Transcript of Washington State Court Hearing On 10-30-2015

Hearing on Motions
October 30, 2015
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THE SUPERIOR COURT OF THE STATE OF WASHINGTON
IN AND FOR THE COUNTY OF KING
----------------------------------------------------------------CYNTHIA WILSON, Individually and as
Personal Representative of the Estate
of Reba Golden, Deceased, and on behalf
) No. 13-2-29535-1 SEA
of Statutory Beneficiaries VICTORIA
MARINCIN and PAUL D'OYLEY; and VICTORIA
MARINCIN and PAUL D'OYLEY; Individually,
et al,
)
Plaintiffs,
v.
)
)
Jens R. Chapman, M.D., et al.

Defendants.
)
)
----------------------------------------------------------------HEARING ON MOTIONS
October 30, 2015
The Honorable Dean Lum Presiding
----------------------------------------------------------------
Transcribed by:
Reed Jackson Watkins, LLC

Court-Certified Transcription
206.624.3005
Reed Jackson Watkins Court Certified Transcription
Electronically signed by Marjie Jackson (601-293-514-5743)
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A P P E A R A N C E S
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Counsel for Plaintiffs:
DANIEL L. HANNULA
HAROLD THADDEUS DODGE, JR
Rush Hannula Harkins & Kyler
4701 South 19th Street, Suite 300
Tacoma, Washington 98405-1177
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Counsel for Defendant Hansjorg Wyss:
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STEVEN J. BORANIAN
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Reed Smith
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101 Second Street, Suite 1800
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San Francisco, California 94105
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Counsel for Defendant Jens Chapman, M.D.
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JOHN A. ROSENDAHL
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Fain, Anderson, Van Derhoef, Rosendahl, O'Halloran, Spillane
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1301 "A" Street, Suite 900
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Tacoma, Washington
98402-4299
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Counsel for Defendants Huggins, Higgins, Bohner, and Walsh:
JASON LEVIN
Steptoe & Johnson, LLP
633 West Fifth Street, Suite 300
Los Angeles, California 90071
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Counsel for Defendants State of Washington, et al.:
MICHAEL MADDEN
WILLIAM J. LEEDOM
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Bennett, Bigelow & Leedom, P.S.
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1700 Seventh Avenue, Suite 1900
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Seattle, Washington 98101
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Counsel for Defendants Synthes, Inc., Norian
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Nash Corp.:
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CHRISTOPHER W. TOMPKINS
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Betts, Patterson & Mines, P.S.
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701 Pike Street, Suite 1400
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Seattle, Washington 98101-3927
Corp., and Kensey
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JAMES T. SMITH
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Blank Rome, LLP
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130 North 18th Street
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Philadelphia, Pennsylvania 19103-6998
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-o0o-
October 30, 2015
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THE COURT:
Thank you, please be seated.
Good afternoon,
Counsel.
MULTIPLE SPEAKERS:
THE COURT:
Good afternoon, Your Honor.
All right.
We're being recorded.
We don't
have a court reporter here, but we're on the recording
system.
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Let's go ahead and have counsel enter their appearances

starting with plaintiff's counsel.
MR. HANNULA:
Your Honor, my name is Dan Hannula, one of
the attorneys for the plaintiff.

MR. DODGE:
Harold Dodge, Your Honor, one of the attorneys
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for the plaintiff.
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MR. ROSENDAHL:
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Excuse me, Your Honor.
John Rosendahl for
Dr. Chapman.
MR. BORANIAN:
Stephen
Boranian for Defendant Hansjorg Wyss.

MR. SMITH:
Jim Smith for
Synthes and Norian.
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THE COURT:
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MR. MADDEN:
Okay.
And, Your Honor, Mike Madden for the
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University of Washington, Harborview Medical Center, Doctors
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Daines and Morsette.
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THE COURT:
Thank you.
MR. LEVIN:
Jason Levin of
Steptoe & Johnson for Defendants Huggins, Higgins, Bohner
and Walsh.
MR. LEEDOM:
Bill with Leedom Mike Madden and UW.
MR. TOMPKINS:
Chris Tompkins representing Synthes, Norian
and Mr. Wyss.
THE COURT:
And then do we also have other interested parties,
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Counsel, good afternoon.
Counsel?
MR. HANNULA:
Yes, Your Honor.
Reba Golden.
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MS. WILSON:
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MR. D'OYLEY:
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MS. MARINCIN:
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THE COURT:
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These are the children of
Hi, Your Honor, I'm Cindy Wilson.

Hi, Your Honor, I'm Paul D'Oyley.
I'm Victoria Marincin.
And otherwise we just have observers.
And
members of the public are completely welcome.

So we -- let's see.
We have several motions on and let's
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see if we can figure out a logical way for us to divide up
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our time.
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to dismiss Criminal Profiteering Act Claim, Count No. 9, I
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believe, and Leading Organized Crime Claim, Count No. 10.
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There have been several joinders -- there had been a joinder
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of that particular motion and obviously opposition and
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reply.
We have the motion for partial summary judgment
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We also have -- is it pronounced Weiss, Wiess (phonetic)?
MR. BORANIAN:
THE COURT:
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It's Mr. Wyss, Your Honor.
Wyss; I'm sorry.
Mr. Wyss's motion for
summary judgment on Count No. 10.

And there's essentially a joinder on -- a request -- a
separate motion to dismiss the outrage cause of action
mentioned in Count No. 11.
particular motion.
the outrage claim on summary judgment, there's been a reply,
There have been joinders in that
The plaintiff has filed an opposition to
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and again, there have been joinders by University of
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Washington and Harborview, Chapman, State of Washington.
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And then there's a third substantive motion is Defendants'
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motion for summary judgment to dismiss the punitive damages
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portion of the claim that would relate to paragraph, I
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believe -- or Count No. 14.
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opposition as well as a reply filed.
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There was a plaintiffs'
We also have several procedural motions.
There's a motion
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to strike portions of Mr. Hannula's declaration.
And then
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there's also a motion to strike several of the plaintiffs'
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doctors' declarations as well.
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Counsel, the -- in terms of the doctors' motion to strike,
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you may -- honestly, given the volume of material here, that
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was the one part there I felt I had to go line by line and I
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just did not complete with going through that.
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should proceed with oral argument with the assumption that
But you
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the Court may disregard certain portions of that particular
declaration -- those particular declarations.
should proceed, I guess, arguing in the alternative.
Similarly, on the motion to strike Mr. Hannula's
But you
declaration, I don't find that there's a basis to strike,
for example, the actual documents that were attached to it.
There's been an argument that Mr. Hannula was describing the
significance of these documents.
as a fact expert or a fact witness, he's just describing
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He's not really proffered
what documents were disclosed in discovery.

And there's been an argument that this was a circumvention
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of the briefing limits, but I'm able to separate out what
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was descriptive as opposed to substantive evidence.
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think Mr. Hannula was attempting to be a fact witness or
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anything else like that.
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disregarding what was stated -- what was essentially
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argument in the declaration.
I don't
I think I'm capable of
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But let's not do that again, okay, Mr. Hannula?
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All right.
Counsel, let's -- we have three major motions.
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Have folks figured out -- have you discussed what order you
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want to handle this in?
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Mr. Madden?
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MR. MADDEN:
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We have, Your Honor.
I think we are in
agreement; of course, what we agree on doesn't matter.

THE COURT:
Makes a difference to me.
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MR. MADDEN:
The RICO motion is the most probably
important and should be taken first.
agreed that we would take the outrage motion and the
punitive damages last.
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And then I think we've
Our further discussion was, however much time we had, that

it be divided half and half:
Plaintiff and Defendants.
THE COURT:
Sure.
MR. MADDEN:
time on that.
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THE COURT:
All right.
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THE CLERK:
No.
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THE COURT:
So you have about -- a little bit over two
And we're responsible for monitoring our own
So do we have a 4:00?
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hours.
But we should probably take a little time for people
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to go to the restroom in kind of the middle of it.
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have about -- well, you could probably -- you could probably
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spend your 20 minutes a side plus, you know, brief joinders
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from folks who joined.
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they've joined.
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the folks sitting at the table.
So we
I'm certainly letting folks talk if
But, you know, the prime argument is for
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But let's go ahead and -- let's go ahead and start with
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the first motion, and then we'll see where we get and see
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how much time we have left on the others.
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So your motion.
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MR. HANNULA:
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THE COURT:
Your Honor.
Is that fine?
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MR. HANNULA:
And what everybody has stated here is fine
with one exception, Your Honor.
RICO motion, we may go more than 20 minutes, but we will not
go 20 minutes on the other two.
THE COURT:
MR. MADDEN:
That's fine.
I would ask that on the
That's fine.
Thank you, Your Honor.
May it please the
Court, again I'm Mike Madden.
Washington and affiliated defendants.
for summary judgment on the plaintiffs' criminal
10
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I represent the University of

This is our motion
profiteering claim.
The key issue as we see it in this case is -- in this
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motion is:
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disclose the risks of surgery that converts run of the mill,
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lack of informed consent claim under RCW Chapter 7.70 into a
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crime?
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Is there some level of alleged failure to
And in this regard what I understand the plaintiffs to say
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is that the risks associated with Norian cement were so
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severe that Dr. Chapman's alleged -- alleged, I emphasize --
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failure to disclose them converts their lack of informed
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consent claim into an assault claim.
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The case law in Washington very clearly precludes this
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effort by the plaintiffs.
In fact, there's no case in the
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country that we've been able to find that permits such a
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claim to go forward.
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briefly walk through the relevant statutes, because this is
And what I'd like to do is just to
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a statutory claim, and then turn to a discussion of the
cases and then the facts.
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THE COURT:
Okay.
So I have some questions for you, but
I'll hold off for about ten minutes and let you go ahead -MR. MADDEN:
Your Honor, as you know, the best thing that
can happen to a lawyer in front of the Court here is to get
questions from the Court and answer them.
important thing I can do here today because I know you've
read the materials.
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THE COURT:
That's the most
Yeah, and there were a lot of materials.
But
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I guarantee you, as you folks know, I -- it's amazing to me
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that some lawyers think we don't read all this stuff.
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maybe in the old days, judges didn't read it, but I --
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Mr. Leedom knows I read every single thing you put in front
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of me.
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And
So I spent a lot of time on this case.
But, Counsel, why don't you just go ten minutes and then
I'll hop in and ask you some questions.
MR. MADDEN:
All right.
So we'll see where we are in ten
minutes.
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THE COURT:
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MR. MADDEN:
All right.
Okay.
Well, this is the statute.
And, of course,
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it speaks of an act of criminal profiteering that is part of
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a pattern of criminal profiteering activity.
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terms are defined in the statute.
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under the plaintiffs' theory of the case, the acts of
The key thing here is
And those
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criminal profiteering are assault and second-degree felony
murder.
you know this better than I, but these are the statutory
definitions, and we come to the key one:
assault.
And I'm not going to tarry very long here because
Second-degree
What's important to emphasize here, though, is that this
case isn't just a case about whether Plaintiffs can make out
a civil battery claim.
Dr. Chapman and colleagues, can be deemed to have committed
10
these crimes:
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murder.
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It's about whether the defendants,
Second-degree assault, second-degree felony
Secondarily -- I'm going to come back to this -- the
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plaintiffs have to prove that these alleged acts were part
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of a pattern.
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this.
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And as I said, I am going to come back to
Let's talk about second-degree assault.
Battery is a
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completed assault.
And under the criminal case law,
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second-degree assault by battery requires an intentional
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touching that recklessly inflicts substantial bodily harm.
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Those are the elements of the crime.
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plaintiffs -- or they agree with us -- is that consent
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negates assault.
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assault.
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plaintiffs would have to prove what's called medical battery
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as a predicate to their criminal charge, to their criminal
What we on with the
Where there is consent, there is no
And in the civil context they have to -- the
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theory.
rule across the country, a medical battery occurs only where
there is -- and this is a quote from Bundrick -- a total
lack of consent to the procedure performed.
there's no case in the country that's been cited or that
we've been able to find that permits a medical battery claim
based on the alleged failure to disclose the risk of a drug
or device.
And under the case law, under our case law and the
And as I said,
Bundrick, sort of the key case from our Court of Appeals
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2005, this is a case where the plaintiff claimed that she
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didn't consent to a resident performing a part of the
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procedure.
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that the plaintiff had not expressed that condition.
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becomes a conditional consent case, something else I'm going
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to talk about a little bit in a few minutes.
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The Court actually rejected that claim saying

That
Bundrick relies on an earlier case, Miller v. Kennedy.
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Miller was one of the pre-statutory cases that was trying to
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draw the line between medical battery and informed consent.
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And the reason that was important and the reason this is
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sort of important here, usually you see plaintiffs trying to
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plead medical battery for two reasons:
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around the requirement of expert testimony.
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particularly in California, is to get around limits on
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damages and avail themselves in California of punitive
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damages that are available under California law.
One, is to get
Second,
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Now, we have a similar thing going on here.
The
plaintiffs want to avail themselves of the availability of
double damages and fees and costs under the criminal
profiteering statute.
think there's any doubt about that.
Now, what constitutes consent?
So that's the motivation.
I don't
This case that we cited --
I think we -- I hope we provided you a copy from the New
Mexico Supreme Court builds on the case actually that Miller
cited which is Cobbs v. Grant from the California Supreme
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Court.
It's, again, a seminal decision that's written by
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Justice Mosk.
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pre-statutory era the differentiation between medical
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negligence, lack of informed consent, and battery.
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Cobbs clearly says, again, total lack of consent, that's a
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battery; anything else, that's medical negligence or
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informed consent.
And it, again, is trying to describe in a
And
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So we come down to this Gerety case from the New Mexico
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Supreme Court, which again, is based on Cobbs and this is
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what they said:
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which must be disclosed is quite narrow.
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has to inform the patron of the nature of the procedure;
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that is, what the doctor proposes to do.
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To defeat a battery claim, the information

The physician only
Now, I said I'd turn to the facts and I'm a few minutes
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in.
Here's what the record shows.
This is Ms. Wilson's
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deposition testimony and she says -- she acknowledges that
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her mother consented to a surgery by Dr. Chapman on her
spine intended to respond to the issues related to the fall
that she had in Honduras.
preoperative visit.
THE COURT:
Right.
The record also shows this
And none of this is disputed.

So the argument is that it's a
different -- there's -- she consented to X, but you did Y,
right; isn't that the argument?
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MR. MADDEN:
Well, if that's the argument, it doesn't fit
the facts.
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THE COURT:
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MR. MADDEN:
All right.
I consented to X and you did X.
You didn't
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tell me, according to the plaintiff, that you were going to
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use this particular device during the surgery that has these
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alleged risks associated with it.
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That is not enough to take you out of the civil arena and
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into the criminal arena.
It isn't even enough to take you
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from informed consent to medical battery because the rule
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is:
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see -- here's the description of the surgery.
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plaintiffs don't disagree that this was the surgery that was
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contemplated.
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discussion about a form of cement.
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Ms. Wilson says, Well, I don't remember Norian being
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mentioned, and if it was, I surely would have.
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remember this other cement.
Did you consent to the surgery?
And here, we can
They also acknowledged that there was

They say well --
The
But I do
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Here's the consent form signed by Ms. Golden on the day of
surgery; describes the operation that's to be done:
posterior spinal fusion, L1 corpectomy, T9, T10, L2, L4
vertebroplasty.
Bleeding, infection, neurovascular damage, need for further
procedures, and signed by the decedent.
A T9 L2
Received the following information:
When you get to the plaintiffs' claim, it is clearly for
lack of informed consent.
relayed as far as using this particular drug and if he had
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told her and I the details behind it, it would never have
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been consented to.
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She said, Had there been anything
Well, that is a statutory informed consent claim.
Pure
and simple.
The next thing I would point out this is not, as the
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plaintiffs would have it, a conditional consent case.
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the Conditional Consent Doctrine, Bundrick is an example,
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the plaintiff has the right -- a patient has a right, I
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should say, to condition their consent:
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use a certain drug; that's the Duncan case from Arizona.
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But the conditions have to be communicated and the physician
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has to willfully disregard the conditions.
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here.
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no evidence of any willful disregard.
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Under
No resident, don't
No such evidence
No evidence of any conditions placed on the consent,
Now, the plaintiffs want to make an argument under the

Restatement -- several arguments under the Restatement.
But
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the first under Restatement (Second) 892(b), that the
consent is ineffective.
says:
concerning the extent of the harm to be expected and the
mistake is known to the other or induced by the other's
misrepresentation.
Ms. Golden knew that the surgery could result in death.
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9
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But here's what the Restatement
First, there has to be a substantial mistake
Neither of those elements is present.
In block here, this is from her diary, and this is her

handwriting:
What are the possible problems I could
encounter from this type of surgery?
Death, et cetera.
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This is from the consent that I showed you before.
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are the following additional detailed information she
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received?
14
What
Bleeding, neurovascular damage.
She also knew -- this isn't -- this isn't necessary, but
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it adds to the strength of our case.
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risk of cement embolizing into the blood stream.
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Court will understand by now that the plaintiffs' theory of
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the case is that Norian cement as opposed to PMMA the
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logical -- which is the logical culprit here, if there is
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one.
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caused blood clots.
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Ms. Golden knew about that and was advised of that risk
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prior to surgery, accepted it.
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She knew about the

And the
But that Norian cement got into the blood stream,

Okay.
Well, according to Ms. Wilson,
This is -- let's look at the statute, the informed consent

statute, because I think when you have those facts in mind,
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you'll see that the plaintiffs' claim fits perfectly, right.
These are the elements of a statutory informed consent
claim:
patient of a material fact.
being aware or fully informed of such material fact.
statute, which is intended by the legislature to be the
exclusive remedy for personal injury damages related to
health care in Washington, it fits perfectly on our facts.
The health care provider failed to inform the
THE COURT:
The patient consented without

That
So what -- what do you make of -- I mean,
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there's an allegation that what we -- the injuries caused
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here kind of were at the juncture of the entrepreneurial
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versus -- entrepreneurial practice -- the entrepreneurial
13
aspect of the practice of medicine versus the practice of
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medicine.
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purely, you know, the practice of medicine, diagnosis, that
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kind of thing are involved.
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lawsuit is we're at the juncture or alleged juncture of the
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practice of medicine and the entrepreneurial aspect of the
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practice of medicine.
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the legislative intent on that part of the -- that juncture?
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And so there are obviously pure cases in which
MR. MADDEN:
The flavor of this particular
What do you have to say about that,
Well, that would be a relevant consideration
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if the plaintiffs were pleading a claim under the Consumer
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Protection Act.
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And I apologize, I have a terrible time with case names,
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but I believe it's the Jeckle v. Wright case that's cited in
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our materials.
Because Jeckle says, you know, as part of
informed consent, a physician doesn't have to inform the
patient about financial motivation that they may have.
they may be liable under the Consumer Protection Act for the
entrepreneurial aspects.
But
But that's not relevant when we're trying to figure out
the line between, you know, medical battery/criminal assault
and lack of informed consent.
plaintiffs' theory -- which I think they can't really
And the reason is this:
The
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articulate a stopping point for it -- it essentially ends up
11
consuming all of informed consent.
12
is, well, you know, this is a really dangerous product.
13
Okay.
14
the manufacturer of the product, although unlike the Jeckle
15
case where the doctor is benefitting, you know, item for
16
item by promoting the particular drug, there's no such
17
evidence here.
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less based on how much Norian he used.
We dispute that.
Because what they say
The doctor had a relationship with
I mean, Dr. Chapman didn't get paid more or
19
And so what you end up, Your Honor, if you come back to
20
your point is what our courts have repeatedly rejected is
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the physician doesn't have to say to the patient and oh, by
22
the way, you know, I'm recommending the surgery, I think you
23
need this surgery, and you should know that I stand to make
24
$2,000 from doing your surgery.
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material risk of treatment nor is it relevant to the
Why?
Because it's not a
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baseline issue for medical battery which is:
have the patient's consent to this particular touching?
THE COURT:
Do I -- do I
I guess my question was really designed to --
designed to kind of test the limits of your exclusivity
argument.
of action, medical malpractice cause of action, those
were -- that's a legislative intent, you say, to give
plaintiffs causes of action for these kinds of injuries.
You're saying, well, the informed consent cause
MR. MADDEN:
10
THE COURT:
Correct.
And so the exclusivity portion of your
11
argument.
12
allegations -- disputed allegations, but where you're
13
dealing with allegations of entrepreneurial conflict of
14
interest, entrepreneurial -- the business of medicine, and
15
so you have issues where, you know, arguably Consumer
16
Protection Act might be triggered.
17
trigger or could it go over at a certain point to a little
18
RICO, big RICO, lead to organized crime?
19
But when you're dealing with, again,
MR. MADDEN:
No.
So is that the only
Because if we go back to the very first
20
case in Washington, the Miller v. Kennedy case, it said,
21
look, the line is now clear between medical battery and lack
22
of informed consent.
23
surgery, then it falls on the negligent side of the line and
24
it's not an intentional tort.
25
THE COURT:
Right.
If there's any form of consent to that
So that's your touchstone right there,
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2
which is presumably is where you started with that point.

MR. MADDEN:
Absolutely.
I mean, I -- you know, I don't
think I could do anything except cite the Washington cases
that have been settled now for many years.
THE COURT:
MR. MADDEN:
THE COURT:
MR. MADDEN:
THE COURT:
10
Right.
So can I ask you questions?
I've now been going a long time.

So let's talk about your five year -Yep.
-- five year -- you have presumably a slide.
It might be easiest to talk about that.
11
MR. MADDEN:
12
THE COURT:
Let me go down here to the very end.

So I read the statute about -- literally, a
13
dozen times, and is it ambiguous?
14
and it says, A pattern of criminal profiteering activity
15
means engaging in at least three act of criminal
16
profiteering the last of which occurred within five years.
17
And presumably -- and after the commission of the earliest
18
act of criminal profiteering.
19
MR. MADDEN:
20
THE COURT:
Or -- I mean, I read it
Right.
So if I understand it, your argument is that
21
the earliest act of criminal profiteering is the earliest
22
anybody knows of?
23
MR. MADDEN:
24
THE COURT:
25
MR. MADDEN:
This is not -Doesn't it have to be the plaintiff?

I don't mean to interrupt, Your Honor, but
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this is not my argument, this is the plaintiffs' argument.
THE COURT:
MR. MADDEN:
Right.
So the plaintiffs' argument, and they've
articulated it in their briefing, is that 2002 when
Dr. Chapman is first documented using Norian and the last is
in July 2009, and they have to use July 2009 because they
have another client whose surgery occurred in July 2009.
THE COURT:
MR. MADDEN:
10
11
Right.
So this is not my theory of the facts.
This
is the plaintiffs' theory of the facts.

THE COURT:
Well, is that -- he doesn't have to choose the
12
2003 act, does he?
13
2008, so long as there's three of them, right?
14
that -- isn't that another construction of the statute?
15
MR. MADDEN:
He can choose the one that occurred in

Isn't
Well, here's his problem, it again is
16
confined by the pleadings -- and I shouldn't say he, but
17
their problem.
18
federal charges that they attached to their complaint and
19
incorporated.
20
market Norian XR off-label began in 2002 and ended in the
21
fall of 2004.
22
say, oh, wait, we incorporated that, we pled that 2002, but
23
now we want to pick another year that fits five years back
24
from July 2009.
25
Is their claim is predicated entirely on the
And those federal charges say that scheme to
So they're stuck with that.
They can't just
And, you know, I know the plaintiffs say, look, this leads
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to an absurd result, but as the ADA commentator pointed out,
this language here essentially serves as a secondary statute
of limitations, and I think the legislature could rationally
have believed that beyond five years the connections become
too remote and the potential for abuse is too high.
THE COURT:
Well, if I construe it your way, somebody who
only engages in three acts of criminal profiteering could
be -- they'd have -- the plaintiffs would have a cause of
action.
10
But somebody who engaged in criminal profiteering
for the last 30 years couldn't bring a cause of action --
11
MR. MADDEN:
12
THE COURT:
13
That -- but that --- and there would be hundreds of plaintiffs
and --
14
MR. MADDEN:
That is the natural implication of this --
15
THE COURT:
16
intended that?
17
MR. MADDEN:
Would the legislature really would have
Well, I can only say this:
Okay, RICO
18
statutes in the civil context are notoriously subject to
19
abuse.
20
federal law in this regard, I think could rationally have
21
thought, you know, it would be obviously easy to say, wait a
22
minute, remember, we had a RICO -- an enterprise in Pierce
23
County years ago with the sheriff and prosecutor and now
24
something's happened to me, and it's 25 -- it's 30 years
25
later, but this guy got some of the same people involved,
And the legislature, because they deviated from the
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2
let me tag that together.

THE COURT:
But that couldn't happen because -- because
there would have to be at least one within the last five
years, right?
MR. MADDEN:
THE COURT:
MR. MADDEN:
THE COURT:
MR. MADDEN:
10
There would be to be -Or three --- well, the language is --- three within the last five years, right?
Is it has to be three, the earliest no more
than five years from the last.
11
THE COURT:
12
MR. MADDEN:
Right.
So if you could pick the last one and say,
13
well, this is when the enterprise started and now I'm within
14
five years with the last act and just randomly pick the
15
starting point, I don't think that makes any sense -- and it
16
also defies truth.
17
THE COURT:
Well, I mean, it may be a secondary statute of
18
limitations, but the statute of limitations could be
19
triggered from now looking back five years as opposed to
20
your typical statute of limitations which is triggered at
21
the beginning, right?
22
MR. MADDEN:
23
is looking back.
24
THE COURT:
25
MR. MADDEN:
Well, correct.
This is a look back -- this
Right.
Could I just -- I want to -- I know I burned
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up some time.
THE COURT:
MR. MADDEN:
Sure.
But I want to go right back to just the
pattern issue because I think this is actually --
THE COURT:
MR. MADDEN:
Sure, sure.
Go ahead.
-- actually turns out to be very easy.
So we
have the federal charge that the plaintiffs are relying on
that describes this scheme to illegally market Norian XR for
vertebral compression fractures between 2002 and the fall of
10
2004.
The FDA began investigating in May 2004.
Norian XR
11
was pulled off the market in late 2004.
12
out a "dear surgeon" letter that says, you know, please
13
understand that the other forms of Norian, SRS and CRS, are
14
not intended for use in the spine, and then we have the
15
Golden surgery in August of 2007.
2007, Synthes sends
16
And, you know, the issue I think here is that there's no
17
rational motive for anyone, Synthes, Dr. Chapman or anyone
18
to at the time the feds are continuing to investigate,
19
there's a grand jury going on, to be involved and continuing
20
to market this device for an off-label use where the device
21
is no longer even being supplied.
22
that --
23
THE COURT:
24
MR. MADDEN:
25
And so I think that
Do you get that inference on summary judgment?

Well, it's not an inference.
It's an absence
of -- in order for the plaintiffs -- so this is what the
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Matsushita case describes is in order for the plaintiffs to
be entitled to the inference, the opposing party, it's got
to be rational, it's got to be plausible.
the case law says.
at risk with our Supreme Court.
THE COURT:
Now, that's what
I know that you may feel that okay, I'm
Well, I don't know about that.
I just -- I
just -- it's -- as the incoming chief criminal judge of this
jurisdiction, I see lots of people who don't do things that
you would think they would do.
But, you know, that kind
10
of -- but can you talk about -- I'll give you a little bit
11
more time.
12
MR. MADDEN:
13
THE COURT:
14
15
Yep.
Let's see, there's the argument, let's see, on
the -- I believe it's on this motion about taking the Fifth.

MR. MADDEN:
All I can say is my clients didn't take the
16
Fifth, and our case law says that the adverse inference is
17
available only against the invoking party.
18
THE COURT:
Okay.
It is a co-defendant, but the
19
co-defendant invoked the Fifth, an individual -- you're
20
representing the hospital -- the medical --
21
MR. MADDEN:
Yeah.
And to be clear, no one affiliated
22
with the University of Washington or Dr. Chapman took the
23
Fifth.
24
25
Mr. Levin's clients took the Fifth.
THE COURT:
Okay.
Do you want to save some time for
rebuttal?
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MR. MADDEN:
I would like to save some time.
I think my
colleagues are looking at me like I burned up more than I
should have.
THE COURT:
MR. HANNULA:
MR. TOMPKINS:
MR. HANNULA:
MR. TOMPKINS:
THE COURT:
10
11
12
Okay.
Counsel.
Your Honor -Just a couple points.

Oh, sorry.
I didn't realize you were (inaudible).
And just when everybody speaks, just identify
yourself for the first time on the record, so...

MR. TOMPKINS:
Yes, Your Honor, Chris Tompkins for Synthes
and Norian.
13
THE COURT:
Synthes, yeah.
14
MR. TOMPKINS:
And I want to just address two points that
15
we raised in our reply on this motion.
The first goes to
16
what you just asked about, the adverse inference and the
17
assertion of the Fifth Amendment.
18
employees of my client who did make that assertion.
19
we've cited both in Washington state including the Ikeda
20
case that the plaintiffs rely on, a federal court case
21
applying Washington law and other cases from around the
22
country, an adverse inference standing alone without
23
corroborating evidence to support it is not adequate to
24
create an issue of material fact to prevent summary
25
judgment.
And it was former
But as
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THE COURT:
So what's -- what is corroboration?
Is it
enough that you have some documents which allegedly
corroborate it?
MR. TOMPKINS:
Well, let me talk about that, Your Honor,
because that was the other point I wanted to make.
The
documents before you, Mr. Madden pointed out that the
federal indictment says that the improper marketing at
Synthes went on from 2002 to 2004.
the documents before it -- we raised this issue in our reply
If the Court looks at
10
as well -- they are from prior to up through 2004.
There is
11
no document which suggests that there was any ongoing
12
conspiracy or illegal marketing or other improper activity
13
leading to Dr. Chapman's surgery on Ms. Golden in 2007.
14
In fact, the only documents before the Court from 2007 are
15
the Synthes letter to all surgeons saying Norian CRS and SRS
16
are not intended for use in the spine.
17
use in the spine is intrinsic to the structure -- or the
18
stability, rather, of the spine and they can't be used.
19
There's also a cal- -- two other documents from 2007
The FDA says that
20
before you are the report to the FDA of Ms. Golden's death
21
and a calendar of the sales representative for Synthes.
22
there's a gap, Your Honor, between -- oh, and by the way the
23
alleged conspiracy in the federal indictment and the
24
arguments that the plaintiffs have raised were related to a
25
product named Norian XR which was originally developed for
But
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use in the spine.
Norian XR was removed from the market in
2004.
anything after 2004 and Ms. Golden's surgery in 2007.
And so to come back to your question about what's
So there's no connection or tie, Your Honor, between
corroborating evidence.
There would have to be enough
evidence, Your Honor, to create an issue of fact that there
was ongoing conspiratorial activity between my clients,
Mr. Boranian's clients and Mr. Lavine's clients and the UW
defendants to tie that to the Reba Golden surgery in order
10
to allow the Fifth Amendment invocation to create an issue
11
of fact and defeat summary judgment, and there simply is
12
not.
13
THE COURT:
14
And, Counsel?
15
MR. MADDEN:
16
THE COURT:
All right.
Thank you.
17
All right.
Let's see.
Mr. Hannula.
18
Thank you very much.
Not yet, Your Honor.
Thank you.
And this is the one
you want to take some additional time on?
19
MR. HANNULA:
20
THE COURT:
21
MR. HANNULA:
Okay.
Yes, I do, Your Honor.

Which is fine.
I'm a little bit concerned that this was
22
brought by the University of Washington, and now we've had
23
Synthes address the Court, too.
24
some additional time if others are going to address motions
25
that I didn't anticipate, Your Honor.
And so I just want to have
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Your Honor, I'm going it -- in terms of the argument that
I was going to make, I'm going to go a little bit out of
order here.
or not Reba Golden gave consent to this procedure.
Your Honor, I think that that is really the crux of this
motion.
raised a material fact, I think the evidence is clear that a
criminal enterprise continued at least through the surgery
of Joan Bryant on July 6th of 2009, and clearly was ongoing
And I will address first this issue of whether

And,
I think the evidence clearly, in terms of have we
10
as of August 17th, 2007, when Reba Golden died on the
11
operating table.
12
moment.
And I will address that further in a
13
First of all, Your Honor, the law in the state of
14
Washington is clear that there is a separate claim for
15
medical battery if the plaintiff does not give consent to
16
the surgery actually performed by the physician who is
17
performing the procedure.
18
In this case, Your Honor, Cynthia Wilson has testified --
19
and let's talk about this.
The third issue is whether the
20
plaintiffs have demonstrated genuine issue of material fact
21
that Reba Golden and the other victims in the predicate acts
22
suffered medical battery amounting to assault in the second
23
degree.
24
First of all, the declaration of Cynthia Wilson states
25
that her mother never gave consent to any surgery involving
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the use of Norian cement in her spine.
The declarations of
plaintiffs' medical experts, Dr. Faller and Dr. Kowalski
state in no uncertain terms that there was no consent by any
of the victims of the predicate acts under our RICO claim to
any surgery by Dr. Chapman wherein he used Norian cement in
their spines.
Your Honor, as I've stated, Washington is one of a number
of jurisdictions that recognizes that a surgeon who performs
surgery on a patient without the patient's consent can be
10
found liable for medical battery and criminal assault in
11
Washington.
12
surgery is usually a question of fact for the jury.
And whether or not a patient consented to a
13
Now they've cited the Bundrick v. Stewart case, Your
14
Honor, and I know that the Court is familiar with those
15
facts.
16
position that she did not give permission for a particular
17
doctor to assist in her surgery.
18
Appeals held that the trial court's summary judgment
19
dismissal of plaintiff's assault claim against Dr. Jain was
20
error in the face of plaintiff's evidence that she gave no
21
consent for Dr. Jain to treat her.
22
to the procedure, and that's what Mr. Madden is hanging his
23
hat on -- he's clinging to it in this case, Your Honor.
24
in that case she clearly agreed to the procedure that she
25
underwent.
But Your Honor, in that case, it was the plaintiff's
In that case, the Court of
She clearly gave consent
She didn't agree to the procedure performed by
But
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2
this particular physician.

Your Honor, the consent form signed by Reba Golden makes
absolutely no mention of Norian cement being used in this
procedure.
But if you looked at what she agreed to, it doesn't say
anything about Norian cement.
cement.
particularly Norian cement.
Counsel showed you that document, Your Honor.
There's no mention of Norian
In fact, there's no mention of any cement, but
Now, the consent form that she signed is a consent form
10
that any of us would sign if we went to get our broken
11
finger operated on or if we went to have a doctor with a
12
scope look at our knee or our shoulder to see if anything
13
was wrong.
14
if you had agreed voluntarily to an experiment in an
15
institution in which the doctor who was performing the
16
procedure would have to answer to an internal review board
17
made up of physicians, lawyers, medical ethicists, and
18
others at the institution to make sure that patients who
19
undergo human experimentation are protected.
20
did not happen in this case.
21
This is not a consent form that you would sign
That clearly
Cynthia Wilson was present at every doctor's visit where
22
this surgery was discussed, has testified that there was
23
never a discussion of the use of Norian bone cement, and her
24
mother gave no consent whatsoever to the implementation of
25
Synthes Norian cement into her spine.
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Further, as I've stated, the declarations of Dr. Kowalski
and Dr. Faller both state unequivocally that neither
Ms. Golden or the other victims of the criminal profiteering
activity gave any consent at all to the surgeries in which
Dr. Chapman injected Norian cement in their spines.
testified further that once Dr. Chapman made the decision to
use Norian cement under circumstances where he knew this was
a non-FDA approved use, where he knew the FDA had determined
that it was contraindicated for spinal use -- that letter
They
10
that Mr. Madden references in January of 2007 stated
11
unequivocally:
12
SRS or CRS or XR for that matter, was not to be used in the
13
spine.
The FDA has determined that Norian cement,
14
That's a very important distinction, Your Honor, because
15
not only -- you know, doctors can do some things off-label
16
when it's their understanding that there's no prohibition
17
against that.
18
contraindicated for use in the spine which he used in the
19
Reba Golden case.
20
But here this doctor knew that he was
They further testified -- that is Dr. Kowalski and
21
Dr. Faller -- that once Dr. Chapman made the decision to use
22
Norian cement under those circumstances, again, where it was
23
non-approved by the FDA and in fact, contraindicated by the
24
FDA, and under the circumstances where Dr. Chapman, who had
25
done research on pigs with this product, knew how dangerous
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it was, under those circumstances, Dr. Chapman was no longer
acting in the patient's best interests; and therefore, any
consent that she gave was vitiated by that because there is
no longer a physician/patient relationship.
I will get to this more in the tort of outrage argument,
Your Honor, but clearly the Hippocratic Oath in and of
itself says that the doctor is to do no harm.
8
9
And in the tort of outrage, I'll talk a lot more about how
inviolate this country and other civilized countries
10
consider the protections that patients are entitled to when
11
they are being experimented on.
12
Your Honor, in the United States of America and, in fact,
13
the rest of what I would call civilized society, doctors
14
cannot experiment on human beings without their knowledge
15
and consent and without all of the safeguards required by
16
the Food and Drug Administration.
17
including the University of Washington, that engages in
18
human experimentation can only do so under the auspices of
19
the rules and regulations of the FDA.
20
institutions are required to be supervised and controlled by
21
an investigatory review board, which I've already discussed,
22
that's made up of not only doctors but ethicists, lawyers
23
and others who are there to protect the patients and to make
24
sure that the doctor is not engaging in an experiment beyond
25
what has been approved and consented to.
And any institution,
And doctors at those
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Patients, Your Honor, who understand and consent to be a
part of a human experiment know what they're getting into.
Reba Golden and these other patients, including Joan
Bryant -- who I also represent her family -- were never
given that opportunity and never protected as the law
requires.
Again, Bundrick v. Stewart clearly stands for the position
that normally whether or not a patient gave consent is an
issue of fact and that in Washington there is clearly a case
10
of medical battery if a doctor performs a procedure which
11
the patient did not consent to.
12
Your Honor, we have cited other jurisdictions that have
13
established the well-recognized principle that a patient's
14
consent to surgery is not a free license for the surgeon to
15
do any and everything he or she chooses to do.
16
distinction was clearly drawn by the California Supreme
17
Court in Cobb v. Grant, cited in our brief, where the court
18
states:
19
perform one type of treatment and subsequently performs a
20
substantially different treatment for which consent was not
21
obtained, there is a clear case of battery.
22
The
Where a doctor obtains consent from the patient to
THE COURT:
So is this a situation where a different type
23
of surgery was performed or there was a non-disclosure that
24
a particular material was going to be used which was perhaps
25
contraindicated or, under your words, experimental?
So in
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other words --
MR. HANNULA:
THE COURT:
-- should -- there was clearly consent to a
surgery.
MR. HANNULA:
THE COURT:
Yes.
We agree, yes.
And there was clearly -- she clearly knew that
there were risks of the surgery.
MR. HANNULA:
THE COURT:
She didn't know --
Correct.
-- that the particular type of cement was
10
going to be used.
11
misrepresentation case or is this a straight lack of consent
12
case?
13
MR. HANNULA:
14
THE COURT:
15
MR. HANNULA:
So is this more an alleged
I'll answer that in a couple of ways.
Sure.
First of all, Dr. Kowalski and Dr. Faller in
16
their declarations have both testified that -- and there's
17
evidence from Cindy Wilson that Dr. Chapman in one of the
18
discussions -- even though he didn't put it in his consent
19
form -- discussed with Reba Golden using an acrylic cement,
20
PMMA.
21
Norian cement.
22
product.
Norian cement is a calcium phosphate-based
23
product.
And even before Synthes launched their illegal
24
test market, which Dr. Chapman was a part of, Synthes and
25
Dr. Chapman knew that this product, because it was calcium
Your Honor, this is a very different cement from

This is acrylic, it's an acrylic-based
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phosphate-based, formed and accelerated clots.
And as the Court can imagine, once this gets into the
blood stream and starts forming and accelerating clots and
making them bigger, they're going to go into the heart and
lungs and they're going to kill someone.
and Kowalski have testified to is when Dr. Chapman advised
Reba Golden and her daughter that he was going to use PMMA,
that was a U.S. FDA approved product for use in the spine.
What Dr. Faller
We know that not only was Norian cement not approved, the
10
FDA had made a determination that it was contraindicated for
11
use in the spine.
12
testified, Your Honor, that that was a completely different
13
procedure than the one consented to; and therefore, there
14
was no consent.
Dr. Faller and Dr. Kowalski have both
15
Your Honor, we've cited not only the Cobb case in
16
California, but we cited the Duncan case in Arizona.
17
the Duncan case, the plaintiff was going to have an MRI and
18
she consented to the MRI but she advised the doctor that she
19
would only agree to demerol or morphine to basically render
20
her unconscious or at least unaware of what was going on.
21
And in
When she got to the hospital, the nurse said we're going
22
to use fentanyl.
She said, no, I will not agree to that.
23
will only consent to demerol or morphine.
24
okay, we will -- we'll use demerol or morphine.
25
went and used fentanyl.
The nurse said,

Instead she
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The Supreme Court in -- the trial court was in the
position that Mr. Madden has asked you to be in, in that the
trial court ruled that the plaintiff in the Arizona case did
not have a claim for assault, battery, on the basis that she
had consented to the procedure.
of Arizona reversed it, and their clear holding in that case
was:
you misrepresent what you're going to do and someone
consents to a procedure based upon the misrepresentation,
10
then you have not given consent and you have a claim for
11
assault, period.
12
The Supreme Court of State
You cannot misrepresent what you're going to do.
If
That's what that case stands for.
And, you know, it's -- you know, they want to distinguish
13
this case because they want to say, well, you know,
14
Dr. Chapman never misrepresented anything to Reba Golden.
15
Oh, he just never mentioned or told Reba Golden that he was
16
going to use a product that was not approved by the FDA and,
17
in fact, the FDA had determined it was contraindicated for
18
the very use that he used it on Reba Golden.
19
So our experts believe, first of all, that there was --
20
first of all, at the time that Dr. Chapman performed this
21
procedure, he was not acting in their best interests; and
22
therefore, any consent was vitiated.
23
procedure that was done was not the procedure that she
24
consented to.
25
that have medical battery are very clear that under those
They also say that the
And I think the cases in our jurisdictions
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circumstances, that is the medical battery and that is not
an issue of informed consent.
Your Honor, I'll touch briefly on this position that the
defense has taken which, candidly, I find very hard to
understand and accept.
Court is that well, the three predicate acts have to be
within a five-year period.
THE COURT:
which is the --
10
MR. HANNULA:
11
THE COURT:
12
Counsel, why don't you go to the next issue
Fifth Amendment inferences.

MR. HANNULA:
14
THE COURT:
invoked --
MR. HANNULA:
17
THE COURT:
18
MR. HANNULA:
19
THE COURT:
Right.
-- by individuals -Right.
-- who -- let's put aside the -- you know, the
non-medical defendants.
21
MR. HANNULA:
22
THE COURT:
23
Yes, Your Honor.
So you have the Fifth Amendment being
16
20
Okay.
I'm interested in hearing from you on the
13
15
But what they're trying to tell this
Yes.
You have Mr. Madden, who is representing the
hospital, and -- at a minimum let's say the hospital --
24
MR. HANNULA:
25
THE COURT:
Yes.
-- and the University of Washington.
So how
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is that inference triggered against his clients?
cleaner analysis.
MR. HANNULA:
THE COURT:
5
6
7
arguments.
That's the
Yes.
The other defendants arguably have different
But let's take that -- those defendants.
MR. HANNULA:
In other words, you're really speaking of
Dr. Chapman and Hansjorg Wyss --
THE COURT:
Right.
MR. HANNULA:
-- the CEO and major stockholder of Synthes,
10
Incorporated before he sold it to Johnson & Johnson.
11
yes, those two both answered questions.
But
12
First of all, you know it's our position that they are
13
co-conspirators, and questions that were directed to the
14
four criminal defendants who would not answer any questions
15
and took the Fifth in this case were part of that conspiracy
16
and we can take the inferences from that.
17
But, Your Honor, we have what I would argue is an
18
abundance of evidence that clearly creates a material fact
19
as to whether there was, in fact, a conspiracy, how long it
20
lasted and -- and, Your Honor, that each one of these people
21
was a part of it and it was for the purpose, obviously, from
22
Hansjorg Wyss's position, to continue to grow his company
23
and to increase the value of his company.
24
And he recruited Dr. Chapman and Dr. Chapman -- and I am
25
still somewhat shocked as to why he did what he did, but he
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had a considerable financial basis to do so.
discuss that further, Your Honor.
And I can
Your Honor, and I want to go back for just a minute
because in these motions, the defendants have represented
that this is merely a products liability case and merely a
medical malpractice claim.
this case and wash away their outrageous and criminal
conduct which caused the death of Reba Golden.
They're asking you to sanitize
In sentencing, the four criminal defendants who are part
10
of this case, Your Honor, Judge Legrome gave a statement and
11
I quote:
12
they were given -- is warranted because the guideline
13
sentence would not adequately address the unprecedented
14
nature of the criminal conduct of Huggins and his
15
co-defendants.
16
parallel.
17
grave and the scale and the deception of the Food and Drug
18
Administration can only be characterized as extreme.
19
The variance -- in terms of how much jail time
The scope of their scheme is without
The risk created for an unsuspecting public were
He went on to say, The extreme risk created by the Synthes
20
product, indeed the uncertain nature of the product itself,
21
was repeatedly brought to the attention of Huggins and his
22
fellow executives by medical consultants, researchers and
23
surgeons who had used the product only to experience serious
24
complications.
25
expressly considered and ignored.
These strident and abundant warnings were

Huggins and his
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confederates closed their eyes to the death of two
unsuspecting patients, who, as it turned out, were little
more than subjects in a Synthes experiment.
Your Honor, the defendants, all of them, have represented
to you that if there was a criminal conspiracy, it ended
when the FDA began its investigation into Synthes marketing
of Norian cements for use in the spine in the spring of
2004.
Your Honor, we have Exhibit 124 which is a part of our
10
documents.
This is a document produced by the University of
11
Washington setting forth the dates and times Dr. Chapman and
12
other University of Washington spinal surgeons injected
13
Norian cement into the spines of their patients.
14
document reflects the fact that after the FDA investigation
15
began in 2004, Dr. Chapman injected Norian cement into the
16
spines of 33 patients between July of 2004 through July 6th,
17
2009.
The
18
At this procedures, Your Honor, there is documented proof
19
that Synthes representative -- a Synthes representative was
20
present in the operating room with Dr. Chapman, including
21
during Reba Golden's surgery on August 17th, 2007 and Joan
22
Bryant's surgery on July 6th, 2009.
23
Now, we asked the defendant, Synthes to provide
24
information as to who was present in each of those
25
procedures.
They didn't answer that interrogatory
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completely, but they did give us the calendar of Synthes
representative, Jeff Hunt.
Dr. Chapman used Norian cement at Harborview from February
of '05 through Reba Golden's surgery, through Joan Bryant's
surgery on July 6th of '09, that representative was there in
the operating room with him every single time.
And for every procedure that
The investigation started in 2004.
The indictments did
not come down -- in other words, the four criminal
defendants in this case were not charged with crimes nor was
10
Synthes charged with a crime until June of 2009,
11
approximately three weeks before Dr. Chapman operated on
12
Joan Bryant and she died on the operating table on July 6th
13
of 2009.
14
We've talked about in our brief the fact that we are
15
entitled to certain inferences, Your Honor.
But I'd ask the
16
Court to look at the documents that have been presented.
17
Exhibit 1 establishes that almost immediately after
18
Hansjorg Wyss purchased the Norian company and it become a
19
part of the Synthes Corporation, Synthes was aware that the
20
FDA considered bone cement use in the spine to be an, in
21
quotation marks, hot button issue.
22
if they were going to be able to market Norian cement for
23
use in the spine, it would require formal FDA approval and
24
they would have to go through the entire FDA approval
25
process, which is costly and takes three to five years and
And Synthes recognized
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2
sometimes longer.
Exhibit 2, Your Honor, a document dated February 2000
records a meeting in which Hansjorg Wyss told all the
Synthes attendees that Synthes would be doing a strong push
for vertebroplasty.
that Reba Golden consented to as referenced in the consent
document.
compression fractures.
Vertebroplasty is one of the procedures
This is one of the ways to treat vertebral
Exhibit 3 is an email of February 24th, 2000, from the
10
defendant, Tom Higgins to Hansjorg Wyss outlining the
11
formation of a plan that proposes an illegal test market for
12
Norian cement.
13
Exhibit 4 is a Synthes market investigation study also in
14
2000 directed to the huge profit potential for using Norian
15
cement to treat vertebral compression fractures of the
16
spine.
17
Exhibit 6 is a critical document, Your Honor, it is a
18
management review board meeting of August 15th, 2000, led by
19
CEO Hansjorg Wyss.
20
management review board meeting.
21
majority stockholder.
22
Johnson in 2011 for $20 billion.
23
that public company was $10 billion.
CEO Hansjorg Wyss was at every

He's the CEO, he's the
This company was sold to Johnson &

Hansjorg Wyss's share of
24
Each of those management review board meetings were
25
attended by upper management, including Mr. Huggins, the
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president of Synthes of North America, and Mr. Higgins, the
president of Synthes spine.
page 2, the decision was made to launch an illegal test
market for the purpose of getting surgeons to treat patients
with Norian cement injected into their spine.
In that meeting, if you look at
Exhibit 10, Your Honor, is a management review board
meeting on November 15th, 2001, approximately one year
later.
attendance, including Huggins and Higgins, in which the
Again led by Hansjorg Wyss with upper management in
10
decision that had been made in the prior MRB meeting, which
11
is Exhibit 6, was reaffirmed.
12
In fact, in that meeting there was a discussion -- it's on
13
page 3.
14
Synthes spine, brings up the fact that oh, do you think we
15
should do or consider a long time IDE, that's an
16
investigational device exception; that's part of the
17
process.
18
three to five years to get the FDA to approve it if it's
19
found to be safe.
20
FDA approval.
21
There's a discussion, Tom Higgins, the president of
Actually, it's the part of the process that takes
But that's a part of the process to get
The IDE study -- Your Honor, was they rejected the IDE
22
study.
In other words, Your Honor, the topic was raised at
23
this management review board meeting as to whether they
24
should proceed with attempting to get Norian cement into the
25
spine legally and lawfully and the decision of Hansjorg Wyss
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and the management review board was:
proceed lawfully, we will get surgeons to do 60 to 80
procedures and we'll help them publish their results.
No, we will not
That, Your Honor, is an illegal test market and it really
forms the basis for the criminal charges against Synthes,
Norian, and all the criminal defendants.
Exhibit 17A is an email from Synthes medical director,
Dr. Ken Lambert to Ms. Thongpreda dated June 2nd of 2002.
She was the project group manager of the Norian cement
10
spinal project.
In that email Dr. Lambert makes reference
11
to the upcoming test market and tells her in no uncertain
12
terms that what they are doing is human experimentation.
13
Exhibit 17A also reflects the fact that Dr. Lambert sent
14
that email that he had sent to the group project manager
15
directly to Hansjorg Wyss.
16
Your Honor, Exhibit 27 is a document that was prepared by
17
the University of Washington researchers, including Dr. Jens
18
Chapman, where they advised Synthes that they believed that
19
Norian cement was a thrombogenic agent; that is, it produced
20
an accelerated clot formation.
21
preliminary studies on the pigs -- they didn't complete any
22
studies, but they did preliminary studies on the pigs and
23
they were very concerned that that could pose extreme danger
24
if it was placed into patients' spines.
25
And they had done
This letter was written on June 28th of 2002 -- and, Your
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Honor, later I would talk about the Nuremberg document that
says if you're going to put -- if you're going to do human
experimentation with a device or drug you don't know what
the reaction in a human being is going to be, you do it with
animals first.
That's a part of the process of safety.
Think about this, Your Honor, in June of 2002 -- the end
of June of 2002, Synthes, first of all, has received a
letter from their -- from their -- from their medical
director saying, what you're about to do is human
10
experimentation, and they're also provided with a letter
11
that says, look, we haven't completed any studies, we
12
proposed these studies; but what we have done, we believe
13
this is potentially a thrombogenic agent.
14
of 2002.
15
test market was started on September 1st, 2002.
That's June 28th
There' no dispute, Your Honor, that the illegal
16
And perhaps, Your Honor, more astounding is the fact that
17
Dr. Chapman, Exhibit 124, reflect the fact that Dr. Chapman
18
injecting Norian cement into the spine of one of his
19
patients at the University of Washington on September 6th of
20
that year, five days after -- five days after the test
21
market was launched.
22
And I won't go into all of the poor results they had, but
23
there was a death in the first test market in January of
24
2003.
25
was a third death in January of 2004.
There was a second death in September of 2003.
But Synthes having
There
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not even completed the animal studies kept pursuing this
test market.
evidence shows at least from the material -- do we have any
evidence to suggest that this was ongoing?
is absolutely.
uses of Norian cement in the spines of his patients was done
subsequent to the beginning of the investigation by the FDA
in 2004.
And we believe, Your Honor, again, that the
Absolutely.
And the answer
Because most of Dr. Chapman's
Now, Your Honor, now the question becomes:
Well, what is
10
the connection between the University of Washington and
11
Dr. Chapman?
12
of the test market.
13
documentation.
14
when the second test market was launched in September of
15
2003 that within three weeks Dr. Chapman had performed two
16
surgeries on his patients with the Synthes representative in
17
attendance and who filled out a test market form that he
18
sent back to Pennsylvania, the corporate headquarters of
19
this company.
20
Well, first of all, we know that he's a part

That is clearly established by the
In fact, we have documents that show that
Your Honor, you should look at Exhibit 36 and Exhibits 168
21
through 176 and Exhibit 232.
In early 2003, Tom Higgins
22
wrote a report to Michael Huggins in which he stated that:
23
In terms of our relationship with the doctors, we should
24
change our model.
25
three or four surgeons who we are going to call tier one
And he said, We should have a group of
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physicians.
in that document, Your Honor, it's Exhibit 36.
going to do is we're going to pay these doctors
approximately $75,000 a year, they'll be part of our board,
and there will be three or four of them, and we'll provide
significant sums to the institutions they practice in.
And what we are going to do -- and this is all

What we're
Your Honor, Exhibits 168 through 176 at 232 establish
this:
That no later than October 1st, 2003 within ten
months of this being written from Higgins to Huggins,
10
Dr. Chapman became a paid consultant for Synthes and became
11
a member of their manufacture review board.
12
relationship continued for almost nine years.
13
continued at least through June 30th of 2012.
That
We know it
14
From at least June 2007 to June 2012, Dr. Chapman was on
15
the board of trustees of the AL Foundation, an organization
16
totally funded by Synthes for which he was paid.
17
From January 21st, 2010, to December 31st, 2012,
18
Dr. Chapman head a position of chairman of the board of AL
19
Spine of North America, an organization totally funded by
20
Synthes for which he was paid 10,000 per year and $1,000 per
21
meeting.
22
From at least April of 2008 to January 21st of 2012
23
Dr. Chapman was editor and chief of EBSS, a publication of
24
AL Spine International; again, an organization totally
25
funded by Synthes for which he received at least $18,400 per
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year.
Not only that, Hansjorg Wyss in 2003 donated at least $2
million to fund the Hansjorg Wyss chair at the University of
Washington which Dr. Chapman was the original holder of and
remained the holder of until he left the University of
Washington in October of 2014.
In addition, the Hansjorg Wyss Foundation and Synthes
committed to donating an additional 500,000 per year for
five years to the University of Washington beginning in 2004
10
and an additional 100,000 per year for research performed
11
directly by Dr. Chapman.
12
Dr. Chapman and the University of Washington, Your Honor,
13
benefitted handsomely from their relationship with Hansjorg
14
Wyss and Synthes, Incorporated.
15
So we're not just talking about inferences here, Your
16
Honor.
17
shows, first of all, a pattern of criminal conduct.
18
that occurred, people went to jail for it, people who are
19
parties to this lawsuit or refuse to answer.
20
Dr. Chapman in the presence and with the support of Synthes
21
representatives continued to use Norian cement in the spines
22
of his patients from the time of the -- that the -- after
23
the investigation started in 2004 up until Joan Bryant died
24
on July 6th of 2009, 33 separate occasions.
25
We're talking about considerable documentation that
Your Honor, I'll be done now.
We know that
I appreciate the Court's
We know
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indulgence.
this case is extremely dangerous.
is that it is okay for a doctor to perform a surgery when he
either misrepresents what he's going to do or doesn't tell
the patient what he intends to do.
informed consent, that's assault and battery.
But what Mr. Madden is asking you to find in

What he's trying to say
That's not just -- just
And if we were to allow doctors to do what Mr. Madden
wants you to do in this case, then we're going to have more
Dr. Chapmans because what he did, Your Honor, was
10
inexcusable under the circumstances.
Because if there was
11
any physician who knew the dangers of Norian cement, it was
12
Dr. Chapman, and he knew that as early as 2002 and he knew,
13
again, that this cement was not approved by the FDA and, in
14
fact, it was contraindicated for use in the spine.
15
sadly and tragically, Joan Bryant and in this case Reba
16
Golden died as a result.
And
17
THE COURT:
18
Mr. Madden, about ten minutes or so and then we'll take a
19
20
recess.
MR. MADDEN:
Thank you.
Your Honor, I think that very
21
early in Mr. Hannula's argument you asked him the
22
controlling question, which is -- I wrote it down:
23
there a different type of surgery or was this a failure to
24
disclose the use of a contraindicated device?
25
Mr. Hannula went off and told you about what his experts had
Was
And
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to say and what Ms. Wilson has to say which is:
consent to -- Ms. Golden didn't consent to a surgery
involving Norian cement and wasn't advised of the risk of
Norian cement.
consented.
case law and the case law around the country.
there isn't a single case anywhere in the country like this
that holds a doctor can be liable for medical battery, let
alone criminal assault.
10
11
12
We didn't
But this was the surgery to which Ms. Golden
And that is the line of demarcation under our

As I said,
The Bundrick and the Arizona case, Duncan, those are

conditional consent cases.
In Bundrick, it's an issue of fact.
The patient claimed,
13
I said, no residents.
14
didn't say that.
15
well, there's an issue of fact, but we don't need to retry
16
the case because it was tried on an informed consent basis,
17
and you lost, Plaintiff.
18
The doctor said, yes, I did -- you
The doctor disagreed.
So no claim.
The Duncan case exactly as Mr. Hannula described it:
19
patient says, no fentanyl.
20
fentanyl.
21
have that predicate here.
22
23
24
25
The court said,
The nurse says, okay, no
And then they use fentanyl.
THE COURT:
The
Again, you don't
A couple other things --
Although your doctor did say a -- did specify
a certain kind of cement, right?

MR. MADDEN:
the point.
According to the plaintiffs.
The point is:
Did the patient condition her
But that's not
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consent?
know, my mother said, The only cement I'll consent to is
polymethylmethacrylate, we might be in the Duncan arena.
But they're not saying that.
If the plaintiffs were sitting here saying, you
THE COURT:
Well, actually, wouldn't you be better off if
your client -- well, the nurse -- the doctor, whoever had
communications, had not specified any kind of cement
whatsoever?
MR. MADDEN:
10
THE COURT:
11
12
Well -We would be in the -- undoubtedly not be in
the -MR. MADDEN:
No, we'd be in exactly the same spot, and
13
that is the problem.
14
there are dozens, sometimes hundreds of drugs and devices --
15
THE COURT:
16
MR. MADDEN:
Because, you know, in a given surgery
Sure.
-- not all of them are going to be described,
17
certainly not all of them are going to be written down in a
18
form.
19
a bad result and we can go through the implant list and the
20
pharmaceutical list and we can find something and we can get
21
an expert to say, you didn't disclose that, and that's
22
really risky stuff, and now I've got a battery claim and now
23
I've got a criminal assault claim.
24
saying.
25
But what the plaintiffs say is after the fact, we get
And that's what they're
That is what they're saying.
And if that becomes the law, I don't think you're going to
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find many people willing to do these kinds of high-risk
surgeries that Dr. Chapman did.
remedy for that.
says, I'm saying, you know, you can excuse the failure to
disclose.
guilty of a crime and you can't hold him and his employer
liable for punitive damages.
8
9
10
11
The legislature provided a
Mr. Hannula is all way off base when he
What I'm saying is you can't find the doctor
And that's all I'm saying.
Now, I -- Mr. Hannula, I had a hard time with his roadmap,

if there was one, but there's a couple things I think are
important to say, and then I'll wind up.
First of all, this whole notion of the role of the FDA,
12
the FDA does not regulate the practice of medicine.
The
13
Supreme Court has said that, the FDA acknowledges that.
14
the FDA does is it regulates drug and device manufacturers.
15
Physicians use drugs and devices off-label every day:
16
Harborview, in spine surgery, at Children's Hospital.
17
Because for the very reason that you can't test drugs and
18
devices on children in this country, virtually everything
19
that's used in the children's hospital is off-label.
20
And the case law -- and we cited it in our brief.
All
At
It's
21
in -- it's on page 4 of our reply brief.
22
around the country says, in fact, a physician doesn't have
23
to disclose the off-label nature of a drug or device in
24
order to obtain informed consent because it's irrelevant.
25
THE COURT:
So is this -- although, obviously we're at
The case law
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summary judgment, are we talking -- is it up to the jury to
decide whether this is off-label?
contraindicated makes a difference?
MR. MADDEN:
Whether off-label versus
In an informed consent context, yes.
This is
not an informed consent context.
to touching, to the surgery.
exception cases described in Cobb where somebody says, well,
I consent to my surgery on my left ear but not on my right
ear.
10
11
This is a lack of consent
This isn't like one of the
I consent to an exploratory surgery but not a
mastectomy.
Those are the examples given in Cobb.
This case -- and the Court was right on point, this is a
12
case where the surgery that was performed is exactly the
13
surgery to which Ms. Golden gave her consent.
14
The last thing I think worthy of mention in response to
15
Mr. Hannula's talk is this:
There's a lot of discussion
16
about this is human experimentation and it violates the
17
Nuremberg Code.
18
federal regulations and no claim for violation of Nuremberg
19
Code, and there's a very good reason for that, and you see
20
that the plaintiffs' experts wanted to go down this road but
21
there's a case, a decision by Judge Lasnik that summarizes a
22
lot of federal case law in a case that we litigated a few
23
years back -- and this is in our motion to strike on page 5
24
-- but it's Wright v. Fred Hutchinson Cancer Research
25
Center, that says, no, there's no -- there is no claim under
Well, there's no claim for violation of
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2
those federal regulations governing research.

Now, this actually doesn't apply, but this is Mr. Hannula
and his experts trying to make up legal conclusions about
the effect of things when the focus is:
consent to this surgery?
answer is yes.
THE COURT:
Counsel, let's -- I'll see you at a quarter after.
9
10
11
12
Did this patient
And on this record, the undisputed
Thank you, Mr. Madden.
Everybody, there's restrooms down the hallway.

And, Counsel, then we'll -- so, we'll go back to the other
two motions that are pending.
THE CLERK:
All rise.
13
Okay.
The Court is in recess.
(Recess)
14
THE COURT:
15
to go ahead?
All right, let's see.
16
MR. BORANIAN:
17
THE COURT:
18
MR. BORANIAN:
Counsel, so do you want
All right.
Go ahead.
Your Honor, Steven Boranian for Defendant
19
Hansjorg Wyss.
20
in this lawsuit, and he was the principal shareholder and
21
the Chairman of Synthes throughout the relevant time period;
22
although he no longer holds those positions.
23
Mr. Wyss is one of the individual defendants
It's important to me to point out at the outset that
24
Mr. Wyss has never been accused of any crime.
25
been the subject of any regulatory or criminal
He has never
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investigation.
Synthes, when government lawyers started asking questions,
they didn't even sit down with Mr. Wyss and ask him about
the facts that now form the basis for this lawsuit.
somewhat removed from those events.
When the FDA investigators showed up at
He was
The first person, Your Honor, to ask Mr. Wyss -- other
than his own lawyers, to ask Mr. Wyss about the facts of the
this case was Mr. Hannula in Mr. Wyss's deposition some
months ago; although Mr. Hannula does not cite even a single
10
line of that deposition to the court in opposing Mr. Wyss's
11
motion.
12
If he had, the Court would know that Mr. Wyss testified
13
under oath.
14
testified that he was unaware of any scheme or plan to
15
illegally market Norian XR for the spine, and that if he had
16
known about it, he would have put an end to it.
17
He showed up.
He did not take the Fifth.
He
And I say that now, Your Honor, because that is why it is
18
impermissible and unfair to draw inferences from the Fifth
19
Amendment privilege taken by other individual defendants.
20
The whole point of inferences under Washington law is so
21
that someone who takes the privilege takes responsibility
22
for his or her decision to do so and, of course, Mr. Wyss
23
decided to testify and did so truthfully.
24
So about today's motion, Your Honor --
25
MR. HANNULA:
Your Honor, I never like to interrupt but
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3
I'm just unclear, what motion are we arguing at this point?

MR. BORANIAN:
Well, I was just getting to that.
Mr. Wyss's motion for summary judgment.
THE COURT:
MR. BORANIAN:
THE COURT:
Okay.
Including the outrage claim.
I presume principally the outrage claim, but
your other motion was a tag-along, right?
the other motion, so --
This is
MR. BORANIAN:
So tag-along on
Well, Mr. Wyss is unique among the
10
defendants here today because we're asking for a complete
11
summary judgment, Your Honor.
12
today, the plaintiffs will come away with their product
13
liability claims against the product manufacturers and their
14
medical malpractice claims against the healthcare providers,
15
but Mr. Wyss is asking for a complete summary judgment, and
16
that makes him different.
No matter what happens here
17
There are only four claims alleged against him, and those
18
are the -- I'm going to cover in any detail only the outrage
19
claim.
20
criminal profiteering claim, Mr. Madden has covered that and
21
we'll cover it no further.
22
23
24
25
There might have been confusion on that.
On the
Punitive damages, Mr. Smith will cover that briefly, and

we'll cover that no further.
On -- let me focus on outrage.
And on outrage it's
important to understand the time frame.
It's been mentioned
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a couple of times, but it's important so I will say it
again.
Norian had Norian cement products.
product called Norian XR bone cement sometime after that,
and then they allegedly started what has been called a test
market for Norian XR in 2002.
Synthes bought a company called Norian in 1999.

Synthes launched a
The FDA commenced its investigation in 2004, and Synthes
stopped selling the product in 2004.
heard that, okay?
The Court has already
In addition to that, I can add that a
10
Synthes employee name Ken Geskes, who testified in this case
11
in his deposition, he conducted an audit of Synthes
12
marketing after the FDA investigation and found that there
13
had been no off-label marketing of any product after 2004.
14
When you listen to Mr. Hannula's recitation of the facts,
15
his reading of the exhibits, which we object to much of
16
that, but taking it at face value, Your Honor, the latest
17
date I heard when it comes to the actual marketing, the
18
actual use of Norian XR cement, was 2004.
19
the time frame here.
20
So we agreed on
The alleged test marketing and the alleged criminal
21
conduct, so to speak, ended in 2004, and that is three years
22
before Reba Golden's surgery.
23
On these facts --
24
THE COURT:
25
MR. BORANIAN:
So where did the cement come from, then?

The cement that was used with Ms. Golden
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was a product called Norian CRS, which is a very, very
similar product.
XR.
It has one fewer ingredient than Norian
The point is that Norian XR and the promotion of Norian XR
is what prompted the government investigation, which
eventually led to the criminal investigation.
and Synthes put an end to the promotion of that particular
product in 2004.
again, version of the facts and you look at the exhibits,
10
11
But the FDA
And when you listen to Mr. Hannula's,
there is no dispute on that.
That came to an end in 2004.
On these facts, our motion is brought on a very
12
straightforward ground.
13
claim of outrage, it can be brought only by an immediate
14
family member of the person who was the object of the
15
defendant's extreme and outrageous conduct and who was
16
present at the time of such conduct.
17
Washington law is clear that for a
And, more importantly, I think, for purposes of today's
18
argument, is that multiple plaintiffs over years have
19
presented egregious allegations to Washington's courts,
20
including the Washington Supreme Court.
21
courts to relax that presence requirement, and the courts
22
have declined to do so in every instance.
23
They have asked the
What you will hear from Mr. Hannula is some very
24
inflammatory argument regarding human experimentation.
25
There is no question that human experimentation, per se,
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would be, if proven, outrageous.
But the courts have
explained every time they have been asked to address this
that there is no basis in the law to make an exception to
the presence requirement, and that is true even when the
allegations presented are of the most egregious nature.
That's typical of an outrage claim.
outrageous conduct to plead such a claim.
You have to have
So the fact that we will hear about experimentation, maybe
even about terrorism, that really doesn't have any impact on
10
the presence requirement, not in the state of Washington.
11
THE COURT:
Let me ask you a question.
12
MR. BORANIAN:
13
THE COURT:
14
MR. BORANIAN:
15
THE COURT:
16
MR. BORANIAN:
17
THE COURT:
18
the complaint.
19
different issue in a few minutes, a different motion, but
20
there is an issue of punitive damages in this case, and part
21
of that -- part of one of the elements of a punitive damages
22
request, which are typically not a separate cause of action
23
but typically an element of another cause of action which
24
allows punitive damages -- question for you:
25
your motion on outrage does not necessarily -- you're
Yes, sir.
We're talking about a tort of outrage.

Correct.
A cause of action.
Yes.
That has been pled in a specific paragraph of

So we're going to get to that in a few -- a
I assume that
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seeking a motion for summary judgment on the tort of
outrage.
preclude a plaintiff from pursuing punitive damages based
upon outrageous conduct, does it?
That doesn't necessarily, in and of itself,
MR. BORANIAN:
That's correct.
A different issue, right?

It does not preclude the
plaintiff from pursuing punitive damages against defendants
against whom that plaintiff has remaining causes of action.
8
9
10
THE COURT:
Right, right.
That has to be under a
different cause of action.

MR. BORANIAN:
Correct, if the Court grants Mr. Wyss's
11
motion, then all the claims against him will be dismissed
12
and there is nothing left to support a claim for punitive
13
damages.
14
The impact of your question, though, is that there will be
15
claims remaining in this case no matter what happens here.
16
Punitive damages are not available against the healthcare
17
provider defendants.
18
with or without an outrage claim -- plead punitive damages
19
against the medical device manufacturer defendants in
20
connection with the product liability claims.
21
They can plead punitive damages --
Now, there are reasons why we think Plaintiffs cannot
22
sustain their burden on punitive damages.
23
cover that, but granting my motion for outrage does not
24
necessarily affect punitive damages against other
25
defendants, Your Honor.
Mr. Smith will
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THE COURT:
Okay, thank you.
MR. BORANIAN:
So what about the facts of this case?
Well, the conduct that Plaintiffs attribute to Synthes and
to Mr. Wyss occurred years before Reba Golden's surgery and
even longer before Plaintiffs claimed to have learned about
any of this, which, again, was years after that.
So, you know, when you have -- what you have here, then,
is not only a physical separation of the plaintiffs from
this alleged conduct, but also this temporal separation, you
10
know, spanning several years.
11
Your Honor, at least not without going against the law of
12
the state of Washington.
13
That's not an outrage claim,
The other conduct that they allege was outrageous was the
14
actual treatment of Reba Golden, you know, with Norian
15
cement, which led to her passing away, but they were not
16
present for that either.
17
when Dr. Chapman actually used Norian, and they were not
18
present when Ms. Golden sadly passed away.
19
about it all after the fact.
20
They admit they were not present
They learned
And I think that's probably the most important thing I'm
21
going to say today, Your Honor.
The plaintiffs' entire
22
claim for outrage is based on what they learned after the
23
fact.
If you look at page 5 of their opposition, they
24
say:
Well, of course we weren't there when our mother
25
passed away, but it doesn't matter because we didn't
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experience any outrage anyway until we learned about all
this after the fact.
mother's demise, they wouldn't have experienced any outrage
at that time, they learned about it all years later.
Even if they had been there for their
I believe from Mr. Hannula, the plaintiffs made this
concession because they had to on these facts, but it's
critical.
claim is all about.
resulting in outrage, that much they admit.
It's critical because it shows what their outrage

They did not perceive any conduct
They
10
experienced their alleged emotional distress based on
11
learning on about the circumstances much later.
12
And the cases are clear that an outrage claim does not lie
13
when you learn about it from somebody else after the fact.
14
We have cited multiple cases in our reply, Your Honor.
15
the case of the mother who learned later that her daughter
16
was molested.
17
were the facts of the Schurk case where the Washington
18
Supreme Court said, no, summary judgment should be affirmed
19
on outrage because the plaintiffs were not present.
20
And those are not the only examples, Your Honor.
Take
It's horrifying, it's outrageous, but those
There
21
were many others.
So what we have heard from the plaintiffs
22
is that they have this criminal conspiracy that they say
23
goes over many years and that they were close enough.
24
that might plead a product liability claim, that might even
25
plead a medical malpractice claim, but it doesn't fit for an
Well,
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outrage.
Outrage is when there is some outrageous conduct
aimed at somebody.
immediate family member, you have to be present to perceive
that.
And if you want to make that claim as an
That's all I have to say, Your Honor.
THE COURT:
You have time for
rebuttal.
MR. BORANIAN:
THE COURT:
10
Questions?
Thank you.
And counsel have joined -- other counsel have
joined in this motion, correct?
11
MR. BORANIAN:
12
THE COURT:
13
Mr. Hannula?
14
MR. HANNULA:
Correct.
Thank you.
Okay, thank you.
Yes, Your Honor.
15
Your Honor, I just want to briefly respond to what I -- I
16
think I understood Mr. Boranian's initial comments
17
regarding -- I think he was referring -- I think it's to --
18
and I may be wrong on the numbers, but I believe
19
Allegation 9 or the one that's the RICO violation, we
20
obviously argue that with Mr. Madden, and I believe that
21
counsel on behalf of Hansjorg Wyss is taking the position --
22
and I think that's exactly what they said in the brief, that
23
if for some reason you dismiss Count 9, then you would have
24
to dismiss Count 10 because there was no criminal enterprise
25
that Mr. Wyss led.
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And I want to make sure that the Court understands the
defendants' position.
I believe what they have, in essence,
said is, if Count 9 is dismissed, the RICO violation, then
Count 10 has to be dismissed.
into my argument, because I clearly believe that Count 9
should not be dismissed and that we have provided evidence
on summary judgment to support the fact that Mr. Wyss led
this criminal enterprise and continued to lead it.
And I don't want to go back
The only other thing I'm going to say, Your Honor, is
10
don't get confused by the difference between Norian XR,
11
Norian CRS or Norian SRS.
12
product.
13
is exactly the same except for it had barium sulfate in it,
14
which was easier to see on x-ray, but they are all the same
15
calcium phosphate-based product.
They are exactly the same
SRS and CRS are exactly the same.
And Norian XR
16
And, again, I'm not going to argue what we believe to be
17
an ongoing criminal enterprise at least through July 6th of
18
2009.
19
Your Honor, this argument on the tort of outrage I believe
20
boils down to, you know, their argument that under no
21
circumstances if the immediate family is not present when
22
the outrageous conduct occurs -- if they are not present,
23
then they cannot pursue a tort of outrage claim.
24
25
Your Honor, clearly the other courts in the United States

have held that presence is not a requirement.
We have cited
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a number of cases, Your Honor.
They're in our brief.
of those cases being Goldberg-Botvin vs. The Islamic
Republic of Iran.
Republic of Iran, et cetera.
One
Another case being Bennis vs. The Islamic
And in the Goldberg-Botvin vs. The Islamic Republic of
Iran, the court did not require presence of the immediate
family members in a case of outrageous conduct that was
terrorism.
the restatement is very clear because the restatement
And the court, in citing the restatement -- and
10
expresses no opinion as to whether there may not be other
11
circumstances under which the action may be subject to
12
liability if immediate family members who suffer are not
13
present at the time the outrageous conduct occurs.
14
Your Honor, it's our position that human experimentation
15
is comparable to terrorism.
16
that human experimentation, especially if it occurs in the
17
United States, is arguably worse and more outrageous than
18
terrorism, usually at this time caused by what is happening
19
in the Middle East but caused by people that don't
20
understand or appreciate our rule of law.
21
And, Your Honor, I would argue
This human experimentation of Reba Golden occurred in the
22
United States.
It occurred because of the acts and conduct
23
of Mr. Wyss, the four criminal defendants, Synthes,
24
Dr. Chapman and the University of Washington.
25
frankly, Your Honor, who are privileged.
People, quite
I believe some of
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the corporate defendants were Wharton and Harvard graduates.
Mr. Wyss is a Swiss citizen who we know sold his company for
more than $10 billion in the United States.
Dr. Chapman, a German physician but a United States
citizen, is practicing medicine at the University of
Washington.
Washington for seven years.
these circumstances, what these people did in combination
was outrageous.
10
You know, I went to the University of

I take pride in that, but under
And we would argue, Your Honor, that the outrageous
11
conduct -- some of that conduct was actually witnessed by
12
the plaintiffs in this case.
13
Dr. Chapman -- you know, Mr. Madden, at the end of his
14
argument said:
15
of medicine.
16
And when I say that, it's that
Well, the FDA doesn't control the practice
It does control clinical experimentation.
If you were
17
going to do a clinical trial on a medical drug or a medical
18
device, you have to follow the rules and regulations
19
promulgated by the U.S. FDA.
20
regulations were promulgated principally to protect patients
21
under these circumstances.
22
23
MR. MADDEN:
And those rules and
Your Honor, this is just a backdoor way to
revisit the prior motion.
24
THE COURT:
25
Finish.
Okay.
Overruled, Counsel.
Go ahead.
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MR. HANNULA:
Your Honor, I'm sorry, I lost my train of
thought for just a moment.
that, but what I was going to get to is, in fact, some of
the outrageous conduct was actually witnessed by the
plaintiffs in this case.
Reba Golden's daughter, go to some of the appointments.
Vicki Marincin went to one, at least one.
her son, went to at least one or more than one.
I'm not blaming Mr. Madden for
Not only did Cynthia Wilson, ^
And Mr. D'Oyley,
And it's our position, Your Honor, that Dr. Chapman
10
misled, deceived and lied to Ms. Golden as to what his true
11
intention was as it related to the surgery, and that he was
12
going use a drug or a medical device that, as I've said more
13
than once, was not approved by the FDA and it was
14
specifically contraindicated for use in the spine.
15
And what he subjected Ms. Golden to was -- he really, in
16
all honesty, Your Honor, he stripped Ms. Golden of her
17
dignity.
18
and was paid by, she became for him a human guinea pig.
19
That's what she became.
20
She became -- for him and the people he worked for
Your Honor, as I think I indicated in the prior argument,
21
if Dr. Chapman was going to experiment with Norian cement,
22
first of all, there would have to be FDA approval for him to
23
do so.
24
established at the University of Washington and Harborview
25
Medical Center an investigatory or internal review board
And, if he did that, there would have to be
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made up of the people that I talked about before.
Every medical device or every drug, not only must they
follow the rules and regulations of the FDA, they must also
be under the auspices and the control of this IRB, this
internal review board.
And I would argue, Your Honor, that, based upon the FDA's
determination as to the danger of this device if implanted
or injected into the spine, if anyone at that point in 2007
had even thought of seeking FDA permission for use of that
10
drug -- use of that device in the spine, U.S. FDA would not
11
have allowed them to do so.
12
has a pattern of continuing to use that drug -- or that
13
device at least 33 times after the investigation is
14
commenced by the FDA.
15
Yet, Dr. Chapman, as we know,
And, again, Your Honor, they were not allowed -- that is,
16
her family members were not allowed to be in the operating
17
room.
18
the Synthes representative was allowed to be in there, but
19
the family was not.
20
was a barrier created by the defendant under these
21
circumstances.
22
There's probably some good reasons for that.
I mean,
They were in the waiting room, but that
And, again, Your Honor, I would argue to this court that,
23
under the circumstances, human experimentation done by
24
United States corporations in concert with American
25
physicians, an institution here at the University of
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Washington which I hold in high regard, is outrageous
conduct in the terms of what they did.
And, Your Honor, just briefly, I want the Court -- and
we've cited these in our brief, but if you take a look at
the Nuremburg code, which, as the Court is well aware, was
formulated as a result of what happened in Nazi, Germany,
where medical doctors in the name of science tortured a lot
of people; Jewish people and others, gays and others who
they thought were inferior.
But the first thing that the
10
Nuremberg code says is the voluntary consent of the human
11
subject is absolutely essential.
12
13
14
Did Reba Golden consent to the use of Norian cement in her

spine on August 17, 2007?
I would submit that she did not.
Paragraph 3 of the Nuremberg code says:
The experiment
15
should be so designed and based on the results of animal
16
experimentation and a knowledge of the national history of
17
the disease or other problem under study.
18
Synthes never completed their animal studies, studies that
19
were started by Dr. Chapman, but both Dr. Chapman and
20
Synthes knew that the limited studies that they had done
21
showed that this device posed extreme and lethal potential
22
dangers for any patient whose spine was injected with it.
23
If we go, Your Honor, to the Belmont Report, and I think
24
as the Court is aware, that report was -- the genesis of
25
that report is what they did to those poor black men down
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south where there was state-sponsored experimentation of
black men who they knew had syphilis.
treating it, they told these men that they were being
treated for a blood condition.
was.
simply monitoring to see what happened for untreated
syphilis.
the outrage in the United States as a consequence of that
was monumental, Your Honor.
10
And instead of
They never told them what it
And they weren't really treating, they were just
All these men died of untreated syphilis.
And
And in the Belmont Report, one of the things that it talks
11
about is beneficence when we're talking about
12
experimentation.
13
not only by respecting their decisions and protecting them
14
from harm, but almost by making efforts to secure their
15
well-being.
Persons are treated in an ethical manner
And it goes on and on from there.
16
And the Helsinki report --
17
THE COURT:
18
MR. HANNULA:
We better just go a few more minutes.

Yes.
I don't have much else to say, Your
19
Honor, other than I think this is an extremely unique case.
20
And presence is not required if the conduct is to such an
21
extreme, as terrorism is.
22
And, Your Honor, the cases that they cite were always
23
individual cases.
I'm not -- I would agree, all of the
24
outrage that was not determined to be the tort of outrage,
25
you know, was because there was no presence there.
But
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these were, in essence, cases involving individuals against
individuals.
I would argue, like terrorism, human experimentation is in
the public domain.
It doesn't just involve one individual;
it involves us all.
And just as terrorism does not require
presence for the tort of outrage to be claimed against the
defendants by the immediate family, I would argue that human
experimentation falls within that same arena.
10
THE COURT:
11
Counsel.
12
MR. MADDEN:
Your Honor, the Court in Goldberg vs. [sic]
13
Botvin, the case that was cited to by Mr. Hannula,
14
said:
15
activities in both its extreme methods and aims.
16
of terrorism are, by their very definition, extreme and
17
outrageous and intended to cause the highest degree of
18
emotional distress; literally terror.
19
Your Honor, terrorism is unique.
Terrorism is unique among the type of torturous

All acts
The analogy being drawn
20
to terrorism cases is completely inapt, and it comes not
21
from a single Washington authority.
22
do away with a requirement that the Washington Supreme Court
23
has vigilantly protected, that is, the requirement of
24
presence.
25
to the presence requirement.
It is a reach to try to
There is no terrorism or extra outrage exception
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Now, a couple of more things.
Mr. Hannula's understanding
of my position on Count 10 is exactly correct.
leading a criminal enterprise must fall along with the claim
for criminal enterprise, Count 9.
before, I apologize but it's in our papers.
One other point.
Count 10 for
And if I didn't say that
Mr. Hannula says that Plaintiffs
actually did seek -- actually did witness some of the
conduct, and he cites visits with Dr. Chapman.
are three things wrong with that, Your Honor.
10
Well, there
The first is that none of that conduct is alleged or
11
attributed to Mr. Wyss or to Synthes or to anyone but
12
Dr. Chapman.
13
of presence on those facts, but more importantly, again,
14
they did not experience any outrage when they were with
15
Dr. Chapman.
16
An outrage claim cannot be based on that form
And I will read from page 5 of their opposition where
17
Plaintiffs say, "Ms. Golden's children would not have
18
experienced during the surgery the outrage that is the
19
subject of their claim any more than they did during the
20
medical consultations they witnessed leading into it.
21
was only with the realization that their mother and they, at
22
the cost of her life, had been duped by the defendants'
23
deceit, misrepresentation into becoming an unwitting" -- and
24
I will paraphrase from here -- subject of experimentation,
25
did they actually experience outrage.
It
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That is to say, they experienced outrage when someone else
told them about it later, and that is the quintessential
case that the Washington Supreme Court has said:
outrage claim does not lie.
No, an
Now, Mr. Hannula has described outrageous conduct.
described allegations, but there are remedies for that.
There are criminal remedies.
already in this case.
of torts.
10
11
12
Some of them have come to bear
There are civil remedies, other kinds
The tort of outrage, however, does not lie in
this case for any reason.

With that, I will ask that the Court grant complete
summary judgment for Hansjorg Wyss.
13
THE COURT:
14
All right.
So we have our last motion, Counsel.
15
He has
Let's go
10, 15 minutes, and you will save time in rebuttal.
16
MR. SMITH:
17
THE COURT:
Thank you.
18
MR. SMITH:
Just so I'm clear, you have a hard stop at
19
4:00 or --
20
THE COURT:
No, but --
21
MR. SMITH:
In the word of my former managing partner, I'm
22
23
24
25
going to try to be rapier-like.

THE COURT:
Okay.
Just go 10 or 15 minutes and then we'll
-MR. SMITH:
Got it.
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THE COURT:
minutes, okay?
MR. SMITH:
Thank you.
THE COURT:
Thank you.
MR. SMITH:
Your Honor, again, Jim Smith on behalf of
-- save the rapier, and we'll just go 10 or 15
Synthes and Norian.
Thank you for this opportunity, Judge.
So I'm here on the summary judgment on the punitive.
I think just still, to its essence, there are two primary
arguments that we're fighting about here.
10
11
12
The first one is:
Is it time barred?
And
Is the claim for
punitive damages out because it wasn't timely brought?

And the second is:
Even if you could overcome that, can
13
there be a claim for punitive damages here anyway in light
14
of the record that was presented to you at the time the
15
parties moved for summary judgment on the matter?
16
So quick background.
We know the plaintiff filed the
17
amended complaint asking you to apply Pennsylvania law
18
because, in Washington, no punitive damages.
19
and I think we all agree with that.
20
no punitives on the wrongful death claim -- or the wrongful
21
death part of the claim.
22
recoverable on the survivorship.
23
We know it --
In Pennsylvania we know
Punitive damages can be

We all agree.
We know that there is a two-year statute of limitations in
24
Pennsylvania to pursue the survivorship and the wrongful
25
death claim.
I think we all agree with that.
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We know that Washington law says, if you're going to go
outside of Washington, then look to the jurisdiction where
you want to apply the law for purposes of the statute of
limitations.
I think we all agree with that.
We know that Pennsylvania says two years for purposes of
the statute of limitations, and here's where we start to
disagree.
the code in Washington for the estate provision because it's
clear -- I think we all agree that if we stick with the law
Because the first argument is:
Please look to
10
and you don't apply that estate provision, the punitive
11
damages claims are out of this case.
12
So the question is:
13
under 4.18.040?
14
needs to be resolved.
15
answer is no.
16
Should you apply the escape clause
I think that's the first question that

And I would suggest to you that the
And the reason for that, Judge, is, in my view, a -- it's
17
multifaceted, but this is a rare instance where I exactly
18
looked to the brief of my adversary.
19
Court's attention to page 11 where they say that you only
20
apply the estate provision in extreme cases if there is a
21
strong public policy to do so.
22
And I would invite the
And I think that if you just look at the facts of this
23
case, you can't get there.
And the reason you can't get
24
there is because the public policy here in this jurisdiction
25
is that you don't get punitive damages.
And the exception
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is, if you want to get away from that public policy, I will
let you go look somewhere else, but you got to follow their
rules.
And now what they're saying is:
We do want to go look
somewhere else but we don't want to follow that rule and
we're asking you to invoke an exception so that you could
allow something to happen that, by definition, is against
public policy here.
And if you look at all the cases they cite, every one of
10
them, where the court invoked that provision, it was to
11
promote a policy in this jurisdiction.
12
case here, Judge.
13
That wouldn't be the
That's Argument One.
Second argument with respect to that is that when you look
14
at that provision, the escape clause should only be if it
15
was unfair and if there is some substantial difference
16
between the two, and there really isn't.
17
I think it's mis-cited in the plaintiffs' brief, but it's
18
two years in Pennsylvania; it's three years in Washington.
19
Both jurisdictions recognize the doctrine of fraudulent
20
concealment.
In my view -- and
21
And I would submit to you that there is no substantial
22
difference and there is no unfairness following the rule of
23
law that exists here which says:
24
exception, follow the rule, look to Pennsylvania.
25
Don't invoke the
When you apply the facts to Pennsylvania, I think we all
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agree that the claim is barred by the statute of
limitations.
I just want to touch on fraudulent concealment for a
second because it's important.
It's raised in my
adversary's brief.
different than the discovery rule -- and the test is that
there was some independent act of concealment which the
plaintiffs justifiably relied upon.
their brief -- I think it's on page 12 if I'm not mistaken,
10
Judge -- the allegation is that there was an FDA report that
11
was delayed until July 31, 2009.
12
than coming from Synthes and Norian, the report came from
13
Dr. Chapman and the hospital and, therefore, that's the
14
triggering event.
The test for that -- it's obviously
And if you look at
And the report, rather
15
Well, even if that's true -- and there's no evidence --
16
there is no evidence in this record that Synthes knew that
17
there was some allegation that Norian caused the death in
18
2007 of Ms. Golden -- there's no evidence of that, Judge.
19
And the only evidence there is is that this report came out.
20
Well, that gets you to 2009, 2011.
21
until 2013.
22
The case wasn't filed
The next point that I wanted to make, Judge, is even if
23
you were to say:
All right, you know what, I'm going to
24
bend the rule, somehow I'm going to allow this to occur,
25
there can't be a claim for punitive damages here, and let me
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explain to you why.
your earlier questions.
And I think you touched on it in one of
The law in Pennsylvania is clear, and it's the Pioneer
case:
If no cause of action exists, the independent
action -- that there is no independent action for a claim
for punitive damages.
So even though it's pleaded as a claim in this case, if
you want to file Pennsylvania law, in Pennsylvania we would
file what's called a preliminary objection and we move to
10
strike it because it's not an independent cause of action.
11
So punitive damages are an element of damages.
12
cause of action exists?
13
Well, here we go again.
So what
When we moved for summary
14
judgment, we brought to your attention five instances where
15
we asked the plaintiffs in interrogatories and document
16
requests, as long as over a year ago, about what damages
17
they're pursuing.
18
claim, you have to pursue a claim for lost income or
19
earnings, for conscious pain and suffering, for medical
20
expenses, for burial and funeral expenses.
21
And we know that for a Survivor Act
Five times, Judge, five times they told us that they were
22
not pursuing damages for any of those claims.
23
And they're attached to our motion for summary judgment.
24
25
Five times.
And what happens when we -- when they realize that

punitive damages are an element of damages and there must be
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a cause of action, a light bulb goes off.
bulb is:
Survivorship Act because we told the other side five times
that we don't have any damages.
And the light
Holy smokes, we're not pursuing a claim under the
So what do they do?
They do exactly what I would
respectfully submit to you the law doesn't allow them to do.
Presto, on the day that they file their opposition to our
moving papers, they supplement their answers to
interrogatories and document requests.
10
And I just want to point this out, Judge.
Do you see
11
where they struck out the "14" and put "1st day of August,
12
2015"?
13
August wasn't the day that they gave us these responses.
14
These response were given to us over a year ago.
15
we took depositions.
16
that were being pursued, et cetera.
17
they told us in their document requests.
18
do is they add on a response where they tell us in an
19
interrogatory that their estimated costs and expenses
20
associated with in wrapping up Reba Golden's affairs -- we
21
don't know what that means -- a memorial service, et cetera,
22
but we ask for the documents.
23
Since then
We asked the parties about the damages

And they confirmed what
And now what they
They tell us in another supplemental response:
Documents
24
for the estimated cost and expenses associated with the
25
memorial service are being searched for and will be provided
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as they are found.
We still haven't gotten them.
THE COURT:
You wouldn't doubt there were burial costs,
though, would you?
MR. SMITH:
I don't.
THE COURT:
Yeah.
MR. SMITH:
I don't, Judge.
look at the Exterra case.
know.
But here's the thing, and I
There are rules of law, as we all
And we, as lawyers, are trained to follow them.
And
10
we adopt positions on behalf of our clients.
There are
11
consequences that come with it.
12
Exterra case where the court said, "Out of fairness to the
13
opponents, Exterra may not respond to discovery with one
14
version of the facts and then testify in response to a
15
summary judgment motion with contradictory facts.
16
Self-serving affidavits contradicting prior depositions
17
cannot be used to create an issue of material fact."
And I read to you from the
18
And then the court goes on to say, "The cited opinions
19
concern incongruous deposition testimony, not interrogatory
20
answers.
We discern no relevant difference between the two,
21
however.
Interrogatory answers are also given under oath
22
and may be used to impeach.
23
incongruous testimony rule to interrogatory answers.
24
deposition, the party has scant time to respond to a
25
question.
More reasons exist to apply the
A party has at least 30 days to reflect on an
In a
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2
interrogatory question before answering."

And what's happening here, Judge, just to crystalize it
for you is:
But for the answer -- the supplemental answer,
there is no claim because there is no basis for a
survivorship claim.
claim, if you apply Pioneer, the Pennsylvania case that we
brought to your attention, there is no punitive damages,
because punitive damages can't exist unless there's a claim.
And in order for them to have the claim, you would have to
It's out.
And because there is no
10
allow them to do what Exterra said you can't do.
So I would
11
respectfully submit to you, it's for those two reasons.
12
The first is, there's no -- enforce the public policy of
13
this jurisdiction by saying, you know what, we're following
14
a statute of limitations in Pennsylvania.
15
policy.
That's the
16
Two, even if you ignore that argument -- I sure as heck
17
don't want you to -- there is no claim here unless you allow
18
them to walk away from Exterra and the other cases that we
19
cited in our brief.
20
And unless you have questions, I will sit down, Judge.
21
THE COURT:
22
Thank
you.
23
Counsel?
24
MR. HANNULA:
25
Appreciate it.
Well, Your Honor, it appears that his
primary argument is that:
Well, they do have a survivor
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claim for funeral and burial expenses, but because they
didn't put it in their answer to interrogatories the first
time they have no right to amend it.
We can amend our answers to interrogatories.
still ongoing.
notice of the fact that Reba Golden died and she had funeral
and burial expenses.
8
9
And we absolutely do.

Discovery is
And I think the Court can take judicial
And so we have a claim under the Survivor Act.
I don't
think -- and I'm not sure exactly what he's referring to.
10
Usually what they're referring to is if someone answers
11
deposition questions in one way and then answers -- and then
12
in some sort of motion files an affidavit that is in
13
conflict with the deposition answers, then it might be
14
deemed -- you know, maybe portions of it would be stricken
15
or all of it would be stricken.
16
But that's not the question here, Your Honor.
17
claim.
18
and there is absolutely no prejudice to the defendant on the
19
basis that we have amended our answer to include burial and
20
funeral expenses, which candidly we probably should have
21
included before.
22
as Mr. Smith from Pennsylvania believes it to be.
23
24
25
We have amended our answer.
We have a
Discovery continues,
But Washington law is not nearly as harsh
And now I will go on with my argument.
Your Honor, there
are two issues to this motion.

The first is whether, under the survival statutes, the
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estate of Reba Golden has a claim for punitive damages under
Pennsylvania law to punish defendants for their outrageous
conduct separate and apart from any compensatory damages
claimed.
First, Your Honor, the law is clear that but for
Pennsylvania's strict application of its two-year statute of
limitations with no provision for discovery, Pennsylvania
would allow for a punitive damage claim in this case.
have cited a number of cases that currently stand for the
10
proposition that Pennsylvania law allows punitive damages
11
for survival claims.
12
We
In the case of Moyer vs. Phillips, this is a Pennsylvania
13
case cited along with other cases, the courts of
14
Pennsylvania have recognized that punitive damages are
15
consistent with the Survival Act and do survive.
16
damages additionally recoverable under the Survival Act are
17
for the pain and suffering of the decedent, the loss of
18
earnings, medical expenses, and in cases of death, funeral
19
and burial expense.
20
The
In the cases we have cited, Your Honor, it is clear that
21
punitive damages under Pennsylvania law are a separate
22
independent item of damages available to the estate of the
23
deceased tort victim.
24
damages that a victim would have had, had she survived, go
25
to the estate.
Under Pennsylvania law, the punitive
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The plaintiffs, in their discovery responses which were
attached to Harold Dodge's declaration, my co-counsel, set
forth the Estate of Reba Golden's claim for her funeral and
burial expenses.
Pennsylvania law is, in essence, exactly like Washington
law as it relates to claims of lost earnings and burial
expenses, et cetera, as being survival claims that survive
the death of the plaintiff and can be brought by the
personal representative.
10
That's the situation here.
Clearly, Your Honor, Pennsylvania law does allow recovery
11
of punitive damages in product liability cases.
And we have
12
cited the case of Daniels vs. Wyeth Pharmaceuticals.
13
don't think that's in dispute.
14
As we have set forth in our brief, Your Honor, though,
15
punitive damages are generally not available in Washington.
16
They may be awarded where the offending conduct occurs in
17
the state whose law permits punitive damages.
18
We have, in our brief, quoted at length the case of Singh,
19
S-I-N-G-H vs. Edwards Life Sciences.
The Singh case
20
involved facts similar to those in this case.
21
heart-monitoring device was defective, causing severe burns
22
to the patient's heart.
23
there was a flaw in the heart-monitoring device as early as
24
1998.
25
did not recall the product or warn the user.
In Singh, a
The California manufacturer knew
Even with this knowledge, the California manufacturer
The plaintiff
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was injured in 2004, and following an FDA investigation, the
product was recalled in 2006.
In deciding that punitive damages under California law
could be brought in Washington, the court stated, and I
quote -- the court of appeals stated, and I quote, "Even
though Washington has a strong policy against punitive
damages, it has no interest in protecting companies that
commit fraud."
A similar result was reached by the Federal District Court
10
for the Western District of Washington in the 2012 case of
11
Bryant vs. Wyeth Pharmaceutical.
12
involved alleged misconduct occurring in Pennsylvania by a
13
Pennsylvania corporate defendant, as is the case here.
14
court noted that different issues in the same case may be
15
governed by the laws of difference states.
16
stated, and I quote, "A court may be required to apply the
17
law of one forum to one issue, while applying the law of a
18
different forum to another issue in the same case."
As in our case, Bryant
The
The court
19
As in the Singh case, the court held that Pennsylvania
20
punitive damages law applied because the wrongful conduct
21
was centered at its corporate headquarters.
22
case, the facts are nowhere near as egregious as the facts
23
in the Golden case here, Your Honor.
In the Bryant
24
In the Bryant vs. Wyeth case, the issue was Wyatt's
25
failure to update breast cancer warnings on its PREMPRO
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label.
This was a drug that was approved for us by the FDA,
unlike the situation we have here.
the plaintiffs in the instant case based their punitive
damages claim almost entirely on conduct and omissions
committed by the Pennsylvania defendants in Pennsylvania,
where all decisions about manufacturing and marketing the
bone cements were made; where knowledge concerning the
danger to patients from the bone cements used in the human
spine was accumulated; where the decisions to proceed with
10
illegally promoting the bone cements for use in the human
11
spine were made; where the decisions to bypass FDA rules and
12
regulations to obtain approval for this device were made;
13
and where the Pennsylvania defendants were headquartered.
14
You Honor, the punitive damage claim in this case is
As in Singh and Bryant,
15
brought only against the defendants Synthes and its leader
16
Hansjorg Wyss and the four defendant corporate officers who
17
pled guilty and went to jail for illegally and unlawfully
18
promoting marketing and distributing Norian cement.
19
So the second issue the Court must decide on this motion
20
is whether, in the circumstances of this case -- because
21
Pennsylvania punitive law should, could and should apply in
22
this case under these facts.
23
must decide on this motion is whether in the circumstances
24
of this case, the difference between Pennsylvania's strict
25
two-year statute of limitations, which does not allow for
The second issue the Court
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discovery, and Washington's three-year statute of
limitations, which does allow extension of time for
discovery, is both substantial and unfair under RCW
4.18.040; justified in requiring the application of
Washington statute of limitations rather than Pennsylvania's
in the punitive damage claim.
When we look at these statutes, Pennsylvania is
substantially different than Washington and does not afford
these plaintiffs a fair opportunity to seek justice.
10
Court is aware and as we have briefed, Washington has
11
enacted the Uniform Conflict of Laws Limitation Act.
12
Act states, and I quote, "If the Court determines that the
13
limitation period of another state applicable under RCW
14
4.18.020 and 4.18.130 is substantially different from the
15
limitation period of this state and is not afforded a fair
16
opportunity to sue upon, or imposes an unfair burden in
17
defending against the claim, the limitation period of this
18
state applies."
19
As the
The
As stated in the official comments in the Uniform Act, the
20
section I just quoted provides an escape clause that will
21
enable the Court in extreme cases to apply Washington's
22
statute of limitation.
23
As we've set forth in our brief, the principal author of
24
the Uniform Conflict of Law Act was Dean Robert Leflar, who
25
has commented further on situations calling for the exercise
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of this escape clause.
Specifically identifying the
situations of the state's refusal to apply this discovery
rule, Dean Leflar states, and I quote, Your Honor, "Not all
jurisdictions, however, have adopted the discovery rule like
Pennsylvania.
running at the moment the tortious act was done, even though
the victim could do not know of the harmful consequences
until some later time, perhaps after the statutory period
had run.
In sum, the statute is deemed to begin
In these cases, the court of another state might
10
well find unfairness in the first state's accrual rule and
11
that it has not afforded a fair opportunity to sue upon the
12
claim."
13
Your Honor, this is the very case where the Court is
14
compelled to follow RCW 4.18.040 and apply Pennsylvania law
15
as to punitive damages but apply Washington's statute of
16
limitations to that claim.
17
Your Honor, if there was an extreme case where this should
18
be applied, it is the Golden case.
19
the egregious and outrageous conduct on the part of Synthes
20
that resulted in Reba Golden's death, but I would ask Your
21
Honor to keep in mind that Reba Golden was never told that
22
Norian cement was going to be injected into her spine.
23
After she died, her relatives were never told of it.
24
25
I will not again discuss
Synthes, Dr. Chapman and the University of Washington had

a duty to report Reba Golden's death and the fact that
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Norian cement could have been the cause of it within 30 days
of the date of her death, and that had to be provided to the
FDA.
July 30, 2009, almost two years later, the same day that
Joan Bryant's death was reported.
recall, died on July 6th of 2009.
Reba Golden's death was not reported to the FDA until
And Joan Bryant, if you
And Counsel has stated to this court that, well, Synthes
had no idea that Reba Golden died as a result of Norian
cement.
That is untrue.
The Synthes representative was in
10
the operating room at the time, and he has an absolute duty
11
to report the death if there is the possibility -- not
12
probability -- but possibility if the device involved could
13
have caused the death.
Synthes did not do so.
14
Again, Your Honor, until our investigator contacted the
15
Golden family in 2012, they had no idea that their mother
16
had been injected with Norian cement.
17
circumstances, where Synthes engaged in criminal conduct to
18
pursue an illegal test market to get Norian cement in the
19
spines of patients in this country without first following
20
all the rules and regulations required of them by the FDA,
21
those rules and regulations, as the Court is aware, were
22
established to protect patients from harm.
Under the
23
And knowing -- Synthes knowing that Norian cement posed
24
unreasonable risks of harm to patients but proceeded with
25
the illegal test market anyway, it would be grossly unfair
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for the Court in these circumstances to dismiss Plaintiffs'
punitive damage claim on the basis that Pennsylvania's harsh
two-year statute of limitation is applicable.
Your Honor, there were absolutely no circumstances wherein
Reba Golden or her children would have known that they had
viable claims against Synthes and the corporate defendants,
particularly where Synthes' course of conduct was
consciously designed to keep this information from patients
like Reba Golden and her family.
10
Again, Your Honor, this is an extreme case, and under
11
these circumstances, appreciating the outrageous and
12
criminal conduct of Synthes and its corporate defendants,
13
Defendants' motion to dismiss the punitive damage claim
14
should be denied.
15
16
THE COURT:
17
Counsel?
18
MR. SMITH:
Thank you, Judge.
A couple of points.
I want
19
to start with the right to amend.
There is a distinction,
20
and it's a different legal test between the right to amend
21
or supplement an answer or discovery and what your
22
obligations are in connection with opposing a motion for
23
summary judgment.
24
happened here is exactly what Exterra said shouldn't happen,
25
which is, you take a position, the other side relies upon
And we can't lose sight of fact that what
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that position, discovery gets taken, then a party moves for
summary judgment, and there is -- and I think we heard it --
an "oops" moment, and the "oops" moment is, oh, geez, if I
say this, then I can get around that motion.
And as I read these cases, Judge, in particular Exterra,
Exterra says you can't do that, you just can't.
So this is
not a question about being able to supplement an answer to
an interrogatory.
fundamentally change your position in a lawsuit in order to
This is a question about being able to
10
stave off a motion for summary judgment.
11
different situations, two totally different legal tests.
12
Point two.
13
case, Judge.
14
what happened in Singh is exactly what didn't happen here.
15
We came before this court saying, you know what, we're going
16
to assume the conflicts analysis, which hasn't been done
17
yet, we'll allow the application of Pennsylvania law for
18
purposes of this motion.
19
Singh.
Two totally
Singh has nothing to do with this
And I'm sure you've read Singh.
As you know,
Singh was about the application of the conflicts analysis.
20
We haven't even gotten to that question yet.
21
assuming, for purposes of today, that Pennsylvania law
22
controls and we say is barred by the statute of limitations.
23
So next point.
We're
I never heard an answer to the question
24
that I raised before Your Honor, which is the public policy
25
issue.
As I read the comments to the code, it says:
Court
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in exceptional extreme circumstances when we're fostering a
public policy of this jurisdiction, then you can invoke the
exception.
are no punitive damages.
every horrible thing, every horrible thing that we heard in
this courtroom today only happened in the state of
Washington, there would be no punitive damages, because
that's the public policy in this jurisdiction.
The public policy in this jurisdiction is there

So if -- whatever -- assuming
And what my adversary is saying is:
10
on its head and find a way around it.
11
law, Judge.
12
promote.
13
Let's turn that rule

And that's not the
That's not what that section was designed to
Next point.
Where has the plaintiff been?
If what
14
they're saying is true, and for purposes of my argument,
15
I'll assume it's true, that somehow Synthes had an
16
obligation on -- when Ms. Golden passed away to file a
17
report with the FDA.
18
if I recall the date correctly.
19
31st of 2009 that the hospital and Dr. Chapman filed a
20
report in connection with Ms. Bryant.
21
implication to that, then, is that got the meter running.
22
That was August of 2007.
Where have they been?
August 17th,
And it wasn't until July
And somehow the clear
What -- is there any evidence
23
before the Court that, first of all, Synthes did anything?
24
What you heard was that -- the unrefuted testimony from
25
Geskes is that they were monitoring off-label promotion and
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2
that there was none of it.

Remember, Judge, there is no question what happened here
in 2002 through 2004 was wrong.
before the federal judge and pleaded one of these companies
guilty to it.
the only evidence before the Court is that it stopped in
2004.
did the plaintiff do?
Court that they did anything?
I did.
I was the lawyer who stood
We're now talking about 2007.
And
And so from 2007 until 2013, almost six years, what

Is there any evidence before the
They just allowed time to
10
pass.
11
information to them, that they were misled in any way.
12
of that evidence is before you, Judge.
13
Pennsylvania law, which you should, this case is untimely --
14
or the claim for punitive damages, it's out.
15
There is no evidence that anybody provided false

None
And when you look to
So I would respectfully submit to you, Judge, that when
16
you apply the law here to these facts that the only
17
conclusion that you should get to is that the punitive
18
damages should be dismissed and, therefore, I would
19
respectfully request that the punitive damage claims against
20
all the defendants be dismissed in the case.
21
Thank you, sir.
22
THE COURT:
23
All right.
Counsel, thank you very much for your
24
argument.
Thank you very much for your briefing.
25
I've spent a lot of time on this case.
This case deserves a
Again,
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lot of time.
appreciate, though -- perhaps more than you know, I
appreciate your advocacy and I appreciate hearing very well
prepared lawyers.
enjoy leading reading novels, and it's my particular
affliction that I enjoy reading legal briefs.
appreciate that very much.
8
9
There's a lot of material here.
I appreciate your briefing.
And though I
Some people
So I
Now, there are a couple procedural motions pending, but I

have some tentative rulings on the motions to strike.
They
10
will likely be granted in part, but, again, I will have to
11
be giving you -- I will give them to you specific -- with
12
specificity because the record is very important as to what
13
I strike and what I don't strike.
However, the substance of
14
the attachments are not stricken.
The exhibits are not
15
stricken.
16
As to Mr. Hannula's declaration, the problem is,
17
essentially, that there's some argument that, you know,
18
included in the declaration, and the Court -- actually, the
19
Court is mindful there are at least a couple cases recently
20
discussing whether the court of appeals prefers that we not
21
strike portions of declarations or exhibits but simply rule
22
on objections because, essentially, the material still
23
should be before the appellate court in order to -- so they
24
appreciate what's actually before the trial court.
25
Court should simply make a record, at least in some of these
And the
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cases, make a record of what it's relying on and what it's
not relying on, as opposed to striking a reference.
But I'm not sure it makes a difference here, because I'm
trying to be clear about what I'm considering and what I'm
not considering.
Hannula's argument in his declaration.
contained in his brief.
about how we don't want backdoor overlength briefs.
but that doesn't affect, I don't think, the materiality or
I'm not going to be considering Mr.

His argument is
And so we had an earlier discussion

So --
10
the admissibility of the exhibits in Mr. Hannula's --
11
attached to Mr. Hannula's declaration.
12
Similarly, although there appear to be some objectionable
13
material in the two doctors' -- Plaintiffs' doctors'
14
declarations, I don't think the bulk of the material will be
15
stricken, but I will get you specific orders referencing
16
exactly what is and is not stricken from those declarations.
17
Now, let's take the third motion first.
We have first a
18
motion to dismiss the punitive damage claims.
And these
19
punitive damage claims are only made against certain
20
defendants, and I believe they are not made against the
21
medical defendants.
22
They're not made against the University of Washington.
23
And so this involves the discussion, of course, of
They're not made against the hospital.
24
Pennsylvania statute of limitations and Washington statute
25
of limitations.
Clearly, there are different statute of
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limitations.
I think the parties agree under Washington law
we have a three-year statute of limitations with a discovery
rule proviso.
two-year, strictly construed statute of limitations with no
discovery rule proviso.
substantive law which provides for punitive damages.
also have Washington substantive law, which obviously does
not allow for punitive damages.
And then under Pennsylvania law, we have a
And we also have a Pennsylvania

And we
So the question here is -- and under the Uniform Conflict
10
of Laws statute which has been codified under Washington --
11
under RCW 4.18.040, the statute of limitations of this state
12
providing substantive law here, Pennsylvania, is
13
significantly different than that of Washington's, as I
14
think has been agreed, and this court will find that it
15
would result in unfairness and injustice to the plaintiff if
16
we were to simply apply the two-year statute of limitations.
17
There is, again, no discovery rule on the two-year strict
18
Pennsylvania procedural law.
19
under Pennsylvania law is a survival claim and separate and
20
apart from compensatory damage claims.
21
the plaintiff has now asserted a factual basis, in other
22
words, funeral expenses, and asserted an economic damages
23
claim which, if allowed, would provide the basis for a
24
survival claim.
25
The punitive damage claim
And in either event,
Now, I read the Exterra case, and I'm usually familiar
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with a situation outlined by Mr. Hannula, that is that you
have a party taking a position in, for example, a
deposition, and he or she says the light was green.
then the opposing party files a motion for summary judgment
and the deponent ends up filing a declaration contradicting
the earlier deposition testimony, no, the light was red.
And that's a classic, clean situation that we usually
encounter and one which the court of appeals and the Supreme
Court in numerous cases, not just Exterra but numerous
10
11
And
cases, says that that is simply not allowed.

It's a little bit different situation when you have a
12
deposition -- or excuse me, interrogatory answers, which --
13
and particularly different if we are still -- we are not at
14
the close of discovery, we are still within the discovery
15
period in which discovery responses are fluid.
16
Court cannot find any prejudice here in allowing the
17
plaintiff to amend the discovery responses.
18
again, ample discovery time left over.
19
stretch of the imagination for anybody to think that a
20
Plaintiff estate -- or excuse me, it's not a stretch to
21
imagine -- to imagine that anyone would have funeral
22
expenses if they died.
23
And the
There's still,
And it is not a
So this court will deny the motion for summary judgment on
24
punitive damages, and the Court will allow the punitive
25
damage claim to proceed against certain defendants, so that
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2
3
is the third motion first.

The second motion is, and I'm going to mispronounce his
name again.
Could you help me again, please?
MR. BORANIAN:
THE COURT:
Mr. Hansjorg Wyss.
Wyss.
Mr. Wyss's motion for summary judgment,
which encompasses four subparts.
And so I'm going to simply
just rule in context.
as to the punitive damage claims is denied.
ruling in a moment on his motion for summary judgment on
Obviously, his joinder as to the -Now, I will be
10
Counts 10 and I believe 11, but let's talk about the tort of
11
outrage portion of his motion, which relates to Count No. --
12
I believe it is 11.
13
The tort of outrage is a specific cause of action.
And
14
it, again, is different from the outrageous conduct that
15
could be proven in order to establish punitive damages, and
16
I think we have established that it's a separate analysis,
17
so regardless of what the Court does on the tort of outrage
18
claim, it's a separate analysis to determine whether
19
outrageous conduct -- evidence of outrageous conduct is
20
admissible to prove punitive damages under Pennsylvania law.
21
So let's be clear about that.
22
But the tort of outrage has some very specific legal
23
requirements, and it's not enough to say that the conduct
24
was, in and of itself, outrageous.
25
understanding, something is outrageous.
I mean, that's a lay

And Mr. Hannula has
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certainly identified activity which, if found by a jury,
could support a finding that something was outrageous, but
that's not the legal -- the end of the legal test.
under Washington law, the party making the tort of outrage
claim has to be present at the time of the outrageous
conduct.
the time of the operation.
they were not present at the time of the alleged outrageous
conduct, which appears to be -- and I will have some further
10
observations on this -- which appears possible the operation
11
itself, the use of the cement and the actual surgery itself.
12
So since they weren't present, under Washington law they
Because,
And clearly, these claimants were not present at

They were not -- in other words,
13
cannot assert a claim for the tort of outrage.
And the
14
Washington State Supreme Court has been given the
15
opportunity to expand this doctrine on numerous occasions,
16
and so far they have declined to accept the invitation to
17
expand that doctrine.
18
doctrine, but Washington has not.
Other states have expanded that
19
There is an interesting factual twist to this particular
20
case, which I don't know that makes a difference ultimately,
21
but there is an allegation that part of the outrageous
22
conduct was actually done in the presence of some of the
23
children, in the context of that they attended some of the
24
pre-operative meetings, some of the meetings with the doctor
25
to discuss the surgery itself.
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And so there is an interesting argument to be made that,
well, that portion of the alleged outrageous conduct
occurred in their presence.
However, the touchstone of this claim is that the cement
was actually used in the surgery itself.
If, for example,
the children had attended these conferences and the surgery
had never occurred, there would not be a cause of action.
There would be no damages, no causation, nothing.
actual surgery occurred, I'm not seeing how this could be
Until the
10
served as a factual basis for the tort of outrage.
And
11
since they weren't present at the time of the surgery and
12
since this is not a terrorism case, the Court will grant
13
summary judgment on the tort of outrage for each defendant
14
against which that cause of action is asserted.
15
Now, let's turn to the first motion, with the
16
understanding that Mr. Wyss has also moved for summary
17
judgment on this motion.
18
determinative as to the claim against him for leading a
19
criminal enterprise as well, but this turns on the
20
resolution of the first motion brought by Dr. Chapman and
21
the University of Washington for partial summary judgment,
22
and that is a motion to dismiss the Criminal Profiteering
23
Act Claim under Count No. 9.
24
25
And also, obviously, it would be
Again, Synthes has joined this particularly motion.

Again, Dr. Wyss has joined this particular motion as well.
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First, the Court -- I spent a lot of time on reading and
rereading -- I think I told you, rereading the statute.
I have to say I will find that the plaintiffs'
interpretation of the Criminal Profiteering Act five-year
period is the correct interpretation.
would be to -- would lead to absurd results and actually end
up immunizing or punishing less more culpable individuals
and corporations, and I don't think that the legislature
would ever intend those kinds of results.
10
And
To hold otherwise
Now, as to the issue of intent, the Court will find that
11
there are genuine issues of material fact whether the --
12
whether the consent was given to a different procedure than
13
the one performed due to the different kind of cement used.
14
The fact that the consent was given to surgery generally
15
does not -- is not conclusive and does not end the inquiry.
16
Obviously, the Cobbs case has been cited to us, but there
17
are others as well.
And normally consent is a question for
18
the jury.
19
decide whether it would have made a difference to the scope
20
of the consent whether it would have been disclosed that it
21
was this cement versus that cement, whether there was other
22
types of considerations involved from the doctor's
23
standpoint.
24
Court will find that it is a jury question in this
25
particular case.
This court will find it's up to the jury to
This is a jury question typically, and the
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Similarly, as to the length of time of the alleged -- that
the alleged criminal enterprise occurred.
Again, it's -- we
look not only at direct evidence but circumstantial
evidence.
light most favorable to the nonmoving party, and
circumstantial evidence of alleged duration of criminal
profiteering activity can be used.
all inferences must be made in favor of the nonmoving party,
the Court will deny the motion for summary judgment relating
The Court is required to view the evidence in the
And given the fact that
10
to the Criminal Profiteering Act claim, and obviously then
11
will deny Dr. Wyss's motion for leading organized claim --
12
dismiss the leading organized claim in Count No. 10.
13
14
15
Counsel, do you wish to prepare orders separately, or do

you want to try to do that today before you leave?
MR. BORANIAN:
Your Honor, I would suggest that we would
16
prepare it, circulate an order and get it to you sometime
17
next week.
18
MR. HANNULA:
You Honor, I have orders denying summary
19
judgment on the issues of punitive damages and on the issue
20
of the criminal profiteering and would ask that, you know, I
21
can have -- I've got copies for every one of them but, you
22
know, it is late and I respect the Court's time.
23
24
25
MR. BORANIAN:
Your Honor, we don't know whether they
include all of the pleadings that were considered -THE COURT:
Right, okay.
Counsel, let's go ahead and
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circulate them.
MR. HANNULA:
THE COURT:
All right, Your Honor.

Get them to me, again, the formal order by
next -- in a week.
MR. HANNULA:
THE COURT:
We will, Your Honor.

And if you disagree, you send in your version
and you send in your version, okay?
want you to incur any more costs coming down here than need
to be, so you send me the material.
10
Counsel, thank you very much.
All right.
So I don't
Counsel, my assumption is
11
that this may be one of the last times I see you.
12
likely be seeing Judge Rogers from now on, so I appreciate
13
all of your hard work.
14
MR. HANNULA:
15
THE COURT:
Thank you.
16
THE CLERK:
All rise.
17
You will
Thank you.
The Court is in recess.
(Conclusion of hearing.)
18
19
20
21
22
23
24
25
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C E R T I F I C A T E
2
3
STATE OF WASHINGTON
4
5
)
)
COUNTY OF SNOHOMISH
6
7
I, the undersigned, do hereby certify under penalty
of perjury that the foregoing court proceedings were transcribed
under my direction as a certified transcriptionist; and that the
10
transcript is true and accurate to the best of my knowledge and
11
ability, including any changes made by the trial judge reviewing
12
the transcript; that I received the audio and/or video files in
13
the court format; that I am not a relative or employee of any
14
attorney or counsel employed by the parties hereto, nor
15
financially interested in its outcome.
16
17
18
19
IN WITNESS WHEREOF, I have hereunto set my hand this

4th day of November, 2015
20
21
22
23
24
Marjorie Jackson, CETD
25
206.624.3005
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Hearing on Motions

October 30, 2015

Personal Representative of the Estate

of Reba Golden, Deceased, and on behalf

) No. 13-2-29535-1 SEA

of Statutory Beneficiaries VICTORIA

MARINCIN and PAUL D'OYLEY; and VICTORIA

MARINCIN and PAUL D'OYLEY; Individually,

Jens R. Chapman, M.D., et al.

Reed Jackson Watkins, LLC

Reed Jackson Watkins Court Certified Transcription

Electronically signed by Marjie Jackson (601-293-514-5743)

October 30, 2015

Counsel for Plaintiffs:

HAROLD THADDEUS DODGE, JR

Rush Hannula Harkins & Kyler

4701 South 19th Street, Suite 300

Tacoma, Washington 98405-1177

Counsel for Defendant Hansjorg Wyss:

101 Second Street, Suite 1800

San Francisco, California 94105

Counsel for Defendant Jens Chapman, M.D.

Fain, Anderson, Van Derhoef, Rosendahl, O'Halloran, Spillane

1301 "A" Street, Suite 900

Reed Jackson Watkins Court Certified Transcription

Electronically signed by Marjie Jackson (601-293-514-5743)

October 30, 2015

Counsel for Defendants Huggins, Higgins, Bohner, and Walsh:

Steptoe & Johnson, LLP

633 West Fifth Street, Suite 300

Los Angeles, California 90071

Counsel for Defendants State of Washington, et al.:

Bennett, Bigelow & Leedom, P.S.

1700 Seventh Avenue, Suite 1900

Seattle, Washington 98101

Counsel for Defendants Synthes, Inc., Norian

Betts, Patterson & Mines, P.S.

701 Pike Street, Suite 1400

Seattle, Washington 98101-3927

Corp., and Kensey

Blank Rome, LLP

130 North 18th Street

Philadelphia, Pennsylvania 19103-6998

Reed Jackson Watkins Court Certified Transcription

Electronically signed by Marjie Jackson (601-293-514-5743)

October 30, 2015

October 30, 2015

Thank you, please be seated.

Good afternoon, Your Honor.

We're being recorded.

have a court reporter here, but we're on the recording

Let's go ahead and have counsel enter their appearances

Your Honor, my name is Dan Hannula, one of

the attorneys for the plaintiff.

Harold Dodge, Your Honor, one of the attorneys

for the plaintiff.

Excuse me, Your Honor.

John Rosendahl for

Good afternoon, Your Honor.

Boranian for Defendant Hansjorg Wyss.

Good afternoon, Your Honor.

Jim Smith for

Synthes and Norian.