Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
`Page 1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` * * *
` GENERICO, LLC and
` FLAT LINE CAPITAL, LLC,
` Petitioner,
` vs. CASE NO. IPR2016-00297
` DR. FALK PHARMA GmbH,
` Patent Owner.
` * * *
`
` Deposition of ALAN VICTOR SAFDI,
`M.D., F.A.C.G., Witness herein, called by the
`Petitioner for cross-examination pursuant to the
`Rules of Civil Procedure, taken before me, Stacey
`M. Mortsolf, a Notary Public in and for the State
`of Ohio, at the Kingsgate Marriott, 151 Goodman
`Drive, Cincinnati, Ohio, on Wednesday,
`November 16, 2016, at 9:46 a.m.
` * * *
`
`Mike Mobley Reporting
`800-894-4327
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 1
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
` (Thereupon, Exhibit 2011, Ulcerative
` Colitis Practice Guidelines in
` Adults (Update): American College
` of Gastroenterology, Practice
` Parameters Committee, was
` identified.).......................... 142
` (Thereupon, Exhibit 1055, Efficacy
` and safety of oral ridogrel in the
` treatment of ulcerative colitis:
` Two multicentre, randomized,
` double-blind studies, was marked for
` purposes of identification.).......... 148
`
` EXAMINATIONS CONDUCTED PAGE
` BY MR. SILBERSHER:.................... 7
` BY MS. CRAMER:........................ 150
`
` EXHIBITS MARKED
` (Thereupon, Exhibit 2035,
` Declaration of Alan Victor Safdi,
` M.D., F.A.C.G., was identified.)...... 9
` (Thereupon, Exhibit 1050,
` Declaration of Alan Victor Safdi,
` M.D., F.A.C.G., was marked for
` purposes of identification.).......... 56
` (Thereupon, Exhibit 1001, United
` States Patent, Patent No.: US
` 8,865,688 B2, was identified.)........ 68
` (Thereupon, Exhibit 2039, Trials
` article, was identified.)............. 79
` (Thereupon, Exhibit 1012, Press
` Release, was identified.)............. 97
` (Thereupon, Exhibit 1014, EndoNurse,
` was identified.)...................... 97
`
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` (Thereupon, Exhibit 1051, Securities
` and Exchange Commission Form 8-K,
` Date of Report, September 5, 2007,
` was marked for purposes of
` identification.)...................... 99
` (Thereupon, Exhibit 1052, Securities
` and Exchange Commission Form 8-K,
` Date of Report, January 11, 2006,
` was marked for purposes of
` identification.)...................... 99
` (Thereupon, Exhibit 1053, GI News
` Round Up - 08/20/15 to 09/11/15, was
` marked for purposes of
` identification.)...................... 106
` (Thereupon, Exhibit 1054, Review
` Article: Increasing the dose of
` oral mesalazine therapy for active
` ulcerative colitis does not improve
` remission rates, was marked for
` purposes of identification.).......... 126
` (Thereupon, Exhibit 2026, SAG-19,
` was identified.)...................... 136
`
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`APPEARANCES:
` On behalf of the Petitioner:
` Kroub, Silbersher & Kolmykov PLLC
` By: Zachary Silbersher
` Gaston Kroub
` Attorneys at Law
` 305 Broadway
` 7th Floor
` New York, New York 10007
` Zsilbersher@kskiplaw.com
` 917-609-2296
`
` On behalf of Mylan Pharmaceutical Inc:
`
` Parker Poe
`
` By: Micheal L. Binns
` Robert Florence
` Attorneys at Law
` 1180 Peachtree Street NE
` Suite 1800
` Atlanta, Georgia 30309
` Michealbinns@parkerpoe.com
` 678-690-5703
` On behalf of the Patent Owner and Alan V.
` Safdi, M.D., F.A.C.G.:
`
` Womble Carlyle Sandridge & Rice LLP
`
` By: Kristen Healey Cramer
` Dana K. Severance
` Attorneys at Law
` 222 Delaware Avenue
` Suite 1501
` Wilmington, Delaware 19801
` Kcramer@wcsr.com
` 302-252-4333
`
` * * *
`
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`Page 3
`
`Mike Mobley Reporting
`800-894-4327
`
`Page 5
`2 (Pages 2 to 5)
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 2
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
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` ALAN VICTOR SAFDI, M.D., F.A.C.G.
`of lawful age, Witness herein, having been first
`duly cautioned and sworn, as hereinafter
`certified, was examined and said as follows:
` MR. SILBERSHER: Zach Silbersher on
`behalf of the petitioners, and I'm joined with my
`partner, Gaston Kroub.
` MS. CRAMER: Kristen Cramer on behalf
`of patent owner Dr. Falk Pharma as well as the
`witness, Dr. Safdi, and my colleague, Dana
`Severance from Womble Carlyle.
` MR. FLORENCE: Robert Florence and
`Micheal Binns with the law firm of Parker Poe
`Adams & Bernstein on behalf of Mylan
`Pharmaceuticals, Inc., who has a pending motion
`for joinder for this IPR.
` MS. CRAMER: And before we start, I'd
`just like to put on the record Dr. Falk's
`objection to the presence of Mylan at this
`deposition. Mylan did file a petition in IPR
`20161386 seeking joinder to Generico's IPR in
`2016297. Dr. Falk Pharma filed in opposition to
`Mylan's joinder on the basis that Dr. Falk
`believes that Mylan's petition is time barred as
`well as the prejudice to Dr. Falk and sought
`
`Page 6
`
`protections from the Patent Trial and Appeal Board
`if joinder were granted, and we just wanted to
`note that for the record.
` MR. SILBERSHER: Okay.
` * * *
` CROSS-EXAMINATION
`BY MR. SILBERSHER:
` Q. Good morning, Dr. Safdi.
` A. Good morning.
` Q. My name again is Zach Silbersher,
`and I represent the petitioners in this
`proceeding. I understand that you've been
`deposed before, is that correct?
` A. Yes, I have.
` Q. I'm just going to briefly go over
`some ground rules. I'm going to ask you a
`series of questions today. If at any time you
`don't understand my question or you'd like me
`to repeat my question, please let me know. Is
`that understood?
` A. Yes, it is.
` Q. Okay. And if you do answer my
`question, I'm going to assume that you
`understood my question, okay?
` A. That's very reasonable.
`
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` Q. Is there any reason that you do
`not believe you're competent to testify today?
` A. None.
` Q. Are you on any medication that you
`think might impair your ability to testify?
` A. I'm on no medication.
` Q. Okay. I think we'll go for
`roughly an hour at a time, but if at any time
`you want to take a break, please let me know.
` A. Thank you very much.
` Q. And I also know that this is a
`relatively small room, so if it gets hot, there
`is a thermostat here, or if it gets too cold,
`just let me know.
` A. I'm married. Whatever
`temperature's fine with me.
` Q. So have you been deposed before?
` A. Yes, I have.
` Q. When were you deposed before?
` A. Probably some time beyond three or
`four years ago, and then for Novel and Mylan.
` Q. Three or four years ago you were
`deposed in connection with -- could you be more
`specific?
` A. I was an expert witness in a
`
`Page 8
`
`medical malpractice case.
` Q. Okay. And have you been deposed
`in connection with any other cases?
` A. Novel and Mylan.
` Q. So was that two separate
`depositions?
` A. Two separate depositions.
` Q. And when did those depositions
`occur?
` A. I don't recall the exact dates.
`Within the last couple years.
` Q. Okay.
` A. One of them this year where I met
`these gentlemen, and the other one would be a
`year or two years ago, but I don't recall the
`exact dates.
` Q. Okay. So have you been deposed
`before in any other capacity as an expert
`witness other than what you've mentioned?
` A. No, I have not.
` Q. I'm going to start by showing you
`what's been previously marked Exhibit 2035.
` (Thereupon, Exhibit 2035, Declaration
`of Alan Victor Safdi, M.D., F.A.C.G., was
`identified.)
`
`Page 7
`
`Mike Mobley Reporting
`800-894-4327
`
`Page 9
`3 (Pages 6 to 9)
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 3
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
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`BY MR. SILBERSHER:
` Q. I'm going to tell everybody that
`I've only brought four copies of every
`document. Do you recognize this document?
` A. Yes, I do.
` Q. Is this your declaration that you
`submitted in this proceeding?
` A. The front page is. I'd have to
`look at each page to see if they're all
`consistent. Yes, it is.
` Q. Did you prepare this document
`yourself?
` A. In consultation with counsel.
` Q. Did you write the document
`yourself?
` A. Significant portions of it, yes.
` Q. Do you recall what portions you
`did not write?
` A. Not offhand. We could go through
`it portion by portion, but most of the medical
`aspects of I did.
` Q. Okay. Now, there's a number of
`exhibits that are cited in this declaration.
`Did you identify those exhibits yourself?
` A. Some of them.
`
`Page 10
`
` Q. Were some of them identified by
`your counsel?
` A. Well, we need to go through the
`exhibits. What page are you referring to?
` Q. Well, I'm just asking generally.
`We don't have to go through each exhibit. Were
`any of the exhibits identified by your counsel?
` A. Yes.
` Q. Okay. Can we turn to page 7,
`paragraph 14. Okay. In this paragraph you
`indicate that you've performed studies on
`variety of mesalamine drugs including Apriso,
`is that correct?
` A. That's correct.
` Q. Could you describe the drug -- the
`studies that you performed in connection with
`Apriso?
` MS. CRAMER: Objection. Form.
` THE WITNESS: We were an investigator
`site in regards to the Apriso studies.
`BY MR. SILBERSHER:
` Q. When you say we, who do you mean?
` A. The president of Ohio
`Gastroenterology and Liver Institute. That's
`my group. Also the president and consultant
`Page 11
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`for clinical research, and we performed studies
`in conjunction with the Apriso studies. We
`were not the sole investigator site.
` Q. So what were the studies performed
`in conjunction with the other studies?
` A. Which studies are you referring
`to?
` Q. Well, I'm asking you. Could you
`describe at least some of what you performed?
` A. Well, there's a study to document
`that you can maintain remission using a DAI
`score of zero and one in regards to rectal
`bleeding and mucosal appearance and endoscopic
`scoring system. Maintaining remission for a
`six-month period in a two to one randomization.
`So it is a 2 to 1 randomization in parallel
`studies that are being done. Also, in
`conjunction with Salix Pharmaceuticals,
`conducted pharmacokinetic studies.
` Q. And what were those
`pharmacokinetic studies?
` A. We assumed, based upon previous
`literature or previous understandings, that
`there would be significant food effects of
`administration of drugs. So one is to look at
`Page 12
`
`the food effect of administration of this pH6
`dissolution compound. The other one is looking
`at q.d. or once a day dosing compared to twice
`a day dosing to see if there was any
`differences pharmacokinetically.
` Q. And was there a name for that
`study?
` A. Yeah, there is, but I don't recall
`the numbers offhand.
` Q. Do you recall roughly when you
`performed that study?
` A. No, I don't.
` Q. Was it within the past five years?
` A. No, it wasn't.
` Q. It was more than five years ago?
` A. Yes, it was.
` Q. Okay. In the second sentence of
`paragraph 14, you say you performed studies
`involving dissolution of pH dependent
`mesalamine in the form of Asacol. Could you
`describe that study in more detail?
` A. Yes. Mesalamine, everybody is
`under the misconception that all mesalamine
`drugs, if they have the same pH coding, are
`going to be identical, which is -- my theory
`
`Page 13
`4 (Pages 10 to 13)
`
`Mike Mobley Reporting
`800-894-4327
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 4
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
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`was that this is not true. You may have two pH
`7 dissolution drugs and you're going to think
`they work pharmacokinetically identically.
` We've had patients for years
`stating that mesalamine tablets were coming
`out -- or they saw fragments or whole tablets
`in their stool. So this is a study of 30, I
`believe -- it's been a while, but it's 30
`volunteers, and I think we were able to obtain
`data from 27 volunteers.
` We would collect their stool after
`administering mesalamine compounds in the form
`of pH 7 Asacol. And 55 percent of the patients
`had fragments -- significant fragments within
`the stool. We assumed in the past it was inert
`incipients or outer coating of that; however,
`we found out surprisingly that every single one
`of those fragments had detectable drug within
`it.
` So even though it should have
`dissolved, it did not. That's the importance
`of doing pharmacokinetic studies on every
`single mesalamine product you have. You can't
`take a study and just assume that it's going to
`dissolve based upon in vitro studies. So it
`
`Page 14
`
`was pretty interesting that we found that a
`drug that should have dissolved in these
`patients was not in a significant portion of
`people with pH 7 dissolution.
` Also, these were healthy
`volunteers who didn't have a disturbance of pH
`within their gastrointestinal tract. So IBD
`patients are quite different. So we may see --
`our theory was we'll probably see an increase
`in IBD patients which clinically we had been
`seeing.
` Q. So did the drug have an enteric
`coating on it?
` A. Yes, it does.
` Q. And when you say that it didn't
`dissolve, did you mean the enteric coating did
`not dissolve?
` A. Portions of the enteric coating
`did not dissolve.
` Q. Okay. So the study investigated
`to what extent there was inefficacy of this
`drug based upon the dissolution of the enteric
`coating?
` A. No.
` MS. CRAMER: Objection. Foundation.
`
`Page 15
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` THE WITNESS: That's not the basis of
`the study. The study was a pharmacokinetic study
`to see if there's dissolution, whether it be
`inside the capsule, did not dissolve, or the
`outside. We couldn't detect based upon looking at
`drug levels. So we would collect the fragments,
`send them off for analysis, and we did not send
`them off for microscopic analysis to see, you
`know, was there complete dissolution of the
`outside. So you mentioned efficacy study. It was
`not an efficacy study. It had nothing to do with
`efficacy. These were people without disease.
`BY MR. SILBERSHER:
` Q. Okay. But you were looking at
`whether or not -- when you say the outside --
`strike that. When you say the outside, you
`mean the enteric coating on the drug?
` MS. CRAMER: Objection. Form.
` THE WITNESS: The outside -- we
`wanted to just see -- you know, again, I think
`you're trying to somewhat misconstrue what I'm
`trying to say. I'm probably not being clear
`enough. That is not the premise of the study.
`BY MR. SILBERSHER:
` Q. That's fine.
`
`Page 16
`
` A. The premise of the study, as I
`just mentioned, was -- I can't tell you whether
`the outside dissolved completely or not. My
`assumption is it did not.
` Q. But when you say the outside, I
`just want to know, what was the outside? When
`you refer to the outside, what do you mean?
` A. There's a EUDRAGIT coating on it.
` (Thereupon, the Notary Public
`interrupted the proceedings for clarification.)
` THE WITNESS: So there's a EUDRAGIT
`coating on that. I can't tell you whether the
`EUDRAGIT had dissolved or not. The tablets were
`coming out in the stool in part of fragments or
`whole, and it was to see if this passed through
`the gastrointestinal tract without bioavailability
`to the mucosal surface. So if they're coming out
`in the stool, they're not bioavailable to the
`mucosal surface.
`BY MR. SILBERSHER:
` Q. Okay. When you say it's, what do
`you mean? Meaning the capsule including the --
` A. The entire drug administration, so
`it's -- you know, you look at a drug. We
`didn't break this apart to see which portions
`Page 17
`5 (Pages 14 to 17)
`
`Mike Mobley Reporting
`800-894-4327
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 5
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
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`of this were flawed. What we did look at is is
`there a portion of this -- and I can't tell you
`which portions of that came out in significant
`fragments or pieces.
` Q. Okay. Are there any other studies
`that you performed in connection with
`mesalamine drugs?
` MS. CRAMER: Objection. Form.
` THE WITNESS: Yes, I believe so. I'd
`have to go through an extensive research
`experience, so I think we did -- I'm not certain,
`but I think we were involved in Pentasa and other
`mesalamine studies over the years, yes.
`BY MR. SILBERSHER:
` Q. Do you recall what other --
` A. As well as balsalazide.
` Q. Are there any other -- so
`specifically do you recall any other
`pharmaceutical drug brand names that you were
`involved in?
` A. I believe COLAZAL. Asacol has
`been mentioned there. I believe Pentasa,
`Apriso. I'm not certain -- I'm not certain if
`we were involved with Lialda or not.
` Q. Okay. So, moving on, you are a
`Page 18
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`gastroenterologist at the Ohio Gastroenterology
`and Liver Institute, is that correct?
` A. That's correct.
` Q. And how long have you been within
`that practice?
` A. Thirty-three years.
` Q. Thirty-three years? And could you
`describe your practice?
` A. It's a single specialty
`gastroenterology practice that encompasses
`treating patients throughout the region as well
`as I get referrals for inflammatory bowel
`disease patients from other areas. There's at
`any one time 18 to 20 gastroenterologists
`within the practice. There's a variety of
`mid-level providers. We cover inpatient work
`for multiple hospitals within the region, and
`we also have a clinical research arm. We have
`endoscopy centers.
` Q. So do you treat patients with
`Crohn's disease?
` A. Yes, I do.
` Q. As well as ulcerative colitis?
` A. Yes, I do.
` Q. And could you describe like the
`Page 19
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`demographics of the patients that you see? So,
`to be more specific, do they cover a broad
`range of ages?
` A. Yes, they do, except I do not see
`pediatric patients anymore.
` Q. Okay. So that would be patients
`under the age of --
` A. Depends on the size of the
`individual because our anesthesia professionals
`don't like relatively small people. They're
`used to adults, although a lot of kids are
`bigger than me by the time they're 14 now.
`Most of the time I won't see people under the
`age of 16.
` Q. Sixteen?
` A. Under the age of 16.
` Q. Okay.
` A. A lot of nurses and doctors ask me
`to see their children, and sometimes we'll make
`exceptions.
` Q. Do you see patients over the age
`of 70?
` A. Yes, I do.
` Q. Are a large percentage of your
`patients over the age of 65 or 70?
`
`Page 20
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` A. Can you define large percentage?
` Q. More than 50 percent?
` A. I have no idea.
` Q. Okay. And you see men and women?
` A. Yes, I do.
` Q. And do you treat patients with
`active ulcerative colitis?
` A. Yes, I do.
` Q. And as well as -- and you treat
`patients in the course of maintaining remission
`of ulcerative colitis?
` A. Yes.
` Q. So when you are diagnosing a
`patient with active ulcerative colitis, can you
`describe what factors you take into
`consideration?
` A. That's a relatively open-ended
`question. Somebody -- first of all, when I'm
`diagnosing, you will come see me with symptoms.
`I'm not going to know you have ulcerative
`colitis. So at that point I develop a
`differential diagnosis of all the different
`things you could have including infectious
`etiology, medication induced, other etiologies,
`pain or diarrhea or cramps that you're having.
`Page 21
`6 (Pages 18 to 21)
`
`Mike Mobley Reporting
`800-894-4327
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 6
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
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` We always want to look at other
`treatable etiologies initially. It's a pretty
`extensive evaluation, depending upon the
`patient, the age, and other things. We will go
`through an extensive pre-endoscopic evaluation.
`Sometimes I can figure it out just by the stool
`studies and it may not be inflammatory bowel
`disease; it may be some other etiology that's
`easily treatable.
` It could be campylobacter, it can
`be salmonella. It can be shigella. It can be
`clostridium difficile toxin induced --
` (Thereupon, the Notary Public
`interrupted the proceedings for clarification.)
` THE WITNESS: It could be salmonella,
`campylobacter, shigella, clostridium difficile
`toxin induced disease, or even medication-induced
`disease. It can be ischemic, not enough blood
`supply to the bowel. So we'll go through -- and
`there's a lot more things that we take a look at.
`If we get to the point where we're not certain
`what it is, often we'll do an endoscopy.
`BY MR. SILBERSHER:
` Q. And do you perform endoscopies
`yourself?
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`Page 22
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` A. Yes, I do. And I'll go ahead and
`perform an endoscopy on that patient. We will
`do adequate amount of mucosal assessment. We
`look not only at the colon but also at the
`ileum. Almost 100 percent of the time I will
`look at the ileum, terminal ileum, as well as
`the colon.
` We'll be getting appropriate
`biopsies if the mucosa looks abnormal. If we
`think it's ulcerative colitis, we're going to
`define it -- not just the word ulcerative
`colitis. We define the extent of the disease.
`So ulcerative colitis is not a term we tend to
`use by itself. It's ulcerative colitis to
`where? What is the extent of the disease?
` So we'll be doing appropriate
`biopsies on that patient as well as I may
`repeat some of the stool studies because often
`one set of stool studies may not be adequate
`during that period of time.
` Then we'll be analyzing histologic
`material, which is the biopsy material, to see,
`again, is this consistent with ulcerative
`colitis. So that's the initial assessment.
` Q. Okay. So when you're treating
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`patients who are in remission with ulcerative
`colitis, what factors do you look at to
`determine whether they're still in remission?
` MS. CRAMER: Objection. Form.
` THE WITNESS: Again, that's a very
`open-ended question and very difficult to answer
`because each patient is different. It depends
`upon the extent of disease that they had. It
`depends on duration of disease that one has. If
`you've had disease for 30 or 40 years, often
`you're going to be getting routine endoscopic
`evaluations to look for dysplasia or abnormal cell
`lines that have developed within the
`gastrointestinal mucosa. There's three different
`types of remission we look at.
` So the word remission means very
`little to a gastroenterologist. You have, you
`know, in regards to treatment of patients right
`now, we have an endoscopic remission, we have a
`symptomatic remission, and we're evolving, not
`quite there yet, to even looking at histologic
`remissions.
`BY MR. SILBERSHER:
` Q. Could you describe each of those
`briefly?
`
`Page 24
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` A. Symptomatic is what it means.
`Does the patient have symptoms? Do they have
`diarrhea? Do they complain? Do they feel
`okay?
` Q. Would that include stool
`frequency?
` A. Yeah. Diarrhea would include
`stool frequency, yes.
` Q. Would that include rectal
`bleeding?
` A. That is a sign rather than a
`symptom, so there's a difference between signs
`and symptoms. But we do ask about signs also,
`you're correct. So we do ask about rectal
`bleeding in all patients. We ask about stool
`frequency.
` We also ask about nocturnal
`symptoms. If you're waking up at night with
`symptoms, if you go to the bathroom two or
`three times during the day, that may not be
`abnormal for you. If you have nocturnal
`diarrhea or waking up in the middle of the
`night with bowel movements, that's very
`abnormal even if you're only going two or three
`times per day.
`
`Page 23
`
`Mike Mobley Reporting
`800-894-4327
`
`Page 25
`7 (Pages 22 to 25)
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 7
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
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` We ask about Tenesmus, so -- which
`is, you know, where you went to the bathroom,
`feel like you didn't empty completely, and have
`to sit back down but no bowel movement comes
`out. So they wouldn't truly have diarrhea, but
`they feel like they never empty completely.
` We ask about constipation because
`during periods of flares, they may actually
`complain of constipation, not just diarrhea.
` So we have endoscopic evaluations.
`We have symptomatic. We ask about symptoms.
`We ask about signs. We look at duration of
`disease, thinking about how often should we
`evaluate them endoscopically. And then we look
`at side effects of the medication, so part of
`maintaining somebody in remission is I'm giving
`them medications; am I causing any toxicity
`secondary to my treatment, are there any drug
`side effects secondary to my treatment.
` Q. Do you -- in connection with
`symptomatic remission, do you ask about the
`patient's subjective impressions of their own
`disease?
` A. Not -- I apologize. Not in the
`terms you just used because my patients may not
`
`Page 26
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`understand what you just said.
` Q. Okay. Well, do you ask them how
`they feel and take that into consideration?
` A. Obviously. You know, when I first
`walk in, no matter who the patient is, we spend
`five minutes just talking about their life, are
`they able to exercise, how do they feel. It's
`not just how do you feel and what is your
`impression of your disease, are you able to go
`to the gym? Can you finish a workout? Can you
`take a walk without having diarrhea or stools?
` So it's a constellation of
`questioning that goes on, and a lot of these
`patients, because they have inflammatory bowel
`disease and that's a significant portion of my
`practice, I get to know them extremely well.
`It's not a very quick office visit. It's a
`very prolonged office visit.
` Q. It takes a while to go through all
`the factors and --
` A. Yes.
` Q. -- discussion with the patient?
` A. If you're going to do a good job,
`it takes quite a while.
` Q. And do you have a rating system
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`that you use to assess to what extent a patient
`is in whatever form of remission?
` MS. CRAMER: Objection. Form.
` THE WITNESS: Do I have a -- in
`research, yes, I have a grading system I use for
`remission, and I have a rating system I've used
`for treatment of active disease. Most of the
`rating systems right now, you know, are specific.
`We always include mucosal appearance in regards to
`that rating system. I still use it in my own
`head.
` I don't write down a specific -- if
`you're asking me do I write down a number for each
`one of these patients? No, I do not write down a
`number. I write down my clinical assessment of
`how they're doing because it's more complex than
`just a number. Are they compliant with their
`medications? Are they taking them first thing in
`the morning? Are they taking them with foods?
`They're not forgetting them? Are they taking --
`if they're Vitamin D deficient, are they taking
`Vitamin D? So there's an entire assessment. So
`it would be very difficult to say, okay, you have
`a number of three, you're doing great.
`BY MR. SILBERSHER:
`
`Page 28
`
` Q. Okay. But you -- so you don't
`have a formal rating system, but you take all
`these factors into consideration?
` A. Yes. I think most physicians do.
` Q. Okay. And what drugs do you
`prescribe for ulcerative colitis?
` A. Quite a few. You want me to go
`through all of them?
` Q. Well, why don't you start going
`through them?
` A. We use 5-ASA drugs. Often the
`initial drug, depending upon the severity of
`the disease, in ulcerative colitis patients, I
`use not just drugs but lifestyle changes.
`There are studies that your diet may make a
`difference in regards to inflammatory bowel
`disease. We look at Vitamin D. There are
`studies Vitamin D may make a difference.
`Vitamin D levels may make a difference in
`patients with inflammatory bowel disease.
` If they're not responding to those
`therapies, you know, there's a step-up and
`step-down type approach, but compared to
`Crohn's disease, we'll often do a step-up
`approach in these patients, and we'll use
`
`Page 27
`
`Mike Mobley Reporting
`800-894-4327
`
`Page 29
`8 (Pages 26 to 29)
`
`GeneriCo, Flat Line Capital
`Exhibit 1056 Page 8
`
`

`

`Generico, LLC, et al. v. Pharma, GmbH, Dr. Falk
`
`Alan Victor Safdi, M.D., F.A.C.G.
`
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`immunomodulators such as methotrexate or
`6-mercaptopurine, Azathioprine in patients. We
`may go straight to biologics or a combination.
`The biologics that I will use, there are quite
`a few different ones. We use golimumab. Maybe
`I'll use brand names. They're easier.
`Simponi, now Stelara, Humira.
` Q. Do you use Remicade?
` A. Remicade.
` Q. So with respect to 5-ASA drugs,
`could you list the brand names that you've
`described?
` A. That I've prescribed in my
`lifetime?
` Q. Yes.
` A. Initially, sulfasalazine,
`azulfidine is the brand name; balsalazide,
`COLAZAL, Giazo, another form of balsalazide but
`at 1.1 gram. We'll use Apriso, Lialda, Asacol,
`a couple times Delzicol, Kinase, Rowasa enema.
` Q. So with respect to the drugs you
`just mentioned, how do you decide to use one
`drug versus another one?
` A. Compliance is an issue in
`patients. I assess compliance. Response is an
`Page 30
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`issue. So are they responding to my current
`therapy. With Asacol, in the past, as I
`mentioned previously, I would ask the patients
`are their tablets coming out in the stool. If
`they are, because I document that, that's
`actual drug that they're losing, I will