA, Lewis

DH, Song A, Starzyk RM, Mascioli SR, Dawkins KD, Baim OS: Drug-eluting stent

thrombosis in routine clinical practice: 2 year outcomes and predictors from the TAXUS

ARRNE Registries. Circ Cardiovascular Interventions. 2009,2:285.

48. Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS,

Goodman SG, White HD, MahafIey KW, Pollack CV Jr, Manoukian SV, Widimsky P,

Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington

RA; CHAMPION PLATFORM Investigators. Intravenous platelet blockade with

cangrelor during PCI. N Engl J Med. 2009 361(24):2330

49. Kreutz RP, Stanek EJ, Aubert R, Yao J, BreaU IA, Desta Z, Skaar TC, Teagarden JR,

Frueh FW, Epstein RS, Flockhart DA: Impact of proton pump inhibitors on the

effectiveness of clopidogrel after stent placement: The Clopidogrel MEDeO Outcomes

Study. Pharmacotherapy. 2010 30 (8): 787.

50. Jaradat ZA, Sayfo SM, BreaU JA: Percutaneous alcohol septal ablation following

surgical myectomy. J Invasive Cardiol. 201022 (8): 207.

51. Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL Dens J,

Hagiwara N, Allocco OJ, Dawkins KD; PLATINUM Trial Investigators: A prospective,

randomized evaluation of a novel everolimus-eluting coronary stent: the PLAT~'UM (a

Prospective, Randomized Multicenter Trial to Assess an Everolimus-Eluting Coronary

Stent System [pROMUS Element] for the Treatment of Up to Two de Novo Coronary

Artery Lesions) trial. JAm Coil Cardiol2011. 57: 1700

52. Bolad lA, Alqaqa'a A, Khan B, Srivastav SK, von der Lohe E, Sadanadan S, BreaU JA:

Cardiac events after non-cardiac surgery in patients with previous coronary intervention

in the drug-eluting stent era. J Invasive Cardiol. 2011; 23 (7): 283

53. Suradi H, BreaU JA: Successful use of the lmpella device in Giant Cell Myocarditis as a

bridge to permanent left ventricular mechanical support. Tex Heart Inst. 2011; 38(4): 437

54. Furlan AI, Reisman Massaro J, Mauri L, Adams H, Albers GW, Fe1berg R, Herrmann H,

Karr S, Landzberg M, Raizner A, Wechsler L. CLOSURE I Investigators: Closure or

medical therapy for cryptogenic stroke with patent foramen ovale. N Engl.T Med. 2012;

366 (11): 991

Jeffrey Alan Breall (18)

Articles (continued):

55. Kreutz RP, Nystrom P, Kreutz Y, Miao J, Destra Z, BreaU JA, Li L, Chiang CW, Kovacs

R, Flockhart DA, Jin Y: Influence of'paraoxonase-I Q192R and cytochrome P450 2C19

polymprphisms on clopidogrel response. Clin Pharm: Advances and Applications. 2012.

4: 13.

56. Kreutz RP, BreaU JA, Kreutz Y, Owens J, Lu D, Bolad I, von der Lohe E, Sinha A,

Flockhart DA: Protease receptor-I (PAR-I) mediated platelet aggregation is dependent on

clopidogrel response. Thromb Res. 2012. March 27.

57. Roe MT, Armstrong PW, Fox KA, White RD, Prabhakaran D, Goodman SG, Cornel JH,

Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA,

Ruzyllo W, Dalby AJ, McGuire OK, Leiva-Pons JL, Parkhomenko A, Gottlieb S,

Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B,

Gasparovic V, Corbalan R, Cinteza M, McLendon RC, Winters KJ, Brown EB,

Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS

Investigators: Prasugrel versus c1opidogrel for acute coronary syndromes without

revascularization. N Engl J Med. 2012.367:14.

58. Farkouh MS, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen

OJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau

R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava E, Buse J, Reub W,

Smith CR, Muratov V, Bansilal S, King S 3rd,Bertrand M, Fuster V; FREEDOM Trial

Investigators: Strategies for multivessel revascularization in patients with diabetes. N

Engl J Med. 2012. 367:2375.

59. Godley RW, Joshi K, BreaU JA: A comparison of hand injection versus automated

contrast injectors during cardiac catheterization . .J Invasive Cardiol. 2012. 24:628.

60. Kreutz RP, Owens J, Brean JA, Lu D, von der Lohe E, Bolad I, Sinha A, Flockhart DA.

C-reactive protein and fibrin clot strength measured by thromboelastography after

coronary stenting. Blood Coagu/ Fibrinolysis. 2013 3:321.

61. Kreutz RP, Owens J, Jin Y, Nystrom P, Desta Z, Kreutz Y, BreaU lA, Li L, Chiang C,

Kovacs RJ, Flockhart DA. Cytochrome P450 3A4*22, PPAR- c, and AR.'1\fT

polymorphisms and clopidogrel response. Clin Phannacol20135: 185.

Book Chapters:

1. BreaU JA, Gersh BJ. The Results of Transluminal Interventions in Coronary

Artery Disease. In: Bertrand M, Serruys P, Sigwart U, eds. Handbook of Car-

diovascular Interventions. London, UK: Churchill Livingstone, 1996,501-514.

2. BreaU JA, Rodak DJ: Intermediate Coronary Syndrome. In: Conti CR, ed.

Adult Clinical Cardiology Self Assessment Program (ACCSAP) on CD-ROM.

American College of Cardiology/American Heart Association, 1997; 2000.

3. Gersh BJ, BreaU JA, Diver D.T:The Ro]e of Primary Angioplasty in the

Management of Acute Myocardial Infarction. In: Opie LH and Yellon DM, ed.

Cardiology at the Limits.The Rustica Press, 1997,26-49.

Jeffrey Alan Breall (19)

Book Chapters: (continued):

4. Diver DJ, BreaU JA: Balloon valvuloplasty: aortic valve. In: Yusef S, Cairns JA,

Camm AJ, Fallen EL, Gersh BJ, ed. Evidence Based Cardiology. Tavistock

Square, London: BMJ Books, BMA House, 2nd ed. 2003, 782-795.

5. Meuth MJ, Green CE, BreaU JA: Interventional techniques for coronary artery

disease. In: Taveras JM & Ferrucci JT, eds. RADIOLOGY Diagnosis*Imaging*

Intervention. 2: 132. Philadelphia, PA: Lippincott Williams & Wilkins, 1999.

6. Meldrum DR, Raiesdana A, BTeal! lA, Brown JW: Heart Transplantation. In: Harken

AH & Moore EE, eds. Abernathy's Surgical Secrets, 91 :319. Philadelphia, PA: Hanley

& Belfus, 2004

7. Meldrum DR, RaiesdanaA, Breall JA, Brown JW: Heart Transplantation. In: Harken

AH & Moore EE, eds. Abernathy's Surgical Secrets, 91 :323. Philadelphia, PA: Hanley

& Belfus, 2004

8. Breall JA, Aroesty 1M, Simons M: Overview of the management of unstable angina

and acute non-ST elevation (non-Q wave) myocardial infarction. In: Rose BD, ed.

UpToDate™ in Cardiovascular Medicine, Waltham, MA, 2012

9. Brean JA, Simon M: Risk stratification after unstable angina or non-ST elevation

(non-Qvwave) myocardial infarction. In: Rose BD, ed. UpToDate™ in Cardiovascular

Medicine, Waltham, MA, 2012

10. BreaU JA, Simons M: Coronary arteriography and revascularization

following unstable angina or non ST-elevation (non-Q wave) acute myocardial

infarction. In: Rose BD, ed. UpToDate™ in Cardiovascular Medicine, Waltham, MA,

2012

11. Emery M, BreaU JA: Disparities in the delivery of cardiovascular care. In: Rose BD,

ed. UpToDate™ in Cardiovascular Medicine, Waltham, MA, 2012

Non-peer reviewed publications:

No-Reflew Phenomenon During PCI I Diagnostic and Invasive Cardiology July] 5, 2011

When to Consider Revascularization of Coronary Chronic Total Occlusion] Diagnostic

and Invasive Cardiology March 19, 2012

Understanding Contrast-Induced Nephropathy I Dr Cardiology May 15,2012

Justifying the Use of Vascular Closure Devices rDI Cardiology September 13,2013

Abstracts

1. Brean JA and Nicoll CS: Somatotrophic Effects of Prolactin in Neonatal Rats.

Western Regional Conference on Endocrinology. Santa Cruz, CA 1978.

2. Clyman RI, BreaU J, Maher P, Campbell D, Maury F: Thyroid Hormones and the

Ductus Arteriosus. The Society for Pediatric Research. Washington, D.C. 1985.

3. BreaU JA, Watanabe J, Grossman W: Comparative Effects ofULFS-49 and

Verapamil on Heart Rate and Contractility in Isolated Hearts. American College of

Cardiology. Atlanta, GA 1991.

Jeffrey Alan Breall (20)

Abstracts (continued):

4. Cohen DJ, BreaU JA, Ho KKL, Bairn DS: Comparative Costs of Two New

Technologies, Conventional Angioplasty, and Bypass Surgery for Elective Coronary

Revascularization. American Heart Association, New Orleans, LA 1992.

5. Cohen DJ, Kuntz R., Brean JA, Ho KKL., Goldman L, Weinstein MC, Baim DS: The

Incremental Cost-Effectiveness of Coronary Stenting versus Conventional

Angioplasty: A Decision-Analytic Model. American Reali Association, New

Orleans, LA 1992.

6. Gibson CM, Cannon CP, Piana RN, Maher KA, Davis SD, Brean JA, Davis V, Diver

DJ: Relationship of Coronary Flow to Myocardial Infarction Size: Two Simple

Methods to Sub-classify TIMI Flow Grades. American Heart Association, New

Orleans, LA 1992.

7. Gibson CM, Piana RN, Davis SF, Maher KA, BreaU JA, Davis V, Diver DJ, Bairn

DS: hnprovement in Minimum Lumen Diameter During First Day After

Thrombolysis. American Heart Association, New Orleans, LA 1992.

8. Gibson CM, Cannon CP, Piana RN, Breall JA, Davis SF, Maher KA, Flatley M,

Davis V, Diver DJ, Bairn DS for the TIMI 4 Study Group: Consequences ofTThtII

Grade 2 vs. 3 Flow at 90 Minutes Following TIrrombolysis. American College of

Cardiology, Anaheim, CA 1993.

9. Cohen DJ, Kuntz RE, Friedrich SP, Gordon PC, BreaU JA, Ho KK, Weinstein MC,

Bairn DS: Cost-Effectiveness of Directional Atherectomy, Stenting, and

Conventional Angioplasty in Single-Vessel Disease: A Decision-Analytic Model.

American College of Cardiology, Anaheim, CA, 1993.

10. Gordon P, Kugelmass AD, Breall JA, Friedrich SP, Cohen DJ, Diver DJ, Bairn DS:

Selective Use of Balloon Post-dilation Can Safely Improve the Results of Successful

(but Sub-optimal) Directional Coronary Atherectomy. American Heart Association,

Atlanta, GA 1993.

11. Cohen DJ, Gordon PC, Friedrich SP, Breall JA, Diver DJ, Weinstein MC, Bairn DS:

The Cost-Effectiveness of Selective Adjunctive Balloon Dilation after Successful (but

Sub-optimal) Directj.onal Coronary Atherectomy: A Decision-Analytic Model.

American Heart Association, Atlanta, GA 1993

12. Moscucci M, Kugelmass AD, Piana RN,Gordon PC,Wood M, Friedrich SP, Breall

JA, Kuntz RE: The Value of Using Simple Logistic Models of Target Site-Related

Clinical Events in the Evaluation of Vein Graft Restenosis. American Heart

Association, Atlanta, GA 1993.

13. Diver DJ, Brown BG, Breall JA, Berger C, Dunn S, ThompsonB, McCabe CH,

Braunwald E: Characterization of Patient Management and Outcomes in the TIMI-

IlIA Trial. American College of Cardiology. Atlanta, GA 1993.

14. Sack MN, Katz P, McCown R, BreaU JA, Rackley CE: An Enzyme Linked

Immunosorbent Assay of Autoantibodies to Oxidized Low-Density Lipoproein as a

Predictor of Coronary Artery Disease. American College of Cardiology. Atlanta, GA

1993.

Jeffrey Alan Breall (21)

Abstracts (continued):

15. Bui MN, Moutsatsos G, Sack MN, Lu D, BreaU lA, Katz P, Rackley CE:

Autoantibody Titers to Oxidized LDL in Patients with Coronary Artery Disease and

Stable and Unstable Angina. American Federation for Clinical Research. San Diego,

CA 1995.

16. Gannuscio JR, BreaU JA, Diver DJ, Lawrence W; PTCA Clinical Process Team

Decreases Hospital Costs and Length of Stay. Transcatheter Cardiovascular

Therapeutics. Washington, D.C. 1996.

17. Arora UK, Chari R, BreaU JA, Diver DJ, Weissman NJ: Does Coronary

Calcification Predict Atherosclerotic Placque Burden: A 3-Dimensional Intravascular

Ultrasound Analysis. American Heart Association, New Orleans, LA 1996.

18. Weissman NJ, Chari R, Mendelsohn FO, Foster GP, Anderson WD, BreaU JA,

Tanguay J, Diver DJ, Gersh BJ: Patient and Plaque Characteristics Associated with

Coronary Remodeling: An Intravascular Ultrasound Analysis. American College of

Cardiology, Anaheim, CA 1997.

19. Weissman NJ,Arora UK, BreaU JA Gannuscio JR, Diver DJ, Gersh BJ: In Vivo

Gender Differences in Coronary Artery Plaque Morphology Assessed by Intravascular

Ultrasound. American College of Cardiology, Anaheim, CA 1997.

20. Arora UK, Chari R, Mendelsohn FO, Foster GP, Breall JA, DiverDJ, WeissmanNJ:

Altered Plaque Distribution in Hypertensive Patients. American College of

Cardiology, Anaheim, CA 1997.

21. Arora UK, Chari R, BreaU JA, Diver OJ, Weissman NJ: Calcified Luminal Surface

Area: An Improved Method to Quantify Coronary Calcification Using 3D NUS

Analysis. American Society of Echo cardiography, Orlando, FL 1997.

22. Arora UK, Chari R, Mendelsohn FO, BreaU JA, Diver DJ, Weissman NJ: Increased

Coronary Atherosclerotic Plaque Burden and Calcification in Diabetic Patients by 3D

Intravascular Ultrasound Analysis. American Heart Association, Orlando, FL 1997.

23. Arora UK, Chari R, BreaU JA, Diver DJ, Weissman NJ: The Aging Atherosclerotic

Plaque: In Vivo Morphologic Analysis and Gender Differences using Intravascular

Ultrasound. American Heart Association, Orlando, FL 1997.

24. Arora UK, Chari R, Breall JA, Diver OJ, Weissman NJ: Adventitial Changes with

Atherosclerosis: In Vivo Observations and Implications for IVUS Assessment of

Plaque Morphology. American Heart Association, Orlando, FL 1997.

25. Arora UK, Little RW, Chari R, BreaU JA, Diver DJ, Weissman NJ: Are Plaques

Different in African Americans? A 3D Intravascular Ultrasound Study of Coronary

Plaque Morphology. American Heart Association, Orlando, FL 1997.

26. Berger AK, BreaU JA, Johnson AE, Schulman KA, Gersh BJ, Oetgen WJ, Pirzada

SR, Frederick PR, Every NR: Primary Angioplasty versus Thrombolytic Therapy in

the Elderly: The CCP Experience. American Heart Association, Orlando, FL 1997.

27. Berger AK, Johnson AE, Breall JA, Oetgen WJ, Marciniak TA, Gersh BJ, Schulman

KE: The Effect of Diabetes on Mortality in Medicare Beneficiaries with Acute

Myocardial Infarction? American Heart Association, Orlando, FL 1997.

Jeffrey Alan Breall (22)

Abstracts (continued):

28. Every NR, Pirzada SR, Frederick PD, Robinson MB, BreaU JA, Schulman KA:The

Association Between Procedure Volume and Mortality in Primary PTCA: The CCP

Experience. American Heart Association, Orlando, FL 1997.

29. Deutch E, Gordon PC, Diver DJ, Breall JA, fitzPatrick M, Senerchia C, Ho KKI:

Safety and Efficacy of Coronary Stenting after Recent Myocardial Infarction: Results

From the Stent Anticoagulation Regimen Study (STARS). American Heart

Association, Orlando, FL 1997.

30. Patel SR, BreaU JA, Gersh BJ, Levy: Does Bradycardia Promote Coronary Collateral

Growth in Humans? American College of Cardiology, Atlanta, GA 1998.

31. Berger AK, Johnson AE, BreaU JA, Schulman KA, Gersh B1: Does Diabetes Affect

the Clinical Presentation of Elderly Patients with Acute Myocardial Infarction?

American College of Cardiology, Atlanta, GA 1998.

32. Oetgen WJ, Berger AK, Edris DW, Lesher ML Jones J, Sdhuster M, Karge G, BreaU

lA, Fitzgerald M, Molinari GF: hnprovement in Treatment Quality Indicators For

Elderly Patients with Acute Myocardial Infarction: The Cooperative Cardiovascular

Project in Maryland and the District of Columbia. American College of Cardiology,

New Orleans, LA 1999.

33. Kalaria VG, Breall J, Class S, Sprague K, Bahro AG, Falcone W, Shoultz C,

Dorogy ME: The Safety & Economic Impact of Immediate Ambulation after

Diagnostic Catheterization Using a Suture Mediated Closure Device. Society of

Cardiac Angiography and Intervention. Boston, MA 2003.

34. Karlsson G, Rehman J, Meltser HM, Kalaria VG, BreaU JA: High Rate of Stent

Thrombosis in Cocaine Users Undergoing Coronary Stent Placement. American

College of Cardiology, New Orleans, LA 2004.

35. Rampurwala A, BreaU J, von der Lohe E: Trend Towards Reduced Vascular

Complications in Women Undergoing Diagnostic Heart Catheterization with 4 French

Versus 6 French Catheters. Society for Cardiac Angiography and Interventions,

Chicago, IL 2006.

36. Kerieiakes D, Turco M, McLaurin B, Feldman R, Farhat N, BreaU J, Foster M: The

AMEthyst Trial; A prospective randomized controlled study of the Medtronic

Interceptor PLUS Coronary Filter System for PCI of Degenerative SVG. TeT

Washington, DC 2007.

37. Lasala JM, Cox DA, Morris DL, Breall JA, Mahoney PD, Horwitz PA, Shaw D,

Mandinov L, Dawkins KD: TAXUS Mitigates the Effects of Diabetes on Restenosis

Independent of Patient Risk Profile: 2-Year Results of the TAXUS ARRIVE

Program. TCT. Washington, DC 2008.

38.singh IM, Antoun PS, Shoemaker TJ, Terry C, Kwo PY, Tector JA, Breall JA,

Sadanandan S: Cardiac Catheterization as a Strategy for Pre-Operative Risk

Stratification in Patients Undergoing Liver Transplantation. SCAl Washington DC

2008

Jeffrey Alan Breall (23)

Abstracts (continued):

39. Stanek EJ, Aubert RE, Flockhart DA, Kreutz RP, Yao J, BreaU JA, Desta Z, Sklaar T,

Freuh FW, Teagarden JR, Epstein RS: A National Study of the Individual Proton

Pump Inhibitors on Cardiovascular Outcomes in Patients Treated with Clopidogrel

Following Coronary Stenting: The Clopidogrel Medco Outcomes Study. SCAL Las

Vegas, NV 2009

jE:~ffrey .A. Brec111 M.D., Ph.C).

Jeffrey A. Breall M.D., Ph.D. L. Todd Kelly, Esq.

13960 Salsbury Creek Dr The Carlson Law Firm, p,e.

Carmel, IN 46032 11606 N, IH-35

317 -496-8680 Austin, TX 78753

jbreall@iu.edu

March 18,2014

RE: Nancy Jo Rodriguez

Deat Mr. Kelly:

Thank you very much for the opportunity to review the records in the case

involving the above named individual. At your request, Thad the opportunity to

review, in detail, all of the materials which you sent to me including Ms.

Rodriguez's various in-patient hospital records at Seton Northwest, outpatient

cardiology records from Austin Heart, extended care facility records at Ashwood

Assisted Living, and her outpatient counseling records.

I hold a medical license .in the State of Indiana. I am over eighteen, years of age,

and of sound mind. I earned my undergraduate degree from the University of

California, and my medical degree from Albert Eins tein College of Medicine. I

have been practicing cardiovascular medicine for 21 years. By virtue of my

education, training and experienced, I am qualified to render opinions regarding

the standard of care in treating a patient such as Nancy Jo Rodriguez, as well as

causation In this case. I was practicing medicine at the time of the care rendered .in

this matter and continue to practice medicine at the time of this report.

I possess the following qualifications for rendering my opinions in the above-

referenced matter: I am currently board certified by the American Board of

Internal Medicine in the fields of Cardiovascular Diseases as well as in

Interventional Cardiology; I have published numerous articles In these fields and I

teach these subjects to trainees 011 a daily basis; I hold numerous administrative

positions. To further delineate these qualifications, an update copy of my

{'YII77t'11111f11 oitae is enclosed.

EXHIBIT

I o 43

In my opinion the care and treatment provided to Nancy Jo Rodriguez by Austin

Heart fell below the accepted standards of care in the following particulars:

Despite Dr. David Kessler, one of her cardiologists from Austin Heart, requesting

tbat the Pradaxa be discontinued (in this patient who, at best, has bipolar disorder

and at times was confused, this was a reasonable request), Pradaxa therapy

nevertheless was continued after bet acute hospitalization. This request to stop

the medication was not appreciated by her primary cardiologist, Dr, Vivek

Goswami (who was in the same group as Dr. Kessler). Furthermore, Ms.

Rodriguez appeared to be obtaining refills for this medication authorized by

nurses and staff of this same heart group who recommended discontinuing this

medication (Austin Heart). The standard of care would have been to follow the

orders of Dr. Kessler to stop the administration of Pradaxa,

FaiIme to discontinue the Use of Pradaxa was a direct cause of her subsequent

acute admission to the hospital with hypotension, acute kidney injury and apparent

gastrointestinal bleeding - known side effects of the over-usc of Pradaxa, Ms.

Rodriquez's entire hospitalization was attributable to the failure to stop Pradaxa

therapy as ordered by Dr. Kessler. More likely than not, had the Pradaxa

medication been discontinued as requested, Ms. Rodriguez's hospitalization would

never have needed to take place.

I hold these opinions to a reasonable degree of medical certainty. They are based

upon my education, training and experience as well as the records which I have

reviewed,

If I can answer any further questions or he of any further service, at any time,

please do not hesitate to contact me immediately.

Professor of Clinical Medicine

,,)

APPENDIX 4

LEXSTAT

LexisNexis (R) Texas Annotated Statutes

a member of the LexisNexis Group

*** This document is current through the 2013 3rd Called Session ***

CIVIL PRACTICE AND REMEDIES CODE

TITLE 4. LIABILITY IN TORT

CHAPTER 74. MEDICAL LIABILITY

SUBCHAPTER H. PROCEDURAL PROVISIONS

GO TO TEXAS CODE ARCHIVE DIRECTORY

Tex. Civ. Prac. & Rem. Code § 74.351 (2014)

§ 74.351. Expert Report

(a) In a health care liability claim, a claimant shall, not later than the 120th day after the date each defendant's original

answer is filed, serve on that party or the party's attorney one or more expert reports, with a curriculum vitae of each

expert listed in the report for each physician or health care provider against whom a liability claim is asserted. The date

for serving the report may be extended by written agreement of the affected parties. Each defendant physician or health

care provider whose conduct is implicated in a report must file and serve any objection to the sufficiency of the report

not later than the later of the 21 st day after the date the report is served or the 21 st day after the date the defendant's

answer is filed, failing which all objections are waived.

(b) If, as to a defendant physician or health care provider, an expert report has not been served within the period

specified by Subsection (a), the court, on the motion of the affected physician or health care provider, shall, subject to

Subsection (c), enter an order that:

(1) awards to the affected physician or health care provider reasonable attorney's fees and costs of court incurred

by the physician or health care provider; and

(2) dismisses the claim with respect to the physician or health care provider, with prejudice to the refiling of the

claim.

report are found deficient, the court may grant one 30-day extension to the claimant in order to cure the deficiency. If

the claimant does not receive notice of the court's ruling granting the extension until after the 120-day deadline has

passed, then the 30-day extension shall run from the date the plaintiff first received the notice.

(d) to (h) [Reserved].

(i) Notwithstanding any other provision of this section, a claimant may satisfy any requirement of this section for

serving an expert report by serving reports of separate experts regarding different physicians or health care providers or

regarding different issues arising from the conduct of a physician or health care provider, such as issues of liability and

causation. Nothing in this section shall be construed to mean that a single expert must address all liability and causation

issues with respect to all physicians or health care providers or with respect to both liability and causation issues for a

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Tex. Civ. Prac. & Rem. Code § 74.351

physician or health care provider.

U) Nothing in this section shall be construed to require the serving of an expert report regarding any issue other

than an issue relating to liability or causation.

(k) Subject to Subsection (t), an expert report served under this section:

(I) is not admissible in evidence by any party;

(2) shall not be used in a deposition, trial, or other proceeding; and

(3) shall not be referred to by any party during the course of the action for any purpose.

(l) A court shall grant a motion challenging the adequacy of an expert report only if it appears to the court, after

hearing, that the report does not represent an objective good faith effort to comply with the definition of an expert report

in Subsection (r)(6).

(m) to (q) [Reserved].

(r) In this section:

(I) "Affected parties" means the claimant and the physician or health care provider who are directly affected by

an act or agreement required or permitted by this section and does not include other parties to an action who are not

directly affected by that particular act or agreement.

(2) "Claim" means a health care liability claim.

(3) [Reserved].

(4) "Defendant" means a physician or health care provider against whom a health care liability claim is asserted.

The term includes a third-party defendant, cross-defendant, or counterdefendant.

(5) "Expert" means:

(A) with respect to a person giving opinion testimony regarding whether a physician departed from accepted

standards of medical care, an expert qualified to testify under the requirements of Section 74.40 I;

(B) with respect to a person giving opinion testimony regarding whether a health care provider departed from

accepted standards of health care, an expert qualified to testify under the requirements of Section 74.402;

damages claimed and the alleged departure from the applicable standard of care in any health care liability claim, a

physician who is otherwise qualified to render opinions on such causal relationship under the Texas Rules of Evidence;

(D) with respect to a person giving opinion testimony about the causal relationship between the injury, harm, or

damages claimed and the alleged departure from the applicable standard of care for a dentist, a dentist or physician who

is otherwise qualified to render opinions on such causal relationship under the Texas Rules of Evidence; or

(E) with respect to a person giving opinion testimony about the causal relationship between the injury, harm, or

damages claimed and the alleged departure from the applicable standard of care for a podiatrist, a podiatrist or physician

who is otherwise qualified to render opinions on such causal relationship under the Texas Rules of Evidence.

(6) "Expert report" means a written report by an expert that provides a fair summary of the expert's opinions as of

the date of the report regarding applicable standards of care, the manner in which the care rendered by the physician or

Page 2

Tex. Civ. Prac. & Rem. Code § 74.351

health care provider failed to meet the standards, and the causal relationship between that failure and the injury, harm,

or damages claimed.

(s) Until a claimant has served the expert report and curriculum vitae as required by Subsection (a), all discovery in

a health care liability claim is stayed except for the acquisition by the claimant of information, including medical or

hospital records or other documents or tangible things, related to the patient's health care through:

(I) written discovery as defined in Rule 192.7. Texas Rules of Civil Procedure;

(2) depositions on written questions under Rule 200. Texas Rules of Civil Procedure; and

(3) discovery from nonparties under Rule 20S. Texas Rules of Civil Procedure.

(t) If an expert report is used by the claimant in the course of the action for any purpose other than to meet the

service requirement of Subsection (a), the restrictions imposed by Subsection (k) on use of the expert report by any

party are waived.

(u) Notwithstanding any other provision of this section, after a claim is filed all claimants, collectively, may take

not more than two depositions before the expert report is served as required by Subsection (a).

HISTORY: Enacted by Acts 2003, 78th Leg., ch. 204 (H.B. 4), § 10.01, effective September 1,2003; am. Acts 2005,

79th Leg., ch. 635 (H.B. 2645), § I, effective September I, 2005; am. Acts 2013, 83rd Leg., ch. 870 (H.B. 658), § 2,

effective September I, 2013.

Page 3

APPENDIX 5

LEXSTAT

LexisNexis (R) Texas Annotated Statutes

a member of the LexisNexis Group

*** This document is current through the 2013 3rd Called Session ***

CIVIL PRACTICE AND REMEDIES CODE

TITLE 4. LIABILITY IN TORT

CHAPTER 74. MEDICAL LIABILITY

SUBCHAPTER I. EXPERT WITNESSES

GO TO TEXAS CODE ARCHIVE DIRECTORY

Tex. Civ. Prac. & Rem. Code § 74.402 (2014)

§ 74.402. Qualifications of Expert Witness in Suit Against Health Care Provider

(a) For purposes of this section, "practicing health care" includes:

(I) training health care providers in the same field as the defendant health care provider at an accredited

educational institution; or

(2) serving as a consulting health care provider and being licensed, certified, or registered in the same field as the

defendant health care provider.

(b) In a suit involving a health care liability claim against a health care provider, a person may qualify as an expert

witness on the issue of whether the health care provider departed from accepted standards of care only if the person:

(1) is practicing health care in a field of practice that involves the same type of care or treatment as that delivered

by the defendant health care provider, if the defendant health care provider is an individual, at the time the testimony is

given or was practicing that type of health care at the time the claim arose;

(2) has knowledge of accepted standards of care for health care providers for the diagnosis, care, or treatment of

the illness, injury, or condition involved in the claim; and

(3) is qualified on the basis of training or experience to offer an expert opinion r

This text is long and has been trimmed here. Open the source document for the complete record.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.