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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
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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.
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{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
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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.
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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
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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
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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
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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,
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1 I bellwether case pending before Your Honor, the Hayes
2 Terry case Your Honor had decided it under Alabama law,
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and Pennsylvania choice of law principles that the
Alabama punitive damages claim would survive at this
point.
THE COURT: Right.
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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
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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
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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
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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.
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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.
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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
- ----- ----- - --- --
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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
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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.
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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,
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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
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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.
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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
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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
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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
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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,
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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.
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I am here on this first motion in limine,
2 Your Honor, dealing with adverse event reports. As
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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
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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
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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,
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8 1 Your Honor, is there has to be encephalopathy, and
encephalopathy is a brain swelling that presents in two
ways.
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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
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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
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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
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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.
(Pause in proceedings. )
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
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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. "
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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
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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.
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"More than 80 percent of patients were transferred from
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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
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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
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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.
THE COURT: Thank you.
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
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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.
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"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.
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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
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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.
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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
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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
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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
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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.
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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?
(Pause in proceedings.)
THE COURT: Good morning, Mr. Tisi.
MR. TISI: Good morning, Judge. If you give
me a moment I want to grab some stuff.
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(Pause in proceedings. )
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
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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
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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
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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.
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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
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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
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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,
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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
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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
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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.
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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.
(Pause in proceedings.)
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
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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
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1 1 know acute liver failure is extremely rare.
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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.
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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
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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
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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
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1 I ASTs, we have animal studies, we have case reports and
case series . 2
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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
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causation analysis.
MR. TISI: Correct.
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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
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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
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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 - -
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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.
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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.
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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
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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.
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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,
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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 .
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MR. HEWES: Yes, Your Honor, thank you.
THE COURT: Thank you. All right. The
evidence relating to employee compensation. That is
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·+ the defendant ' s motion in limine number four. What are
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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
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1 I not in dispute. I 2 1 You did rule that the specifics, including
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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
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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
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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
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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.
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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
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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 --
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THE COURT: Well, you want to bring up
2 company loyalty as a bias issue?
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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
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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
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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
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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
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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.
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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
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cases, they don ' t really stand for that broad
proposition stated in the memo.
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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?
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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
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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.
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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
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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
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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?
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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 .
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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.
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MR. ABERNETHY: Thank you, Your Honor.
(Pause in proceedings. )
THE COURT : Motion in limine 16 has to do
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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
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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
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MR. HEWES: B from the plaintiffs.
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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,
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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.
(Pause in proceedings. )
THE COURT : Sure.
{Pause in proceedings. )
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
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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?
THE COURT: All right.
(Pause in proceedings. )
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.
{Pause in proceedings. )
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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.
(Pause in proceedings.)
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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,
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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
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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.
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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.
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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
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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.
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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,
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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
(Pause in proceedings.)
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
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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
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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.
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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.
(Pause in proceedings.)
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.
(Pause in proceedings.)
THE COURT: Thank you.
Your Honor?
MR. HEWES: The Watkins paper is an example
of a randomized double blind placebo controlled trial
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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
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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
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her gastric bypass surgery as to what they believe is
an increased risk factor.
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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.
(Pause in proceedings. )
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.
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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.
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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
{Pause in proceedings. )
let me approach.
THE COURT: All right, thank you.
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
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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.
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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.
{Pause in proceedings. )
MR. TISI: There is a little bit of a story
8 here, Judge. The first thing that happens is they note
q
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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
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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
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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 --
(Pause in proceedings. )
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
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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?
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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.
(Pause in proceedings.)
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.
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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 --
(Pause in proceedings.)
MR. TISI: -- it says on page -- the last
page, 93, it says, 11We conclude that the initiation 11
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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.
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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.
(Pause in proceedings. )
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
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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
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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.
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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,
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AASLD says and the FDA saying you shall not do it. The
truth of the matter is, and it's been repeatedly
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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.
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1 i So under Rule 703, it's very clear that it comes in.
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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.
THE COURT: All right.
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
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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 .
(Pause in proceedings. )
MR. TISI: And it's Exhibit B to our motion.
(Pause in proceedings. )
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
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question; and what the conclusions were of the AASLD.
What did -- what did the documents say and how did you
communicate it?
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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
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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
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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.
(Pause in proceedings. )
MR. TISI: And you will -- you will see in
Exhibit G that it primarily -- schedule A asks them to
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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,
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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
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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
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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
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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,
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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
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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.
THE COURT: Thank you.
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.
THE COURT: All right, thank you.
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points?
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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
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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
Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 102 of 107
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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.
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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.
THE COURT: All right.
Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 103 of 107
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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
Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 104 of 107
,
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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
Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 105 of 107
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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 .
THE COURT: All right, thank you.
MR . TISI: Judge, I know that I'm probably
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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 . )
* * *
Case 2:13-md-02436-LS Document 270 Filed 09/17/15 Page 107 of 107
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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