Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 1 of …20-%2009... · 2019. 2. 8. · Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 1 of 107 N RE: IN THE UNITED COURT

Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 1 of 107

N RE:

IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN DISTRICT OF PENNSYLVANIA

MDL NO. 13-2436

YLENOL (ACETAMINOPHEN) KETING, SALES PRACTICE

PRODUCTS LIABILITY ITIGATION

Philadelphia, Pennsylvania August 26, 2015 10:06 a.m.

TRANSCRIPT OF CASE MANAGEMENT CONFERENCE BEFORE THE HONORABLE LAWRENCE F. STENGEL

UNITED STATES DISTRICT JUDGE

PPEARANCES,

For the Plaintiffs: LAURENCE S. BERMAN, ESQUIRE Levin, Fishbein, Sedran & Berman 510 Walnut Street suite 500 Philadelphia, PA 19106

R. CLAY MILLING, ESQUIRE Henry, Spiegel & Milling 950 East Paces Ferry Road suite 2450 Atlanta, GA 30326

CHRISTOPHER V. TISI, ESQUIRE Ashcraft & Gerel Suite 400 2000 L Street, N.W. Washington, DC 20036

Transcribers Limited

1 7 Riddmid Drii,e

Sewdl, NJ 08080

8%-'589-6100 • 8'56·589-9005


' 3

., 5

6

7

8

9

10

1 I

12

13

14

15

16

17

18

19

' 20

:0 21

0 22

23

24

25

APPEARANCES

For the Defendants:

Audio Operator:

Transcribed By:

( Continued)

MADELINE M. SHERRY, ESQUIRE Gibson, P.A. 1700 Two Logan Square 18th and Arch Streets Philadelphia, PA 19103

DAVID ABERNETHY, ESQUIRE Drinker, Biddle & Reath, LLP One Logan Square Suite 2000 Philadelphia, PA 19103

MICHAEL B. HEWES, ESQUIRE Butler Snow 1300 25th Avenue Suite 204 Gulfport, MS 39501

MS. O'NEILL, ESQUIRE (No appearance provided)

Laura Buenzle

Brad Anders

Proceedings recorded by electronic sound recording; transcript produced by computer-aided transcription service.

2


0

2

3

4

5

fi

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

3

{The following was heard in open court at

10:06 a.m.)

THE COURT: Good morning.

ALL: Good morning, Your Honor.

THE COURT: Please be seated. This is our

monthly case management conference in this Tylenol MDL,

and we have an agenda this morning and I thank counsel

for working together to prepare that agenda.

We have Mr. Berman, Mr. Milling and Mr. Tisi

here for the plaintiffs.

MR. BERMAN: Good morning, Your Honor.

MR. MILLING: Good morning, Your Honor.

MR. TISI: Good morning, Your Honor.

THE COURT: Mr. Abernathy, Ms. Sherry, Mr.

Hewes and Ms. O'Neill for the defense.

MR. ABERNETHY: Good morning, Your Honor.

MR. HEWES: Good morning 1 Your Honor.

MS. SHERRY, Good morning, Your Honor.

MS. O'NEILL, Good morning, Your Honor.

THE COURT, Your numbers are dwindling on

that side of the room. Then we have, it looks like,

nine counsel participating by telephone and they are

most welcome.

Let's start just with an update on the New

Jersey litigation. I have your letters from the


2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

- 23 �

24

25

plaintiffs' side and from the defense side. But, if

you could, Mr. Berman, just give me an update on where

we are with the New Jersey case.

MR. BERMAN: Certainly, Your Honor.

Yesterday late in the afternoon, and this is a

significant update, Judge Johnson made a variety of

rulings on the dispositive motions that are pending in

the New Jersey cases.

4

There are two cases pending there as

identified in the status letters. One case is known as

Taylor and the other case is known as Jackson. Judge

Johnson has decided that the Jackson case will be the

case to be tried. That is a New Jersey plaintiff case.

Taylor is an Oklahoma plaintiff case.

So, his covering letter to the parties stated

as such, although he reminded the parties that both

cases do remain before the court. I do have copies of

the orders and memoranda that he issued if the Court

would like those copies, and I can provide those to

you. I don't know if you want them or not, but if you

do --

THE COURT: Sure.

MR. BERMAN: -- if I may, and I believe

defense counsel have those.

THE COURT: I am happy to have them. Can you


©

2

3

4 I 5

6

7

8

9

10

1 1

12

13

14

15

16

17

18

19

20

21

22

23

24

25

5

hand them to Melissa, please.

MR. BERMAN: If I may approach?

THE COURT: Yes

MR. BERMAN: Thank you.

(Pause in proceedings.)

THE COURT: Thank you.

MR. BERMAN: Basically, Your Honor, with

respect to those rulings, as I stated he selected the

Jackson case as the case to go to trial and that is a

New Jersey plaintiff case.

What he ruled on yesterday was dispositive

motions and he decided that the case would proceed on

the basis of a design defect and theory of law. That

from the plaintiffs' perspective is a result of some of

the peculiarities of New Jersey law as to what is

available to be able to be litigated in a New Jersey

case .

I don't want to try to characterize what he

said or didn't say, but he did grant dispositive

relief to the defendants on the failure to warn claim,

on the warranty claim, and on the punitive damages

claim.

I would like to point out however that,

again, this we feel at least was as a peculiarity of

New Jersey law and the application of New Jersey choice


0

3

4

6

7

8

9

10

11

12

18

14

15

16

17

18

6

of law principles.

And, Your Honor has no New Jersey plaintiff

cases in this court because there would be a lack of

diversity of citizenship. I believe there may be six

or eight New Jersey cases that are pending before Judge

Johnson. The cases may or may not all be governed by

this ruling because of the timing of the date when Ms.

Jackson ingested her Tylenol.

It was a 2011 ingestion and as Your Honor may

recall from some of the materials in this case, there

was a change of warnings and other changes that

occurred in 2010.

The other case, the Taylor case, will proceed

on the basis of design defect and failure to warn, the

judge determining that under New Jersey choice of law

principles, Oklahoma law would apply for those

compensatory damage claims.

However, the judge did decide that under New

i9 Jersey choice of law principles, that the punitive

20

21

22

23

24

25

damages claim would be governed by New Jersey law and

he did grant defendants dispositive relief on that

claim.

If I may, Your Honor, that is somewhat

consistent with what Judge Johnson ruled last year in

the Lyles case relating to Alabama in our case,


0

1 I bellwether case pending before Your Honor, the Hayes

2 Terry case Your Honor had decided it under Alabama law,

3

4

5

6

and Pennsylvania choice of law principles that the

Alabama punitive damages claim would survive at this

point.

THE COURT: Right.

7

7

8

9

10

MR. BERMAN: I don't know if I have much else

to say about that. We are still scheduled for argument

tomorrow on additional kept motions, the equivalent of

Daubert motions. Briefing is still being completed on

11

12

13

14

15

17

the in limine motions.

My co-counsel may correct me if I am wrong,

but I believe there may be arguments scheduled next

week on some of those issues as well. The judge has

not changed the trial date as far as we know.

THE COURT: And when are you selecting a

jury?

18 MR. BERMAN: I believe it was around

19 September 17th or 18th. The 13th and 14th were the

20

21

22

24

25

Rosh Hashanah holidays -

THE COURT: Right.

MR. BERMAN: -- and he may have said the

14th. I am fairly certain he did not say the 13th

which is a Monday.

MR. MILLING: I think it's the 16th, Your


2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

2 1

0 22

23

24

25

Honor, and then I think the trial starts the next week,

maybe the 21st. Those are approximate dates

THE COURT, Okay.

MR. MILLING: -- but pretty close.

THE COURT: And will you be involved in

trying those cases?

Tisi.

MR. MILLING: Yes, sir, I will be as will Mr.

THE COURT: Right, okay. Do the defendants

have anything to add to the New Jersey report?

MR. HEWES: Nothing to add, Your Honor.

THE COURT: Okay. All right. Thank you.

(Pause in proceedings. )

THE COURT: At this point, I think we can

move to a discussion of the motions in limine.

MR. HEWES: Your Honor, I did have one

housekeeping issue I would like to bring up with the

Court.

THE COURT: Go ahead, Mr. Hewes.

8

MR. HEWES: It involves a potential discovery

dispute I just want to give Your Honor a heads up on.

Last month before the July conference, the

first week of July the plaintiffs served a hundred-plus

request for admissions on us, generic request for

admissions.


0

2

3

• I

6

7

8

9

10

1 1

12

13

14

15

16

17

18

19

20

21

22

23

24

25

9

We contacted them and met and conferred and

pointed out that per Your Honor's CM0-13 which states

11 Given that written discovery has already been served

and responded to in the New Jersey State Court

proceedings in individual Federal Court cases that have

since been transferred to this MDL, the PSC will not

serve additional generic written discovery, including

requests for admissions without first attending leave

of court."

We put that in the agenda for the July

conference. The plaintiffs said they didn't want that

in the agenda, so they withdrew the request for

admissions.

We submitted the agenda to you. Fast forward

to this past Friday, Your Honor, we submitted the

agenda to you with nothing on it. Late in the

afternoon on Friday, the plaintiffs again served us

with 141-plus generic request for admissions without

seeking leave of Court.

I just want to let the Court know we will

probably be -- even though we don't have a conference

next month, and I know a lot is going on with the Pope

coming, we will probably be submitting a discovery

dispute letter on this to Your Honor.

We don't believe that they should be served

- ----- ----- - --- --


1 I 2

4

s

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

0 ,,, "'

23

24

25

10

without first seeking leave of Court and giving us the

opportunity to respond and show that Federal Rule 26,

this information has been asked about and could have

been received from other topics throughout the millions

of documents that we served, the dozens of depositions

that have been taken.

So, with the trial starting in three weeks we

were frankly surprised to get these requests for

admissions without leave of Court and we would ask that

Your Honor -- when it comes up we will be asking Your

Honor to either strike them or allow us to respond and

possibly give us some extra time considering we are

going to be involved in a trial in three weeks.

THE COURT: Okay. We can certainly address

that in a conference call outside of the regularly

scheduled case management conferences, but you will be

in trial I think for most of September I would think

and into early October.

MR. HEWES: Yes, Your Honor.

THE COURT: When do we have our next case

management conference? Is that in October?

MR. HEWES, It's late October.

THE COURT, Late October, all right. Could

we defer this discussion until then?

MR. HEWES: We certainly would like to


2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

0 22

23

24

25

11

considering we've got a lot going on, Your Honor.

THE COURT: Mr. Milling?

MR. MILLING: I don't want to fall on my

sword. I was not here for the last -- I served what's

in the I was not here for the last conference. It

was my understanding that that was, as I understood it,

and I must have got it wrong, that it was brought up

and that essentially leave was either granted or there

was a discussion about this happening.

From the way my team described it, we were

told by McNeil! that I had initially drafted the

request to admit too broadly as request - - would say

McNeil! was aware of something and something.

I will tell you that every one of the request

to admit virtually I took word-for-word from deposition

testimony. I am trying to streamline not only this

trial but I deliberately served the request to admit

again and went through and redid them precisely so they

could be answered before the New Jersey trial because I

want to streamline all this litigation.

I don't want to try -- have to prove facts

that have been admitted to by corporate executives that

have been discussed throughout this litigation and that

I have cited in 141 requests to admit virtually

verbatim.


0

12

I have said in almost every request that

2 McNeill admits based on the sworn testimony of the

3 witness who served in this capacity the following. So,

5

6

7

8

9

10

11

12

13

14

15

1b

17

18

19

20

21

22

23

24

25

I have made it very simple, and I don't -- with all

respect, if I did it wrong, I apologize, but I don't

see this as a big burden.

I do see this as an opportunity for the

parties to get resolution on discrete facts that,

therefore, we don't have to try ever again because they

will either be admitted or denied.

THE COURT: Would those admissions then be

useful in the New Jersey case?

MR. MILLING: I believe they would.

THE COURT: All right. Is the defense

willing to answer those in advance of the New Jersey

case?

MR. HEWES: Respectfully, Your Honor, we

think that he should follow the procedures laid out to

the Court and the timing here is suspect. Federal

Rules of Civil Procedure 26 (b} (2) (c) (1) says that 11 If

the plaintiff has had ample opportunity to obtain the

information by discovery in this action, it's not

proper. 11

We deserve the opportunity to respond to a

motion for leave of Court to serve these requests for


2

3

" I

5

6

B I

I 10

11

12

13

14

15

16

17

18

19

20

21

0 22

23

24

25

admission in any event. And, you know, they are 30

days out to answer and we did have some exchange for

request for admission regarding documents. The

plaintiffs asked for 60 days extension for those, we

gave it to them.

13

Regardless of whether this goes forward now,

we are going to be petitioning for additional time to

respond to these, not to get around the trial. But,

responding to 141 generic request for admissions is a

pretty (inaudible) undertaken especially when they are

not allowed by the Court.

My intention and I was assuming Mr. Milling

would grant it, was to ask for at least 30 or 60 more

days to address this or put this off until the end of

trial.

But, for them to serve them after we served

the agenda, after we had already gone through this in

July is problematic for us, Your Honor, frankly. He

said he got them directly from depositions. These

questions were asked at depositions, Your Honor.

So, if Your Honor orders us to respond to

them, certainly we will, but we think that the proper

procedure should be followed. We think that we deserve

an opportunity to petition the Court and show why these

requests for admissions are improper in the first place


0

14

before we have to substantively address them.

2 The only reason I am bringing it up, Your

3 Honor, is because I didn't want Your Honor to be

•

' e '

7

8

9

'0

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

surprised and say why didn't you bring this up at our

conference when you knew they were pending, and that's

why I am {inaudible) here today.

THE COURT: Okay.

MR. MILLING: Your Honor, just the last point

again, just following the sword, but I think

respectfully two things. This is going to help us a

lot with our deposition designations, number one. We

are not going to have to play a lot of deposition

testimony if the points are admitted. It is going to

shorten the trial tremendously.

Number two, I think really what the defense

is doing is putting procedure over substance. If I

didn't get leave of Court I apologize. We are in

discovery in this case, this trial has been pushed back

to November.

I have gone through great lengths to pull out

specific facts that work its way through the chronology

that the Court is familiar with, and I think really

what we are hearing is that the defense -- the request

to admit are tough on both parties.

But they are really designed to streamline


2

3

4

5

6

7

8

9

10

1 1

12

13

14

15

16

17

18

u

20

21

0 22

23

24

25

15

the evidence, you know, and while they have -- they are

going to claim they don't have time, to the flip side

is as to one of our a project that is highly

confidential, we can't discuss, I just received two

days ago 24,000 more pages on that issue that we

discussed last year and we're three weeks out from

trial, and I've got to go through that so we are both

working.

But, to me to say I want to go through the

procedure of filing a letter to ask the Court for leave

of Court when our trial is in November and there is no

question what I am doing. I am litigating and I am

trying to advocate my position, I am trying to

crystallize it.

It is what litigants do before trial and it

seems to me it would help us on deposition

designations, streamline New Jersey, and streamline

this case and delay would further none of those, quite

frankly.

MR. HEWES: I don't know what --

THE COURT: Have you requested leave of Judge

Johnson to file these

MR. MILLING: Discovery is closed in that

case. That is why I did not serve them in that case.

MR. HEWES: And, respectfully, Your Honor,


2

3

4

5

6

7

8

9

10

1 1

12

13

14

15

16

17

18

18

20

i 21

0 22

23

24

25

16

these cases were filed in 2011. These depositions were

taken over a year ago. To serve them on the eve of

trial in a different jurisdiction and making the

argument that they needed to be answered to respond to

another trial is a little but disingenuous.

THE COURT: Yes. I am willing to handle them

in the context of this case. I am not willing to

expedite the responses so that they can be used in the

New Jersey case.

MR. MILLING: Fair enough.

THE COURT: All right. So, we will put those

on the -- I think you should file your response or your

request for leave to respond to those --

MR. HEWES: Yes, Your Honor.

THE COURT: -- and we will get that on the

October agenda.

MR. HEWES: Thank you, Your Honor.

MR. MILLING: Can I get credit for honesty?

THE COURT: Yes, absolutely, absolutely.

Okay. Let's talk about the evidence to the motion to

exclude evidence or reference to adverse and reports.

That's motion in limine one. Mr. Hewes.

MR. HEWES: Yes, Your Honor, thank you, and

good morning again. Michael Hewes on behalf of

defendants McNeil! and Johnson and Johnson.


0

,-

17

I am here on this first motion in limine,

2 Your Honor, dealing with adverse event reports. As

3

4

5

6

7

Your Honor is aware, adverse event reports are nothing

more than anecdotal submissions reporting an alleged

ingestion or an alleged exposure followed by some type

of event.

They are racked with hearsay. They can range

from somebody taking the medication and immediately

throwing up and reporting that as an adverse event.

10 the extreme where somebody takes the medication and

gets hits by a bus and it's later reported that they 11

To

12

1 3

14

15

16

17

18

19

20

21

22

23

24

25

took the medication and died, and so they run the whole

gamut, Your Honor.

They are multiple layers of hearsay. For

instance, an adverse event can be an intake person

reporting a report from a nurse who received an event

from a doctor who took a history from a mother who is

talking about the medication her teenager ingested.

Adverse events as they relate to

acetaminophen are problematic for two reasons. They

are problematic because they lack a comparator or a

control group, and they are problematic because when we

are talking about over-the-counter medications, unlike

prescription medications the dosing history which is

crucial to these type cases is often lost, and with


0

�

•

4

5

6

7

acetaminophen it is kind of a double whammy because

Your Honor has heard about acute liver failure and to

properly diagnose acute liver failure, if somebody

presents with acute liver failure two clinical signs

have to be present.

One, there has to be coagulopathy present

which is a blood clotting issue, and the second issue,

18

•

10

8 1 Your Honor, is there has to be encephalopathy, and

encephalopathy is a brain swelling that presents in two

ways.

11

12

13

14

15

16

17

18

19

20

21

22

23

24

�

It presents with alter mentation and it

presents with {inaudible) or somebody who has passed

out and so it is impossible to get a good history if

somebody presents with acute liver failure.

Because of the problems with adverse events,

on the hierarchy of epidemiological evidence, the

adverse events are on the bottom rung. We have

randomized double blind placebo controlled trials at

the top which you have two groups, an exposed group and

a non-exposed group under a given medication in

detailed doses.

They are tracked over a period of time, and

the exposed group is compared to the non-exposed group

to see if there is any evidence of causation and, of

course, they are double blind because neither the


2

3

' 5

6

7

8

g

10

11

12

13

14

15

16

17

18

10

20

21

@ 22

23

24

25

----- -- --

19

patients nor the clinicians know what dose was given.

If you go lower on the hierarchy of

epidemiological evidence, you have cohort studies.

Cohort studies are studies of exposure with an exposed

group and a non-exposed group, and you may see somebody

who receives the medication, compare the medical

records of somebody who has not received the

medication.

They are tracked over a period of time

prospectively to see if there is an event, or they are

retrospectively tracked to see if there is any type of

event and they are compared to see if there is a

statistically significant risk associated with the

medication.

Lower down on the pole, Your Honor, on the

hierarchy, you have case control studies which are

similar to retroactive cohort studies, but they are

based upon an outcome, so the clinicians will find the

disease, they will match it with a demographically

similar group of people or persons and they will

backtrack it to see if they can assign a relative risk.

Common in these three reliable

epidemiological studies or types of studies is the

control group. You have an exposed group with the

control group and the comparisons are made to see if


.

3

4 I

5

6

7

8

g

10

1 1

12

13

14

15

16

17

18

19

20

2 1

22

23

24

25

there is any legitimate scientific basis to assign an

exposure to a reported event.

And below these control groups you have

adverse events. You have case reports which are

20

basically adverse events that are published in the

literature are case series, which are a series of case

reports published in the literature.

These adverse events, as it relates to

acetaminophen and it relates to over the counter drugs

in the literature have been consistently and repeatedly

found to be unreliable and they have been consistently

and repeatedly found to be lacking from a scientific

perspective.


MR. HEWES: May I approach?

THE COURT: Yes.

MR. HEWES: I don't intend to spend a whole

lot of time on this, Your Honor, but I want to touch on

a few of the pieces of literature that discussed these

as well as the FDA's opinion on adverse event reports,

as well as the -- he just gave me the register, but the

reference manual and scientific evidence, which is

published by the judicial center.

In the Schnapps (ph) case, Your Honor, which

is an abstract discussing reported cases, you notice in


3

.j

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

0 22

23

24

25

the abstract they say "We conclude that information

regarding dose ingestion given by patient admitted to

hospital for self-poisoning is inaccurate and often

exaggerated. "

21

If you turn two pages in, Your Honor, two

pages in, the Schnapps authors state 11 The inaccuracy of

information concerning drug consumption volunteered by

patients attempting self-poisoning has been alluded to

in the literature. 11

And they talk about the management of

specifically acetaminophen, and they say 11 The

management of acetaminophen overdose should be based

entirely on the level and time course of serum

acetaminophen concentrations rather than on the dosage

reported by patients. 11

If you turn to the next study from veterinary

and human toxicology, in the abstract the authors here

say the lack of injury and exposed patients underscores

the peril of attempting to assess through all of the

risk factors without an appropriate control group, and

they are talking about the fallacy of using adverse

event reports to assess risk in the absence of a

control group.

If you turn to the next paper, Your Honor,

this is kind of an important paper because it is cited


1

,,

" 5

6

7

8

9

10

11

12

1'.-l

14

15

16

17

18

19

20

:, 21

"' 22

23

24

25

I 22

by the plaintiffs in almost every single brief that

they have. It is the Larson paper from 2005 published

in Hepatology Journal. This paper, Your Honor, is

published by the acute liver failure study group.

When we get to try this case I am sure you

will hear ALFSG or ALSFG as my partner continually

mispronounces it, or acute liver failure study group

cited over and over and over again.

And the acute liver failure study group is a

registry. It is below adverse event reports in that it

reports on groups of patients, and doesn' t break down

individual patients in their reporting.

And the acute liver failure study group is

held up by the plaintiffs to support allegations that

therapeutic doses or near therapeutic doses of

acetaminophen can lead to liver injury or acute liver

failure.

And if you turn a few pages in, Your Honor,

to page 1, 369, here is what the acute liver failure

study group says about the reliability of its data. It

says 11 Patients by definition, 11 and they are talking

about acetaminophen here, n patients by definition have

altered mentation making accurate history taking

difficult or impossible. 11

And then it is talking about their data.


0

23

"More than 80 percent of patients were transferred from

, I 2 other institutions, often after significant

3

4

5

6

7

g

10

11

1 2

13

14

1 5

16

17

18

1 9

20

21

22

23

24

25

!

encephalopathy had set in, compromising her history, 11

in other words, the time of the last dose, total dose

ingested, et cetera. And then they say on the next

page 11 Precise information on dosing is often difficult

to acquire in some of these patients. 11

In the next article from the Gregory from

2010 in the Journal of Investigative Medicine the

authors state "Acetaminophen dosing information is not

always obtainable. When it is, it adds little to the

clinical assessment. Severity of encephalopathy is a

more reliable indicator. "

The next paper, Your Honor, from the Journal

of Therapeutics, it is the Monte (ph) paper. It gives

some statistics to it, and if you turn to page three of

the Monte paper and the results it talks about the

accuracy of the ingestion histories and this is the

Monte paper from -- it says ACCP on the top right

corner, Your Honor.

THE COURT: Right.

MR. HEWES: And on page three the Monte

authors say 11 The accuracy of self-reported ingestion

histories was poor when compared with confirmatory

testing. Only 30 percent of the self-reported


2

3

.j

5

6

7

8

9

1 0

11

12

p .,

14

15

16

17

18

19

20

21

0 22

23

24

25

24

histories cross-referenced with actual histories are

accurate, " and that gives a snapshot into the accuracy

of the reporting of these adverse events and the

reliability of adverse events.

And I have only got a few more, Your Honor.

The next one is an important one. It is from the FDA

and the Federal Register. It ' s specifically 71 Federal

Register 77314.

And the FDA was discussing acetaminophen

toxicity and acetaminophen hepatotoxicity and the FDA

expressly weighed in on the reliability not only of

adverse event reports, but of adverse event reports

related specifically to acetaminophen.

It is a few pages in, Your Honor, on page

77321, and the FDA is talking about this adverse event

report database and said, 11 The FDA noted that there are

limitations to interpretations to interpreting the AERS

data, 11 that's adverse event report system data.

"Dosing information may be unreliable. Acetaminophen

products are generally taken on an as needed basis, so

the actual dose ingested can be difficult to ascertain.

11 There is no certainty that all of the adult

cases, including in this analysis, were unintentional.

A stigma may be associated with reporting suicide.

Some cases may be reported as unintentional when they


1

2

4 :

5

6

7

8

9

10

11

12

1 3

14

1 5

16

17

18

19

20

21

0 22

23

24

25

25

are intentional overdoses.

"In addition, spontaneous reporting systems

cannot provide certainty that acetaminophen was the

cause of any of the reported adverse event. 11 And I

want to turn to the last document, Your Honor. The

document in between is the codification of the post

marketing reporting of adverse events. It says on the

last section that they are not reliable there either.

I want to turn to the reference manual and

scientific evidence. I have attached pages from the

third edition. I did not attach the entire document

because it is 1, 034 pages and I didn't think Your Honor

wanted to see that.


MR. HEWES: But, this is put out by the

Federal Judicial Center, and they talk about anecdotal

reports, which are the same as adverse event reports.

Now, on page 218, here is what the reference manual and

scientific evidence says when talking about the

validity of adverse event reports.

It says 11 Anecdotal evidence usually amounts

to reports that events of one kind are followed by

events of another kind. 11 That's the temporal following

word report happens and it happens afterwards . And the

next sentence is crucial. It says HTypically, the


0

2

6

8

9

10

1 1

1 2

1 3

1 4

1 5

16

17

18

19

20

2 1

22

23

24

25

26

reports are not even sufficient to show association. 11

And that is j ust the tip if the iceberg, Your

Honor, in terms of the literature and the FDA's

pronouncements and the reference on the manual and

scientific -- the reference manual and scientific

evidence repeatedly states that adverse event reports

are not reliable for purposes of proving causation for

two purposes.

Again, the reliability of the reporting is

suspect and, number two, they lack an adequate control

group which is necessary in order to show either a

cause and effect relationship or a relative risk or a

statistically significant risk.

But, it is not limited to literature, Your

Honor. Judges in courts throughout this jurisdiction

and other j urisdictions have examined this issue and in

the Soldo v. Sandoz, 244 F.Supp 2d 434 the court said

it better than I could when talking about the viability

of the usefulness of adverse event reports.

And I hate to do a lot of reading, but this

is going to take just a minute. But, they say 11 Case

reports, which may or may not be published in the

scientific or medical literature, describe isolated and

uncorroborated instances of medical events occurring

coincident with the use of a prescription drug.


0

2

3

4

5

6

7

8

9

10

11

1 2

1 3

1 4

15

1 6

1 7

18

19

20

21

22

23

24

25

"They tend to be brief recitals of events

which do not consider potential alternate causes or

attempt to investigate or to explain methods of

causation.

27

11 Case reports do not use control groups, are

not susceptible to statistical analysis of risk and are

not verifiable through meaningful peer review. Case

reports are not controlled studies. For any given case

report no scientifically probable conclusion can be

drawn that the suspect drug caused the reaction.

" The event report and the case report may

have been related to an underlying disease. The event

report and in a case report may have occurred by chance

at the same time that the suspected drug was taken. 11

And so that court is one example of the courts

discussing the lack of reliability associated with

adverse event reports.

Recently, in the Eastern District of

Pennsylvania in 2012 in the Collie Wolf (ph) case the

court said they granted the defendant ' s motion to

strike adverse event reports .

It said that "The defendants assert that

adverse event reports are hearsay and are not

substantially similar to the facts of this case and

should be excluded. 11


, I 3

4 I

,

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

i 21

0 22

23

24

25

28

It said -- the court said 11 Defendants are

correct that adverse event reports are inadmissible

hearsay when offered to prove the truth of the matter

asserted in the case. The reports submitted to the FDA

allege entry when neither hearsay is offered on the

issue of defendant's notice, 11 which leads me to my next

point.

The plaintiffs are going to get up here and

say well, Judge, if you don't use it for the purposes

of causation, we don't intend to offer adverse event

reports for causation purposes, we tend to offer them

for notice purposes.

And I would submit to Your Honor that while

courts have repeatedly allowed adverse event reports in

for the purposes of notice, when the adverse event

reports are in opposite to the epidemiological studies

that I discussed and the epidemiological hierarchy,

which hold in this case, which conclude in this case

that there is no reliable scientific evidence to

support a suggestion that therapeutic or near

therapeutic doses can lead to acute liver failure,

there is not one, Your Honor, and if the adverse event

reports go against the body of 100 or 150 clinical

reports or clinical studies the adverse event reports

shouldn't be admitted for notice.


' 3

4

5

6

7

8

9

10

1 1

12

13

14

15

16

17

1 8

19

20

21

"

@ 22

23

24

25

29

But, even if they are admitted for notice,

Your Honor, they should be limited to the facts in the

case that's present. From a temporal standpoint,

meaning they should not go past the date of ingestion

in the case, and if the case has individual factors

that are important to the outcome of the case, the

adverse event report should reflect that.

And the plaintiffs have cited a case that

came out in the 1990s, it was the Bonetti (ph} case

involving Tylenol where the individual was drinking

alcohol. He allegedly took Tylenol at therapeutic

doses and brought suit. He alleged that the

acetaminophen at therapeutic doses could have caused

acute liver failure and in his case there was a unique

risk factor that they allege.

They allege that because he was an alcohol

drinker that placed him at increased risk. And the

Court in Bonetti allowed again for -- the court said

uwe find that the district court did not abuse its

discretion in admitting the DERs, 11 they called them

drug experience reports, but it is the same thing, 11 in

case summaries because the plaintiff offered the

evidence solely to prove notice. 11

Then, they said 11 Because all of the reports

at issue involved liver injury associated with


0

2

3

4

5 I

e I

, I

9

10

1 1

1 -"

13

14

15

16

17

1 8

1 9

20

2 1

22

23

24

25

30

therapeutic doses of Tylenol in alcohol drinkers, they

found they were sufficient to show notice.

In this case, Your Honor, we have a situation

that lines up almost exactly with Bonetti, but instead

of alcohol we have a patient, an individual who

received -- who had gastric bypass surgery a year

before she had her event that caused her death, which

we believe it's sepsis, they believe it' s liver damage,

but that's a different day to argue which of it caused

her death.

The plaintiffs have put at issue in the case

and have made a key issue in the case her gastric

bypass surgery, and the plaintiffs have said because

this plaintiff had gastric bypass surgery a year before

her event it somehow effected her ability to absorb

nutrients and it somehow placed her in a starvation

state.

And because she had gastric bypass surgery

she had one of those unique increased risk factors that

other people don't have and that is why the

acetaminophen caused her injury at therapeutic doses.

They identified Timothy Davran (ph) , a

hepatologist, and in his report he says 11 It is my

expert opinion that Ms. Hayes' acute liver failure was

caused by acetaminophen poisoning related to Tylenol


' "

3

4

5

6

8

9

10

1 1

12

13

14

15

10

17

1 8

19

20

21

0 22

23

24

25

31

ingestion for therapeutic purposes due to several

features including she had risk factors for accidental

acetaminophen poisoning, including prior bariatric

surgery. 11

We deposed him because this bariatric surgery

procedure is not supported by the type of clinical data

that's reliable either, and we asked him about it. And

he says "She was not eating well and I think had

another risk factor, as expressed in my report, for

developing severe liver injury from acetaminophen,

namely bariatric surgery."

He went on to state at his deposition, 11 She

had acute liver failure from acetaminophen and prior

bariatric surgery." That's on page 324 of his

deposition. At the end of his deposition he went on --

THE COURT: Whose deposition is this?

MR. HEWES: I am sorry, this is Dr. Timothy

Davran, Judge. I have got a copy of the transcript if

you would like it. He said "In addition, as I said,

she almost by definition has a chronic starvation

state, which resulted in a nearly 200-pound weight loss

over a year.

11 That wasn't because, you know, of anything

other than the fact that she was not absorbing calories

and was, you know, losing a profound amount of weight. 11


0

�

1- - --- --- --- -- - - - --- --- - -�

32

1 I

And the only reason I am bringing this around, Your

Honor, because to point out that if Your Honor allows

adverse event reports for the purposes of notice, in

this case the plaintiffs have brought in an expert and

have put before the Court and will put before the jury

that Ms. Hayes was a unique individual from a risk

perspective because not only did she take acetaminophen

at recommended doses, she had this prior bariatric

surgery which allegedly put her at a higher risk.

4

s

6

7

8

q

10

1 1

12

1 3

1 4

15

16

17

18

19

20

21

22

23

24

25

And if Your Honor is going to allow adverse

event reports for notice to show that we should have

warned of this bariatric surgery risk or we should have

warned about acute liver failure if somebody has an

increased risk factor, the adverse event reports used

for notice should predate her 2010 ingestion and they

also should include a bariatric surgery element with

acute liver failure to properly be on notice for the

purposes of this individual case.

THE COURT : Thank you.

MR. HEWES: Thank you.

THE COURT: Who wants to respond?


THE COURT: Good morning, Mr. Tisi.

MR. TISI: Good morning, Judge. If you give

me a moment I want to grab some stuff.


2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

0 22

23

24

25


MR. TISI: Good morning, Your Honor.

THE COURT : What is it that you -- good

morning. What is it that you expect to put into

evidence regarding adverse event reports?

33

MR. TISI: Your Honor, there is -- let me

answer that directly and then backtrack and give you

some context . we expect to put in there have literally

been if not dozens, hundreds of adverse events

published and unpublished that talk about risk of

acetaminophen toxicity including acute liver failure at

or near four grams spanning almost a period of 30 or 40

years.

In addition, there is a subset of those

reports. In particular, you heard a lot from Mr. Hewes

about how unreliable they are because these are

over-the-counter drugs and people take them. There are

cases reported in the medical literature and I can

provide them to you.

I don' t have copies here but, for example,

there is an article by Forge (ph) , an article by

Claridge, an article by Kratovic (ph) , there is a bunch

of articles and they are really unique, Judge, in that

these are people who developed acute liver failure

while in a hospital setting while the patient was being


2

3 '

"

6

7

g

1Q

11

12

13

15

16

1 7

1 8

1 9

20

21

22

23

25

34

given four grams or even less by a doctor, and I can't

stress the importance of that enough.

They have marched in here saying all of these

case reports are unreliable. And they have -- but, we

do have a subset of cases where in a controlled setting

doctors reporting I gave these patients four grams,

they developed acute liver failure.

So, there are -- while there is a large

umbrella of case reports out there and case series that

talk about a risk at four grams and I would like to at

least go through some of them and how reliable they

are, because the FDA has used them, the American

Association for the Study of Liver Diseases uses them.

Everybody who does drug induced liver disease

refers to them, but there are several buckets of

adverse events that bear on the issues in this case.

So, it is kind of a long answer to what would appear to

be a very simple question, but I am trying to answer it

as directly as I can.

THE COURT: Okay.

MR. TISI : There are a lot of case reports,

there are a lot of case series and I would emphasize

this. This was kind of taking myself out of my

prepared remarks here, but we spent a lot of time last

time talking about, for example, the FDA working group


2

3

4

5

6

7

8

g

10

11

12

13

14

15

16

17

18

19

, 20

21

0 22

23

24

25

35

document .

On page 11 of that document, and I have it

and I can show you what it says. It starts out with

Mr. Hewes' argument. In fact, he could have written

it. It says 11There is no reliable scientific evidence

that there is a risk at four grams. 11

Then, the FDA working group says 11 But, there

are two registries that show a risk at four grams.

There are multiple cases that are reported in the

medical literature that are, " they use the word

" convincing cases that show that there is a risk."

And then they address Mr. Hewes' argument .

They say "But, McNeill says, 11 and it is on page 12 of

that document, "McNeill says that case reports can't be

used for causation and case reports can't be used, 11 and

what they say is -- in effect why don't I just give you

a copy of it with highlighted?

It says 11 But, there is so much here that that

in connection with other evidence makes us believe that

we should" -- that the FDA and the company should take

risk reduction measures.

So, I think it is not just the quality of the

reports, not just the category of the reports, but the

volume of the reports that have gone on over 30 years.

So, with that, unless you have another question on


2

' 4

5

6

8

9

10

11

12

1 8

14

15

16

17

18

19

20

2 1

0 22

23

24

25

that, I am happy to go into it and I will see if I

can pull that document for you so you can have it for

you.

3 6

I just want to back up for a minute to what

the law says. The vast majority of the courts have

observed that published and unpublished case reports

are both relevant and admissible on two separate issues

in a pharmaceutical case.

Number one is the issue of pharmacovigilance.

I am sure you have heard that term and seen it woven

throughout the different motions, but I am going to

take a moment and try to explain why they are so

important.

Number two, they are part of a causation

assessment . I am going to give you at least two cases

that I think - - two court cases that I think illustrate

both issues.

One is the one that we discussed last time

and it is Decker versus GE Health Care, 770 F.2d 378,

and that is Sixth Circuit, {2014) . In that case

well, I will talk about the facts in a minute.

The other one is the case that Mr. Hewes

identified, Bonetti versus McNeill, and that is 66 F.3d

1378, and that is the Fourth Circuit, {1994) . Those

are pharmacovigilance cases.


2

J

4

C

B

7

8

' 10

1 1

12

1 ::J

14

15

1 G

17

1 8

19

20

21

0 22

23

24

25

3 7

In addition, courts have held that in certain

circumstances, and this is consistent with the -- in

fact, I was a little surprised that Mr. Hewes brought

up the manual for scientific evidence, because there is

another section of it that talks about this.

There are -- the courts and the manual for

scientific evidence have said very clearly that while

case reports alone may sometimes be suspect, and they

are not always suspect, because you can't just make a

broad, broad statement about them, when they are used

in the context of other scientific evidence they can be

corroborative and supportive of the causal inference.

So, for example, and you haven't gotten to

the issue of Daubert and I know those are on your

plate, but the causation experts in this case will

testify, Dr. Davran (ph) , Dr. Kapowitz (ph) and all of

them will testify.

In fact , defense experts will testify that

there are over 600 drugs that are capable of causing

acute liver failure and hepatotoxic events, 600 drugs.

Not a single one of them have the kind of studies that

Mr. Hewes has indicated is necessary.

There are no placebo control trials which

show acute liver failure compared to placebo. If there

wa such a clinical trial the drug would never be


2

3

4

5

6

7

8

9

10

1 1

1 2

13

14

15

16

17

18

19

20

21

@ 22

23

24

25

38

marketed. Okay. There is no epidemiology study with a

control group which would show acute liver failure.

I would ask you to ask Mr . Hewes if the

opportunity -- can you name one of any of the 600 drugs

that the medical and scientific community says can

cause acute liver failure has an epidemiology study.

There is not one.

So, what does the medical and scientific

community do to make that causation assessment?

Experts in drug induced liver disease look to multiple

things. They look at clinical trial data showing

elevations in ALTs and ASTs, and as you will hear

probably later on today when we argue other issues

there are clinical trials which consistently show

elevations in ALTs and ASTs.

They look at toxicology data to the extent

that we have it and in this case we do, because it is a

direct toxin. But, they also look at case reports and

case series, exactly what the FDA did in this case.

And so backing - - let me go back to the

issue. Some cases that have used case reports for the

causal inference, not pharmacovigilance, which would be

notice, okay, but for the causation assessment, our In

Re: Phenylpropanolamine, another MDL involving a drug

capable of causing high blood pressure and strokes, and


0

1

2

3

4

.s

6

7

8

8

10

1 1

1 2

13

14

15

39

that is 289 F.2d 1230, and that is the Western District

of Washington, 2003 .

There is Mccarrell versus Hoffman Roche and

that is 209 Westlaw 614484120 -- I am sorry, 2009. And

then there is a case out of this district, Judge

Dubois' opinion ion Wolf versus McNeill, 2011, U.S.

Lexis 47710.

So, let me back up for a moment and talk

about what a case report is because sometimes there is

a miss -- kind of a misunderstanding of what they are

and where they are relevant in drug litigation.

A case report can be either published or

unpublished. A published case report often appears in

the medical literature. They can be either reported as

a single event, or they can be reported as a group of

16 events, a case series, where a doctor, for example,

17

18

19

20

21

22

23

24

25

says I note five cases reported in my clinic that show

X.

OJcay. They are an attempt to try and

identify not only causation, but risk factors, et

cetera. And in this case there are literally hundreds

of individual case reports reported in the medical and

scientific literature on a variety of issues relevant

to this case, not just bariatric surgery .

There are cases reported at a mere four


2

" •

' 6

8

9

10

11

12

13

14

15

16

17

18

19

20

' 21

© 22

23

24

25

I

40

grams, literally hundreds of them. There are cases

reported in the medical literature where the acute

liver failure study group analyzed, and I will talk

about that for a moment, but the acute liver failure

study group is a federally funded, FDA funded, National

Institute of Health funded network of people whose sole

purpose is to study acute liver failure. It is a multi

center, it has centers here, I think University of

Pennsylvania.

It is based in Texas, but it is UCLA,

Harvard, University of Pittsburgh, Northwestern

University, a lot of different universities have come

together and they feed cases of acute liver failure to

a central repository where they are studied.

That, Judge, is epidemiology. That is shoe

leather epidemiology, looking at patterns, risk

factors, et cetera. So, there are reports of acute

liver failure study group. As I indicated, there are

cases where people were hospitalized and we know

exactly how much they took. So, that's -- those are

reported cases.

Then, there are unpublished cases. Okay.

There are cases that are reported, for example, to

McNeill, and that's part of their pharmacovigilance

responsibilities and I will talk about that in a


2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

1 8

1 9

20

21

0 22

23

24

25

moment.

There are cases that are reported to the

company saying -- by doctors who took the time out of

their day to say look, I have a patient that has been

on acetaminophen for X number of days and, you know,

they have acute liver failure. I think it is an

adverse event associated with your drug .

They report them to the FDA. It is a

41

voluntary system, but it is a reporting of it is not

written in the peer reviewed literature that way. And

those are done in the context of both the company and

the FDA trying to get their arms around the risk

profile of a drug .

And that is the importance of

pharmacovigilance . So, let me take a moment and talk

about pharmacovigilance for a second. And the issue

is, and I want to turn to the notice issue first,

because this is the pharmacovigilance issue.

The question is are adverse event reports,

published and unpublished, admissible in a

pharmaceutical case on the issue of notice when they

are relevant to the issue of pharmacovigilance.

So, let's talk about pharmacovigilance, and

if you don' t mind I will take a moment and explain what

it is, why the FDA considers it so important.


2

3

• 5

6

7

8

9

10

1 1

12

13

14

15

16

17

18

1 9

20

� 21

0 22

23

24

25

THE COURT: I think I have a sense of that.

MR. TISI: Okay.

THE COURT: So, let's move this along. We

have a lot of motions to review.

MR. TISI: All right. So, the FDA --

THE COURT: So, how is it relevant to

pharmacovigilance?

42

MR. TISI: So, the FDA, and I will move that

along, but I want the Court to have a copy of the

pharmacovigilance guidance document, which it may not

have keyed into in the context of this case. May I

approach, Your Honor?

THE COURT: Yes.


THE COURT: Thank you .

MR. TISI: And I won't go through it in

detail, Judge, but on page three, four and ten of this

document

THE COURT: Right .

MR. TISI: -- it talks about the importance

of case reports and what it specifically says is while

companies are required to conduct clinical trials

before a case is before a drug is marketed, once a

drug is marketed to millions of people adverse event

reports are like sentinel - - they are important events


2

3

4

5

6

7

8

9

10

11

12

1 3

14

15

16

17

1 8

19

20

C 2 1

0 22

:;' 23

:;, 24

25

43

that help define the risk profile of a drug.

And on page three it says " Postmarking a

safety data collection and risk assessment based on

observational data, 11 which is what we are talking about

here, 11 are critical for evaluating and characterizing a

product's risk profile and making informed decisions on

risk mitigation, 11 and that is on the bottom of page

three.

So, these case reports are really important

to help companies and the FDA decide what are we going

to do, how are we going to warn? How are we going to

instruct people on the safe use of the drug? Are we

going to restrict the drug? Are we going to take risk

reduction measures?

And on page four of the document it says --

it talks about the issue of safety signals. And it

says safety signals can arise in a lot of different

contexts, but it says even a -- 11 signals can arise from

post marketing data and other sources, such as

pre-clinical data, " that's toxicology " and events

associated with other products in the class.

" It is possible that even a single, well

documented case report can be reviewed as a signal

particularly if the report describes a positive

rechallenge or is extremely rare, 11 and of course we


1

0

44

1 1 know acute liver failure is extremely rare.

2

3

4

C "

6

' d

' 1 0

1 1

1 2

13

1 4

15

16

17

18

1 9

20

2 1

22

23

24

25

On the basis of pharmacovigilance the parties

in this case have indicated -- in fact, we attached an

exhibit to our motion, Nelson pages 9 9 to 100 of Ed

Nelson who was one of the chief medical executives for

McNeill and he said that individual case reports can

result even to the withdrawal of a drug and there are

plenty of instances where that happened.

So, the question is are these admissible for

notice and pharmacovigilance. In the Decker case where

the court addressed the issue squarely and found that

the evidence of pharmacovigilance is critical to

proving a failure to warn case.

And it refers specifically in that case

the company had received several unreported events

associated with an MRI drug and the defendant in that

case attempted to exclude that evidence, saying that it

was irrelevant, unreliable and the court said that it

comes in on the issue of notice and pharmacovigilance

and, in fact, because of that the expert in the case,

who is the expert in this case had indicated that that

was a basis to change the label. And the court said it

clearly was appropriate. The district court did not

abuse its discretion in reaching the conclusion that

the AERs were admissible.


' 3

4

5

7

8

9

10

11

12

13

14

15

16

17

18

19

20

' 21

0 22

23

24

25

r -- - - -- - - - -- - - -- --- - - -- -�

I I

45

The same thing was true in the Bonetti case.

In that case there was plenty of cases. So, I want to

move onto the issue of causation, so it clearly comes

in on the issue of notice.

The Court -- as I indicated, the Court has

not yet had an opportunity to consider Daubert issues

related to drug induced liver disease, but if I could

just give a preview of the arguments?

In this case, because this case involves drug

induced liver injury and acute injury there is a

methodology that has been published in the peer

reviewed literature for 20 some odd actually, since

the mid 1980s called CAM methodology, C-A-M, causation

assessment methodology.

That methodology is basically a differential

diagnosis methodology that experts use, and they use it

because as I have indicated, most drugs do not have

clinical trials for acute liver failure.

It is just simply impossible to do. You

can't power a study to study this disease, and every

expert in this case agrees that there are no

epidemiology studies.

So, what they do is they look for -- they do

a differential diagnosis, but in that context the court

-- the experts in drug induced liver disease considers


0

46

what's called the drug signature.

In other words, what does clinical experience

'.� show about the risk profile of a drug? So, for

4 1 example, acute liver failure associated with

5 acetaminophen is fairly unique in that you have a

6 pattern of a rise of ALTs, for example, that go to

7 towering, usually go to very towering, over 1, 000

8 units, which is pretty significant in the absence of

9 1 bilirubin rise, that's not true with other drugs for

10

11

12

13

14

15

16

17

18

18

20

21

22

23

24

25

example.

You have and how did they figure that out?

Well, they figured it out by looking at the experience

reported in case reports and case series and that's why

the acute liver failure study group does these studies

and that's why they put them out. There are clinical

guidance for people.

So, what experts in drug induced liver

disease, if we talk about -- Mr. Hewes has talked about

the hierarchy of evidence, but these evidence don't

stand alone. There is epidemiology studies. If you

have them, great. Okay. we have them in this case.

Okay.

We have a study by Sepate {ph) , which talks

about - - which shows a relative risk is a population

study . We have clinical trial data showing ALTS and


®

; ·- ---- - - - - - - - -· �------------- - -�

47

1 I ASTs, we have animal studies, we have case reports and

case series . 2

. 1

4

5

6

7

8

9

10

1 1

12

V:l

14

15

16

17

18

19

20

21

22

23

24

25

And rather than looking at each of these

individually, what experts in the field typically do is

they look at them collectively. They say do all of

this data, when you put them all in a bucket does it

make sense?

Okay. And that is what the court -- that is

why the court in the Wolf case in this courthouse,

Judge DuBois said in the case of SJS, Stephens Johnson

Syndrome with Motrin, another McNeill product, said not

only can -- not only do experts rely on differential

diagnosis methodology, but they are allowed to look at

case reports in the medical literature. And if I will,

if you will indulge me for --

THE COURT: We are really getting ahead,

though, into the Daubert and the science issues in this

case.

MR. TISI: Well, it is, but I don' t want the

Court to be under a misimpression that these - - the

case reports are important.

THE COURT: I understand your position that

the case reports --

MR. TISI: Are part of --

THE COURT: have a relevancy in the


0

,, C

j

causation analysis.

MR. TISI: Correct.

4 8

THE COURT: And I think you certainly make a

4 good case for their relevance in the notice and

5 pharmacovigilance.

6 MR. TISI: Okay. So, as long as the Court

7 understands that there really are two -- and I want to

8 address the one issue I think that -- I don't know, it

q ' was a little misleading, I think, on the scientific

10 the manual for scientific evidence.

1 1 The manual on scientific evidence allows

12

13

14

courts to admit case reports. In fact, that was noted

by Judge Wolf, excuse me, Judge DuBois in the Wolf

case. It said -- she said 11 Case studies are reports of

1 5 clinical events involving only one or few people.

16 Reference manual on scientific evidence at page 474. 1 1

17 She went on to say that they can be

18

1 9

20

2 1

22

23

24

25

considered on causation in connection with other

evidence. So, I am a little bit perplexed that the

scientific evidence manual can be used and this Court

has found that it can be used in causation and yet we

have a page or two from the manual that says otherwise.

THE COURT: I have the manual in my chambers.

MR. TISI: I think you can check it.

THE COURT: And I - -


0

2

3

4 9

MR. TISI: But, I think it is on page 474 and

there are plenty of cases that talk about this.

THE COURT: I moderated the session on use of

4 scientific evidence at the last Third Circuit

s conference.

6

7

MR. TISI: Then, I shouldn' t have --

THE COURT ; I have at least a superficial

B sense of that .

9 MR. TISI: Then I should not have even given

10 my argument here , Judge .

1 1 THE COURT: But, it is a very good resource

12 from the Federal Judicial Center.

13

14

15

16

17

18

20

2 1

22

23

24

25

MR . TISI: And like everything else, I think

the Court -- I think in every one of these cases, and I

have argued this motion in several different cases, I

think what is really important is we look at why they

are being offered. I mean, if you have - - I mean, for

example, if you have a case of a challenge or

rechallenge, a single case alone can be evidence of

causation.

THE COURT: Right.

MR. TISI: If you have multiple cases showing

the same thing occurring out of one clinic, that can be

evidence of causation. So, you really can ' t make a

broad brush like anything else, a broad brush


0

3

so

generalization about them, but in particular where they

can be used in the context of everything else we know

about this drug, it is pretty clear that they should be

admitted in this case, both on notice and for

5 causation, and they are the kinds of things under Rule

6 1 703 that experts rely on typically. The FDA does as

7 i well. Thank you.

•

1 0

1 1

12

13

1 4

15

16

17

18

19

20

21

22

23

24

25

THE COURT : Thank you, Mr. Tisi .

MR. HEWES : Your Honor, may I follow up for

two minutes?

THE COURT: You can have 30 seconds, what do

you want to say?

MR . HEWES: I will only take 30 seconds.

Last week we had the opportunity to start arguing our

expert motions before the New Jersey court and prior to

that we presented I will call it a science day, too,

Your Honor, even though it wasn't officially asked to

be a science day. Judge Johnson said if we wanted to

bring in audio visuals we could.

We walked through the multiple scientific

bases, the epidemiological studies, the clinical

studies, the animal studies and put them in context as

to their assertion that acetaminophen at four grams or

less can cause acute liver failure, and I j ust don ' t

know if -- I know we are not to Daubert motions yet,


2

3

4

5

6

7

8

9

10

1 1

1 2

1 3

1 4

1 5

1 6

17

1 8

19

20

21

0 22

23

24

25

51

but if Your Honor would entertain an hour or two

between now and the next time we meet it may be

beneficial to clear up whether there is a scientific

basis to assert or to show notice of acute liver

failure at four grams, and it would put some of these

motions in limine in context that the plaintiffs are

arguing, because we walked through the first studies

from 1970 up to studies in 2014 to show, despite what

plaintiffs say, they are multiple epidemiologic studies

which show from a scientific basis, from a clinical

basis it is physiologically impossible for your body to

not produce enough glutathione to counter-effect

acetaminophen when taken at therapeutic doses.

There is not one study, Your Honor, that has

shown that acetaminophen when taken at therapeutic

doses raises your liver enzymes more than 1, 000, and

1, 000 is the generally accepted number for

hepatotoxicity, there is not one.

And I was going to leave Your Honor with some

studies, but I think my 30 seconds is up, but if Your

Honor would like us to come back we would certainly

entertain that option.

THE COURT: I think when we talk about these

issues in the Daubert context I think that is very

helpful .


0

MR. HEWES: Yes, Your Honor, thank you.

THE COURT: Thank you. All right. The

evidence relating to employee compensation. That is

52

·+ the defendant ' s motion in limine number four. What are

7

CJ

9

10

1 1

12

13

14

15

10

17

18

1 9

20

21

22

23

24

25

you trying to keep out here?

MR. ABERNETHY: I am glad you asked that

question, because I think it is the primary thing I

want to say. We are not, and I will tell you what we

are not trying to keep out as well as what we are,

because I think that is important.

We are not suggesting that you can't bring

out in support of an argument for bias that a witness

who is testifying in this courtroom is employed by one

of the defendants.

THE COURT: Right.

MR. ABERNETHY: That is going to come out

anyway when any witness testifies. We are not

suggesting that you can ' t bring out the fact, if it is

a fact, that the witness who is testifying has some

ownership interest in the company.

What we are saying should be kept out is the

amount of salary, the amount of stock options, the

specific dollar numbers. There is a lot of argument in

the response to this motion about the fact of

employment being admissible for this purpose, that ' s


0

53

1 I not in dispute. I 2 1 You did rule that the specifics, including

3

4

5

6

q

1 C

11

12

1 3

14

15

1 6

17

1 8

19

20

21

22

23

24

25

I I

the dollar amounts were discoverable. I am not trying

to relitigate that, that is done, the discovery was

taken.

But, while the plaintiffs suggest in their

opposition that it is the same thing, you have already

ruled on this, respectfully, Your Honor, I think every

judge and every trial lawyer knows that discoverability

is not the same as admissibility, and all kinds of

stuff is ruled to be discoverable under Rule 26, but

isn't allowed in .

THE COURT , Right.

MR. ABERNETHY: So, again, we are talking

about bias, and here is the question that I would like

Your Honor to consider. You are a juror, the CEO, John

Doe testifies , we bring out in cross-examination that

John Doe is the CEO, full-time employee, his livelihood

depends on the defendant.

Fair enough, every juror is allowed to

consider and apply common sense and decide does that

indicate bias or not. Now, we ask the CEO what is your

salary, $400, 000, maybe it is $500, 000.

THE COURT: A month.

MR. ABERNETHY: Maybe it is $300, 000. I


©

--�- - -- - ----- - -- -- - - - - --- - - - -- -�

54

actually don ' t know the answer to any of that question

2 and I didn't bother looking it up. But, my point is

0 how does that - - what does a juror do with that? Can a

� j uror decide you are more biased at $400, 000 than 350,

5 less biased at 75 than 150? It doesn ' t prove anything

6 is the simple point.

7 What it does do is tend, in the same way that

3 all attribution of financial numbers, especially big

9 financial numbers, to appeal to bias on the basis of

10 wealth, and beyond that, it invades the financial

1 1 privacy of the witnesses for no purpose.

12 Now, you might in many cases , Your Honor,

13 invade the financial privacy of a witness where it is

14 actually material and proves something. But, remember,

15 your prior ruling was this is discoverable and you made

16 a point in your order saying it is confidential.

17 In cross it is not confidential. We are

18 talking about having witnesses talk about their

19 personal finances in open court where it can't be

20 confidential.

21 Again, in many cases you might do that if it

22

23

24

.'25

proves something, but it doesn't prove anything to a

juror in terms of whether the witness is biased that he

makes $100 , 0 0 0 instead of 5 0 or 5 0 0 instead of 2 0 0 . It

simply doesn't tend to prove or show anything that is


0

- -�--- --- - - - -- --- ----- -- �

55

material or useful to the juror.

And the motion raises also the issue of

:; employee experts. I think the Morrow (ph) case which

we cited is right about this, although I acknowledge

� 1 Your Honor didn't find it persuasive in terms of

6 discoverability.

7 If you have an expert everybody knows a paid

8 expert who is not an employee of the parties, you are

9 allowed to ask how much they are getting paid every

10 hour, because that is what they are getting paid in

1 1 connection with this case.

12 An employee expert should be crossed on that

1 3 if the employee expert is being paid something

14 separate, specific for the case, that is not part of

1 5 their normal compensation .

16 But, there is no reason why an employee who

77 may testify to an expert opinion, but isn't doing

18 anything other than doing their job and being paid

19 their normal salary to be cross-examined on a specific

20 dollar amount of their salary.

21

22

23

2'

25

So, our simple point is the dollar numbers,

as opposed to the fact that this is your livelihood

just doesn't prove anything that is useful to the jury

and it has a tendency to appeal to prejudice and it

clearly when done in court invades the privacy of the


2

3

4

5

u

7

,

•

10

1 1

,� 1 3

14

15

1 G

17

18

19

20

21

0 22

, 23

24

25

witness.

And so that dollar -- those dollar numbers

ought to he excluded.

THE COURT: Thank you, Mr. Abernethy. What

is it that the plaintiff wants to introduce?

MR. TISI: If I may, Your Honor? As Mr.

5 6

Abernethy noted, Your Honor did review this issue with

respect to discovery disputes. A number of the defense

witnesses are both fact witnesses, but also expert

witnesses in the case.

And maybe not so much as experts in

connection with offering typical expert reports, but

they are going to bring to the trial the idea that they

are long-time employees or former employees of the

company and they have a unique expertise about the

products of the company and they are going to testify

with an aura as though they have a level of expertise.

Now, these employees will have earned their

livelihood for dozens of years by way of their

employment. I think our view is that what defendants

are trying to do is to sort of tilt the scale and

create an unfair advantage whereby they will bring in

employee witnesses who will testify about their

experiences and employment associations with the

company --


0

--�-- --

57

THE COURT: Well, you want to bring up

2 company loyalty as a bias issue?

3

. ,

5

MR. TISI: Well, the loyalty .

THE COURT: All right.

MR. TISI: But, I think the degree of loyalty

6 is reflected by the amount that had been paid or the

7 extent of their financial considerations. One of the

1 f_;

1 1

12

exhibits that we presented to our response was the

deposition of Dr. Temple, and the back of that exhibit

includes his comprehensive consultation agreement.

And I believe, if I recall, he has a scope of

work, how he is going to consult, things like that. It

10 is really an expert, it is a quasi-expert named in a

14

1 5

16

17

18

20

21

22

23

24

25

different way.

I think we should be permitted to bring that

out to the jury, particularly with Dr. Temple being a

witness who will be predominantly portrayed in the

litigation.

Another exhibit, Exhibit 3, I think it was,

we showed that Ms. Fallon who was deposed was being

paid by the defendants to appear and to provide

testimony. I think it was $200 per hour.

So, these are things that I think the jury is

entitled to know. Clearly the defendants are going to

attack the plaintiffs' experts by the amount of money


2

:3

4

:,

6

8

9

10

1 1

12

1 3

14

15

16

17

18

1 9

20

21

,

0 22

23

24

25

- --· - -- -- - - --- --- - --- - - - - - - --

58

that they have been paid and argue bias and things of

that sort.

We just don 1 t want to be -- have the scales

tilted against us and our ability to do that with

respect to witnesses who are disguised as fact

witnesses where they are really going to be proffered

generally as expert witnesses.

break.

THE COURT: All right. Thank you.

MR. TISI: Thank you.

THE COURT: All right. Let's take a short

(Recess, 11: 17 a.m. to 11 : 33 a. m. )

THE COURT: Please be seated.

{Pause in proceedings. )

THE COURT ; I think in the interest of time,

I -- we have a pretty good handle on motion in limine

six, and I think I can do that on the papers.

I would like to talk about motion in limine

15, the media reports relating to Tylenol. And the

defendant has moved to exclude those as inadmissible

hearsay. Mr. Abernethy?

MR. ABERNETHY: Your Honor, motion in limine

number 15 is a categorical motion. It is addressed

it is a categorical motion in part. It's addressed to

media reports, newspaper articles, TV reports, radio


0

2

3

4

6

7

8

g

10

1 1

12

13

14

15

16

17

1 8

1 9

20

21

22

23

24

25

reports, as --

THE COURT: Sure.

MR . ABERNETHY : a class, but it also

addresses several specific reports that are mentioned

specifically in the motion.

THE COURT: Right.

59

MR. ABERNETHY: And the motion is based on

what I think is a pretty straightforward principle that

actually isn't in dispute here. You can't prove the

material facts relevant to the case by offering

newspaper articles and TV news reports that relate

those facts because it's hearsay, there's no

reliability, there's no applicable exception.

I don't think the plaintiff really takes

issue with that principle . I think one of the

principle thrusts of the opposition is this kind of

motion in limine just shouldn't be considered.

They cite a number of cases for the very

broad principle that there' s a lot of potential items

in this category, you shouldn't look at these

categorically on a motion in limine, you should wait

and look at them case by case at trial and consider

whether any individual document is admissible.

I think if you look at the footnote in cases

on page two of their memo and actually look at those


2

3

4

5

6

7

8

9

1" "

11

12

1 3

14

15

16

17

1 8

19

20

21

0 22

23

24

25

cases, they don ' t really stand for that broad

proposition stated in the memo.

6 0

I think the case that the plaintiffs cite

that actually has the most to say here is the EEOC

versus Wal-Mart case. And if you look at that case,

what you see the judge saying, and I think quite

legitimately and quite valid here, is it's actually

desireable to rule on these categories of evidence in

limine before trial so that the parties can prepare for

trial in light of the court's rulings and that what you

do when you say I don't want to look at a broad

category of evidence, we'll deal with it case by case,

you wind up with a trial where the jury is sitting a

lot while the lawyers are hashing out objection by

objection and document by document what is or isn't out

when a lot of those issues are broad issues that could

have been resolved before trial.

I think it's important, Your Honor, to

remember where we are. This is a selected bellwether

case approaching trial. It's already had trial dates.

So the plaintiffs say a number of times in their

opposition wel l , some media reports may be relevant and

admissible for notice, or they may be relevant and

admissible for some other purpose. Okay, but which

ones?


"'

I think when we put the principle forward

2 that media reports are generally inadmissible, if the

3 j plaintiffs' position is well, there are certain ones

4

5

6

7

3

that we want to use and that are admissible for

particular purposes and not as hearsay proof of the

facts in them, then it would be reasonable to expect

them to tell us what those are and why they're

admissible so we can actually deal with them.

61

q

10

In fact, they don't even address the specific

ones we raise. They say okay, the defendants listed a

1 1 number of specific reports that they say are

12 inadmissible, but the court should weigh those

1 3

14

15

individually. Okay, but based on what? If you're the

plaintiff, why are they admissible if you're taking the

position that they're admissible? It seems to me

16 1 reasonable to expect.

1 7 THE COURT : This might be premature then. I

18 mean if there's a pretrial memorandum submitted that

19 has, you know, say, for example, this American Life

20

21

22

23

24

25

transcript or tape, and the plaintiff has a stated

intention to use something like that or an article

in a publication, then we can talk about those

specifics. Unless is the plaintiff prepared today to

say what exactly you hope to use -- from various media

sources?


©

, -- - - - - - --- - --- --- -- --- - ---- - ---- - --

1 !

2

3

5

6

7

s

g

1 0

1 1

12

14

15

16

17

H I

19

20

21

22

23

24

25

MR. TISI: No, Your Honor. I n fact, I am

familiar with the typical Eastern District process of

having a pretrial memorandum and identifying the

exhibits .

62

And to the extent I was going to argue

against the motion, and I was going to argue that at

this time I think it is premature and it's overly broad

and not specific. We had some difficulty understanding

precisely what is

THE COURT: Yes, I'm not going to rule out

categorically media reports. I mean there are

statements that come up in interviews that might be

relevant.

I think we have to look at specifics, and

perhaps when we have a pretrial memorandum and a

pretrial conference and we see what it is the

plaintiffs hope to put in, we're in a better position

to do that, and we can do that in advance of trial. I

appreciate Mr. Abernethy's concern that we not have the

jury sitting for a long period of time, but we can

resolve these at a pretrial conference I think. So I' m

going to take this under advisement until we have a

pretrial conference.

MR. TISI: Thank you, Your Honor.

THE COURT: All right, thank you.


0

2

3

MR. ABERNETHY: Thank you, Your Honor.


THE COURT : Motion in limine 16 has to do

63

4 with the American Association for the Study of Liver

Diseases and a 2006 press release. Again, are these

6 are these issues that - - does the plaintiff know if

those will be offered into evidence at the time of

trial? 8

9

10

1 '

12

13

14

15

16

17

18

19

20

21

22

23

24

25

to - -

okay.

MR. BERMAN: Yes, Your Honor, and I ' m happy

THE COURT: And you will be using those,

MR. BERMAN: I will be using those and --

THE COURT : All right. Well, then let's hear

from Mr. Hewes.

MR. HEWES: Thank you, Your Honor. And, Your

Honor, may, for efficiency purposes, the plaintiffs'

motion in limine E, which is scheduled to be argued

today, his motion to strike certain testimony of Sherry

Cathcart (ph) , who is the executive director of the

AASLD, and it may be helpful to take these up together,

but we can do it, of course, any way Your Honor would

like it to be done because they are inextricably

intertwined, as they say, Your Honor .

THE COURT: Right. And that's motion in


2

3

4

s

e

7

8

9

1U

11

12

IC

'

14

15

16

17

18

1 9

20

21

0 22

23

24

25

limine --

MR. HEWES: B from the plaintiffs.

64

THE COURT: Right. Okay. We can talk about

those together, sure.

MR. HEWES: Sure. And the AL -- the American

Liver Foundation is a little different. And just by

way of contacts, Your Honor, Mr. Tisi suggests that

they would be interested in introducing the AASLD paper

at trial. That is an understatement. The AASLD

document has appeared in every brief and has been

discussed at every deposition.

THE COURT: Yes .

MR . HEWES: It's been waved around like

gospel multiple times , And, as you see in our papers,

Your Honor, the AASLD paper is nothing more than a

response from the AASLD.

The AASLD is an organization of liver

specialists, and it says on their website, 11 With a

mission to advance the science and practice of

hepatology and to promote liver health and patient

care. 11 It's a group of hepatologists who convene

periodically to discuss issues related to the liver.

In 2006, the FDA in the Federal Register

published a request for comments on ten different

things dealing with insets to include acetaminophen,


0

3

4

5

6

7

8

9 I

10

1 1

12

13

14

1 5

16

17

18

19

20

21

22

23

24

25

65

dealing with dosing, dealing with suggested changes to

the label in advance of the 2009 final rule.

In April of 2007, the AASLD, I've got the

document if you want it, but I think Your Honor has a

copy, submitted a memorandum to the FDA which

essentially lays out the AASLD's position. Do you

have a copy of it, Your Honor? Would you like a

copy?

THE COURT: I'm sorry, what am I looking for?

MR. HEWES: Sure.

MR. ABERNETHY: I have a - - I have a copy.


THE COURT : Sure.


THE COURT: Thank you. Do you have this,

Melissa? Okay.

MR. HEWES: And this document dated April

27th, 2007, is to the FDA. And you'll see, Your Honor,

it is responsive to the questions the FDA - - the FDA

asked people, institutions, former manufacturers to

respond to. So it is one of many responses considered

by the FDA when the FDA asked for comments related to

acetaminophen.

But, the AASLD document is simply not

relevant here, Your Honor. The plaintiffs are -- and


2

3

4

5

8 I

9

1 0

11

12

13

14

15

16

17

18

19

20

C 21 ;;

0 22

23

24

25

6 6

we'll see it in the Sherry Cathcart brief. Sherry

Cathcart is the executive director of the AASLD. She,

in fact, was the first individual deposed in this case.

And it' s kind of a scratch your head motion

that the plaintiffs filed, Your Honor, because on one

hand, they designated testimony from Sherry Cathcart

related to the AASLD, but on the other hand, they tried

to strike any testimony that we designated because it

was cross-examination, and there is good reason they

did not want that testimony in.

The AASLD's position paper is simply that.

It's a position paper from the AASLD. And the AASLD's

suggestions to the label and the AASLD's suggestions to

the FDA were never adopted by the FDA. And I've got a

copy of Ms. Cathcart's transcript if I could provide it

to Your Honor because I want to cite to it?



MR. HEWES: Chris, do you have a copy of her

transcript?

MR. TISI: I do, I'm fine.

MR. HEWES: Okay.

MR. TISI : Thank you.



.'2

3

4

5

6

7

8

0

10

11

12

13

1'

15

16

17

18

19

20

21

0 22

23

24

25

MR. HEWES : I hate to do this to Your Honor,

but I ' m going to give you the non-condensed one, so

it ' s kind of a phone book.

THE COURT: All right. Right there.


6 7

MR. HEWES: The plaintiffs do not want any of

the cross-examination to come in because it goes to the

relevance of the document, Your Honor. And,

specifically, Sherry Cathcart was asked at her

deposition how relevant the AASLD' s position is to

pharmaceutical companies and to the pharmaceutical

industry.

And on page 131 we asked her the question,

and I asked her, 11 The AASLD recognizes that the FDA is

the rule making authority for pharmaceutical

manufacturers, correct? 11 She said, 11 Correct. 11

And I asked her, "And the FDA and the AASLD

recognizes that manufacturers are bound by the FDA ' s

directive regarding labeling and packaging of their

products, correct?" "Correct. "

11And you agree that the AASLD is not a rule-

making authority, correct? 11 11 Correct. n And I'm on

page - - sorry, Your Honor, I'm on page 130 and 131.

THE COURT: Right.

MR. HEWES: And then I ask her on page 131,


3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

0 22

,y 23

24

25

6 8

18, after I asked her -- after she confirmed on 131 15

that the AASLD is not a rule making authority, 11 And you

are not critical or the AASLD is not critical of a

pharmaceutical company for following the FDA's mandates

regarding labeling, correct? 11 11 Correct. 11

11 And the AASLD, 11 on page 13 2, 11 is not

critical of a pharmaceutical manufacturing company for

following the FDA's directives regarding packaging,

correct? 11 11 Correct . u

Page 132, line 21, 11 You ' re not critical of

manufacturers for not adopting the AASLD's

recommendations, are you? 11 11 No." And this is the

important one, Your Honor. All of them are pretty

important, but this is the most important.

On page 133, line three, I asked her, 11 And,

in fact, when the AASLD has a recommendation for a

labeling change, the proper way -- or a packaging

change, the proper way to get that effective is to go

through the FDA, correct? 11 She said "That ' s our

understanding, yes."

And the important element or the backup

element to this, Your Honor, is that after the AASLD

submitted its recommendations to the FDA, the FDA

summarily rejected them, Your Honor. The FDA did not

adopt any of the recommendations made by the AASLD in


2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

© 22

23

24

25

69

regards to the label in its 2007 memo.

In fact, in the 2009 Federal Register on page

139 -- 19391, the FDA said the AASLD submission doesn't

include any data to support its recommendation. The

AASLD also referenced fasting, and the FDA likewise

struck this. The other thing is, Your Honor -- so for

that reason, it's pure hearsay. It is not supported by

any reliable scientific evidence.

It was not adopted by the FDA, and the

executive director at her deposition expressly stated

that this was the province of the FDA for rule making,

it was the province for the FDA for regulation

issuance, and that the AASLD is not a rule making

authority. And for that reason, Your Honor, we have a

lot of 403 issues here because even if argument this

morning, the plaintiffs have said well, the AASLD

recommended this and McNeill should have been put on

notice for that.

If this document is allowed in, the jury has

the potential to give it more credence than it ' s worth.

And if the plaintiffs want to suggest that it is for

notice, on page 135 and 136 and 195 and 196, Ms.

Cathcart makes it clear that every time she discusses

hepatotoxicity in the context of her AASLD deposition,

she was talking about in the context of overdose.


0

2

3

4

5

6

7

8

g

10

11

12

13

14

15

16

17

1R

19

20

21

22

23

24

25

70

Plaintiffs here, Your Honor, in this case

have alleged that the plaintiff took the dose, took the

acetaminophen at a recommended dose or at a therapeutic

dose, and so it has no relation to this case in

addition to being globally unreliable from a hearsay

perspective, and also from a notice perspective, Your

Honor, and if you look at if you look at what the

plaintiffs are arguing is notice globally, as we

suggested at (inaudible) , since the 1970s, the FDA has

known of the risk of acetaminophen liver damage when

taken in overdose. McNeill has conceded that . That is

not an issue that notice needs to come around to .

In 2002, the FDA asked and started

investigating and looking at clinical studies and

looking at clinical data to see what kind of notice was

out there for not only the FDA, but for manufacturing

companies .

And the FDA's vision is a lot wider than a

pharmaceutical company's like McNeill's, Your Honor,

because in addition to seeing all of the clinical data

and the clinical trials and having epidemiologists and

scientists to examine that, the FDA has their own

database which collects not only the reports from

McNeill, but from every other acetaminophen

manufacturer out there.


©

e

7

3

1 0

1 1

1 2

·13

14

15

1b

17

1 8

19

20

21

22

23

24

25

And with all the notice the plaintiffs said

are out there, it's the same notice that the FDA got.

And the notice issue came to a head in April of 2009

when the FDA said we've looked at the data for seven

years, we ' ve seen what's out there, here's the issue

and here's how I want you to change your label.

71

Here's what the FDA said. They said add one

word, add "severe." They didn't say I agree with the

AASLD and we should change the packaging. They didn't

say I agree with the AASLD or the ad com {ph) and we

should make acetaminophen prescription. They didn't

say I agree with other groups, I think acetaminophen

should go off the market.

They didn't say a host of things that the

plaintiffs are suggesting should be noticed, including

the AASLD document, and so it's not valid for that

reason.

Now, Mr. Tisi is probably going to get up

here and say well, Mr. Hewes asked questions to Ms.

Cathcart that were inappropriate in that they were

outside the scope of her designated testimony. And if

you ' ll see by the testimony we cite in our motion, Your

Honor, it is directly responsive to the issues as set

forth in her deposition notice .

Her deposition notice, and I'm kind of


2

3

4

.5

,, 7

a

9

1 ' '

1 1

12

Vi

14

1 .5

1b

17

18

19

20

21

0 22

23

24

25

72

crossing over into their motion right now, said that

she would be testifying on testimony concerning the

AASLD including its membership, mission, and structure,

and this is important, number two and three, "the

circumstances surrounding the initiation and creation

of the AASLD memorandum to the FDA, including the

authors and contributors responsible for its content,

the conclusions and recommendations made by AASLD in

its memorandum and any efforts made by the AASLD to

communicate its conclusions and recommendations. 11

So the cross-examination that was done and

the cross-examination that was cited in our brief and

that's cited by the plaintiff is proper

cross-examination.

The bottom line is, Your Honor, they don't

want it out there because they don't want the jury to

hear that this AASLD document that they have been

pounding into the ground, that they've been carrying in

their flag since day one, is not relevant to the issues

because they don't want the jury to hear that the

AASLD's own executive director said we ' re not a rule

making authority, we defer to the FDA. We don't

criticize a company for following the FDA directives.

That is effective cross-examination, it's relevant

cross-examination, and it's relevant to the issues.


0

2

4

6

7

8

g

10

1 1

12

14

15

16

17

19

20

21

22

23

24

25

7 3

Finally, Your Honor, I suspect we're going to

hear a suggestion by the plaintiffs in their argument

that during the course of the deposition, which went on

for several hours, and it was in D. C. and the air

conditioner wasn't working so we all looked rough at

the end of the day, that I wore down and I ended up

asking her questions that were more Sherry Cathcart

questions instead of a 30 (b) (6) AASLD questions.

Well, I want to briefly address that, and I

will provide Your Honor with a few cites from her

transcript. On page 136, I asked her - � excuse me,

page 135, line 19, "When you said excessive dosage, you

meant taking more than the recommended dose of four

grams per day, correct? 11 She said, 11 In my view, yes, 11

and I said, " Your view being the AASLD's view,

correct? 11 and she said, 11 Yes. 11

Page 136 (N) , " And so every time during this -

- during your testimony today when you talked about the

AASLD's position on acetaminophen hepatotoxicity, you

were talking about it in the context of overdose,

weren't you? " 11 Yes. 11

Page 195 -- I'm sorry for eating up this

microphone, Your Honor. I'll do better on that. Page

195 and 196, beginning on line 14, the second paragraph

which you read in your initial question today says,


3

4

5

6

7

8

9

1 0

1 1

12

13

14

15

16

17

18

19

20

" 21

0 22

23

24

25

11The AASLD is fully supportive of the agency's

conclusion that acetaminophen hepatotoxicity is an

important health consideration, correct? 11 11 Correct. 11

74

11 And you've already testified that that was

in the context of overdose and in the context of taking

alcohol, correct? 11 " Correct. 11 And then I asked her,

11 That's the AASLD's position, isn't it? 11

" Correct. "

She said,

Page 198, 11 S0 the AASLD' s official position,

is it not, that acetaminophen is generally considered

safe and effective? 11 I didn't ask if that was her

position. I asked if it was the AASLD's position. She

said, 11 Yes. 11

Page 200, 11 The FDA' s position is consistent

with the AASLD's position regarding the safety and

effectiveness of acetaminophen, correct? 11 Consistent

with the AASLD's position, not her position. She said,

11 Correct. 11


MR. HEWES: Page 2 2 8 , 11Is it the AASLD's

official position that four grams per day is a safe

daily dose for any person, that's correct? 11

11 Correct. 11

She said,

And in the first set of questions, Your

Honor, I'm not going to read through them again, but


., 3

4

5

6

7

B

9

10

11

12

13

14

15

16

17

18

19

20

21

0 22

23

24

25

' '

7 5

every question was prefaced with, "The AASLD

recognizes, 11 11 The AASLD recognizes, 11 " The AASLD is not

a rule making authority, " and 11 The AASLD's

recommendations. 11

And so to suggest that the questions I asked

her in cross-examination were, number one, outside the

scope of her deposition is just incorrect. And, number

two, to suggest that I was eliciting questions that

were Sherry Cathcart's opinion and not the AASLD's

opinion is likewise incorrect because peppered

throughout the deposition I make it clear in my

questioning that I'm asking about the AASLD's position.

Plaintiffs would like to say that it's Sherry

Cathcart's position because they don't like some of the

testimony she gave, but that does not make it worthy of

exclusion.

Judge Johnson addressed this issue in the New

Jersey case when he was scratching his head as well

that the plaintiffs can on one hand, designate their

direct testimony from deposition but vehemently object

to any type of cross-examination testimony. And he

said that he thought it was a valid cross and that the

scope would be direct - - would be addressed at the time

of court .

So in summary, Your Honor, the AASLD document


i-

'

' I

'

4

5

6

7

8

9

10

11

12

1 3

1 4

15

16

17

18

19

20

21

0 22

23

24

25

is a document prepared by an outside organization who

recognizes it has no binding authority on anybody, on

any pharmaceutical company. It is not related to the

issues in this case, and we don't think it should be

allowed in. Moreover, the contents of the document

were never, ever adopted by the FDA.

7 6

Now, there's one more element to this, Your

Honor. There' s an American Liver Foundation document.

The American Liver Foundation document, and this is

going to be a lot quicker, was a press release that the

American Liver Foundation issued after the New England

Journal of Medicine published

Journal of Medicine.


I think it was the

MR. HEWES: Excuse me, the Journal of the

American Medical Association published in 2006. It was

a paper

Chris,

authored by one of the plaintiffs' experts.

do you have a copy?

MR. TISI: I do.

MR. HEWES , May I approach,

THE COURT: Yes.



Your Honor?

MR. HEWES: The Watkins paper is an example

of a randomized double blind placebo controlled trial


©

; -- -- --- - - -------------------- -

77

accessing the safety of acetaminophen when taken at

� recommended or therapeutic doses .

3 The patients in the Watkins study were given

,i I acetaminophen for 14 days and there was a transient

6

7

8

9

j(_)

11

12

1 3

14

15

16

17

1 8

10

20

21

22

23

24

25

l

elevation in the ASL ASTs and ALTs in the Watkins

study, but as the study shows, Your Honor, none of the

elevations reached 1, 000, which is considered the level

for hepatotoxicity amongst scientific circles. But,

regardless, the Watkins study was being commented on by

the American Liver Foundation and that's what the

subject of the press release is.

I t ' s not relevant to this case as to the

contents of the Watkins study or their interpretations.

The Watkins study, which has been commented on,

identified patients who took acetaminophen a period of

14 days.

In the case before the Court, Your Honor, the

plaintiffs are alleging that Ms. Hayes only took

Tylenol for six days. And so any discussion as to that

paper in the context of a press release is not only

hearsay, but it is not relevant to the case.

Moreover, as I stated earlier, in terms of

this case, there's nothing in the Watkins case that

addresses Ms. Hayes' condition which has been put at

issue - - put at issue by the plaintiffs, and that is


0

2

4

5

6

9

10

1 1

12

1 3

14

1 5

1 6

17

18

19

20

21

22

23

24

25

,- -- --- - - - - - - -- - - - - - - -- �

her gastric bypass surgery as to what they believe is

an increased risk factor.

78

There's inherent 403 risk, as I said, both in

the AASLD document and in the American Liver Foundation

document that it will be held to be more valuable than

it actually is considering it was not adopted by the

FDA and considering the fact that this is not any type

of guidance or a regulatory push for a pharmaceutical

manufacturer.

THE COURT: Thank you. Mr. Tisi.


MR. TISI: Judge, if it's okay I would like

to separate the two motions

THE COURT : Sure.

MR. TISI: because one is clearly a

procedural motion. The Cathcart deals with the scope

of permissible cross-examination under Rule 3D (b) (6) .

The first one is an evidentiary motion, so if I could

separate them out.

THE COURT: Yes, that's fine .

MR. TISI: They relate to the same subject,

but it is different. All right. So, let me turn to

the issue of the AASLD and acute liver failure --

THE COURT: We're talking about documents

MR. TISI: - - motion.


' I I

2

3

4

5

6

7

9

10

1 1

12

13

14

15

1 6

17

1 8

18

20

21

0 22

2 23

24

25

79

THE COURT , -- documents issued by the AASLD?

MR. TISI, Correct.

THE COURT , Right.

MR. TISI , Motion in limine 16.

THE COURT , All right.

MR. TISI , The two issues are number one,

are - - is the 2007 recommendations of the AASLD

admissible in this case as non-hearsay notice under

Rule 801, and is it the kind of evidence , the

recommendation of an organization like this, the kind

of - - the kind of evidence that an expert would rely on

under Rule 703? That's the first issue. It ' s really

an evidentiary issue.

The second one or the second question is are

the 2006 recommendations to the American Liver

Foundation an evidence that McNeill attempted to

manipulate the American Liver Foundation to change

their position relevant and admissible to defendants'

conduct in this case?

THE COURT: So what evidence do you have that

they -- that they tried to manipulate the AASLD's

findings?

MR. TISI: The AASLD or the ALF?

THE COURT: I ' m sorry, the ALF.

MR . TISI : Okay. The ALF, they are attached.


0

2

4 I

5 i

B

9

10

1 1

12

14

1 5

16

17

18

19

20

21

22

23

24

25

8 0

This is what happened and this is the -- it's laid out

in our motion, Judge. But the first thing that

happened was the press release was issued. The

second -- the second day, and I have the documents

here, Your Honor.

THE COURT: Now, which is the press release?

Is this the April 27 document?

MR. TISI: Yeah, let me give it to you,

Judge, so you have a copy of it.

THE COURT: April 27, 2007?

MR. TISI: Corr - - it's the

THE COURT: We don't have that? Okay.

MR. TISI: No, that's --

THE COURT: Okay. That's something else.

MR. TISI: I'm sorry.

THE COURT: Okay.

MR. TISI: Let me give


let me approach.


MR. TISI: This is Exhibit C to our motion,

Judge. This is the press release of the American Liver

Foundation immediately following the American Liver

Foundation issuance.

And you see what they say here, and there's a

little bit of a ~ - and I want to talk about the Watkins


1

2

3

4

5

6

1

8

g

10

1 1

12

13

1 4

15

16

17

18

19

20

:e 2 1

0 22

23

24

25

I

8 1

paper in a moment, but it says, 11 The American Liver

Foundation recommends that people not exceed three

grams a day , u okay, and it said, " on the basis of the

Watkins Kapowitz (ph) paper , " and that is at issue in

this case because the issue in this case is whether or

not we know that Ms. Taylor took - - I'm sorry, I'm

getting my cases confused.

THE COURT: Ms. Hayes.

MR. TISI: We know that Ms. Hayes took four

grams a day for five days and she took it according to

the labeling instructions. And so what's happening

here is the American Liver Foundation is saying on the

basis of this study, they recommend moving the dose

down from four grams to three grams. And, again, this

is 2 0 0 6 , some five years before McNeill ended up

actually doing it.

What is really important here, Judge, is

immediately following this release, the company pretty

much swung into action to try and get the American

Liver Foundation to change its recommendation because

it knew it was coming up that there was going to be an

advisory committee that was scheduled in the future and

they did not want -- they did not want these

professional organizations to weigh in on this issue,

and I will provide you with copies.


0

:c

' 3

4

5

6

7

·-- -- -- - -- --- - - - -- - - -- -- �

82

We provided them in the testimony, but these

are j ust examples. We provided testimony and exhibits

in our brief, but I'm going to provide you with Exhibit

Number 13 and Exhibit Number 15 of our -- these are

examples.


MR. TISI: There is a little bit of a story

8 here, Judge. The first thing that happens is they note

q

10

1 1

that the press release was issued, and they said there

were -- if you look at the first e-mail, Exhibit 13,

the comment internal document of the company says,

12 11 They are recommending three grams a day. We need to

1 �1

u

15

1 6

17

18

19

20

21

22

23

24

25

fix this. 11 okay.

The next doc -- and so what happens is, and

the testimony has been developed, what they did was

they went out and they met with the American Liver

Foundation, agreed to provide the American Liver

Foundation with a couple hundred thousand dollars,

okay.

And then, ultimately, when the American Liver

Foundation did provide a commentary to the FDA in

response to its 2006 proposed rule and request for

comments, there was a, and I don't have it. I don't

have it with me. It's in our brief, but there was a

comment that said nice work with the American Liver


2

3

4

5

6

7

8

9

10

1 1

12

13

1 4

1 5

1 6

17

1 8

19

20

t' 21

© 22

23

24

25

83

Foundation.

I think the reasonable inference from all of

this is that the FDA -- is that the company pretty much

went to work trying to neutralize this organization and

the recommendations that they made to lower the total

daily dose from four grams to three grams.

And so the importance of this document is A,

for notice that professional organizations were

recommending a lowering of the dose based upon the

available scientific data, and number two, the

company's response to that doc -- that document, which,

frankly, was extraordinarily manipulative. And if you

give me one moment, Judge, I think I have that

document. It is attached to the --


MR. TISI: Exhibit Number 21 to our brief

says, " Respond from the American Liver Foundation to

the company, " dated October 30th, 2007, saying 11Just

wanted to let you know the check for $275, 000 arrived

today. "

The next document is a document from I

believe it's a company that says by the way, nice

oh, Exhibit Number 19, which says -- is dated May 30th,

2007, after the American Liver Foundation did not make

its recommendation to the FDA. It says -- Ashley


2

3

4

5

6

7

8

9

10

11

12

1 3

14

15

16

17

18

19

20

21

0 22

23

24

25

84

McEvoy, who is one of the chief executives at McNeill,

writes, " Nice job with the ALF. " So, Judge, it ' s not

just -- it ' s not just the recommendations themselves

which would come in as notice, but it ' s also the

company's response to that.

I would like to turn my attention to the

AASLD document which has been the subject of a lot of

discussion. First, the AASLD recommendations are

admissible - - of notice to the company of

recommendations made by the largest professional

organization of hepatologists in the United States and,

it is, therefore, admissible under Rule 801. I t is

also admissible because it is the kind of thing that

experts can rely upon both hepatologists and people

labeling, and that would be under Rule 703.

You've heard a lot from Mr. Hewes about what

the FDA did and what the FDA didn't do, but as you will

recall from the -- from the failure to warn arguments,

the issue is not what the FDA did and did not do with

respect to the over- the-counter drug. It may be

relevant in some instances.

But, the ultimate question that the jury is

going to be called upon to ask is what did McNeill do

based upon what it knew and what it understood and was

their conduct reasonable?


2

3

4

5

6

7 '

8

9

10

1 1

12

13

14

15

16

17

18

19

20

21

0 22

23

24

25

8 5

And it is going to be our position, and it' s

no surprise, that we had the company out here taking a

position, and it was in direct contradiction to almost

every hepatologist, hepatology expert organization, the

FDA, the scientists at the FDA, and this is part of

that pattern.

Now, before I go into the argument in detail,

there really are a lot of things in this particular

motion that were, frankly, not only misleading, but in

some instances a clear misstatement of the record.

On page six of the motion, McNeill says that

the - - Ms. Hayes took drug for a six to eight period

between August 12 and August 18, and she took both

extra strength Tylenol and Lorcet. That is not true.

The medical records and the testimony

indicate that she took only Tylenol, and that is

important because that would keep her within the

therapeutic range. And, Judge, I ' m going to provide

you with a copy of her medical records.


MR. TISI: The medical record says after she

got out of the hospital on the 12th, she took Lorcet

and but she did not want to take a narcotic so began

taking extra strength Tylenol, a couple tablets three

times a day.


1

' 3

4

5

6

7

8

9

10

1 1

12

1 3

14

15

16

17

1 8

1 9

20

21

cC 22

23

24

25

I

I I

8 6

Another - - the second document is her

discharge summary. It says, 11 The patient approximately

two weeks ago had lumbar surgery and stated she was

taking Lorcet. She then took a few of those but did

not really want to take a narcotic analgesic, so she

began taking acetaminophen. To read the defendant ' s

brief, you would think that she was taking them at the

same time. She clearly wasn't.

They also make reference to the Watkins

Kapowitz paper, and Mr. Hewes made the same statement

today. They say that the studies showed that after two

weeks there was an elevation in ALTs, and they suggest

that there is no other clinical trial that found what

the Watkins Kapowitz study found. I ' m going to address

both of those.

First, this was a 14-day trial. However, the

elevations began to be seen in that trial after four

days, okay. People started dropping out of the study

and started being withdrawn from the study. The

article at the end of it says an association between

I'm sorry. And I have -- if you look at the study

itself --


MR. TISI: -- it says on page -- the last

page, 93, it says, 11We conclude that the initiation 11


0

8 7

1 ' I'm sorry -- "the initiation of treatment have healthy

adults with acetaminophen taken at the maximum daily

dose for four or more -- for four or more days

frequently causes elevation and ALTs. 11 To read their

art -- their brief, you would think that it was only

after two weeks. That is simply not true.

2

s

4

5

6

7

8

9

10

11

12

.,, '"

14

15

16

17

1 8

E-!

20

21

22

23

24

25

The second thing that they make -- the second

representation that they make with respect to the

article is -- upon which the - - both the ALF and the

American Association for the Study of Liver Diseases'

recommendations were made is that there is no other

clinical trial -- that the observation was made that

there was no other clinical trial that corroborated

what Dr. Kapowitz and Dr . Watkins found. That -- the

fact that they noted that in the record doesn't mean it

doesn't exist.

In fact, there is a - - immediately following

this, the company did an internal meta-analysis of its

own clinical trials, and I will provide that to you.


MR. TISI: And found exactly what Dr.

Kapowitz and Dr. Watkins did. So it is misleading.

And we provided an exhibit to your clerk, to Melissa

here. It is not - - it is very misleading to say that

the recommendations of the AASLD and the


1

2

3

4

5

6

7

8

g

1 0

1 1

12

1 3

1 4

15

16

17

1 8

19

20

� 21

® 22

23

24

25

'

I I

88

recommendations of the ALF misstated what was found in

the article itself.

The third thing that came out from the

argument that I -- is misleading, it implies the AASLD

is a 11 small group. 11 In fact, every hepatologist who

will testify in this case is a member of the AASLD. It

is the single largest group -- professional group of

hepatologists in the - - hepatology in the United

States .

It is a -- it is akin to the more commonly

understood groups like the American College of

Radiology, the American College of Cardiology, and

different professional groups that represent the

interest of people in that particular -- that

particular field. This is not some fringe group . This

is -- these are the people with whom the FDA consults

repeatedly on drug-induced liver disease.

And to that extent, Judge, I would provide

you with the document we used with one of the defense

experts. It is the website page from the AASLD. So to

the extent that Mr. Hewes meant to suggest that this is

some small fringe group, it is to the contrary.

On page three of its brief, it refers to the

2006 proposed rule that says the FDA found

acetaminophen generally safe and effective. That is


:y

2

3

4

5

6

7

8

9

89

also misleading and misstates the case.

In fact, after reviewing the case reports and

case series on page 77329 of the Federal Register, the

FDA specifically said that the FDA believes that these

data support the previous conclusion that acetaminophen

toxicity is an important public health consideration

and that additional labeling is necessary for it to

continue to be safe and effective.

So with those with those errors, frankly,

10 identified in their brief, I want to turn to the

11 recommendations that were made. The AASLD recommended

12 1 several things.

13

H

15

16

17

18

19

20

21

22

23

24

25

Number one is they said there was a risk at

four grams, that there are risk factors including

malnutrition, recommended that they lower the dose,

identified acetaminophen toxicity as a serious health

problem, not only for overdose, but hepatotoxicity in

general.

While it was sent to the FDA, it was also

sent to McNeill, who rejected it for years. Dr.

Kuffner (ph) was aware of it, Dr . Temple was aware of

it. I have the testimony. I'm happy to provide it if

the Court were inclined .

Now, much was made of the fact that the FDA

11 rejected it. 11 There's a big difference, frankly,


0

9 0

1 [ between the FDA not mandating what the -- what the

AASLD says and the FDA saying you shall not do it. The

truth of the matter is, and it's been repeatedly

0

3

4

5

6

7

8

9

1 0

1 1

1 2

13

14

15

16

17

18

19

20

21

22

23

24

25

recognized and is -- the AS excuse me, that McNeill

was free to adopt any of these recommendations at any

time for this over-the-counter drug that was not

subject to a final ruling. So it is clearly noticed

under Rule 801 that a major professional organization

had serious concerns and what McNeill did in response.

Moreover and separately, experts typically

rely on the AASLD. In fact, that's why the FDA reached

out to the AASLD to get their input in the first place.

The working group recognized the AASLD and, you know,

one would if the AASLD I mean I am going to ask

the Court to indulge me a moment.

Let's assume that the AASLD had come out with

recommendations contrary to what they came out with.

Let's assume they said, you know, there is no reason to

lower the dose, this is safe and effective for

everybody, okay.

If our experts had not at least considered

the recommendations of the AASLD, the defendant would

walk in the court and say by the way, Your Honor, this

was inappropriate methodology that they didn ' t even

consider the recommendations made by this organization.


cc:

0

,- -- - - - - - - --- --- - - - - - - - - - -- - - -�

91

1 i So under Rule 703, it's very clear that it comes in.

2

Cl

4

5

6

7

8

9

1 0

11

12

13

14

15

16

17

1 8

19

20

2 1

22

23

24

25

I talked about the

THE COURT: Mr. Tisi, in your presentation at

trial, will your liability expert refer to this AASLD

report?

MR. TISI: Both of them, both the liability

expert and the causation expert.

Judge.


MR. TISI: And this is how it will come out,

THE COURT: So it comes in?

MR. TISI: It comes in.

THE COURT: Okay.

MR . TISI: And it comes in and it also

comes in because it was provided to the company. It

comes in as something you rely on and it comes in that

way. So, you know, I

THE COURT: I understand your position.

MR. TISI: Okay. So now the next question,

frankly, is the question of Sherry Cathcart. And I ' ve

got to tell you, Judge, this is as much a deposition by

ambush as I've ever seen.

The AASLD memorandum has been in -- at the

center of this case from day one. Frankly, there are a

lot of important dep -- exhibits in this case, but this


2

3

4

5

6

7

8

9

10

1 1

12

13

14

15

16

17

1 8

' " 20

21

0 22

23

24

25

92

and the working group document from the FDA are two

very important pre-haze ingestion pieces of evidence

that put the company on notice that people were looking

at the data very differently than the company was

looking at the data.

So in order to establish the authenticity of

this document, we sent out -- now, actually, it came

out of New Jersey. We asked for commission from New

Jersey for the AASLD, a corporate deposition under that

rule, which would be the equivalent of Rule 30 (b) (6)

We asked very specific and limited target areas of

testimony. We asked for them - - and I have a copy of

the notice .


MR. TISI: And it's Exhibit B to our motion.


MR . TISI: And if you look at what we asked

Judge Hapie (ph) at the time to grant us permission to

take, we asked five categories of information:

testimony about the mission of the AASLD, clearly

non-medical, non-legal issue.

Number two, the circumstances surrounding the

creation of this AASLD memorandum, okay, and that was

attached as Exhibit 1. Meaning when did you initiate

it, when was -- how was it approved by the -- by the


0

93

2

3

4

1 I organization? It was clearly a records kind of

question; and what the conclusions were of the AASLD.

What did -- what did the documents say and how did you

communicate it?

5

6

7

8

9

10

1 1

12

13

14

15

16

17

18

19

20

21

22

23

24

25

It was very clear, and as a result of that,

the AASLD did not designate a doctor or a scientist or

a lawyer. It designated the equivalent of the -

Sherry Cathcart was the executive director of the

organization.

In order to try to frame this question of how

unfair this was to this witness, I tried to think about

what we do in a regular practice . I issue a notice of

deposition, a records deposition, to a hospital to get

medical records on a plaintiff, let's say Ms. Hayes.

I get the witness in the chair, she produces

the medical records . I say when were these generated,

how did they -- how did they keep them in the normal

course of business, who are they disseminated to, and

then I start asking her questions about the care and

treatment of the patient. That would be un -- it would

not only be unfair, it would be totally outside of the

scope of what the documentation was.

So even though this motion is styled as a

motion in limine with respect to Ms. Cathcart, it is

really the AASLD. They designated this witness as a


0

94

third party to testify to very specific areas. They

2 had no reason to believe that they would be questioned

::t about the underlying data surrounding the AASLD

'+ i document.

5 They had no reason to believe and did not

6 prepare her to testify to what the opinion of the

8

9

10

11

12

1 3

1 4

15

16

1 7

18

19

20

21

22

23

24

'" _,

organization is about the relationship between the

company and the FDA is. And they made that clear.

In fact, on numerous occasions, the lawyer

for the AASLD said, you know, counsel, we didn't

prepare this witness for this question. You're going

way beyond what the notice said.

Now, I would say, Judge, if this was a

corporate witness of a party, I'm sure that there would

be a lot more flexibility to this, but this is a third

party witness who did not have any understanding about

the issues related to this case.

I would also add that the -- that the comp

that McNeill had every opportunity to expand the

categories within the 30 {b) (6) notice. In fact, it

issued a cross notice in this court, and I'm going to

provide that, it's Exhibit G to our motion.


MR. TISI: And you will -- you will see in

Exhibit G that it primarily -- schedule A asks them to


0

9 5

I prod -- asks the AASLD to produce documents, which the I

2 I AASLD did, okay, but it did not add to the categories

3 of testimony for which it would be giving notice that

4 it would be asked.

5 And so what this cross-notice simply did was

8 say oh, and by the way, Ms. Cathcart, when you show up

7 to answer the questions that are enumerated in

5 plaintiffs' notice, please bring some documents.

8 That's all that -- all this was.

10 So what ultimately happened, Judge, is she

1 1 gets into deposition and I asked the questions that I

1 2 intended to ask. I said I asked how is this -- how

i 3 was this document prepared? Well, it was sent to the

14 governing counsel. It was made up of five doctors.

15 Who drafted it? Well, you know, it was Dr. Lee and Dr.

16 Maher, different people that put it together. Was it

17 formally voted on? Yes, it was. Where did it go? It

18 went to the FDA. Was it published online? Yes, it

19 was, it was a very basic nuts and bolts kind of thing,

20

21

22

23

24

25

okay?

I asked her are you a doctor? She said no.

Do you have any medical training. She said no. I

asked her did -- are you a lawyer? She said no. Do

you have any legal training? She joked and she said

well, after this experience, I'm not sure I want to


2

3

4

5

6

7

8

9

10

1 1

1 2

1 3

14

15

1b

1 7

18

19

20

21

0 22

23

24

25

96

have any legal training. I asked her whether or not

she had any role in drafting the documents and

analyzing the data, she said no.

Even with that, the defense -- the defense

went on a very unfair examination of her, and you heard

some of it today. What is the position of the AASLD

about the legal responsibilities to follow FDA

mandates? How is Ms. Cathcart supported to know that,

you know.

How is she supposed to know when he puts an

article of the Astropowitz (ph) article or the Larson

(ph) article in front of her and asks her is it -- you

know, isn't it true that this was the focus of this

article? She wasn't the author of the article. She's

not a doctor. She's not capable of interpreting that.

And she made that abundantly clear over and over again.

a summer

Frankly, as counsel said, it was

day and there was no - - there was

THE COURT :

MR. TISI:

Air conditioning?

- - air conditioning,

a

no

and

- -

- -

it

the

was

witness, frankly, was like -- by the end of it, she was

like just answering questions, frankly, as witnesses

would do.

But, she kept saying -- the common thread to

all of this is, Judge, we asked very specific questions


:�

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

18

20

21

0 22

23

24

25

about what we wanted the AASLD to -- we put them on

notice about what we wanted them to testify to.

The defendant had notice of what we said.

97

The defendant could have said -- expanded the notice,

and if they had done that, I am absolutely confident

that the AASLD would have either prepared this witness

or would have provided a doctor or scientist or a

lawyer to answer some of the questions that Mr. Hewes

proposed. They didn't do that. And so that ' s really

- - that's really, frankly, unfair to the witness.

Now, I'm going to quote you what she said.

Actually, a funny kind of an epilogue to all this. I

took the deposition of Dr. Robert Brown, who is an

expert for the defendant in this case. He happens to

be a member, as all these hepatologists are, of the

AASLD.

And I asked him, I said well, you ' re a member

of the organization, do you know who Sherry Cathcart

is? And he said oh, yeah, I know Sherry. She ' s the

executive director. And I said is she a scientist? He

laughed at me, he said no . I said is she a doctor?

No. I s she a lawyer? 11 I don ' t think so, no. She ' s

not a regulatory person in any way. I don ' t know her

background, but I'm sure not. 11 "

And would you go to her for any science,


:;

3

4

5

6

7

iJ

9

10

1 1

12

13

14

15

16

17

18

19

20

"' 21

0 22

23

24

25

I I

r ·-· - - -- - -- - -- -- - - - -- ------- -

medical, or regulatory issues? 11 u No. n 11 Would you go

9 8

to her for finding out what ' s going on within the

organization from an administrative standpoint?" 11 Yes,

that's what I would do. 11 And that's on pages 127

124 to 126 of Dr. Brown's deposition.

I mean honestly, Judge, any person who knows

the AASLD and anybody's who's been involved in this

case, the lawyers, as we are, would laugh at the fact

that the kinds of questions that Mr. Hewes asked this

witness, would laugh at the fact that he was asking

those questions. And to put that before a jury as the

position of the organization, which is what a 30 (b) (6)

deposition is, is absolutely unfair and contrary to

what 30 (b) (6) requires.

So it is not so much that it's not I don't

want the jury - - repeated references were made that I

don't want the jury to hear contrary evidence in this

case.

I want the jury to see and weigh all of the

evidence, but it does have to be reliable. And when

they put forward - - when McNeill is asking an executive

secretary of the AASLD's medical, scientific, and

research questions, it is absolutely unfair .

So we prepared Exhibit G -- excuse me,

Exhibit -- a chart, because we tried to figure out the


2

3 i

4

5

6

7

8

9

10

11

12

13

14

15

16

17

1 8

19

20

2 1

0 22

23

24

25

9 9

best way to do this, enumerating the categories of

information that we think should be stricken from this,

testimony concerning the content, the meeting, and

interpretation of FDA regulations, and I cited them,

testimony concerning the duties of the FDA, I cited the

page and line, testimony giving scientific opinions of

the -- on the medical literature, I cited page and

line.

Testimony concerning the interpretation of

medical literature, I cited page and line . So I

provide this to the Court hopefully as a guide so at

least you would understand the categories that we are

looking to strike.


MR. TISI : I've gone on about this because I

feel passionately about what happened to Ms. Cathcart

because I was -- having been there . I have no problem

with the jury considering the evidence in this case . I

have no problem with bad evidence coming in in a case.

I'll fight my hardest against it.

But, we can't be unfair to witnesses, and

this was absolutely unfair and contrary to Rule

30 (b) (6) , and that's why we're asking it to be

stricken, not because it's unfavorable to us.



e

3

4

5

6

7

8

9

1G

1 1

1 2

13

14

15

16

17

18

19

20

21

0 22

t 23

M

25

points?

100

MR. TISI: Thank you.

MR. HEWES: May I address one issue on those

THE COURT: Yes.

MR. HEWES: I will be brief, Your Honor. If

Your Honor is inclined to allow the AASLD document in,

the plaintiffs have already said they're going to cite

it as an authoritative document by their experts.

Who better than to describe the document and

to put the document in context than the executive

director of the AASLD? And let me be perfectly clear.

This was not a deposition notice by the plaintiff to

authenticate some documents. This was a deposition

that the AASLD lawyer in advance of the deposition sent

us documents showing that the 2007 memorandum was

suspect because it was ghost-written by an author who

didn't want his name on it.

Let me be perfectly clear as well to recite

what Mr. Tisi didn't cite in the context of what was in

the deposition notice. It was not authenticate this

document.

It was testimony concerning the AASLD,

including its membership, mission, and structure. Part

of the AASLD's mission, membership, and structure, Your

Honor, is to interact with the FDA, as evidenced by the


0

2

3

4

5

6

7

8

9

1 0

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

101

2007 document . I asked plenty of questions about the

AASLD's interactions with the FDA.

Number two, "The circumstances surrounding

the initiation and creation of the AASLD memorandum to

the FDA, 11 these are the plaintiffs' words, 11 including

the authors and contributors responsible for its

content and the process by which the memorandum was

approved by the AASLD . 11

There is no doubt that I spent a lot of time

going through their creation of this document and the

interaction with the FDA related to the creation of the

document and why the author of the document was not

interested in having his name on it . And that is

relevant evidence to the j ury, as it puts the document

in context.

Number three, " The conclusions and

recommendations made by the AASLD in its memorandum and

any efforts made by the AASLD to communicate its

conclusions and recommendations. " That is the AASLD's

interaction with the FDA. And I set it up, I put it in

context, and I made it clear. Sherry Cathcart did not

say I don't know the answer to this or I can't answer

this when I asked her, 11 This is a recommendation to the

FDA. Is it binding? " " No. 11 She knew that.

binding on pharmaceutical companies? 11 nNo . n

11 Is it

11Are you


0

critical of pharmaceutical companies if they don ' t

i f they don' t follow your recommendation ? " And she

102

::i said, " No, 11 and she was perfectly entitled to it. And

4 1 if I suggested that the AASLD is a small number, Your

5 I Honor, that was not intentional because it is a group

Li of hepatologists in the country.

7

8

9

10

1 1

1 2

'1:1

1 ·'>

15

16

17

1 8

19

20

2 1

22

23

24

25

counsel

Next one , plaintiffs ' words

THE

for - -

MR .

THE

MR.

THE

MR .

COURT :

HEWES,

COURT:

HEWES:

COURT :

HEWES:

Mr. Webster was present as

As counsel .

Ms. Cathcart, right?

Yes, sir.

And for the AASLD?

He was, Your Honor.

THE COURT: Right. And I'm just as you're

talking, flipping through this transcript, and I note

that he's objecting to the scope of the deposition and

even makes the comment that she was not called to vet

the article and indicated she wasn't qualified to vet

the article.

So there was some discussion with counsel for

the AAS -- AASLD during the deposition about the scope

of her examination, right?

MR. HEWES: There was some, Your Honor.



2

3

,1

'

6

7

8

9

10

1 1

12

13

14

15

16

1 7

18

18

20

21

© 22

;,: 23

24

25

103

MR. HEWES : And you'll see when you look at

our deposition designations we struck that portion of

the testimony in the Laos (ph) case regarding her

interpreting - - her interpreting scientific articles.

We don't intend to include that here at her deposition

testimony as well.

THE COURT: But you went into it at the

deposition?

MR. HEWES: I did go into it at the

deposition --

THE COURT: Yes .

MR. HEWES: -- because the article that I

recited was authored by the author who did not want his

name on any of the other article - - on the other

article, and that's how the link came to be. And the

AASLD has taken certain positions and has actually

issued position papers on hepatotoxicity, authored by

the same author, Dr. Will Lee, and I was exploring them

in that context. The (inaudible) which Mr. Tisi cited

is a Will Lee article.

The other thing, Your Honor, it ties into

you're reading my mind because the next thing the

plaintiffs put out on the 3D (b) (6) notice was, "The

efforts of the AASLD and the AASLD public policy

committee to address the issue of acetaminophen


,

3

4

5

6

7

" 9

10

1 1

12

lo

14

15

16

17

1 8

1 9

20

2 1

0 22

23

24

?5

104

toxicity. 11

This is the plaintiffs' language in their

notice, Your Honor . The subject of the deposition that

they put out there, one of them was, "To address the

efforts of the AASLD to address the issue of

acetaminophen toxicity. 11 The questions that I asked

that we designated are directly relevant to this case.

Of course plaintiffs are strong advocates for

this. Of course they don ' t want this in, Your Honor,

because, again, they' ve been talking about the AASLD

since 2012 in every deposition and every hearing and in

every document that's filed, and they don't want any

shadows cast on that, and the fact remains is that

Sherry Cathcart was properly designated. We don't

intend to designate any testimony from her that is not

within the scope of what the plaintiffs asked about.

And, frankly, her interactions and the AASLD's

interactions and the FDA is the subject of the

deposition itself because it's the subject of the 2007

memorandum, which is a direct interaction back and

forth with the FDA. And that's what the questioning

focused on and that's what the question was based on.

Briefly, to address one point regarding the

American Liver Foundation article, the suggestion that

McNeill paid off the American Liver Foundation and the


'.�

3

4

5

6

7

8

Ci

1 0

11

1 2

13

14

15

16

17

1 8

19

20

21

0 22

_;: 23

24

25

105

American Liver Foundation changed its topic or changed

its position, it' s wrong.

Actually, if all the documents are cited, the

agreement to assist the American Liver Foundation was

done after the American Liver Foundation memorandum was

issued and it was part of a number of payments that

McNeill made to various organizations when they were

considering the American Liver Foundation publication.

And I've got the documents if Your Honor wants to see

the, and I ' ll gladly give them to you if you want to -

if you want to look at them.

As to the AASLD, Your Honor, if Your Honor is

inclined to allow it, I think it would be highly

prejudicial to not allow the context of it putting in .

And, finally, I don't like being told that I

misrepresented something, Your Honor, because I make

every effort to make proper representations . Mr. Tisi

handed you some medical records, but he didn't hand you

medical record bates number HKHMDR18 where the doctor

wrote, 11 The patient has been taking Tylenol and Lorcet

for pain everyday until bedtime, n and just to clear up

that question as to whether she was taking multiple

medications .


MR . TISI: Judge, I know that I'm probably


'

0

6

' I

8 I 9

10

1 1

12

1 3

14

1 5

16

1 7

18

19

20

21

22

23

24

25

overstaying my we lcome , but I j ust want to say one

thing if you don ' t mind .

106

THE COURT : Apparently I don ' t . Go ahead.

MR . TIS I : No, I ' m waiting for you - - i f you

would prefer me to sit down .

THE COURT , Yes, I ' ve heard enough.

MR . TISI : Okay .

THE COURT: Thank you .

MR . TIS I , Thank you .

THE COURT , All right, tha t ' s as far as we ' re

going to go today, folks. We have one motion we didn ' t

get to that will take some time to talk about , and I

have a 1 : 30 oral argument . So, we ' ll reconvene I think

we ' re looking at October at this point , and we ' ll put

an agenda together as we approach that date . All

right , thank you .

MR . TISI : Thank you, Your Honor .

MR . HEWES : Thank you, Your Honor .

{Proceedings adjourned, 12 : 3 8 p . m . )

* * *


3

4 '

5

6

6 I

g

w

11

12

1 3

14

15

16 I

17

i8

19

20

2 1

0 22

23

24

2.5

CERTIFICATION

I, Brad Anders, do hereby certify that the

foregoing is a true and correct transcript from the

electronic sound recordings of the proceedings in the

above-captioned matter.

, Date

Documents

Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 1 of …20-%2009... · 2019. 2. 8. · Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 1 of 107 N RE: IN THE UNITED COURT