UNITED STATES DISTRICT COURT

DISTRICT OF NEW HAMPSHIRE

Karen L. Bartlett

v. Civil No. 08-cv-00358-JL

Mutual Pharmaceutical

Company, Inc.

SUMMARY ORDER

Attached are the court’s rulings on the parties’ objections

to the deposition testimony of witness Dr. Joel Stein, who has

been deemed unavailable to testify at trial under Rule 32(a)(4)

of the Federal Rules of Civil Procedure (see doc. 275).

SO ORDERED.

____________________________

Joseph N. Laplante

United States District Judge

Dated: August 24, 2010

cc: Bryan Ballew, Esq.

Keith M. Jensen, Esq.

Patrick J. O’Neal, Esq.

Eric Roberson, Esq.

Christine M. Craig, Esq.

Timothy P. Beaupre, Esq.

Jeffrey D. Geoppinger, Esq.

Joseph P. Thomas, Esq.

Paul J. Cosgrove, Esq.

Linda E. Maichl, Esq.

Stephen J. Judge, Esq.

Pierre A. Chabot, Esq.

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Witness_ Joel Stein, M.D. - Vol. 1.txt: 1:1 - 1:19

1 UNITED STATES DISTRICT COURT

2 FOR THE DISTRICT OF NEW HAMPSHIRE

3 

4 KAREN L. BARTLETT and Case No.: 08-CV-358-JL

GREGORY S. BARTLETT,

5 

6 Plaintiffs,

7 vs.

8 MUTUAL PHARMACEUTICAL

COMPANY, INC. and UNITED

9 RESEARCH LABORATORIES, INC.

10 Defendants.

11 -------------------------------------------------x

12 VIDEOTAPE DEPOSITION of JOEL STEIN, M.D.,

13 taken by Plaintiffs held at Weill Cornell Medical

14 Center/New York-Presbyterian Hospital, Division of

15 Rehabilitation, 525 East 68th Street, New York, New

16 York 10065, on Thursday, August 6, 2009, commencing

17 at 2:31 p.m., before Julia Moksin, a Shorthand

18 (Stenotype) Reporter and Notary Public within and for

19 the State of New York.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 10:13 - 10:15

13 Q Please state your name for the

14 record.

15 A Joel Stein.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 10:21 - 11:10

21 Q I always like to start depositions,

22 Dr. Stein, by kind of giving the jury an idea of

23 where you fit into the picture of Karen

24 Bartlett's treatment.

25 And it's my understanding, Doctor, 

00011

1 that Karen had over a hundred days in about five

2 hospitals starting at Caritas and then Tufts and

3 then about 70 days in Mass General, then about

4 five days in Northeast Rehab, then back to Mass

5 General for about 11 days, and then finally to

6 where you were involved in her care and

7 treatment at Spaulding Rehabilitation Center for

8 about three weeks.

9 Does that sound about right to you,

10 sir?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 11:13 - 11:15

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13 A It's Spaulding Rehabilitation

14 Hospital, not center. Aside from that, it

15 sounds accurate.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 11:24 - 12:20

24 Doctor, is it your understanding

25 that of Karen's over hundred-plus days of 

00012

1 hospitalizations you were involved in her last

2 hospitalization; and she was discharged home

3 from Spaulding Rehabilitation, and you were her

4 attending doctor there for a portion of her time

5 at Spaulding?

6 A Yes, that's correct.

7 Q And is it correct that you were

8 Karen Bartlett's attending physician at

9 Spaulding Rehabilitation for approximately the

10 last two of her three weeks there, sir?

11 A That's approximately correct.

12 Q Is that true because for

13 approximately the first week of her

14 hospitalization at Spaulding you were not in the

15 hospital at that time?

16 A That's correct.

17 Q So when you got back on duty, you

18 immediately became her attending physician; is

19 that fair?

20 A That's correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 13:7 - 13:12

7 Q Sure. Let me go over some of your

8 qualifications that makes you a highly qualified

9 physician to be Karen Bartlett's attending

10 physician, and let me start out with where

11 you're licensed. You're licensed in both the

12 states of New York and Massachusetts, correct?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 13:15 - 15:3

15 A I am licensed in both New York and

16 Massachusetts.

17 Q And you are triple board-certified,

18 is that right, Dr. Stein?

19 A I am board-certified in internal

20 medicine and in physical medicine and

21 rehabilitation. I was at one time certified in

22 electrodiagnostic medicine; however, that

23 certification, I believe, has lapsed.

24 Q And you didn't make any attempt to

25 keep that third board-certification? 

00014

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1 A That is correct, I chose not to

2 pursue recertification because my practice

3 changed.

4 Q So as we speak you're double

5 board-certified in internal medicine and

6 physical medicine and rehabilitation?

7 A That is correct.

8 Q And in the past you've been an

9 instructor in medicine at Harvard Medical

10 School, correct?

11 A Correct.

12 Q You've been an assistant professor

13 for a time in the Department of Physical

14 Medicine and Rehabilitation at Harvard Medical

15 School?

16 A Correct.

17 Q Then you were an associate

18 professor at Harvard Medical School?

19 A That's correct.

20 Q Then you became the interim chair

21 of the department of physical medicine and

22 rehabilitation at Harvard Medical School?

23 A That's correct.

24 Q And since then you have moved on

25 and you became the professor and chief of a 

00015

1 division of rehabilitation medicine at Weill

2 Cornell Medical College of Cornell's University,

3 correct?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 15:6 - 15:11

6 A That's correct.

7 Q Back while you practiced at

8 Spaulding for approximately eight years, like

9 1996 or 2004, you were the director of the burn

10 rehabilitation program at the Spaulding Rehab

11 Hospital in Boston; is that right?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 15:14 - 17:3

14 A That's correct.

15 Q Please tell us, Dr. Stein, what is

16 the relationship between Spaulding

17 Rehabilitation Hospital and Massachusetts

18 General Hospital?

19 A Both hospitals are part of the

20 partners health care system. They are

21 affiliated institutions as such.

22 Q Are they juxtaposed, can you walk

23 out of one into the other, are they across the

24 street?

25 A They are several blocks from one 

00016

1 another, approximately a ten minute walk.

2 Q What is the relationship,

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3 Dr. Stein, between Spaulding Rehab Hospital and

4 Harvard Medical School?

5 A Spaulding Rehab Hospital is a

6 Harvard Medical School affiliate.

7 Q Got it. When you were the director

8 of the burn rehab program at Spaulding, to give

9 the jury an idea, how many burn units are in the

10 greater Boston area that might have patients,

11 treat them, and potentially refer them to

12 Spaulding for burn rehabilitation?

13 A I'm aware of two acute burn

14 rehabilitation -- excuse me, two acute burn

15 centers in the Boston area, one at Mass General

16 Hospital and the other at Brigham And Women's

17 Hospital.

18 Q In addition to your teaching, you

19 have obtained a lot of fellowship and grant

20 support work for studies you have done, correct?

21 A I have been involved in research,

22 yes.

23 Q And in addition to your research,

24 according to your CV, you published some 38

25 original articles, correct? 

00017

1 A That sounds approximately correct.

2 I haven't counted them today, but that's

3 approximately correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 17:9 - 17:21

And what are your

10 primary medical areas of interest, Dr. Stein?

11 A My primary area of interest is

12 stroke rehabilitation and other neurologic

13 rehabilitation.

14 Q If you could turn, Dr. Stein, to

15 Exhibit 22. Let me start with that. And that

16 is a Mass General one-page record, and it's a

17 nursing note speaking of a conversation that

18 occurred between a nurse and Karen Bartlett's

19 husband, Greg, about Sulindac and -- the bottle

20 of it and that 60 tabs were prescribed and 40

21 taken. Do you see that, sir?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 17:24 - 20:3

24 A I'm reviewing it. Let's see.

25 (Perusing document.) Yes. 

00018

1 Q Do you know whether or not you

2 would have had access to that page after Karen

3 Bartlett was transferred to Spaulding

4 Rehabilitation Hospital?

5 A It's unlikely.

6 Q Exhibit 23 is a typed-up physical

7 therapy service record.

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8 Would you have had access to that

9 document at Spaulding?

10 A I don't believe so.

11 Q Exhibit 24 is a typed-up infectious

12 disease consult, dated March 4, 2005.

13 Would you have had access to that

14 while you were at Spaulding treating Karen

15 Bartlett?

16 A It's uncertain. Some of these

17 typed consultations are placed in the electronic

18 medical record which I did have access to, but I

19 have no way of knowing from this printout

20 whether this one was, in fact, in that record or

21 not.

22 This is a signed copy that was

23 printed, obviously, and placed in the medical

24 record. It's unlikely that I would have had

25 access to the signed copy, but it's possible I 

00019

1 had access to an unsigned copy.

2 Q Got ya. And the unsigned copies

3 would be electronically signed in and that's

4 what you would have had access to via computer?

5 A Perhaps. I don't know if this was,

6 in fact, in the electronic medical record. I

7 can't tell.

8 Q Thank you. Please give us an idea

9 of the types of documents that would have been

10 in the electronic medical record at Mass General

11 that you likely would have had access to when

12 you were reviewing Karen's history.

13 A I would have had access to the

14 discharge summary, to selected consultations

15 that were placed in the electronic medical

16 record; although, I couldn't tell you which

17 specific ones without having access to that

18 record.

19 And I would have had access to

20 laboratory results, to x-ray studies, to

21 operative reports. Those are the major types of

22 data I would have had access to.

23 Q And is it -- is it my presumption

24 correct that in the care and in the course and

25 scope of your treatment of Karen Bartlett you 

00020

1 would have accessed electronically what you

2 deemed relevant to your care and treatment from

3 Mass General's records?

Witness_ Joel Stein, M.D. - Vol. 1.txt: Page 20, Line 6

6 A Yes.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 20:9 - 21:4

9 Q And why do you do that?

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10 A I access records as needed to help

11 me in the care of the patient so I understand

12 their medical condition and the treatments that

13 they might require.

14 Q Have you had a chance to review

15 some or all of the Spaulding Rehab records that

16 pertained to your participation in Karen

17 Bartlett's care and treatment before we began

18 that deposition today, sir?

19 A I have had a chance to review some

20 of those records which were provided to me by

21 you. It does not appear to be a complete record

22 of the chart, but I do believe it contains all

23 of my own notes.

24 Q And but for getting the records

25 from me because you're now at Weill Cornell, you 

00021

1 wouldn't have had access to them unless you

2 called your former facility, Spaulding, and got

3 them yourself, correct?

4 A That is correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 21:7 - 21:19

7 Exhibit 26, Dr. Stein, is a second

8 infectious disease consult. It is dated March

9 24, 2005, again, it's the signed version.

10 Can you take a few moments to look

11 at that and tell us whether or not you would

12 have likely had access to the electronic

13 unsigned version of that, please?

14 A It's possible, but I have no way of

15 knowing for certain.

16 Q From a review of your notes and

17 discharge summary, Dr. Stein, is it correct to

18 state that you had knowledge of the reported

19 history of Sulindac and said use?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 21:22 - 22:5

22 Q It is. Your discharge summary is

23 Exhibit 34, sir.

24 A (Perusing document.) As best I can

25 determine from my note, my knowledge was that 

00022

1 she had been treated with a nonsteroidal

2 anti-inflammatory drug, but I'm not -- I did not

3 record what specific medication that was here.

4 I couldn't say whether I was aware of it or not,

5 but I didn't record it.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 22:11 - 22:15

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11 So is it correct to state,

12 Dr. Stein, that you had knowledge that she took

13 NSAIDs, you know Sulindac's an NSAID, but you

14 didn't make any specific reference to which

15 NSAID she took?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 22:18 - 25:6

18 A That is correct.

19 Q Okay. Exhibit 26, page 476, the

20 bottom. It is the last page, Dr. Stein, the

21 impression of this infectious disease fellow

22 states "this is a 45-year-old woman with TEN,

23 likely secondary to NSAIDs who currently has a

24 multifocal pneumonia with associated effusions."

25 Do you see that? 

00023

1 A Yes.

2 Q Was that your understanding when

3 you were the attending physician by the end of

4 your treatment of Karen Bartlett?

5 A Regarding the cause of her -- I'm

6 not sure I understand your question. It's a bit

7 broad. Regarding her pneumonia, regarding her

8 TEN, regarding the nonsteroidal etiology?

9 Q Regarding her TEN and etiology.

10 A It was my understanding that

11 nonsteroidal use was entertained as one of the

12 possible causes of her TEN. It was not entirely

13 clear at the time. To -- to me that had been,

14 you know, whether that was, in fact, the cause,

15 but I was aware of that.

16 Q Thank you, Doctor.

17 And because Exhibit 27, the ID

18 attending note is in cursive, you would not have

19 had that, right, or have had access to that,

20 right?

21 A Presumably not.

22 Q Exhibit 28 is the discharge

23 summary, and it is -- on the last page you will

24 see it is dictated by a Sally Morton, NP.

25 Do you know what NP stands for, Dr. 

00024

1 Stein?

2 A Nurse practitioner.

3 Q Would you have -- let me ask you,

4 if you hypothetically had access to two

5 infectious disease consults, the very ones that

6 we just very quickly went over and a nurse

7 practitioner's indication of a discharge

8 summary, where would you have placed your focus

9 in terms of getting a picture about this

10 patient?

11 A I think that's a very difficult

12 question to answer. I think it depends with

13 regard to what particular aspect of her care.

14 If, for example, the question was what

15 infections does she have or what treatment would

16 be appropriate, certainly I would generally

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17 defer to the infectious disease consultant.

18 There are other aspects of the

19 history that might or might -- or the course

20 that might or might not be more accurately

21 reflected in the nurse practitioner's note.

22 Q Got it.

23 A I wouldn't say one trumps the other

24 inherently.

25 Q Would it be fair to say you would 

00025

1 look at all the data, but if you were looking at

2 questions regarding infectious disease, I'm

3 asking you would you put more credence in the

4 infectious disease doctor's statements about

5 that than a nurse practitioner's?

6 A Generally, yes.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 25:8 - 25:15

8 Would you have likely seen Exhibits

9 29 and 30, which are the history and physical

10 and discharge summary respectively from

11 Northeast Rehab Hospital?

12 A Most likely not. Occasionally

13 these records are duplicated, xeroxed and sent

14 with the patient's chart, but I would say that's

15 infrequent and unlikely to have been the case.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 25:17 - 28:11

17 What, if any, affiliation does

18 Northeast Rehab Hospital have with MGH or

19 Harvard Medical School?

20 A None that I'm aware of.

21 Q In retrospect in reviewing your

22 records, do you know why Ms. Bartlett went from

23 Mass General for approximately, give or take, 70

24 days to Northeast Rehab for about five days and

25 then back to MGH and then to Spaulding Rehab, 

00026

1 specifically, why Northeast Rehab and then

2 Spaulding Rehab; do you know what the answer is

3 to that?

4 A I could speculate, but I don't know

5 for certain. My understanding is the patient

6 resided in New Hampshire. Northeast Rehab is

7 located in New Hampshire, and it's quite

8 possible she preferred to be closer to home.

9 But that's speculation.

10 In terms of coming to Spaulding

11 afterwards, she obviously had a deterioration in

12 her medical status while at Northeast Rehab. I

13 assume that she chose not to return there, or

14 her physicians advised her to stay closer and

15 come to our program instead.

16 Q Got it. Thank you, Doctor.

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17 Let's go to Exhibit 31. Let me

18 know when you are there, please.

19 A All set.

20 Q Is that April 27th history and

21 physical the first formal document that's

22 created when Karen Bartlett would have arrived

23 as a new inpatient at Spaulding Rehab?

24 A It's the first physician

25 documentation I would expect. 

00027

1 Q And that tells us and it reported

2 that Ms. Bartlett, Karen, had been at Mass

3 General from February 4, '05 and that she had a

4 toxic epidermal necrolysis at greater than 40

5 percent of her total body surface area, correct?

6 A I'm looking where it says that in

7 the notes, if you give me a moment. (Perusing

8 document.)

9 Admitted on 2/4/05 with right toxic

10 epidermal necrolysis, the greater than 40

11 percent total body surface area.

12 Q And two sentences later it says she

13 spent 65 days in the hospital. Did you

14 understand that to be a reference to how long

15 she was at Mass General?

16 A Yes.

17 Q And then it tells us a couple of

18 lines later she was able to be discharged to

19 Northeast Rehab on April 14, 2005, right?

20 A Correct.

21 Q And you understood that to be that

22 she went from MGH for about 65 days to Northeast

23 Rehab, correct?

24 A That's correct.

25 Q And then the next sentence tells us 

00028

1 she was subsequently -- that means after

2 Northeast Rehab -- back at Mass General,

3 correct?

4 A That's correct.

5 Q And then she is admitted to Mass

6 General on 4/18, so four or five days at

7 Northeast Rehab, and now it's April 27th, so she

8 is in Northeast Rehab for about -- or she's back

9 at Mass General for about 11 days before she

10 arrives at Spaulding; does that sound right to

11 you?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 28:14 - 28:25

14 A It looks more like nine days to me.

15 Q Okay. Thank you.

16 And the doctor who signed this and

17 wrote this up was a colleague of yours named

18 Dr. Lie-Nemeth, correct?

19 A Yes.

20 Q Dr. Lie-Nemeth reports that her

21 hospital course, referring to Mass General, was

22 significant because she was intubated, she had a

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23 tracheostomy, and she had a vancomycin resistant

24 bacteremia, in addition to other things,

25 correct? 

Witness_ Joel Stein, M.D. - Vol. 1.txt: 29:3 - 29:19

3 A I'm reviewing -- I'm sorry. What

4 page are you on?

5 Q Same page. I'm on like the fifth

6 line, under HPI.

7 A Intubation, trach placement, VRE,

8 yes. Okay. That's accurate.

9 Q And SVT stands for supraventricular

10 tachycardia, Doctor?

11 A Yes.

12 Q Is that fancy for an abnormally

13 increased heart rate?

14 A It's more precise, but it

15 essentially -- yeah, an example of an abnormally

16 increased heart rate. It's one type.

17 Q And ARDS is acute respiratory

18 distress syndrome?

19 A That's correct, adult.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 30:1 - 32:21

1 Q And that she also had a deep vein

2 thrombi of the right common femoral vein.

3 A Deep venous thrombosis, correct.

4 Q And she also had MSSA, patient

5 developed hyperemia. Can you tell us what that

6 is, please?

7 A She had a methicillin sensitive

8 staph aureus. That's what MSSA stands for,

9 bacteremia. And she had anemia. Her hyperemia

10 is a different issue. That's on another line.

11 Q And the very last sentence of that

12 paragraph it says -- it tells us what her sodium

13 level was, and it says that level was secondary

14 to her being dehydrated; is that right?

15 A That is correct.

16 Q Okay. Now that we have that,

17 please paint the picture, if you will, medically

18 speaking, of what Karen's status was upon

19 presentation to Spaulding.

20 A She was obviously had had a serious

21 illness with a very complex and lengthy hospital

22 course related to her toxic epidermal necrolysis

23 and related complications as detailed in the

24 note.

25 At the time of her arrival, she 

00031

1 continued to have difficulty with swallowing.

2 She had a nasogastric feeding tube in place to

3 assist with that. She had a tracheostomy tube

4 for her respiratory difficulties. She was

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5 experiencing generalized anxiety. She had some

6 corneal damage from the TEN, which was being

7 managed with topical medications and followed by

8 an ophthalmologist, and she was deconditioned

9 and in need of physical rehabilitation services.

10 Q Tell us to the extent you can,

11 Doctor, with the benefit of the notes that

12 you've gone back and reviewed at my request --

13 and thank you for doing so -- why Karen needed

14 to go back to Mass General a second time after

15 she had a brief hospitalization at Northeast

16 Rehab?

17 A It sounds like there were multiple

18 factors. I wasn't involved in her care or the

19 decision to bring her back to Mass General, but

20 as documented in this note, it sounds as though

21 there were concerns about her wounds and that

22 was why she was referred for evaluation at Mass

23 General.

24 The dehydration with the sodium of

25 155 is a fairly serious medical condition and 

00032

1 required, as noted here, a substantial volume of

2 intravenous fluids, which I assume was the

3 primary reason for her rehospitalization at Mass

4 General.

5 Q What insight, if any, do you have

6 on what caused that significant dehydration?

7 A I'd be speculating, most likely she

8 had inadequate amounts of fluid that she was

9 receiving through her nasogastric tube combined

10 with perhaps higher losses of fluid through

11 breathing through her trach and perhaps through

12 perspiration or wounds or other sources. But

13 it's a combination of either not enough water in

14 or too much out or somewhat of both.

15 Q Is one of the very important things

16 that you began to manage after you later got

17 back to the hospital and became Karen's

18 attending physician, is her nutrition either

19 through a nasogastric tube or later on a

20 gastrostomy tube inserted into her abdomen?

21 A That is correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 32:23 - 35:9

23 Is it not uncommon for patients to

24 become dehydrated despite being on a feeding

25 tube through their nose or a feeding tube 

00033

1 through their stomach?

2 A It does occur.

3 Q Why does it occur, Doctor? In

4 other words, one would logically think if

5 someone has a feeding tube through their nose or

6 feeding through their stomach, it's being

7 monitored, the perhaps assumption would be that

8 you wouldn't get dehydrated. Why does it occur?

9 A The management of patient's fluid

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Page 12

10 and nutrition is not always given sufficient

11 priority by medical staff, or maybe they lack

12 knowledge of that.

13 In addition to that, estimates of

14 what people need are often inaccurate. You

15 know, rule of thumbs formulas that are used may

16 not, in fact, reflect any individual patient's

17 needs. And if monitoring is not performed

18 frequently, then because the person is unable to

19 take fluid by mouth it's very easy for them to

20 end up with abnormal electrolytes.

21 For an individual who is able to

22 drink by mouth and has access to water, you

23 would normally feel thirst and would replenish

24 your fluids automatically without requiring any

25 medical intervention. 

00034

1 Q Thank you, Doctor. I'll go to page

2 3 of Dr. Lie-Nemeth's history and physical, and

3 under functional history, she reports that Karen

4 requires contact guard assistance for transfers.

5 What does that mean?

6 A It means she needed someone

7 standing next to her with a hand placed on her

8 body for guidance for moving from the bed to the

9 wheelchair or the wheelchair to standing or

10 other activities, changes in position or

11 location.

12 Q Does that mean that Dr. Lie-Nemeth

13 believes she is not able to walk alone without

14 assistance?

15 A It means that she would not be safe

16 at that point in time to get out of bed and walk

17 by herself.

18 Q Okay. So in her next sentence

19 where she says she can walk for 220 feet, do you

20 interpret that to mean is that she can walk that

21 far with assistance?

22 A It's unclear from this note. It

23 may be that the patient requires the contact

24 guard assistance for the change in position, but

25 once she is upright and walking, she may not 

00035

1 require that much assistance. It is somewhat

2 ambiguous.

3 Q And 220 feet -- I guess 300 feet is

4 a football field, so 220 feet is something like

5 being able to make it from the end zone to the

6 other side's 30 yard line. With that as a

7 reference guide, do you interpret that sentence

8 to mean that she is unable to walk more than

9 that approximately 70 yards?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 35:12 - 35:24

12 A It's difficult to say. Oftentimes

13 we will comment on how far a patient can walk.

14 We don't generally walk them to exhaustion or

15 until they fail. So I would interpret this as

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Page 13

16 she can walk at least 220 feet, but it is

17 possible that she could walk further.

18 I'll mention that that's a

19 fairly -- for someone being admitted to a

20 rehabilitation hospital, that's a pretty good

21 distance. It is not the size of a football

22 field inside the hospital, so there are limits

23 to how far a patient can physically walk on the

24 unit.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 36:10 - 36:12

Before I go on with this

11 page, please flip to Exhibit 33, bottom right,

12 1548. Tell me when you are there, please.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 36:20 - 38:1

20 A I see it. I have it.

21 Q Okay. And hopefully the next page

22 of that shows that that is signed by a Dr. Jacob

23 Holzer. Does your copy show that?

24 A Yes.

25 Q And Dr. Jacob Holzer is a 

00037

1 psychiatrist that you worked with, let me try,

2 for years at Spaulding Rehabilitation?

3 A I don't recall exactly how long he

4 worked there. I believe it was perhaps two or

5 three years. I don't recall.

6 Q Okay. And did you participate in

7 the care and treatment of many patients with

8 Dr. Holzer in his two or three years there?

9 A Yes.

10 Q Did you find him to be a competent,

11 qualified psychiatrist who aided you in taking

12 care of your patients?

13 A Yes.

14 Q Dr. Holzer reports in his first

15 paragraph about two-thirds of the way down, in

16 the middle it says "was followed by the burn

17 psychiatry service." Do you see that?

18 A Yes.

19 Q And in the last sentence,

20 Dr. Holzer reports "psychiatry is requested to

21 consult as a follow-up to MGH course." Do you

22 see that, sir?

23 A Yes.

24 Q Now, let's go back to

25 Dr. Lie-Nemeth, and she reports under review of 

00038

1 symptoms --

Witness_ Joel Stein, M.D. - Vol. 1.txt: 38:8 - 40:13

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8 Q She reports "positive for anxiety."

9 Go down under psych: She reports "mood is

10 anxious." And flip to the next page, please,

11 under psych No. 4, second or third sentence, she

12 reports "psychiatry at Mass General has

13 recommended discontinuation of Seroquel." Do

14 you see that?

15 A Yes.

16 Q When you reviewed these records,

17 would it have been your understanding and is it

18 now that Karen Bartlett was seen at the

19 suggestion of the doctors at Mass General that

20 she see psychiatrists there, so Dr. Lie-Nemeth's

21 recommendation that she see a psychiatrist at

22 Spaulding would have been at least a second

23 facility who saw a need for Karen Bartlett to

24 get psychiatric evaluation or treatment,

25 correct? 

00039

1 A She ordered a psychiatry consult.

2 It seems to have been aware of the MGH

3 recommendation to continue psychiatric care, and

4 I think in her own assessment, although I can't

5 speak for her, and only per her written record

6 but seemed to feel it was appropriate.

7 Q Okay. And in that same paragraph

8 4, Dr. Lie-Nemeth not only suggests or

9 recommends psychiatry, but that she follow-up

10 with psychology, as well, correct?

11 A That's correct.

12 Q And the psychologist that was --

13 then evaluated Ms. Bartlett pursuant to

14 Dr. Lie-Nemeth's recommendation was Dr. Richard

15 Goldberg?

16 A That's correct.

17 Q For how many years, if at all, did

18 you work with Dr. Richard Goldberg?

19 A Approximately 16 years.

20 Q Did you find him in those

21 approximately 16 years to be a qualified,

22 capable psychologist who aided you in the care

23 and treatment of your patients?

24 A Yes.

25 Q Back to Dr. Holzer's comment 

00040

1 followed by burn psychiatry service at MGH,

2 first up, for how many years do you best

3 estimate that you were at Spaulding Rehab and

4 potentially getting referrals from the burn

5 service at MGH?

6 A I don't recall. Several years, I'd

7 have to look at my own resume to see. The years

8 that I indicated that I was the director of the

9 burn program would have been the approximate

10 same years.

11 Q On your resume it says '96 to 2004,

12 so eight, nine or ten years?

13 A That sounds about right.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 41:8 - 42:2

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8 Was it common for MGH severely

9 burned patients with having never seen a

10 psychiatrist or psychologist before, to your

11 knowledge, to be referred by MGH Burn Service to

12 psychiatry?

13 A My understanding was that it was

14 common practice to refer patients with severe

15 burns at Mass General to psychiatry regardless

16 of any premorbid conditions they may have had.

17 Q When you say "regardless of any

18 premorbid conditions," is what that means for

19 people who might not understand that that they

20 had never seen a psychologist or psychiatrist

21 before that in their life?

22 A Correct. Regardless of whether

23 they had that care or not previously it was

24 commonly ordered there.

25 Q It may or may not seem obvious to 

00042

1 those listening to us, why was it common for

2 people in a burn unit to be sent to psychiatry?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 42:5 - 45:4

5 A The nature of burn injuries are

6 that they are both painful and disabling and are

7 rather devastating events when they are severe

8 for the recipient. There is substantial medical

9 literature documenting the psychiatric impact of

10 major trauma and burns in particular, so for

11 that reason I think this is fairly routine

12 practice at most burn centers.

13 Q And Dr. Holzer's, the psychiatrist,

14 initial or his May 4th consultation with Karen,

15 that would have come the day after you arrived

16 back at the hospital and first saw Karen on May

17 the 3rd, correct, sir?

18 A That is correct.

19 Q And your first written note is

20 Exhibit 33, 1518 on the bottom, correct?

21 A Yes.

22 Q And there you record, amongst other

23 things, that you're considering a pulmonary

24 consult regarding a possible tracheostomy

25 decannulation, correct? 

00043

1 A Right. I think it was -- I just

2 said pulmonary consult regarding possible trach

3 decannulation. I don't think I was considering

4 it, I believe I was planning it.

5 Q Thank you. Tell us what that is,

6 please?

7 A Trach decannulation is removal of

8 the tracheostomy tube.

9 Q And tracheostomy tube is what,

10 please?

11 A It's a tube placed into the trachea

12 to allow the patient to breathe through the

13 tube. It goes into the front part of the neck.

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14 Q And it is your -- do you have an

15 understanding of for how long at Mass General

16 and her approximate 65 days there or her about

17 four days at Northeast Rehab or her about eight

18 days at second time at Mass General that Karen

19 was breathing through her neck by means of a

20 tracheostomy?

21 A I'd have to go back and review the

22 Mass General records. Generally speaking,

23 someone with her type of medical condition would

24 have probably received a tracheostomy fairly

25 early in her course and had it for the majority 

00044

1 of that time, but I'd have to verify that.

2 Q Please go to Exhibit 32 and let me

3 know when you are there.

4 A Okay.

5 Q And that is a couple of days before

6 you arrived back at the hospital, an ocular or

7 eye consult of Karen that was done on April 29,

8 2005, correct?

9 A That's correct.

10 Q And that was done by a Dr. Tsai who

11 works at the Massachusetts Eye and Ear

12 Infirmary, right?

13 A That's correct.

14 Q And Dr. Tsai under allergies lists

15 NSAIDs, comma, Sulindac, right?

16 A Actually, that may have been

17 recorded by the staff at Spaulding. I believe

18 it was. I don't believe that's her record, but

19 ours.

20 Q Got ya. So the way you read this

21 from results down would have been Dr. Tsai's

22 writing and above that was probably this

23 Spaulding recommendation?

24 A That's correct.

25 Q Okay. What Dr. Tsai, then, reports 

00045

1 is that Karen on April 29, '05 now at Spaulding

2 for a couple of days is that she has early

3 scarring at corneas and severe dryness, right?

4 A That's Correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 45:7 - 45:24

7 Dr. Tsai's fourth recommendation is

8 to tape eyelids shut when patient is sleeping,

9 right?

10 A That's correct.

11 Q Would that have been followed every

12 night while Karen was at Spaulding to tape her

13 eyelids shut when she was sleeping?

14 A It should have been, but I can't --

15 I would have to review the nursing records to

16 see if that's the case. Generally speaking,

17 these recommendations would be followed

18 carefully.

19 Q Why would it have been your

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20 understanding that this ophthalmologist or eye

21 doctor is recommending that Karen now

22 approximately 80 days after she first got to

23 Mass General is still having a recommendation to

24 have her eyelids shut, taped at night?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 46:3 - 49:8

3 A Generally speaking, patients who

4 are having corneal damage or dryness or other

5 issues related to corneal injury, one of the

6 major treatments is to protect them from

7 excessive air exposure and using a combination

8 of lubricants during the daytime and taping the

9 eyelids shut at night is fairly common.

10 Q Dr. Tsai recommends a follow-up on

11 May 2nd, and the next page shows us that she saw

12 Karen Bartlett on May 2nd, correct?

13 A That is correct.

14 Q Now, when Mass eye/ear

15 ophthalmologists were seeing Karen while she was

16 soon to become a patient of yours at Spaulding,

17 where were they physically seeing her,

18 Dr. Stein?

19 A At Mass's Eye and Ear Infirmary.

20 Q And tell us how she got there and

21 how far it was from Spaulding.

22 A It is physically attached to Mass

23 General Hospital, although it is an independent

24 facility, and it's approximately several blocks.

25 It's a ten-minute walk. Driving it can be 

00047

1 anywhere from five minutes to an hour-and-a-half

2 depending on traffic.

3 Q So she would have been physically

4 transported there, how?

5 A Typically by ambulance or perhaps

6 by a chair car or ambulette. I don't know in

7 her case which was used.

8 Q Is a chair car the same thing as

9 ambulette?

10 A Yes, they're used interchangeably.

11 Q What is an ambulette, please?

12 A It's a van that is designed for

13 transporting patients with medical needs. It's

14 usually for patients that are wheelchair

15 requiring so that the patient is assisted in the

16 wheelchair into the van and the wheelchair is

17 secured, and they can be driven safely that way

18 as opposed to an ambulance where a patient is

19 brought in by stretcher.

20 Also, the degree of medical

21 supervision is substantially greater in an

22 ambulance. And our standard practice at

23 Spaulding at the time was to use the lesser

24 degree of medical resources when medically

25 appropriate. 

00048

1 Q Sure. The very next page on May

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2 3rd show us that she had a consult or a

3 follow-up with the burn clinic and the

4 requesting doctor was you, Dr. Joel Stein,

5 correct?

6 A I am listed as a requesting M.D. I

7 don't actually know who wrote the order. It may

8 have been written prior -- probably was written

9 prior to my assuming her care because it would

10 have been scheduled since I assumed her care on

11 May 3rd. It was probably written by Dr.

12 Lie-Nemeth.

13 Q Thank you, Doctor.

14 And same question: How physically

15 would Karen have gotten from Spaulding to go

16 back for a follow-up to the burn clinic?

17 A Either by chair car or by

18 ambulance. I'm not certain which.

19 Q And do you know whether that -- can

20 you tell whether that follow-up occurred on

21 April 3rd?

22 A It can't be determined from this

23 note. I believe it did occur, but I can't

24 verify that. It is not atypical for the Burn

25 Service not to provide a written response on 

00049

1 this form, so the absence of that does not

2 indicate that it did not occur.

3 Q The next page shows it was a third

4 consult with an ophthalmologist from Mass Eye

5 and Ear in this instance with a Dr. Azar

6 Dimitri, correct, sir?

7 A Actually it is signed by Dr. Tsai,

8 if I'm looking at the same note. This is 1560?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 50:1 - 51:1

Q Let's go to the last page. Does

2 that appear to be a record of a fourth consult

3 for Karen with Mass Eye and Ear while she was at

4 Spaulding?

5 A Is this 1562?

6 Q Yes, sir.

7 A Yes, it does appear to be that way.

8 Q And on all four of those consults,

9 the allergies listed are NSAIDs, Sulindac,

10 correct?

11 A I have to verify that, but I

12 imagine so.

13 (Perusing document.) That is

14 correct.

15 Q And all we spoke about is the eyes.

16 Also, on the follow-up for the burn clinic and

17 the consult for the G-tube placement, which is

18 the feeding tube into her stomach, on both of

19 those consults the allergies listed is also

20 NSAID Sulindac, correct?

21 A That is correct.

22 Q Now, go back and move to

23 Dr. Lie-Nemeth's original history and physical.

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24 She states in the physical examination "there is

25 a stage II ulcer on Karen's back with no 

00051

1 drainage." What does that mean, Doctor?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 51:10 - 53:9

10 A That refers to a decubitus ulcer

11 that was graded as stage II. Staging system

12 indicates the depth. Stage I is generally

13 redness. Stage II is superficial skin abrasion

14 or breakdown. So this is a relatively mild

15 degree of skin breakdown, and her exam indicates

16 that there was no drainage from the wound, which

17 is a -- generally a favorable finding.

18 Q And then her plan underlined is

19 decreased functional status secondary to toxic

20 epidermal necrolysis syndrome, correct?

21 A That's correct.

22 Q Secondary generally means cause,

23 right; in other words, do you interpret

24 Dr. Lie-Nemeth's note to mean that she believes

25 that Karen had decreased functional ability 

00052

1 because of her TEN?

2 A That's correct.

3 Q And she tells us the components of

4 that decreased functionability are that she has

5 weakness in her legs, she has decreased

6 activities of daily living, she has less mobile

7 and she has less ability to swallow?

8 A That's correct.

9 Q And her plan to hopefully treat

10 these medical issues of Karen's is a number of

11 things, including physiatry, PT, OT,

12 speech-language, breathing therapy and

13 psychology, amongst other things, correct?

14 A I'm not sure what you mean by

15 "breathing therapy," respiratory therapy if

16 that's what you mean.

17 Q Yes, it is what I meant, and I was

18 going to ask you that. Other than that

19 correction, is that list all true?

20 A Yes.

21 Q And let's start with that. What is

22 respiratory therapy, Doctor?

23 A Respiratory therapists are trained

24 in the management and assistance of patients

25 with pulmonary issues with respiratory issues. 

00053

1 They, in a hospital setting, would typically

2 assist with trach care, with suctioning, to

3 remove secretions from the tracheostomy tube

4 with oxygen therapy, with anything involving

5 breathing aids or apparatuses.

6 Q Respiratory therapy is the

7 extremely important task of making sure

8 someone's tube through which they are breathing

9 through their neck is functional?

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Witness_ Joel Stein, M.D. - Vol. 1.txt: 53:12 - 54:9

12 A That is a component of their task,

13 correct. They share that task with others, such

14 as nursing but that is correct.

15 Q What is physiatry, Dr. Stein?

16 A Physiatry is another term for the

17 medical specialty of physical medicine and

18 rehabilitation.

19 Q And PT that means you -- Dr. --

20 your colleague, Dr. Lie-Nemeth, had planned for

21 her physical therapy?

22 A Correct.

23 Q And she had planned for

24 occupational therapy?

25 A Correct. 

00054

1 Q Now, when she planned for Karen's

2 speech-language pathology, please tell us what

3 that means.

4 A Speech-language pathology is

5 synonymous speech therapist, the term that they

6 prefer; and they deal with several issues, and

7 in this particular patient, they would have been

8 focusing on her swallowing since I'm not aware

9 that she had any difficulty speaking.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 54:11 - 54:25

11 The goals were to have a modified

12 independent to independent level for all

13 activities of daily living and mobility,

14 correct?

15 A That's correct.

16 Q Tell us what that means.

17 A Independent level would mean that

18 you can do everything yourself. An able-bodied

19 person with no medical issues or disability

20 would be able -- would be independent.

21 Modified independent is when you

22 are able to achieve the activity on your own,

23 but require a device or some modification of the

24 activity to perform it. For example, walking

25 with a cane would be modified independence. 

Witness_ Joel Stein, M.D. - Vol. 1.txt: 55:13 - 58:7

13 On the last page, Dr. Lie-Nemeth

14 has "an estimated length of stay of two weeks

15 and potential is good."

16 Does that mean she thinks there is

17 a good chance it might be a two-week hospital

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18 stay?

19 A Give me one moment. (Perusing

20 document.)

21 Q Sure.

22 A So she is estimating the stay at

23 two weeks. In terms of potential being good, I

24 think what she is referring to is her overall

25 rehabilitation potential is good. I don't think 

00056

1 that's a reflection on the accuracy of the two

2 weeks estimate, but more on her overall

3 likelihood of improvement and success.

4 Q Okay. Thank you, Doctor. And what

5 it turned out to be is a approximately

6 three-week hospitalization. We know that from

7 your discharge summary, Exhibit 34, correct?

8 A That's correct.

9 Q Now, she was -- your colleague said

10 that her recommendation was to continue Karen on

11 Valium. What is Valium, Doctor?

12 A Valium is a benzodiazepine

13 medication. It's used as an anxiolytic and as a

14 sleep aid, as well.

15 Q Does anxiolytic mean and in Karen's

16 situation did you understand that it was being

17 given to her because of her anxiety?

18 A That's correct.

19 Q Is it also a powerful sedative and

20 muscle relaxer?

21 A It has both of those

22 characteristics, as well.

23 Q And the plan was to wean her off

24 methadone which was -- means to hopefully get

25 her off it, correct? 

00057

1 A That's correct.

2 Q Would it have been your

3 understanding that she was being given methadone

4 for pain management?

5 A Yes. It's commonly used in the

6 burn unit, at least it was at the time at Mass

7 General as a pain medication, and it has a

8 favorable pharmacologic profile that they have

9 reasons to select it.

10 Q Now, she also reports that

11 psychiatry at Mass General had recommended

12 taking Karen off of Seroquel; is that right?

13 A That is correct.

14 Q What would have been your

15 understanding as to why psychiatry at Mass

16 General wanted to take her off that drug and

17 tell us what that drug is, please?

18 A I can't comment on their rationale.

19 I don't have access to their notes.

20 Seroquel is an atypical

21 antipsychotic medication. It is used as a sleep

22 aid and as an antianxiety medication to some

23 extent, as well. It has a variety of complex

24 actions that are not fully understood, including

25 the suggestion that it might be of some benefit 

00058

1 for depression, as well, although that's not so

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2 clear.

3 Q As we have pointed out, the

4 recommendation to consult psychiatry and

5 psychology was basically following up on

6 something that already occurred at Mass General?

7 A That's correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 59:19 - 59:20

19 Q Exhibit 33, 1528, at the bottom.

20 Tell me when you're there, please.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 59:25 - 62:22

25 A Okay, I have that. 

00060

1 Q Is that your May 9th note regarding

2 Karen?

3 A At the top, yes.

4 Q Those are your initials about

5 halfway down the page?

6 A That's my signature.

7 Q Okay. Thank you.

8 Tell us what's going on there in

9 terms of your assessment and plan. This would

10 be approximately Karen's 11th day at the

11 hospital, right?

12 A Roughly.

13 Q Tell us what's going on at that

14 time, please.

15 A She had been decannulated, her

16 tracheostomy tube had been removed. She was

17 doing well from a respiratory standpoint. She

18 had had a modified barium swallow and had not

19 done well in terms of her swallowing safety.

20 That was attributed to concerns about anxiety

21 and also the presence of the tracheostomy tube.

22 She was continuing on therapeutic

23 feeds which indicates small amounts of feeding

24 given by the speech therapist rather than more

25 substantial amounts of food for nutritional 

00061

1 purposes, and our plan was to repeat the

2 swallowing study shortly.

3 We had also -- were changing the

4 tube feedings that were going through her

5 nasogastric tube at that time to what are called

6 boluses which are larger amounts given less

7 frequently. And a community outing was being

8 planned.

9 Q Let's start with the community

10 outing being planned, what's that about, please?

11 A Part of your program for

12 transitioning patients back to the community is,

13 when feasible, to get them outside the hospital

14 and to participate in activities in the

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15 community under the supervision of the

16 therapist.

17 Q What would that entail; in other

18 words, where would you go, what would you do?

19 A The activities varied. I couldn't

20 say without seeing the therapist notes what was

21 done here, but the source of things that were

22 commonly done were is there is a science museum

23 several blocks from the hospital, patients would

24 often go there on an outing, they would also

25 sometimes go to the nearby North Station Boston 

00062

1 Garden and do shopping there or something.

2 Q All right. Tell us from a lay

3 perspective what this modified barium swallow

4 study is, please, and what it is designed to

5 tell a physician.

6 A A modified barium swallow study is

7 an x-ray study that is performed. It's a video

8 of the swallowing, and the patient is given a

9 material that is visible on the x-ray images to

10 chew and swallow or to drink. Different

11 textures are given and the patient's swallow

12 mechanism is observed, whether the food goes

13 down the esophagus, whether it goes down into

14 the trachea and the airways where it doesn't

15 belong. Those sorts of things are observed.

16 Q Tell us about the difficulties, if

17 any, of having both a tracheostomy, in other

18 words the tubes that you are breathing through

19 your neck, as well as a nasogastric tube, so you

20 are getting fed through your nose down to your

21 abdomen; does that simultaneous link of medical

22 devices create problems?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 62:25 - 64:17

25 A Both nasogastric tube and a 

00063

1 tracheostomy tube can interfere with swallowing

2 to some extent, and the combination certainly

3 could cause additive effects in terms of

4 interfering with swallowing.

5 Q What was going on with -- in your

6 estimation with Karen's difficulty swallowing?

7 A I think at that moment in time, or

8 looking back?

9 Q Looking back.

10 A Looking back, it appears that there

11 were probably multiple factors. The presence of

12 the tracheostomy tube was probably a

13 contributing one, the nasogastric tube, as well.

14 In addition she was subsequently evaluated by an

15 ENT physician and found to have evidence of a

16 vocal cord paralysis.

17 Q We all understand a vocal cord is

18 what we need to speak, but what was your

19 understanding of what caused the vocal cord

20 paralysis, if you have an understanding?

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21 A If I could just correct that and

22 say right vocal cord paralysis.

23 Q Okay. Thank you.

24 A The cause of the paralysis was

25 uncertain. Dr. Suzuki, Bruce Suzuki, who 

00064

1 evaluated the patient raised the possibility

2 that it might have been related to her

3 intubation, but it was uncertain.

4 Q Let me kind of ask a global

5 question. Looking back from your review of your

6 records regarding Karen Bartlett and those of

7 your colleagues at Spaulding Rehabilitation

8 Hospital, in your estimation was essentially all

9 of Karen Bartlett's physical medical issues a

10 result of and compatible with the fact that she

11 had TEN?

12 A All of her issues appeared to

13 derive ultimately from that original inciting

14 factor.

15 Q The inciting factor being the fact

16 that she had TEN?

17 A Correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 64:21 - 65:18

Let's go to Exhibit 31, page 2,

22 and there your colleague Dr. Lie-Nemeth lists 19

23 medications. And that's what she shows up at

24 Spaulding that Karen is then on, correct?

25 A That's correct. 

00065

1 Q Excluding the multivitamin and any

2 others that you have to exclude, are essentially

3 all of those medications, looking back, Dr.

4 Stein, in your view, medications that Karen

5 needed as a result of her TEN?

6 Another way of stating that is had

7 she never had TEN, she wouldn't have been on

8 these 19 medications maybe except a

9 multivitamin?

10 A As far as I know, she was not on

11 any of these medications prior to her

12 hospitalization, so I think it's safe to assume

13 they are all being used to treat the

14 complications of the TEN.

15 Q And the vocal cord paralysis,

16 secondary to possibly intubation would have been

17 one of many examples of things that occur as a

18 result of TEN, fair?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 65:21 - 67:16

21 A Right. Yes I would agree with

22 that.

23 Q Let's go, on the same topic, to

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24 your discharge summary, please, Exhibit 34.

25 Tell me when you're there. 

00066

1 A Okay.

2 Q Is that your signature on page 2?

3 A That is my signature.

4 Q And you list on discharge eight

5 medications that Karen is then on, correct?

6 A That's correct.

7 Q Looking back and based upon a

8 reasonable degree of medical certainty, were all

9 of those medications that she was on upon

10 discharge maybe except the multivitamins all as

11 a result of Karen having TEN and the

12 complications thereof?

13 A Yes.

14 Q Let's go back to, we previously

15 referenced Dr. Holzer's typed-up psychiatry

16 consult. It's in the middle of Exhibit 33, tell

17 me when you're there, 1548 at the bottom.

18 A Okay.

19 Q And Dr. Holzer, the psychiatrist

20 there, reports on her mental state, towards the

21 right, "became tearful during meeting discussing

22 length of hospital course." The very last line

23 of the same page she reports, "she does report

24 having a difficult time feeling demoralized,

25 upset about length of hospitalization, misses 

00067

1 home."

2 Do you see those entries?

3 A Yes.

4 Q I occasionally ask stupid, obvious

5 questions, but is it your understanding that

6 those symptoms, those signs would have been as a

7 result of Karen having TEN in this extremely

8 long hospitalization at many different

9 hospitals?

10 A Yes.

11 Q When Dr. Holzer reports, under

12 mental state line, reports chronic

13 claustrophobic SXS.

14 First of all, do you know what that

15 is an abbreviation for?

16 A Symptoms.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 67:19 - 68:8

What do you

20 interpret Dr. Holzer's reporting there when she

21 has claustrophobic symptoms, chronically --

22 strike that.

23 First of all, when he says

24 "chronically," does he mean that the symptoms

25 are appearing over a long period of time? 

00068

1 A It's hard to be certain what his

2 intention was. I would interpret this as

3 indicating that this may actually precede her

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4 hospitalization. It's not rare for people who

5 are otherwise fully functional and not in

6 psychiatric treatment to have feelings of

7 claustrophobia the same way some people are

8 afraid of snakes or heights.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 68:21 - 69:15

21 Q He also, in his clinical

22 impression, Dr. Holzer, reports "now recovering

23 with wide areas of burns complicated hospital

24 course." Do you see that?

25 A Yes. 

00069

1 Q And then on the next page

2 Dr. Holzer says, second line, "right now would

3 recommend continuing with Valium as needed,

4 which patient reports is helpful for phobic

5 symptoms and acute anxiety." Is that right?

6 A Yes.

7 Q How would you have interpreted

8 that; what does that mean?

9 A He is recommending continuing use

10 of the Valium as needed which the patient has

11 found helpful for some of her symptoms.

12 Q When he says "phobic symptoms,"

13 what do you understand that to mean?

14 A Fear, I'm not sure of what. It's

15 unclear from his note.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 69:20 - 70:2

20 Who was the pulmonologist, based

21 upon your review of the records, that was

22 involved in Karen's care at Spaulding?

23 A Dr. Douglas Johnson.

24 Q Can you please help me find his

25 first note. I think I found it on page 1523, 

00070

1 and it's about two-and-a-half pages long,

2 correct?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 70:7 - 71:9

7 A Yes, I see it on 54 on -- yes, the

8 bottom of 1523.

9 Q Yes, sir. And would you,

10 Dr. Stein, have reviewed that as part and parcel

11 of your care and treatment?

12 A I would have, yes.

13 Q Tell us, then, from your

14 perspective what Dr. Johnson, the lung

15 specialist, the pulmonologist, is reporting

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16 there that would have been important for you?

17 A Perhaps I can skip to the

18 impression recommendations, which is the essence

19 of the notes. He had some concerns based on

20 prior chest x-ray and his examination that she

21 might have a left-sided pleural effusion, and he

22 recommended that we get particular chest x-rays

23 to evaluate that.

24 He removed a suture that had been

25 left in place. He changed one of her 

00071

1 medications or recommended its change to as

2 needed, the albuterol. And he recommended a

3 culture and gram stain of a sputum specimen.

4 Q Let's start with pleural effusion.

5 What is that, please, Doctor?

6 A Fluid around the lung.

7 Q And that can be caused by many

8 things; can it not?

9 A That's correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 71:16 - 74:10

16 Q What was going to be used to

17 attempt to hopefully overcome that issue?

18 A In terms of assessing the issue, a

19 chest x-ray was advised with what are called

20 decubitus films, where the patient lies on their

21 side to see if there is fluid there, whether it

22 is -- how much of it is present and whether it

23 is mobile or if it's fixed in location.

24 Q And was that -- and this was a May

25 4th note, the day after you started actively 

00072

1 treating Karen. Tell us as time went on was

2 that pleural effusion, did it resolve?

3 A It appeared to have been improving

4 and required no further treatment during her

5 Spaulding stay.

6 Q This lung doctor, Dr. Johnson,

7 reports that he removed a tracheostomy retention

8 suture; is that correct?

9 A That's correct.

10 Q Please tell us what that is and why

11 it was done.

12 A It's a suture that's placed at the

13 time of the insertion of the tracheostomy tube

14 to hold it in place and keep it from falling

15 out. Typically the sutures are removed because

16 after a period of time the tracheostomy is more

17 secure and the risk of it coming out is less

18 substantial.

19 In her case because of her multiple

20 medical issues perhaps and multiple

21 institutions, the suture was left in place

22 longer than is typical and he removed it.

23 Q Typically how long are these

24 tracheostomy sutures left in?

25 A I'm not certain. 

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00073

1 Q In relation, to give us a visual,

2 of the Adams apple, where are these sutures?

3 A The tracheostomy tube would be near

4 the Adams apple and the suture would be right

5 adjacent to it that would be holding it to the

6 skin there.

7 Q And a suture could be, to use an

8 analogy which I'm sure is inaccurate, if we are

9 talking about stitches here, how many stitches

10 would that be?

11 A One.

12 Q The actual tracheostomy is round,

13 correct?

14 A I'm not sure if I understand by the

15 tracheostomy. The tube itself is cylindrical,

16 it has various other components. There is a

17 flange on the outside of it, various other

18 pieces.

19 Q The part that holds to your neck is

20 at the end of a cylinder and it's round; is that

21 right or wrong?

22 A Correct. In essence, correct.

23 Q How does one stitch hold a round

24 presumed piece of plastic to your neck?

25 A Imagine you have a tube inserted 

00074

1 into another tube, which is what's happening

2 here. The tracheostomy tube is going into the

3 trachea, which is the body's own breathing tube.

4 It rests there, and it is not inclined to move

5 unless it is pulled out. So what the suture

6 does is prevent it from inadvertently being

7 pulled out or falling out, but it can't

8 otherwise move around very much because it is

9 held in place by the surrounding tissues. I

10 probably need to draw you a diagram.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 74:17 - 76:3

17 Q Let's go to the next page 1522. Is

18 the top entry there the entry of the

19 psychologist, Dr. Richard Goldberg?

20 A Yes.

21 Q Can you please do us a favor and

22 read into the record because I can't read it.

23 A "5/04/05 psychology reviewed notes

24 by psychiatry. Dr. Holzer recommends continuing

25 with Valium. Patient appears" -- I'm not sure I 

00075

1 can read that word -- "in mood, not tearful

2 today," underlined "feels she is finally

3 adjusting better to staff. Notice she has

4 well" --

5 Q -- groomed?

6 A It says "well groomed." I think

7 that -- I'm not sure. Notice she is well

8 groomed, perhaps? It is unclear what that

9 middle word is.

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10 "Sitting up in chair with" -- I

11 can't read the next few words. The next line,

12 "told me she finally feels she is making some

13 progress, happy that trach retention is removed

14 and looks forward to eventual decannulation.

15 And no trach, no complaints."

16 Q And so what she is reporting there

17 is the suture that was just removed by

18 Dr. Johnson?

19 A That's correct.

20 Q And did it give her -- is it easier

21 to breath when the trach retention is removed?

22 Why is she reporting, to your estimation, that

23 she is better off?

24 A It's unlikely that she was

25 physically able to feel or be aware of the 

00076

1 suture. I imagine it was more the idea of it

2 being removed.

3 Q Right.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 76:22 - 78:22

22 Q Please go to Exhibit 33, 1529 at

23 the bottom. Tell me when you are there, sir.

24 A 15 --

25 Q -- 29. 

00077

1 A Okay.

2 Q What is that page of May 10, '05?

3 A This is a team rounds note.

4 Q What is that?

5 A In a rehab hospital, there is a

6 periodic meeting of the team, generally at least

7 once a week. It varies from institution to

8 institution, and frankly, I don't recall at the

9 time there how often we were doing this.

10 But the physician, the case manager

11 and the therapy team, nursing typically, get

12 together and review a patient's progress, any

13 barriers to continue progress and they try to

14 determine a discharge plan and estimate the

15 length of stay and the level of functioning at

16 discharge.

17 Q Is a accurate way to define your

18 role in Karen's treatment from 5 -- from May 3rd

19 through her discharge on May 19th, is that --

20 well, of course, you are not a pulmonologist or

21 a burn surgeon. You were her attending

22 physiatrist which meant that you led the team in

23 terms of deciding what ultimately would be Karen

24 Bartlett's care and treatment?

25 A That's correct. 

00078

1 Q On May 10th she was seen by

2 Dr. Richard Goldberg, psychologist. Again, if

3 you would be kind enough again to read his entry

4 on the next page, I'd appreciate it.

5 A "Patient seen for psychotherapy.

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6 She is anxious today for two reasons, one,

7 husband last night had tightness in his chest

8 and was taken to Holy Family Hospital Methuen

9 for observation; two, she failed" I think the

10 word is -- "failed the MBS test."

11 Q Let me stop you right there. Is

12 that right, true, and accurate?

13 A It's not a -- I would never -- it's

14 not a pass/fail exam. It's a common

15 colloquialism among team members, but it's not a

16 very accurate way to describe it.

17 Q When the team member says that,

18 what does it mean to you?

19 A It means he is a psychologist and

20 the patient told him that she failed, but I --

21 it's not a pass/fail exam.

22 Q And then you tell us, how did she

Witness_ Joel Stein, M.D. - Vol. 1.txt: 79:5 - 80:11

please proceed with reading that,

6 Doctor.

7 A "Despite anxiety she has been

8 walking."

9 Q Worked up?

10 A I think it might be "walking around

11 unit with minimal assistance. She does not need

12 increase in anxiolytic medications. She said

13 that she wants to get reports on husband. He

14 has been feeling" -- I think it might be --

15 "overwhelmed by her being hospitalized at the

16 same time he works as lineman" -- I think that

17 says -- "and takes care of the house." I'm not

18 sure what that says works at something. Let's

19 see, something "history of claustrophobia and is

20 very sensitive to changes. Will follow

21 closely."

22 Q Thank you. I'd like to ask you a

23 question about some of Karen's doctors at MGH.

24 First off, as a physiatrist would

25 it be fair to say you're much better at judging 

00080

1 someone's prominence in your field, physiatry,

2 than some other field like burn surgery; would

3 that be a fair general statement?

4 A I guess.

5 Q With that said, would it be your

6 understanding, both then and now, that Karen's

7 three surgeons, burn surgeons, particularly at

8 MGH that of Dr. John Schultz, Dr. Robert

9 Sheridan and Dr. John Ryan are highly regarded,

10 preeminent burn surgeons widely known for their

11 experience and skill?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 80:14 - 83:12

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14 A I believe you're referring to

15 Colleen Ryan, not John.

16 Q I think I'm referring to John.

17 A John Sheridan -- Rob Sheridan

18 rather, John Schultz, and I think Colleen Ryan.

19 In any case, it's an outstanding

20 team there. Dr. Sheridan and the rest of the

21 team are nationally renown as burn surgeons, and

22 it is a leading center for burn.

23 Q And you would include both Dr. Ryan

24 and Dr. Schultz in that category, as well?

25 A Sure. 

00081

1 Q Who did this ENT consult on --

2 A That consult on 5/10 was performed

3 by Dr. Bruce Suzuki.

4 Q And like all the consults, that

5 would have been done on your direction, correct?

6 A Or Dr. Lie-Nemeth's. I believe

7 this is probably at my request.

8 Q And what would you have taken away

9 from this ear nose and throat consult?

10 A He identified a right vocal cord

11 paralysis, which he attributed possibly to the

12 intubation. She also had pharyngeal weakness,

13 and he was suggesting a gastrostomy tube to help

14 eliminate the need for the nasogastric tube.

15 He also recommended speech evaluate

16 her for any speech difficulties but noted that

17 she was actually pretty well compensated for her

18 right vocal cord weakness. She was, in fact,

19 receiving speech and language pathology services

20 already at this time.

21 Q He says he is considered a peg, and

22 I take it that's a gastronomy tube.

23 A A peg is another term for

24 gastrostomy tube, that's correct.

25 Q And that was later put in instead 

00082

1 of her nasogastric tube?

2 A That's correct.

3 Q And on the next day, May 11th, you

4 have a note, and that would have been for time

5 reference, approximately two weeks into her

6 hospitalization at Spaulding, correct?

7 A I'm sorry. On 5/11?

8 Q Yes, sir.

9 A Roughly, yes.

10 Q And roughly two weeks into her

11 hospitalization is one of the things in your

12 assessment and plan you're speaking of is that

13 she is, in fact, going to get this gastrostomy

14 tube instead of her nasogastric tube.

15 A I indicated that I would discuss it

16 with the patient and then prepare for actually

17 making that -- prepare for that procedure by

18 putting her on Fragmin instead of Coumadin.

19 Q Those are both blood thinners,

20 correct?

21 A Anticoagulants, correct.

22 Q And you're prescribing these

23 anticoagulants/blood thinners because of her

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24 deep vein thrombi, correct?

25 A That is correct, because of her 

00083

1 history of deep venous thrombosis.

2 Q A deep vein thrombi is not an

3 uncommon occurrence of either surgeries or

4 lengthy hospital stays, correct?

5 A It's a common complication seen in

6 patients in her circumstance with complex

7 hospital courses.

8 Q Okay. Deep vein thrombi are

9 anticoagulation problems where there is too much

10 clotting, and the clotting forms a clot usually

11 in the legs or arms, and the concern is it might

12 travel to the lungs or pulmonary system, fair?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 83:15 - 87:17

15 A Broadly stated, yes.

16 Q You told us that Karen went ahead

17 and got this gastrostomy tube placed in her

18 stomach, correct?

19 A That's correct.

20 Q Who did that procedure and where

21 was it done?

22 A It was done in Mass General

23 Hospital by radiology -- interventional

24 radiology. I'm not sure I know the

25 radiologist's name. 

00084

1 Q So, again, that would have involved

2 the transfer of Karen by ambulance or ambulette

3 to Mass General for that procedure?

4 A That's correct. She would not have

5 been admitted there. It was simply a same-day

6 procedure.

7 Q That would have been a couple of

8 hours at MGH and then however long it took to

9 transfer her back?

10 A That's correct.

11 Q What day was that done, please?

12 A It appears to have been done on May

13 16, 2005.

14 Q You're on page which that tells you

15 that?

16 A I'm seeing that in my note on page

17 1544. In fact, there is a note from the

18 resident on duty that evening confirming that

19 she returned after peg placement.

20 Q The resident's note is on the top

21 of 1544?

22 A On 1545, it's titled PM&R ROC, and

23 it stands for resident on call.

24 Q Got it. Can you read us that

25 resident's note, please? 

00085

1 A "Subjective: Called to see patient

2 regarding return from peg placement. Patient

3 complains of increased gas. Instructions state

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4 may use peg if positive bowel sounds.

5 Objective: Abdomen plus bowel sound times 4,

6 slightly decreased, mild diffusely tender.

7 Abdomen without rebound. Assessment plan one,

8 status postpeg, positive bowel sound. Okay to

9 use peg. No tube feeds times 24 hours per nurse

10 instructions."

11 Q And when he says "okay to use peg,"

12 does that mean you can turn the peg on or off?

13 A It means it is okay to provide the

14 patient fluids and feedings through the tube, as

15 well as medications.

16 Q Was Karen getting both medication

17 and nutrition through this gastrostomy tube that

18 was surgically inserted in her stomach or

19 abdomen?

20 A Correct.

21 Q And this resident physician made

22 that note on May 15th at 9:00 o'clock?

23 A 9:00 p.m.

24 Q What is his or her name?

25 A David Wang. 

00086

1 Q You would have had many resident

2 physicians who have been involved in the care

3 and treatment of Karen and ultimately reporting

4 to you their observations, correct?

5 A She was not on a teaching service.

6 I don't believe I had a resident following her

7 at the time, so there were probably a few

8 involved, but not many.

9 Q Would those doctors who were in the

10 residency program had been participating in the

11 team meetings that you were ultimately in charge

12 of?

13 A I don't believe they were in her

14 case.

15 Q So the team meetings would have

16 comprised what health care providers, please,

17 that you were in charge of?

18 A Generally or the specific meetings

19 that occurred with her? I can say generally who

20 attends, but --

21 Q Generally, please.

22 A Generally it includes the

23 physician, the case manager, a nurse, the

24 physical, occupational, and speech therapists.

25 That's the core team. 

00087

1 Q Okay. Thank you.

2 I forgot to ask you something about

3 the pulmonologist's note which I will find, and

4 I'm going back and finding it. Here it is.

5 Dr. Johnson, the pulmonologist,

6 notes on page 25 he speaks of a question of

7 tracheobronchitis; what is that and what was he

8 questioning, please?

9 A Tracheobronchitis is an infection

10 of the trachea and bronchi. It is generally a

11 less severe condition than pneumonia; and he was

12 raising the possibility, although it was

13 ultimately not felt to be the case.

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14 Q Thank you.

15 How many swallow studies did Karen

16 have at Spaulding?

17 A It appears she had two.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 88:5 - 89:22

5 Is this your entry on the bottom of

6 1545 on May 17, '05?

7 A Yes.

8 Q Can you read us your assessment

9 plan, please?

10 A "Begin use of G-tube and G-tube

11 removed. Resume Coumadin, continue Fragmin

12 overlap, continue IV fluids until tolerating

13 G-tube feeds."

14 Q Tell us what that means, "continue

15 IV fluids until tolerating G-tube feeds."

16 A Because she had just had the

17 gastrostomy tube placed, some patients have some

18 certain transient weakness of the stomach

19 muscles, if you will, or reduced stomach

20 activity. So some people have difficulty in

21 absorbing the tube feeds when initially begun

22 after placement of the tube.

23 To ensure she didn't become

24 dehydrated we were continuing the intravenous

25 fluids until we were confident that she was able 

00089

1 to tolerate adequate amounts of fluid and

2 nutrition by the gastrostomy tube.

3 Q This IV fluid was through IV in her

4 arm or centrally located or where?

5 A I don't see it in my notes. I'm

6 not certain.

7 Q It could have been either?

8 A Correct. More than likely it was

9 in her arm, but I can't verify that.

10 Q And then teach us, please, what is

11 the preferred or more effective route at

12 delivering medications, if there is one, between

13 an IV and a G-tube.

14 A It's not a question of being more

15 effective. It depends on the medication.

16 Generally speaking, we prefer to avoid

17 intravenous medications when we can because it

18 creates a greater risk to the patient. You can

19 get infections through an IV and that sort of

20 thing. So in general when we can provide oral

21 medications or via a gastrostomy tube, we prefer

22 to do that.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 90:8 - 91:8

8 Q Okay. Let's go to your discharge

9 summary, please.

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10 A What exhibit is that?

11 Q Thirty four.

12 And in your approximate third

13 sentence, fourth line, you said she had a

14 lengthy hospital course and required intubation

15 and tracheostomy placement, as well as

16 nasogastric tube feedings.

17 So that's referenced to which

18 hospitalizations, please?

19 A Multiple hospitalizations prior to

20 her Spaulding arrival, so as you have identified

21 previously, initial hospitalization at a

22 community hospital and then subsequent transfer

23 to Mass General at some point, et cetera.

24 Q Thank you.

25 And would it be fair to say that 

00091

1 while it wasn't your primary mission to

2 determine the etiology of Karen Bartlett's TEN,

3 it was something, a piece of data that was

4 important to you just like all other data in

5 caring for the patient, and obviously it had

6 potential implications regarding what you might

7 advice the patient to avoid in the future to

8 obviously hopefully avert this situation again?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 91:13 - 93:2

13 A Yes.

14 Q Thank you.

15 And in your second sentence you

16 write, "the exact etiology was" -- you are

17 referring to her TEN and it says -- "exact

18 etiology was unclear. The possibility of

19 nonsteroidal anti-inflammatory drugs" -- or

20 NSAIDs for short -- "or some food were

21 considered."

22 Is that what you wrote?

23 A That's what I wrote.

24 Q Tell us, please, Dr. Stein, are you

25 aware of any patient that you have ever treated 

00092

1 or known of where a conclusion was made that

2 they got TEN from or diagnosis was made that

3 they actually got TEN from Chinese food or food

4 or a stomach flu?

5 A I have not cared for any patients

6 in whom that was the -- aside from this

7 possibility, but no other patients for whom that

8 was entertained as a diagnosis.

9 Q Let me be broader then.

10 Have you ever seen or heard of any

11 study which in your view or estimation where you

12 were told that establishes a causal link or

13 raises a strong evidence of a causal link

14 between any food or Chinese food and getting TEN

15 or toxic epidermal necrolysis?

16 A I have not seen any literature to

17 that affect; although, this is not an area of

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18 expertise for me, and it's not literature that I

19 normally would seek out or read.

20 Q Understood. Is it also fair to say

21 that while you know of a lot of literature and

22 hear about a lot of literature as the -- as a

23 doctor, even though it's not in your particular

24 area of expertise, where you might read the

25 JAMA, you might occasionally read an NAJM, even 

00093

1 though it's not in your particular area of

2 expertise, fair?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 93:5 - 93:6

5 A I do read articles in general

6 medical journals about a variety of topics.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 93:11 - 94:3

11 Have you ever read or heard of a

12 published case series or even a case report,

13 meaning a single case, where any doctor in any

14 publication ever reported in his or her

15 estimation a link at all between any food,

16 Chinese food included, and getting TEN, toxic

17 epidermal necrolysis?

18 A I have not seen any such reports.

19 Q Bearing in mind that the Mass

20 General infectious disease consults we have

21 looked at including the one of March 24, '05

22 that diagnosed TEN likely secondary to NSAIDs,

23 and both infectious disease consults had NSAID

24 at the top of their differential without mention

25 of Chinese food as a possible cause; is it also 

00094

1 your understanding that the NSAID Sulindac would

2 have been the more likely cause of Karen

3 Bartlett's TEN and not some food she ate?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 94:6 - 94:12

6 A I have indicated I am not an expert

7 in this area. My limited knowledge of it would

8 lead me to suspect that the nonsteroidal

9 anti-inflammatory medication might be a more

10 likely candidate, but it's a very limited

11 knowledge of this area.

12 Q But bearing in mind it's, what you

Witness_ Joel Stein, M.D. - Vol. 1.txt: 95:1 - 95:8

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1 Q Sure. Is what supports the

2 testimony you just gave that the NSAID Sulindac

3 is more likely the cause of Karen Bartlett's TEN

4 is the lack of ever hearing any study that ties

5 food with TEN and the lack of ever hearing any

6 colleague of yours in your medical career tell

7 you that they believed anyone they had ever seen

8 got TEN from food, Chinese food included?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 95:11 - 95:18

11 A To reiterate, it has not been a

12 topic that I have invested a lot of time in, so

13 you are correct in your conjecture that I have

14 not heard about this from others, you know as

15 food as a cause, but I -- there is a long list

16 of things that may cause it that I haven't heard

17 about, so I really have to reemphasize that this

18 is not an area of expertise of mine.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 95:21 - 96:5

21 My questions obviously asked about

22 food or Chinese food. Let me be a little

23 broader, Doctor.

24 Have you ever heard of any study

25 that claims there is a causal link or is 

00096

1 evidence of a causal link between -- I used the

2 word any food before, let me elaborate, I mean

3 food poisoning, seafood, fruit, Mexican food,

4 Greek food on the one hand, and getting TEN on

5 the other hand?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 96:8 - 96:19

8 A I'm unaware of any such studies --

9 let me restate that. I have not seen any such

10 studies.

11 Q And of course, there's studies in

12 the next question.

13 Have you ever heard of any

14 published case series of even a single case

15 report where any doctor in the world ever

16 suggested that there might be a link between any

17 type of food, food poisoning, seafood, fruit

18 Italian, Mexican, Greek on the one hand and

19 getting TEN on the other hand?

Witness_ Joel Stein, M.D. - Vol. 1.txt: Page 96, Line 22

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22 A I have not seen any such reports.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 96:24 - 99:13

It is a medical term for a

25 stomach flu, fair? 

00097

1 A Sure.

2 Q Have you ever heard of any study

3 that supports a causal link or is evidence of a

4 causal link between a stomach flu or

5 gastroenteritis on the one hand and getting TEN

6 on the other hand?

7 A No.

8 Q Have you ever heard any doctor at

9 any time in your career or read any medical

10 record any time in your career that lead you to

11 believe that any doctor thought, conjectured,

12 concluded, or diagnosed that the stomach flu or

13 gastroenteritis on one hand caused TEN on the

14 other hand?

15 A It was alluded to in this patient's

16 record, aside from that, no.

17 Q You and Keith Jensen, for the

18 record, have never met before, correct, Dr.

19 Stein?

20 A Not in person, no.

21 Q We have spoken approximately how

22 many times before your deposition, sir?

23 A I believe twice.

24 Q Okay. And how many of those

25 approximate two conversations were substantive; 

00098

1 let me define substantive as conversations that

2 actually involved your care and treatment of

3 Karen Bartlett as opposed to

4 when-can-you-be-available-for-your-deposition5 type communications?

6 A Just one of them.

7 Q When was that conversation?

8 A Early this week.

9 Q Did I advise you that you had the

10 right to, if you chose, to send me a bill for

11 your customary hourly rate to compensate you for

12 time spent away from your practice of seeing and

13 treating patients for the time you spent

14 reviewing these records of your former patient

15 or speaking with me or giving your deposition

16 today?

17 A Yes.

18 Q What is your customary and hourly

19 rate that you might intend to charge in that

20 regard?

21 A $225 an hour.

22 Q As we sit here now, just best

23 estimate, sir, what's your estimate of how many

24 hours that you've spent in reviewing the records

25 and/or speaking with me and now giving your 

00099

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1 deposition for a couple, three hours?

2 A In addition to the time today, I

3 believe approximately two hours of time prior to

4 that.

5 Q Would it be fair to say, Dr. Stein,

6 that while you've been kind enough at my request

7 to review your old medical records from

8 Spaulding Rehab of your care and treatment of

9 Karen Bartlett and I have agreed to compensate

10 you for your time away from your medical

11 practice that I have not retrained you in any

12 way in relation to this lawsuit?

13 A Correct.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 123:4 - 124:24

4 Q Dr. Stein, has all of your

5 testimony that you provided today been to your

6 ability based on a reasonable degree of medical

7 certainty or probability?

8 A I'm not sure I fully understand

9 that term, but to the best of my understanding

10 of that term, yes.

11 Q Do you recall the questions you

12 were asked by counsel for the defendant

13 regarding whether or not you've published or

14 gotten sought or received grants regarding

15 studying the cause or etiology of TEN or adverse

16 reactions?

17 A Yes.

18 Q Have you ever published or sought

19 grants regarding the proper utilization of

20 NG-tubes or G-tubes or the treatment of VRE

21 bacteremia, SVTs, ARDS, DVT or maintaining

22 proper anticoagulation levels, any of those

23 things?

24 A Yes.

25 Q Which ones? 

00124

1 A I've published a little bit on the

2 use of anticoagulation and the risk of false --

3 on anticoagulation, and I have published on the

4 use of feeding tubes, gastrostomy tubes in

5 stroke survivors.

6 Q Got ya. The other area is

7 NG-tubes, VRE bacteremias, SVTs, ARDS, DVTs.

8 You've never published or sought any grant

9 moneys to research those areas, fair?

10 A That is correct.

11 Q Nonetheless, do you consider

12 yourself capable and qualified of knowing how

13 and when and why to prescribe and administer

14 NG-tubes and competent and qualified to know

15 how, when, and why to manage and respond to or

16 refer to specialists if you are dealing with VRE

17 bacteremia, SVTs, ARDS and DVT?

18 A Yes.

19 Q Simply stated, is it fair to state

20 that you have expertise as the medical doctor

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21 you are, double board-certified, licensed in two

22 states, professor at Harvard for many, many

23 years, in many areas that you've never published

24 and never sought any grant money for?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 125:2 - 125:4

2 A I would agree that I have expertise

3 in areas outside of those in which I have

4 published or sought grant funding.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 125:13 - 125:20

Speaking of food

14 additives, Dr. Stein, have you ever heard of a

15 study that links causally or that provides

16 evidence to anyone's estimation of a causal

17 relationship between food additives on the one

18 hand and getting TEN on the other hand?

19 A I'm not familiar with any such

20 study.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 126:1 - 127:14

Have you ever heard

2 of any published case series or even a single

3 case report or any doctor in your career ever

4 musing, diagnosing, or concluding that any

5 patient in the history of the world has ever

6 gotten TEN, toxic epidural necrolysis, from a

7 food additive?

8 A With the exception of this

9 particular case where there is speculation about

10 the role of food, I'm not familiar with any

11 other reports.

12 Q Is it correct to state that you

13 understood, even though you are not a burn

14 surgeon, but you were the director of burn

15 rehabilitation at Spaulding Rehab for

16 approximately eight or ten years that you then

17 understood and still now understand that TEN is

18 an extremely serious disease, defining serious

19 as having a very high risk of death and often

20 involving ocular complications including

21 blindness?

22 A That is consistent with my

23 understanding of TEN, yes.

24 Q And when you mentioned to counsel

25 for the defendant that if you were to -- I think 

00127

1 you used the word critique your discharge

2 summary, you might have mentioned her eye

3 involvement.

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4 Would it be fair to say that if, in

5 fact, it is true that as we sit here in August

6 2009, Karen Bartlett has undergone eight

7 different eye surgeries all under the care of

8 Mass Eye & Ear Infirmary and might soon undergo

9 a ninth and has extremely limited vision, many

10 doctors would define it as legally blind in both

11 eyes, those are, if true, rather severe

12 complications which have lasted at least

13 approximately four years beyond your last care

14 and treatment, fair?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 127:16 - 128:6

16 A Yes, I would agree.

17 Q Do you recall the defense

18 attorney's questions regarding a history of

19 atopic conditions?

20 A Yes.

21 Q And you mentioned there is a note

22 of eczema somewhere in the record?

23 A Yes.

24 Q What is an atopic condition?

25 A I'm not an expert in atopic 

00128

1 dermatitis, but generally it's sort of a skin

2 rash typically that often characterizes eczema,

3 as well. People with atopic dermatitis or

4 eczema are also prone to certain other allergic

5 phenomenon or, for example, they may have asthma

6 or related conditions.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 128:9 - 128:24

Have you ever heard of

10 either a study linking or a study purporting to

11 provide evidence in favor of a causal link

12 between or have you ever heard of a case series

13 or case report or have you ever heard of a

14 doctor in your entire career opine, conclude,

15 surmise, mention that any atopic condition on

16 the one hand might be a cause for toxic

17 epidermal necrolysis on the other hand?

18 A I'm not familiar with any such

19 literature, again, reminding you that I'm not

20 someone that follows this literature, and I

21 couldn't speculate on what might be published

22 that I haven't read.

23 MR. JENSEN: After the word

24 literature, nonresponsive.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 129:2 - 129:11

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2 Q And have you ever heard any doctor

3 in your entire career conclude, opine, mention

4 that they believe some atopic condition had ever

5 caused TEN in any patient of theirs or any

6 patient they knew of?

7 A No.

8 Q And what your discharge summary

9 stated -- tell me when you are there, please,

10 sir.

11 A Yes, I'm there.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 130:13 - 130:25

13 Is your entry of previously healthy

14 woman in your discharge summary, is what that

15 means, Doctor, is from your perspective from all

16 the information you had, (a) to the extent you

17 looked at electronic records from Mass General,

18 and (b) from all the physicians that and other

19 health care providers with whom you worked at

20 Spaulding, there is nothing about Ms. Bartlett's

21 history which contributed to any of the

22 conditions you treated, other than the NSAID,

23 which was identified in the Spaulding records by

24 the Mass Eye & Ear Infirmary doctors as Sulindac

25 or the concept that was floated of some food? 

Witness_ Joel Stein, M.D. - Vol. 1.txt: 131:3 - 131:16

3 A The statement said that she was

4 previously healthy it's an overall

5 characterization of her state of health. I

6 wouldn't read it as anything more than that.

7 Q Referring you, Doctor, to Exhibit

8 32. Tell me when you are there, please.

9 A Okay.

10 Q Those six pages are four consults

11 from Mass Eye & Ear, one consult from Mass

12 General burn surgery and one consult from Mass

13 General radiology for a G-tube placement. And

14 all six of them all identify an allergy to NSAID

15 and specifically identifies Sulindac and no

16 other NSAID, correct?

Witness_ Joel Stein, M.D. - Vol. 1.txt: 131:19 - 132:10

19 A Just to clarify, these forms which

20 were sent from Spaulding to the outside

21 facilities all list nonsteroidal

22 anti-inflammatory drugs, as well as Sulindac as

23 allergies, nonsteroidal anti-inflammatory drugs

24 being a broader category that includes Sulindac.

25 That was recorded by the Spaulding nursing or 

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00132

1 clerical staff from the record of allergies.

2 Q Thank you, Doctor.

3 And you've never seen any reference

4 to any NSAID other than Sulindac at any

5 Spaulding record or any Mass General record; is

6 that correct?

7 A I have not seen any.

8 MR. JENSEN: Thank you again

9 for your excellent care and

10 treatment of Karen Bartlett, Doctor.

Witness_ Joel Stein, M.D. - Vol. 1.txt: 135:4 - 135:20

4 Q Doctor, have you ever heard anyone

5 in the history of medicine suggest that when you

6 start taking a medication like Phenytoin, brand

7 name Dilantin, well after you get TEN, like in

8 this example that the defense attorney just

9 showed you on May 8th, and she had TEN by

10 February 2nd or February 4th at the latest, so

11 this is three months and about five days later,

12 have you ever heard anyone suggest that taking a

13 drug three months after you get TEN might have

14 caused your TEN three months before then?

15 A No.

16 Q Simply stated, a drug can't

17 possibly cause a disease when you had that

18 disease three months before you took the drug;

19 is that a fair and correct statement?

20 A Yes.

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 Page 38 of 44 

Deposition of Joel Stein, M..D. – August 6, 2009

Pg: 18 Ln: 1 - 5 

Objection: Irrelevant. 

Annotation: 

 18: 1 Q Do you know whether or not you 

 2 would have had access to that page after Karen 

 3 Bartlett was transferred to Spaulding 

 4 Rehabilitation Hospital? 

 5 A It's unlikely. 

Pg: 18 Ln: 6 - 10 

Objection: Irrelevant. 

Annotation: 

 18: 6 Q Exhibit 23 is a typed-up physical 

 7 therapy service record. 

 8 Would you have had access to that 

 9 document at Spaulding? 

 10 A I don't believe so. 

Pg: 25 Ln: 8 - 15 

Objection: Irrelevant. 

Annotation: 

 25: 8 Would you have likely seen Exhibits 

 9 29 and 30, which are the history and physical 

 10 and discharge summary respectively from 

 11 Northeast Rehab Hospital? 

 12 A Most likely not. Occasionally 

 13 these records are duplicated, xeroxed and sent 

 14 with the patient's chart, but I would say that's 

 15 infrequent and unlikely to have been the case. 

RULING: 

RULING: 

RULING: 

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 Page 39 of 44 

Pg: 91 Ln: 15 - 23 

Objection: Irrelevant. 

 Rule 401. 

 Rule 403. 

 Rule 26(a)(2)(A). 

Annotation: 

 91:15 And in your second sentence you 

 16 write, "the exact etiology was" -- you are 

 17 referring to her TEN and it says -- "exact 

 18 etiology was unclear. The possibility of 

 19 nonsteroidal anti-inflammatory drugs" -- or 

 20 NSAIDs for short -- "or some food were 

 21 considered." 

 22 Is that what you wrote? 

 23 A That's what I wrote. 

Pg: 110 Ln: 8 - 25 

Objection: Subject of Plaintiff’s Motion In Limine No. 14 

 Rule 401. 

 Rule 403. 

 Rule 26(a)(2)(A). 

Annotation: 

110: 8 Q We had marked this document 

 9 previously. I don't remember what the exact 

 10 number was, but this is the document that in the 

 11 first paragraph "history of present illness 

 12 provides the exact etiology was unclear, though 

 13 the possibility of nonsteroidal 

 14 anti-inflammatory drugs or some food was 

 15 considered." Did I read that correctly? 

 16 A Yes. 

 17 Q And that's your statement, Doctor? 

 18 A It is. 

 19 Q What is etiology? 

 20 A Cause. 

 21 Q Did you reach any conclusion to a 

 22 reasonable degree of medical or scientific 

 23 certainty about the cause of Mrs. Bartlett's 

 24 condition? 

 25 A No. 

RULING: 

RULING: 

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 Page 40 of 44 

Pg: 118 Ln: 4 - 6 

Objection: Subject of Plaintiff’s Motion In Limine No. 14 

 Rule 401. 

 Rule 403. 

 Rule 26(a)(2)(A). 

Annotation: 

118: 4 Q Would you agree that an opinion on 

 5 that issue would be beyond what you saw and what 

 6 you did to and for Ms. Bartlett? 

Pg: 118 Ln: 17 - 23 

Objection: Subject of Plaintiff’s Motion In Limine No. 14 

 Rule 401. 

 Rule 403. 

 Rule 26(a)(2)(A). 

Annotation: 

118:17 Q Doctor, my question is a little 

 18 different. If I understand your prior testimony 

 19 correctly, tell me if I'm wrong, but as you sit 

 20 here today, you do not have an opinion to a 

 21 reasonable degree of scientific medical 

 22 certainty about what caused Ms. Bartlett's SJS 

 23 or TEN? 

Pg: 120 Ln: 1 - 6 

Objection: No Question asked. 

Annotation: 

120: 1 A The impression that -- from the 

 2 prior physicians that cared for her and carried 

 3 forward in my notes is that it was due to an 

 4 uncertain cause, perhaps a nonsteroidal 

 5 antiinflammatory medication, perhaps food 

 6 related. 

RULING: 

RULING: 

RULING: 

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 Page 41 of 44 

Pg: 120 Ln: 7 - 10 

Objection: Irrelevant. 

 Rule 26(a)(2)(A). 

Annotation: 

120: 7 Q So your testimony is consistent 

 8 with the statement in your discharge summary, 

 9 correct? 

 10 A Correct. 

Pg: 120 Ln: 22 - Pg: 121 Ln: 6 

Objection: Subject of Plaintiff’s Motion In Limine No. 14 

 Rule 401. 

 Rule 403. 

 Rule 26(a)(2)(A). 

Annotation: 

120:22 Do you knowif Ms. Bartlett had a 

 23 history of atopic conditions prior to the 

 24 incident that required your care and treatment? 

 25 A I don't recall seeing that in the 

121: 1 record. It was indicated. I'm sorry. If you 

 2 look at page 9 of the -- what do they call them? 

 3 Q The Bates number? 

 4 A Bates number, thank you. 

 5 Eczema is listed as a past medical 

 6 history item. 

Pg: 121 Ln: 7 – 13 

 

Objection: Irrelevant. 

Annotation: 

121: 7 Q How many patients have you treated, 

 8 Doctor, that have experienced SJS or TEN? 

 9 A I'm not certain. If I had to make 

 10 an estimate, it would be less than five. 

 11 Q Is SJS and TEN a rare condition? 

 12 A I'm not sure the definition of 

 13 rare, but it is, I would say, relatively rare. 

RULING: 

RULING: 

RULING: 

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 Page 42 of 44 

Pg: 121 Ln: 14 - 18 

Objection: Rule 401. 

 Rule 26(a)(2)(A). 

Annotation: 

121:14 Q Do you have an understanding one 

 15 way or the other if SJS and TEN are a recognized 

 16 adverse event with a wide variety of drugs? 

 17 A That is my understanding, that 

 18 there are multiple causes. 

Pg: 132 Ln: 16 - 24 

Objection: Rule 401. 

 Rule 403. 

 Rule 26(a)(2)(A). 

Annotation: 

132:16 Q You've been asked a couple of times 

 17 now about all kinds of literature concerning a 

 18 possible association between NSAIDs and SJS or 

 19 TEN, and I think basically you've testified that 

 20 you don't follow the literature in that regard. 

 21 And my question to you specifically 

 22 is that following the literature in that regard, 

 23 would any event be outside the course and scope 

 24 of your treatment of Ms. Bartlett, correct? 

Pg: 133 Ln: 11 - 13 

Objection: Irrelevant. 

Improper inclusion of statement by Counsel which cannot 

possibly be evidence or relevant. 

Annotation: 

133:11 treatment at Spaulding, do you know if she 

 12 received a medication called Phenytoin? 

 13 MR. JENSEN: Can you say that 

RULING: 

RULING: 

RULING: 

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 Page 43 of 44 

Pg: 134 Ln: 19 - 24 

Objection: Rule 26(a)(2)(A). 

 Irrelevant. 

 Rule 401. 

 Rule 403. 

Annotation: 

134:19 Q Do you know if Phenytoin sodium has 

 20 been associated with SJS or TEN? 

 21 A Absolutely. That's a yes. It is 

 22 one of the more, to my limited knowledge of the 

 23 field, one of the more commonly identified 

 24 causes. 

Plaintiff's Counter Designation. 

Pg: 135 Ln: 4 - 20 

Annotation: 

135: 4 Q Doctor, have you ever heard anyone 

 5 in the history of medicine suggest that when you 

 6 start taking a medication like Phenytoin, brand 

 7 name Dilantin, well after you get TEN, like in 

 8 this example that the defense attorney just 

 9 showed you on May 8th, and she had TEN by 

 10 February 2nd or February 4th at the latest, so 

 11 this is three months and about five days later, 

 12 have you ever heard anyone suggest that taking a 

 13 drug three months after you get TEN might have 

 14 caused your TEN three months before then? 

 15 A No. 

 16 Q Simply stated, a drug can't 

 17 possibly cause a disease when you had that 

 18 disease three months before you took the drug; 

 19 is that a fair and correct statement? 

 20 A Yes. 

 

RULING: 

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148

JOEL STEIN DEPOSITION – AUGUST 6, 2009

Pg: 49 Ln: 15 - 25

Annotation:

49:15 A Right. I think it says that on top

 16 because that's who the appointment was made

 17 with; however, it seems quite clear that

 18 Dr. Tsai wrote this note. I imagine she saw the

 19 patient. I don't know who Dr. Azar was. It's

 20 possible he was a resident or fellow.

 21 I don't -- it's really difficult

 22 for me to determine each person's role, but it

 23 seems fairly clear that Dr. Tsai did, in fact,

 24 evaluate the patient and wrote this note on May

 25 9th.

Pg: 112 Ln: 10 - 17

Annotation:

112:10 Q Do you have an understanding, one

 11 way or another, if there are food additives that

 12 can cause Stevens-Johnson syndrome or TEN?

 13 A I'm unaware. I don't know.

 14 Q Just so I understand your testimony

 15 correctly, you did not diagnose Stevens-Johnson

 16 syndrome or TEN in Ms. Bartlett, correct?

 17 A No, I did not.

OBJECTION: No question. Irrelevant.

 

OBJECTION: The first question and answer 

are irrelevant. The fact that he has no knowledge on 

a topic defines irrelevance. It is also the lack of an 

undesignated opinion.

 

RULING:

RULING:

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149

Pg: 113 Ln: 7 - 17

Annotation:

113: 7 Q As I understand your prior

 8 testimony, you were unable because you were not

 9 available at the facility to treat Ms. Bartlett

 10 for the entire course of her stay at Spaulding

 11 Rehab; is that correct?

 12 A I was only available for a portion

 13 of it, that's correct.

 14 Q Why were you unavailable for a

 15 portion of her treatment?

 16 A I'm not certain. I'm guessing I

 17 was on vacation, but I really don't know.

Pg: 113 Ln: 24 - Pg: 114 Ln: 20

Annotation:

113:24 Q Can you read for me or I'll read

 25 it, sir, on hospital course, which is Exhibit 4,

114: 1 page 3, bottom of the page, "patient was

 2 admitted for multidisciplinary rehabilitation

 3 program. She made steady gains in all areas.

 4 Her skin healed well, and she had no significant

 5 open lesions at the time of discharge. She was

 6 advised to use moisturizers and avoid sun

 7 exposure."

 8 A That's correct.

 9 Q "The patient made steady gains with

 10 regard to her respiratory function. She was

 11 decannulated and had no further difficulty with

 12 regard to her pulmonary function."

 13 Did I read that correctly, sir?

 14 A Yes.

 15 Q And, Doctor, can you tell me if

 16 that is a fair and accurate summary of her

 17 condition at the time she left Spaulding Rehab

 18 Hospital?

OBJECTION: Second question and answer are 

irrelevant.

 

RULING:

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150

 19 A Those statements are fair and

 20 accurate. There are other statements that I

Pg: 116 Ln: 8 - Pg: 117 Ln: 3

Annotation:

116: 8 Q Did Mr. Jensen comment to you about

 9 the claims or defenses in the lawsuit?

 10 A He indicated the lawsuit was

 11 contending that the nonsteroidal

 12 anti-inflammatory medication was the cause of

 13 her TEN and subsequent medical conditions, so

 14 that's sort of the essence of the lawsuit.

 15 Q Did he identify for you which

 16 nonsteroidal anti-inflammatory medication was

 17 allegedly at issue?

 18 A I believe he said Sulindac. He may

 19 have used the generic name. I don't recall.

 20 Q Do you have an understanding if

 21 Sulindac is a generic or branded product?

 22 A You know, I'm not certain.

 23 Q There was some discussion about

 24 your review of the scientific literature. Did,

 25 in fact, you review any of the scientific

117: 1 literature concerning adverse drug events prior

 2 to the deposition today?

 3 A No.

OBJECTION: The remaining portion of his 

answer after “accurate” should not be excluded as it 

is responsive to the question.

 

OBJECTION: The questions at lines 20 & 23 

are irrelevant.

 

RULING:

RULING:

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