DR. MICHAEL N. HELMUS, PH.D.
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` ZIMMER BIOMET HOLDINGS, INC.,
` Petitioner,
` v.
` FOUR MILE BAY, LLC,
` Patent Owner.
`
` Case IPR2016-00012
` Patent 8,821,582 B1
`
` DEPOSITION OF DR. MICHAEL N. HELMUS, PH.D.
` New York, New York
` Thursday, September 22, 2016
`
`Reported by:
`KATHY S. KLEPFER, RMR, RPR, CRR, CLR
`JOB NO. 112812
`
`TSG Reporting - Worldwide 877-702-9580
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`Page 3
` DR. MICHAEL N. HELMUS, PH.D.
`
` A P P E A R A N C E S:
`
`CONLEY ROSE
`Anticipated Successor Lead Counsel for Patent
`Owner Four Mile Bay, LLC
` 1001 McKinney Street
` Houston, Texas 77002
`BY: CHARLES ROGERS, ESQ.
`
`PAUL HASTINGS
`Attorneys for Petitioner Zimmer Biomet
`Holdings, Inc.
` 200 Park Avenue
` New York, New York 10166
`BY: YOUNG PARK, ESQ.
` - AND -
` 875 15th Street, NW
` Washington, D.C. 20005
`BY: PAROMITA CHATTERJEE, ESQ.
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`Page 2
` DR. MICHAEL N. HELMUS, PH.D.
` September 22, 2016
`
` Deposition of DR. MICHAEL N. HELMUS,
`PH.D., held at the offices of Paul Hastings
`LLP, 200 Park Avenue, New York, New York,
`before Kathy S. Klepfer, a Registered
`Professional Reporter, Registered Merit
`Reporter, Certified Realtime Reporter,
`Certified Livenote Reporter, and Notary
`Public of the State of New York.
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`Page 4
` DR. MICHAEL N. HELMUS, PH.D.
`DR. MICHAEL N. HELMUS, PH.D., called as a
` witness, having been duly sworn by a Notary
` Public, was examined and testified as
` follows:
`EXAMINATION BY
`MR. YOUNG:
` Q. Good morning, Dr. Helmus.
` A. Good morning.
` Q. Would you please state your name and
`your home address for the record, please.
` A. Yes. Michael N. Helmus, 2 Jamesbury
`Drive, Worcester Mass, 01609. That's our main
`home.
` Q. And have you had your deposition taken
`before?
` A. I've had depositions taken before, but
`not with respect to this case.
` Q. Okay. But in district court actions
`you've had your deposition taken before?
` A. Yes, I have. Yes.
` Q. So you're generally familiar with the
`ground rules for a deposition; is that right?
` A. That's correct. And we reviewed
`changes in the way the depositions have occurred
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`Page 5
` DR. MICHAEL N. HELMUS, PH.D.
`since my last one.
` Q. Okay. And when you say "we've
`reviewed changes in the way the depositions have
`occurred since my last one," what do you mean?
` A. There were some procedural changes in
`terms of how -- I'm trying to remember. This
`was yesterday, so...
` I don't remember the details. We just
`talked about some -- it was just some procedural
`aspects or differences. I think the last
`deposition I gave was over five years ago. So
`there were some changes in the law, I remember.
`Sorry.
` Q. What's your understanding of these
`procedural changes?
` A. Just give me a second because I was
`thinking about it.
` Oh, I'm sorry. It was in terms of
`some of the discussions that might take place;
`that you can't have any discussions that take
`place between the attorney on our side and
`myself during the day of the deposition. That
`was basically what we discussed.
` Q. So your understanding is you're not
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` DR. MICHAEL N. HELMUS, PH.D.
`allowed to have any substantive discussions
`regarding the deposition --
` A. Correct.
` Q. -- regarding the course of today's
`deposition?
` A. That's correct.
` Q. And just for the sake of the court
`reporter, if you just give me a second to
`complete my question before you respond.
` A. Sure.
` Q. And I will do the same for you. I
`think it's something that the court reporter
`will appreciate.
` Agreed?
` A. Agreed.
` Q. So you understand that, during the
`course of the day, I will be asking you
`questions, and it is your obligation to give
`truthful responses?
` A. Correct.
` Q. And you are prepared today to give the
`most complete, truthful responses to your
`knowledge to my questions; is that right?
` A. That is right.
`
`Page 8
` DR. MICHAEL N. HELMUS, PH.D.
`Though I have testified at arbitration
`proceedings with respect to patents.
` Q. The three times that you have given
`your deposition testimony, were they in your
`capacity as a fact witness or an expert witness
`or something different?
` A. Both. So there was a fact witness, I
`believe there was once as a re-exam, and as well
`as another as an expert in litigation.
` Q. So, just to be clear on the record,
`how many times have you given expert testimony
`in a deposition and how many times have you
`given fact testimony in a deposition?
` A. So, again, I might be unclear of the
`total number, but clear -- only once as a fact
`witness and then twice as an expert,
`approximately. There could be one more in
`there, but I don't remember.
` Q. Can you tell me about the two cases
`where you have given testimony as an expert
`witness?
` A. In terms of the type of case or...
` Q. Let's start there.
` A. So one was a re-exam, and it was for
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` DR. MICHAEL N. HELMUS, PH.D.
` Q. If you don't understand one of my
`questions, would you agree to ask me to clarify
`my question so that I can reform or reask it?
` A. Yes.
` Q. Is there any reason that you can think
`of sitting here right now as to why you would
`not be able to give complete and truthful
`responses to my questions?
` A. Not that I know of.
` Q. When was the last time you had your
`deposition taken?
` A. Oh, it was over five years ago. I
`just can't remember the exact date.
` Q. Okay. And how many times have you had
`your deposition taken?
` A. I believe it's three times.
` Q. And have you ever given testimony at
`trial?
` A. Yes, I have.
` Q. How many times have you given
`testimony at trial?
` A. Well, actually, only once. It was a
`fact witness for my own patents, and the other
`cases were settled before they went to trial.
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`Page 9
` DR. MICHAEL N. HELMUS, PH.D.
`the side of the defendant, and the other was in
`a patent litigation case that would have gone to
`one of the district courts.
` Q. Let's talk about the re-exam. When
`you say "side of the defendant," do you mean the
`patent owner or the patent challenger?
` A. The patent owner.
` Q. What was the technology at issue?
` A. Drug eluting-stents.
` Q. So nothing relating to orthopedic
`implants?
` A. That is correct.
` Q. And can you tell me about the patent
`litigation where you gave expert testimony?
` A. It was drug-eluting stents. All
`three, the fact witness and the two other cases,
`were drug-eluting stents.
` Q. And in the patent litigation where you
`gave expert testimony, nothing in that case
`related to orthopedic implants; is that correct?
` A. That's correct.
` Q. How much are you being paid for this
`post-grant proceeding?
` A. So it's my normal consulting rate for
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`Page 10
` DR. MICHAEL N. HELMUS, PH.D.
`litigation and expert testimony, which is $400
`an hour.
` Q. And prior to preparing for this
`deposition, how much time have you spent on this
`matter?
` A. Oh, I don't have the total number of
`hours in my head. I mean, the time that I would
`have taken to write the reports and plus review
`documents for today's deposition. I don't want
`to give an incorrect testimony. I would have to
`look at my records.
` Q. And I'm just trying to get a sense of
`how much time you took in the process of writing
`your expert report -- expert declaration. Can
`you give me some estimate as to how much time
`you spent on that process?
` A. I mean, that was the beginning of the
`summer or mid-summer. So, I mean, I just don't
`want to estimate. I would have to go back to my
`records and look. I don't like to estimate. I
`mean, it's whatever -- it was a reasonable
`amount of time that you take to write a
`document, but I don't want to estimate because
`I, you know, the records are all submitted and
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`Page 12
` DR. MICHAEL N. HELMUS, PH.D.
`a conclusion on it, but I don't remember the
`details.
` Q. And maybe I was not clear on my
`question so I'll ask it differently.
` When did you start working,
`substantively working, on this case?
` A. Sometime in the beginning of the
`summer.
` Q. Would that be June or July?
` A. Definitely July and probably June. I
`just don't remember the dates.
` Q. If it was in June, would it have been
`late June?
` A. I don't remember.
` Q. Can you tell me about how you were
`contacted about this case?
` A. Yes. I'm listed as an expert with a
`contract technical organization that has experts
`that they contact when they have casework called
`ORC, and they contacted me because of my
`qualifications in their database, and they were
`contacted by this side.
` Q. Can you tell me about the discussion
`you had with ORC initially?
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` DR. MICHAEL N. HELMUS, PH.D.
`the number of hours and I would want to look at
`those. I don't like to estimate.
` Q. Do you know if it's less than 100
`hours?
` A. I don't want -- I want to sit with my
`documents. I didn't really sit there and think
`about the number of hours that I took on it.
` Q. So when were you first contacted about
`this case?
` A. I would say it was in the spring. I
`don't remember which month.
` Q. Spring of 2016?
` A. 2016, yeah.
` Q. Just to kind of remind you if we
`cannot talk over each other, that would be of
`great benefit to the court reporter.
` Now, after you were contacted in the
`spring of 2016, did you start working on this
`matter right away?
` A. No, I had to submit my qualifications.
`I don't know -- I do not know the process they
`used to select their -- select me as an expert,
`so I can't say. It was probably within a couple
`months that we got to the point where we came to
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`Page 13
` DR. MICHAEL N. HELMUS, PH.D.
` A. They asked me what my background was
`in patents and patent litigation and my
`background with respect to hips, and so I
`provided them that information.
` Q. And then what happened?
` A. There probably was a delay, and then
`they contacted me and then I was put in contact
`with the patent owner.
` Q. Now, in these initial discussions with
`ORC, did they tell you anything about the case?
` A. No.
` Q. They just told you that there was a
`case about hip implants?
` A. Specifically, I don't remember. It
`was -- they certainly said hip orthopedic
`implants. They may or may not have said hip and
`they may or may not have said porous. I just
`don't remember.
` Q. Did they tell you that it was a Patent
`Office proceeding?
` A. I don't remember. Just that it
`related to patents, and I don't remember if they
`discussed it as a Patent Office action or if it
`was -- I don't know if they gave any detailed
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` DR. MICHAEL N. HELMUS, PH.D.
`discussion at that point. It was pretty
`generic.
` Q. When were you first contacted by a
`representative of Four Mile Bay?
` A. I think I said that, you know, I gave
`them the information, there was a delay, and
`then I was contacted. Whatever that delay was.
`It was probably two weeks to a month, but I
`can't say.
` Q. And during the course of today's
`deposition, if I refer to FMB, will you
`understand that to mean Four Mile Bay?
` A. Yes.
` Q. And that is the patent owner in this
`case, correct?
` A. Correct.
` Q. Who from FMB first contacted you?
` A. Phillip Lyren.
` Q. And can you tell me what you recall
`about that initial discussion?
` MR. ROGERS: I'm going to object to
` the question to the extent that it calls for
` disclosure of attorney-expert
` communications.
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`Page 16
` DR. MICHAEL N. HELMUS, PH.D.
`this call?
` A. No.
` Q. Had you ever heard of FMB prior to
`this call?
` A. No.
` Q. In this initial call, did Mr. Lyren
`tell you anything about his patent?
` A. I do not honestly recall. I don't
`recall.
` Q. Have you had subsequent discussions
`with Mr. Lyren?
` A. Yes.
` Q. How many do you recall having?
` A. Anywhere from two to four.
` Q. Can you tell me about the next
`discussion that you had with Mr. Lyren?
` MR. ROGERS: I'm going to object to
` the question to the extent that it calls for
` the disclosure of attorney-expert
` communications.
` Q. All right. Let me ask a predicate
`question. First of all, do you recall the next
`subsequent discussion that you may have had with
`Mr. Lyren?
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` DR. MICHAEL N. HELMUS, PH.D.
` Q. Well --
` A. You want to rephrase that?
` Q. I'll ask a different question.
` Had you been retained by FMB prior to
`any discussion with Mr. Lyren?
` A. I don't believe so. I mean, again, I
`don't remember the specifics anymore, but I
`believe we had a generic discussion so that he
`could gauge my qualifications.
` Q. So he hadn't offered you a position as
`an expert witness in this case at that time,
`correct?
` A. I do not believe so.
` Q. So let me reask my question. In that
`initial discussion with Mr. Lyren, what do you
`recall?
` A. As I said, it was generic discussion,
`mostly based on my qualifications and not the --
`and not any other details, I don't believe.
` Q. Was anyone else on the call --
` A. No.
` Q. -- between you and Mr. Lyren?
` A. No.
` Q. Had you heard of Mr. Lyren prior to
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` DR. MICHAEL N. HELMUS, PH.D.
` A. I don't remember the sequence and I
`don't remember the specific details, but I was
`probably retained at that point, and then -- and
`had appropriate discussions at that time that
`related to what my role in the case would be.
` Q. Now, did Mr. Lyren, when he was
`speaking with you, tell you that he was acting
`in the capacity of a client or the attorney
`representing Four Mile Bay?
` MR. ROGERS: Object to the question to
` the extent that it calls for disclosure of
` attorney-expert communications.
` MR. PARK: I disagree with that.
` Q. Go ahead.
` A. So what -- I'm sorry, so could you
`clarify what you mean by those terms?
` Q. Sure. Well, when you spoke with Mr.
`Lyren after the initial discussion --
` A. Uh-huh.
` Q. -- did he inform you that he was
`representing -- talking to you in the capacity
`of an attorney for FMB?
` MR. ROGERS: I'm going to object.
` Q. That's a yes or no question.
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`Page 18
` DR. MICHAEL N. HELMUS, PH.D.
` A. Well --
` MR. ROGERS: Hold on. I'm going to
` preserve the objection. I'll object to the
` question to the extent that it calls for the
` disclosure of attorney-expert communications
` and object to the form of the question to
` the extent it calls for legal conclusion.
` MR. PARK: Let me ask you this,
` counsel, for the record. Is Phillip Lyren
` representing -- is he an attorney for FMB?
` MR. ROGERS: Yes.
`BY MR. PARK:
` Q. Now, without discussing the substance
`of any discussion you may have had with any
`attorney for FMB, can you describe for me the
`process by which you prepared your expert
`declaration?
` A. It's --
` MR. ROGERS: I'm going to insert an
` objection before you answer. I'm going to
` object to this line of inquiry concerning
` the mechanics of declaration preparation as
` what the board has referred to as a waste of
` time for both the witness and the board.
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` DR. MICHAEL N. HELMUS, PH.D.
`do you mean?
` A. Say that again?
` Q. You said "I review them"?
` A. I review the documents and the salient
`points that I was told are part of this case.
` Q. Did you do any prior art searching?
` A. Prior art searching. I would not call
`it prior art searching. I have a vast
`experience related to the technical aspects of
`this case, so I reviewed what I knew in the case
`and reviewed -- I had written a report, as I
`mentioned, in the background of my
`qualifications in 1975, I believe, related to
`the departmental honors project that I did on
`porous stainless steel with respect to -- I did
`a preliminary report on porous stainless steel
`as orthopedic implant materials, and then I did
`a project on corrosion resistance of porous
`stainless steel.
` I have looked up my papers on that.
`So, I mean, it was my work, and then I reviewed
`my work with respect to -- and publications that
`I had where I referred to orthopedic implants
`and porous coatings as part of refreshing my
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` MR. PARK: Counsel, just so that we
` don't get off on the wrong foot for the
` remainder of this deposition, you're
` certainly free to object to form of my
` question, but if you would refrain from any
` type of speaking objections, I would
` appreciate that.
` MR. ROGERS: That's a form objection.
`BY MR. PARK:
` Q. You can continue.
` A. Well, I mean, I'll say that, in a
`generic way, all the work that I have done in
`preparing my work for cases such as this are --
`it's exactly the same. You know, I find out
`what the issues are related to the case. I
`review them. Review -- you know, sit and review
`what I believe is -- I believe are the salient
`points from my side and my expertise that are
`relevant to this. I review the relevant
`documents and then start to write my report.
` Q. Did you write the first draft of your
`declaration?
` A. I believe I did.
` Q. And when you say "I refer them," what
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`memory on things that I had prepared in the
`past.
` Q. And specifically my question to you
`is, in connection with preparing your expert
`declaration, did you, outside of the articles
`and publications that you authored, did you
`separately look to see what was available in the
`relevant time period for purposes of your
`declaration?
` A. If I cited references in my -- if I
`cited references in my papers, then I may have
`looked at the references that I cited. So --
`and as part of that process, you know, it's a
`tree. So if I looked at some of -- a reference,
`I may have looked at his references, but it was
`all started from the references that I had in my
`own collection of papers and data.
` Q. So is it fair to say that you did not
`conduct a systematic search --
` A. That is correct, I did not do a
`systematic search.
` Q. You have to let me complete my
`question.
` Is it correct to say that you did not
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`Page 22
` DR. MICHAEL N. HELMUS, PH.D.
`conduct a systematic search to see what type of
`prior art references were available in the
`2000 -- by the 2002-2003 time period?
` A. That is correct, I did not do a
`systematic search.
` Q. Did you, in preparation of your expert
`declaration, conduct any type of search of the
`commercial products that were available? And
`I'm referring to hip implants that were
`available in the United States by 2003.
` A. I did not.
` Q. Did you look at any product brochures
`for hip implants that were available by that
`time?
` A. I did not.
` Q. Do you know anything about FMB other
`than that they are the patent owner in this
`case?
` A. Other than what was on LinkedIn for
`Phillip Lyren's description, no.
` Q. Do you know if FMB does any research
`and development?
` A. I have no idea.
` Q. Do you know if Phillip Lyren does any
`
`Page 24
` DR. MICHAEL N. HELMUS, PH.D.
`before you were retained for this case?
` A. No.
` Q. Did you know of any application
`leading to that patent before you were contacted
`for this case?
` A. Say it again.
` Q. Did you know of any patent application
`leading to the '582 patent prior to being
`contacted for this case?
` A. No.
` Q. Did you review the patent, the '582
`patent, before agreeing to be engaged for this
`matter?
` A. It's probable. I just don't remember
`the timing.
` Q. As you read the '582 patent, did it
`seem familiar to you, like something you had
`read previously?
` A. No.
` Q. Now, in preparing your declaration,
`did you speak with anyone other than counsel for
`FMB?
` A. No.
` Q. So you didn't talk to any physician?
`
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`Page 23
` DR. MICHAEL N. HELMUS, PH.D.
`research and development in the field of hip
`implants?
` A. I never asked him. I don't know.
` Q. Do you know anything about Mr. Lyren's
`technical, scientific background?
` A. Not that I remember. I may have -- we
`may have discussed -- the only thing I remember
`discussing is that he went to Case Western
`Reserve and that I am a graduate of Case Western
`Reserve for graduate school, and that was about
`it.
` Q. And what do you recall Mr. Lyren going
`to Case Western Reserve for?
` A. He told me and I don't remember.
` Q. Did you know about the '582 patent?
` During the course of the day, we're
`obviously going to be talking about U.S. Patent
`No. 8,821,582. You expect that to happen,
`right?
` A. Yes, quite.
` Q. If I refer to that patent as the '582
`patent, you will know what I'm referring to?
` A. Yes.
` Q. Did you know about the '582 patent
`
`Page 25
` DR. MICHAEL N. HELMUS, PH.D.
` A. No.
` Q. When was the last time you reviewed
`your declaration?
` A. Probably parts of it I may have
`even -- I was listening to a PDF reader, voice
`reader, of the declaration as I was taking the
`subway this morning.
` Q. Is there anything in the declaration
`sitting here right now that you would like to
`change?
` A. Absolutely nothing.
` Q. And since you've submitted your expert
`declaration, you have had a chance to review the
`entirety of your declaration at least once,
`correct?
` A. That's correct.
` Q. Now, earlier I asked you about your
`prior testimony.
` A. Uh-huh.
` Q. This question is a little bit
`different. Have you ever been retained as an
`expert in a litigation or a Patent Office
`proceeding involving orthopedic implants?
` A. No.
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`Page 26
` DR. MICHAEL N. HELMUS, PH.D.
` MR. PARK: At this time, I'm handing
`to the witness a document that's been marked
`FMB Exhibit 2050. It is Exhibit A that was
`attached to the declaration of Dr. Helmus in
`connection with FMB's motion to amend.
` (FMB Exhibit 2050, Exhibit A attached
`to the Declaration of Dr. Helmus in
`connection with FMB's response to
`evidentiary objections which was marked as
`Exhibit 2044, marked for identification, as
`of this date.)
` MR. PARK: Counsel, are you okay with
`my description of where Exhibit A comes
`from?
` MR. ROGERS: I think it came from not
`the motion to amend but the declaration in
`response to evidentiary objections.
` MR. PARK: And that was Exhibit 2044?
` MR. ROGERS: Yes.
` MR. PARK: For the record, I'll note
`that what's currently been marked as FMB
`Exhibit 2050 is a document titled Exhibit A.
`It appears to be the CV of Dr. Michael
`Helmus which was also produced in this case
`
`Page 28
` DR. MICHAEL N. HELMUS, PH.D.
`portion of your curriculum vitae?
` A. So it's -- when I use the term
`"commercialization," I'm using it in the
`broadest sense from the process to go from
`development, you know, R&D, basic, any parts of
`the process that lead to FDA approval and
`commercialization, so if -- when I would put
`together this description, one of the areas that
`I was probably thinking in most detail related
`to a project that I had in some consulting
`roles. One of them was at Arthur D. Little in
`the 1986-ish timeframe -- '86, I'll take the
`"ish" out -- and we had a project to develop the
`next-generation fatigue-resistant bone cement,
`and as part of our project, we actually
`discovered that it was a more fruitful approach
`to modify an existing bone cement with knowledge
`of what makes a bone cement resistant or more
`resistant to fatigue and improve its strength
`characteristics. So that was a project we did
`for a major medical device orthopedic implant
`company.
` So in my view of what I described as
`commercialization, which actually that bone
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`Page 27
` DR. MICHAEL N. HELMUS, PH.D.
` as Exhibit A to Exhibit 2044.
`BY MR. PARK:
` Q. Are you familiar with the document
`that's been marked FMB Exhibit 2050?
` A. Yes.
` Q. What is this?
` A. It's my curriculum vitae or résumé.
` Q. Is this a current curriculum vitae?
` A. It's probably the -- one of the most
`up to date. I can't tell you -- every so often
`I find a typo and correct it or something gets
`added here and there, but it's, yes, it seems to
`be the most up to date.
` Q. Can you take a look at the -- near the
`bottom of the first page of FMB 2050 --
` A. Yes.
` Q. -- in the last paragraph, which starts
`with the word "commercialization of Medical
`Devices," do you see that?
` A. Yes.
` Q. It says "Orthopedic Implants."
` A. Yes.
` Q. Can you describe for us what the
`context of orthopedic implants is in this
`
`Page 29
` DR. MICHAEL N. HELMUS, PH.D.
`cement was commercialized by that company, and
`so as part of the commercialization process, we
`were instrumental in defining how they could
`improve their product.
` Q. Okay. Are there other experiences
`that you've had in the commercialization of
`orthopedic implants?
` A. I'm sure there are. Just probably so
`many different projects that I've had over time,
`but I did a consulting project for a -- what
`I'll describe as a research institute, where
`they were concerned with a particulate release
`from a type of implant, which I'm not at liberty
`to say, orthopedic implant. And so I gave an
`expert opinion on the biocompatibility and the
`suitability of the device with respect to the
`particulate issue.
` Q. And when was --
` A. And that was -- give me a second.
`That was probably about five-plus years ago, in
`that timeframe.
` Q. So around 2011, 2012?
` A. Could be, or it could have been
`earlier. I just don't remember the exact date,
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`Page 30
` DR. MICHAEL N. HELMUS, PH.D.
`but it was in that timeframe.
` Q. Could it have been as early as 2005?
` A. No.
` Q. Was the orthopedic implant a hip
`implant?
` A. No.
` Q. Did the consulting role have anything
`to do with porous coatings?
` A. No.
` Q. Do you recall any other experience in
`the commercialization of a medical device?
` A. Of a medical device?
` Q. Excuse me. Of an orthopedic implant,
`commercialization of an orthopedic implant?
` A. None that come to mind right now, but
`that does not mean that I did not.
` Q. Now, you mentioned your experience at
`Arthur D. little.
` Well, let me give you your
`declaration.
` MR. PARK: At this time I'm handing to
` the witness a document that's been marked
` FMB Exhibit 2041, which is titled the
` Declaration of Michael N. Helmus.
`
`Page 32
` DR. MICHAEL N. HELMUS, PH.D.
`in the U.S. an orthopedic hip implant from
`Waldemar Link.
` Q. What was your consulting role on that
`project?
` A. It was a long time ago. I believe it
`related more to issues related to
`biocompatibility and possibly some of the
`testings that might be necessary to doing the
`device, but I don't remember the specifics.
` Q. Okay. Do you remember anything more
`about the biocompatibility issue that you worked
`on?
` A. There were ceramic components, and I
`don't remember if the ceramic component was the
`ball and/or the acetabular cup or both, but
`there was a ceramic component to the device
`which made it unique for the U.S. market at that
`time.
` Q. And when you say the ball, what
`portion of the hip implant are you referring to?
` A. The ball. It's called the ball. It's
`a ball that goes on top of the neck.
` Q. Okay.
` A. Yeah.
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`Page 31
` DR. MICHAEL N. HELMUS, PH.D.
` Q. Will you take a look at the document
`that I just handed to you and let me know if
`that is a correct copy of FMB Exhibit 2041?
` A. It appears to be.
` Q. Okay. If you would turn to paragraph
`8 of your declaration.
` A. Uh-huh.
` Q. Paragraph 8 is describing your
`experience at Arthur D. Little, correct?
` A. I went to page 8.
` Q. Paragraph 8.
` A. Yes.
` Q. Is that correct; that you worked at
`Arthur D. Little, or ADL, from 1985 to 1988?
` A. Yes.
` Q. Prior to your experience at Arthur D.
`Little, you reference your experience at Bard
`Implants, do you see that?
` A. Correct. Uh-huh.
` Q. Did your experience at Bard Implants
`involve orthopedic devices?
` A. Yeah, it did include one orthopedic
`device. I was an internal consultant on the
`project they had to bring to commercialization
`
`Page 33
` DR. MICHAEL N. HELMUS, PH.D.
` Q. That's what I wanted you to put on the
`record.
` A. Okay.
` Q. Did the Bard implant have any type of
`coating on the neck body --
` A. Well, first of all --
` Q. -- or the stem?
` A. -- it was Waldemar Link' product and
`Bard was potentially going to be the company to
`distribute it and work on FDA approval in the
`U.S., so it wasn't a Bard product.
` I don't believe there was a coating,
`but I don't remember the specifics.
` Q. Do you remember anything about what
`the surface of the hip stem looked like?
` A. My memory is that it was a smooth,
`non-coated hip, but again, I'll have to say that
`I don't remember the specifics.
` Q. What type of testing might you have
`been involved with with respect to this Waldemar
`Link product?
` A. I would have recommended testing, and
`I probably would have reviewed the FDA
`guidelines at that time, but I don't remember
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