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home page return to prior page Heath Deposition - Zoll vs. Cardiac Resuscitator Corporation 1985
The Background: Interested in the history of preapplied electrodes for AED defibrillators and external noninvasive pacing? What follows is a legal deposition given by Roger Heath in 1986 when Zoll Medical sued Cardiac Resuscitator Corporation (now
Laerdal Medical or Agilent). Mr. Heath hand made, by himself, the first electrodes for the very first automatic defibrillators made by Cardiac Resuscitator Corporation (CRC). Before there was a Zoll Medical, there was Roger Heath with his 'combo pads' invention and the AED made by CRC..
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF OREGON
ZMI CORPORATION, )
)
Plaintiff, )
)
vs. ) Civil Action No. 85-910
)
CARDIAC RESUSCITATOR )
CORPORATION, )
)
Defendant. )
The deposition of ROGER LEE HEATH, call by the
Defendants for examination, pursuant to notice and pursuant to
the Federal Rules of Civil Procedure for the United States
District Courts pertaining to the taking of depositions, taken
before JAYNE A. GREYBAR, Certified Shorthand Reporter and Notary
Public within and for the County of Cook and State of Illinois,
at Suite 3614, 55 East Monroe Street, Chicago, Illinois, on
Friday, the 4th day of April, 1986, at 10:00 o'clock p.m.
Appearances:
MR. G. ROGER LEE,
Fish & Richardson,
(One Financial Center,
Boston, Massachusetts, 02111.)
On behalf of the Plaintiff;
MR. WILLIAM A. BIRDWELL,
Spears, Lubersky, Campbell, Bledsoe,
Anderson & Young,
(800 Pacific Building,
Portland, Oregon, 97204.)
On behalf of the Defendant;
MR. GOMER W. WALTERS,
Haight, Hofeldt, Davis & Jambor,
(55 East Monroe Street, Suite 3614,
Chicago, Illinois, 60603.)
On behalf of the Witness and
R2 Corporation.
(Witness sworn.)
Whereupon:
R O G E R L E E H E A T H
called as a witness herein on behalf of the Defendant, having
been first duly sworn, was examined upon oral interrogatories and
testified as follows:
D I R E C T E X A M I N A T I O N
by Mr. Birdwell
Q. Would you state your full name for the record, please?
A. Roger Lee Heath.
Q. Would you give your address also?
A. If I give the address, will the business address do?
Q. That's fine.
A. 8222 Lehigh Avenue, Morton Grove, 60053.
MR. BIRDWELL: I want you to understand this is a
deposition both of R2 Corporation and of yourself. The purpose
of the deposition is for an action brought by ZMI Corporation
against Cardiac Resuscitator Corporation for patent infringement
in the United States District Court for the District of Oregon.
The testimony which you are about to give may be used as evidence
in the case.
Are you represented by Counsel at this
deposition?
A. Yes.
Q. Would you briefly describe your formal education?
A. My formal education, I graduated from high school in
Tulsa, Oklahoma, Thomas Edison High School.
I attended Oklahoma State for one semester
and came to Chicago. As far as a formal education, my education
personifies itself more as field and clinical experience with
many experts and engineers and businesspeople within the
industry.
Q. Can you describe that in greater detail, the salient
experiences that you've had?
A. I spent six and a half or seven years -- I don't know
the exact length of time -- working in service, distribution,
sales of medical products locally in the Chicago area; and then
with R2 Corporation as a senior executive for the past seven
years.
Q. So that I have a clear picture, would you describe what
your previous places of employment have been, say, since you're
about 21?
A. The company that I went to work for was originally
Zenco Engineering Corporation.
Q. How do you spell that?
A. Z-e-n-c-o.
Then --
Q. Excuse me. Perhaps you could give dates and state what
these companies do.
A. I don't know that I could recall the exact dates.
Q. As best as you can recall.
A. '71, '72, I began at Zenco, which really I was then put
into a division or a group adjoining that which was called Medi-
Zenco, which was this distribution group I'm referring to. That
eventually began a group -- well, part of Zenex Corporation here
locally.
Q. When was that?
A. That was until about 19- -- well, 1979.
Q. When did this division become Zenex Corporation --
become part of Zenex corporation?
A. I don't recall.
Q. And then what happened in 1979?
A. 1979, I left Zenex or was removed from Zenex, and I
began R2 Corporation. And since that time, I've been employed
exclusively by R2 Corporation.
MR. WALTERS: Off the record.
(Discussion had off the record.)
MR. BIRDWELL: Q. Do you recall roughly what time
of year it was that you left Zenex?
And now I understand it is really 1978.
A. No, I don't.
Q. Fall, spring, summer?
A. I don't recall exactly.
Q. And did you found R2 Corporation?
A. Yes.
Q. What business does R2 Corporation engage in?
A. R2 manufactures disposable electrodes and cable-
adapting systems for use with medical electronics equipment.
Q. What business was Zenex Corporation in?
Was it a corporation, I assume?
A. Yes.
They were involved in machining different types of
industrial equipment, distribution of medical products and
manufacture of electrodes.
Q. Medical electrodes?
A. Yes.
Q. What business -- What part of their business were you
working in?
A. I was working in the distribution of the medical
electronics equipment.
Q. Including the electrodes?
A. Yes.
Q. More than ten?
A. No.
Q. Somewhere between five and ten then?
A. Correct.
Q. Were you always in the distribution of medical
electrodes -- medical electronics equipment and electrodes?
A. Yes.
Q. What is your current position with R2 Corporation?
A. Vice Chairman, President, CEO and Director of Research
and Development.
Q. Have you had any other positions with R2 Corporation
A. Yes. Chairman.
Q. Are you familiar with the electrodes that Zenex
Corporation -- medical electrodes that Zenex Corporation
manufactured?
First of all, did they manufacture them?
A. Yes.
Q. Are you familiar with what they manufactured while you
were working there?
A. Yes.
Q. Was there more than one kind?
A. Yes.
Q. What were the different kinds that you recall?
A. They manufactured conventional snap-type ECG monitoring
electrodes, grounding pads for electrosurgery and defibrillator
pads.
MR. BIRDWELL: I received two packets of documents. I
understand that one was in response to the Defendant's subpoena
and another was in response to the Plaintiff's subpoena. Do you
have any further documents that you're producing at this time?
MR. WALTER: We have no further documents to produce at
this time. We do have a copy of the Heath patent that we can
produce.
MR. BIRDWELL: Were there other documents that you have
that fall within the scope of either of the subpoenas?
MR. WALTERS: Well, --
MR. BIRDWELL: That R2 or Mr. Heath has?
MR. WALTERS: First, in response to the CRC subpoena,
we feel that we have produced all documents that fall within the
area of the subpoena. There are, of course, numerous documents
relating to the use of the electrodes and to various applications
for them; but as far as the electrodes' structure, we have
produced all of the documents except those that specifically
relate to the structure of the metallic element of the electrode,
as that involves some highly confidential information which we
are not willing to produce.
With respect to the ZMI deposition, as I indicated
in a letter to Mr. Lee, we made an attempt, an extensive attempt
to find the prior art -- to find art that related to stimulation,
including among other things, defibrillations and pacing and to
electrodes structure, per se. As I indicated in my letter, we
make no representation that that is all of the prior art that
might be existing somewhere in our files; but we made a
reasonable effort to get everything that we could find. And we
made no effort to determine, number one, whether it constituted
prior art with respect to the patent in suit, nor did we make an
effort to determine whether, it related to the validity of that
patent.
MR. BIRDWELL: Q. I take it there are papers that
relate to the use of the R2 electrodes, but that you didn't see
them as falling within the scope of what was requested?
MR. WALTERS: That's correct.
MR. BIRDWELL: I would like you to mark this as
Defendant's Exhibit 835, please.
(Defendant's Exhibit No. 835 for Identification
was no marked as of 4-4-86.)
Q. Mr. Heath, I show you a copy of an article -- excuse me
-- a paper bearing the date February, 1977. In the upper
left-hand corner it says, "Bi-PAK 2." It appears to be a
document of Zenex Corporation. Do you recognize this Exhibit
835?
A. Yes.
(There was a short interruption, after which
the following proceedings were had, to
wit:).
MR. BIRDWELL; Q. What does that Exhibit 835
relate to?
A. The Bi-PAK 2 defibrillator pads manufactured by Zenex
Corporation.
Q. Were you personally familiar with those pads?
A. Yes.
Q. Is that what's shown in the picture on the front of the
document?
A. That is a mockup of the pads prior to the pads actually
being manufactured.
Q. Can you describe the structure of those pads?
A. Yes.
Q. Not the mockup, but the actual pad with which you were
familiar?
A. Yes.
Q. Would you do so?
A. Yes. There's a molex connector with pre-attached lead
wires leading to foam laminations, a disk -- large foam disk on
the pad, and that's laminated with a stainless steel element that
was riveted to the wire, and that was laminated between a ring of
foam which acted as the skin adhesive on the outer circular area.
On the inner area is a reticulated foam that is impregnated with
a conductive media.
Q. Would you be able to draw a cross section of that
structure?
A. Yes.
Q. Let me give you a piece of paper and ask you to draw a
cross section of that, of the structure of those electrodes of
the type to which Exhibit 835 relates.
A. (Witness indicating).
Q. May I should be more explicit.
That would be what I call a blowup. That's fine.
Go ahead.
A. Should I label this?
Q. Please. I would like to label it, if you would read
off the parts.
A. Styrene cover, foam adhesive ring, conductive media,
reticulated foam, stainless steel element, wire, foam disk
backing (indicating).
Q. Now, would you briefly describe how those parts fit
together?
I take it that's a blowup, is that right?
MR. WALTERS: Excuse me, Counsel. For the record,
should we mark this as an exhibit?
MR. BIRDWELL: Yes. Let's mark that as Defendant's
Exhibit 836.
(Defendant's Exhibit No. 836
for Identification was so
marked as of 4-4-86.)
THE WITNESS: A. Okay. I will assemble it from
the back moving towards the patient's side, back of the electrode
moving toward the patient's side.
There is a foam disk backing. The wire is
put in place, can or cannot be connected mechanically to the
foil, has been done both ways, in this case, the stainless steel
element, not foil. Reticulated foam is then placed over the
foil. The foam ring is usually then placed holding the
reticulated foam in place with the small ears, making contact on
the outside with the foam disk backing, and it is trapped so as
to hold the reticulated foam in place. The conductive media is
then placed within the reticulated foam, and usually there is a
paper backing on the top of this which is then removed and the
styrene cover is in place to seal the electrodes until it is
used.
MR. BIRDWELL: Q. What part of the electrode --
Let me back up.
This electrode is something to be placed on
the skin of a subject?
A. Yes.
Q. What part of the electrode touches the skin?
A. Two parts touch -- Well, three components of this touch
the skin. The adhesive ring on the outside holds it and adheres
it to the skin. The reticulated foam makes contact with the
conductive media, as well, directly with the skin.
Q. What is the nature of the conductive medium that was
used by Zenex?
A. It is a conventional -- Well, I would say a
conventional electrode gel for these kinds of applications.
Q. Was that a gel that has a --
How would you characterize the conductivity of the
gel, do you know?
A. Well, most of these gels are saline-filled gels, the
primary component being water, to make contact with the skin.
Q. Do you have any understanding of how well the gel
conducts electricity, the gel that was used by Zenex?
A. I can't recall exactly.
Q. Did any metal part of the electrode touch the skin?
A. The stainless steel element did not touch the skin.
Q. Did the wire touch the skin?
A. The wire did not touch the skin.
Q. So did any metal part touch the skin?
A. Well, if there is saline or -- All salts are metal
components, in effect.
Q. Metal ions?
A. They are metal ions. So the salt could be
characterized, I suppose -- If it were potassium or sodium, those
are all metals. But I am rather confused as to whether that
would be --
Q. Did any solid metal --
A. No.
Q. -- (continuing) pure metal, I should say, touch the
skin?
A. No.
Q. You were referring to chemical compounds that have
metal ions in it?
A. Yes. Those are normally not called metals. Metal
salts.
Q. Were there any other electrodes manufactured by Zenex
that had the same configuration?
A. No.
MR. LEE: Could you mark on your tape? I may want
you to read back something later.
MR. BIRDWELL: Q. You mentioned that there were
electrosurgical electrodes manufactured by Zenex, I believe, is
that correct?
A. Yes.
Q. What did they look like?
A. They were a different shape, did utilize some similar
component structure, but were a different shape.
Q. Are you able to draw what they were like?
A. Yes.
Q. I hand you a piece of paper.
A. I will state each part that I have drawn as I label it
again.
Again, a styrene cover is used, not
particularly a foam ring, because the conductive center area is
kind of a figure-eight shape, but this is the piece that comes in
contact with the skin. I'll call it adhesive, self-adhesive
foam.
Q. That's what holds the electrode to the skin, is that
right?
A. Yes, that's correct.
A conductive media again; reticulated foam.
In this case, the Zenex electrode had two separate elements which
were also stainless steel, two wires separately connected either
mechanically -- mechanically to the separate elements, and
finally the back foam which was more or less square-shaped foam.
The wires lead to a connector.
MR. BIRDWELL: I would ask the Court Reporter
to mark that as Defendant's Exhibit 837.
(Defendant's Exhibit No. 837 for
Identification was so marked as of
4-4-86.)
Q. In a manner similar to what you did with Exhibit 836,
would you describe how that electrode in 837 goes together in
relation to the skin?
A. Yes. The back foam -- Again, the product can be
assembled in one direction or the other, but the primary method
used by Zenex was to place the back foam, then to place the
elements, adhere them to the back foam.
Q. Those are the metal elements?
A. Yes, the stainless steel elements.
Then the green reticulated foam would be placed.
The outside self-adhesive foam would then be placed around the
green reticulated foam. At that time the conductive media would
be placed into the electrode, and the protective paper covering
the adhesive would then be pulled off, and the styrene cover
placed over the electrode.
Q. Would you do likewise in Exhibit 836?
A. Skin or patient side, back side (indicating).
Q. Now, referring again to 837, the electrosurgery --
Is that called ESU?
A. Yes.
Q. The ESU electrode, do you know what the conductive
medium was?
A. Yes. This was, again, a conductive gel or media placed
into the green reticulated foam.
Q. Do you have any understanding of what the relative
conductivity of that medium was?
A. Yes. I do know that that was without a salt or saline.
Q. What sort of material was it?
A. Again, it was primarily a gelatin material that was
composed primarily of water.
Q. Do you know how the conductivity of the gel in the
electrode shown by Exhibit 836 compares to the conductivity of
the gel -- of the conductive medium of the electrode shown in
Exhibit 837?
A. Yes. I would say the gel in Exhibit 836 is slightly
more conductive than the gel in 837.
Q. Do you know why that is?
A. Yes. Because of the saline or sales that would be in
Exhibit 836 that would not be in Exhibit 835.
Q. If I can trouble you for one more drawing, are you able
to draw the type of EKG electrode that -- didn't you mention that
Zenex made an EKG electrode?
A. Yes.
Q. Are you able to draw that?
A. Yes.
Q. Would you do so?
A. Again, as I label them, I'll read them off.
This is the top snap eyelet or, I should say,
stud. This is a plastic ball, a label, a paper adhesive or it
could be foam as well.
Q. Did they use foam or paper alternatively?
A. Used both alternately.
A paper cover over that paper foam adhesive, an
eyelet, snap eyelet or element; screen wire, and this is usually
a plastic material, Teflon; conductive media; and a styrene base.
MR. BIRDWELL: I would like the Court Reporter to mark
that drawing as Defendant's Exhibit 838.
(Defendant's Exhibit No. 838 for
Identification was so marked as of
4-4-86.)
Q. Again, would you mark the skin side and the
back side and explain how the parts go together?
A. Top or back side; skin or patient side (indicating).
Q. Would you explain how the parts fit together?
A. Okay. Beginning from the top down, there is a top snap
stud that Zenex punched a hole in. This was to form a valve with
the plastic ball. Zenex had a unique -- has a unique feature
where you can inject gel -- should the electrode dry out at a
later point, you can inject gel into the electrode. The label is
actually adhered to the paper or foam adhesive. On the base is
the paper of the foam adhesive, and that is all then snapped
together with the snap eyelet or element that comes up -- back
from the patient or skin side towards the -- and merges with the
top snap stud. Over the bottom then is placed a screen wire,
plastic Teflon piece, nonconductive piece, and the styrene base
is then assembled, and the conductive media is actually injected
through the valve after the electrode is completely assembled.
Q. What sort of conductive medium is used?
A. Two kinds were used. One was without saline or salts
again, the other one was with saline.
Q. Were these media sold by Zenex?
A. Yes.
Q. Why were two different kinds made available?
A. In some instances, the less saline would cause less
skin irritation to occur. In other words, the saline gels in
some instances could cause skin irritation.
Q. Were there any particular applications in which that
arose?
A. Particularly in the concern for application on infants.
Q. The screen material, what that -- I take it that was
not metal, is that correct?
A. That is correct.
Q. In the electrodes shown in Exhibit 838, did any metal
part touch the skin when the electrode was applied?
A. No.
Q. And that's also the case for the electrode in Exhibit
837, is that right?
A. That's correct.
Q. The top snap stud, was that made of metal?
A. Yes, it was.
Q. And what is this part?
A. Snap eyelet or element.
Q. Was that made of metal?
A. Yes.
Q. Now, I believe you previously testified that corrected
your testimony and indicated that you had left Zenex in 1978, is
that right?
A. I don't recall the exact date.
Q. When you had left, was Zenex manufacturing the
electrodes of the three types shown respectively in Exhibit 836,
837, and 838?
A. Yes.
Q. How long had they been manufacturing electrodes of
those types?
A. I don't recall exactly how long.
Q. Well, do you recall whether it had been more than, say,
two years?
A. I think it was probably more than a year. I'm not
certain how long exactly.
Q. Do you have any way of determining when you formed R2
Corporation?
A. Do I have a way of --
Can you repeat the question?
Q. Do you know of any records or know of any way how you
could determine when you formed R2 Corporation?
A. Yes. I could look at the corporate records.
MR. BIRDWELL: Would they be available here for him to
determine that?
MR. WALTERS: I'm not sure. I do have the articles
here. I can take a look and see. If it will be of any help, I
think it will show that it was June of 1978 that R2 was
incorporated.
MR. BIRDWELL: Do you have any doubt about that?
MR. WALTERS: I know it was the summer of 1978. It
might have been July, but I am pretty sure it was June.
MR. BIRDWELL: Are you willing to stipulate to that,
subject to correction later?
MR. LEE: I am not willing to stipulate to it. At that
point, I have no idea of what significance it has. You seem to
think it has some.
MR. BIRDWELL: Well, let's go on.
Q. Did you form R2 Corporation after you left
Zenex?
A. I don't recall the exact sequence.
Q. Do you have any way of telling when you left Zenex
Corporation?
A. Yes, I believe so.
Q. How would you determine that?
A. I was discharged. I believe that there is a document
on that.
Q. Is that available here to find out?
A. I should correct that. I think that document exists.
I'm not certain.
Q. Do you have any doubt that these -- that electrodes of
these three types were being manufactured and sold by Zenex in
1978?
A. No.
Q. Is it your recollection that they were being
manufactured and sold in 1978?
A. Yes.
Q. Did you ever have occasion to learn of any electrodes,
any of these three electrodes shown in Exhibits 836, 837, 838 to
be used in a pacing application, cardiac pacing application?
MR. LEE: I would like the question read back.
(Pending question read.)
THE WITNESS: Could you read that back for me, please?
(Pending question reread.)
MR. BIRDWELL: Q. Do you want me to restate it?
A. Yes.
Q. Did you ever have any occasion to learn of any of these
three electrodes illustrated by Exhibits 836, 837 and 838 being
used in a cardiac pacing application?
A. I don't recall learning of an instance of that.
Q. You don't recall one way or the other?
A. One way or the other.
Q. Are you familiar with the term "external noninvasive
pacing"?
A. Yes.
Q. Would you explain what that means to you?
A. External pacing, as I understand it, is where two --
usually two electrodes are applied to a subject and then small
electrical pulses are delivered to the subject causing
contraction of the heart within the patient and blood flow. And
that to me is external pacing.
Q. What if anything is your understanding about where the
electrodes are applied to the patient?
A. As I understand, they've been applied with two
electrodes on the front of the patient, and it has also been
applied -- electrodes applied on the front and back of the
patient.
Q. Do you mean on the surface of the skin?
A. Yes.
Q. Now, do I correctly understand that this --is it
correct that this Exhibit 835 describes the electrode which you
have illustrated in Exhibit 836?
A. Exhibit 836 illustrates the element of that electrode.
Q. Electrodes of the type referred to in Exhibit 835, were
they actually sold by Zenex?
A. Yes.
Q. And the ones that were sold had the structure shown in
Exhibit 836?
A. Yes.
Q. Can you tell me if this description in Exhibit 835 is
an accurate description of those electrodes insofar as it
attempts to describe them?
A. Could you restate the question, please?
Q. Sure. Can you tell me whether the description of Zenex
electrodes in Exhibit 835 is an accurate one?
A. I believe there is an error.
Q. What is that?
A. It refers to the electrodes to be used for ECG
monitoring. They would work initially for ECG monitoring; but
should a shock be delivered through these, they may not work for
continuous ECG monitoring. I think this represents that this
will be continuous ECG monitoring.
Q. Is it otherwise accurate?
A. Yes.
MR. BIRDWELL: Off the record.
(Discussion had off the record.)
MR. BIRDWELL: Q. Do you know an individual by the
name of Paul Zoll?
A. Yes.
Q. Can you identify this document bearing a date of August
26, 1977? It appears to be a letter addressed to Paul Zoll,
bears the name Roger Lee Heath on the bottom.
A. Yes. That is a letter that I sent from Zenex -- or a
copy of a letter I sent from Zenex to Paul Zoll on that date.
Q. That's when you were employed by Zenex?
A. I was an associate of Zenex at the time.
MR. BIRDWELL: I would like that document marked with
Defendant's Exhibit 840.
(Defendant's Exhibit No. 840 for
Identification was so marked as of
4-4-86.)
Q. Can you identify this document which appears
to be a quotation of some kind addressed to Paul Zoll, MD?
A. I believe it is a quotation that was sent with this
letter, but it says September rather than August. So I'm
confused as to whether the date was actually in August or
September.
Q. Do you recall sending him a quotation such as that that
you're looking at there?
A. Yes.
Q. Was it at about the time that you sent the letter
marked Exhibit 840?
A. I believe they were sent at the same time.
MR. BIRDWELL: I'd like this document marked
Defendant's Exhibit 841, the one that has "Quotation" at the top.
(Defendant's Exhibit No. 841 for
Identification was so marked as of
4-4-86.)
Q. Can you identify this document that bears the
date October 11, 1977, and appears to be addressed to Paul Zoll,
MD with your name on the signature line?
A. This appears to be a letter I sent to Paul Zoll on that
day -- a copy of a letter, I should say.
MR. BIRDWELL: I'd like the Court Reporter to mark this
letter as Exhibit 842.
(Defendant's Exhibit No. 842 for
Identification was so marked as of 4-4-86.)
Q. Is this your signature at the bottom of the
letter?
A. Yes, it is.
Q. Do you have any reason to doubt this letter was sent on
or about that date?
A. No.
Q. How did it come about that you had these communications
with Dr. Zoll? Would you describe how you -- what occurred to
cause those communications?
A. I don't recall.
Q. Do you recall any discussions with Dr. Zoll at about
the time these communications occurred?
A. Yes. I remember some phone calls.
Q. What do you recall about those phone calls?
A. Somehow I became aware of his apparent look into
preapplication of pads for defibrillation, and I can't recall
whether I called him or he called me or how that happened.
Q. Did you have any discussions about the use of the
electrodes?
A. Yes. I do remember that he was surprised that somebody
was already manufacturing some pads for this kind of application.
Q. Did he indicate any reason as to why he was surprised
about that?
A. Up to that point, I believe he was contacted by NDM
Corporation to use some of their pads for that application.
Q. How does that explain why he was surprised? I am
sorry. I did not understand.
A. The NDM pads were not made for this application, but
they were going to try to use them for this. The NDM pads were
actually for electrosurgery, not for defibrillation. He was not
aware that somebody was already making electrodes that were build
for defibrillation application.
Q. Did you actually send Dr. Zoll some electrodes at the
time of these letters?
A. Yes.
Q. These materials on this quotation, are they materials
that you sent to Dr. Zoll?
A. I believe I sent him several of these materials, not
all of them.
Q. Which ones do you think that you sent him?
A. I sent him some of the electrodes and perhaps a
connection cable only.
Q. Approximately how many electrodes would you estimate
you sent him at that time?
A. I would say a minimum of ten and perhaps twenty or
thirty.
Q. It was in 1977 that you sent him the electrodes?
A. Yes.
Q. Were any of the electrodes that you sent him -- Did any
of the electrodes that you sent him have a structure like any of
those structures shown in Exhibits 836, 837 or 838?
A. Yes. The structure was similar to that in Exhibit 836.
Q. Did it differ in any respects?
A. Those electrodes could have been sent without a saline
gel. That may be the only difference.
Q. When the electrodes manufactured by Zenex were made,
assembled, did Zenex ordinarily seal them with a gel inside?
A. Yes, they did.
Q. In order to have sent him electrodes without an
electrode gel, would you have had to make a special order?
A. Yes.
Q. Do you recall having done that?
A. No.
Q. What makes you think maybe they were sent without the
gel?
A. I think they were sent with gel, but I did not have
sufficient controls over the manufacturing to know if the gel was
with saline or without saline.
Q. So it might have been some conductive medium other than
a saline material?
A. Yes.
Q. Do you have some reason to think you might have used a
different conductive medium, he might have wanted a different
conductive medium than saline material.
A. There was no specification for the type of conductive
material at all on the part of Dr. Zoll.
Q. What about on the part of Zenex, -- maybe you said
this, but I can't recall -- was the electrode of the type shown,
of type 836 ordinarily sold with a saline-type gel?
A. I believe it may have been sold both way.
Q. Did you discuss with Dr. Zoll --
First of all, let me back up. Is this Paul Zoll
the same Paul Zoll associated with ZMI Corporation?
MR. WALTERS: I'm going to have to object to that
Counsel. I'm not sure how Mr. Heath would know that.
MR. BIRDWELL: Q. Do you still know who this Paul Zoll
is, this Dr. Paul Zoll?
A. Yes.
Q. Tell me what you know about Dr. Paul Zoll, about where
he resides and where he practices medicine.
A. The Paul Zoll I contacted was in Brookline,
Massachusetts.
MR. LEE: Plaintiff stipulates it is the same Paul
Zoll.
MR. BIRDWELL: Okay. Fine.
Q. Now, with this Paul Zoll, did you discuss the
use of the electrodes, the use to which he was going to put the
electrodes you sent him?
A. Excuse me. I'm distracted. It is on Brookline Avenue
in Boston, Massachusetts.
Repeat the question, please.
Q. Did you discuss with Paul Zoll the use to which he was
going to put these electrodes that you were sending him?
A. Yes.
Q. What do you recall about those discussions?
A. He said he was preappling them for external
defibrillation.
Q. Were the electrodes ordinarily sent in pairs or were
they sent individually or in some other combination?
A. They were sent with two of the elements as shown in
Exhibit 836 with wires preattached leading to a connector.
Q. How large was the -- The electrode represented by
Exhibit 836, how large was the reticulated foam component?
A. Approximately eight centimeters.
Q. I take it that the foam was circular in shape, disk
shaped, is that right?
A. Yes.
Q. And eight centimeters in diameter approximately?
A. Approximately.
Q. Was that the case for all of the Zenex electrodes at
that time?
A. I believe so.
Q. Do you have any idea of what the surface area of the
electrodes represented by Exhibit 837 was, that is, the surface
area of the reticulated foam component?
A. I don't recall exactly.
Q. In this Exhibit 835 where it has the word "Features,"
below that with some sentences and dots it says, with respect to
the Zenex electrodes, "Eliminates defibrillator skin burns caused
by close electrodes or inadequate gel and guards against such
occurrences." Do you know that is being referred to there?
A. The first part of that statement refers to a problem
when defibrillator paddles are used where gel can become smeared
across the front of the chest; and when the high energy is
discharged from the defibrillator, arcing can then occur between
the electrodes causing a burn.
The second part of that statement refers to an
instance where when gel is applied to conventional defibrillator
paddles, they may not cover the whole surface of the pad.
Q. What feature of the electrodes shown by Exhibit 836 --
feature or features prevents the second part of that statement
from occurring?
A. With the conductive media properly spread over the
whole surface of the reticulated foam, such a problem should not
occur.
Q. Was that accomplished by the type of electrode shown by
Exhibit 836?
A. Yes.
Q. What was it that -- What about the electrode
accomplished that result, what structural feature?
A. Well, one of the simple features is that the gel could
be preapplied to the whole surface and in a non-emergency
situation, and the styrene cover would preserve that media until
use.
Q. What was the reticulated foam material, what was that
made out of, what sort of material was that?
A. I'm not certain of that.
Q. Was it a synthetic material?
A. Yes. It was a plastic synthetic material.
Q. Was it like a sponge?
A. Yes.
Q. Approximately how thick was it?
A. In this instance, I believe it is three-sixteenths of
an inch thick.
Q. Was the gel absorbed into it once the gel was placed on
it?
A. The gel was actually pressed into it. It wasn't
particularly absorbed, although I suppose that term could be
used.
Q. It was inside the sponge, as well as on the surface I
take it?
A. Yes.
Perhaps this is a good time to break for lunch?
MR. BIRDWELL: Yes, that would be fine.
(The deposition in the above-
entitled cause was recessed for
lunch at 12:15 until 1:00 p.m.)
MR. BIRDWELL: Q. I understand that you are able from
having checked your records to be able to determine an exact date
when you terminated your relationship with Zenex?
A. August 7, 1978.
Q. Thank you.
And the electrodes in Exhibit 835 were being
manufactured and sold at the time that you terminated your
relationship with Zenex?
A. Yes.
Q. Incidentally, was this document marked Exhibit No. 835,
was that published by Zenex?
A. It was printed by Zenex.
Q. Well, was it distributed?
A. Yes, it was distributed.
Q. Was that a marketing brochure of some kind?
A. Yes.
Q. Was it distributed prior to your department from Zenex?
A. Yes.
Q. In the correspondence with Paul Zoll, it says that you
are enclosing complete data and samples on -- it says, "I am
enclosing complete data and samples on our new defibrillator ECG
electrode system called the Bi-PAK 2." Is that what's referred
to in Exhibit 835?
A. Yes.
Q. It goes on to say that "Ours, however, should provide a
larger area than the NDM electrosurgical pads"?
A. Yes.
Q. Do you recall why that was a matter of concern?
A. Yes. The NDM pads, having small contact area, would
higher current concentrations and greater probability of burn.
Q. Was that something that Paul Zoll was concerned about?
A. I don't know.
Q. Did he request a large area of pads?
A. I don't believe he made that statement.
Q. Well, what I'm trying to determine is whether this is
something you simply volunteered for some reason or whether this
was in response to a concern or request or communication on the
part of Paul Zoll?
A. I don't think I could recall that accurately.
Q. Did you know what use that Paul Zoll was putting these
pads to?
A. I knew that he was using them for defibrillation.
Q. At about that time, was it your view that it was
generally understood that a larger area -- I am sorry. I will
ask a different question.
At about that time, that is, the time this letter
was sent, the letter marked Exhibit 840, was it your view that it
was generally understood among people dealing with electrodes of
this type that the larger surface area would reduce current
concentration?
MR. LEE: Object.
MR. WALTERS: I am going to object.
MR. BIRDWELL: Q. Did you have any understanding as to
what larger surface electrodes would do with respect to current
concentration at the time you sent this letter?
A. Yes.
Q. And what was your understanding?
MR. WALTERS: Would you repeat that question before
this one?
(Requested question read.)
MR. BIRDWELL: Q. What was your understanding?
A. My understanding was that it would -- with larger
contact area, the current concentrations would be distributed
over a larger area.
Q. Were you familiar with the term "current density" at
about that time?
A. Yes.
Q. Can you relate current density to current concentration
such as you just mentioned?
A. Yes. My initial familiarity with that was in
electrosurgical pads where the amount of current per square
centimeter had been used to determine the risk of a burn.
Q. And what affect would the size of the electrode have on
the current per square centimeter?
A. The larger the amount of area of the electrode, the
lower current per square centimeter.
Q. How did you learn about that?
MR. WALTERS: Learn about what?
MR. BIRDWELL: Q. Well, what were your sources of
information regarding the relationship between the size of the
electrode and the current per square centimeter?
MR. WALTERS: Apart from his own experience you mean?
MR. BIRDWELL: Well, if that was one of his -- I'm
asking for all sources of information that he recalls.
THE WITNESS: A. In the context of electrosurgery, the
NFPA or the National Fire Prevention Association does have a
criteria for electrosurgical electrodes and their theoretical
safety if a large enough area is used.
MR. BIRDWELL: Q. Was there any other source of
information about that that you recall?
A. No.
Q. Did you have a view at the time as to whether that
subject was generally known among physicians dealing with
electrosurgical electrodes?
MR. WALTERS: Counsel, I'm not clear what that refers
to.
MR. BIRDWELL: What he just described in answer to the
previous question, the relationship between electrode size and
current per square centimeter.
MR. WALTERS: I wonder if you's restate that question,
please. I am kind of lost.
MR. BIRDWELL: Q. At about the time of these
communications with Dr. Zoll represented by Exhibits 840 and 842,
did you have any view as to whether the relationship between
electrode size and current per square centimeter was understood
by physicians dealing with electrosurgical electrodes?
A. I don't know.
Q. Was that discussed with people who buy the Bi-PAK or
other Zenex products, the Bi-PAK 2 or other Zenex products?
A. I believe that was represented in Exhibit 840.
Q. What is it about Exhibit 840 that -- What is it in
Exhibit 8490 that tells you that?
A. Would you restate your question again?
Q. Whether the relationship between electrode size and
current per square centimeter was discussed by physicians who
were using electrosurgical electrodes such as the Bi-PAK 2?
MR. WALTERS: You's asking him if he knows if
physicians discussed that relationship with one another or with
him or --
MR. BIRDWELL: If physicians were aware of that
relationship is all I'm trying to find out, if he had any
knowledge of physicians being aware of that relationship.
MR. WALTERS: I will object to the question then as
calling for speculation.
MR. BIRDWELL: No, no. I am asking for his knowledge.
I am asking for in about the time he was communicating with Dr.
Zoll with these letters here, whether he was aware of -- whether
he knew that physicians were aware of the relationship between
current per square centimeter and electrode size.
MR. WALTERS: The problem I have with the question is
that I don't know how he could know what somebody else knows or
doesn't know.
MR. BIRDWELL: Well, if they said something.
MR. WALTERS: Ask him if someone said something to him.
THE WITNESS: A. I don't know.
MR. BIRDWELL: Q. Do you have any idea why you said in
Exhibit 840 that -- wrote this sentence, "Ours, however, should
provide a larger area than the NDM electrosurgical pads you have
been using"?
A. I don't think I understand that question.
Q. Do you know why you wrote this sentence right here?
A. Because I believe I understood the importance of a
larger contact area.
Q. And that was?
A. For reduced impedance and lower current density.
Q. Did you ever discuss that subject with any physicians
at about that time?
A. I discussed it with Paul Zoll.
Q. What were the circumstances under which you discussed
it with Paul Zoll?
A. Telephone conversation.
Q. Was that before or after this letter marked Exhibit
840?
A. I don't recall.
Q. Would you relate the substance of the telephone
conversation as best as you can recall?
A. As I recall, I was concerned that the NDM pads might
cause a burn because of their structure.
Q. And you related that to Paul Zoll?
A. Yes.
Q. What did you explain to him that you were concerned
about the size of the pad?
A. Yes.
Q. Did he understand that as far as you could tell?
A. I don't know.
Q. Do you have any reason to believe he did understand it?
A. Yes, I believe he understood it.
Q. He didn't tell you he doesn't understand what you're
talking about or anything like that?
A. My impression was that he understood what I was saying.
Q. Did you have any other telephone conversations with
Paul Zoll about that time, say, in 1977?
A. Yes, I had several.
Q. I would like you to relate to me what you recall about
each of those telephone conversations.
A. As I stated earlier, he was surprised that a product
was made for this purpose already.
Q. He related that to you in a telephone conversation.
A. Yes. He commented that he felt it was an important
idea or product and he wanted to use it in his research on this
methodology.
Q. What was the methodology that he was doing?
A. I'm referring to the product of preapplied
defibrillation pads.
Q. Did you have any knowledge about what sort of work he
was doing with these pads?
A. No. I sent him the pads, and he only reported back the
defibrillation results. I have no other knowledge.
Q. Does the term "hot spots" have a meaning to you with
respect to electrodes?
A. Yes, it does.
Q. Did it have a meaning to you back in 1977 when you were
working for Zenex?
A. Yes, it did.
Q. What was the meaning it had to you back in 1977?
A. The meaning was a high current concentration that could
cause a burn.
Q. Was there anything about the Zenex electrode of the
type shown in Exhibit 836 that tended to alleviate hot spots?
A. I would have to ask as compared to what?
Q. Well, say as compared to a plain metal electrode that
would be placed against the skin.
A. Like a defibrillator paddle?
Q. Yes.
A. Yes.
Q. What is that?
A. The uniform conductive media and pressure of that media
against the skin would cause more uniform distribution.
Q. What are you referring to when you say the "uniform
conductive media"?
A. In that it is applied uniformally over the whole
surface in the same thickness and amount.
Q. What is it about the structure of the electrode shown
in Exhibit 836 that accomplishes that result?
A. The thickness of the conductive media, the amount of
pressure represented more equally across the surface against the
skin of that media, and the fact that it existed over the whole
surface uniformally.
Q. What structural components produce that result?
A. The self-adhesive foam ring holds it uniformally
against the skin, and the reticulated foam and conductive media
make uniform contact with the skin, and the element on the
opposite side is also held by the foam disk backing uniformally
against the media.
Q. Did you have any understanding as to whether they --
that structure was -- Excuse me.
Did you have any understanding as to whether the
Zenex electrodes, the Bi-PAK 2, were constructed by Zenex in
order to reduce hot spots or eliminate them perhaps?
A. Yes. I believe it was constructed to reduce hot spots.
Q. How big a company was Zenex? How many employees I
guess is one way of looking at it?
A. I don't recall the exact number, but I would estimate
between 15 to 30 employees at any one time.
Q. Did you have a title as an employee of Zenex?
MR. WALTERS: Objection. There is no foundation that
he was an employee.
MR. BIRDWELL: Oh.
Q. Were you an employee of Zenex?
Let me ask you a slightly different
question.
What was your business relationship with Zenex?
A. I was an associate, managing distribution of the
medical electronics equipment.
Q. When you say you were an associate, did they pay
withholding tax for money that you made?
First of all, maybe you don't know. Were you
salaries?
A. I did pay withholding tax, but there was an
understanding between Zenex and I on distribution of the medical
electronics equipment.
Q. Were you paid by commission?
A. Really, the group which distributed the equipment paid
its own expenses, and then the profits were divided.
MR. WALTERS: I'm --
MR. BIRDWELL: I don't want to get into this too far.
I am really trying to get at something different.
Q. Where physically were you located?
A. We were located in a section of Zenex' facilities.
Q. Were you familiar with what was going on in the company
generally?
A. Yes.
Q. Had you talked with the people who designed the
electrodes?
A. Which electrodes are you referring to?
Q. Okay. I'm thinking specifically about the Bi-PAK 2.
MR. WALTERS: Could we go off the record for a moment,
please?
(Discussion had off the record.)
MR. BIRDWELL: Back on the record.
Q. What I'm trying to find out is if you were
familiar with the reasons that the Bi-PAK 2 electrodes were made
with the structure that they were in fact made with?
A. Yes.
Q. Do you know of any reason why -- Let me back up.
I think you said that the electrodes represented
by the drawing, Exhibit 837, and those represented by the
drawing, 836, had a conductive media with respectively different
conductivities. Is it correct that the conductivity of the
electrode 836, the conductivity of the conductive media in that
electrode was different than the conductivity of the electrode
shown in Exhibit 837?
MR. WALTERS: And by the "electrode," you mean the
whole structure now?
MR. BIRDWELL: No. Actually, I'm just talking about
the conductivity of the respective conductive media.
THE WITNESS: I need you to restate the question.
MR. BIRDWELL: Q. Is it correct that there was a
difference between the conductivity of the conductive medium in
Exhibit 836 and the conductivity of the conductive medium in
Exhibit 837?
A. Yes. Most of the time they were different.
Q. Now, I think you answered earlier as to what brought
about the difference in conductivity; one had saline components
and the other did not. But can you tell me why they were made
differently?
A. The element or electrode in 836 I believe from time to
time had the same media as in the electrode of 837. Normally the
electrode in 836 would have the saline and be lower in
resistance.
Q. Why would they normally have made that electrode that
way as compared to the electrode in 837? Why did they normally
make it that way?
A. Normally the saline would be added to the electrode in
836 to lower its resistance.
Q. Do you know why that was done?
A. From the beginning of this kind of technology, there's
always been concern over the amount of pressure or impedance that
would result with this kind of product. Paddles use pressure on
them to lower the impedance.
Q. Are you saying that using a saline solution contributed
to lowering the impedance of the electrode shown in 836?
A. That was the intent. I do not know whether it did.
Q. Why would it be preferable or acceptable to use an
electrode of higher impedance -- a medium of higher impedance in
the electrode shown by Exhibit 837?
A. Can you repeat the question?
Q. I am asking why Zenex found it acceptable to use an
electrode of higher impedance -- I am asking why Zenex found it
acceptable to use a conductive medium for the electrode shown in
837 that resulted in a higher impedance than that of 836?
A. I think the concern was whether the higher saline or
saline gel could cause the electrode to corrode or have a shorter
shelf life. I don't think it was related so much to the concerns
by some people within the company of the resistance.
Q. Some people were concerned about the resistance though,
is that right?
A. Yes.
Q. Why were they concerned about the resistance?
A. Because without the pressure, we would have to --
paddle pressure, we'd have to lower the resistance as much as
possible.
Q. Did you have any other communications with Paul Zoll
regarding the Zenex electrodes, that is, other than the documents
that we've seen here and the telephone conversation that you have
related?
A. I don't recall.
Q. Did Paul Zoll ever report to you anything about the
performance of the Zenex electrodes?
A. Yes. In a phone conversation.
Q. What did he report to you?
A. He reported the approximate electrical resistance with
pressure and without pressure on the pads.
Q. About when did he do that?
A. That was just before his presentation at the Purdue
conference on resuscitation.
Q. When was that?
A. I believe it was in '78. I don't recall the exact
month.
Q. Does this abstract on this document relate to what
you're talking about.
A. Yes, it does.
Q. That's the abstract where it says, "Zoll, Zoll, Frank
and Belgard"? I left out the initials.
A. Yes.
Q. That was a Purdue conference that occurred you believe
in about 1978?
A. Yes.
MR. BIRDWELL: Would the Court Reporter mark this as
Defendant's Exhibit 843?
(Defendant's Exhibit No. 843 for
Identification was so marked as of 4-4-86.)
Q. Do you have the complete document from which
this Page 56 of abstract came?
A. I don't know.
Q. Do you know what the document was?
A. Yes.
Q. What was it?
A. It was a journal called Medical Instrumentation. That
is a publication of the Association for Advancement of Medical
Instrumentation.
Q. About when were these abstracts published?
A. I don't recall the exact date.
Q. Was it prior to the conference that you referred to?
A. No. It was after the conference.
Q. Did you attend the conference?
A. Yes, I did.
Q. Did you attend Paul Zoll's presentation?
A. Yes, I did.
Q. I'm making an assumption. Did he make a personal
presentation?
A. Yes.
Q. Did he hand out any paper?
A. No.
Q. And it was, did you say, just before that presentation
that he related to you the results of the Zenex electrodes?
A. Yes.
Q. What did he say about the resistance of the electrodes?
A. He said the resistance without pressure was
approximately 70 ohms. If he applied pressure, there was about a
10 ohm drop on each of the pads.
Q. Do you have any understanding as to why he was
concerned about the resistance of the electrodes?
A. It is generally thought in defibrillation that
impedance should be -- or resistance should be low to achieve
adequate current flow to get the desired result.
Q. This abstract says, "It appears likely that 12
centimeter preapplied pads would be superior to electrodes now in
clinical use." Do you see that in there?
A. Yes.
Q. Do you know what he was referring to?
MR. LEE: Objection. It is not possible for him to
know.
MR. BIRDWELL: I don't know. He might have attended
the conference. He said he did.
MR. LEE: How would you know what Dr. Zoll had in mind
when he wrote that?
MR. BIRDWELL: He may well have some understanding of
where the 12 centimeter pads came from.
MR. LEE: That isn't what you asked.
MR. BIRDWELL: Fine.
Q. Do you know? You can answer the question.
You don't have to worry about his objections.
A. I don't know.
Q. Had you heard about using 12 centimeter pads?
A. We discussed it in a phone conversation when he called.
Q. You discussed that with Paul Zoll?
A. Yes.
Q. Prior to this conference?
A. Yes.
Q. What did he have to say about 12 centimeter pads?
A. His concern was paddle pressure and whether it was
necessary, and I did point out that you could lower the impedance
by making a larger pad.
Q. Did you suggest 12 centimeters?
A. I don't know.
Q. Do you know of any pads that were made prior to that --
Excuse me.
Did you know of any electrodes that were made
prior to that conference which were 12 centimeters in diameter?
A. Yes. Anterior-posterior defibrillator paddles use a 12
centimeter posterior paddle for the most part.
Q. What is the anterior paddle?
A. It is usually eight centimeters or larger.
Q. That was what was being used at about that time?
A. For defibrillator paddles.
Q. Did you know of any pads that had a sponge material
between the metal and the skin -- Excuse me.
Did you know of any electrodes that had a sponge
material between the metal and the skin that were 12 centimeters
in diameter?
A. No.
Q. Did you supply any electrodes to Paul Zoll that were
larger than eight centimeters in diameter?
A. At a later date, yes.
Q. When was that?
A. After the establishment of R2.
Q. When was R2 established?
I guess we asked that earlier.
Was R2 established at about the time you
terminated your relationship with Zenex?
A. At approximately the same time.
Q. So would it be fair to say that that was in 1978?
A. Yes.
Q. How long after that did you supply to Paul Zoll
electrodes that were larger than eight centimeters in diameter?
A. I don't know the exact date.
Q. Do you recall the circumstances?
A. I recall that I had forwarded him a letter stating that
I was now making larger pads of 12 centimeters in diameter.
Q. Here, I had forgotten about this. Do you recognize
this document?
A. Yes, I do.
Q. What is that?
A. That is a copy of correspondence to Ross Zoll and Paul
Zoll from R2 Corporation.
Q. Did you write this letter?
A. Yes, I did.
MR. BIRDWELL: I would like the Court Reporter to mark
this letter bearing the date September 15, 1979, as Defendant's
Exhibit 839.
(Defendant's Exhibit No. 839 for
Identification was so marked as of 4-4-86.)
Q. I see this refers to a system including 12
centimeter size electrodes?
A. That is correct.
Q. Is that what you were referring to a few moments ago?
A. Yes, it is.
Q. How long after the letter did you supply Paul Zoll with
a 12 centimeter electrode?
A. I don't recall.
Q. Did you have any communications with Paul Zoll between
the time of the Purdue conference and the time of this letter,
Exhibit 839?
A. I don't recall.
Q. Did you have any communications with Ross Zoll?
A. I don't recall.
Q. What is the next thing you recall by way of
communication or relationship with Paul Zoll after the Purdue
conference occurred, the one for which the abstract on 843 is
prepared?
A. I am sorry.
Q. What's the next communication or interaction between
you and Paul Zoll that you recall occurred after the Purdue
conference?
A. I believe this letter was the first formal
correspondence with him.
Q. Was there anything informal that occurred in that time?
A. I don't recall.
Q. Did Paul Zoll respond to this letter of September 15,
1979?
A. I don't recall.
Q. When you were working for Zenex, was the Bi-PAK 2 that
they sold ordinarily sold in pairs of electrodes?
A. Yes. I believe you asked me that question earlier.
Yes.
Q. Sorry. I don't mean to be redundant.
A. That's fine.
Q. Were the electrodes of the same or were they of
different sizes?
A. They were the same size.
Q. Where were they ordinarily placed on the body in use?
A. I don't know.
Q. Well, this --
A. The brochure shows two positioning locations. I don't
know on which it was actually placed.
Q. Can you explain to me what is meant here by "anterior-
posterior placement" in Exhibit 835?
A. Simply, one electrode is placed on the back of the
patient, the other one is placed on the front.
Q. To your knowledge, did Zenex ever make electrodes for
defibrillation where the two electrodes were of different sizes?
A. Not to my knowledge.
Q. Did you know of anybody else at that time making
electrodes of two different sizes?
A. Only the reusable defibrillator paddles.
Q. Those were just the plain metal ones?
A. Yes. For anterior-posterior defibrillation.
Q. Posterior was usually 12 centimeters or larger?
A. Yes.
Q. Can you identify this letter addressed to Roger Lee
Heath with a date September 10, 1980, signature, Barbara Corl?
A. Yes.
Q. Did you receive that letter?
A. Yes, I did.
MR. BIRDWELL: I would like the Court Reporter to mark
as Defendant's Exhibit 844.
(Defendant's Exhibit No. 844 for
Identification was so marked as of 4-4-86.)
Q. Can you identify this document with an
apparent R2 letterhead dated September 24, 1980, with your name
as the signatory?
A. Yes, I can identify it.
Q. Is that a letter that you sent -- a copy of a letter
that you sent to Barbara Corl at Cardiac Resuscitator
Corporation?
A. Yes, it is.
MR. BIRDWELL: I would like the Court Reporter to mark
that with Exhibit No. 845.
(Defendant's Exhibit No. 845 for
Identification was so marked as of 4-4-86.)
Q. Is what is stated in the September 24, 1980,
letter correct?
A. Yes, it is.
Q. At the time that you wrote the September 24, 1980,
letter that is Exhibit 845, what products of Cardiac Resuscitator
Corporation were you aware of?
A. I was aware of the Heart Aid early model, and it was an
article I saw in the Medical Instrumentation.
Q. Were you aware it had the pacing function?
A. Yes, I was.
Q. Can you identify this letter bearing Production No.
CO220 dated March 9, 1981, with your name as the signatory?
A. Yes.
Q. What is the letter?
A. The letter is from me to Barbara Corl.
Q. And you did send that letter?
A. I did send that letter.
MR. BIRDWELL: I would like the Court Reporter to mark
this as Exhibit 846.
(Defendant's Exhibit No. 846 for
Identification was so marked as of 4-4-86.)
Q. Can you identify the letter with the date
March 12, 1981, bearing Production No. CO221?
A. I don't recall this for some reason.
Q. Is there a Technical Division of R2 Corporation?
A. Yes. That is a correct address.
Q. Do you ever recall having any communications with a
Janie Hagberg at Cardiac Resuscitator Corporation?
A. I do recall having a conversation with a quality
control person. I don't remember her name.
Q. Does the subject matter of this letter appear familiar
to you?
A. Yes, it does.
Q. Do you remember having communicated with someone at
Cardiac Resuscitator Corporation regarding that subject matter?
A. Yes, I do.
MR. BIRDWELL: Would you please mark this as
Defendant's Exhibit 847?
(Defendant's Exhibit No. 847 for
Identification was so marked as of 4-4-86.)
Q. Would you identify this document marked with
Production No. CO 222, please?
A. That is the artwork supplied for the Heart Aid to R2.
Q. Was that supplied for use with R2 electrodes?
A. It was supplied for a -- I'll say custom made version
of R2 style electrodes, yes.
Q. Custom made for?
A. CRC..
MR. BIRDWELL: Would the Court Reporter mark that as
Exhibit 848, please?
(Defendant's Exhibit No. 848 for
Identification was so marked as of 4-4-86.)
Q. Would you identify the document bearing
Production No. CO223? It appears to be a letter dated March 26,
1981.
A. Yes. This is correspondence from R2 to CRC.
Q. Did you write that letter --
A. Yes, I did.
Q. -- (continuing) sent to CRC?
A. Yes.
MR. BIRDWELL: Will the Court Reporter mark this as
Defense Exhibit 849?
(Defendant's Exhibit No. 849 for
Identification was so marked as of 4-4-86.)
Q. Does this Exhibit 848 relate to either of
Exhibits 846 or 849?
A. Yes.
Q. Would you explain, please, which it relates to and how?
A. The artwork referred to in these letters is this
(indicating).
Q. Was the same artwork --
A. I don't know which letter it's associated with -- which
particular letter it's associated with. It looks like a final
version. So I would suspect it was this letter (indicating).
Q. The March 26, 1981, Exhibit 849?
A. Yes. It is difficult to tell because the artwork was
very close to being the same.
Q. I would like you to look at Exhibit 573. Does that
help you any?
A. Yes. That is the artwork within a package with a pad
that we manufacture.
Q. Now, in the letter marked Exhibit 845 dated September
24, 1980, you indicate that you enclosed information on the R2
Apex-Posterior electrode. Would you describe what electrode it
is that you're referring to?
A. That is an electrode manufactured by R2.
Q. Do you still manufacture that electrode?
A. Yes, we do.
Q. Were you manufacturing it at the time you wrote this
letter?
A. Yes.
Q. Did that electrode have -- Can you make a drawing of
that electrode in the same manner you made these previous
drawings?
A. You mean the structure of that electrode?
Q. The structure, yes.
A. It's very much like the structure in --
Q. Exhibit 836?
A. Exhibit 836.
Q. In what respects does the structure differ from that
structure shown in Exhibit 836?
A. It did not differ largely. There were small
improvements and changes in the chemistry that is used within the
gel metal or media metal interface.
Q. The electrode you're referring to in Exhibit 845 I take
it then had all of these components which you have identified in
Exhibit 836?
A. That is correct.
Q. Was there anything about the geometry, not about the
chemistry, but about the geometry of any of the components that
was different from that shown in Exhibit 836?
A. Yes. There is a little more -- The geometry was still
a circle, but there was a little more adhesive area used in the
element here.
Q. Do you mean that the foam adhesive ring had a --
A. There was much more adhesive in that area.
Q. Had greater adhesive area?
A. Yes.
Q. What about the reticulated foam, did it have the tabs?
A. It had the tabs as shown there.
Q. But there was some difference in chemistry I take it?
A. I'm uncertain about that. The first pads I don't know
-- I can't recall the exact chemistry.
Q. Now, in this letter marked Exhibit 845 you say, "I
offered the Apex-Posterior Electrode as a possible alternative to
the somewhat controversial tongue-epigastric placement." What do
you mean by that?
A. The tongue-epigastric that is used in this setup --
Q. That's this Exhibit 848?
A. 848.
-- (continuing) was somewhat controversial because
the one electrode made contact on the tongue. That was
considered by many physicians to be risky in some ways as far as
managing cardiac arrests.
Q. What I'm really -- Go ahead. What I want to know is
what you meant by an alternative?
A. The alternative is two pads with our Apex-Posterior
Electrode.
Q. So you were suggesting to CRC that it use two of the
type of pads you were making at the time instead of one pad and
the tongue?
A. Exactly.
Q. What does the "Apex-Posterior" term mean?
A. "Apex" means placing anterior, on the front near the
cardiac apex or where the apex of the heart is. The posterior is
on the back, the upper right posterior side.
Q. So you were suggesting by this letter that CRC use
instead of one electrode on the epigastrial area and one on the
tongue, using one in what you refer to as the apex area and one
on the back?
A. Yes.
Q. And those were electrodes of the type having the
structure shown in Exhibit 836?
A. The structure similar to that shown in Exhibit 836.
Q. What became of this suggestion, do you know?
A. It was not adapted by CRC until a much later date where
they actually used two of these pads in that fashion.
I'm sorry. I'm thinking in strictly terms of the
Heart Aid.
The first use of two of these pads was with the
Pace Aid.
Q. Incidentally, why did you think that would be an
appropriate thing to do for the Heart Aid?
And as I understand, you knew the Heart Aid at
that time to have a pacing function as well as a defibrillation
function, is that correct?
A. Yes.
MR. LEE: Objection. Compound; unclear.
MR. BIRDWELL: Q. Did you understand that the Heart
Aid device that was being marketed by Cardiac Resuscitator
Corporation at the time this letter was written had both a pacing
function and a defibrillation function?
A. Yes, I was aware of that.
Q. Why did you think that using two of R2's pads --
electrodes in the manner that you suggest in this letter would be
appropriate for that product?
A. Well, I had concerns that these electrodes would be too
high an impedance, first of all, --
Q. By "these" you're referring to?
A. -- (continuing) because of their smaller contact area.
Q. Which ones are you referring to?
A. The tongue and then the epigastric electrode. It was 8
centimeters, not 12 centimeters.
Q. The epigastrial?
A. Yes. Like our Apex-Posterior Electrode.
And in fact, I recall a telephone call from Dr.
Aronson's secretary asking me why we used such large area
electrodes, and I explained the primary concern was impedance and
that it should be low so that adequate current can traverse the
heart for successful defibrillation. I was also aware at this
time that front-to-back pacing would reduce the amount of trauma
to the patient.
Q. By the time that you wrote this letter marked Exhibit
845, had you sold to anyone else electrodes of the type you're
referring to?
A. I don't understand.
Q. Were your electrodes on the market by the time you
wrote this letter?
A. Yes.
Q. How long had they been on the market?
A. I don't know the exact date. We had a period of
testing, and we ran a lot of tests, and I don't know the exact
date. I'd have to go back to records and find out.
Q. I take it you thought that your electrodes would work
for both the pacing and defibrillation function of the Heart Aid
apparatus?
A. Yes.
Q. Would you identify this document which appears to be a
letter dated June 24, 1981, bearing Production No. CO224?
A. I recognize the signature and the stationery.
Q. Whose signature is that?
A. That is Roxanne Seefeldt.
Q. Who is she?
A. At that time, Administrative Liaison. Right now she is
Chief Operating Officer, R2.
Q. And the letterhead, is that R2 Corporation.
A. That is R2 Corporation letterhead.
MR. BIRDWELL: Would you mark this as Defendant's
Exhibit 850, please?
(Defendant's Exhibit No. 850 for
Identification was so marked as of 4-4-86.)
Q. Can you identify this letter dated July 1,
1981, bearing Production No. CO227?
A. Yes, I recognize it. This is correspondence to Roxanne
at R2.
MR. BIRDWELL: Would you mark that as Defendant's
Exhibit No. 851?
(Defendant's Exhibit No. 851 for
Identification was so marked as of 4-4-86.)
Q. Would you identify the document with
Production No. CO228?
A. I recognize this as correspondence to CRC from R2.
Q. Is that your signature?
A. Yes, it is.
MR. BIRDWELL: Would you mark this as Exhibit 852,
please?
(Defendant's Exhibit No. 852 for
Identification was so marked as of 4-4-86.)
Q. Now, from this correspondence that you've just
looked at and from your memory as well, can you determine about
the time when you first supplied Cardiac Resuscitator Corporation
with electrodes manufactured by R2 Corporation?
A. I'd have to draw a --
You mean electrodes that were --
Q. Okay. I am talking about any electrode manufactured by
R2 Corporation, whether for custom purpose or any other purpose.
A. It was actually prior to this. Bill --
What is his last name?
Q. Bill Durhum you mean (phonetic)?
A. No. For the Heart Aid originally, I want to say --
Who was the former General Manager? Bill Miller?
I don't remember his name.
MR. LEE: Bill Fleming?
THE WITNESS: Yes. Bill Fleming was actually -- I am
sorry. My memory is coming back a little bit here.
MR. BIRDWELL: That's why we put these in front of you.
Hopefully they'll refresh your memory.
THE WITNESS: I had forgotten about Bill Fleming. Bill
had actually called me, and he was the one who actually specified
this design as far as using the more adhesive area and
everything.
MR. BIRDWELL: Q. That was while he was employed by
Cardiac Resuscitator Corporation?
A. Yes. As I understand, General Manager.
Q. And while he was employed by Cardiac Resuscitator
Corporation, you supplied to CRC electrodes made by R2
Corporation?
A. Yes.
Q. And were those electrodes your standard electrodes or
were they something else?
A. They were virtually identical -- I'd say virtually
identical to this electrode, this exhibit.
Q. That's Exhibit 573?
A. 573, yes. They were not necessarily packaged like
this. The first electrodes were unpackaged.
Q. Do you know for what purpose they were going to use
those electrodes?
A. Yes. I understood with the Heart Aid at that time.
Q. Did you ever discuss with Bill Fleming the Pace Aid
product or pacing products?
A. No.
Q. Do you recall any further communications with Cardiac
Resuscitator Corporation regarding your suggestion that they use
two of these electrodes like Exhibit 573 rather than one tongue
electrode and one epigastrial electrode?
A. Bill indicated to me in a phone conversation that he
was for that application, but Dr. Aronson since he was Medical
Director felt they ought to retain the tongue-epigastrial.
Q. So that was discussed with Bill. When you say "Bill,"
you mean Bill Fleming?
A. Yes. Bill was very much for using the two pads.
Q. Do you recall -- Well, did Bill Fleming say why he was
for using the two pads?
A. He felt it was more acceptable in the marketplace.
Q. Are you able to determine -- Did you eventually start -
- First of all, did you eventually start supplying R2 electrodes
for use -- Excuse me.
Did you eventually start supplying R2 electrodes
so that two could be used for the Heart Aid or the Pace Aid
products?
A. We furnished a product. We did not specify how it
would have to be used.
Q. You didn't ever supply it with a single -- two pads
with a single connector then?
A. No.
Q. They've always been supplied with one connector?
A. I believe we sent samples of our Apex-Posterior
Electrode to Bill.
Q. Do you know when you first sent a sample of an Apex-
Posterior Electrode?
A. It had to be pretty close to the time that I saw the
Diack article when I made the call. Bill had to make his
modified design from our existing components. There was not a
lot of money apparently or something for this kind of thing, and
they needed to move quickly. That was one reason why we used
components that are used in our Apex-Posterior pads in the
structure of this pad for CRC.
Q. Did Bill Fleming indicate that he had tried two of
these pads rather than one tongue pad and one epigastrial pad?
A. No, he did not indicate that to me.
Q. Can you identify this document marked November 1, 1981?
A. Yes.
Q. What is that?
A. That is a note I made for internal use to our marketing
people, mainly our sales representative.
MR. BIRDWELL: Would you mark that exhibit or that
document as Exhibit 853?
(Defendant's Exhibit No. 853 for
Identification was so marked as of 4-4-86.)
By the way, Mr. Walters, this has a word
"Confidential" across it. Did you intend that to be treated as
confidential under the protective order or is that something that
is on there that is no longer applicable?
MR. WALTERS: Off the record for a moment.
(Discussion had off the record.)
MR. WALTERS: Back on the record.
That stamp was placed on the document at a
previous date, and we are not asserting present confidence, that
it involves confidential information, if that makes any sense.
THE WITNESS: That was stamped confidential the day it
was written.
MR. BIRDWELL: Q. In this paper it says, "As an
integral part of this application, we have anticipated a feature
on the Apex-Posterior Electrode for transcutaneous noninvasive
cardiac pacing. We were inspired by a study which involved a
similar method in 1955 before even external defibrillation was
attempted." What was that study that you were referring to
there?
A. That study -- When we found R2, Ms. Seefeldt and I did
considerable research at medical libraries here in Chicago and
came upon a study that -- it was actually a report in JAMA, the
Journal of the American Medical Association, in November of 1955.
Several physicians -- I think one's last name was
Douglas, the other was Weaver in Jamaica, New York -- had a
patient in Stokes-Adams attacks; and they had an old Linenthol
external pacer flown in. As I understand, the patient was stated
as being deeply comatose and markedly cyanotic. After prolonged
periods of asystole or heart standstill, they hooked up the
pacer. The --
If you would like me to go in and describe the
study?
Q. Yes, please.
A. They hooked up the pacer, and in two hours the patient
had a complete neurological recovery. There were no invasive
methods by which they could put leads directly into the heart; so
they began to experiment with electrode position on the patient.
They found that with one electrode on the front and one on the
back, posteriorly, that there was much less distress to this
patient; and they maintained him alive for a week, which was the
subject of the paper. And I believe the paper was published at
the time the patient was asymptomatic, had apparently returned to
his own self-sustaining heart rhythms and was discharged
asymptomatic at the time of the report.
Q. You said a Linenthol external pacer. Is that something
manufactured by Electrodyne or by whom?
A. I don't recall.
Q. Do you recall how the article described --
By the way, was a copy of that article produced?
A. It is mentioned in correspondence to Zoll. I don't
know that we have any other documentation on it.
MR. LEE: Is this the Douglas article?
THE WITNESS: Yes, the Douglas article.
MR. LEE: Off the record.
(Discussion had off the record.)
MR. BIRDWELL: Q. Do you have any other records, any
earlier records, any records earlier than November 1, 1981, and I
guess any records earlier than your letter to Dr. Diack that show
that it had occurred to you to use R2 electrodes in an external
noninvasive pacing application?
A. Is the question regarding any documents that exist?
Q. Yes. There is this document, and then with -- I'm
accepting this for purposes of this question, your letter, too,
other than the letter to Dr. Diack.
A. I don't know. Our pads are intended for stimulation,
external stimulation.
Q. Any type of stimulation, is that correct?
A. That's correct.
MR. LEE: Objection. That is a leading question.
MR. BIRDWELL: Q. Is there any kind of stimulation
that you didn't anticipate your pads could be used for electrical
stimulation at the time you made the product?
MR. LEE: Objection. I don't think that question is
clear.
MR. BIRDWELL: I'll ask the question another way.
Q. When you first started manufacturing -- When
R2 Corporation first started manufacturing its electrodes, were
there any types of electrical stimulation that you did not
consider appropriate for their use? I'm talking about medical
therapeutic applications.
A. Would you read the question back?
Q. At the time R2 Corporation started manufacturing its
electrodes, were there any medical therapeutic electrical
stimulation applications that you did not consider appropriate
for their use?
A. Not that I can recall.
Q. Would it be fair to say you considered pacing then an
appropriate application for their use?
A. Definitely.
Q. At that time?
A. Yes.
MR. BIRDWELL: Let's take a break for about fifteen
minutes.
MR. WALTERS: Fifteen, twenty minutes. (Whereupon, a
short recess was taken.)
MR. BIRDWELL: Q. In this document marked Exhibit 853,
in the third paragraph, I'd like you to read that third
paragraph, please.
A. "Upon our indirect suggestion --"
Q. You don't have to read it out loud. You can read it to
yourself.
A. Okay. Thanks.
Q. What were the circumstances you were referring to in
that third paragraph where it refers to a recent study upon your
indirect suggestion?
A. Just a moment.
Dr. Zoll requested electrodes for the -- from me,
from R2, for this study. That is not the study in Medical
Instrumentation here. It was related later in Medical
Instrumentation, another abstract out of the Purdue conference.
And called me back and told me the results. He was excited as
can be.
Q. What was the study?
A. External pacing human subjects.
Q. When did this occur?
A. I don't know the exact dates because I wasn't there.
Q. Was it prior to that document?
A. Yes.
Q. How much?
A. I don't know.
Q. When did you send in the him the electrodes for the
study?
A. I have not tracked that down. I would suppose it's in
the UPS records somewhere in our place. I don't know. That's a
long time ago.
Q. How much prior to that was it, what's your best
estimate?
A. That I sent him electrodes?
Q. Yes.
A. It's so long ago, I can't recall.
Q. What were the electrodes like that you sent him?
A. They were Apex-Posterior Electrodes.
Q. Did they have the structure shown in Exhibit 836?
A. Yes.
Q. Were they your standard electrodes, standard R2
electrodes?
A. Yes.
Q. When you sent them to him, did you understand that they
were for external noninvasive pacers?
A. Yes.
Q. Do you recognize this document dated September 10,
1981, addressed to Paul Zoll, showing you as the signatory?
A. Yes, I do.
Q. Did you send that letter?
A. Yes, I did.
MR. BIRDWELL: Would the Court Reporter mark that as
Defendant's Exhibit 854?
(Defendant's Exhibit No. 854 for
Identification was so marked as of 4-4-86.)
Q. Did you send the electrodes to Paul Zoll
before or after this letter dated September 10, 1981?
A. I don't recall.
Q. Have you read the letter?
A. Yes.
Q. In the letter it says in the third paragraph, "We have
been supporting research for simultaneously using transcutaneous
pacing and have been pacing dogs with as little as 40-50 ma with
capture and very little thoracic twitching." What is that
referring to?
A. That is referring to our pads that were sent with a
special cable for a very old Zoll pacer, Electrodyne TR3, I
believe, that was volunteered for doing some dog research in
external pacing at Newark Beth Israel Hospital in Newark New,
Jersey.
Q. Is that with someone named Bill Rathyen?
A. Yes.
Q. Whose idea was it to do that?
A. Bill contacted us to use our electrodes for ECG
defibrillation during special procedures at that hospital, were
very popular in certain special procedures, high risk procedures;
and we got in on a discussion of what all the different functions
of pads were intended to do, and he was most enthusiastic about
the idea of doing external pacing. So I offered to make -- He
said he had an old Zoll pacer. I offered to make him a cable
which he could at least use in dogs experiment.
MR. LEE: Could I have the last portion of that answer
read back?
(Requested portion read.)
MR. BIRDWELL: Q. In the discussion, who suggested
that these pads might be suitable for pacing -- these electrodes
might be suitable for pacing?
A. Me.
Q. At that time, had you previously heard anything about
work being done by Paul Zoll on the subject of transthoracic
pacing?
A. I don't recall.
Q. Did you get your idea from Paul Zoll --
A. I --
Q. -- (continuing) at that time?
A. As I stated earlier, stimulation and pacing was always
considered as part of the R2 objective with this standard set of
electrodes. I talked with a lot of people of external pacing,
and I don't believe the idea was from Zoll, but I don't recall
the whole conversation completely.
Q. Had anybody previously used any -- To your knowledge,
had anybody previously used any R2 electrodes for external
noninvasive pacing?
A. Well, the --
MR. WALTERS: Excuse me. Previous to what?
MR. BIRDWELL: Previous to this discussion he had with
Bill Rathyen.
THE WITNESS: A. Well, I know that at least in the
tongue-epigastrial application it had been used, and I believe
that most physicians would qualify that as external pacing.
MR. BIRDWELL: Q. Other than used by Cardiac
Resuscitator Corporation, did you know of any places where R2
electrodes had been used for external noninvasive pacing?
A. Paul Zoll --
No. I'm sorry.
Q. I am talking about prior to your discussion with Bill
Rathyen.
A. It is so long ago, I don't recall the sequence. At
that time, --
Q. Well, maybe this will help you.
A. I am a little mixed up on time.
Q. Would you tell me if you can identify these two
documents?
A. Yes. This is correspondence in January of '81 from R2
to Bill Rathyen regarding using our electrodes for pacing.
Q. We should take them one at a time I suppose.
The first one bearing a date of January 27, 1981,
showing you as the signatory, did you write that letter?
A. Yes, I wrote these letters.
MR. BIRDWELL: Will the Court Reporter mark that as
Exhibit 855?
(Defendant's Exhibit No. 855 for
Identification was so marked as of 4-4-86.)
Q. And did you write the letter bearing the date
January 29, 1981, with your name as signatory?
A. Yes.
MR. BIRDWELL: Would the Court Reporter mark this as
Exhibit 856?
(Defendant's Exhibit No. 856 for
Identification was so marked as of 4-4-86.)
Q. Is this document bearing a date February 10, 1981, and
showing you as the signatory also a letter which you sent to Bill
Rathyen?
A. Yes.
MR. BIRDWELL: Will the Court Reporter mark this as
Defendant's Exhibit 857?
(Defendant's Exhibit No. 857 for
Identification was so marked as of 4-4-86.)
Q. Incidentally, in Exhibit 857 it says, "I have
noticed your paper given in the last AAMI meeting on
relationships of impedances of pacemaker electrodes."
A. That is implantable pacemaker electrodes.
Q. What I would like to do is just hand you a group of
documents and ask you to tell me if you can identify them? Let's
just --
Could you mark these with consecutive exhibit
numbers, please?
MR. LEE: Could I inquire as to which exhibit you were
referring to when you referred to implantable devices?
THE WITNESS: (Indicating).
MR. WALTERS: And the witness pointed to DX 857.
(Defendant's Exhibit Nos. 858 - 863 for
Identification were so marked as of 4-4-86.)
MR. BIRDWELL: Q. I am going to hand you a set of
documents with Exhibit Nos. 858 through 863 and ask you if you
would look at them one at a time and identify them, if possible,
by the exhibit number and telling me what he they are?
A. This is Exhibit No. 858. This is a speed letter that
was enclosed with cables forwarded to Newark Beth Israel Hospital
to Bill Rathyen in the Cardiac Lab for research in pacing in
dogs.
Q. Is that sent by R2?
A. Sent by me at R2, yes.
Q. What's the date?
A. The date is February 25, 1981.
Exhibit 859, this is a confirmation from Bill
Rathyen of receipt of the electrodes for external pacing research
from Newark Beth Israel.
Exhibit No. 860, March 26, 1981, letter from
Newark Beth Israel. It is a letter outlining data on the results
of using R2 pads for external stimulation or pacing in dogs.
Exhibit No. 862 dated January 27th, 1981, is a
drawing I did of a cable system for an old Zoll pacer and
Hewlett-Packard defibrillator, to interface the two systems with
our electrodes for external pacing, defibrillation and
monitoring.
Exhibit No. 863 dated January 27th, 1981, is a
different style cable for the same -- adapted the same two units.
I don't recall which of these two systems -- Oh. The one that
was sent to Newark Beth Israel was the version on Exhibit 862.
Q. Did you identify 861?
A. 862 is the cable system that was sent.
Q. I am wondering, did you identify this one?
A. Oh, 861. I am sorry. That is the second page of the
letter dated March 26th, 1981, outlining the data of using R2
pads for external pacing in dogs.
I should probably qualify that and say a dog. I
don't know if he did more dogs.
Q. Now, do all of these exhibits, 858, 859, 860, 861,
relate to this work being done by Bill Rathyen?
A. Yes.
Q. What about Exhibits 862 and 863, why were they done?
A. Those were done to illustrate for him the means by
which he could adapt his existing instruments to do this
research.
Q. Who did this drawing?
A. I did both of those drawings.
Q. Both 862 and 863?
A. Yes.
Q. Did you do them on the date that is marked there?
A. Yes. January 27th, 1981.
Q. Had you discussed this application with Paul Zoll?
A. I don't know.
Q. Who is Bill Rathyen, was he a physician?
A. No. He was a cardiac technician who worked in the
Special Procedures Lab.
Q. Do you know if he was acquainted with Paul Zoll?
A. I do not know.
Q. Did he ever mention Paul Zoll's work in your
conversations with him?
A. Yes, we did discuss Zoll at points. I don't recall --
He is familiar with Zoll. I don't recall when we
talked about Zoll.
Q. Did you discuss Paul Zoll's more recent work as
distinguished from what he did, say, up to about 1975?
A. I think at that time I had had the impression that
there was a lot of interest building on external pacing. I don't
recall completely.
Q. You don't recall whether you discussed Paul Zoll?
A. Yes.
Q. In this Exhibit 854 you say that you observed that Paul
Zoll was talking again on external cardiac stimulation at the
next Purdue conference. What did you mean by "again" there?
A. I think that's probably an error. When I say external
cardiac stimulation, that would include fibrillation in that
context. He's always been vocal, but stimulation could include
fibrillation. That may have been in the context he was using
because he had spoken earlier on defibrillation.
MR. LEE: Which line in the exhibit were you referring
to?
MR. BIRDWELL: First line in the first paragraph.
Q. The research that you were referring to in the
third paragraph, is that the research by Bill Rathyen or
something else?
A. I'm sorry. The second paragraph?
Q. The third paragraph.
A. Yes, that is Bill Rathyen.
Q. Was there any other experimentation or research that
you were aware of at this time with external noninvasive pacing
apart from whatever CRC was doing?
A. I don't think so.
Q. Have you ever had any discussions with Paul Zoll or the
company ZMI about supplying them with electrodes?
A. From time to time after I first supplied Zoll some of
the pads, he called wanting more pads. I sent him a second
shipment of pads, but the third time he called I had the sense
that he was not, at least in the past, working exclusively with
us. I had another manufacturer indicate that they were also
making some pads for him, and so I turned him down on the third
call.
Q. Who was the other manufacturer?
A. The other manufacturer was Medic Plastics,
Incorporated.
Q. Where are they located?
A. I think they're in western New York. I'm not
completely sure of that.
Q. What was the nature of the indication you got that they
might be supplying him with electrodes?
A. Their President mentioned that to me at the American
Society of Anesthesiology meeting. I can't recall the exact year
date, but there is a meeting once a year of the ASA.
Q. Did you first supply -- I may have asked this already,
but I will try again here.
Did you first supply Paul Zoll with R2 electrodes
subsequent to the letter marked Exhibit 854 or before?
A. I don't recall.
Q. When Paul Zoll -- When you spoke with Paul Zoll
regarding the use of your electrodes, did he ever indicate that
they were unsuitable in any way for what he was doing?
A. No.
Q. Did you ever have any discussions with him about
electrode impedance with respect to what he was doing at the
time?
A. No.
Q. Did he ever complain about the -- or say anything --
I should say, did he ever comment on the quality
of manufacture of the electrode?
A. No.
Q. Did he ever indicate any dissatisfaction with any
feature or aspect of your electrode?
A. No.
Q. Did he ever indicate satisfaction?
A. He was -- When he called me back in that one instance
after he had initiated pacing in humans there, he was -- he
called me, he seemed most pleased. I assumed it was because the
electrodes had worked.
Q. He didn't say why though?
A. I am sorry.
Q. He didn't go into detail though I take it?
A. No.
Q. He wanted more electrodes?
A. Later he wanted more electrodes, yes.
Q. You were giving him electrodes on a free basis I take
it so he could run experiments?
A. That is correct.
Q. You would have been happy to sell him electrodes if he
wanted to buy them?
A. Certainly. At a much later date, I did make an attempt
to sell ZMI electrodes. I saw -- was it Rolf Stuts on CBC
Morning News, and called them that day or the following day
congratulating them and still indicating that I would like to
work with them.
Q. And what was their response?
A. There was no return response.
Q. Did they ever discuss price with you?
A. No.
Q. Is it correct, they never got into any details about
whether you could supply them with the quantities or any sorts of
things that --
A. No.
Q. -- (continuing) if they were seriously thinking about
your electrodes they would --
A. No.
Q. So it would be fair to say that they never expressed
any interest in getting your electrodes any way other than free?
A. I don't know as I would go far as just to say that.
Q. They never offered to pay for any?
A. They never offered to pay for any, that's correct.
Q. Earlier you referred to, I believe, a -- Well, I am
sorry. Maybe you didn't refer to it.
In Exhibit 844 there's a reference to an article
in Design News. Is that this article?
A. Yes, it is.
MR. BIRDWELL: I would like the Court Reporter to mark
this article Exhibit No. 864.
(Defendant's Exhibit No. 864 for
Identification was so marked as of 4-4-86.)
Q. This article shows a date of May 26th, 1980.
Had you started manufacturing and selling R2 electrodes by that
time?
A. Yes.
Q. How long before that approximately had you started
manufacturing and selling R2 electrodes?
A. I don't recall exactly.
Q. Well, would it have been more than a year of less than
a year?
A. I might add that there was a lot of research that went
on, too, in this period. I don't know if -- It's going so far
back, I don't know.
Q. I would like you to refer back to Exhibit 836. In this
structure which, as I understand it, applies both to the Zenex
defibrillation electrode, to your R2 electrode and to the custom
electrode that you supplied to CRC, is that correct?
A. Correct.
Q. In that electrode, what is the purpose -- what is the
reason in this electrode structure for placing a reticulated foam
member between the metal member, the stainless steel element, and
the skin?
A. Is your question in the context of this or --
Q. First in the context of the Zenex electrode, do you
know why they placed that foam member between the metal and the
skin?
A. The conductive media must be held in place by some
means, that's why.
Q. You were aware I take it that some electrodes were used
where gel was just placed on metal and that was put against the
skin?
A. Yes. Like defibrillator paddles.
Q. So why not just do that, just metal with gel on it
rather than use the reticulated foam, why didn't they back at
that time?
A. Well, --
Q. If you know.
A. Well, there are several purposes. The primary purpose
is to hold the conductive media and an adequate amount of
conductive media. It is uniform throughout the whole surface in
its thickness and its uniformity. That's the main objective of
it.
Q. What other purposes, do you recall?
A. That's the primary purpose. I don't know any others.
Q. You said there are several purposes. Might there have
been other purposes that you're unaware of because you didn't
actually design it, that is, the Zenex; is that what you're
suggesting?
A. Not at all. When you look at electrodes -- I mean,
there is a lot of purposes for the conductive media. Good ion
transfer from the metal to the skin. Also, there's more --
having more gel there as opposed to a small amount on the surface
of a paddle, for example, could dry out very quickly because
there is very little there. This you have a consistent,
relatively large amount there.
Q. The regular defibrillator paddles where they would put
gel on the metal and put it against the skin, would they produce
hot spots?
A. They would be very likely to produce some hot spots due
to the nonuniform nature of the -- And perhaps some part of the
gel might not even cover part of the paddle.
Q. Is it correct that the reticulated foam between the
metal and the skin as used in the structure in Exhibit 836 helped
to eliminate or reduce the likelihood of hot spots?
A. Yes.
Q. Was that one of the reasons that the foam was used in
the Zenex electrode, to your knowledge?
A. Yes.
Q. Do you know of any manufacturers to whom the Zenex
electrode -- any of the Zenex electrodes were supplied for use
with a pacing apparatus?
MR. LEE: Can I have the question read back? I didn't
get it all.
(Pending question read.)
THE WITNESS: A. I am not aware of any.
MR. BIRDWELL: Q. Do you know of any defibrillation
apparatus that were in existence at the time you worked for Zenex
that also had a pacing function in them?
A. Yes.
Q. Which are those that you recall?
A. There are several. Do you want me to --
Q. Please.
A. The old American Optical Lown Cardioverter had a built-
in external pacer which used two small electrodes in a front-to-
back fashion for external pacing.
There was a portable defibrillator manufactured by
Zenith-Travenol which had a built-in external pacer.
Q. What sort of electrodes did it use?
A. I'm not familiar with the electrodes it used.
Q. What was the name, Travenol?
A. Yes. Zenith-Travenol.
Those are two I knew of. I suppose some monitor
defibrillators made by Hewlett- Packard at one time had an
external pacemaker. And the Electrodyne system which was a Zoll
pacer was also -- that pacer could have been added to a monitor
defibrillator I suppose.
Q. Do you know, did Zenex supply electrodes to any of
those manufacturers for use with defibrillators that also had an
external pacing function?
A. There is a considerable time difference. As I
understand the Lown system, I believe -- I do not know for
certain -- but I believe the external pacing system on that was
designed by Dr. Edmark who later was employed by Physio-Control.
We did supply some pads to Bill Newman at Physio-Control from
Zenex.
Q. Do you know what those were for?
A. They were the Zenex defibrillation pads.
Q. I mean, do you know what he was going to use them for?
A. I don't know.
Q. Was that a one-time deal or was it an ongoing supply or
what?
A. It was more or less a one-time deal.
Q. Are there any other instances that you can think of
where Zenex pads were supplied to defibrillator manufacturers who
manufactured a product also with an external pacer?
A. No.
Q. Other than Cardiac Resuscitator Corporation, has R2
Corporation supplied any electrodes to a defibrillator
manufacturer whose produce, defibrillator product also has a
pacing function?
A. Could you repeat the question, please?
Q. Has R2 Corporation supplied any of its electrodes to
anyone other than CRC for use with a defibrillation apparatus
that also has an external pacing function?
MR. WALTERS: You mean at anytime up to the present?
MR. BIRDWELL: Yes.
MR. WALTERS: I think I am going to object to that, any
current things, I don't see any relationship.
MR. BIRDWELL: Well, let's say prior to the issuance of
the patent which was, I think, September, 1982.
THE WITNESS: A. I don't believe so, no.
MR. BIRDWELL: Can you identify this document which was
produced in response to the subpoenas?
A. Yes. This was included with the letter from Bill
Rathyen from Newark Beth Israel Hospital, and it is a photocopy
of a recording of R2 pads performing external pacing on a dog.
Q. Which letter is that you're talking about?
First let's get this -- I would like this
photocopy marked as Defendant's Exhibit 865.
(Defendant's Exhibit No. 865 for
Identification was so marked as of 4-4-86.)
THE WITNESS: A. Yes. That belongs to Exhibits 860
and 861.
MR. BIRDWELL: Q. Exhibit 865 belongs to 860 and 861?
A. Yes.
Q. Do you know what an "HP 7804A" is?
A. That is a Hewlett-Packard defibrillator.
Q. This --
A. Excuse me. I may be in error. I think I recall now
that when Bill set up, he in fact did not use a Zoll pacer. He
found an old Hewlett-Packard pacer, and I think that is an HP
pacer that's referred to by that model number.
MR. LEE: Off the record.
(Discussion had off the record.)
MR. BIRDWELL: Q. Can you tell or do you know if in
the test being run represented by Exhibit 865 the dog's heart was
being captured?
A. Yes.
Q. It was?
A. Yes.
Q. Did you have any discussion with Mr. -- Who is the
fellow at Beth Israel?
A. Bill Rathyen.
Q. -- (continuing) Rathyen regarding the width or duration
of the pacing pulse?
A. I don't recall.
Q. Can you identify this document marked with Plaintiff's
Production Nos. 03996 and 03997?
A. Yes. That is a correspondence to Paul Zoll from me,
November 10th, 1981.
MR. BIRDWELL: Would the Reporter mark that as Exhibit
866?
(Defendant's Exhibit No. 866 for
Identification was so marked as of 4-4-86.)
And would you mark this with Exhibit 867?
(Defendant's Exhibit No. 867 for
Identification was so marked as of 4-4-86.)
Q. Can you identify the document marked Exhibit
867?
A. Yes.
Q. What is that?
A. That is a letter I sent to Paul Zoll on January 11,
1982.
Q. Regarding that document marked Exhibit 867, did Paul
Zoll have any comment to you at anytime about what you're
suggesting there, this Apex-Posterior or, for that matter, the
anterior-posterior?
A. No, I don't believe I had a response from him on this.
Q. Now, referring to Exhibit 866, it indicates that -- you
say, "I am also enclosing samples of our electrodes for your
consideration." This is dated November 10, 1981. I would like
you to look at that and see if that refreshes your memory as to
when you first sent R2 electrodes to Paul Zoll?
A. I don't recall if this was the first time.
Q. Can you reach any conclusion by reading the letter as
to whether you sent him electrodes before?
A. I don't recall.
Q. Can you identify this document marked with production
numbers of the Plaintiff 04005, 04006?
A. Yes.
Q. What is that?
A. That is a copy of our first piece -- one of our first
pieces of literature at R2.
MR. BIRDWELL: I would like the Court Reporter to mark
that Exhibit No. 868.
(Defendant's Exhibit No. 868 for
Identification was so marked as of 4-4-86.)
Q. This Exhibit 868 says, "Copyright, 1979." Was
that published in 1979? Was it distributed to the public in
1979?
A. I don't recall the date it was actually distributed to
the public. That would indicate more when it was printed.
Q. What is the date "November, 1979" to the right?
A. That would be when we printed it. I don't know when we
began distribution of it.
Q. Is it correct that in early 1979 you had some brochures
printed?
A. We had some earlier sheets, but I don't believe we
distributed those at anytime. I remember that had a lot to do
with the fact that we were very much in the research mode, I
believe.
Q. Do you have any reason to doubt that that Exhibit 868
was published in 1979?
A. No.
Q. The earlier brochures that you believe you had printed,
were they like that or were they different?
A. They were different.
Q. Do you have copies of those?
A. We may have copies of them.
MR. BIRDWELL: Do you know of those have been produced?
MR. WALTERS: They have not been produced. They are in
the file history of the patent, of the Heath patent.
MR. BIRDWELL: Do you have a copy of those here? I
don't have a copy of those here, to my knowledge anyway.
MR. WALTERS: I assume I have one in the patent file.
MR. BIRDWELL: Is it a clean copy, one that we could
photocopy?
MR. WALTERS: I could check.
MR. BIRDWELL: Since it is quarter at four, do you
suppose we could take a brief break and check that?
MR. LEE: It is looking to me like it is going to be a
long deposition.
(Whereupon, a short recess was taken.)
(Defendant's Exhibit Nos. 869 - 887 for
Identification were so marked as of 4-4-86.)
MR. BIRDWELL: I've had a bunch of documents marked in
the interim.
MR. WALTERS: Good.
MR. BIRDWELL: Q. I show you a document that's been
marked as Exhibit 878. Do you recognize that document?
A. Yes.
Q. What is that?
A. The series of sheets?
Q. Yes. Are they all part of one thing or are they
different?
A. They're all kind of separate, but --
Q. Maybe you could start from the front.
A. The front page is on our ECG electrodes, not on our
defibrillation pads. What we did was our own test of all the
major manufacturers of ECG monitoring electrodes actually on the
body, the actual variations in impedance in frequency versus
impedance primarily for ECG monitoring.
Q. Is the structure of your ECG electrodes like any of
those structures shown in Exhibit 836, 837, or 838?
A. We have two structures. This was -- Actually yes. It
is a much smaller version of the 836 structure.
Q. Same structure, but not as much diameter?
A. Yes.
Q. What was the diameter?
A. The diameter -- Well, actually, it is the same as on
our pediatric defibrillator pads.
Q. What is that?
A. Four and a half centimeters in diameter.
Q. Are there other differences between your ECG electrode
and your defibrillation electrode?
A. No.
Q. Or your stimulation electrode?
A. No. It was primarily very small.
Q. No chemical or material differences?
A. Pretty much the same.
Q. Is there a way of determining the date when this first
page was produced?
A. I probably have a file somewhere at R2 that would
reveal the date.
Q. What is the second page of Exhibit 878?
A. Second page is a -- it's the defibrillator pads for ECG
monitoring demonstrating a difference in impedance accounting for
much greater amplitude in the electrocardiogram as a result of
the larger pads being used.
Q. So those --
A. One is a set of conventional ECG electrodes, and one is
the use of R2 pads on the same subject and the same -- without
altering the controls on the defibrillator monitor. We then took
the traces; and because the larger electrodes are lower in
impedance for ECG monitoring, there is a much larger trace.
Q. Aside from the custom pads that you make for CRC and
possibly some custom pads for someone else, I don't know, what
different types of -- how many different types of electrodes does
R2 make?
A. We make the multi-function pads, we make the ECG
electrodes for monitoring only, we make grounding pads for
electrosurgery, and we have made some specialized electrodes for
special procedures which are very small in volume and very
isolated. I could go into those.
Q. No. That's fine.
A. And then we make the cables to adapt all the
instruments to the electrodes.
Q. Now, you have been talking about defibrillation pads.
You are use the term pad and electrodes interchangeably?
A. For pads I usually say electrodes. For electrodes
usually are the smaller electrodes.
Q. But the pads are actually electrodes, generically
speaking?
A. Yes, that's right.
Q. Now, the structure -- is it correct that the structure
of the defibrillation -- or you called them multi-purpose?
A. Multi-function pads.
Q. Multi-function pads, that structure has remained the
same over the years, is that right?
A. Yes.
Q. And it's the same structure as the ECG pads or
electrodes?
A. As part of our ECG pads. As I said, there are two
structures for ECG products.
Q. Now, this second page of Exhibit 878, can you say
approximately when it was printed?
A. It has -- It looks like July 6, '81, is the date listed
on it.
Q. Do you believe that to be the date?
A. Yes.
Q. Were the first two pages of this exhibit publicly
distributed?
A. Yes.
Q. On or about the time they were produced?
A. Yes.
Q. What is the third page of the exhibit?
A. Third page is a list of all our products, a brief
description of each one in 1980. This was actually done as a
part of a whole cable chart listing all the different
instruments. This could have been generated before some of these
products were actually available.
Q. I believe down the page you will see there is a
"Copyright, 1979" and a date, "November, 1979." Was that --
A. That is probably an error because in some instances
where we transfer our artwork, we would end up with -- You know,
when we transfer just the bottom of the page onto another page,
we would not always correct this in a few instances at least.
Q. Do you know that to be an error or --
A. I don't know that to be an error, but I would suspect
that it is with this date up here being not the same.
Q. You did indicate though that the brochure could have
been prepared before the products were available?
A. Yes. Because we had to assemble our cable chart early
on.
Q. Well, is there -- do you have any way of ascertaining
what date that third page was prepared?
A. No.
Q. Other than the date in the upper right-hand corner, is
there anything else that would suggest to you that it was not
prepared in 1979?
A. That's not immediately evident.
Q. Is it possible it was prepared in 1979?
A. I don't know. I suppose it would be possible if these
dates are down here, but I don't know.
Q. Was this a publicly distributed document, this third
page?
A. Yes.
Q. What is the fourth page?
A. The fourth and fifth page are actually reproductions of
Exhibit 868.
Q. And were they publicly distributed?
A. Yes.
Q. Were they produced about the date -- Were they produced
in 1979 as suggested by the date down in the lower left-hand
corner?
A. I suspect they were printed in 1979, yes.
Q. Would you think that this third page was printed in
1979, or do you still have the same problem?
A. I don't know.
Q. Given that this is a -- this third page is a listing of
1980 products, can you say whether it was likely to have been
distributed in early 1980, or can you say about what time of year
in 1980 it was likely to have been distributed?
A. I really don't know. This had very limited
distribution and was used, I think primarily internally.
Q. This is a Plaintiff's production number though, 03985.
We obtained that from the Plaintiff. Can you explain how the
Plaintiff would have gotten one, ZMI Corporation?
A. It could have gone to Zoll. It was distributed to a
few select people, but not on a broad scale, no. Those may well
have been attached to one of the letters that I sent earlier.
Q. Do you have some idea of which letter it would have
been sent with?
A. No.
Q. Would it help possibly to look at the letters? Do you
think you could identify from that, just looking at the letters
to Zoll?
A. I don't know.
Q. Here is one, here is one.
(Documents tendered to witness.)
A. I do not know if it was attached to this letter, but I
would suspect that it might have been.
Q. May I see that exhibit?
A. I make some reference here -- This was an ECG related
impedance kind of demonstration.
Q. 878 was?
A. I make reference here to promotional literature that I
was working on to further complement this line. This might have
been the preliminary release of some of the data we were
generating.
Q. This one sheet though with the Production No. 3985 has
a date in the right-hand corner of 1980, and that letter was
November, 1981.
A. I think I am too confused to known which letter it was
attached to.
Q. Do you have any records that would say when this was
printed and distributed?
What I asked is whether you would have any records
that would indicate when that one sheet actually was printed?
A. I don't know. I suspect this was still attached to
this letter because I notice that the Evanston Fire Department
trace, the second sheet of this exhibit, since it is July of '81,
I think it's highly probable it was with this here. I don't
think -- Unless these were --
MR. LEE: I can't hear you.
MR. BIRDWELL: Speak up a little bit.
THE WITNESS: A. I can't tell which one it went with.
MR. BIRDWELL: Q. On this sheet marked 3985 in Exhibit
878, it refers under "ESU Anti-Shock Return Electrode" to the
elimination of hot spots. Do you see what I am pointing to?
A. Yes.
Q. Do you understand what that's referring to?
A. Yes. That's referring to the electrosurgical
application where hot spots can occur.
Q. Is that a current concentration like you were referring
to earlier with respect to hot spots?
A. Well, it is a different kind of current; ut, yes, it is
because of a high current concentration that a hot spot would
occur.
Q. A different kind in that it is a radio frequency
signal?
A. Exactly.
Q. Now, just before the break I had asked for some
brochures, and you indicated there were some in the file history,
and I see in this portion of the file history here what's been
marked Exhibit 884, "Declaration of Roger Lee Heath." Paragraph
5, in February of 1979, apparently you indicated some brochures
were printed and that a few of the brochures were distributed.
Is that affidavit -- That is a Declaration of
yours, is that correct?
A. That's correct.
Q. I am sorry?
A. That is correct.
Q. Are these brochures, 885, 886, and 887, are those the
brochures that you were referring to in Paragraph 5 of your
Declaration?
A. Yes.
Q. So some of those were distributed --
A. Yes.
Q. -- (continuing) in February of 1979, is that correct?
A. Yes.
Q. By February of 1979, --
This Declaration in its entirety, Exhibit 884, is
there anything incorrect about it?
A. Yes, it is complete.
Q. Is it correct?
A. Yes.
Q. By February, 1979, had you constructed electrodes of
the type shown in these brochures, Exhibits 885, 886, and 887?
A. Yes.
Q. The electrodes that you took to Johns Hopkins, which
type of electrode were they? This is referred to in Paragraph 4.
A. The brochures refer to all the same electrode.
Q. This is the multi-purpose electrode?
A. Yes. They are divided into separate markets really.
Q. Is that the type of electrode you were referring to
here in Paragraph 4 of your Declaration?
A. Yes.
Q. From the time that you constructed those electrodes
until you sold your first electrodes as stated here in Paragraph
4, were you -- what were you doing with regard to the electrodes
from the time you first took them to Johns Hopkins until the time
you sold some as indicated in your Declaration?
A. They were both modifications from additional research
in the gel, in the metal, type of metal being used, as well as in
the cables used to connect the electrodes.
Q. Were you continuously working on that until you
actually sold some?
A. Yes.
Q. Did the electrodes that were constructed in --
constructed by March, 1979, did they have the structure shown by
Exhibit 863?
MR. WALTERS: 836.
MR. BIRDWELL: I am sorry. 836.
THE WITNESS: A. No, they did not. There were
differences that specify stainless steel. We did not use
stainless steel in the R2 products.
MR. BIRDWELL: Q. Was the geometric structure shown
the same as in Exhibit 836?
A. Yes.
Q. So there was a different material used as the metal?
A. Yes.
Q. Were there any other differences from what's shown in
Exhibit 836?
A. No.
Q. What was the conductive medium?
A. Conductive medium may have been changed, but it was
still a conductive medium as shown in that exhibit.
Q. Was it a gel-type by nature of some sort?
A. Yes.
Q. With some sort of conductive material in it?
A. Yes.
Q. And had you constructed that type of electrode by
February, 1979, by the time these brochures were produced?
A. I don't understand.
Q. Had you constructed an electrode -- Had R2 Corporation
constructed an electrode of the type shown in Exhibit 836?
A. Yes. With the exception of some of those materials,
but geometrically it was the same.
Q. By February of 1979, is that right?
A. Yes.
Q. Had they been constructed in 1978, at anytime by the
end of 1978?
A. I don't recall.
Q. Well, at the time these brochures were prepared, had
they been constructed for several months or a year or a short
period of time? This Declaration indicates February of 1979 that
these brochures were prepared.
A. I don't recall.
Q. You terminated your relationship with Zenex in 1978.
How soon after you terminated your relationship with Zenex had
you constructed an electrode?
A. I don't recall.
Q. I've marked this document with Exhibit No. 880. Can
you identify the document?
A. Yes. This is a letter from me to Cardiac Resuscitator
Corp.
Q. In that exhibit it says, "I addressed this question at
least five years ago when I began to design this concept." What
are you referring to there?
A. I'm referring to probably the defibrillator pads at
Zenex in which some of these problems first began to be
addressed.
Q. What are the problems that were addressed?
A. Just the -- Whether it should be of a -- Whether it
should use snap connections, is that I refer to here. That's
early on. Do you have disposable leads? Do you have disposable
connectors? Those are all early, early questions.
MR. LEE: What is the control number?
MR. BIRDWELL: CO230.
Q. At the time you left Zenex, did you already
have a concept in mind for a product that you would make?
A. I had some initial concepts.
Q. Did those concepts include this type of a structure as
shown by Exhibit 836, with the possible exception of this
specific material for the --
A. Yes. Except for the specific material, the same
general geometric configuration.
Q. Was your concept -- Did your concept include this
multi-purpose electrode notion that you referred to before?
A. Yes, I believe so.
Q. And that is what ultimately resulted after some
development in the multi-purpose electrode that R2 marketed, is
that correct?
A. Yes.
Q. This Exhibit 573, this is an electrode manufactured by
R2 for CRC, the Defendant in this case, right?
A. Yes.
Q. In what general respects does this electrode differ
from the R2 electrode?
A. There are several differences. First, it uses more
adhesive area, it has a wire furnished by CRC, and the pads are
packaged in a single, one-pad fashion. R2 pads are two pads with
preattached wires and a single connector. So the primary
distinction is that it has a separate kind of wire and a little
more adhesive area.
Q. Are there differences in the materials used?
A. The materials are substantially identical to materials
used in R2 products.
Q. And except for the stainless -- for the material used
in place of the stainless steel element, is it structurally the
same as Exhibit 836, as this?
A. Yes.
Q. And what is the metal that's used? Is it a metal
that's used in place of a stainless steel element?
A. Yes.
Q. What is it?
A. It is a tinfoil.
Q. This shows an expiration date of August 15, 1982. What
was the shelf life of these electrodes?
A. I don't know how long we were actually dating those at
that time.
Q. Can you identify this document?
A. This is a series of documents forwarded by John Gunn,
an employee of R2 at the same, who communicated this to Cardiac
Resuscitator Corporation..
Q. There it indicates I believe on the third page,
December 6, 1984, "The product is then expiration dated for 11
months to assure product usability." See what I'm referring to
there?
A. Yes.
Q. Did that change over the period of time that R2
manufactured electrodes, or was that the time that you shot for?
A. It has changed. It has improved over a period of time.
Q. Do you recall what the minimum shelf life was?
A. I think the minimum was six months.
Q. To your knowledge, did CRC spec the shelf life?
A. I do not know.
Q. Did Paul Zoll ever mention or discuss Cardiac
Resuscitator Corporation with you?
A. No.
Q. Did he ever discuss the subject of hot spots with you?
A. No.
Q. Did you ever have any discussions with Ross Zoll?
A. Yes.
Q. Did he ever discuss Cardiac Resuscitator Corporation
with you
A. Yes.
Q. When was that?
A. It was at the -- It was at the AAMI meeting in San
Francisco; and before the exhibits became very busy, Ross Zoll
came over to talk to me and say hi.
Q. When was that meeting?
A. I'd have to collect the date back in San Francisco. I
don't know. I don't know when the date would be. It would be
sometime around -- I would say between probably '82 to '84 or
somewhere in that range.
Q. What does AAMI stand for?
A. The Association for Advancement of Medical
Instrumentation.
Q. Did you go to a Purdue conference in September, 1981
where Paul Zoll talked about external noninvasive pacing?
A. Yes, I was there.
Q. Was this AAMI conference before or after that?
A. It was after that.
Q. Would you relate the discussion that occurred between
you and Ross Zoll at that meeting?
A. Yes. I indicated that I would still like to work with
them. He indicated that they were experimenting with different
pad configurations. He asked me some questions regarding area of
the electrodes, and I think that's all.
Q. What did he ask you about the area of electrodes?
A. He was inquiring about what I felt was optimum
electrode size.
Q. Had you met ross Zoll before that time?
A. At the Purdue conference, yes.
Q. He was at the Purdue conference in 1981, or are you
talking about the earlier one in 1978?
A. I think the -- I don't recall accurately.
Q. The Purdue conference, was it the one about external
noninvasive pacing or was it the one earlier about defibrillation
electrodes?
A. I think it may have been the one about pacing, but I'm
not certain about that.
Q. Did you have any discussions with him at that time?
A. He and Paul introduced themselves to me, and we talked
at that conference.
Q. What was the discussion about?
A. Paul Zoll said "We've been looking for you for years"
to me and asked some questions, not very specific.
Q. Did he say why he had been looking for you for years?
A. No.
Q. Was this before or after you had corresponded with him?
A. This is after I had corresponded with him.
Q. Do you have any understanding what he meant by "looking
for you for years"?
A. My impression was that he had -- or I had -- or R2 had
developed the technology in electrodes that was necessary to make
these functions efficacious.
Q. So it wasn't that he didn't know where to find you if
he wanted to look for you, given that you had corresponded with
him?
A. That's correct.
Q. Something about what you were doing that interested him
in looking for you?
A. Yes.
Q. Later at the AAMI conference when you talked with Ross
Zoll, you indicated earlier that you had discussed CRC?
A. Yes.
Q. What was discussed about CRC?
A. I think it was very superficial, only that they were
doing something in external pacing, and we really did not talk
too much about it. I do believe that I did say to him that we
were furnishing the pads.
Q. Did he say anything about CRC with respect to any
patient application or patent?
A. No, he did not.
Q. Did he say anything about CRC's products?
A. No. I think we may have touch on the -- on what we
agreed was an unconventional methodology, the tongue-epigastric
configuration.
Q. Have you -- Since that AAMI conference, have you talked
with Ross Zoll?
A. No, I have not.
Q. Have you ever discussed this lawsuit with any
representatives of ZMI?
A. No, I have not.
Q. Have you spoken with any colleagues or associates of
Paul Zoll with respect to his work in the area of cardiac
stimulation at any time?
A. My last conversation directly with the company was -- I
believe his name is Rolf Stuts -- after the CBS Morning News
portrayed the use of the ZMI pacer.
I talked to a physician who was or is an associate
of Zoll in the past who actually visited R2.
Q. Who was that?
A. His name is Dr. Replogo, and he is a cardiac surgeon at
Michael Reese Hospital here in Chicago.
Q. Michael Reese?
A. Yes. Michael Reese Medical Center here in Chicago.
Q. How do speel "Replogo"?
A. R-e-p-l-o-g-o.
Q. When did yo talk with him?
A. I don't recall the exact time or date.
Q. Approximately how long ago was it?
A. It was a long time ago. It is pretty difficult for me
to recall.
Q. Was that before or after the Purdue conference where
Paul Zoll talked about external noninvasive pacing?
A. It was before.
Q. Was it before or after the previous Purdue conference
where Paul Zoll talked about defibrillation electrodes?
A. It was after that.
Q. What did you talk to him about?
A. Primarily pacing without trauma or pain.
Q. And what did he have to say?
A. His words were, "You mean you don't have to thump on
the chest anymore?" And I said, "Yes." And he said, "Well,
that's important." He asked a lot of questions about how the
electrodes could be configured, how the wave form could be
configured, how the position of the pads could enhance pain-free
pacing, and indicated that he would like to do some research with
us in that area.
MR. LEE: I would like that question and answer
read back.
(Requested portion read.)
(Discussion had off the record.)
MR. BIRDWELL: Q. Now, Dr. Replogo came to
see you, is that right?
A. That's correct. With a colleague.
Q. Who is the colleague?
A. Dr. Campbell.
Q. Where is Dr. Campbell located, do you know?
A. He is also at Michael Reese Hospital.
Q. Here is Chicago?
A. Yes.
Q. How did it come about that they came to see you?
Q. As I understand, R2 Corporation's counsel was at a
gathering in the evening with some friends, cocktail party, and
someone there, apparently Dr. Replogo or a friend of Dr. Replogo,
bumped into him and he was talking about R2 and the possibility
of doing this procedure; and together their interests apparently
connected of who those people were and resulted |